News & Insights
Keytruda plus chemotherapy reduced risk of death by 27% versus chemotherapy as first-line treatment for locally advanced or metastatic esophageal cancer.- Merck Inc.
Merck announced first-time data from the pivotal Phase III KEYNOTE-590 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer .
World’s largest study of cardiovascular disease in type 2 diabetes shows need for improved knowledge.
Novo Nordisk announced the results of the CAPTURE study, a global non-interventional study to uncover the prevalence of cardiovascular disease and risk and its management in people living with type 2 diabetes.
CHMP recommends extension of Fycompa indication to children with partial onset seizures.- Eisai
Eisai Co., Ltd. announced that it has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) on the license extension application submitted by its U.K. subsidiary Eisai Ltd. regarding the use of its in-house discovered and developed anti-epileptic agent (AED) Fycompa(R) (generic name: perampanel) in the treatment of pediatric patients.
Novartis provides update on AVXS-101 Intrathecal Clinical Development Program for spinal muscular atrophy.
Novartis Gene Therapies recently received feedback from the FDA following their review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA).
FDA approves new formulations of Clinimix and Clinimix E to support parenteral nutrition- Baxter
Baxter International Inc. a global leader in clinical nutrition, announced the FDA approval of new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections.
Johnson & Johnson initiates pivotal global phase III clinical trial of JNJ 78436735, Janssen’s COVID-19 vaccine candidate.
Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase III trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ 78436735 , being developed by its Janssen Pharmaceutical Companies.
First patient randomised in the phase III DISSOLVE clinical programme of SE L212 for chronic refractory gout.- SOBI + Selecta Biosciences
Swedish Orphan Biovitrum AB (publ) (Sobi) and Selecta Biosciences, Inc. announced the commencement of the phase III clinical programme of SEL 212 for chronic refractory gout, with the randomisation of the first patient in the study.
Semorinemab,anti-Tau antibody, in early Alzheimer’s disease fails in Phase II trial.- AC Immune + Genentech Roche.
AC Immune SA announced that Genentech, a member of the Roche Group, has informed the Company of top line results from a Phase II trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer’s disease (AD) which show that semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo.
Illumina acquires Grail and with it Galleri a cancer screening test
Illumina, Inc.and GRAIL, a healthcare company whose mission is focused on multi-cancer early detection, announced they have entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion upon closing of the transaction.
Roche acquires Inflazome and its early stage NLRP3 inhibitors.
Inflazome announced that it has closed a share purchase agreement with Roche in which Inflazome’s shareholders received an upfront payment of €380 million, and are eligible to receive additional contingent payments to be made based on the achievement of certain predetermined milestones.Inflazome was founded in 2016 by leading medical researchers Prof Matt Cooper (University of Queensland, Australia) and Prof Luke O’Neill (Trinity College Dublin, Ireland).
The addition of ipatasertib to paclitaxel in patients with PIK3CA/AKT1/PTEN-altered hormone receptor–positive, HER2-negative advanced breast cancer did not improve survival.- Genentech/Roche
Improvement in progression-free survival (PFS) and objective response rate (ORR) was not observed with the addition of ipatasertib from Genentech/Roche to paclitaxel in patients with PIK3CA/AKT1/PTEN-altered hormone receptor–positive, HER2-negative advanced breast cancer , missing the primary and secondary end points of the phase III IPATunity130 trial for which results were presented during the 2020 European Society of Medical Oncology (ESMO) Virtual Congress.
Phase III CheckMate-577 trial of Opdivo shows benefits in oesophageal cancer.- BMS
Bristol Myers Squibb announced that checkpoint inhibitor treatment Opdivo (nivolumab) demonstrated its efficacy in the phase III CheckMate-577 trial involving patients with oesophageal or gastroesophageal junction cancers who had previously received neoadjuvant chemoradiation therapy and tumour resection.
FDA gives priority review for bb 2121 for multiple myeloma.- BMS
Bristol Myers Squibb and bluebird bio, Inc. announced that the FDA has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Verzenio significantly reduced the risk of cancer recurrence by 25% for people with HR+, HER2- high risk early breast cancer.- Eli Lilly
Eli Lilly and Company announced Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25 percent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.747; 95% CI: 0.598, 0.932; p = 0.0096).
CHMP recommends a new 100 mg/mL intravenous (IV) advanced formulation of Ultomiris.- Alexion Pharma
Alexion Pharmaceuticals, Inc.announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization in the European Union for a new 100 mg/mL intravenous (IV) advanced formulation of Ultomiris (ravulizumab).
Late-breaking ESMO presentation shows Libtayo monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of greater than 50%.- Regeneron + Sanofi.
Positive pivotal trial data for the investigational use of PD-1 inhibitor Libtayo (cemiplimab) in first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) were shared in a presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Abbott receives CE Mark for next-generation MitraClip heart valve repair device to treat mitral regurgitation.
Abbott announced it has received CE Mark for its fourth-generation MitraClip Transcatheter Mitral Valve Repair System , the leading minimally invasive mitral valve repair device in the world.
CHMP recommends Nyvepria pegfilgrastim biosimilar.- Pfizer.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nyvepria, intended to reduce the duration of neutropenia and to help prevent febrile neutropenia after cytotoxic chemotherapy.
CHMP recommends Lynparza to treat metastatic castration-resistant prostate cancer with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations.- AstraZeneca + Merck Inc.
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
CHMP recommends Lynparza for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient -positive advanced ovarian cancer. AstraZeneca + Merck Inc.
Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.
Tagrisso reduced the risk of disease recurrence in the brain by 82% in the adjuvant treatment of early-stage EGFR-mutated lung cancer.- AstraZeneca
Results from a prespecified exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a clinically meaningful improvement in central nervous system (CNS) 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.
Opdivo + Cabometyx demonstrates significant survival benefits in patients with advanced renal cell carcinoma in pivotal phase III CheckMate -9ER Trial.- BMS + Exelixis
Bristol Myers Squibb and Exelixis, Inc announced the first presentation of results from the pivotal Phase III CheckMate -9ER trial , in which Opdivo (nivolumab)in combination with Cabometyx (cabozantinib) demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), in previously untreated advanced renal cell carcinoma (RCC).
Lynparza reduced the risk of death by 31% in BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer in phase III PROfound trial. AstraZeneca + Merck Inc.
Final results from the Phase III PROfound trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus enzalutamide or abiraterone in men with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 or ATM gene mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
CHMP recommends MenQuadfi for prophylaxis against invasive meningococcal disease .- Sanofi Pasteur
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product MenQuadfi, intended for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.
CHMP recommends Obiltoxaximab SFL to treat anthrax.- SFL Pharmaceuticals Deutschland GmbH.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Obiltoxaximab SFL, intended for the treatment or post-exposure prophylaxis of inhalational anthrax.
Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting.
Eli Lilly and Company announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555.
Phase III EORTC1325/KEYNOTE-054 trial of Keytruda meets secondary endpoint in melanoma.- Merck Inc
Merck announced new and updated findings from the Phase III EORTC1325/KEYNOTE-054 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma.
Phase III SOLAR-1 trial of Piqray shows efficacy in advanced PIK3CA breast cancer.- Novartis
Novartis announced results of the final overall survival (OS) analysis from the phase III SOLAR-1 trial, which evaluated Piqray (alpelisib) in combination with fulvestrant, compared to fulvestrant alone, in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer patients with tumors harboring a PIK3CA mutation.
Deciphera presents data from Qinlock Program in patients with gastrointestinal stromal tumor at the ESMO Virtual Congress 2020.
Deciphera Pharmaceuticals, Inc. announced the presentation of nine month follow-up data from the Company’s Phase III INVICTUS study of Qinlock in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) and intra-patient dose escalation data from the ongoing Phase 1 study of Qinlock in patients with second-line through fourth-line plus GIST
Phase III ASCENT study of Trodelvy shows improved survival in triple negative breast cancer.- Immunomedics
Immunomedics announced that results from the confirmatory Phase III ASCENT study showed that Trodelvy (sacituzumab govitecan-hziy) significantly extended overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared to treatment of choice (TPC) standard single-agent chemotherapy in brain metastases-negative patients with mTNBC who had previously received at least two prior therapies for metastatic disease.
Genentech presents new data from multiple phase III studies of Tecentriq in triple-negative breast cancer at ESMO virtual congress 2020.- Genentech/Roche
Genentech, a member of the Roche Group announced that it presented the latest results from three Phase III studies from the Tecentriq (atezolizumab) clinical development program in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Novartis reports late-breaking data from phase III COMBI-i trial of spartalizumab (PDR 001) with Tafinlar and Mekinist in advanced melanoma.
Novartis announced detailed results from the Phase III COMBI-i trial evaluating the investigational immunotherapy spartalizumab (PDR 001) in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib) compared to Tafinlar + Mekinist alone.
CHMP positive for Olumiant to treat atopic dermatitis. Eli Lilly
Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
PACIFIC phase III trial data at ESMO showed an estimated 35% of non-small cell lung cancer patients treated with Imfinzi had not progressed after four years.- AstraZeneca
Updated results from the PACIFIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who had not progressed following concurrent chemoradiation therapy (CRT).
Five-year data from the SOLO-1 phase III trial is the longest follow-up analysis for any PARP inhibitor in the 1st-line maintenance setting to treat advanced BRCA-mutated ovarian cancer. AstraZeneca + Merck Inc.
AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a long-term progression-free survival (PFS) benefit versus placebo as a 1st-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who had a complete or partial response following platinum-based chemotherapy.
BeiGene presents data at ESMO virtual congress 2020 on phase III trial of tislelizumab in first-line non-squamous non-small cell lung cancer.
BeiGene, Ltd. announced the first reported data from RATIONALE 304, the Phase III trial of its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a potential first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which takes place on September 19-21., RATIONALE 304, Phase III Trial of Tislelizumab in Combination with Chemotherapy in First-Line Locally Advanced or Metastatic Non-Squamous NSCLC.":Poster #1263P.
CHMP recommends approval of Exparel in post surgical pain.- Pacira BioSciences
Pacira BioSciences announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Exparel (bupivacaine liposome injectable suspension) for postsurgical analgesia.
CHMP recommends approval of Opdivo + Yervoy in non-small cell lung cancer.- BMS
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have no sensitizing EGFR mutation or ALK translocation.
Phase III trial of Padcev meets primary endpoint in urothelial cancer.- Astellas Pharma and Seattle Genetics
Astellas Pharma and Seattle Genetics announced that a phase III trial of Padcev (enfortumab vedotin-ejfv) met its primary endpoint of overall survival compared to chemotherapy for previously treated locally advanced or metastatic Urothelial Cancer.
CHMP recommends approval of Zejula for ovarian cancer.- GlaxoSmithKline
GlaxoSmithKline announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Zejula (niraparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.
CHMP recommends approval of Tecentriq plus Avastin for unresectable hepatocellular carcinoma.- Roche
Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Phase III JAVELIN Bladder 100 study of Bavencio in urothelial carcinoma published in NEJM.- EMD Serono + Pfizer
EMD Serono and Pfizer announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study of Bavencio (avelumab) online ahead of print in The New England Journal of Medicine.
Genentech’s phase III EMPACTA study showed Actemra reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19 associated pneumonia.- Genentech/Roche
Genentech, a member of the Roche Group announced that the Phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]).
Phase Ib/II trial of PCM 075 shows efficacy in metastatic KRAS colorectal cancer.- Cardiff Oncology
Cardiff Oncology announced an electronic poster presentation of clinical data further demonstrating the safety, efficacy and durability of response of PCM 075 (onvansertib) in KRAS-mutated metastatic colorectal cancer (mCRC) patients.
ChemoCentryx announces FDA acceptance of the avacopan NDA for the treatment of ANCA-associated vasculitis.
ChemoCentryx, Inc., announced that the FDA has accepted the Company’s New Drug Application (NDA) for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA-Associated Vasculitis and has set 7 July 2021 as the Prescription Drug User Fee Act (PDUFA) goal date for the avacopan NDA.
Phase III CheckMate -214 trial of Yervoy + Opdivo shows sustained benefits and four year survival rate in advanced renal cell carcinoma.- BMS
BMS announced that more than half of advanced renal cell carcinoma (RCC) patients treated with the Opdivo(nivolumab)plus Yervoy(ipilimumab)combination were alive after four years across the entire study population of the Phase III CheckMate -214 clinical trial.
Real-world study of Nerivio Migra in migraine published in Pain Medicine.- Theranica
Theranica announced the publication of a new real-world post-marketing surveillance study in Pain Medicine that demonstrates the safety, efficacy and consistency of the company's Nerivio therapeutic wearable device.
FDA expands approval of CINtec PLUS Cytology test in HPV-positive patients.- Roche
Roche announced FDA approval for the expanded use of CINtec PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV).
Novartis Tafinlar + Mekinist demonstrates long-term, relapse-free survival benefit for high-risk, stage III melanoma patients in study published in NEJM.- Novartis
Novartis announced previously reported data from the Phase III COMBI-AD study were published in The New England Journal of Medicine .
MIRROR open-label trial data published in Journal of Rheumatology shows 79 percent of gout patients achieved a complete response using Krystexxa with methotrexate.- Horizon Therapeutics
Horizon Therapeutics plc announced the publication of the complete dataset on the primary endpoint from its "Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving Krystexxa (MIRROR) open-label trial in the Journal of Rheumatology.
Health Canada approves Tremfya to treat psoriatic arthritis.- Janssen Pharma
Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada has approved Tremfya (guselkumab injection) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.
Study of Ajovy in migraine published in Neurology journal.- Teva Pharma
Teva Pharmaceutical Industries announced that results from the 52-week, multicenter, randomized, double-blind, parallel group study evaluating monthly or quarterly Ajovy (fremanezumab-vfrm) injection in adults with chronic migraine (CM) or episodic migraine (EM), were published online ahead of print in Neurology.
EU submission complete for Opdivo + Yervoy application to treat untreated, unresectable malignant pleural mesothelioma. - BMS
Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated a type II variation application for Opdivo(nivolumab) plus Yervoy(ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM).
Novartis reports positive topline results from the first phase III trial of Beovu versus aflibercept in patients with diabetic macular edema (DME).
Novartis reported the first interpretable results of the Phase III KITE study , assessing the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema (DME).
Orexo commences patent infringement litigation against Sun Pharmaceutical.
Orexo AB (publ.), announces it has filed a patent infringement action in the United States District Court for the District of New Jersey, against Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc.
Recovery in hospitalized patients with COVID-19 in NIAID-sponsored ACTT-2 trial of baricitinib plus remdesivir.
Eli Lilly and Company and Incyte announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Alexion and Caelum Biosciences announce start of phase III studies of CAEL 101 in AL amyloidosis.
Alexion Pharmaceuticals, Inc. and Caelum Biosciences announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical program to evaluate CAEL 101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis.
Complete Response Letter for terlipressin to treat hepatorenal syndrome type 1.- Mallinckrodt
Mallinckrodt Plc announced that the FDA has issued a Complete Response Letter (CRL) regarding the company's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).
Seattle Genetics and Merck Inc., announce two strategic oncology collaborations affecting ladiratuzumab vedotin and tucatinib.
Seattle Genetics, Inc. and Merck announced two new strategic oncology collaborations. The companies will globally develop and commercialize Seattle Genetics’ ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in phase II clinical trials for breast cancer and other solid tumors.
GEMINI Phase III trial of AXS 05 shows improved outcomes in depression.- Axsome Therapeutics
Axsome Therapeutics announced that AXS 05 (bupropion + dextromethorphan) rapidly and significantly improved patient-reported outcomes of depression in patients with major depressive disorder (MDD) in the GEMINI Phase III trial.
Vertex Pharmaceuticals applies at EMA for expanded indication of Kaftrio to treat cystic fibrosis in patients ages 12 years and older. .
Vertex Pharmaceuticals Incorporated announced the European Medicines Agency (EMA) has validated a Type II Variation Marketing Authorization Application (MAA) for the expanded indication of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat CF in patients ages 12 years and older with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Myovant Sciences presents additional data on bone mineral density in women with uterine fibroids from phase III LIBERTY program of relugolix combination therapy.
Myovant Sciences announced the presentation of one-year data on bone mineral density (BMD) from the Phase III LIBERTY program evaluating the safety and efficacy of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids.
Gilead Sciences acquires Immunomedics and with it, Trodelvya treatment for triple negative breast cancer
Gilead Sciences, Inc. and Immunomedics announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Immunomedics for $88.00 per share in cash.
NIH ACTIV initiative launches adaptive clinical trials of blood-clotting treatments for COVID-19.- BMS + Pfizer
The National Institutes of Health has launched two of three adaptive Phase III clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19.
Study 402 positive results evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.-Intra-Cellular Therapies
Intra-Cellular Therapies, Inc. announced positive topline results from its Phase III clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder In Study 402, once daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206; effect size = 0.27).
Positive results from PEDFIC 1 trial of odevixibat to treat progressive familial intrahepatic cholestasis.- Albireo Pharma Inc.
Albireo Pharma, Inc. announced positive topline results from PEDFIC 1, a global Phase III clinical trial evaluating the efficacy and safety of odevixibat and the largest study ever conducted in PFIC1 and PFIC2.
Negative results from phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis .- Corbus Pharmaceutical Holdings Inc.
Corbus Pharmaceuticals Holdings, Inc. announced topline results from the 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc) .
Satsuma Pharmaceuticals announces topline results from EMERGE phase III trial of STS 101 nasal powder for the acute treatment of migraine.
Satsuma Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company, announced topline results from its Phase III EMERGE efficacy trial of STS 101 (dihydroergotamine (DHE) nasal) powder as an acute treatment for migraine. Although topline data showed numerical differences in favor of STS 101 3.9 mg and 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) at two hours post-administration, these differences did not achieve statistical significance for either dosage strength.
New data reinforce Ocrevus as a highly effective treatment for people with multiple sclerosis.- Genentech/Roche
Genentech, announced new data that show Ocrevus (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT) .
Reyvow showed significant therapeutic gains of 17-21% for pain freedom at 2 hours and met all 18 gated endpoints. Eli Lilly
Adults who took Reyvow (lasmiditan) C-V from Eli Lilly, for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 4.6 times greater odds, respectively, of achieving pain freedom at 2 hours compared to those taking placebo (co-primary endpoint), according to results from the recently completed Phase III study CENTURION .
Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis.
Novartis announced new post hoc data showing the efficacy and safety of Kesimpta (ofatumumab), a targeted B-cell therapy, in patients with relapsing forms of multiple sclerosis (RMS) who are newly diagnosed as well as ongoing safety study findings .
Neurocrine Biosciences presents new data analyses demonstrating efficacy of once-daily Ongentys in patients with Parkinson's disease at the MDS Virtual Congress 2020.
Neurocrine Biosciences, Inc. announced new data from two post-hoc analyses of Phase III data, demonstrating that once-daily Ongentys (opicapone) capsules decreased "off" time and increased "on" time without troublesome dyskinesia as an add-on therapy to levodopa/carbidopa in patients with Parkinson's disease who experience motor fluctuations.
Phase IIIb EXCHANGE and EXPAND trials show Mayzent as safe in multiple sclerosis.- Novartis
Novartis announced that Mayzent (siponimod) analyses from the Phase IIIb EXCHANGE and EXPAND trials showed Mayzent to be a safe treatment option that has benefits in cognitive performance and reduces the risk of disability progression in patients with progressing MS.
Phase III FAP-310 trial of CPP-1X/sul in familial adenomatous polyposis published in NEJM.- Cancer Prevention Pharma
Cancer Prevention Pharmaceuticals announced The New England Journal of Medicine (NEJM) has published results from its landmark FAP-310 Phase III clinical trial of CPP-1X/sul (eflornithine + sulindac) as a pharmaco-preventive treatment for adults with familial adenomatous polyposis (FAP).
New England Journal of Medicine publishes positive final results from phase 1/IIa study of BIVV001 in people with severe haemophilia A. Sanofi + Sobi
he New England Journal of Medicine published positive final results from the phase 1/IIa trial evaluating the safety, tolerability and pharmacokinetics of BIVV001 (rFVIIIFc-VWF-XTEN) in adult patients with severe haemophilia A .
Fasenra success in phase III OSTRO trial for treatment of nasal polyps.-AstraZeneca
High-level results from the OSTRO Phase III trial showed AstraZeneca’s Fasenra (benralizumab) compared with placebo demonstrated a statistically significant improvement in the size of nasal polyps and in nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) .
Janssen Biotech files sBLA at FDA for Darzalex Faspro to treat light chain (AL) amyloidosis.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies.
FDA approves Trelegy Ellipta to treat asthma. GSK
GlaxoSmithKline plc and Innoviva, Inc. announced the FDA has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD).
Phase III SAkuraStar and SAkuraSky trials of Enspryng shows efficacy in neuromyelitis optica spectrum disorder.- Genentech/Roche
Genentech/Roche are presenting new Enspryng (satralizumab-mwge) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system, in addition to longer-term efficacy data supporting the continued effect of Enspryng on reducing the risk of NMOSD relapse, as well as its favorable benefit:risk profile.
Genentech/Roche initiates phase III trial programme for fenebrutinib in multiple sclerosis.
Genentech, a member of the Roche Group announced the initiation of an innovative Phase III clinical trial program for its investigational medicine fenebrutinib in multiple sclerosis (MS), along with a higher-dose Phase III clinical trial program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with MS .
Brukinsa filed with Health Canada to treat Waldenström’s macroglobulinemia. BeiGene Ltd
BeiGene, Ltd. announced that its New Drug Submission (NDS) for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) has been accepted by Health Canada and granted priority review status.
TransCon hGH filed with EMA for pediatric growth hormone deficiency.- Ascendis Pharma
Ascendis Pharma announced the submission of a MAA to the EMA seeking approval for TransCon hGH (lonapegsomatropin), an investigational long-acting once-weekly prodrug of somatropin (human growth hormone or hGH), previously known as ACP 001, for the treatment of pediatric patients who are diagnosed with growth hormone deficiency (GHD).
Merck Inc., announces positive topline results from two phase III adult studies evaluating V114, an investigational 15-valent pneumococcal conjugate vaccine, including pivotal trial.
Merck inc., announced that two Phase III studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives.
Genentech/Roche announced a higher-dose phase III clinical trial program for Ocrevus and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with Multiple Sclerosis.
Genentech/Roche announced a higher-dose Phase III clinical trial program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with MS.
AZD 1222 vaccine phase III trial for coronavirus-19 is paused.-AstraZeneca
As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD 1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.
Biogen data presented at MS Virtual 2020, ACTRIMS/ECTRIMS meeting advances understanding of clinical and health disparities in Multiple Sclerosis .
Biogen Inc. announced findings from two large, real-world studies that provide insight into the clinical and health disparities that exist for people living with multiple sclerosis (MS) .
RedHill Biopharma’s opaganib demonstrates complete inhibition of SARS-CoV-2.
RedHill Biopharma Ltd. announced that opaganib demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID19, achieving complete blockage of viral replication in an in vitro model of human lung bronchial tissue.
Phase III COUGH-1 and COUGH-2 trials of MK 7264 shows mixed results in chronic cough.- Merck Inc
Merck Inc announced the results from two pivotal Phase III trials (COUGH-1 and COUGH-2) evaluating the efficacy and safety of MK 7264 (gefapixant), an investigational, orally administered, selective P2X3 receptor antagonist, for the potential treatment of refractory or unexplained chronic cough.
Phase III ADAPT-PO trial of SPR 994 shows efficacy in complicated urinary tract infection.- Spero Therapeutics
Spero Therapeutics announced positive topline results from ADAPT-PO, the pivotal Phase III clinical trial evaluating Spero’s oral antibiotic candidate, SPR 994 (tebipenem HBr), for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
Phase III PEDFIC 1 trial of A 4250 meets primary endpoints in progressive familial intrahepatic cholestasis.- Albireo
Albireo Pharma announced positive topline results from PEDFIC 1, a global Phase III clinical trial evaluating the efficacy and safety of A 4250 (odevixibat) and the largest study ever conducted in PFIC1 and PFIC2.
Liminal BioSciences announces resubmission of BLA to FDA for Ryplazim to treat congenital plasminogen deficiency.
Liminal BioSciences Inc. announced that the company, through its U.S. subsidiary Prometic Biotherapeutics Inc., has filed a resubmission of the Biologics License Application (BLA) for Ryplazim (plasminogen) with the FDA for the treatment of congenital plasminogen deficiency (C-PLGD).
The Lancet publishes detailed vosoritide phase III data demonstrating statistically significant increase in annualized growth velocity (AGV) over 52 weeks in children with achondroplasia.- BioMarin
BioMarin Pharmaceutical Inc. announced that The Lancet has published online results from a randomized, double-blind, phase III, placebo-controlled, multicenter trial for vosoritide , an investigational analog of C-type Natriuretic Peptide (CNP), in children aged 5 to 18 years with achondroplasia.
Post hoc analysis of Enerzair Breezhaler shows reduction in exacerbation rates of asthma.- Novartis
Novartis announced that high-dose, once-daily Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) significantly reduces both moderate-or-severe and severe asthma exacerbation rates in patients whose asthma is uncontrolled on medium- or high-dose long-acting beta2-agonist (LABA)/inhaled corticosteroids (ICS), when compared with a once-daily medium-dose of the same treatment.
EU approves variation to MAA for Imbruvica plus Rituxan in chronic lymphocytic leukaemia.- Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved a variation to the marketing authorisation for Imbruvica (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients.
Scottish Medicines Consortium (SMC) accepts Iluvien intravitreal implant for prevention of relapse in recurrent non-infectious uveitis. -Alimera Sciences
The Scottish Medicines Consortium (SMC) has accepted Iluvien (190µg fluocinolone acetonide (FAc) intravitreal implant in applicator) from Alimera Sciences, for use within NHS Scotland for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in adults.
Acasti Pharma reports topline results from phase III TRILOGY 2 study of CaPre in patients with severe hypertriglyceridemia.
Acasti Pharma Inc. focused on the research, development and commercialization of its prescription drug candidate CaPre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), announced top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase III TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia.
FDA approval of Gavreto to treat RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. -Blueprint Medicines + Genentech/Roche
Blueprint Medicines Corporation announced that the FDA has approved Gavreto (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. The approval is based on data from the Phase 1/II ARROW clinical trial, which showed efficacy for Gavreto in patients with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.
FDA accepts for review NDA for pralsetinib to treat patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. -Blueprint Medicines + Genentech/Roche
Blueprint Medicines announced the FDA has accepted the company's new drug application (NDA) for pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.
EMA’s safety committee (PRAC) recommended revocation of the marketing authorisations of 5-mg ulipristal acetate to treat symptoms of uterine fibroids.- AbbVie + Gedeon Richter
EMA’s safety committee (PRAC) recommended the revocation of the marketing authorisations of 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids, as a review carried out by the committee confirmed liver injury, including the need for liver transplantation, caused by these medicines.
Supplemental BLA filed with FDA for Yescarta in relapsed or refractory indolent non-Hodgkin lymphoma.- Kite Pharma/Gilead Sciences
Kite Pharma/Gilead Sciences have submitted a supplemental Biologics License Application (sBLA) to the FDA for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma - relapsed or refractory indolent non-Hodgkin lymphoma (NHL) - after two or more prior lines of systemic therapy.
New analysis of COVID-19 studies shows mortality benefit of inexpensive steroids.
A meta-analysis of pooled data from seven completed studies involving 1,703 critically ill COVID-19 patients showed that the administration of corticosteroids reduced mortality compared to standard-of-care (SOC) treatment.
Akebia Therapeutics announces top-line results from its PRO2TECT global phase III program of vadadustat for treatment of anemia due to chronic kidney disease in adult patients not on dialysis.
Akebia Therapeutics, Inc. announces top-line results from PRO2TECT, the second of its two global Phase III cardiovascular outcomes programs.
Bavencio from Merck KGaA and Pfizer is available under the Early Access to Medicines Scheme (EAMS) as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.
Bavencio (avelumab) from Merck KGaA and PFizer is available under the Early Access to Medicines Scheme (EAMS) as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC - bladder cancer) that has not progressed with first-line platinum-containing chemotherapy.
Phase III trial enrolling up to 30,000 adults aged 18 years or over to assess safety, efficacy and immunogenicity of AZD 1222 for the prevention of COVID-19.-AstraZeneca
AZD 1222 development expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity.
Phase III trial of Kevzara did not meet its primary or secondary endpoints in hospitalised patients with COVID-19.- Sanofi
Sanofi announced that the global Phase III trial investigating intravenously administered Kevzara (sarilumab) at a dose of 200 mg or 400 mg in severely or critically ill patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo added to usual hospital care.
European Commission approves Imfinzi to treat extensive small cell lung cancer.-Astra Zeneca.
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.
FDA approves Onureg for the continued treatment of adult patients with acute myeloid leukemia. - BMS
Bristol Myers Squibb announced that the FDA has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
Preliminary study of T 705 shows efficacy in COVID-19 with data is published in The Lancet.- Fujifilm
The Lancet has published a preliminary study report on Turkey's using T 705 (favipiravir), from Fujifilm, produced by Hisun, to treat COVID-19. The report says after favipiravir was used in hospitals across Turkey for five days, the percentage of patients requiring ICU admission diminished from 24% to 12%, whilst the percentage intubated fell from 77% to 66%. These differences were both statistically significant.
FDA approves cobas HIV-1/HIV-2 Qualitative Test for HIV diagnosis.- Roche
Roche announced that FDA approval for the cobas HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas 6800/8800 Systems in the U.S. The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.
Ionis Pharmaceuticals to acquire remaining stake in Akcea Therapeutics
Ionis Pharmaceuticals, Inc. and its affiliate Akcea Therapeutics, Inc. announced that they have entered into a definitive agreement under which Ionis will acquire all of the outstanding shares of Akcea common stock it does not already own, approximately 24%, for $18.15 per share in cash.
Nestle acquires Aimmune Therapeutics inc.
Aimmune Therapeutics Inc. a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, announced that it has entered into a definitive agreement for Sociétés des Produits Nestlé, S.A. to acquire Aimmune for $34.50 per share in an all-cash transaction, implying a fully-diluted equity value of $2.6 billion.
Results from EVAPORATE trial of Vascepa in coronary atherosclerosis published in European Heart Journal.- HLS Therapeutics
HLS Therapeutics announced that final results with Vascepa (icosapent ethyl) in patients with coronary atherosclerosis, from the EVAPORATE Trial were presented at ESC Congress 2020.
Phase II/III COMET-ICE trial of VIR 7831 in COVID-19 doses first patient.- Vir Biotechnology + GlaxoSmithKline
Vir Biotechnology and GlaxoSmithKline announced that the first patient was dosed last week in a phase II/III study with VIR 7831 (also known as GSK 4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalisation.
Phase III data on Vimpat in primary generalized tonic-clonic seizures published in Journal of Neurology, Neurosurgery & Psychiatry.- UCB
UCB has announced the publication of the Phase III study results of Vimpat (lacosamide) as adjunctive treatment for uncontrolled primary generalized tonic-clonic seizures (PGTCS), in the Journal of Neurology, Neurosurgery & Psychiatry.
IRB approves phase III trial of bucillamine in COVID-19.- Revive Therapeutics
Revive Therapeutics announced that the Company’s Phase III clinical trial protocol to evaluate the safety and efficacy of bucillamine in patients with mild-moderate COVID-19 received approval from the independent Institutional Review Board ("IRB") at Advarra, a premier IRB services company in North America.
Positive headline results from the Vyepti RELIEF study for preventive migraine therapy.- Lundbeck
H. Lundbeck A/S announced headline results from the parallel group, double-blind, randomized, placebo-controlled RELIEF study that assessed the efficacy and tolerability of Vyepti (eptinezumab) when initiated during a migraine attack in patients who are candidates for preventive therapy.
New analysis of ORION 10 and ORION 11 trials shows high consistency in lowering LDL-C in individual response with investigational inclisiran.- Novartis
Novartis announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran , a first-in-class investigational treatment for hyperlipidemia in adults.
bluebird bio presents new results from elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy for cerebral adrenoleukodystrophy. (CALD).
bluebird bio, Inc. announced updated results from the clinical development program for its investigational elivaldogene autotemcel (eli-cel, Lenti-D ) gene therapy in patients with cerebral adrenoleukodystrophy (CALD) , including long-term results from the Phase II/III Starbeam study (ALD-102/LTF-304) and data from the Phase III ALD-104 study.
Positive results from phase III DAPA-CKD trial of Farxiga to treat chronic kidney disease.-AstraZeneca
Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Farxiga (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with chronic kidney disease (ckd) stages 2-4 and elevated urinary albumin excretion. the results were consistent in patients both with and without type-2 diabetes (t2d).
Phase III EXPLORER-HCM trial of MYK 461 in obstructive hypertrophic cardiomyopathy published in The Lancet.- MyoKardia
MyoKardia announced that 30-week results from its pivotal Phase III EXPLORER-HCM clinical trial of MYK 461 (mavacamten) for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM) were presented during a live Hot Line session at the European Society of Cardiology Congress 2020 and were simultaneously published in The Lancet.
HAUSER-RCT Phase IIIb study of Repatha in heterozygous familial hypercholesterolemia published in NEJM.- Amgen
Amgen announced positive data from the HAUSER-RCT Phase IIIb study evaluating the safety and efficacy of Repatha (evolocumab) in pediatric patients, 10-17 years of age, with heterozygous familial hypercholesterolemia (HeFH).
FDA needs more time to review Tlando to treat testosterone deficiency.- Lipocine Inc.
Lipocine Inc. announced that the FDA has informed the Company that it needs additional time to complete its review of Tlando's New Drug Application ("NDA") and is committed to taking action as expeditiously as possible.
FDA expands indication for Veklury to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. Gilead Sciences
Gilead Sciences, Inc. announced the FDA expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury (remdesivir) to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
Full results of EMPEROR-Reduced phase III study of empagliflozin in heart failure.-Eli Lilly + Boehringer
Full results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, showed that empagliflozin was associated with a significant 25 percent relative risk reduction in the primary endpoint of time to cardiovascular death or hospitalization due to heart failure.
Outlook Therapeutics reports topline results and positive proof-of-concept for ONS 5010 / Lytenava from NORSE 1 trial to treat wet AMD.
Outlook Therapeutics, Inc. announced topline results demonstrating anticipated safety and efficacy and positive proof-of-concept of ONS 5010 / LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD) from its NORSE 1 clinical study , the first of two registration clinical trials.
Odonate Therapeutics announces positive top line results from CONTESSA, a phase III study of tesetaxel in patients with metastatic breast cancer.
Odonate Therapeutics, Inc. announced positive top-line results from CONTESSA, a Phase III study of tesetaxel in patients with metastatic breast cancer (MBC).
New England Journal of Medicine publishes phase 1/II data for Retevmo in Advanced RET-Driven Lung and Thyroid Cancers.- Eli Lilly
Eli Lilly and Company announced that the New England Journal of Medicine (NEJM) published Phase 1/II study results of the registrational trial for Retevmo (selpercatinib), the first and only therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Novartis investigational novel STAMP inhibitor asciminib meets primary endpoint of Phase III chronic myeloid leukemia study.
Novartis announced that, at primary analysis, the Phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib The study evaluates asciminib – a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) – in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs).
Phase III PSOARING 1 and PSOARING 2 trials of GSK 2894512 meets primary endpoints in both trials for plaque psoriasis.- Dermavant Sciences
Dermavant Sciences announced positive results from phase III PSOARING 1 and PSOARING 2, two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of GSK 2894512 (tapinarof cream), 1% in adult patients with plaque psoriasis.
FDA awards Emergency Use Authorization for Advanta Dx SARS-CoV-2 RT-PCR Assay in COVID-19 detection.- Fluidigm Corp
Fluidigm Corporation announced it has received Emergency Use Authorization (EUA) from the FDA for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus, designed to be run on the Fluidigm Biomark HD microfluidics platform.
EU approves Blenrep for multiple myeloma.- GlaxoSmithKline
GlaxoSmithKline announced the European Commission has granted conditional marketing authorisation for Blenrep (belantamab mafodotin-blmf) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
EU Commission grants conditional approval for Idefirix in highly sensitized kidney transplant patients in the European Union.- Hansa Biopharma
Hansa Biopharma , the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that the European Commission has granted conditional approval for Idefirix in highly sensitized kidney transplants patients.
Idhifa did not meet the primary endpoint of overall survival in the IDHENTIFY study to treat acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation.- BMS
Bristol Myers Squibb announced that the Phase III IDHENTIFY study evaluating Idhifa (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation The safety profile of Idhifa was consistent with previously reported findings.
Sarepta completes filing of casimersen to treat patients with Duchenne Muscular Dystrophy who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.
Sarepta has completed the submission of a rolling NDA to the FDA seeking accelerated approval for casimersen (SRP-4045).
FDA grants priority review for tepotinib for the treatment of metastatic NSCLC with tumors with a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping.- Merck KGaA
Merck KGaA, announced that the FDA has accepted and granted Priority Review to the new drug application (NDA) for once-daily, orally-dosed tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping, as detected by an FDA-approved test. Tepotinib was granted Priority Review and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which is intended to create a more efficient review process to bring safe and effective treatments to patients as early as possible.
Rinvoq filed with FDA and MAA for active ankylosing spondylitis.- AbbVie
AbbVie announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for Rinvoq (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis.
First participants dosed in trial of AZD 7442 to assess the combination of two monoclonal antibodies against COVID-19.-AstraZeneca
The first participants have been dosed in a Phase I trial of AZD 7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19 .
BMS acquires Forbius and its potent inhibitors of TGF-beta 1 & 3.
Bristol Myers Squibb and Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases, announced that they have entered into a definitive agreement under which Bristol Myers Squibb will acquire Forbius. Forbius has developed a portfolio of highly selective and potent inhibitors of TGF-beta 1 & 3, which are key mediators of immunosuppression and fibrosis.
NMPA (China) approves Zercepac to treat Breast Cancer and Gastric Cancer -Shanghai Henlius Biotech.
Shanghai Henlius Biotech, Inc. announced that the trastuzumab biosimilar ???® (HLX02, EU brand name: Zercepac), developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA).
Phase III study of Estybon fails to meet primary endpoint in higher-risk myelodysplastic syndromes.- Onconova Therapeutics
Onconova Therapeutics announced that INSPIRE, the company’s pivotal Phase III study assessing the efficacy and safety of Estybon (IV rigosertib) in higher-risk myelodysplastic syndromes (HR-MDS) patients, did not meet its primary endpoint of improved survival.
Phase III COMBI-i study of PDR 001 + Tafinlar + Mekinist fails to meet primary endpoint in melanoma.- Novartis
Novartis announced that the Phase III COMBI-i study evaluating the investigational immunotherapy PDR 001 (spartalizumab), in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib), did not meet its primary endpoint of investigator-assessed progression-free survival.
European Commission approves Kaftrio to treat cystic fibrosis in people ages 12 years and older.- Vertex Pharma.
Vertex Pharmaceuticals Incorporated announced that the European Commission (EC) has granted marketing authorization for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor to treat people with cystic fibrosis (CF) ages 12 years 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.
Virtual FDA advisory committee meeting to review NDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder tentatively scheduled for 9 October 2020.- Alkermes plc.
Alkermes plc announced that a joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) has been tentatively scheduled for 9 October, 2020.
Keytruda + chemotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in locally advanced or first-line metastatic esophageal cancer.-Merck Inc.,
Merck Inc., announced that the pivotal Phase III KEYNOTE-590 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy (cisplatin plus 5-fluorouracil [5-FU]), met its primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with locally advanced or metastatic esophageal cancer.
FDA approves Kyprolis + Darzalex + dexamethasone combination to treat multiple myeloma- Amgen
Amgen has announced the FDA has approved the expansion of the Kyprolis (carfilzomib) U.S. prescribing information to include its use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens — once weekly and twice weekly — for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received one to three previous lines of therapy.
Momenta Pharma is acquired by Johnson & Johnson and with it nipocalimab
Momenta Pharmaceuticals, Inc., a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases announced that it has entered into a definitive agreement for Johnson & Johnson to acquire Momenta for $52.50 per share in an all-cash transaction, implying a fully-diluted equity value of $6.5 billion.
Gilead Sciences and Galapagos NV receive complete response letter from FDA for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis.
Gilead Sciences, Inc. has announced that the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA).
Genentech/Roche to collaborate with Regeneron for the development and distribution of REGN-COV2 worldwide.
Genentech, a member of the Roche Group announced that Genentech and Roche are joining forces with Regeneron in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe.
FDA issues complete response letter for valoctocogene roxaparvovec gene therapy for severe hemophilia A. BioMarin.
BioMarin Pharmaceutical Inc. announced that the FDA issued a Complete Response Letter (CRL) to the Company's Biologics License Application (BLA) for valoctocogene roxaparvovec gene therapy for severe hemophilia A on August 18, 2020.
Tecentriq + Avastin approved by Health Canada for unresectable or metastatic hepatocellular carcinoma.- Genentech/Roche
Hoffmann-La Roche Limited announced that Health Canada has granted market authorization for Tecentriq (atezolizumab for injection), in combination with Avastin (bevacizumab), for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy.
The FDA has accepted the sBLA for Imfinzi and granted Priority Review in the US for a new four-week, fixed-dose regimen for NSCLC and bladder cancer-AstraZeneca.
AstraZeneca's Imfinzi (durvalumab) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for a new four-week, fixed-dose regimen for treatment in the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer.
Vanda Pharma reports interim analysis that tradipitant may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia in the ODYSSEY study.
Vanda Pharmaceuticals Inc. reported that interim analysis showed tradipitant may accelerate clinical improvement in SARS-CoV-2 (COVID-19) pneumonia in the ODYSSEY study .
CHIASMA OPTIMAL Phase III trial of Mycapssa in acromegaly published in Journal of Clinical Endocrinology & Metabolism.- Chiasma
Chiasma announced the online publication of results from its CHIASMA OPTIMAL Phase III clinical trial of Mycapssa (octreotide oral) for acromegaly in the Journal of Clinical Endocrinology & Metabolism. The publication, entitled, “Maintenance of acromegaly control in patients switching from injectable somatostatin receptor ligands to oral octreotide therapy,” was lead authored by Susan Samson, M.D., Ph.D., FRCPC, FACE, who served as principal investigator of the CHIASMA OPTIMAL clinical trial.
FDA accepts filing sNDA for Tyvaso inhaled solution for the treatment of pulmonary hypertension associated with interstitial lung disease .- United Therapeutics
United Therapeutics Corporation announced that the FDA accepted for review the supplemental New Drug Application (sNDA) for Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD).
NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids accepted for review by the FDA.- Myovant Sciences
Myovant Sciences announced that its New Drug Application (NDA) for once-daily, oral 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 has been accepted for review by the FDA.
Phase III ENLIGHTEN-2 trial of ALKS 3831 in schizophrenia published in American Journal of Psychiatry.- Alkermes
Alkermes announced the publication of results from the phase III ENLIGHTEN-2 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, American Journal of Psychiatry.
Deciphera announces publication of Qinlock phase 1 study results in patients with gastrointestinal stromal tumor in Journal of Clinical Oncology.
Deciphera Pharmaceuticals, Inc. announced that the Journal of Clinical Oncology has published results from its Phase 1 study of Qinlock, the Company’s switch-control tyrosine kinase inhibitor, in patients with second-line through fourth-line plus gastrointestinal stromal tumor (GIST).
Sanofi acquires Principia Biopharma Inc.
Sanofi and Principia Biopharma Inc., a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion (on a fully diluted basis).
Missed the digital ILC 2020? Here’s a look back at the highlights
The digital ILC 2020 recently brought together over ten thousand scientific and medical professionals from a broad range of fields for three days of virtual sessions, ePosters and plenaries. If you couldn’t make it, catch-up with our highlights from this year’s congress.
FDA Advisory Committee recommends Ryoncil to treat pediatric patients with steroid-refractory acute graft versus host disease. -MesoBlast Ltd
Mesoblast Limited announced that the Oncologic Drugs Advisory Committee (ODAC) of the FDA voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (Ryoncil in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
Complete Response Letter for Ryanodex to treat exertional heat stroke.- Eagle Pharma
Eagle Pharma has received a further Complete Response Letter for its New Drug Application (“NDA”) for Ryanodex for the treatment of exertional heat stroke (“EHS”). Eagle has decided that it will no longer pursue this indication.
FDA approves Enspryng to treat neuromyelitis optica spectrum disorder.- Genentech/Roche
Genentech, a member of the Roche Group announced that the FDA has approved Enspryng (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
Moletest (Scotland) Ltd, offers nomela, the first and only rule-out screening test for skin lesions suspected of melanoma.
Moletest (Scotland) Ltd, is offering primary care professionals the opportunity to substantially reduce the number of unnecessary dermatology referrals to secondary care by over 50% with nomela , the first and only professional medical rule-out screening test for skin lesions suspected of melanoma.
Phase III clinical trial of Solosec shows efficacy in trichomoniasis STI.- Lupin Pharma
Lupin Pharmaceuticals announced results from its pivotal Phase III clinical trial to assess efficacy and safety of single-dose Solosec (secnidazole) 2g oral granules in female patients with trichomoniasis, the most common non-viral, curable sexually transmitted infection (STI) in the U.S.
Anvisa has granted permission to commence a phase III study of lenzilumab in patients with COVID-19 in Brazil.- Humanigen
Humanigen announced that the Brazilian regulatory agency, Anvisa, has granted permission to commence a Phase III study of lenzilumab in patients with COVID-19 in Brazil.
EMA validates MAA for vosoritide to treat children with achondroplasia.- BioMarin
BioMarin Pharmaceutical Inc. announced that the European Medicines Agency (EMA) validated the Company's Marketing Authorization Application (MAA) for vosoritide, an investigational, once daily injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia, the most common form of disproportionate short stature in humans.
FibroGen initiates Phase III LELANTOS trial for pamrevlumab in combination with corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy.
FibroGen, Inc. announced the initiation of LELANTOS, a Phase III, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).
FDA accepts application for Xolair prefilled syringe for self-administration across all indications. Novartis
Genentech, announced that the FDA accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair (omalizumab) across all approved U.S. indications.
Results from the Phase III VIALE-A clinical study of Venclexta with Vidaza in acute myeloid leukemia (AML) in NEJM.- AbbVie
AbbVie announced the publication of results from the Phase III VIALE-A clinical study in patients with AML in the New England Journal of Medicine (NEJM). The study, which evaluated newly-diagnosed AML patients who had not yet been treated and were unable to tolerate traditional intensive chemotherapy, found that Venclexta (venetoclax) in combination with Vidaza (azacitidin
Thermo Fisher acquisition of Qiagen will not proceed
Thermo Fisher Scientific Inc.announced that its offer to acquire all of the ordinary shares of QIAGEN N.V.has lapsed. Based on information provided by the settlement agents for the offer, Deutsche Bank Aktiengesellschaft and American Stock Transfer & Trust Company, 107,546,187 QIAGEN shares, representing 47.02% of the issued and outstanding ordinary shares of QIAGEN
CheckMate -649, a phase III trial of Opdivo + chemotherapy vs. chemotherapy, meets primary endpoints of superior overall survival and progression-free survival in first-line treatment of gastric and esophageal cancers. BMS
Bristol Myers Squibb announced that CheckMate -649, a pivotal Phase III trial evaluating Opdivo (nivolumab) plus chemotherapy compared to chemotherapy alone as a first-line treatment for metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or esophageal adenocarcinoma
European Commission approves Xolair as an add-on therapy with intranasal corticosteroids for the treatment of severe chronic rhinosinusitis with nasal polyps. - Novartis
Novartis announced that the European Commission (EC) has approved 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)
Australia joins U.S., Switzerland, Canada and Singapore in approval of Tukysa for the treatment of patients with locally advanced or metastatic HER2-positive breast cancer - Seattle Genetics
Seattle Genetics, Inc.has announced that Australian regulatory authorities have approved Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based
Guardant360 CDx first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers. Guardant Health, Inc.
Guardant Health, Inc. announces that the FDA has approved Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor).
VBL Therapeutics announces second successful pre-planned interim analysis with a positive data safety monitoring committee review looking at OS - the primary endpoint of the OVAL Phase III potential registration study of VB 111 in Ovarian Cancer.
VBL Therapeutics announced that the independent Data Safety Monitoring Committee (DSMC) has completed its second, pre-planned interim analysis in the ongoing OVAL Phase III study investigating ofranergene obadenovec (VB 111) in patients with platinum-resistant ovarian cancer, and unanimously recommended that the study continue as planned. In this second interim analysis, the DSMC reviewed
Complete Response Letter for Pedmark for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors. Fennec Pharma
Fennec Pharmaceuticals Inc., announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the FDA regarding its New Drug Application (NDA) for Pedmark(a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients greater than 1 month to 18 years of age
FDA approves Viltepso for Duchenne muscular dystrophy.- NS Pharma/Nippon Shinyaku
The FDA has granted accelerated approval to Viltepso (viltolarsen) injection, from NS Pharma/Nippon Shinyaku, for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This is the second FDA-approved targeted treatment for patients with this type of mutation. Approximately 8% of patients with DMD
REGN 1500 filed with the FDA for homozygous familial hypercholesterolemia.- Regeneron Pharmaceuticals
Regeneron Pharmaceuticals announced that the FDA has accepted for Priority Review a Biologics License Application (BLA) for REGN 1500 (evinacumab) as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH). Evinacumab is the first investigational medicine of its kind to show efficacy in patients with HoFH – including patients with little to no low-density lipoprotein (LDL) receptor function
No FDA decision yet on EM 100 treatment for ocular itching.- Eton Pharma + Bausch & Lomb
Eton Pharmaceuticals, Inc reported that its partner, Bausch & Lomb, has not yet received a communication from the FDA regarding its decision on the review of EM 100. EM 100’s Generic Drug User Fee Act (GDUFA) target action date was August 10th
China National Medical Products Administration (NMPA) approves Truvada for pre-exposure prophylaxis (PrEP). Gilead Sciences.
Gilead Sciences, Inc. announced that the China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg,FTC/TDF). In China, Truvada for PrEP is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg.
CheckMate -577, a phase III trial evaluating Opdivo as adjuvant therapy for resected esophageal or gastroesophageal junction cancer, meets primary endpoint of disease-free survival.- BMS
Bristol Myers Squibb announced the Phase III CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis . In the trial, treatment with Opdivo following neoadjuvant chemoradiation therapy (CRT)
Phase III trial of NT 300 starts for mild or moderate COVID-19.- Romark
Romark announced the initiation of a Phase III clinical trial of its investigational new drug candidate NT 300 (nitazoxanide extended-release tablets) as a treatment for mild or moderate COVID-19. The multicenter, randomized, double-blind trial will study up to 800 people twelve years and older with fever and respiratory symptoms consistent with COVID-19.
Vaxart announces that its COVID-19 investigational new drug (IND) application for an oral vaccine has been filed with the FDA.
Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, announced that its COVID-19 Investigational New Drug (IND) application has been filed with the FDA.
Omeros Corporation reports recovery and survival of all patients in a study evaluating narsoplimab with acute respiratory distress syndrome associated with COVID-19.
Omeros Corporation reported the results of a compassionate-use study evaluating narsoplimab, Omeros’ investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in the treatment of COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe and life-threatening symptom of COVID-19.
Gilead Sciences files NDA at FDA Veklury, an investigational antiviral for the treatment of patients with COVID-19.
Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for Veklury (remdesivir), an investigational antiviral for the treatment of patients with COVID-19.
Phase III ECOSPOR III study of SER 109 shows efficacy in C. difficile infection.- Seres Therapeutics
Seres Therapeutics reported positive topline results from the pivotal Phase III ECOSPOR III study evaluating its investigational oral microbiome therapeutic SER 109 for recurrent C. difficile infection (CDI). The study showed that SER 109 administration resulted in a highly statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI