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).
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).
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.
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.
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.
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.
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.
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.
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) .
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.
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.
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.
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.
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).
Couldn’t make it to ASCO 2020? Here’s what you missed
Bringing together experts from around the world, ASCO 2020 was brimming with fascinating abstracts, posters and virtual symposia. If you missed it, catch up with our summary of the highlights that came up at this year’s congress.
Couldn’t make it to EAN 2020? Here’s what you missed
EAN 2020 recently brought together thousands of neurologists for four days of virtual sessions, ePosters and plenaries. If you couldn’t make it, catch-up on what you missed with our summary of the highlights from this year’s virtual EAN congress.
Study of 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.
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.
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).
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 .
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.
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.
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.
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 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.
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).
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).
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.
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.
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.
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.
EMA accepts MAA for for roxadustat for the treatment of anemia in adult patients with chronic kidney disease.- Astellas + Fibrogen Inc.
Astellas Pharma Inc. and FibroGen, Inc. announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European Medicines Agency (EMA) for regulatory review.
Results of 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).
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.
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.
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.
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).
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.
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).
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 .
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.
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.
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).
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).
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.
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).
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.
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.
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.
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.
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 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 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.
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).
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.
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.
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.
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).
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.
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.
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).
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).
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.
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.
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.
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).
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.
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).
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.
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.
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).
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.
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.
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.
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.
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 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
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.
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 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),
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 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.
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
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).
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).
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.
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.
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.
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.
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.
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 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
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
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.
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.
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.
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 .
CHMP recommends approval of extension to indication of Cablivi for thrombotic thrombocytopenic purpura.- Ablynx
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 Cablivi (caplacizumab-yhdp) from Ablynx. This extension requests that the drug be indicated for the treatment of adults and adolescents of 12 years of age and older weighing at least 40 kg experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.
CHMP recommends approval of Cabazitaxel Accord for metastatic prostate 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 Cabazitaxel Accord (cabazitaxel), from Accord Healthcare, intended for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
CHMP recommends Kalydeco for children and adolescents with cystic fibrosis , ages 6 months and older, to treat cystic fibrosis (CFTR) gene.- Vertex Pharma.
Vertex Pharmaceuticals Incorporated announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of Kalydeco (ivacaftor), to include the treatment of children and adolescents with cystic fibrosis (CF), ages 6 months and older weighing at least 5 kg who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene .
Ayvakit fails to meet primary endpoint in Phase III VOYAGER trial versus regorafenib for gastrointestinal stromal tumor.- Blueprint Medicines Corpn.
Blueprint Medicines Corporation , a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, announced top-line results from the Phase III VOYAGER clinical trial of avapritinib versus regorafenib in patients with locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST).
Picato to treat actinic keratosis is withdrawn from EU.- Leo Pharma
EMA has completed its review of Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, and concluded that the medicine may increase the risk of skin cancer and that its risks outweigh its benefits.
Rolling submission at EMA for remdesivir to treat coronavirus disease.- Gilead Sciences
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). The start of the rolling review only means that the evaluation of remdesivir has started and does not imply that its benefits outweigh its risks.
CHMP recommends Braftovi + cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation.- Pierre Fabre
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 Braftovi.
CHMP recommends Insulin aspart Sanofi, a biosimilar product, intended for the treatment of diabetes mellitus.- Sanofi
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Insulin aspart Sanofi, intended for the treatment of diabetes mellitus.
CHMP recommends Daurismo intended for the treatment of acute myeloid leukaemia .- 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 Daurismo intended for the treatment of acute myeloid leukaemia (AML). The applicant for this medicinal product is Pfizer Europe MA EEIG.
EU gives CE mark approval to SARS-CoV-2 (COVID-19) antibody microarray test as a diagnostic for COVID-19.- Quotient
Quotient announced that it has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE marked its SARS-CoV-2 (COVID-19) antibody microarray. The test is now available for sale in Europe and Switzerland. In one patient, the antibody negative status changed to positive one day after the PCR positive result, and in another patient, the antibody negative status changed to positive four days post PCR result.
FDA approves Darzalex Faspro subcutaneous formulation for multiple myeloma.- Genmab/Janssen Biotech
Genmab announced that the FDA has approved the use of the subcutaneous formulation of daratumumab, Darzalex Faspro (daratumumab and hyaluronidase-fihj). The Biologics License Application (BLA) for this formulation was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen) in July 2019
CHMP recommends approval of Ultomiris for atypical hemolytic uremic syndrome.- Alexion Pharma
Alexion Pharmaceuticals announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending marketing authorization in the European Union for Ultomiris (ravulizumab) for the treatment of patients with a body weight of 10 kg or above with atypical hemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received Soliris (eculizumab) for at least 3 months and have evidence of response to eculizumab.
CC-486 has NDA accepted by FDA for maintenance treatment of adult patients in remission with acute myeloid leukemia.- BMS
Bristol Myers Squibb announced that the FDA has accepted its New Drug Application (NDA) for CC 486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia (AML),
CHMP recommends Enerzair Breezhaler as a maintenance treatment of asthma in adult patients not adequately controlled with a combination of a long acting beta2 agonist (LABA) and a high dose of an inhaled corticosteroid.- Novartis
Novartis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Enerzair Breezhaler (QVM 149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist (LABA) and a high dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.
FDA guidance for Phase III B-SIMPLE 4 trial of SB 206 to treat molluscum contagiosum.- Novan Inc.
Novan, Inc.has announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the FDA regarding SB 206 for the treatment of molluscum contagiosum (“molluscum”).
Phase III FLASH trial of SGX 301 shows increased efficacy in T-cell lymphoma.- Soligenix
Soligenix announced that continued treatment with SGX 301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% in the open-label treatment cycle (referred to as Cycle 2) of its pivotal Phase III FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage cutaneous T-cell lymphoma (CTCL).
NIAID Adaptive clinical trial shows remdesivir accelerates recovery from advanced COVID-19.
Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients, which began on February 21.
CHMP recommends approval of Reblozyl for transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes and transfusion-dependent anemia associated with beta thalassemia.- BMS + Acceleron
-Bristol Myers Squibb and Acceleron Pharma Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of Reblozyl (luspatercept) for the treatment of: 1.Adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy.2. Adult patients with transfusion-dependent anemia associated with beta thalassemia.
FDA gives emergency use authorization to SARS-CoV-2 Total Ab Test for COVID-19 diagnostics.- Bio-Rad Labs
Bio-Rad Laboratories announced that it was granted FDA Emergency Use Authorization (EUA) for the company’s SARS-CoV-2 Total Ab test, the first total antibody test receiving EUA from the FDA. Bio-Rad’s blood-based immunoassay test can help clinicians identify if an individual has developed antibodies against SARS-CoV-2, the virus associated with COVID-19 disease.
EU CHMP recommends approval of subcutaneous Darzalex for multiple myeloma.- Genmab
Genmab announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the use of the subcutaneous formulation of Darzalex (daratumumab) for the treatment of adult patients with multiple myeloma in frontline and relapsed / refractory settings
FDA approves supplemental NDA for Zejula in epithelial ovarian, fallopian tube or primary peritoneal cancer.- GlaxoSmithKline
The FDA has approved GlaxoSmithKline's supplemental New Drug Application (sNDA) for Zejula (niraparib) as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.
New 6-year data for Ocrevus shows earlier treatment initiation nearly halves risk of needing walking aid in relapsing multiple sclerosis- Genentech/Roche
Genentech, a member of the Roche Group announced new analyses of Phase III OPERA I and OPERA II studies, as well as the open-label extensions, showing that Ocrevus (ocrelizumab) treatment reduced the risk of disease and disability progression in RMS and PPMS .
Topline results from the open-label, Phase III SIMPLE trial evaluating 5-day and 10-day dosing durations of remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. Gilead Sciences
Gilead Sciences, Inc. announced topline results from the open-label, Phase III SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease.
European Commission approves Cosentyx for the treatment of patients with active non-radiographic axial spondyloarthritis (nr-axSpA).- Novartis
Novartis has announced the European Commission (EC) has approved Cosentyx (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
Health Canada approves Rozlytrek for NTRK fusion-positive, locally advanced or metastatic solid tumors.- Roche
Hoffmann-La Roche Limited announces that on February 10, 2020, Health Canada, under the Notice of Compliance with Conditions (NOC/c) policy, approved Rozlytrek (entrectinib) for adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.
First patient dosed in avdoralimab phase II clinical trial in COVID-19 patients with severe pneumonia.- Innate Pharma SA.
Innate Pharma SA announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 patients with severe pneumonia.
Traumakine to participate in World Health Organization's (WHO) Solidarity trial investigating potential COVID-19 treatments. Faron Pharma
Faron Pharmaceuticals OY the clinical stage biopharmaceutical company, announces that the Company will donate supplies of its investigational intravenous (IV) interferon (IFN) beta-1a (Traumakine) for 2,000 patients in the World Health Organization's (WHO) Solidarity trial investigating potential COVID-19 treatments.
Axsome Therapeutics announces AXS 05 achieves primary endpoint in the ADVANCE-1 pivotal phase II/III Trial in Alzheimer’s disease agitation.
Axsome Therapeutics, Inc. announced that AXS 05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint in the ADVANCE-1 Phase II/III trial and rapidly, substantially, and significantly improved agitation in patients with Alzheimer’s disease as compared to placebo.
Sanofi and Regeneron provide update on U.S. Phase II/III adaptive-designed trial in hospitalized COVID-19 patients.
Sanofi and Regeneron Pharmaceuticals, Inc., announced the preliminary results from the Phase II portion of an ongoing Phase II/III trial evaluating Kevzara (sarilumab) , an interleukin-6 (IL-6) receptor antibody, in hospitalized patients with “severe” or “critical” respiratory illness caused by COVID-19.
Myovant Sciences announces publication of abstracts detailing efficacy and safety from phase III LIBERTY studies in uterine fibroids in Obstetrics & Gynecology journal.
Myovant Sciences announced that the journal Obstetrics & Gynecology has published three abstracts detailing additional efficacy and safety findings from the Phase III LIBERTY 1 and 2 studies of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids.
Phase III trial of Libtayo as monotherapy for first-line advanced NSCLC stopped early due to highly significant improvement in overall survival.- Sanofi + Regeneron
Sanofi and Regeneron Pharmaceuticals, Inc. announced the primary endpoint of overall survival (OS) was met in a Phase III trial comparing the PD-1 inhibitor Libtayo (cemiplimab) to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in greater than 50% of tumor cells.
FDA approves Ongentys an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.- Neurocrine Biosciences.
Neurocrine Biosciences, Inc. announced that the FDA has approved once-daily oral Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.
Mateon Pharma submits IND to the FDA to approve new phase II study of OT 101 for the treatment of COVID-19 pandemic.
Mateon Therapeutics Inc.announced it has submitted an Investigational New Drug (IND) application to the FDA)to study its investigational drug, OT-101, for the treatment of COVID-19 pandemic.
LivaNova Bi-Flow Cannula Receives CE Mark for extracorporeal membrane oxygenation (ECMO )applications.
LivaNova PLC announced its Bi-Flow Extracorporeal Membrane Oxygenation (ECMO) cannula earned CE Mark approval for ECMO ( Extracorporeal Membrane Oxygenation) procedures where femoral artery cannulation can be applied.
BioNTech AG and Pfizer Inc., initiate a phase 1/II trial of BNT 162 vaccine to prevent COVID-19 infection.
BioNTech AG and Pfizer Inc. have announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/II clinical trial for BioNTech’s BNT 162 vaccine program to prevent COVID-19 infection. BioNTech and Pfizer are jointly developing BNT 162.
BioNTech AG and Pfizer Inc., initiate a phase 1/II trial of BNT 162 vaccine to prevent COVID-19 infection.
BioNTech AG and Pfizer Inc. have announced that the German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 1/II clinical trial for BioNTech’s BNT 162 vaccine program to prevent COVID-19 infection.
ViroKey SARS-CoV-2 RT-PCR Test receives the CE mark for in vitro diagnostic test for COVD-19.- Vela Diagnostics
Vela Diagnostics announced that the manual version of the ViroKey SARS-CoV-2 RT-PCR Test has received the CE mark for in vitro diagnostic use. The test detects SARS-CoV-2 in patients suspected of COVID-19 by their healthcare providers. The ViroKey SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome.
Supplemental applications for Simponi Aria filed with FDA for polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis.- Janssen Biotech
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of two supplemental Biologics License Applications (sBLA) to the FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate.
Siemens Healthlineers has developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood.
Siemens Healthineers announced it is significantly expanding its infectious disease testing capabilities to aid in the COVID-19 pandemic. Recognizing the critical need for accurate diagnostic testing to manage COVID-19, the company has developed a laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies in blood.
FDA approves MenQuadfi, the latest innovation in meningococcal (MenACWY) vaccination .- Sanofi
The FDA has approved a Biologics License Application for MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older.
Lynparza demonstrated overall survival benefit in phase III PROfound trial for BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer .- AstraZeneca + Merck Inc.
AstraZeneca and MSD Inc., announced further positive results from the Phase III PROfound trial of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC) who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal agent (NHA) treatments (e.g. enzalutamide and abiraterone).
The Population Health Research Institute (PHRI) + Bayer Canada Inc. announced plans to launch a major clinical research program aimed at identifying potential COVID-19 treatments.
The Population Health Research Institute (PHRI) and Bayer Canada Inc. announced plans to immediately launch a major clinical research program aimed at identifying potential COVID-19 treatments.
AstraZeneca + Saint Luke’s Mid America Heart Institute initiate phase III DARE-19 trial with Farxiga in COVID-19 patients.
AstraZeneca and Saint Luke’s Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure.
Sanofi brain-penetrant BTK inhibitor SAR 442168 significantly reduced disease activity in Phase IIb trial in relapsing multiple sclerosis.-
Sanofi’s investigational BTK (Bruton's tyrosine kinase) inhibitor, an oral, brain-penetrant, selective small molecule achieved both the primary and secondary endpoints in a Phase IIb trial evaluating efficacy and safety in participants with relapsing forms of multiple sclerosis
Novartis announces data showing Jakavi (ruxolitinib) more effective than best available therapy in acute graft-versus-host disease.
Data from the Phase III REACH2 study published in The New England Journal of Medicine show Jakavi (ruxolitinib) improves outcomes across a range of efficacy measures in patients with steroid-refractory acute graft-versus-host disease (GvHD) compared to best available therapy (BAT).
FDA gives Emergency Use Authorisation for Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2.- Seegene
Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel coronavirus responsible for the COVID-19 disease.
FDA grants Trodelvy accelerated approval for triple-negative breast cancer.- Immunomedics
Immunomedics announced that the FDA has granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with triple-negative breast cancer that has spread to other parts of the body.
Positive results from phase III SPIRIT 2 study of once-daily relugolix combination therapy in women with endometriosis and from ovulation inhibition study.- Myovant Sciences
Myovant Sciences announced that SPIRIT 2, the first of two Phase III studies of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis , met its co-primary efficacy endpoints and six key secondary endpoints.
NICE recommends Vitrakvi to treat neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors. Bayer HealthCare
Vitrakvi (larotrectinib) from Bayer HealthCare, has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of advanced neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumors for patients who have no other satisfactory treatment options.
KALM-2 pivotal phase III trial of Korsuva shows efficacy in chronic kidney disease-associated pruritus.- Cara Therapeutics/Vifor Fresenius
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma announced positive topline data from Cara’s KALM-2 pivotal Phase III trial of Korsuva (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).
Myovant Sciences submits NDA to the FDA for once-daily, oral relugolix for the treatment of men with advanced prostate cancer.
Myovant Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer.
Cobas HPV test approved for use on cobas 6800/8800 system.- Roche
Roche announced FDA approval for the cobas HPV test for use on the fully automated, high-throughput cobas 6800/8800 Systems. The cobas HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples.
Study of Hizentra meets primary endpoint in primary immunodeficiency .- CSL Behring
CSL Behring announced that a clinical study examining faster infusion rates and higher volumes than currently approved for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) (SCIg) in patients with primary immunodeficiency (PI) met its primary endpoint
New Mayzent data published in Neurology shows sustained effect in delaying disability for up to five years in secondary progressive multiple sclerosis .- Novartis
Novartis announced new Mayzent (siponimod) data in the April supplemental issue of Neurology, the medical journal of the American Academy of Neurology.
Positive topline results from pivotal phase III CheckMate -9ER trial of Cabometyx v. sunitinib for advanced renal cell carcinoma.-BMS + Exelixis
Bristol Myers Squibb and Exelixis, Inc. announced that CheckMate -9ER, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).
Ultomiris to initiate a Phase III study to treat COVID-19.-Alexion Pharma
Alexion Pharmaceuticals, Inc.announced plans to initiate a global Phase III study to investigate Ultomiris (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS).
Opdivo + Yervoy improved overall survival in CHECKMATE -743 trial for patients with malignant pleural mesothelioma.-BMS
Bristol-Myers Squibb announced that CheckMate -743, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in previously untreated malignant pleural mesothelioma (MPM) met its primary endpoint of overall survival (OS).
Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalized COVID-19 patients .
Novartis has reached an agreement with the FDA to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease .
FDA approves Jelmyto to treat low-grade upper tract urothelial cancer Urogen Pharma
UroGen Pharma Ltd.has announced the FDA granted expedited approval for Jelmyto (mitomycin) for pyelocalyceal solution, a first-in-class treatment indicated for adults with low-grade upper tract urothelial cancer (LG UTUC). This landmark approval is based on positive results from the Phase III OLYMPUS trial that showed Jelmyto provides an effective, kidney-sparing option for patients with this rare and difficult-to-treat cancer.
Incyte announces initiation of phase III RUXCOVID study for Jakafi as a treatment for patients with COVID-19 associated cytokine storm.
Incyte announced the initiation of RUXCOVID, a global, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC) in patients aged greater than 12 years with COVID-19 associated cytokine storm .
FDA approves Pemazyre to treat cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion.- Incyte Corpn.
Incyte announced that the FDA has approved Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
FDA approves Tukysa + trastuzumab + capecitabine to treat unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases.- Seattle Genetics
Seattle Genetics, Inc. announced the FDA granted approval to Tukysa(tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.
AXS 07 eliminated migraine pain, and substantially and significantly prevented progression of migraine pain in the INTERCEPT phase III trial in the early treatment of migraine.- Axsome Therapeutics
Axsome Therapeutics, Inc. announced that AXS 07 substantially and significantly eliminated migraine pain, and substantially and significantly prevented progression of migraine pain intensity in the INTERCEPT Phase III trial of AXS 07 in the early treatment of migraine.
Zealand Pharma presents positive clinical and health economic outcome data with use of regular human insulin delivered by the V-Go in adults with type 2 diabetes.
Zealand Pharma A/S , announces clinical non-inferiority and positive health economic outcomes with use of regular human insulin (RHI) versus rapid acting insulin (RAI) when delivered by V-Go.
Ontruzant biosimilar to reference product Herceptin, is launched in the US- Merck Inc.
Merck INc., announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. Ontruzant will be introduced in the U.S. at a list price (wholesaler acquisition cost) of approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial (prices are rounded), representing a 15% discount to the current list price of Herceptin.
Phase III trial of tislelizumab + pemetrexed for first-line NSCLC met the primary endpoint of progression-free survival at interim analysis,- BeiGene
BeiGene, Ltd. a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer.
Bausch Health initiates trial program of Virazole to treat hospitalised patients with COVID-19
Bausch Health Companies Inc.announced it has initiated a clinical trial program in Canada evaluating an investigational use of Virazole (Ribavirin for Inhalation Solution, USP) in combination with standard of care therapy to treat hospitalized adult patients with respiratory distress due to COVID-19.
FDA grants Fast Track designation for vutrisiran to treat the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.- Alnylam Pharma
Alnylam Pharmaceuticals, Inc. announced that the FDA has granted Fast Track designation to vutrisiran, an investigational therapeutic for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
AstraZeneca initiates CALAVI study of Calquence to treat cytokine storm associated with COVID-19 infection.
AstraZeneca will initiate a randomised, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients
Health Canada approves Spartan Cube COVID-19 test. - Spartan Bioscience
Spartan Bioscience announced it has received Health Canada approval for its rapid, accurate and portable COVID-19 test. Approval by Health Canada means that tests can now be shipped to Spartan’s federal and provincial government partners starting immediately.
EMA approves Nustendi for primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.- Daiichi Sankyo + Esperion
Esperion announced the European Commission approved the Nustendi (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe.
EMA approves Nilemdo for primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.- Daiichi Sankyo + Esperion
Esperion announced that the European Commission approved the Nilemdo (bempedoic acid) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine.
FDA approves Koselugo to treat paediatric patients two years of age and older with neurofibromatosis type 1 (NF1). - AstraZeneca + Merck Inc.
AstraZeneca and Merck Inc.announced that the FDA has approved the kinase inhibitor Koselugo (selumetinib) for the treatment of paediatric patients two years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Studies MTI-105 and MTI-106 of oral serlopitant did not meet their respective primary endpoint of reduction of pruritus.-Menlo Therapeutics
Menlo Therapeutics Inc. announced top line results from two Phase III clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis (PN), studies MTI-105 and MTI-106.
Keytruda filed at FDA to treat patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high.- Merck Inc.
-Merck Inc., has announced that the FDA has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for Keytruda, Merck’s anti-PD-1 therapy.
Novartis completes safety review and initiates update to the Beovu prescribing information worldwide.
As part of its safety surveillance program, Novartis has been actively evaluating post-marketing cases reported as severe vision loss, retinal artery occlusion and/or vasculitis with Beovu (brolucizumab).
Immunomedics announces phase III ASCENT study of sacituzumab govitecan to treat metastatic triple-negative breast cancer to be stopped for compelling efficacy.
Immunomedics, Inc. has announced that its Phase III confirmatory ASCENT study will be halted due to compelling evidence of efficacy.
China National Medical Products Administration approves tislelizumab to treat metastatic urothelial carcinoma with PD-L1 high expression .- BeiGene Ltd
BeiGene, Ltd. announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Data on 53 patients treated with remdesivir through the compassionate use program is published in New England Journal of Medicine.- Gilead Sciences
Gilead Sciences, Inc. announced results from a cohort analysis of 53 patients hospitalized with severe complications of COVID-19 who were treated with the investigational antiviral remdesivir on an individual compassionate use basis.
LFB announces FDA approval for Sevenfact, a new recombinant coagulation factor VIIIA for for the treatment of Hemophilia A or B with inhibitors.
LFB announced that the FDA has approved the Biologics License Application (BLA) 2061 for Sevenfact, a new recombinant coagulation Factor VIIa [coagulation factor VIIa (recombinant)-jncw], for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with Hemophilia A or B with inhibitors (neutralizing antibodies).
Adial Pharmaceuticals provides update on Phase III ONWARD trial of AD 04 to treat Alcohol Use Disorder.
Adial Pharmaceuticals, Inc. provided an update on its landmark ONWARD Phase III pivotal trial of its lead drug candidate, AD 04 in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD).
Merck KGaA + Pfizer submit application for Bavencio for First-line maintenance treatment of locally advanced or metastatic urothelial carcinoma.
Merck KGaA and Pfizer Inc announced completion of the submission of a supplemental Biologics License Application (sBLA) to the FDA for Bavencio (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) (Bladder Cancer).
MediciNova plans to initiate a clinical trial of MN 166 for COVID-19 Acute Respiratory Distress Syndrome (ARDS).
MediciNova, Inc., announced that it will initiate a clinical trial of MN 166 (ibudilast) for acute respiratory distress syndrome (ARDS) caused by COVID-19 (Coronavirus Disease 2019) .
Abbott's FreeStyle Libre 14 day system now available in the U.S. for hospitalized patients with diabetes during COVID-19 Pandemic.
Abbott announced that the FreeStyle Libre 14 day system, the world's leading continuous glucose monitoring (CGM) technology, can now be used in the hospital setting during the COVID-19 pandemic, according to the FDA.
FDA approves Braftovi + cetuximab for the treatment of BRAFV600E-mutant metastatic colorectal cancer (CRC) after prior therapy.- Pfizer
Pfizer Inc.announced that the FDA has approved Braftovi (encorafenib) in combination with cetuximab (marketed as Erbitux) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation
Health Canada approves Descovy for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.- Gilead Sciences
Gilead Sciences' Canada has filed a supplemental marketing application with Health Canada seeking approval for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets)
FDA extends PDUFA date for review of risdiplam to treat spinal muscular atrophy.- Genetech/Roche
Genentech, a member of the Roche Group announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam with a decision expected by 24 August 2020.
Alnylam completes rolling submission of NDA to the FDA and submits MAA to the European Medicines Agency for lumasiran for the treatment of primary hyperoxaluria Type 1.
Alnylam Pharmaceuticals, Inc. announced the completion of the rolling submission of a New Drug Application (NDA) to the FDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO), in development for the treatment of primary hyperoxaluria type 1 (PH1).
BioMarin plans regulatory submissions in Q3 2020 at FDA and EMA for vosoritide to treat children with achondroplasia.
BioMarin Pharmaceutical Inc. announced that based on recent meetings with health authorities in the US and Europe, the Company plans to submit marketing applications to the FDA and
University of Wisconsin–Madison, FluGen and Bharat Biotech to develop CoroFlu, a coronavirus vaccine.
An international collaboration of virologists at the University of Wisconsin–Madison and the vaccine companies FluGen and Bharat Biotech has begun the development and testing of a unique vaccine against COVID-19 called CoroFlu.
Mateon achieves milestone in development of OT 101 a Phase III clinical drug candidate against COVID-19.
Mateon Therapeutics, Inc.dedicated to development OT101, a TGF-beta antisense drug candidate, announced that Mateon has delivered the requisite testing results to Golden Mountain Partners (GMP) confirming the applicability and potential use
Stratatech/Mallinckrodt initiates a rolling submission to the FDA of StrataGraft ,a regenerative skin tissue therapy, for the treatment of burns.
Mallinckrodt Plc has announced that Stratatech, a Mallinckrodt company, has initiated the rolling submission of a Biologics License Application (BLA) to the FDA seeking approval to market StrataGraft, a regenerative skin tissue therapy.
Phase III FALCON study of bardoxolone in patients with autosomal dominant polycystic kidney disease is paused.- Reata Pharma
Reata Pharmaceuticals, Inc. provided an update on the impact of the COVID-19 pandemic on its clinical programs, drug supply chain, and business operations The Company announced measures it is taking to protect the health and safety of patients and health care workers involved in ongoing clinical studies of its investigational medicines, as well as its employees and collaborators.
The COVID-19 pandemic will not have a significant impact on completion of the Phase III CARDINAL trial of bardoxolone for CKD caused by Alport syndrome.- Reata Pharma
Reata Pharmaceuticals, Inc. provided an update on the impact of the COVID-19 pandemic on its clinical programs , drug supply chain, and business operations.
Reata Pharmaceuticals closes CATALYST study of bardoxolone methyl for connective tissue disease-associated pulmonary arterial hypertension .
Reata Pharmaceuticals, Inc. provided an update on the impact of the COVID-19 pandemic on its clinical programs , drug supply chain, and business operations.
Kiniksa announces early evidence of treatment response with mavrilimumab in 6 patients with severe COVID-19 pneumonia and hyperinflammation.
Kiniksa Pharmaceuticals, Ltd. announced early evidence of treatment response with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFR alpha).
Case study in Wuhan, China shows positive effect of Actemra as a treatment for COVID-19 and is published in Blood Advances
A case study of a patient in Wuhan, China, suggests that the immunosuppressant Actemra (tocilizumab) from Roche may be an effective COVID-19 treatment for very ill patients who also have multiple myeloma and other blood cancers.
Rivaroxaban significantly reduced risk of major venous thromboembolism following non major orthopaedic surgery.
Xarelto ( rivaroxaban) reduced the risk of major venous thromboembolism (VTE) by about 75% in adult patients during a period of immobilization after nonmajor lower limb orthopaedic surgery, when compared to enoxaparin .
interima analysis of phase III Atalante 1 trial of Tedopi meets endpoint in NSCLC but trial on temporary hold.- OSE Immunotherapeutics
OSE Immunotherapeutics announced that the primary endpoint was met in the predefined Step-1 analysis of its Phase III Atalante 1 clinical trial of Tedopi (T-lymphocyte stimulators) in HLA-A2 positive non-small cell lung cancer (NSCLC) patients after failure from immune checkpoint inhibitors (PD-1/PD-L1).
Mallinckrodt and Novoteris receive clearance from Health Canada to start a pilot trial of high-dose inhaled nitric oxide therapy for COVID-19 infection and associated complications.- Mallinckrodt + Novoteris LLC
Mallinckrodt Plc and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced that the Therapeutic Products Directorate Of Health Canada has cleared the companies' joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial
CHMP recommends Nepexto a etanercept biosimilar.- Mylan
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nepexto, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis
CHMP recommends approval of Fluad Tetra adjuvanted quadrivalent influenza vaccine.- Seqirus
Seqirus, a global leader in influenza prevention, announced that its adjuvanted quadrivalent influenza vaccine (aQIV) - launching as Fluad Tetra - has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of the marketing authorisation application (MAA) for use in people aged 65 years and above.