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FDA Accepts Biogens Aducanumab Biologics License Application for Alzheimer’s Disease with Priority Review
Biogen and Eisai, Co., Ltd. announced that the U.S. FDA has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act...
Drug Research
Caprion-HistoGeneX, Viroclinics-DDL Announce COVID-19 Research Partnership
Caprion-HistoGeneX and Viroclinics-DDL announced a new strategic partnership to expand their global capabilities addressing the emerging needs for therapeutic and prophylactic solutions to target infectious diseases including COVID-19. This partnership brings together the leadership of two contract research organizations...
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Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-CoV-2
Pfizer Inc. and BioNTech SE announced that preliminary, peer-reviewed data from their BNT162 mRNA-based vaccine development program, Project Lightspeed, against SARS-CoV-2, were published online in the journal Nature. These preliminary clinical data on BNT162b1, a nucleoside-modified messenger RNA (modRNA)...
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Gilead Submits New Drug Application to U.S. FDA for Veklury for the Treatment of COVID-19
Gilead Sciences, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for Veklury® (remdesivir), an investigational antiviral for the treatment of patients with COVID-19. Veklury is currently available in the U.S. under an...
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Novavax Inc and Serum Institute of India Announce Development and Commercial Collaboration
Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced a license agreement with Serum Institute of India Private Limited (SIIPL) for the development and commercialization of NVX CoV2373, Novavax’ COVID?19 vaccine candidate, in low-...
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Innovent and Eli Lilly Announce Acceptance of a Supplemental NDA of TYVYT in Platinum as First-Line Therapy in Non-Small Cell Lung Cancer in China
Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, jointly announced with Eli Lilly and Company that the National Medical Products Administration...
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Evotec receives CARB-X funding for Resolutes antibiotic project
Evotec SE announced that the Company has entered into a new partnership with the Biotech company Resolute Therapeutics to combat infectious diseases and antimicrobial resistance. The partnership aims to develop a broad-spectrum antibiotic with a new mode of action...
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