Moderna Shot Higher Effectiveness than Pfizer & JJ, CDC Says
A Centers for Disease Control and Protection (CDC) US-based study has found that the Moderna vaccine is more effective than Pfizer & JJ vaccines at preventing hospitalizations due to COVID-19. The agency’s Morbidity and Mortality Weekly Report states that, the...
MS: EMA Committee Supports Diroximel Fumarate Approval
European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced their approval of diroximel fumarate (Vumerity, Biogen Inc) for adults diagnosed with relapsing-remitting multiple sclerosis (MS). Although Diroximel fumarate is...
FDA, EMA Launch PSA Pilot for Complex, Hybrid Generic Drugs
The US FDA (Food & Drug Administration) and the EMA (European Medicines Agency) have launched a joint pilot designed to give parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines (as they’re referred to in the EU). The aim of...
WHO-Backed African Hub to Replicate Moderna COVID-19 Vaccine
The World Health Organization (WHO) has announced that they plan on replicating Moderna’s COVID-19 vaccine to boost COVID-19 vaccination rates and production in Africa. Although efforts have yet to yield results, the plans will allow for more developing countries to...
FDA Accepts Axsome Therapeutics NDA for AXS-07
Biopharmaceutical company Axsome Therapeutics, known for developing innovative therapies for central nervous system (CNS) disorders, announced that the FDA (Food and Drug Administration) has accepted their New Drug Application (NDA) for AXS-07 for acute migraine...
BeiGene’s BLA for Tislelizumab Accepted for Review by FDA
The US FDA (Food and Drug Administration) has accepted for review BeiGene’s Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab to treat patients with reoccurring locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)...