Biohaven Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Developments prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
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European Medicines Agency Accepts Pfizer’s Marketing Authorization Application for Its Investigational 20-valent Pneumococcal Conjugate Vaccine for Adults 18 Years
If approved, the vaccine would help protect adults against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia
NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older. With the MAA acceptance, the formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) begins.
ADC Therapeutics to Participate in Cowen 41st Annual Health Care Conference apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
Provention Bio Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
-U.S. Food and Drug Administration (FDA) filing of a Biologics License Application (BLA) and Priority Review for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals; PDUFA goal date of July 2, 2021-
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RED BANK, N.J., Feb. 25, 2021 /PRNewswire/ Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the fourth quarter and full year ended December 31, 2020. 2020 was a pivotal year for Provention Bio and the type 1 diabetes (T1D) landscape, stated Ashleigh Palmer, CEO of Provention Bio. The FDA s filing of our BLA for teplizumab represents a momentous achievement for Provention Bio in our mission to potentially deliver the first disease-modifying T1D therapy, which may cat
- Full-year 2020 Total Revenues Increased 9% to $1.86 billion
- Company Dose-escalates in PHEarless, a Phase 1/2 Study with BMN 307 Gene Therapy for the Treatment of Phenylketonuria (PKU); the Third Potential Therapeutic Modality in its PKU Franchise
- During the Fourth Quarter, BioMarin Announced Benefit Maintained for Over Two Years in Children with Achondroplasia Treated with Vosoritide in Phase 3 Extension Study
- Marketing Applications for Vosoritide to Treat Children with Achondroplasia under Review in Europe and the U.S.; Committee for Medicinal Products for Human Use (CHMP) Opinion Expected in June 2021
- In January 2021, BioMarin Announced Positive Phase 3 Results with Valoctocogene Roxaparvovec in Adults with Severe Hemophilia A; Study Met All Primary and Secondary Efficacy Endpoints in One-Year Data Set; Mean Annualized Bleed Rate was 0.9 in Subset Dosed More than Two Years Ago