Pfizer and BioNTech submit a variation to EMA with the data in support of a booster dose of COMIRNATY®
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- Category: Business
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Conditional Marketing Authorization (CMA) with data supporting a booster (third) dose of COMIRNATY® (COVID-19 vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. Sandoz strengthens pipeline by entering into agreement for biosimilar bevacizumab, a key oncology medicine
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- Category: Novartis
Sandoz, a Novartis division, today announced that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706). Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF), a key mediator of angiogenesis in cancer, and is used in combination with other treatments(1,2). SK bioscience and GSK start Phase 3 trial of adjuvanted COVID-19 vaccine candidate
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- Category: GlaxoSmithKline
SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination with GSK's pandemic adjuvant following positive interim Phase 1/2 results. Lilly and Lycia Therapeutics enter into strategic collaboration to discover and develop novel lysosomal targeting chimera (LYTAC) degraders
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- Category: Eli Lilly and Company
Eli Lilly and Company (NYSE: LLY) and Lycia Therapeutics, Inc. today announced a multi-year research collaboration and licensing agreement focused on the discovery, development and commercialization of novel targeted therapeutics using Lycia's proprietary lysosomal targeting chimera, or LYTAC, protein degradation technology. AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19
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- Category: AstraZeneca
Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint.
AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo.
Second-generation mRNA COVID-19 vaccine candidate, CV2CoV, demonstrates improved immune response and protection in preclinical study
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- Category: GlaxoSmithKline
CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), and GSK announced the publication of preclinical data investigating immune responses as well as the protective efficacy of CureVac's first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, against SARS-CoV-2 challenge in non-human primates. Pfizer and BioNTech announce submission of initial data to U.S. FDA to support booster dose of COVID-19 vaccine
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies' COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. More Pharma News ...
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