Biogen submits MAA at EMA for aducanumab, an investigational treatment for Alzheimer’s disease.
Eisai Co., Ltd. announced that Biogen has disclosed its submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review of aducanumab, an investigational treatment for Alzheimer’s disease, as of October 2020 in its Q3 2020 Earnings Press Release issued on 21 October 2020.
Antibody cocktail REGN EB3 (Inmazeb) is the first FDA approved treatment for Ebola.-Regeneron
Regeneron Pharmaceuticals, Inc. announced that the FDA approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.
FDA approves a new formulation of Ultomiris with significantly reduced infusion time for for patients with aHUS and PNH.- Alexion Pharma
Alexion Pharmaceuticals, Inc. announced the FDA has approved Ultomiris (ravulizumab-cwvz) 100 mg/mL formulation for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy for adult and pediatric (one month of age and older) patients.
Health Canada approves first-ever gene replacement therapy, Luxturna, a one time treatment for vision loss due to inherited retinal dystrophy with biallelic RPE65 mutations.-Novartis
Novartis Pharmaceuticals Canada Inc. announces that Health Canada has approved Luxturna (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
Health Canada approves Keytruda as first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma.
Merck Inc., announced that Health Canada has approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PDL1 expression [Combined Positive Score (CPS) greater than 1] as determined by a validated test.
Jazz Pharmaceuticals announces SLEEP publication of phase III Xywav oral solution study in cataplexy or excessive daytime sleepiness in patients with narcolepsy.
Jazz Pharmaceuticals plc announced the publication of the global Phase III double-blind, placebo-controlled, randomized-withdrawal, multicenter study of Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution, for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
Merck announces positive topline results from two additional phase III adult studies evaluating V 114, Merck’s investigational 15-valent pneumococcal conjugate vaccine.
Merck Inc.,has announced findings from two additional Phase III studies evaluating the safety, tolerability and immunogenicity of V 114, the company’s investigational 15-valent pneumococcal conjugate vaccine. In the PNEU-PATH (V114-016) study , healthy adults 50 years of age or older received V 114 or PCV 13 followed by Pneumovax 23 one year later.
Two phase III trials of V 114 show efficacy of vaccine in pneumococcal disease.- Merck Inc
Merck Inc announced findings from two additional Phase III studies evaluating the safety, tolerability and immunogenicity of V 114 (PVC 15), the company’s investigational 15-valent pneumococcal conjugate vaccine for the prevention of pneumococcal disease.
Amylyx Pharmaceuticals announces publication of CENTAUR survival data in Muscle and Nerve journal demonstrating a significant survival benefit from AMX 0035 in ALS patients.
Amylyx Pharmaceuticals, Inc.,announced the publication of an overall survival analysis from the CENTAUR trial evaluating AMX 0035 in people with ALS in the neuromuscular disease journal Muscle & Nerve .
FDA grants priority review for Tagrisso for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer.- AstraZeneca
AstraZeneca’s Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application (sNDA) and has also been granted Priority Review in the US for 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.
Endo acquires Biospecifics Technologies and access to Xiaflex and Qwo
BioSpecifics Technologies Corp. announced at it has entered into a definitive merger agreement under which Endo International plc will acquire BioSpecifics for an estimated equity value of approximately $658.0 million ($540.0 million in enterprise value net of cash on hand), or $88.50 per share in cash.
FDA accepts for priority review applications for Opdivo in combination with Cabometyx in advanced renal cell carcinoma. -BMS + Exelixis.
Bristol Myers Squibb and Exelixis, Inc. announced that the FDA has accepted the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA), respectively, for Opdivo(nivolumab) in combination with Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma (RCC).
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. will commercialise mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan. -ImmunoGen.
ImmunoGen, Inc. and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd., announced that the companies have entered into an exclusive collaboration to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan (Greater China).
CHMP recommends Trixeo Aerosphere for maintenance treatment in adult patients with moderate to severe COPD.- AstraZeneca
AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide), has been recommended for marketing authorisation in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist.
CHMP recommends Forxiga to treat heart failure in patients with or without diabetes.- AstraZeneca
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D).
Gilead CEO statement on remdesivir final report for the ACTT-1 Study Group for treatment of COVID-19
Statement from Gilead Sciences CEO: With publication of new data on remdesivir in the New England Journal of Medicine ( see citation below), we have the clearest picture yet of the medicine’s impact on COVID-19.
Aimmune receives positive CHMP opinion on Palforzia for the treatment of peanut allergy in Europe.
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on Palforzia [defatted powder of Arachis hypogaea L., semen (peanuts)] for the treatment of peanut allergy in peanut allergic patients aged 4 – 17 years in the European Union.
Trial finds Olumiant + Veklury cuts time to recovery for patients with COVID-19.- Eli Lilly and Incyte
Eli Lilly and Incyte shared additional data that showed Olumiant (baricitinib) in combination with Veklury (remdesivir) reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir.
Solidarity therapeutics trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19. WHO
In just six months, the world’s largest randomized control trial on COVID-19 therapeutics has generated conclusive evidence on the effectiveness of repurposed drugs for the treatment of COVID-19.
FDA approves Venclexta + azacitidine/decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia . AbbVie + Genentech/Roche
Genentech, a member of the Roche Group announced that the FDA has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
New long-term data from KEYNOTE-021 (Cohort G) reinforce use of Keytruda in certain patients with advanced nonsquamous NSCLC.- Merck Inc.
Merck Inc., announced positive results from two studies from the company’s leading lung cancer clinical development program evaluating Keytruda, Merck’s anti-PD-1 therapy: Keytruda in combination with chemotherapy (KEYNOTE-021 [Cohort G]) and Keytruda in combination with quavonlimab (MK-1308), Merck’s novel investigational anti-CTLA-4 antibody.
Orchard Therapeutics receives positive CHMP opinion for Libmeldy for the treatment of early-onset metachromatic leukodystrophy (MLD).
Orchard Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending full, or standard, marketing authorization for Libmeldy (cryopreserved autologous CD34+ cells encoding the arylsulfatase-A, or ARSA, gene)
CHMP recommends Fintepla for the treatment of seizures associated with Dravet syndrome.- Zogenix
Zogenix announced that the Committee for Medicinal Products for Human Use (CHMP), a part of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of Fintepla (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome, a rare and devastating infant- and childhood onset epilepsy, as an add-on therapy to other antiepileptic medicines for patients two years of age and older.
Emapalumab's efficacy for primary HLH is confirmed by sensitivity analysis presented at ESID2020.- Swedish Orphan Biovitrium
Sobi presented results from the sensitivity analysis from the pivotal phase II/III study (NCT01818492) of emapalumab in patients with primary HLH at the 19th meeting of the European Society of Immunodeficiencies (ESID).
CHMP recommends approval of Oxlumo for primary hyperoxaluria type 1.- Alnylam Pharmaceuticals
Alnylam Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ALN GO1 (lumasiran), an investigational RNAi therapeutic targeting the hydroxyacid oxidase 1 (HAO1) mRNA – encoding glycolate oxidase (GO) – in development for the treatment of primary hyperoxaluria type 1 (PH1).
CHMP recommends approval of KTE X19 in mantle cell lymphoma.- Kite/Gilead
Kite, a Gilead Company, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s Marketing Authorization Application for KTE X19 (brexucabtagene autoleucel), a chimeric antigen receptor (CAR) T cell therapy, as a potential treatment for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
CHMP recommends approval of Tremfya in active psoriatic arthritis.- Janssen Pharma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the expanded use of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union.
FDA approves expanded label for Keytruda in relapsed or refractory classical Hodgkin lymphoma.- Merck Inc
Merck Inc announced that the FDA has approved an expanded label for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
CHMP recommends approval of Vocabria in HIV.- ViiV HealthCare
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Vocabria (cabotegravir injection and tablets), from ViiV HealthCare, in combination with Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.
CHMP recommends extended approval for Dupixent in severe atopic dermatitis in children.- Sanofi
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent (dupilumab), from Sanofi, recommending to extend the approval in the European Union (EU) to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy.
CHMP recommends approval of Opdivo in recurrent or metastatic oesophageal squamous cell carcinoma.- BMS
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the treatment of adults with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
Novartis receives positive CHMP opinion for Leqvio, a potential first-in-class siRNA for the treatment of high cholesterol.
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of Leqvio (inclisiran) for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, marking an important milestone towards it becoming available in the EU.
Eli LIlly acquires Disarm Therapeutics and gains access to SARMI inhibitors to treat axonal degeneration
Eli Lilly and Company announced a definitive agreement to acquire Disarm Therapeutics, a privately-held biotechnology company creating a new class of disease-modifying therapeutics for patients with axonal degeneration.
CE Mark for PrecisionOne a device that provides automated glucose control and real-time blood chemistry analyses for critical care patients. Admetsys.
Admetsys has received CE mark certification for its PrecisionOne system, a device that provides automated glucose control and real-time blood chemistry analyses for critical care patients.
Revance reports positive results from ASPEN-1 phase III trial of daxibotulinumtoxinA for injection in cervical dystonia.
Revance Therapeutics, Inc. , announced positive topline results from its ASPEN-1 Phase III randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia , a chronic and debilitating neurologic condition affecting the muscles of the neck.
FDA 510(k) clearance on the Smart Correction External Fixation System for use in pediatric orthopaedic surgery.-WishBone Medical, Inc,
WishBone Medical, Inc., a leader in pediatric orthopedic medical devices, announced it has received FDA 510(k) clearance on their Smart Correction External Fixation System, which comprises hexapod external fixator hardware and proprietary planning software.
Tepezza data from the phase II clinical trial evaluates longer-term responses in people living with thyroid eye disease (TED).- Horizon Therapeutics
Horizon Therapeutics plc announced new long-term follow-up data from the Phase II clinical trial of Tepezza (teprotumumab-trbw), which showed a sustained response up to one year following completion of treatment for Thyroid Eye Disease (TED).
Real-world analysis of Provenge in prostate cancer shows reduction in risk of death and prolonged OS.- Dendreon Pharmaceuticals
Dendreon Pharmaceuticals announced publication of an analysis examining real-world survival outcomes in men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with Provenge (sipuleucel-T) and commonly prescribed oral treatments.
Real-world study of Gilotrif shows second line treatment efficacy in squamous cell carcinoma of the lung.- Boehringer
Boehringer announced new data for Gilotrif (afatinib) which shows its activity in squamous cell carcinoma of the lung. Analysis from a retrospective, real-world study of patients with metastatic squamous NSCLC who progressed on first-line pembrolizumab plus platinum-based chemotherapy provides effectiveness and safety data for afatinib following immunotherapy (IO) in this second-line setting.
Eli Lilly statement on the NIAID decision to pause enrollment in ACTIV-3 clinical trial of bamlanivimab as a treatment for COVID-19 in hospitalized patients.
Eli Lilly has continued to be in communication with the trial sponsor regarding the recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause enrollment of the study.
Johnson & Johnson temporarily pauses all dosing in Janssen COVID-19 vaccine candidate clinical trials
Johnson & Johnson has temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials, including the Phase III ENSEMBLE trial, due to an unexplained illness in a study participant.
CTI BioPharma initiates rolling submission of NDA for pacritinib in myelofibrosis patients with severe thrombocytopenia.
CTI BioPharma Corp. announced that it has commenced a rolling New Drug Application (NDA) submission to the FDA seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L).
Dupixent significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function in a randomized Phase III trial.- Sanofi + Regeneron
A pivotal Phase III trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
Mallinckrodt secures broad consensus with key stakeholders on comprehensive Chapter 11 restructuring
Mallinckrodt plc announced that it has voluntarily initiated Chapter 11 proceedings in the U.S. Bankruptcy Court for the District of Delaware to modify its capital structure, including restructuring portions of its debt, and resolve several billion dollars of otherwise unmanageable potential legal liabilities.
Phase IIb/III SELECTION trial shows efficacy of filgotinib for the induction and maintenance of remission in moderately and severely active ulcerative colitis.- Galapagos NV + Gilead Sciences
Gilead Sciences, Inc. and Galapagos NV presented late-breaking data demonstrating sustained efficacy and safety with filgotinib, an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active ulcerative colitis (UC) .
Bavencio + axitinib combination accepted for use within NHS Scotland for the first-line treatment of adult patients with advanced renal cell carcinoma. Merck KGaA + Pfizer
Merck KGaA and Pfizer’s immunotherapy Bavencio (avelumab) combined with axitinib is accepted for use within NHS Scotland for the first-line treatment of adult patients with advanced Renal Cell Carcinoma (aRCC).
Complete Response Letter for tramadol i.v. for the management of moderate to moderately severe pain.- Avenue Therapeutics
Avenue Therapeutics, Inc. , a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, announced it has received a Complete Response Letter (“CRL”) from the FDA regarding the Company’s New Drug Application (“NDA”) for IV tramadol.
Safety and efficacy of subcutaneous Entyvio sustained during long-term maintenance therapy in adults with moderately to severely active ulcerative colitis.- Takeda
akeda Pharmaceutical Company Limited announced interim results from the VISIBLE open-label extension (OLE) study on the long-term safety and efficacy of maintenance treatment with the subcutaneous (SC) formulation of the gut-selective biologic Entyvio (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC) .
Xenon Pharmaceuticals receives FDA feedback and plans to initiate XEN 496 phase III clinical trial for the treatment of KCNQ2-DEE before year-end.
Xenon Pharmaceuticals Inc. provided regulatory updates on its proprietary pediatric neurology program, XEN 496, a Kv7 potassium channel modulator that is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE).
BMS presents at UEG week, positive late-breaking data from phase III True North Trial evaluating Zeposia in adult patients with moderate to severe ulcerative colitis
Bristol Myers Squibb announced detailed results from True North, a pivotal, placebo-controlled Phase III trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for patients with moderate to severe ulcerative colitis. (UC).
BridgeBio acquires the shares of Eidos Therapeutics.
BridgeBio Pharma, Inc. a company focused on genetic diseases, and Eidos Therapeutics, Inc. a company focused on transthyretin (TTR) amyloidosis (ATTR), announced they have entered into a definitive agreement under which BridgeBio has agreed to acquire all of the outstanding common stock of Eidos it does not already own, representing approximately 36.3% of Eidos’ outstanding shares.
BNT 162b2 vaccine begins rolling submission with Health Canada for COVID-19.- Pfizer Canada and BioNTech SE
Pfizer Canada and BioNTech SE announced the initiation of a rolling submission to Health Canada for BNT 162b2, the lead candidate from the companies' vaccine development program against COVID-19.
PENELOPE-B trial of Ibrance in early breast cancer did not meet primary endpoint- Pfizer
The German Breast Group (GBG) and Pfizer Inc. announced that the collaborative Phase III PENELOPE-B trial did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy.
Two trials of AZD 7442 combination will enrol over 6,000 adults for the prevention of COVID-19 with additional trials enrolling approximately 4,000 adults for the treatment of SARS-CoV-2 infections.- AstraZeneca
AstraZeneca’s long-acting antibody (LAAB) combination, AZD 7442, will advance into two Phase III clinical trials in more than 6,000 participants at sites in and outside the US that are due to begin in the next weeks .
FDA Advisory Committee votes in support of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder.- Alkermes
Alkermes plc announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the FDA.
Phase III “STOP 301” study of INP 104 shows benefit in migraine.- Impel NeuroPharma
Impel NeuroPharma announced that it has presented patient-reported outcomes data from the Company’s pivotal Phase III, open-label study “STOP 301” of INP 104 (dihydroergotamine mesylate) or DHE using the company’s proprietary POD technology, for the treatment of acute migraine.
Phase III C0311002 study of Somatrogon shows efficacy in growth hormone deficiency.- Pfizer + OPKO Health
Pfizer Inc and OPKO Health announced that C0311002, a Phase III, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with growth hormone deficiency (ghd), met its primary endpoint of improved treatment burden compared to genotropin (somatropin) for injection administered once-daily.
Lilly's OVERCOME study reveals nearly 80% of people reported improvement in their migraine since starting a CGRP monoclonal antibody for preventive treatment.
Nearly 80% of people taking calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) for the preventive treatment of migraine reported their migraine as "better" overall since starting their medication, according to a web-based population survey.
Sobi announces topline phase III data of avatrombopag for the treatment of chemotherapy-induced thrombocytopenia.
Swedish Orphan Biovitrum AB (publ) (Sobi) announced topline results from its phase III study of avatrombopag, an oral thrombopoietin (TPO) receptor agonist, in solid tumour cancer patients with chemotherapy-induced thrombocytopenia (CIT).
Final results of NIAID's ACTT-1 trial published in NEJM expands clinical benefits of Veklury for the treatment of COVID-19.- Gilead Sciences
The New England Journal of Medicine (NEJM) published the final results from the National Institute of Allergy and Infectious Diseases’ (NIAID) double-blind, placebo-controlled, Phase III ACTT-1 trial of Gilead’s investigational antiviral Veklury (remdesivir) for the treatment of adults hospitalized with mild-moderate or severe COVID-19 .
First patient enrolled in NIH phase III trial to evaluate potential COVID-19 hyperimmune medicine. Takeda + CSL Behring
The CoVIg-19 Plasma Alliance, an unprecedented collaboration of leading plasma companies supported by global organizations outside the plasma industry, confirmed that patients are now being enrolled in the Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) Phase III clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Baricitinib has significant effect on recovery time and is most impactful in COVID-19 patients requiring oxygen.- Eli Lilly
Eli Lilly and Company and Incyte are sharing additional data showing baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir .
Pfizer and Sangamo dose first participant in phase III study of giroctocogene fitelparvovec for hemophilia A gene therapy treatment.
Pfizer Inc,. and Sangamo Therapeutics, Inc. a genomic medicines company, announced that the first participant has been dosed in the Phase III AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients.
Post-authorisation study of ID NOW COVID-19 EUA Test confirms results submitted to FDA.- Abbott
Abbott has shared new interim clinical data results on its ID NOW COVID-19 rapid test. The results confirm the data submitted to the FDA in March for Emergency Use Authorization (EUA) and the interim results that Abbott shared in its May 21 press release.
FDA Approves label expansion to allow maximum dose of 60 mg for Palynziq injection for treatment of adults with PKU.- BioMarin
BioMarin Pharmaceutical Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) to increase the maximum allowable dose of 60 mg with Palynziq (pegvaliase-pqpz) Injection for treatment of adults with Phenylketonuria (PKU).
Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs, including interim data on combination therapy.
Eli Lilly and Company announced additional details on its SARS-CoV-2 neutralizing antibody programs – including interim data on combination therapy in recently diagnosed patients with mild-to-moderate COVID-19 – and plans to make these therapies broadly available to patients.
Madrigal Pharmaceuticals announces three abstracts to be presented at The Liver Meeting Digital Experience in November 2020, including phase III MAESTRO-NAFLD-1 trial.
Madrigal Pharmaceuticals, Inc. announced that, based on data from studies with MGL 3196 (resmetirom), three posters and an oral presentation of these data will be presented at The Liver Meeting Digital Experience thee American Association for the Study of Liver Diseases Meeting in November 2020.
Vir Biotechnology + GSK announce global expansion to phase III of COMET-ICE study evaluating VIR 7831 for the treatment of COVID-19.
Vir Biotechnology, Inc. and GlaxoSmithKline plc announced the global expansion to Phase III of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR 7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalisation.
Reyvow C-V demonstrated superior pain freedom at 2 hours in at least 2 of 3 migraine attacks in new phase III CENTURION consistency of effect study.- Eli Lilly.
Adults who took Reyvow (lasmiditan) C-V from Eli Lilly, for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 7.2 times greater odds, respectively, of achieving superior pain freedom at 2 hours post treatment compared to those taking placebo in at least 2 out of 3 attacks (co-primary endpoint), new findings from the recently completed Phase III study CENTURION reveal .
Gilead presents Biktarvy findings from switch studies & analysis of real-world BICSTaR study at HIV Glasgow 2020.
Gilead Sciences, Inc. announced long-term study results , which showed that people living with HIV who switched to the once-daily, single tablet regimen, Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) from a boosted protease inhibitor-based regimen consisting of atazanavir (ATV) or darunavir (DRV) plus either emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) or abacavir (ABC)/lamivudine (3TC) maintained virologic suppression (defined as HIV-1 RNA less than 50 copies/mL) with no emergent resistance, through a maximum of 156 weeks.
Santhera to discontinue phase III SIDEROS study and development of Puldysa in Duchenne muscular dystrophy (DMD) and focus on vamorolone.
Santhera Pharmaceuticals announces the discontinuation of its Phase III SIDEROS study with Puldysa (idebenone) in patients with Duchenne muscular dystrophy (DMD) who are in respiratory decline and receive concomitant glucocorticoid treatment.
BMS to acquire MyoKardia and with it mavacamten for the treatment of obstructive hypertrophic cardiomyopathy
Bristol Myers Squibb and MyoKardia, Inc. announced a definitive merger agreement under which Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or $225.00 per share in cash. The transaction was unanimously approved by both the Bristol Myers Squibb and MyoKardia Boards of Directors and is anticipated to close during the fourth quarter of 2020.
Iterum Therapeutics announces positive pre-NDA meeting with FDA for sulopenem for treatment of uncomplicated urinary tract infections.
Iterum Therapeutics plc , a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings,announced that, based on discussions at a pre-NDA meeting with the FDA, it plans to proceed with an NDA submission for sulopenem etzadroxil/probenecid, a bilayer tablet, for the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone-resistant pathogen.
Mesoblast receives a Complete Response Letter from the FDA for its BLA for treatment of steroid refractory acute graft versus host disease in children.
Mesoblast Limited has announced that the FDA has issued a Complete Response Letter to its Biologics License Application (BLA) for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD).
Gilead Sciences update on supply and distribution of Veklury in the United States.
Since the COVID-19 pandemic began, Gilead has worked diligently to ramp up production and rapidly expand the supply of its investigational antiviral drug Veklury (remdesivir) by making significant investments to increase internal manufacturing capacity, expand contract manufacturing network and implement process improvements.
Amgen announces five-year data that reinforce the safety and efficacy of Aimovig in adult patients with episodic migraine.
Amgen announced that results reinforcing the long-term safety and efficacy profile of Aimovig (erenumab-aooe) in patients with episodic migraine (EM) are being presented at the Migraine Trust Virtual Symposium.
Regeneron's REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non hospitalised COVID-19 patients.
Regeneron Pharmaceuticals, Inc. announced the first data from a descriptive analysis of a seamless Phase 1/II/III trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19 .
FDA approves Opdivo + Yervoy as the first and only immunotherapy treatment for previously untreated unresectable malignant pleural mesothelioma.- BMS
Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the FDA for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
BMS announces update on CheckMate -915 evaluating Opdivo + Yervoy versus Opdivo in resected high-risk melanoma patients.
Bristol Myers Squibb announced results for the co-primary endpoint for CheckMate -915, a randomized Phase III study evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo for patients who have had a complete surgical removal of stage IIIb/c/d or stage IV melanoma .
Cytokinetics announces publication of omecamtiv mecarbil in the GALACTIC-HF trial in European Journal of Heart Failure.
Cytokinetics, Incorporated announced that a manuscript detailing the baseline characteristics from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase III event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil, was published in the European Journal of Heart Failure.
EMA accepts MAA for elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for cerebral adrenoleukodystrophy . bluebird bio Inc.,
bluebird bio, Inc. announced that the European Medicines Agency (EMA) accepted the company’s marketing authorization application (MAA) for its investigational elivaldogene autotemcel (eli-cel, Lenti-D™) gene therapy for the treatment of patients with cerebral adrenoleukodystrophy (CALD).
Teva launches first generic versions of HIV-1 treatments of Truvada and Atripla tablets in the U.S.
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the availability of the first FDA-approved generic versions of Truvada and Atripla tablets ( namely Emtricitabine and Tenofovir Disoproxil Fumarate Tablets).
EMA accepts regulatory submission for avalglucosidase alfa, an enzyme replacement therapy for Pompe disease.- Genzyme/Sanofi
The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) from Genzyme/ Sanofi for avalglucosidase alfa, for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid alfa-glucosidase deficiency).
Sobi and Selecta Biosciences announce topline data of SEL 212 from the phase II COMPARE study supporting the potential for important clinical improvement in patients with chronic refractory gout.
Swedish Orphan Biovitrum AB (publ) (Sobi)and Selecta Biosciences, Inc. announced topline data for the phase II COMPARE study comparing the efficacy of SEL 212, a combination of Selecta's tolerogenic ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase), to pegloticase Kyrstexxa), the currently approved uricase in the US , for the treatment of chronic refractory gout .
Zolgensma data including patients with more severe spinal muscular atrophy at baseline further demonstrate therapeutic benefits.- Novartis.
Novartis Gene Therapies announced new interim data from the ongoing Phase III STR1VE-EU clinical trial for Zolgensma (onasemnogene abeparvovec) that demonstrated patients with spinal muscular atrophy (SMA) Type 1 continued to experience significant therapeutic benefit, including event-free survival, rapid and sustained improvement in motor function and motor milestone achievement, including for some patients with more aggressive disease at baseline compared to previous trials.
FDA accepts sNDa for Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma. - Pfizer
Pfizer Inc. announced that the FDA has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA)for Xalkori (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.
Alnylam reports positive topline results from ILLUMINATE-B phase III study of lumasiran for the treatment of primary hyperoxaluria type 1 in children under the age of six.
Alnylam Pharmaceuticals, Inc. announced positive topline results from the ILLUMINATE-B pediatric Phase III study of 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).
FDA approves Xeljanz to treat polyarticular course juvenile idiopathic arthritis .- Pfizer
Pfizer Inc. announced that the FDA approved Xeljanz (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
FDA approves Alkindi Sprinkle oral granules as replacement therapy for adrenocortical insufficiency.- Eton Pharma
Eton Pharmaceuticals, Inc announced that the FDA has approved Alkindi Sprinkle (hydrocortisone) oral granules as replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.
Ironwood to discontinue IW-3718 development program of IW-3718 in refractory gastroesophageal reflux disease following results from planned efficacy assessment.
Ironwood Pharmaceuticals, Inc. a GI-focused healthcare company, announced that data from IW-3718-302, one of Ironwood’s two identical Phase III trials evaluating IW-3718 in refractory gastroesophageal reflux disease (GERD), did not meet the pre-specified criteria associated with a planned early efficacy assessment.
CE Mark for Freestyle 3 system of glucose monitoring and control.- Abbott
Abbott , the worldwide leader in continuous glucose monitoring (CGM) technology, announced has secured CE Mark (Conformité Européenne) for its next-generation FreeStyle Libre 3 system, which is now approved for use by people living with diabetes in Europe.
INOVIO reports FDA partial clinical hold for planned phase II /III trial of COVID-19 vaccine candidate INO 4800.
INOVIO announced that the FDA has notified the company it has additional questions about the company's planned Phase II/III trial of its COVID-19 vaccine candidate INO 4800, including its Cellectra 2000 delivery device to be used in the trial.
EU approves Ayvakyt for metastatic gastrointestinal stromal tumors.- Blueprint Medicines Corp
Blueprint Medicines Corp announced that the European Commission (EC) has granted conditional marketing authorization to Ayvakyt (avapritinib) as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.
FDA issues Complete Response Letter for Libervant to treat seizure clusters.- Aquestive Therapeutics
Aquestive Therapeutics, Inc. announced that the FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant (diazepam) Buccal Film for management of seizure clusters.
FDA approves Nucala to treat Hypereosinophilic Syndrome. - GSK
GlaxoSmithKline plc announced the FDA has approved Nucala (mepolizumab) for the treatment of adult and paediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for at least six months without an identifiable non-haematologic secondary cause.
European Commission approves Jyseleca to treat adults with moderate to severe rheumatoid arthritis.- Gilead Sciences + Galapagos NV.
Gilead Sciences, Inc.and Galapagos NV announced that the European Commission (EC) has granted marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs).
FDA approves Kalydeco as first and only CFTR modulator to treat eligible infants with CF as early as four months of age.- Vertex
Vertex Pharmaceuticals Incorporated announced the FDA approved Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. Kalydeco is already approved in the U.S. and EU for the treatment of CF in patients ages six months and older.
FDA approves Alaway to treat ocular itching.-Bausch + Lomb
Bausch Health Companies Inc. , Bausch + Lomb, a leading global eye health business, and Eton Pharmaceuticals, Inc.announced that the FDA has approved Alaway Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops (EM-100), as the first over-the-counter (OTC) preservative-free formulation eye drop approved to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander, which is one of the eye symptoms that affects approximately 80 percent of people with allergies.
In an interim analysis Opdivo in CheckMate -274 met primary endpoints of disease-free survival in both all randomized patients and in patients whose tumors express PD-L1 in at least 1% of cells.- BMS
Bristol Myers Squibb announced that CheckMate -274, a pivotal Phase III trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma met its primary endpoints of improving disease-free survival (DFS) versus placebo in both all randomized patients and in patients whose tumors express PD-L1 in at least 1% of cells (programmed death-ligand 1).
Keytruda plus chemotherapy reduced risk of death by 27% versus chemotherapy as first-line treatment for locally advanced or metastatic esophageal cancer.- Merck Inc.
Merck announced first-time data from the pivotal Phase III KEYNOTE-590 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer .
World’s largest study of cardiovascular disease in type 2 diabetes shows need for improved knowledge.
Novo Nordisk announced the results of the CAPTURE study, a global non-interventional study to uncover the prevalence of cardiovascular disease and risk and its management in people living with type 2 diabetes.
Semorinemab,anti-Tau antibody, in early Alzheimer’s disease fails in Phase II trial.- AC Immune + Genentech Roche.
AC Immune SA announced that Genentech, a member of the Roche Group, has informed the Company of top line results from a Phase II trial of the anti-Tau antibody, semorinemab, in early (prodromal to mild) Alzheimer’s disease (AD) which show that semorinemab did not meet its primary efficacy endpoint of reducing decline on Clinical Dementia Rating-Sum of Boxes (CDR-SB) compared to placebo.
First patient randomised in the phase III DISSOLVE clinical programme of SE L212 for chronic refractory gout.- SOBI + Selecta Biosciences
Swedish Orphan Biovitrum AB (publ) (Sobi) and Selecta Biosciences, Inc. announced the commencement of the phase III clinical programme of SEL 212 for chronic refractory gout, with the randomisation of the first patient in the study.
Johnson & Johnson initiates pivotal global phase III clinical trial of JNJ 78436735, Janssen’s COVID-19 vaccine candidate.
Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase III trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ 78436735 , being developed by its Janssen Pharmaceutical Companies.
FDA approves new formulations of Clinimix and Clinimix E to support parenteral nutrition- Baxter
Baxter International Inc. a global leader in clinical nutrition, announced the FDA approval of new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections.
Novartis provides update on AVXS-101 Intrathecal Clinical Development Program for spinal muscular atrophy.
Novartis Gene Therapies recently received feedback from the FDA following their review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA).
CHMP recommends extension of Fycompa indication to children with partial onset seizures.- Eisai
Eisai Co., Ltd. announced that it has received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) on the license extension application submitted by its U.K. subsidiary Eisai Ltd. regarding the use of its in-house discovered and developed anti-epileptic agent (AED) Fycompa(R) (generic name: perampanel) in the treatment of pediatric patients.
Roche acquires Inflazome and its early stage NLRP3 inhibitors.
Inflazome announced that it has closed a share purchase agreement with Roche in which Inflazome’s shareholders received an upfront payment of €380 million, and are eligible to receive additional contingent payments to be made based on the achievement of certain predetermined milestones.Inflazome was founded in 2016 by leading medical researchers Prof Matt Cooper (University of Queensland, Australia) and Prof Luke O’Neill (Trinity College Dublin, Ireland).
Illumina acquires Grail and with it Galleri a cancer screening test
Illumina, Inc.and GRAIL, a healthcare company whose mission is focused on multi-cancer early detection, announced they have entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of $8 billion upon closing of the transaction.
FDA gives priority review for bb 2121 for multiple myeloma.- BMS
Bristol Myers Squibb and bluebird bio, Inc. announced that the FDA has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Phase III CheckMate-577 trial of Opdivo shows benefits in oesophageal cancer.- BMS
Bristol Myers Squibb announced that checkpoint inhibitor treatment Opdivo (nivolumab) demonstrated its efficacy in the phase III CheckMate-577 trial involving patients with oesophageal or gastroesophageal junction cancers who had previously received neoadjuvant chemoradiation therapy and tumour resection.
The addition of ipatasertib to paclitaxel in patients with PIK3CA/AKT1/PTEN-altered hormone receptor–positive, HER2-negative advanced breast cancer did not improve survival.- Genentech/Roche
Improvement in progression-free survival (PFS) and objective response rate (ORR) was not observed with the addition of ipatasertib from Genentech/Roche to paclitaxel in patients with PIK3CA/AKT1/PTEN-altered hormone receptor–positive, HER2-negative advanced breast cancer , missing the primary and secondary end points of the phase III IPATunity130 trial for which results were presented during the 2020 European Society of Medical Oncology (ESMO) Virtual Congress.
CHMP recommends Lynparza for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient -positive advanced ovarian cancer. AstraZeneca + Merck Inc.
Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.
CHMP recommends Lynparza to treat metastatic castration-resistant prostate cancer with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations.- AstraZeneca + Merck Inc.
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
CHMP recommends Nyvepria pegfilgrastim biosimilar.- Pfizer.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nyvepria, intended to reduce the duration of neutropenia and to help prevent febrile neutropenia after cytotoxic chemotherapy.
Abbott receives CE Mark for next-generation MitraClip heart valve repair device to treat mitral regurgitation.
Abbott announced it has received CE Mark for its fourth-generation MitraClip Transcatheter Mitral Valve Repair System , the leading minimally invasive mitral valve repair device in the world.
Late-breaking ESMO presentation shows Libtayo monotherapy increases overall survival in first-line advanced non-small cell lung cancer with PD-L1 expression of greater than 50%.- Regeneron + Sanofi.
Positive pivotal trial data for the investigational use of PD-1 inhibitor Libtayo (cemiplimab) in first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) were shared in a presentation at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
CHMP recommends a new 100 mg/mL intravenous (IV) advanced formulation of Ultomiris.- Alexion Pharma
Alexion Pharmaceuticals, Inc.announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization in the European Union for a new 100 mg/mL intravenous (IV) advanced formulation of Ultomiris (ravulizumab).
Verzenio significantly reduced the risk of cancer recurrence by 25% for people with HR+, HER2- high risk early breast cancer.- Eli Lilly
Eli Lilly and Company announced Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25 percent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.747; 95% CI: 0.598, 0.932; p = 0.0096).
Lynparza reduced the risk of death by 31% in BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer in phase III PROfound trial. AstraZeneca + Merck Inc.
Final results from the Phase III PROfound trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus enzalutamide or abiraterone in men with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 or ATM gene mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.
Opdivo + Cabometyx demonstrates significant survival benefits in patients with advanced renal cell carcinoma in pivotal phase III CheckMate -9ER Trial.- BMS + Exelixis
Bristol Myers Squibb and Exelixis, Inc announced the first presentation of results from the pivotal Phase III CheckMate -9ER trial , in which Opdivo (nivolumab)in combination with Cabometyx (cabozantinib) demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), in previously untreated advanced renal cell carcinoma (RCC).
Tagrisso reduced the risk of disease recurrence in the brain by 82% in the adjuvant treatment of early-stage EGFR-mutated lung cancer.- AstraZeneca
Results from a prespecified exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a clinically meaningful improvement in central nervous system (CNS) disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), after complete tumour resection.
Novartis reports late-breaking data from phase III COMBI-i trial of spartalizumab (PDR 001) with Tafinlar and Mekinist in advanced melanoma.
Novartis announced detailed results from the Phase III COMBI-i trial evaluating the investigational immunotherapy spartalizumab (PDR 001) in combination with the targeted therapies Tafinlar (dabrafenib) and Mekinist (trametinib) compared to Tafinlar + Mekinist alone.
Genentech presents new data from multiple phase III studies of Tecentriq in triple-negative breast cancer at ESMO virtual congress 2020.- Genentech/Roche
Genentech, a member of the Roche Group announced that it presented the latest results from three Phase III studies from the Tecentriq (atezolizumab) clinical development program in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Phase III ASCENT study of Trodelvy shows improved survival in triple negative breast cancer.- Immunomedics
Immunomedics announced that results from the confirmatory Phase III ASCENT study showed that Trodelvy (sacituzumab govitecan-hziy) significantly extended overall survival (OS) and improved overall response rate (ORR) and clinical benefit rate (CBR), compared to treatment of choice (TPC) standard single-agent chemotherapy in brain metastases-negative patients with mTNBC who had previously received at least two prior therapies for metastatic disease.
Deciphera presents data from Qinlock Program in patients with gastrointestinal stromal tumor at the ESMO Virtual Congress 2020.
Deciphera Pharmaceuticals, Inc. announced the presentation of nine month follow-up data from the Company’s Phase III INVICTUS study of Qinlock in patients with fourth-line and fourth-line plus gastrointestinal stromal tumors (GIST) and intra-patient dose escalation data from the ongoing Phase 1 study of Qinlock in patients with second-line through fourth-line plus GIST
Phase III SOLAR-1 trial of Piqray shows efficacy in advanced PIK3CA breast cancer.- Novartis
Novartis announced results of the final overall survival (OS) analysis from the phase III SOLAR-1 trial, which evaluated Piqray (alpelisib) in combination with fulvestrant, compared to fulvestrant alone, in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer patients with tumors harboring a PIK3CA mutation.
Phase III EORTC1325/KEYNOTE-054 trial of Keytruda meets secondary endpoint in melanoma.- Merck Inc
Merck announced new and updated findings from the Phase III EORTC1325/KEYNOTE-054 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma.
Lilly announces proof of concept data for neutralizing antibody LY-CoV555 in the COVID-19 outpatient setting.
Eli Lilly and Company announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced rate of hospitalization for patients treated with LY-CoV555.
CHMP recommends Obiltoxaximab SFL to treat anthrax.- SFL Pharmaceuticals Deutschland GmbH.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Obiltoxaximab SFL, intended for the treatment or post-exposure prophylaxis of inhalational anthrax.
CHMP recommends MenQuadfi for prophylaxis against invasive meningococcal disease .- Sanofi Pasteur
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product MenQuadfi, intended for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.
Phase III JAVELIN Bladder 100 study of Bavencio in urothelial carcinoma published in NEJM.- EMD Serono + Pfizer
EMD Serono and Pfizer announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study of Bavencio (avelumab) online ahead of print in The New England Journal of Medicine.
CHMP recommends approval of Tecentriq plus Avastin for unresectable hepatocellular carcinoma.- Roche
Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
CHMP recommends approval of Zejula for ovarian cancer.- GlaxoSmithKline
GlaxoSmithKline announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Zejula (niraparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.
Phase III trial of Padcev meets primary endpoint in urothelial cancer.- Astellas Pharma and Seattle Genetics
Astellas Pharma and Seattle Genetics announced that a phase III trial of Padcev (enfortumab vedotin-ejfv) met its primary endpoint of overall survival compared to chemotherapy for previously treated locally advanced or metastatic Urothelial Cancer.
CHMP recommends approval of Opdivo + Yervoy in non-small cell lung cancer.- BMS
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have no sensitizing EGFR mutation or ALK translocation.
CHMP recommends approval of Exparel in post surgical pain.- Pacira BioSciences
Pacira BioSciences announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Exparel (bupivacaine liposome injectable suspension) for postsurgical analgesia.
BeiGene presents data at ESMO virtual congress 2020 on phase III trial of tislelizumab in first-line non-squamous non-small cell lung cancer.
BeiGene, Ltd. announced the first reported data from RATIONALE 304, the Phase III trial of its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a potential first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which takes place on September 19-21., RATIONALE 304, Phase III Trial of Tislelizumab in Combination with Chemotherapy in First-Line Locally Advanced or Metastatic Non-Squamous NSCLC.":Poster #1263P.
Five-year data from the SOLO-1 phase III trial is the longest follow-up analysis for any PARP inhibitor in the 1st-line maintenance setting to treat advanced BRCA-mutated ovarian cancer. AstraZeneca + Merck Inc.
AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a long-term progression-free survival (PFS) benefit versus placebo as a 1st-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who had a complete or partial response following platinum-based chemotherapy.
PACIFIC phase III trial data at ESMO showed an estimated 35% of non-small cell lung cancer patients treated with Imfinzi had not progressed after four years.- AstraZeneca
Updated results from the PACIFIC Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival (PFS) benefit in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who had not progressed following concurrent chemoradiation therapy (CRT).
CHMP positive for Olumiant to treat atopic dermatitis. Eli Lilly
Eli Lilly and Company and Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Genentech’s phase III EMPACTA study showed Actemra reduced the likelihood of needing mechanical ventilation in hospitalized patients with COVID-19 associated pneumonia.- Genentech/Roche
Genentech, a member of the Roche Group announced that the Phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]).
Phase Ib/II trial of PCM 075 shows efficacy in metastatic KRAS colorectal cancer.- Cardiff Oncology
Cardiff Oncology announced an electronic poster presentation of clinical data further demonstrating the safety, efficacy and durability of response of PCM 075 (onvansertib) in KRAS-mutated metastatic colorectal cancer (mCRC) patients.
Real-world study of Nerivio Migra in migraine published in Pain Medicine.- Theranica
Theranica announced the publication of a new real-world post-marketing surveillance study in Pain Medicine that demonstrates the safety, efficacy and consistency of the company's Nerivio therapeutic wearable device.
Phase III CheckMate -214 trial of Yervoy + Opdivo shows sustained benefits and four year survival rate in advanced renal cell carcinoma.- BMS
BMS announced that more than half of advanced renal cell carcinoma (RCC) patients treated with the Opdivo(nivolumab)plus Yervoy(ipilimumab)combination were alive after four years across the entire study population of the Phase III CheckMate -214 clinical trial.
ChemoCentryx announces FDA acceptance of the avacopan NDA for the treatment of ANCA-associated vasculitis.
ChemoCentryx, Inc., announced that the FDA has accepted the Company’s New Drug Application (NDA) for avacopan, an orally-administered selective complement 5a receptor inhibitor, for the treatment of ANCA-Associated Vasculitis and has set 7 July 2021 as the Prescription Drug User Fee Act (PDUFA) goal date for the avacopan NDA.
Health Canada approves Tremfya to treat psoriatic arthritis.- Janssen Pharma
Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada has approved Tremfya (guselkumab injection) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.
MIRROR open-label trial data published in Journal of Rheumatology shows 79 percent of gout patients achieved a complete response using Krystexxa with methotrexate.- Horizon Therapeutics
Horizon Therapeutics plc announced the publication of the complete dataset on the primary endpoint from its "Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving Krystexxa (MIRROR) open-label trial in the Journal of Rheumatology.
Novartis Tafinlar + Mekinist demonstrates long-term, relapse-free survival benefit for high-risk, stage III melanoma patients in study published in NEJM.- Novartis
Novartis announced previously reported data from the Phase III COMBI-AD study were published in The New England Journal of Medicine .
FDA expands approval of CINtec PLUS Cytology test in HPV-positive patients.- Roche
Roche announced FDA approval for the expanded use of CINtec PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus (HPV).
EU submission complete for Opdivo + Yervoy application to treat untreated, unresectable malignant pleural mesothelioma. - BMS
Bristol Myers Squibb announced that the European Medicines Agency (EMA) validated a type II variation application for Opdivo(nivolumab) plus Yervoy(ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM).
Study of Ajovy in migraine published in Neurology journal.- Teva Pharma
Teva Pharmaceutical Industries announced that results from the 52-week, multicenter, randomized, double-blind, parallel group study evaluating monthly or quarterly Ajovy (fremanezumab-vfrm) injection in adults with chronic migraine (CM) or episodic migraine (EM), were published online ahead of print in Neurology.
Gilead Sciences acquires Immunomedics and with it, Trodelvya treatment for triple negative breast cancer
Gilead Sciences, Inc. and Immunomedics announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Immunomedics for $88.00 per share in cash.
Myovant Sciences presents additional data on bone mineral density in women with uterine fibroids from phase III LIBERTY program of relugolix combination therapy.
Myovant Sciences announced the presentation of one-year data on bone mineral density (BMD) from the Phase III LIBERTY program evaluating the safety and efficacy of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids.
Vertex Pharmaceuticals applies at EMA for expanded indication of Kaftrio to treat cystic fibrosis in patients ages 12 years and older. .
Vertex Pharmaceuticals Incorporated announced the European Medicines Agency (EMA) has validated a Type II Variation Marketing Authorization Application (MAA) for the expanded indication of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat CF in patients ages 12 years and older with at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
GEMINI Phase III trial of AXS 05 shows improved outcomes in depression.- Axsome Therapeutics
Axsome Therapeutics announced that AXS 05 (bupropion + dextromethorphan) rapidly and significantly improved patient-reported outcomes of depression in patients with major depressive disorder (MDD) in the GEMINI Phase III trial.
Seattle Genetics and Merck Inc., announce two strategic oncology collaborations affecting ladiratuzumab vedotin and tucatinib.
Seattle Genetics, Inc. and Merck announced two new strategic oncology collaborations. The companies will globally develop and commercialize Seattle Genetics’ ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in phase II clinical trials for breast cancer and other solid tumors.
Complete Response Letter for terlipressin to treat hepatorenal syndrome type 1.- Mallinckrodt
Mallinckrodt Plc announced that the FDA has issued a Complete Response Letter (CRL) regarding the company's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).
Alexion and Caelum Biosciences announce start of phase III studies of CAEL 101 in AL amyloidosis.
Alexion Pharmaceuticals, Inc. and Caelum Biosciences announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical program to evaluate CAEL 101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis.
Recovery in hospitalized patients with COVID-19 in NIAID-sponsored ACTT-2 trial of baricitinib plus remdesivir.
Eli Lilly and Company and Incyte announced initial data emerging from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Orexo commences patent infringement litigation against Sun Pharmaceutical.
Orexo AB (publ.), announces it has filed a patent infringement action in the United States District Court for the District of New Jersey, against Sun Pharmaceutical Industries Limited, Sun Pharma Global FZE, Sun Pharma Global, Inc., and Sun Pharmaceutical Industries, Inc.
Novartis reports positive topline results from the first phase III trial of Beovu versus aflibercept in patients with diabetic macular edema (DME).
Novartis reported the first interpretable results of the Phase III KITE study , assessing the efficacy and safety of Beovu (brolucizumab) 6 mg in diabetic macular edema (DME).
Satsuma Pharmaceuticals announces topline results from EMERGE phase III trial of STS 101 nasal powder for the acute treatment of migraine.
Satsuma Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company, announced topline results from its Phase III EMERGE efficacy trial of STS 101 (dihydroergotamine (DHE) nasal) powder as an acute treatment for migraine. Although topline data showed numerical differences in favor of STS 101 3.9 mg and 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia and nausea) at two hours post-administration, these differences did not achieve statistical significance for either dosage strength.
Negative results from phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis .- Corbus Pharmaceutical Holdings Inc.
Corbus Pharmaceuticals Holdings, Inc. announced topline results from the 52-week Phase III RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc) .
Positive results from PEDFIC 1 trial of odevixibat to treat progressive familial intrahepatic cholestasis.- Albireo Pharma Inc.
Albireo Pharma, Inc. announced positive topline results from PEDFIC 1, a global Phase III clinical trial evaluating the efficacy and safety of odevixibat and the largest study ever conducted in PFIC1 and PFIC2.
Study 402 positive results evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.-Intra-Cellular Therapies
Intra-Cellular Therapies, Inc. announced positive topline results from its Phase III clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder In Study 402, once daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score (p=0.0206; effect size = 0.27).
NIH ACTIV initiative launches adaptive clinical trials of blood-clotting treatments for COVID-19.- BMS + Pfizer
The National Institutes of Health has launched two of three adaptive Phase III clinical trials evaluating the safety and effectiveness of varying types of blood thinners to treat adults diagnosed with COVID-19.
Phase III FAP-310 trial of CPP-1X/sul in familial adenomatous polyposis published in NEJM.- Cancer Prevention Pharma
Cancer Prevention Pharmaceuticals announced The New England Journal of Medicine (NEJM) has published results from its landmark FAP-310 Phase III clinical trial of CPP-1X/sul (eflornithine + sulindac) as a pharmaco-preventive treatment for adults with familial adenomatous polyposis (FAP).
Phase IIIb EXCHANGE and EXPAND trials show Mayzent as safe in multiple sclerosis.- Novartis
Novartis announced that Mayzent (siponimod) analyses from the Phase IIIb EXCHANGE and EXPAND trials showed Mayzent to be a safe treatment option that has benefits in cognitive performance and reduces the risk of disability progression in patients with progressing MS.
Neurocrine Biosciences presents new data analyses demonstrating efficacy of once-daily Ongentys in patients with Parkinson's disease at the MDS Virtual Congress 2020.
Neurocrine Biosciences, Inc. announced new data from two post-hoc analyses of Phase III data, demonstrating that once-daily Ongentys (opicapone) capsules decreased "off" time and increased "on" time without troublesome dyskinesia as an add-on therapy to levodopa/carbidopa in patients with Parkinson's disease who experience motor fluctuations.
Novartis presents data at ACTRIMS-ECTRIMS for Kesimpta in newly diagnosed treatment-naïve adults with relapsing multiple sclerosis.
Novartis announced new post hoc data showing the efficacy and safety of Kesimpta (ofatumumab), a targeted B-cell therapy, in patients with relapsing forms of multiple sclerosis (RMS) who are newly diagnosed as well as ongoing safety study findings .
Reyvow showed significant therapeutic gains of 17-21% for pain freedom at 2 hours and met all 18 gated endpoints. Eli Lilly
Adults who took Reyvow (lasmiditan) C-V from Eli Lilly, for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 4.6 times greater odds, respectively, of achieving pain freedom at 2 hours compared to those taking placebo (co-primary endpoint), according to results from the recently completed Phase III study CENTURION .
New data reinforce Ocrevus as a highly effective treatment for people with multiple sclerosis.- Genentech/Roche
Genentech, announced new data that show Ocrevus (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT) .
Phase III SAkuraStar and SAkuraSky trials of Enspryng shows efficacy in neuromyelitis optica spectrum disorder.- Genentech/Roche
Genentech/Roche are presenting new Enspryng (satralizumab-mwge) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system, in addition to longer-term efficacy data supporting the continued effect of Enspryng on reducing the risk of NMOSD relapse, as well as its favorable benefit:risk profile.
FDA approves Trelegy Ellipta to treat asthma. GSK
GlaxoSmithKline plc and Innoviva, Inc. announced the FDA has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD).
Janssen Biotech files sBLA at FDA for Darzalex Faspro to treat light chain (AL) amyloidosis.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies.
Fasenra success in phase III OSTRO trial for treatment of nasal polyps.-AstraZeneca
High-level results from the OSTRO Phase III trial showed AstraZeneca’s Fasenra (benralizumab) compared with placebo demonstrated a statistically significant improvement in the size of nasal polyps and in nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) .
New England Journal of Medicine publishes positive final results from phase 1/IIa study of BIVV001 in people with severe haemophilia A. Sanofi + Sobi
he New England Journal of Medicine published positive final results from the phase 1/IIa trial evaluating the safety, tolerability and pharmacokinetics of BIVV001 (rFVIIIFc-VWF-XTEN) in adult patients with severe haemophilia A .
AZD 1222 vaccine phase III trial for coronavirus-19 is paused.-AstraZeneca
As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD 1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.
Genentech/Roche announced a higher-dose phase III clinical trial program for Ocrevus and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with Multiple Sclerosis.
Genentech/Roche announced a higher-dose Phase III clinical trial program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with MS.
Merck Inc., announces positive topline results from two phase III adult studies evaluating V114, an investigational 15-valent pneumococcal conjugate vaccine, including pivotal trial.
Merck inc., announced that two Phase III studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, met their primary immunogenicity objectives.
TransCon hGH filed with EMA for pediatric growth hormone deficiency.- Ascendis Pharma
Ascendis Pharma announced the submission of a MAA to the EMA seeking approval for TransCon hGH (lonapegsomatropin), an investigational long-acting once-weekly prodrug of somatropin (human growth hormone or hGH), previously known as ACP 001, for the treatment of pediatric patients who are diagnosed with growth hormone deficiency (GHD).
Brukinsa filed with Health Canada to treat Waldenström’s macroglobulinemia. BeiGene Ltd
BeiGene, Ltd. announced that its New Drug Submission (NDS) for Brukinsa (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) has been accepted by Health Canada and granted priority review status.
Genentech/Roche initiates phase III trial programme for fenebrutinib in multiple sclerosis.
Genentech, a member of the Roche Group announced the initiation of an innovative Phase III clinical trial program for its investigational medicine fenebrutinib in multiple sclerosis (MS), along with a higher-dose Phase III clinical trial program for Ocrevus (ocrelizumab) and a distinct Ocrevus trial specifically to support African-American and Hispanic- and Latin-American patients with MS .
The Lancet publishes detailed vosoritide phase III data demonstrating statistically significant increase in annualized growth velocity (AGV) over 52 weeks in children with achondroplasia.- BioMarin
BioMarin Pharmaceutical Inc. announced that The Lancet has published online results from a randomized, double-blind, phase III, placebo-controlled, multicenter trial for vosoritide , an investigational analog of C-type Natriuretic Peptide (CNP), in children aged 5 to 18 years with achondroplasia.
Liminal BioSciences announces resubmission of BLA to FDA for Ryplazim to treat congenital plasminogen deficiency.
Liminal BioSciences Inc. announced that the company, through its U.S. subsidiary Prometic Biotherapeutics Inc., has filed a resubmission of the Biologics License Application (BLA) for Ryplazim (plasminogen) with the FDA for the treatment of congenital plasminogen deficiency (C-PLGD).
Phase III PEDFIC 1 trial of A 4250 meets primary endpoints in progressive familial intrahepatic cholestasis.- Albireo
Albireo Pharma announced positive topline results from PEDFIC 1, a global Phase III clinical trial evaluating the efficacy and safety of A 4250 (odevixibat) and the largest study ever conducted in PFIC1 and PFIC2.
Phase III ADAPT-PO trial of SPR 994 shows efficacy in complicated urinary tract infection.- Spero Therapeutics
Spero Therapeutics announced positive topline results from ADAPT-PO, the pivotal Phase III clinical trial evaluating Spero’s oral antibiotic candidate, SPR 994 (tebipenem HBr), for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
Phase III COUGH-1 and COUGH-2 trials of MK 7264 shows mixed results in chronic cough.- Merck Inc
Merck Inc announced the results from two pivotal Phase III trials (COUGH-1 and COUGH-2) evaluating the efficacy and safety of MK 7264 (gefapixant), an investigational, orally administered, selective P2X3 receptor antagonist, for the potential treatment of refractory or unexplained chronic cough.
RedHill Biopharma’s opaganib demonstrates complete inhibition of SARS-CoV-2.
RedHill Biopharma Ltd. announced that opaganib demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID19, achieving complete blockage of viral replication in an in vitro model of human lung bronchial tissue.
Biogen data presented at MS Virtual 2020, ACTRIMS/ECTRIMS meeting advances understanding of clinical and health disparities in Multiple Sclerosis .
Biogen Inc. announced findings from two large, real-world studies that provide insight into the clinical and health disparities that exist for people living with multiple sclerosis (MS) .
Scottish Medicines Consortium (SMC) accepts Iluvien intravitreal implant for prevention of relapse in recurrent non-infectious uveitis. -Alimera Sciences
The Scottish Medicines Consortium (SMC) has accepted Iluvien (190µg fluocinolone acetonide (FAc) intravitreal implant in applicator) from Alimera Sciences, for use within NHS Scotland for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in adults.
EU approves variation to MAA for Imbruvica plus Rituxan in chronic lymphocytic leukaemia.- Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved a variation to the marketing authorisation for Imbruvica (ibrutinib), extending the approved indication in chronic lymphocytic leukaemia (CLL) to include combination with rituximab for previously untreated adult patients.
Post hoc analysis of Enerzair Breezhaler shows reduction in exacerbation rates of asthma.- Novartis
Novartis announced that high-dose, once-daily Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) significantly reduces both moderate-or-severe and severe asthma exacerbation rates in patients whose asthma is uncontrolled on medium- or high-dose long-acting beta2-agonist (LABA)/inhaled corticosteroids (ICS), when compared with a once-daily medium-dose of the same treatment.
Acasti Pharma reports topline results from phase III TRILOGY 2 study of CaPre in patients with severe hypertriglyceridemia.
Acasti Pharma Inc. focused on the research, development and commercialization of its prescription drug candidate CaPre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), announced top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase III TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia.
Supplemental BLA filed with FDA for Yescarta in relapsed or refractory indolent non-Hodgkin lymphoma.- Kite Pharma/Gilead Sciences
Kite Pharma/Gilead Sciences have submitted a supplemental Biologics License Application (sBLA) to the FDA for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma - relapsed or refractory indolent non-Hodgkin lymphoma (NHL) - after two or more prior lines of systemic therapy.
EMA’s safety committee (PRAC) recommended revocation of the marketing authorisations of 5-mg ulipristal acetate to treat symptoms of uterine fibroids.- AbbVie + Gedeon Richter
EMA’s safety committee (PRAC) recommended the revocation of the marketing authorisations of 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids, as a review carried out by the committee confirmed liver injury, including the need for liver transplantation, caused by these medicines.
FDA accepts for review NDA for pralsetinib to treat patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. -Blueprint Medicines + Genentech/Roche
Blueprint Medicines announced the FDA has accepted the company's new drug application (NDA) for pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.
FDA approval of Gavreto to treat RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. -Blueprint Medicines + Genentech/Roche
Blueprint Medicines Corporation announced that the FDA has approved Gavreto (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. The approval is based on data from the Phase 1/II ARROW clinical trial, which showed efficacy for Gavreto in patients with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.
Bavencio from Merck KGaA and Pfizer is available under the Early Access to Medicines Scheme (EAMS) as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.
Bavencio (avelumab) from Merck KGaA and PFizer is available under the Early Access to Medicines Scheme (EAMS) as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC - bladder cancer) that has not progressed with first-line platinum-containing chemotherapy.
Akebia Therapeutics announces top-line results from its PRO2TECT global phase III program of vadadustat for treatment of anemia due to chronic kidney disease in adult patients not on dialysis.
Akebia Therapeutics, Inc. announces top-line results from PRO2TECT, the second of its two global Phase III cardiovascular outcomes programs.
New analysis of COVID-19 studies shows mortality benefit of inexpensive steroids.
A meta-analysis of pooled data from seven completed studies involving 1,703 critically ill COVID-19 patients showed that the administration of corticosteroids reduced mortality compared to standard-of-care (SOC) treatment.