News & Insights
Topline data for Libtayo to treat advanced basal cell carcinoma
Topline data for a pivotal, single-arm, open-label trial for Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC) who had progressed on or were intolerant to prior hedgehog pathway inhibitor (HHI) therapy were announced .
University of Louisville Division of Infectious Diseases Group B Streptococcus infections Study results
Pfizer Inc. announced detailed results of the first study to show the burden of both invasive and non-invasive Group B Streptococcus infections (GBS) among hospitalized adults in the United States.
INNO2VATE phase III program of AKB 6548 meets primary and secondary endpoints in anaemia due to chronic kidney disease.- Akebia Therapeutics
Akebia Therapeutics announced positive top-line results from INNO2VATE, its global Phase III cardiovascular outcomes program evaluating the efficacy and safety of AKB 6548 (vadadustat), its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis.
Farxiga approved in the US for the treatment of heart failure in patients with heart failure with reduced ejection fraction.- AstraZeneca
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).The approval by the FDA was based on positive results from the landmark Phase III DAPA-HF trial,
Alexion Pharma acquires Portola Pharma and with it Andexxa
Alexion Pharmaceuticals, Inc. and Portola Pharmaceuticals, Inc.announced that they have entered into a definitive merger agreement for Alexion to acquire Portola, a commercial-stage biopharmaceutical company focused on life-threatening blood-related disorders.
FDA extends PDUFA date for liso-cel to treat large B-cell lymphoma. - BMS
Bristol Myers Squibb announced that the FDA has extended the action date by three months for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is November 16, 2020. Subsequent to the submission and
FDA approves Elyxyb for acute treatment of migraine.- Dr. Reddy’s Labs
Dr. Reddy’s Laboratories Ltd. announced approval of Elyxyb (celecoxib oral solution 25 mg/mL) by the FDA. Elyxyb, previously known as DFN 15, is indicated for the acute treatment of migraine with or without aura in adults. Dr. Reddy is working to commercialize this product through partners. Elyxyb is an oral solution of ce
Positive top-line results from Otezla phase III ADVANCE study in mild-to-moderate plaque psoriasis- Amgen
Amgen announced positive top-line results from the ADVANCE trial , a Phase III, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla(apremilast) in adults with mild-to-moderate plaque psoriasis.
FDA approves MET inhibitor Tabrecta for metastatic non-small cell lung cancer with METex14 skipping mutation.- Novartis
Novartis announced that the FDA approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test.
TAVO + Keytruda demonstrated 41% overall response rate and 36% complete response in a late-stage metastatic melanoma study featured in 'Clinical Cancer Research'.- Oncosec Medical.
Oncosec Medical announced published data in Clinical Cancer Research that demonstrated its lead product candidate, TAVO (interleukin-12 or "IL-12" plasmid), in combination with the anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab), produced a 41% overall response rate (ORR), with 36% complete response in a Phase II, single arm study evaluating patients with metastatic melanoma selected to be anti-PD-1 checkpoint resistant.
Health Canada approves Real-Time Fluorescent RT-PCR Kit for detecting SARS-CoV-2.- BGI Genomics
BGI Genomics announced that its subsidiary BGI Americas Corporation has received authorization under Interim Order from Health Canada to supply its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 in the Canadian market.
Rebiotix + Ferring announce first with positive preliminary pivotal phase III data for investigational microbiome-based therapy RBX2660.
Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase III trial of the investigational microbiome-based treatment, RBX 2660.
Positive topline results from the UNITY-CLL phase III study of the combination of umbralisib and ublituximab (U2) for the treatment of chronic lymphocytic leukemia.- TG Therapeutics
Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase III trial of the investigational microbiome-based treatment, RBX 2660.
Results of phase III trial of the efficacy and safety of Recarbrio v. piperacillin and tazobactam in adult patients with HABP/VABP .- Merck Inc.,
Merck Inc., announced results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase III clinical trial evaluating Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).
PINNACLE FLX trial of WATCHMAN FLX LAAC meets endpoints in stroke risk reduction.- Boston Scientific
Boston Scientific announced positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device for patients with non-valvular atrial fibrillation (NVAF).
EU approves Entyvio subcutaneous formulation for active ulcerative colitis or Crohn’s disease.- Takeda
Takeda Pharmaceutical announced that the European Commission has granted a Marketing Authorization for the subcutaneous (SC) formulation of Entyvio (vedolizumab), a gut-selective biologic for use as maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Entyvio
FDA approves Keytruda for use at an additional recommended dose of 400 mg every six weeks for all approved adult indications.-Merck Inc.
Merck announced that the FDA has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for Keytruda, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy.
Higher investigational doses of Trulicity meaningfully reduced A1C and body weight in people with type 2 diabetes.- Eli Lilly
New 36-week data showed higher investigational doses of Trulicity (3 mg and 4.5 mg) were well-tolerated and led to A1C reductions up to 1.9 percent and weight reductions up to 10.4 pounds in people with type 2 diabetes.
FDA approves Retevmo for metastatic RET fusion-positive NSCLC and RET-mutant medullary thyroid cancer.-Eli Lilly
Eli Lilly and Company announced that the FDA approved Retevmo (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC),
La Jolla Pharmaceutical Company to provide Giapreza (Angiotensin II) for emergency medical program in patients with septic shock due to COVID-19 at CHIREC Delta Hospital, Brussels, Belgium.
La Jolla Pharmaceutical Company announced that it is providing Giapreza (angiotensin II) for an emergency medical program in patients with septic shock due to COVID-19 at the Centre Hospitalier Interrégional Edith Cavell (CHIREC) Delta Hospital in Brussels, Belgium.
FDA grants emergency use authorization to the Zero Contact COVID-19 test kit as a saliva-based diagnostic for at home use to detect COVID-19.- Vitagene
Vitagene has announced the availability of 50,000 FDA authorized at home Zero-Contact or Saliva-based COVID-19 test kits for use during the current public emergency to detect COVID-19.
FDA grants emergency use authorisation for Sofia 2 SARS Antigen Test for COVID-19 detection.- Quidel Corp
Quidel Corporation announced that it has received Emergency Use Authorization (EUA) from the FDA to market its Sofia 2 SARS Antigen rapid point-of-care test to be used with the Sofia 2 Fluorescent
Menarini Group to acquire Stemline Therapeutics in transaction valued at up to $677 million and with it Elzonris.
Menarini Group, a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced a definitive agreement under which Menarini Group will acquire Stemline in a transaction valued
FDA gives emergency use authorisation for SARS-CoV-2 IgG test for COVID-19 diagnostics.- Abbott
Abbott announced that the FDA issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT and Alinity i platforms and will have capacity for 60 million tests in June. Data shows reliable results with 99.6% specificity and 100% sensitivity for patients tested 14 days after symptoms began. Abbott expects to submit for CE Mark for its Alinity i SARS-CoV-2 IgG test in the next week and will initiate global shipments immediately.
Phase III BRIDGE trial of PRX 102 met main objectives for safety and efficacy in Fabry disease.- Protalix BioTherapeutics
Protalix BioTherapeutics announced positive topline results from its Phase III BRIDGE clinical trial of PRX 102 (pegunigalsidase alfa), the Company's plant cell-expressed recombinant, PEGylated, cross-linked alpha-galactosidase-A product candidate under development for the treatment of Fabry disease.
Lynparza approved by the FDA as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer. - AstraZeneca + Merck Inc.
AstraZeneca and MSD Inc., announced that Lynparza (olaparib) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.
Vital Patch secures FDA Emergency Use Authorization for cardiac monitoring in COVID- 19 patients.- VitalConnect
VitalConnect announced that it has received FDA Emergency Use Authorization status for use of its VitalPatch to detect changes in the QT interval of hospitalized patients undergoing drug treatment for COVID-19. Hydroxychloroquine and chloroquine, used to treat some COVID-19 patients, are associated with risk of prolonged QT interval that can lead to life-threatening arrhythmias.
Results from interim analysis of RESOLVE-IT phase III trial of elafibranor in adults with NASH and fibrosis. Genfit
Genfit announced results from an interim analysis of the RESOLVE-IT Phase III trial evaluating once-daily, 120mg of elafibranor in adults with non-alcoholic steatohepatitis (NASH).
Sarclisa + carfilzomib + dexamethasone phase III IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma.- Sanofi
The Phase III IKEMA clinical trial evaluating Sarclisa (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma.
Adamis Pharmaceuticals announces new commercialization agreement in the US for Symjepi and Zimhi products
Adamis Pharmaceuticals Corporation announced it is reacquiring from Sandoz Inc. the rights to its Symjepi(epinephrine) Injection 0.3mg, Symjepi (epinephrine) Injection 0.15mg products currently marketed and available in the United States.
Phase III EXPLORER-HCM trial of MYK 461 meets all endpoints in hypertrophic cardiomyopathy.- MyoKardia
MyoKardia announced positive topline data from the company’s Phase III pivotal EXPLORER-HCM clinical trial of MYK 461 (mavacamten) for the treatment of patients with symptomatic, obstructive hypertrophic cardiomyopathy (HCM) (clinicaltrials.gov NCT03470545).
NIH clinical trial testing antiviral remdesivir plus anti-inflammatory baricitinib for COVID-19 begins.
A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun. The trial is now enrolling hospitalized adults with COVID-19 in the United States.
Positive topline data from phase III study of omidubicel in patients with high-risk hematologic malignancies- Gamida Cell
Gamida Cell Ltd.:announced positive topline results from its Phase III clinical study evaluating the safety and efficacy of omidubicel, an investigational advanced cell therapy in development as a potential life-saving treatment option for patients in need of bone marrow transplant The median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001).
Refusal to File letter for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma. BMS + bluebird bio
Bristol Myers Squibb and bluebird bio, Inc. announced that the companies received a Refusal to File letter from the FDA regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory multiple myeloma, which was submitted in March 2020.
Health Canada approves first COVID-19 serological test for use in the country to detect COVID-19 antibodies. DiaSorin
Health Canada says it has authorized the first COVID-19 serological test for use in the country to detect antibodies specific to the virus. DiaSorin, an Italian multinational biotechnology company, had developed the LIAISON test that was also recently approved by the FDA. In a statement Health Canada said it will be used in Canadian laboratories to detect COVID-19 antibodies and help contribute to a better understanding of whether people who have been infected are immune to the virus.
Vanda Pharmaceuticals agrees with the FDA on resubmission of the application for Hetlioz for the treatment of patients with Smith-Magenis syndrome.
Vanda Pharmaceuticals Inc. announced that following the completion of a Type A Meeting with the FDA on 8 May 2020, it has reached agreement with the FDA to resubmit its application for Hetlioz (tasimelteon) for the treatment of Smith-Magenis Syndrome (SMS). As previously disclosed, Vanda received a Refusal to File letter from the FDA on 12 March 2020.
Three-year data from CheckMate -227 confirms durable, long-term survival benefit for Opdivo + Yervoy in metastatic first-line non-small cell lung cancer .- BMS
Bristol Myers Squibb announced three-year follow-up results from Part 1 of the Phase III CheckMate -227 trial , demonstrating that Opdivo (nivolumab) plus Yervoy (ipilimumab) provided sustained improvements in overall survival (OS) and additional efficacy measures as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC).
Opdivo + Yervoy with limited chemotherapy significantly improves overall survival vs. chemotherapy alone for first-line metastatic non-small cell lung cancer in CheckMate -9LA study.- BMS
Bristol Myers Squibb announced three-year follow-up results from Part 1 of the Phase III CheckMate -227 trial , demonstrating that Opdivo (nivolumab) plus Yervoy (ipilimumab) provided sustained improvements in overall survival (OS) and additional efficacy measures as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC).
FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis for cold agglutinin disease.- Sanofi
The FDA has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s.
HD LifeSciences gains 510(k) clearance for its Hive ALIF standalone lumbar interbody fusion system, an adjustable spinal implant.
HD LifeSciences has received FDA 510(k) clearance for its Hive ALIF standalone lumbar interbody fusion system, an adjustable spinal implant. The implant technology enables surgeons to choose between integrated zero-profile fixation or anterior plating and can be adjusted prior to implantation to better fit patient anatomy. The Hive ALIF system offers surgeons a number of configurations for height, width, depth and lordotic choices.
Adcetris receives European Commission approval for treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma.- Takeda + Seattle Genetics
Seattle Genetics, Inc. announced that its collaborator, Takeda Pharmaceutical Company Limited, received approval from the European Commission to extend the current conditional marketing authorization for Adcetris (brentuximab vedotin) to include treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL), in combination with CHP (cyclophosphamide, doxorubicin, prednisone).
Pfizer announces positive top-line results from phase III Lot Consistency Study of 20-Valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age
Pfizer Inc. announced top-line results from a second Phase 111 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) candidate in adults 18 through 49 years of age not previously vaccinated against pneumococcal disease.
FDA approves Pomalyst to treat AIDS-related Kaposi sarcoma. BMS
Bristol Myers Squibb announced that Pomalyst (pomalidomide) was approved by the FDA for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative.
PTI 125 did not meet its primary endpoint in a phase IIb study for Alzheimer's disease.- Cassava Sciences
Cassava Sciences, Inc. reported top-line results from a Phase IIb study of PTI 125, its lead investigational drug, in patients with Alzheimer’s disease. This study did not meet its primary endpoint. The pre-specified primary endpoint was a statistically significant effect of PTI 125 versus placebo on cerebrospinal fluid (CSF) levels of tau protein and other biomarker assessments from baseline to Day 28.
Phase III SEER-1 trial of RGN 259 shows efficacy in neurotrophic keratopathy.- ReGenTree + RegeneRx Biopharma
ReGenTree, a U.S. joint venture company owned by GtreeBNT Co. and RegeneRx Biopharmaceuticals, announced the results of a randomized, double masked, placebo-controlled Phase III clinical trial (SEER-1) using RGN 259 for the treatment of neurotrophic keratopathy (NK).
FDA provide complete response letter for Ayvakit in fourth-line gastrointestinal stromal tumor.- Blueprint Medicines
Blueprint Medicines announced that the FDA has issued a complete response letter (CRL) for the new drug application of Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST). The CRL states that the FDA cannot approve the application.
FDA approves Rubraca for metastatic castration-resistant prostate cancer.- Clovis Oncology
Clovis Oncology announced that the FDA approved Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
FDA approves Opdivo + Yervoy for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L.- BMS
Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 ( greater than 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
FDA approves Qinlock for adults with advanced gastrointestinal stromal tumor.- Deciphera Pharma
Deciphera Pharmaceuticals announced the FDA has approved Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Phase III clinical study of JTA 004 commences to reduce osteoarthritis pain in the knee.- Bone Therapeutics
Bone Therapeutics announces it has commenced treating the first patients for the pivotal JTA 004 phase III clinical study in Hong Kong SAR. Several clinical trial sites in Europe are also expected to resume recruitment activities as COVID-19 lockdown measures are gradually being lifted.
Pascal transcatheter valve repair system receives European approval for tricuspid repair.- Edwards Life Sciences.
Edwards Lifesciences Corporation announced that it has received CE Mark for the Edwards Pascal transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation.
Teleflex announces positive data showing that the UroLift System treating lower urinary tract symptoms due to benign prostatic hyperplasia relieves enlarged prostate symptoms while preserving patients’ sexual function.
Teleflex Incorporated announced that data from two analyses of the UroLift System were presented at the American Urological Association (AUA) 2020 Virtual Science event.
New Spinraza data reinforce sustained efficacy and longer term safety across a broad range of Spinal Muscular Atrophy patients . Biogen Inc.
Biogen Inc. announced additional data from the Spinraza (nusinersen) clinical development program that further demonstrate the sustained efficacy and longer-term safety of Spinraza in a broad range of patients with spinal muscular atrophy (SMA).
Adamis Pharmaceuticals resubmits NDA for Zimhi for the treatment of opioid overdose..
Adamis Pharmaceuticals Corporation announced the resubmission of the Company’s New Drug Application (“NDA”) to the FDA for its Zimhi (naloxone HCI Injection, USP) 5mg/0.5mL product candidate for the treatment of opioid overdose.
Moderna announces positive interim phase 1 data for its mRNA vaccine (mRNA-1273) against novel coronavirus.
Moderna, Inc., announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Nubeqa significantly improved overall survival with a favorable safety profile in men with non-metastatic prostate cancer.- Bayer HealthCare
Darolutamide (Nubeqa) from Bayer Healthcare is shown to significantly improve overall survival (OS) and significantly delay the onset of cancer-associated symptoms, while minimizing the toxicity associated with treating men with non-metastatic castration-resistant prostate cancer (nmCRPC).
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.
FDA approvesTecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer.- Genentech/Roche
Genentech, announced that the FDA has approved Tecentriq (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained greater than 50% of tumor cells [TC ? 50%] or PD-L1 stained tumor-infiltrating [IC] covering greater than 10% of the tumor area [IC ? 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Agios announces publication of Tibsovo phase III data in The Lancet Oncology demonstrating significant improvement in progression-free survival in previously treated IDH1-mutant cholangiocarcinoma patients.
Agios Pharmaceuticals, Inc. announced that The Lancet Oncology has published data from its global Phase III ClarIDHy study of Tibsovo (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation .
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.
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.
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).
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.
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).
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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).
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.
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).
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:
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).
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.
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.
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.
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).
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.
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).
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.
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.
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.
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.