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Russia’s COVID-19 vaccine to enter production, deliver first batch of doses in two weeks

The world's first vaccine registered by Russian authorities, and now the World Health Organisation has said it is in talks with Russia's health ministry for a thorough review of the safety and efficacy of the vaccine, called Sputnik V. While...

TIACA and Pharma.Aero Join Forces to Prepare Air Cargo Industry for COVID-19 Vaccine

The International Air Cargo Association (TIACA) and Pharma.Aero have joined forces to develop global guidance for the air cargo industry to enable optimal transportation of the COVID-19 vaccine. The guidance will be developed gradually in four work packages through...

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...

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...

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)...

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...

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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