News & Insights
Kevzara phase III U.S. trial in COVID-19 patients does not meet endpoints. Sanofi + Regeneron
Sanofi and Regeneron Pharmaceuticals, Inc. announced that the . Phase III trial of Kevzara (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo).
FDA approves Dojolvi for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders. _Ultragenyx.
Ultragenyx Pharmaceutical Inc. announced that the FDA has approved Dojolvi (triheptanoin) as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
Favourable topline results reported from innovaTV 204 trial of tisotumab vedotin for cervical cancer.- Seattle Genetics + Genmab AS
Genmab announced very favorable topline results from the Phase II single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer.
Udenafil filed with FDA for single ventricle heart disease.- Mezzion Pharma
Mezzion Pharma has submitted a New Drug Application (NDA) to the FDA for udenafil to improve the physiology of patients aged at least 12 years with single ventricle heart disease (SVHD) who have undergone the Fontan operation.
Phase III trial of SB 393 plus Vidaza in acute myeloid leukaemia discontinued.- Helsinn + MEI Pharma
Helsinn and MEI Pharma have discontinued a Phase III trial of SB 393 (pracinostat) in combination with Vidaza (azacitidine) in patients with acute myeloid leukaemia (AML) who are unsuitable for standard intensive chemotherapy.
Hansa BioPharma licences Sarepta to develop imlifidase as a potential pre-treatment prior to the administration of gene therapy for muscular dystrophy patients.
Hansa Biopharma the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that it has entered into an agreement with Sarepta Therapeutics Inc., the leader in precision genetic medicine for rare diseases, through which Sarepta is granted an exclusive, worldwide license to develop and promote imlifidase as a pre-treatment to enable Sarepta gene therapy treatment in Duchenne muscular dystrophy (DMD) and Limb-girdle muscular dystrophy (LGMD).
scPharmaceuticals Inc. has resubmitted its NDA to the FDA for Furoscix for the treatment of congestion in patients with heart failure.
scPharmaceuticals Inc. announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the FDA seeking approval of Furoscix (subcutaneous furosemide) for the treatment of congestion in patients with heart failure.
RM 493 filed with MAA for pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.- Rhythm Pharma
Rhythm Pharmaceuticals announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for RM 493 (setmelanotide) for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
FDA approves Bavencio as first line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma
Merck and Pfizer Inc.have announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Bavencio (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
European Commission has granted marketing authorization for Mvabea + Zabdeno vaccine regimen for treatment of Ebola.- Janssen Vaccines + Bavarian Nordic.
Bavarian Nordic A/S announced that the European Commission has granted marketing authorization for Mvabea (MVA-BN Filo) together with Zabdeno (Ad26.ZEBOV), which collectively constitute Janssen’s Ebola vaccine regimen.
Preliminary data shows that BNT 162b1 is safe and immunologically active in COVID-19.- Pfizer and BioNTech
Pfizer and BioNTech announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT 162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2.
Ibsrela filed with FDA for hyperphosphatemia in adult patients with chronic kidney disease on dialysis.- Ardelyx
Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic kidney disease (CKD) on dialysis.
Two phase I studies of INO 4800 report safety in COVID-19.- Inovio
Inovio has announced positive interim clinical data of INO 4800 vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase I clinical trial cohorts. In addition, INO 4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine by January 2021.
EU approves Daurismo for acute myeloid leukemia.- Pfizer
Pfizer announced that the European Commission approved Daurismo (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly diagnosed (de novo or secondary) acute myeloid leukemia (AML) in adult patients who are not candidates for standard chemotherapy.
CONNECT-FX study of Zygel fails to meet endpoints in Fragile X syndrome.- Zynerba Pharma
Zynerba Pharmaceuticals announced top line results from the 14-week pivotal CONNECT-FX study of Zygel (cannabidiol) which assessed its efficacy and safety as a treatment in for behavioral symptoms of Fragile X syndrome (FXS) in 212 patients. Zygel did not achieve statistical significance versus placebo in the primary endpoint of improvement in the Social Avoidance subscale of the Aberrant Behavior Checklist – Community FXS (ABC-CFXS).
Complete Response Letter for HTX 011 as a treatment for postoperative pain.- Heron Therapeutics.
Heron Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the FDA on June 26, 2020 regarding its New Drug Application (NDA) for HTX 011 for the management of postoperative pain.
Complete Response Letter for obeticholic acid for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).- Intercept Pharmaceuticals
Intercept Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).
EU approves Ultomiris for patients with atypical hemolytic uremic syndrome.- Alexion Pharma
Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children with a body weight of 10 kg or above with atypical hemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received Soliris (eculizumab) for at least three months and have evidence of response to eculizumab.
FDA approves Phesgo for HER2-positive breast cancer.- Genentech/Roche
The FDA has approved Phesgo (pertuzumab + trastuzumab + hyaluronidase–zzxf), from Genentech/Roche, for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer.
FABOLUS-FASTER Phase IV trial of Aggrastat in acute coronary syndrome published in Circulation.- Medicure
Medicure announced that results from the investigator sponsored FABOLUS-FASTER Phase IV clinical trial, using Aggrastat (tirofiban) in acute coronary syndrome, have been published in Circulation, a peer-reviewed journal of the American Heart Association.
Phase III RHAPSODY trial of rilonacept meets endpoints in pericarditis.- Kiniksa Pharma
Kiniksa Pharmaceuticals announced that the Phase III RHAPSODY trial showed that rilonacept achieved its primary and all major secondary efficacy endpoints in patients with recurrent pericarditis. Results show that prespecified primary and all major secondary efficacy endpoints were highly statistically significant.
CPP 1X/sul filed with FDA and MAA for treatment of adults with familial adenomatous polyposis.- Cancer Prevention Pharma
Cancer Prevention Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for CPP 1X/sul for treatment of adults with familial adenomatous polyposis (FAP).
RAUORA phase III trial of cytisinicline shows non-inferiority to Chantix in smoking cessation.- Achieve Life Sciences
Achieve Life Sciences announced the successful topline results from the New Zealand RAUORA Phase III non-inferiority clinical trial comparing cytisinicline to Chantix (varenicline) in Maori (indigenous New Zealanders) and whanau (family) of Maori.
UK approves phase II/III study evaluating Yeliva in patients hospitalized with severe SARS-CoV-2 infection.- RedHill Biopharma
RedHill Biopharma Ltd. announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company’s Clinical Trial Authorization application to commence a Phase II/III study evaluating Yeliva (opaganib) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia.
Abbott's optical coherence tomography imaging changed treatment decisions in 88% of artery blockages.
Abbott announced new data from the company's LightLab Initiative that showed optical coherence tomography (OCT) imaging significantly changes how physicians decide to treat a vessel compared to traditional angiography by providing physicians improved visualization within a patient's blood vessels.
CHMP recommends Gencebok for the treatment of primary apnoea of premature newborns.- Gennisium Pharma
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gencebok, intended for the treatment of primary apnoea of premature newborns.
Phase III LOTUS study of Stelara in Systemic Lupus Erythematosus discontinued.- Janssen Pharma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced its decision to discontinue the Phase III LOTUS study of Stelara (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to lack of efficacy in SLE.
CHMP recommends Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.. Hansa BioPharma
Hansa Biopharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of Idefirix (imlifidase) for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
CHMP recommends Aybintio, a bevacizumab biosimilar.-Samsung Bioepis + Merck Inc.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Aybintio, intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
CHMP recommends Livogiva, a teriparatide biosimilar for the treatment of osteoporosis. Alvogen
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Livogiva ( formerly PF 708 and Bonsity in the US), intended for the treatment of osteoporosis.
CHMP negative for Turalio, a medicine intended for the treatment of tenosynovial giant cell tumour.- Plexxikon/Daiichi Sankyo
The European Medicines Agency has recommended the refusal of the marketing authorisation for Turalio, a medicine intended for the treatment of tenosynovial giant cell tumour from Plexxicon/Daiichi Sankyo.
CHMP recommends approval of Veklury for COVID-19 (novel coronavirus).- Gilead Sciences
The EU Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Veklury (remdesivir), from Gilead Sciences, intended for the treatment of (SARS-CoV-2), a novel coronavirus causing a respiratory illness designated as coronavirus disease 2019, or COVID-19.
CHMP recommends approval of Qutavina teriparatide biosimilar for osteoporosis.- EuroGenerics Holdings
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Qutavina (teriparatide), from EuroGenerics Holdings, intended for the treatment of osteoporosis.
EU recommends change to marketing authorisation for Epclusa in chronic hepatitis C virus infection.- Gilead Sciences
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Epclusa (sofosbuvir + velpatasvir), from Gilead Sciences in chronic hepatitis C virus (HCV) infection.
CHMP recommends extending the indication for Remsima SC to include Crohns disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.- Celltrion Healthcare
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Remsima ((CT-P13 SC, biosimilar infliximab) from Celltrion Healthcare Hungary Kft.
FDA approves Mycapssa for long-term maintenance treatment in acromegaly patients.- Chiasma Inc.,
Chiasma, Inc. announced that the FDA approved Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
CSL Behring to acquire global license rights to adeno-associated virus gene therapy program, AMT 061 for hemophilia B from uniQure.
CSL Behring announced that it has agreed to acquire exclusive global license rights to commercialize an adeno-associated virus (AAV) gene therapy program, AMT 061 (etranacogene dezaparvovec), for the treatment of hemophilia B from uniQure , a leading gene therapy company.
Elocta gains increased access for people with haemophilia A in the UK.- SOBI
Through an agreement with National Health Service (NHS) and Sobi,( Swedish Orphan Biovitrium) people living with haemophilia A in the United Kingdom will have increased access to Elocta (efmoroctocog alfa) following a successful bid in the United Kingdom's haemophilia A tender.
European Commission approves Reblozyl to treat myelodysplastic syndromes and transfusion-dependent anemia associated with beta thalassemia.- BMS + Acceleron Pharma
Bristol Myers Squibb and Acceleron Pharma Inc. announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of: 1. Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.
CHMP recommends Xolair an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps.- Novartis
Novartis has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Xolair (omalizumab) as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps (CRSwNP), for whom therapy with INC does not provide adequate disease control.
CHMP positive for treatment of plaque psoriasis with Cosentyx in children and adolescents aged 6 to <18 years.- Novartis
Novartis, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to <18 years.
CHMP grants positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination With Kalydeco (ivacaftor) in people ages 12 and older With Cystic Fibrosis with the most common genotypes.- Vertex
Vertex Pharmaceuticals Incorporated announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Kaftrio -(ivacaftor/tezacaftor/elexacaftor) in a combination regimen with Kalydeco (ivacaftor) 150 mg to treat people with cystic fibrosis (CF) ages 12 and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Operation Warp Speed to test first oral COVID-19 vaccine in non-human primates.- Vaxart
Vaxart, Inc., a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced that its oral COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans by January 2021.
Complete Response for abicipar pegol to treat neovascular (wet) age-related macular degeneration. Allergan/AbbVie + Molecular Partners .
Allergan, an AbbVie Company and Molecular Partners a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin therapeutics, announced that the FDA has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD).
Positive results from second phase III study evaluating once-daily relugolix combination therapy in women with endometriosis.- Myovant Sciences.
Myovant Sciences announced top-line results from SPIRIT 1, the second of two Phase III studies of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis.
Adial Pharmaceuticals commences ONWARD trial of AD 04 as a therapeutic agent for the treatment of alcohol use disorder.
Adial Pharmaceuticals, Inc. announced that it has opened clinical trial sites and is recruiting trial subjects in Latvia after receiving all necessary approvals to commence the landmark ONWARD pivotal Phase III clinical trial in Latvia , including from the State Agency of Medicines of the Republic of Latvia and the Latvian Central Ethics Committee.
FDA approves Keytruda to treat cutaneous squamous cell carcinoma that is not curable by surgery or radiation.- Merck Inc.
Merck announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
La Jolla Pharmaceutical Company acquires Tetraphase Pharmaceuticals and with it Xerava
La Jolla Pharmaceutical Company, which is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, and Tetraphase Pharmaceuticals, Inc. , a biopharmaceutical company focused on commercializing its novel tetracycline Xerava to treat serious and life-threatening infections, announced that they have entered into a definitive merger agreement.
FDA grants accelerated approval for Xpovio to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Karyopharm Therapeutics.
Karyopharm Therapeutics Inc.announced that the FDA has approved oral Xpovio (selinexor), the Company’s first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
Fulcrum THerapeutics initiates phase III trial of losmapimod to treat COVID-19.
Fulcrum Therapeutics, Inc. announced that it received early notification from the FDA that the company may proceed with initiating a Phase III, randomized, double-blind, placebo-controlled trial of losmapimod in higher risk hospitalized adults with COVID-19. Losmapimod is an orally available selective p38/mitogen activated protein kinase (MAPK) inhibitor.
FDA grants emergency use authorisation for GenePro SARS-CoV-2 Test as diagnostic for COVID-19.- Gencurix
Gencurix has received FDA Emergency Use Authorization for its GenePro SARS-CoV-2 Test. It is the second RT-PCR test that Gencurix has launched following the first test assay, GenePro COVID-19 Detection Test released last March.
Phase III RECOVER analysis of Sublocade shows two-year outcome in opioid use disorder.- Indivior
Indivior has announced new data from the two-year phase III analysis of the 24-month real-world observational study, RECOVER in individuals with moderate to severe opioid use disorder (OUD) following their transition from two Phase III clinical trials of Sublocade (buprenorphine extended-release) injection, for subcutaneous use (CIII) into a real-world setting.
Breztri Aerosphere significantly reduced rate of moderate or severe COPD exacerbations in phase III ETHOS trial.- AstraZeneca
Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
First patient enrolled in Sanofi’s phase III trial of SAR 442168 in relapsing multiple sclerosis.- Sanofi
Principia Biopharma Inc. announced that the first patient has been enrolled in its partner Sanofi’s Phase III clinical trial of SAR 442168 in patients with relapsing multiple sclerosis (RMS).
Health Canada approves Kynmobi for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease .- Sunovion
Sunovion Pharmaceuticals Inc. announced on 15 June 2020 hat Health Canada has approved Kynmobi (apomorphine HCI) soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD). OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa.
FDA approves Ilaris to treat adult onset Still’s disease - Novartis
The FDA approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Gilead Sciences gains an interest in Pionyr Immunotherapeutics
Gilead Sciences, Inc. announced that for $275 million the company will acquire a 49.9 percent equity interest in Pionyr Immunotherapeutics Inc., a privately held company developing first-in-class cancer immunotherapies, and an exclusive option to purchase the remainder of Pionyr.
Health Canada approves Qinlock for advanced gastrointestinal stromal tumor.- Deciphera Pharma
Deciphera Pharmaceuticals announced that Health Canada has authorized Qinlock (ripretinib), a switch-control tyrosine kinase inhibitor, for sale in Canada for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib.
FDA accepts NDA for oral relugolix for treatment of advanced prostate cancer.- Myovant Sciences
Myovant Sciences announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the FDA.
Phase III studies of V 114 meet objectives in pneumococcal disease.- Merck Inc
Merck Inc announced results from two initial Phase III studies evaluating the safety, tolerability and immunogenicity of V 114, the company’s investigational 15-valent pneumococcal conjugate vaccine for pneumococcal disease.
Publication of early patient experience with the UroLift System as a superior treatment to Rezum Steam Injection in patients with enlarged prostate.Teleflex Incorporated
Teleflex Incorporated announced the publication of data from a study comparing patient experience of those treated with the UroLift System for benign prostatic hyperplasia (BPH) to those who received the Rezum steam injection.
FDA approves Gimoti to treat gastroparesis- Evoke Pharma Inc.
Evoke Pharma, Inc. a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, announced that the FDA has approved the New Drug Application (NDA) for Gimoti (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
FDA grants accelerated approval for Tazverik to treat follicular lymphoma. Epizyme Inc.
Epizyme, Inc. announced that the FDA has approved the supplemental New Drug Application (sNDA) for Tazverik (tazemetostat) for the following two distinct follicular lymphoma (FL) indications:1. Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Initiation of phase I trial of COVID-19 S-Trimer vaccine (SCB-2019).- Clover Biopharmaceuticals + GSK
Clover Biopharmaceuticals announced the initiation of a Phase I clinical study evaluating the company’s COVID-19 S-Trimer vaccine (SCB-2019) in combination with GSKs pandemic adjuvant system.
First participants dosed in Phase I trial of SCB 2019 vaccine + TLT 9 for COVID-19. Dynavax + Clover Biopharmaceuticals.
Dynavax Technologies announced that the first participants have been dosed in the Phase I clinical trial to evaluate Clover Biopharmaceuticals’ vaccine candidate to prevent COVID-19 that contains the Company’s CpG 1018 adjuvant. In this previously announced collaboration, Clover is advancing its COVID-19 S-Trimer vaccine (SCB 2019), which is based on Clover’s proprietary Trimer-Tag vaccine technology platform, while Dynavax is providing the Company’s proprietary toll-like receptor 9 (TLR 9) agonist adjuvant, CpG 1018.
Ridgeback Biotherapeutics announces the launch of two phase II clinical trials to test the efficacy of EIDD 2801 as an anti-viral treatment for COVID-19.Merck Inc.
Ridgeback Biotherapeutics announces the launch of two Phase II clinical trials to test the efficacy of EIDD 2801 as an anti-viral treatment for COVID-19.
Positive results from randomized controlled trial of CP1 01, an oral microbiome drug, for the prevention of recurrent C. difficile infection.-Finch Therapeutics Group
Finch Therapeutics Group, Inc. announced positive topline results from PRISM3, its multi-center, randomized, double-blind, placebo-controlled Phase II trial of CP 101 , an investigational oral microbiome drug, for the prevention of recurrent C. difficile infection (CDI).
FDA provides complete response letter for resubmission of Contepo in complicated urinary tract infections.- Nabriva Therapeutics
Nabriva Therapeutics has received a Complete Response Letter from the FDA for the New Drug Application (NDA) resubmission seeking marketing approval of Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis. Although Nabriva’s European contract manufacturing partners were prepared for regulatory authority inspections, the CRL cites observations at our manufacturing partners that could not be resolved due to FDA’s inability to conduct onsite inspections because of travel restrictions.
Phase III IPATential150 study with RG 7440 plus Zytiga meets co-primary endpoint in prostate cancer.- Genentech/Roche
Genentech/Roche announced that the Phase III IPATential150 study with RG 7440 (ipatasertib) plus Zytiga (abiraterone) plus prednisone met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumors had PTEN loss.
EMPERIAL-Reduced and EMPERIAL-Preserved trials of Jardiance shows efficacy in chronic heart failure.- Boehringer + Eli Lilly
Boehringer and Eli Lilly announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to exercise ability and symptom improvement with Jardiance (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively.
Brukinsa MAA validated by EMA to treat Waldenström’s macroglobulinemia .- BeiGene
BeiGene, Ltd. announced that its marketing authorization application (MAA) for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA).
FDA approves Crysvita for the treatment of fibroblast growth factor 23 -related hypophosphatemia in tumor-induced osteomalacia (TIO) Ultragenyx + Kyowa Kirin Co., Ltd.
Ultragenyx Pharmaceutical Inc.and Kyowa Kirin Co., Ltd. announced that the FDA has approved Crysvita (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older.
Emgality demonstrates reduction in frequency, duration, and pain severity in patients with episodic and chronic migraine.- Eli LIlly
Emgality (galcanezumab-gnlm) reduces total pain burden in a recent analysis of patients with episodic and chronic migraine. Total pain burden is a patient-centric measure that combines the monthly frequency, duration, and pain severity of migraine.
Keytruda is now approved for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) mutations/megabase] solid tumors.- Merck inc.
Merck Inc., announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [ greater than 10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
FDA approves Cosentyx to treat active non-radiographic axial spondyloarthritis.- Novartis
Novartis, announced that the FDA has approved Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum.
FDA gives accelerated approval to Zepzelca for the treatment of metastatic small cell lung cancer. Jazz Pharma + PharmaMar
Jazz Pharmaceuticals plc announced along with its partner PharmaMar that the FDA approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Verzenio significantly reduced the risk of cancer returning in people with high risk HR+, HER2- early breast cancer.- Eli Lilly
Eli Lilly and Company announced Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone.
Sanofi’s avalglucosidase alfa shows clinically meaningful improvement in critical manifestations of late-onset Pompe disease.
Sanofi’s investigational enzyme replacement therapy (ERT), avalglucosidase alfa, showed clinically meaningful improvement in critical manifestations (respiratory impairment and decreased mobility) of late-onset Pompe disease (LOPD) according to results from the Phase III trial presented at a Sanofi-hosted scientific session.
Phase III VERTIS CV trial with Steglatro meets endpoint in type 2 diabetes + CV.- Merck Inc and Pfizer
Merck Inc and Pfizer announced the presentation of results from the Phase III VERTIS CV cardiovascular (CV) outcomes trial that evaluated Steglatro (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, versus placebo, added to background standard of care treatment, in more than 8,200 patients with type 2 diabetes and atherosclerotic CV disease across 531 centers in 34 countries.
FDA approves Lyumjev (insulin lispro-aabc injection), a new rapid-acting insulin.- Eli Lilly
The FDA has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company's new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.
Lilly begins a phase III clinical trial with baricitinib for hospitalized COVID-19 patients.
Eli Lilly and Company announced that the first patient has been enrolled in a Phase III randomized, double-blind, placebo–controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19 .
FDA approves Semglee an insulin glargine injection biosimilar for types 1 and 2 diabetes.- Mylan + Biocon
Mylan N.V. and Biocon Ltd. announced that the FDA has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.
Phase III BEST trial of THR 1442 shows efficacy in type 2 diabetes with CV risk.- Theracos
Phase III BEST trial data shows that THR 1442 (bexagliflozin) from Theracos, lowers weight, blood pressure and glycated haemoglobin (HbA1c) relative to placebo in patients with type 2 diabetes at high risk for cardiovascular (CV) events.
Results from phase II ACE-CL-001 trial and Phase III ASCEND trials shows long-term efficacy of Calquence in chronic lymphocytic leukaemia.- AstraZeneca
Detailed results from both the Phase II ACE-CL-001 trial and the pivotal Phase III ASCEND trial showed the long-term efficacy and tolerability of Calquence (acalabrutinib), from AstraZeneca, in chronic lymphocytic leukaemia (CLL), one of the most common types of adult leukaemia.
FreeStyle Libre system associated with reduction in HbA1c levels for type 2 diabetes.- Abbott
Abbott announced new late-breaking data demonstrating use of its FreeStyle Libre system, continuous glucose monitoring (CGM) technology, is associated with significant reduction in hemoglobin A1c (HbA1c) levels for people living with type 2 diabetes on either long-acting insulin or non-insulin therapy.
Zealand Pharma presents clinical and non-clinical evidence for dasiglucagon rescue therapy at the 80th Scientific Sessions of the American Diabetes Association.
Zealand Pharma A/S presented elaborated results from two Phase III clinical studies with dasiglucagon as treatment for severe hypoglycemia as well as one preclinical PK/PD study investigating aqueous versus DMSO formulations of glucagon and the pharmacodynamics of dasiglucagon in aqueous solution at the 80th Scientific Sessions of the American Diabetes Association (ADA) held as a virtual meeting June 12-16, 2020.
SOBI acquires rights outside China to SEL 212 a proposed treatment for gout from Selecta Biosciences
Swedish Orphan Biovitrum AB (publ) (Sobi™) and Selecta Biosciences, Inc. announced that the companies have entered into a strategic licensing agreement for the product candidate SEL 212. SEL 212 is a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase) that is designed to durably control serum uric acid, reduce immunogenicity, and allow for repeated monthly dosing for the treatment of chronic refractory gout.
Positive phase III results for Venclexta combination in acute myeloid leukemia presented at EHA 2020.-Genentech/Roche.
Genentech, a member of the Roche Group announced positive results from the Phase III VIALE-A study, evaluating Venclexta (venetoclax) in combination with azacitidine in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy.
Genentech announces 2-year risdiplam data from SUNFISH and new data from JEWELFISH in infants, children and adults with spinal muscular atrophy (SMA).
Genentech, a member of the Roche Group presented two-year data from Part 1 of its pivotal SUNFISH trial in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA) at the virtual Cure SMA Annual Conference, June 8-12, 2020.
Real-world study of Trulicity shows improved adherence and persistence in type 2 diabetes.- Eli Lilly
New real-world data showed Trulicity (dulaglutide), from Eli Lilly, had significantly higher adherence and longer persistence compared to weekly injections of semaglutide or exenatide (BCise pen) in people with type 2 diabetes new to GLP-1 receptor agonist (RA) treatment.
Real-world studies of Ozempic show efficacy and weight reduction in type 2 diabetes.- Novo Nordisk
Novo Nordisk announced results from two real-world studies: EXPERT, which confirms the efficacy Ozempic (once–weekly semaglutide) demonstrated in the SUSTAIN clinical trial programme, and PATHWAY, which supports recommendations in clinical guidelines by showing that initiation of a GLP-1 receptor agonist (GLP-1 RA) helps people with type 2 diabetes reach their blood sugar goals (measured by HbA1c) while also losing weight.
Phase III study of subcutaneous daratumumab combination treatment shows positive response in light chain (AL) amyloidosis.- Janssen R&D
The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the first randomized Phase III study investigating subcutaneous Darzalex (daratumumab) in the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare and potentially fatal disease.
Phase III reSURFACE 1&2 extension studies showed Ilumya offers sustained and improved results in plaque psoriasis.- Sun Pharma
Sun Pharmaceutical Industries announced further evidence of the long-term use and cost-effectiveness of Ilumya (tildrakizumab-asmn) in moderate-to-severe plaque psoriasis. Long-term analyses of the phase III reSURFACE 1 and 2 extension studies found that Ilumya offers sustained and improved results in patients with moderate-to-severe plaque psoriasis who received treatment for up to four years with no new safety concerns recorded.
FDA expands approval for Gardasil 9 to include oropharyngeal and other head and neck cancers.- Meck Inc
Merck Inc announced that the FDA has approved an expanded indication for GARDASIL 9 vaccine for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
Phase III PEGASUS study of APL 2 shows consistent impact in paroxysmal nocturnal hemoglobinuria.- Apellis Pharma
Apellis Pharmaceuticals announced results from its Phase III PEGASUS study of APL 2 (pegcetacoplan) in adults with paroxysmal nocturnal hemoglobinuria (PNH). Results showed that in patients with no or low transfusion requirements, pegcetacoplan was associated with an adjusted mean Hb increase of 2.97 g/dL versus Soliris (eculizumab), which had a mean change of -0.01 g/dL from the 8.9 g/dL baseline.
Phase III PSO-LONG trial of Enstilar meets primary endpoint in plaque psoriasis.- LEO Pharma
LEO Pharma presented results from the Phase III PSO-LONG clinical trial comparing the efficacy and safety of twice-weekly Enstilar (calcipotriene and betamethasone dipropionate) foam, versus foam vehicle for long-term (52-week) maintenance treatment for adult patients with plaque psoriasis.
Phase III clinical data from BE VIVID and BE READY studies of bimekizumab presented at AAD for treatment of psoriasis.- UCB.
UCB, announced the first presentations of data from the Phase III clinical development program of bimekizumab, its investigational IL-17A and IL-17F inhibitor, as part of a virtual session for the American Academy of Dermatology (AAD) 2020 Annual Meeting.
Soleno Therapeutics announces top-line results from phase III trial of DCCR for treatment of Prader-Willi syndrome.
Soleno Therapeutics, Inc. announced top-line results from the Company’s Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS) : DESTINY PWS/C601 :The study did not meet its primary endpoint of change from baseline in hyperphagia. The change was measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 0?36).
IMMerge phase IIIb data shows superior rates of skin clearance for Skyrizi in psoriasis.- AbbVie
AbbVie announced new late-breaking IMMerge Phase IIIb open-label study head-to-head data showing superior rates of skin clearance for Skyrizi (risankizumab)to Cosentyx (secukinumab) at week 52 in psoriasis. Particularly, 66 percent of psoriasis patients receiving risankizumab achieved completely clear skin (PASI100 in the Psoriasis Area and Severity Index) versus 40 percent of patients receiving secukinumab at week 52 (p<0.001).
FDA approval of Uplizna for the treatment of neuromyelitis optica spectrum disorder - Viela Bio
Viela Bio announced that the FDA has approved Uplizna (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses.
New data from HGB-206 study show near elimination of sickle cell disease-related vaso-occlusive crises by LentiGlobin gene therapy and plans to file at FDA in 2021 .- bluebird bio.
bluebird bio, Inc. announced that new data from its ongoing Phase 1/II HGB-206 study of investigational LentiGlobin gene therapy for adult and adolescent patients with sickle cell disease (SCD) show a near-complete reduction of serious vaso-occlusive crises (VOCs) and acute chest syndrome (ACS) These data are being presented at the Virtual Edition of the 25th European Hematology Association (EHA25) Annual Congress.
Pivotal trial of OMS 721 shows good response rate in hematopoietic stem cell transplant-associated thrombotic microangiopathy.- Omeros Corp
Omeros Corporation announced that the results of its pivotal trial of OMS 721 (narsoplimab) in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) demonstrating that targeted upstream inhibition of the lectin pathway of complement – specifically MASP-2 – is a promising treatment strategy for HSCT-TMA.
NICE draft guidance does not recommend use of Cablivi in thrombotic thrombocytopenic purpura.- Sanofi
NICE has announced draft guidelines rejecting Cablivi (caplacizumab), from Sanofi, for use alongside plasma exchange and immunosuppression for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP).
NICE draft guidance rejects the use of Sarclisa combination therapy for multiple myeloma.- Sanofi
NICE has published draft guidelines rejecting use of a combination drug therapy containing Sarclisa (isatuximab), from Sanofi, plus pomalidomide and dexamethasone (pom-dex), to treat multiple myeloma within the NHS.
Phase III trial with Ninlaro meets primary endpoint as first line maintenance treatment of multiple myeloma.- Takeda
Takeda Pharmaceutical will present positive results from TOURMALINE-MM4, a Phase III, randomized clinical trial evaluating the effect of single-agent oral Ninlaro (ixazomib) as a first-line maintenance therapy in adult patients diagnosed with multiple myeloma who had not been treated with stem cell transplantation.
Novo Nordisk acquires Corvidia Therapeutics and with it ziltivekimab.
Novo Nordisk A/S announced that it has entered into a definitive agreement to acquire Corvidia Therapeutics Inc., a privately held, clinical stage company focused on the research and development of transformative therapies for cardio-renal diseases.
ENVISION Phase III study results of Givlaari to treat acute hepatic porphyria were published online in the NEJM.- Alnylam Pharma
Alnylam Pharmaceuticals, Inc. announced that pivotal results from the ENVISION Phase III study of givosiran, an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyria (AHP), were published online in the New England Journal of Medicine (NEJM).
Johnson & Johnson initiates Phase I/IIa trial of Ad26.COV2-S, recombinant, to treat COVID-19.
Johnson & Johnson announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase 1/IIa first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.
Real-world data of terlipressin in hospitalized patients in the U.K. with hepatorenal syndrome type 1 is published in Alimentary Pharmacology and Therapeutics.- Mallinckrodt
Mallinckrodt Plc announced publication of findings from a medical chart study to assess the real-world use of terlipressin and other vasopressors in hospitalized patients with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.
Phase III trials show efficacy of EB 1020 in attention-deficit hyperactivity disorder.- Otsuka Pharmaceutical
Otsuka Pharmaceutical has announced positive top-line results from two, six-week, phase III clinical trials that evaluated the efficacy, safety and tolerability of oral EB 1020 (centanafadine), a novel investigational compound for the treatment of adult patients with attention-deficit hyperactivity disorder (ADHD).
Celyad SA is now Celyad Oncology
Celyad SA ,a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, announced the launch of its corporate rebranding, including changing its name to Celyad Oncology.
Stratatech/Mallinckrodt has completed its rolling submission of its BLA to the FDA for StrataGraft, for the treatment deep partial-thickness thermal burns.
Mallinckrodt Plc announced that Stratatech, a Mallinckrodt company, has completed its rolling submission of a Biologics License Application (BLA) to the FDA for StrataGraft, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns.
Health Canada approves Ziextenzo (pegfilgrastim, reference biologic drug: Neulasta) and Riximyo (rituximab, reference biologic drug: Rituxan) for marketing in Canada. Sandoz Canada
Sandoz Canada Inc., a division of Novartis AG, announced that Health Canada has approved Ziextenzo (pegfilgrastim, reference biologic drug: Neulasta) and Riximyo (rituximab, reference biologic drug: Rituxan) for marketing in Canada.
CE Mark for OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2,.- Opti Medical Systems
OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. announced that it has received the CE mark certification in the European Union for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19.
Phase III DOLOMITES study of roxadustat versus darbepoetin alfa to treat anemia in non-dialysis-dependent adult patients with chronic kidney disease.- Astellas
Astellas Pharma Inc. announced results from the Phase III DOLOMITES study , evaluating the efficacy and safety of roxadustat compared with darbepoetin alfa for the treatment of anemia in non-dialysis dependent (NDD) adult patients with stage 3–5 chronic kidney disease (CKD) (Abstract: MO001).
UCB Pharma acquires Engage Therapeutics and with it Staccato Alprazolam a treatment for termination of epileptic seizure.
UCB announced the acquisition of Engage Therapeutics, Inc. a clinical-stage pharmaceutical company developing Staccato Alprazolam for the rapid termination of an active epileptic seizure, for $ 125 million in cash (subject to certain adjustments) and up to $ 145 million in further potential milestone payments related to clinical development, submission and launch of Staccato Alprazolam.
ALN GO1 filed with EMA and FDA for primary hyperoxaluria type 1.- Alnylam Pharma
Alnylam Pharmaceuticals announced positive Phase III results from the ILLUMINATE-A study of ALN GO1 (lumasiran), an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – in development for the treatment of primary hyperoxaluria type 1 (PH1).
Calquence showed promising clinical improvement in majority of 19 hospitalised COVID-19 patients .- AstraZeneca
Results published in Science Immunology showed that Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease.
New analyses of phase II EQUATOR clinical program support durable efficacy of filgotinib in psoriatic arthritis.- Gilead Sciences, Inc. + Galapagos NV
Gilead Sciences, Inc. and Galapagos NV announced new analyses from two clinical trials evaluating filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with psoriatic arthritis (PsA).
Phase III SELECT-CHOICE trial of Rinvoq meets primary endpoint in rheumatoid arthritis.- AbbVie
AbbVie announced new Phase III data from the SELECT-CHOICE clinical trial in adult patients with moderate to severe active rheumatoid arthritis and prior inadequate response or intolerance to biologic disease-modifying anti-rheumatic drugs (DMARDs), shows that Rinvoq (upadacitinib, 15 mg, once daily) met the primary endpoint of non-inferiority versus Orencia (abatacept) on change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at week 12. In addition, Rinvoq met the key secondary endpoints of superiority versus Orencia on change from baseline in DAS28-CRP at week 12 and proportion of patients achieving clinical remission at week 12 as measured by DAS28-CRP<2.6. the study evaluated rinvoq.
Phase III APeX-2 and APeX-S trials of BCX 7353 show improvements in hereditary angioedema.- BioCryst Pharma
BioCryst Pharmaceuticals announced new data from the phase III APeX-2 and APeX-S clinical trials, which showed that hereditary angioedema (HAE) patients taking oral, once-daily BCX 7353 (berotralstat) experienced sustained decreases in their attack frequency and improvements in quality of life (QoL) scores over 48 weeks.
Interim data from phase III HELP OLE study of Takhzyro shows efficacy in hereditary angioedema.- Takeda
Takeda Pharmaceutical announced findings from two new interim analyses of data from the Phase III HELP (Hereditary Angioedema Long-term Prophylaxis) Study Open-label Extension (OLE), suggesting Takhzyro (lanadelumab) is well-tolerated and can prevent hereditary angioedema (HAE) attacks over an extended treatment period, with sustained and consistent reduction in monthly attack rate across a range of different patient subgroups.
FDA approves Recarbrio in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.- Merck Inc
Merck Inc announced that the FDA has approved a supplemental New Drug Application (sNDA) for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms:
Phase III FINCH 1 and FINCH 3 studies of GLPG 0634 show 52-week efficacy in rheumatoid arthritis.- Gilead Sciences/Galapagos
Gilead Sciences and Galapagos announced Week 52 results from the Phase III FINCH 1 and FINCH 3 studies of GLPG 0634 (filgotinib), an investigational, oral, selective JAK1 inhibitor, in adults with moderately to severely active rheumatoid arthritis (RA).
Inovio and IVI partner with Seoul National University Hospital to start phase 1/II clinical rial of Inovio's COVID-19 DNA vaccine (INO-4800) in South Korea.
Inovio , the International Vaccine Institute (IVI), and Seoul National University Hospital announced a partnership to start a Phase 1/II clinical trial of INOVIO's COVID-19 vaccine INO 4800 in South Korea. The 2-stage trial of INO 4800, the first clinical study of COVID-19 vaccine in Korea, will assess the safety, tolerability, and immunogenicity of the candidate vaccine in 40 healthy adults aged 19-50 years, and will further expand toenroll an additional 120 people aged 19-64 years.
Novartis phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair Breezhaler (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma.
Novartis announced that full results from the Phase IIIb ARGON study were published online in Respiratory Medicine.
Roche’s Elecsys IL-6 test receives FDA Emergency Use Authorisation to help in identifying patients at high risk of severe inflammatory response.
Roche announcedy that the FDA has issued an Emergency Use Authorisation (EUA) for the Elecsys IL-6 test. This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.
Aurinia presents AURORA pivotal trial subgroup analysis of voclosporin for lupus nephritis at the EULAR 2020 E-Congress.
Aurinia Pharmaceuticals Inc. announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented at the European League Against Rheumatism (EULAR) 2020 E-Congress in an oral presentation given by Cristina Arriens, M.D., M.S.C.S., Clinical Assistant Member of the Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation (OMRF).
Novartis PREVENT data shows Cosentyx helps patients realize early and lasting relief in axial spondyloarthritis.
Novartis, announced the full 52-week results from the Phase III PREVENT trial, which reinforce the substantial and sustained benefits of Cosentyx (secukinumab) across the axial spondyloarthritis (axSpA) spectrum.
EU approves Darzalex subcutaneous formulation for multiple myeloma.- Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted marketing authorisation for Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma. Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation.
Phase III monotherapy study (JADE MONO-2) of PF 04965842 in atopic dermatitis published in JAMA Dermatol.- Pfizer Inc
Pfizer Inc. announced that JAMA Dermatology has published complete results from the second Phase III monotherapy pivotal study (JADE MONO-2) of PF 04965842 (abrocitinib), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in patients aged 12 and older with moderate to severe atopic dermatitis (AD).
Hydroxychloroquine does not offer COVID-19 protection after exposure according to University of Minnesota study.
A University of Minnesota trial with results published in the New England Journal of Medicine, goes the furthest in answering the question of whether a decades-old, repurposed hydroxychloroquine can help treat COVID-19, when considering early use after coronavirus exposure.
Tetraphase will now merge with Melinta Therapeutics
Tetraphase Pharmaceuticals, Inc.a biopharmaceutical company focused on commercializing its novel tetracycline Xerava to treat serious and life-threatening infections, announced that it has entered into a definitive merger agreement with Melinta Therapeutics, Inc. pursuant to which Melinta would acquire Tetraphase, through a tender offer, for an aggregate of $39.0 million in cash, plus an additional $16.0 million in cash potentially payable under contingent value rights (“CVRs”) to be issued in the proposed acquisition.
Recent publication of two papers concerning oral Feraccru/Accrufer treatment for iron deficiency.- Shield Therapeutics
Shield Therapeutics plc with its lead product Feraccru/Accrufer (ferric maltol), notes the recent publication of two papers concerning Feraccru/Accrufer.ORal IrON supplementation with ferric maltol in patients with Pulmonary Hypertension (ORION-PH).
New data reinforces improved and durable responses of Orencia in moderate-to-severe early rheumatoid arthritis patients with autoantibodies linked to more severe disease. - BMS
Bristol Myers Squibb announced results from the open-label switch period of Early AMPLE, a Phase IV exploratory biomarker study assessing the differences by which Orencia (abatacept) and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis (RA) patients who tested positive (seropositive) for certain autoantibodies.
Phase IIIb/IV SPIRIT-H2H study of Taltz shows efficacy in psoriatic arthritis.- Eli Lilly
Eli Lilly shared new results from a subgroup analysis of the Phase IIIb/IV, 52-week SPIRIT-Head-to-Head (SPIRIT-H2H) study of Taltz (ixekizumab) versus Humira (adalimumab) in biologic-naïve patients with active psoriatic arthritis (PsA).
Myovant Sciences has submitted an NDA to the FDA for its once-daily relugolix for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.
Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.
Zeposia met primary and secondary endpoints in TRUE NORTH Phase III study for adult patients with moderate to severe ulcerative colitis.- BMS
Bristol Myers Squibb announced results from True North, a pivotal Phase III trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis.
BioMarin provides highlights of 4 Years of clinical data from ongoing phase 1/II study of valoctocogene roxaparvovec gene therapy for severe hemophilia A.
BioMarin Pharmaceutical Inc. announced an update to its previously reported results of an open-label Phase 1/II study of valoctocogene roxaparvovec, an investigational gene therapy treatment for adults with severe hemophilia A.
Brilinta approved by FDA to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease .-AstraZeneca
AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease.
FDA approves supplemental BLA for Taltz for the treatment of active non-radiographic axial spondyloarthritis.- Eli Lilly
Eli Lilly and Company announced the FDA has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation.
Phase II DESTINY-CRC01 trial of Enhertu/Enhurtu demonstrated meaningful activity in patients with HER2 positive unresectable and/or metastatic colorectal cancer.- Daiichi Sankyo + AstraZeneca
Results from the phase II DESTINY-CRC01 trial of Daiichi Sankyo Company, Limited and AstraZeneca’s Enhurtu (fam-trastuzumab deruxtecan-nxki) demonstrated clinically meaningful activity in patients with HER2 positive unresectable and/or metastatic colorectal cancer who received at least two prior lines of standard treatment.
SURE 2 phase III clinical trial of sulopenem fails to meet endpoint in complicated urinary tract infection.- Iterum Therapeutics
Iterum Therapeutics announced that sulopenem did not achieve statistical non-inferiority relative to ertapenem in its SUlopenem for Resistant Enterobacteriaceae (SURE) 2 phase III clinical trial in complicated urinary tract infection (cUTI).
FDA accepts refiling of Fotivda for renal cell carcinoma.- AVEO Oncology
AVEO Oncology announced that the FDA accepted for filing its New Drug Application (NDA) seeking approval for Fotivda (tivozanib), the Company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC).
Phase II DESTINYLung01 trial positive for Enhertu/Enhurtu in HER2 mutant NSCLC.- Daiichi Sankyo and AstraZeneca.
Results from the ongoing phase II DESTINYLung01 trial showed Daiichi Sankyo Company, Limited and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) achieved a clinically meaningful tumor response in patients with HER2 mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease had progressed following one or more systemic therapies.
VBL presents positive interim data from the OVAL phase III pivotal study of VB 111 in ovarian cancer at the ASCO meeting, showing 58% or higher objective response rate
VBL Therapeutics announced the presentation of the positive outcome of pre-planned interim analysis results from the OVAL Phase III pivotal clinical trial of VB III in platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) 2020 virtual annual meeting.
IDMC reports phase III PALLAS trial of Ibrutinib unlikely to meet endpoint in early breast cancer.- Pfizer
Pfizer reports that following a preplanned efficacy and futility analysis, the independent Data Monitoring Committee (DMC) of the collaborative Phase III early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) determined that the trial of Ibrance (palbociclib) plus standard adjuvant endocrine therapy is unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival (iDFS).
CHMP recommends approval of Zabdeno + Mvabea for Ebola.- Janssen-Cilag International
The EMA’s CHMP has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine Zabdeno (formerly Ad26.ZEBOV) + Mvabea (formerly MVA-BN-Filo), from Janssen-Cilag International, that provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged 1 year and older.
CHMP recommends approval of Hepcludex for chronic hepatitis delta virus.- Myr
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Hepcludex (bulevirtide), from MYR GmbH, intended for the treatment of chronic hepatitis delta virus (HDV) infection in adult patients with compensated liver disease.
CHMP recommends approval of Rozlytrek in NTRK fusion-positive solid tumours.- Roche
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from Roche, intended for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
CHMP recommends approval of Rozlytrek for ROS1-positive advanced non-small cell lung cancer.- Roche
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from Roche, intended for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Rozlytrek will be available as hard capsules (100 and 200 mg). Rozlytrek targets cells with constitutive activation of TRK proteins resulting from gene fusions and the proto-oncogene tyrosine-protein kinase ROS (ROS1).
CHMP recommends approval of Xenleta for community-acquired pneumonia.- Nabriva Therapeutics
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Xenleta (lefamulin), from Nabriva Therapeutics, intended for the treatment of community-acquired pneumonia (CAP) in adults.
CHMP recommends Zercepac for treating breast or gastric cancer.- Accord Healthcare
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zercepac (trastuzumab), from Accord Healthcare, intended for the treatment of breast and gastric cancer.
CHMP recommends approval of Lynparza for metastatic adenocarcinoma of the pancreas.- AstraZeneca
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Lynparza (olaparib), from AstraZeneca.
FDA approves Cyramza + erlotinib for first-line treatment of metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations.- Eli Lilly
Eli Lilly and Company announced that the FDA has approved Cyramza (ramucirumab injection, 10 mg/mL solution), in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
FDA approves Tauvid,a radioactive diagnostic agent, for PET imaging to evaluate Alzheimer's disease. Eli Lilly
Tauvid a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).
Santhera provides update on the ongoing regulatory review of Puldysa by the CHMP in Duchenne Muscular Dystrophy.
Santhera Pharmaceuticals announces that the CHMP has granted a requested extension of the clock-stop in the regulatory procedure for its conditional marketing authorization (CMA) application for Puldysa (idebenone) in Duchenne muscular dystrophy (DMD).
Minerva Neurosciences announces results from phase III trial of roluperidone (MIN-101) for treatment of negative symptoms in schizophrenia.
Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced that the Phase III trial of roluperidone to treat negative symptoms in schizophrenia did not meet its primary (reduction in PANSS Marder Negative Symptoms Factor Score or NSFS) and key secondary (improvement in the Personal and Social Performance Scale Total Score or PSP) endpoints.
Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar + Mekinist following surgery.
Novartis announced updated results from the landmark COMBI-AD clinical trial, demonstrating that treatment with Tafinlar (dabrafenib) and Mekinist (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma.
Enhertu significantly improved tumour response rate and overall survival in HER2-positive metastatic gastric cancer in Phase II DESTINY-Gastric01 trial .- AstraZeneca + Daiichi Sankyo.
Detailed results from the positive, registrational, randomised controlled Phase II DESTINY-Gastric01 trial showed AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR) and overall survival (OS) , a key secondary endpoint, versus chemotherapy.
Imfinzi showed a sustained overall survival benefit in 1st-line extensive-stage small cell lung cancer in the Phase III CASPIAN trial. - AstraZeneca
Detailed results from an updated analysis of the Phase III CASPIAN trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting.
FDA approves Zilxi for rosacea.- Menlo Therapeutics
Menlo Therapeutics announced that the FDA has approved Zilxi (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. Zilxi, developed as FMX103 by Menlo's wholly-owned subsidiary Foamix Pharmaceuticals Ltd. is the first minocycline product of any kind to be approved by the FDA for use in rosacea.
Phase III HERO study of TAK 385 for prostate cancer published in New England Journal of Medicine.- Myovant Sciences
Myovant Sciences announced additional results from its Phase III HERO study of once-daily, oral TAK 385 (relugolix) (120 mg) in men with advanced prostate cancer in an oral presentation at the American Society of Clinical Oncology (ASCO)’s ASCO20 Virtual Scientific Program and simultaneous publication in the New England Journal of Medicine (NEJM).
Final phase III PROSPER trial data of Xtandi shows benefits in non-metastatic castration-resistant prostate cancer.- Pfizer and Astellas
Pfizer and Astellas have announced final results from the overall survival (OS) analysis of the Phase III PROSPER trial, which evaluated Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC). In the trial, Xtandi plus ADT reduced the risk of death by 27% (n=1,401; hazard ratio [HR]=0.73; [95% confidence interval [CI]: 0.61-0.89]; p=0.001) compared to placebo plus ADT.
FDA approves Tecentriq + Avastin for people with unresectable or metastatic hepatocellular carcinoma . Genentech/Roche
Genentech, a member of the Roche Group announced that the FDA has approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Piqray + fulvestrant receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation.- Novartis
Novartis has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
FDA approves Dupixent to treat children with atopic dermatitis. Sanofi + REgeneron
The FDA approved Dupixent (dupilumab) from Sanofi + Regeneron for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Genentech/Roche + Gilead Sciences initiate Phase III trial of Actemra + remdesivir in hospitalized patients with severe COVID-19 pneumonia.
Genentech, a member of the Roche Group announced the initiation of a global Phase III, randomized, double-blind, multicenter study (REMDACTA) to evaluate the safety and efficacy of Actemra (tocilizumab) plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.
Phase III ADAURA trial showed treatment with Tagrisso after surgery with curative intent reduced the risk of disease recurrence or death by 80%.- AstraZeneca
Detailed results from the Phase III ADAURA trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
Novartis Kisqali shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease.
Novartis announced a new exploratory subgroup analysis of the Phase III MONALEESA-3 and MONALEESA-7 trials, to be presented during the ASCO20 Virtual Scientific Program, reinforcing the overall survival (OS) benefit of Kisqali (ribociclib).
Merck Inc., and Ridgeback Bio collaborate to advance development of novel antiviral candidate, EIDD-2801 to treat COVID-19 .
Merck Inc., and Ridgeback Biotherapeutics LP, a closely held biotechnology company, announced that the companies have entered into a collaboration agreement to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19.
European Commission approves Zeposia to treat relapsing remitting multiple sclerosis.- BMS
Bristol Myers Squibb announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. With the EC marketing authorization, Zeposia, an oral medication taken once daily, becomes the only approved sphingosine-1-phosphate (S1P) receptor modulator for RRMS patients with active disease.
Hansa Biopharma submits responses to outstanding questions from EMA for imlifidase application in kidney transplantation.
Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that the ongoing EMA review of imlifidase for a potential marketing authorization in Europe is on track.
Aurinia Pharmaceuticals Inc.has completed the rolling submission to the FDA for voclosporin as a potential treatment for lupus nephritis.
Aurinia Pharmaceuticals Inc.has announced the completion of the rolling submission of a New Drug Application (“NDA”) to the FDA for voclosporin as a potential treatment for lupus nephritis , a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
Novartis announces at EAN new data for ofatumumab demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS).
Novartis announced that new ofatumumab data from the Phase III ASCLEPIOS trials and the Phase II APLIOS trial were presented virtually at the 6th Congress of the European Academy of Neurology (EAN) .
FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer.- BMS
Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the FDA for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.
Phase III Archway study of Lucentis Port Delivery System meets primary endpoint in age-related macular degeneration.- Genentech/Roche
Genentech/Roche announced positive topline results from the Phase III Archway study, evaluating Lucentis Port Delivery System (ranibizumab or PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD). PDS is a permanent refillable eye implant, approximately the size of a grain of rice, which continuously delivers a customized formulation of ranibizumab over a period of months.
IAVI and Merck Inc., collaborate to develop vaccine against SARS-CoV-2.
Merck Inc., and IAVI ( International AIDS Vaccine Initiative), a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19.
Couldn’t make it to ASCO 2020? Here’s what you missed
Bringing together experts from around the world, ASCO 2020 was brimming with fascinating abstracts, posters and virtual symposia. If you missed it, catch up with our summary of the highlights that came up at this year’s congress.
Couldn’t make it to EAN 2020? Here’s what you missed
EAN 2020 recently brought together thousands of neurologists for four days of virtual sessions, ePosters and plenaries. If you couldn’t make it, catch-up on what you missed with our summary of the highlights from this year’s virtual EAN congress.
Study of Veklury (remdesivir) for COVID-19 shows the drug is chiefly helpful to patients on supplemental oxygen. Gilead Sciences
A study published in the New England Journal of Medicine has found that remdesivir - the Gilead Sciences drug authorized to treat COVID-19 - is chiefly helpful to those on supplemental oxygen, rather than patients who progress to requiring a ventilator or extracorporeal membrane oxygenation.
Study of hydroxychloroquine for COVID-19 showing increased risk in patients is published in The Lancet
A multinational registry analysis in the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19 was carried out, with results published in The Lancet. According to the paper: “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis”, the registry comprised data from 671 hospitals in six continents.
Phase III trial of entinostat + exemestane in HER+, HER2- breast cancer fails to meet primary endpoint.- Syndax Pharmaceuticals, Inc.
Syndax Pharmaceuticals, Inc. announced receipt of the final results of E2112 the Phase III clinical trial conducted by ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), that evaluated the investigational compound entinostat, Syndax's class I HDAC inhibitor, plus exemestane in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer who have progressed on a non-steroidal aromatase inhibitor. The trial did not achieve the primary endpoint of demonstrating a statistically significant overall survival (OS) benefit over hormone therapy alone .
Positive results from pivotal ROCKstar trial of belumosudil to treat chronic graft-versus-host disease.- Kadmon Holdings Inc.
Kadmon Holdings, Inc. announced positive topline results from the primary analysis of ROCKstar (KD025-213), the pivotal trial evaluating belumosudil (KD 025) in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy Belumosudil (KD025) achieved clinically meaningful and statistically significant Overall Response Rates (ORRs) of 73% with 200 mg once daily (QD) (95% Confidence Interval (CI): 60%, 83%; p<0.0001) and 74% with 200 mg twice daily (bid) (95% ci: 62%, 84%; p><0.0001).
FDA approval for Kynmobi for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease. Sunovion Pharma
Sunovion Pharmaceuticals Inc. has announced that the FDA has approved Kynmobi (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).
FDA approves Phexxi the first and only non-hormonal prescription gel for the prevention of pregnancy.-Evofem Biosciences, Inc.
Evofem Biosciences, Inc. announced that the FDA has approved Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.
Phase III trial of Dupixent meets endpoints in eosinophilic esophagitis.- Sanofi/Regeneron Pharma
Sanofi and Regeneron Pharmaceuticals announced positive results from Part A of the pivotal Phase III trial evaluating Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE).
FDA accepts filing of HypoPal Rescue Pen for hypoglycemia in people with diabetes.- Zealand Pharma
Zealand Pharma announced that the FDA has accepted for filing the company’s New Drug Application (NDA) for the HypoPal Rescue Pen (dasiglucagon) for the treatment of hypoglycemia in people with diabetes.
FDA approves Alunbrig for ALK+ metastatic non-small cell lung cancer.- Takeda
Takeda Pharmaceutical announced that the FDA has approved Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
OLE study of Onpattro shows benefits for polyneuropathy of hATTR amyloidosis.- Alnylam Pharma
Alnylam Pharmaceuticals presented new results from the Global Open-Label Extension (OLE) study of Onpattro (patisiran), an RNAi therapeutic for the treatment of the polyneuropathy of hereditary ATTR (hATTR) amyloidosis in adults, at the European Academy of Neurology (EAN) Virtual Congress.
Abbott announces contract to supply millions of IgG Lab-Based antibody tests to the UK Government.
Abbott has announced a government contract to supply millions of its laboratory-based IgG antibody tests to National Health Service (NHS) laboratories across the UK over the coming months.
EU gives CE mark approval for UltraGene Combo2Screen SARS-CoV-2 assay as a diagnostic for COVID-19.- Advanced Biological Laboratories
Advanced Biological Laboratories (ABL) announced the CE-IVD registration of its UltraGene Combo2Screen SARS-CoV-2 assay, now available for in-vitro diagnostics use.
NICE reverses decision and now recommends use of Tecentriq plus Abraxane in metastatic triple negative breast cancer.- Roche
The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Tecentriq (atezolizumab), from Roche, with chemotherapy drug Abraxane (nab-paclitaxel), for treating patients with metastatic triple negative breast cancer.
EMA validates MAA for both idecabtagene vicleucel (ide-cel, bb2121) for multiple myeloma and CC 486 for the maintenance treatment of patients with acute myeloid leukemia (AML).- BMS + bluebird bio Inc.
Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC 486.
ARCHITECT SARS-CoV-2 IgG test is authorized by Health Canada- Abbott
Abbott announced it received Health Canada authorization under the COVID-19 Interim Order for the ARCHITECT SARS-CoV-2 IgG test, a laboratory-based serology blood test for the detection of the antibody, IgG, that identifies if a person has had the novel coronavirus (COVID-19).
Results of phase IIb/III trial of filgotinib in moderately to severely active ulcerative colitis. Gilead Sciences + Galapagos NV
Gilead Sciences, Inc. and Galapagos NV announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase IIb/III trial evaluating the efficacy and safety of the investigational, oral, once-daily, selective JAK1 inhibitor filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC).
EMA accepts MAA for for roxadustat for the treatment of anemia in adult patients with chronic kidney disease.- Astellas + Fibrogen Inc.
Astellas Pharma Inc. and FibroGen, Inc. announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European Medicines Agency (EMA) for regulatory review.
Results of GERAS-US Study shows societal cost burden for early stages of Alzheimer's disease.- Eli Lilly
Eli Lilly and Company announced baseline results from the GERAS-US Study examining the societal costs associated with mild cognitive impairment (MCI), mild dementia (MILD), and caring for someone with Alzheimer's disease (AD).
JNJ 4528 showed early, deep and durable responses in heavily pretreated patients with multiple myeloma.Janssen Pharmaceutical Companies.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1b/II CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ 4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma.
FDA approves Lynparza to treat HRR gene-mutated metastatic castration-resistant prostate cancer. AstraZeneca + Merck Inc.,
AstraZeneca and MSD Inc.,have announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Journal of Clinical Psychiatry publishes data from Alkermes' ALPINE study in patients with schizophrenia.- Alkermes plc
Alkermes plc announced that data from its phase IIIb ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study were published in the Journal of Clinical Psychiatry.
Data from a Phase III trial of cabotegravir for HIV prevention has been stopped early because of high efficacy .- Viiv Health Care
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders announced the interim analysis of the HIV Prevention Trials Network (HPTN) 083 study evaluating the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention.
Health Canada approves Rozlytrek for ROS1-positive non-small cell lung cancer.- Roche Canada
Roche Canada announced that Health Canada has granted market authorization to Rozlytrek (entrectinib) for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC), not previously treated with crizotinib.
AveXis/Novartis receives EC approval and activates “Day One” access program for Zolgensma, the only gene therapy for spinal muscular atrophy (SMA).
AveXis, a Novartis company, announced the European Commission (EC) granted conditional approval for Zolgensma (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene.