Antibody cocktail REGN EB3 (Inmazeb) is the first FDA approved treatment for Ebola.-Regeneron
Biogen submits MAA at EMA for aducanumab, an investigational treatment for Alzheimer’s disease.
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
FDA approves a new formulation of Ultomiris with significantly reduced infusion time for for patients with aHUS and PNH.- Alexion Pharma
FDA grants priority review for Tagrisso for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer.- AstraZeneca
Amylyx Pharmaceuticals announces publication of CENTAUR survival data in Muscle and Nerve journal demonstrating a significant survival benefit from AMX 0035 in ALS patients.
FDA 510(k) approval for ImmersiveView Surgical Plan-a digital surgery platform..-ImmersiveTouch.
Two phase III trials of V 114 show efficacy of vaccine in pneumococcal disease.- Merck Inc
Gilead CEO statement on remdesivir final report for the ACTT-1 Study Group for treatment of COVID-19
CHMP recommends Trixeo Aerosphere
for maintenance treatment in adult patients with moderate to severe COPD.- AstraZeneca
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. will commercialise mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan. -ImmunoGen.
CHMP recommends Forxiga to treat heart failure in patients with or without diabetes.- AstraZeneca
FDA accepts for priority review applications for Opdivo in combination with Cabometyx in advanced renal cell carcinoma. -BMS + Exelixis.
Endo acquires Biospecifics Technologies and access to Xiaflex and Qwo
Orchard Therapeutics receives positive CHMP opinion for Libmeldy for the treatment of early-onset metachromatic leukodystrophy (MLD).
CHMP recommends Fintepla for the treatment of seizures associated with Dravet syndrome.- Zogenix
New long-term data from KEYNOTE-021 (Cohort G) reinforce use of Keytruda in certain patients with advanced nonsquamous NSCLC.- Merck Inc.
FDA approves Venclexta + azacitidine/decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia . AbbVie + Genentech/Roche
Emapalumab's efficacy for primary HLH is confirmed by sensitivity analysis presented at ESID2020.- Swedish Orphan Biovitrium
Solidarity therapeutics trial produces conclusive evidence on the effectiveness of repurposed drugs for COVID-19. WHO
Trial finds Olumiant + Veklury cuts time to recovery for patients with COVID-19.- Eli Lilly and Incyte
Eli LIlly acquires Disarm Therapeutics and gains access to SARMI inhibitors to treat axonal degeneration
CHMP recommends approval of Opdivo in recurrent or metastatic oesophageal squamous cell carcinoma.- BMS
CHMP recommends extended approval for Dupixent in severe atopic dermatitis in children.- Sanofi
CHMP recommends approval of KTE X19 in mantle cell lymphoma.- Kite/Gilead
Novartis receives positive CHMP opinion for Leqvio, a potential first-in-class siRNA for the treatment of high cholesterol.
CHMP recommends approval of Vocabria in HIV.- ViiV HealthCare
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