Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19
- Details
- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™ (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion.
Pfizer and BioNTech announce collaboration with Biovac to manufacture and distribute COVID-19 vaccine doses within Africa
- Details
- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as "Biovac," a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union.
U.S. FDA grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 vaccine
- Details
- Category: Business
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.
Collaboration between AbbVie, Biogen and Pfizer creates world's largest browsable resource linking rare protein-coding genetic variants to human health and disease
- Details
- Category: Pfizer
The access to the world's largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequence analysis collaboration between AbbVie (NYSE: ABBV), Biogen Inc. (Nasdaq: BIIB) and Pfizer (NYSE: PFE). Managed by the Broad Institute of MIT and Harvard, the browser gives access to results from analyses of whole exome sequencing data from 300,000 UK Biobank research participants.
Tezepelumab granted Priority Review by U.S. FDA
- Details
- Category: Amgen
Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.
Positive new data for Johnson & Johnson single-shot COVID-19 vaccine on activity against Delta variant and long-lasting durability of response
- Details
- Category: Johnson & Johnson
Johnson & Johnson (NYSE: JNJ) (the Company) announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date.
GSK and Alector announce global collaboration in immuno-neurology
- Details
- Category: GlaxoSmithKline
GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical-stage, potential first-in-class monoclonal antibodies (AL001 and AL101) designed to elevate progranulin (PGRN) levels.
More Pharma News ...
- Moderna announces emergency use authorization for its COVID-19 vaccine granted by government of India
- Sanofi launches dedicated vaccines mRNA Center of Excellence
- Roche's Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19 in hospitalised adults and children
- Novartis and Hewlett Packard Enterprise join forces to advance Novartis global health efforts
- BioNTech announces first patient dosed in Phase 2 clinical trial of mRNA-based BNT111 in patients with advanced melanoma
- GSK and Vir Biotechnology announce continuing progress of the COMET clinical development programme for sotrovimab
- AstraZeneca welcomes Court ruling on supply of its COVID-19 vaccine to Europe