Food and Drug Administration (FDA)
NEWS
Flagship Pioneering has partnered with Novo Nordisk to build a portfolio of potential treatments for cardiometabolic and rare diseases.
Jacqueline Shea will take over as the new CEO and announced plans to discontinue its Phase III Innovate trial to prioritize its heterologous booster strategy for COVID-19.
The revised PDUFA action date for miglustat is August 29, 2022, while the new date for cipaglucosidase alfa is October 29, 2022. Amicus expects the agency to approve the applications together.
AstraZeneca and Sanofi’s Phase-III and Phase-IIb clinical trials investigating the efficacy of nirsevimab shows 79.5% efficacy in the prevention of lower respiratory tract infections.
ICER recommended two out of three outpatient treatments for COVID-19 in today’s market, singling out molnupiravir as having inadequate evidence that it is better than symptomatic care.
Current COVID-19 booster shots have a problem: they last only about four months and appear to have limited efficacy in a vaccinated population. Clearly, a more durable approach is needed.
Eisai and Biogen have completed the rolling submission of a Biologics License Application for lecanemab drug to the U.S. Food and Drug Administration.
Orion announced that it will be focusing on pain and oncology going forward. As a result, 32 working professionals within the company will be terminated, although six of those will be offered different positions.
LogicBio Therapeutics has received the green light to continue dosing participants in its Phase I/II Sunrise trial, following a clinical hold placed by the FDA due to adverse events in pediatric patients.
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