AdComm Gives Green Light to GSK’s RSV Vaccine

An FDA advisory committee unanimously agreed yesterday that GlaxoSmithKline’s investigational vaccine Arexvy (RSVPreF3-AS01E) is effective in preventing lower respiratory tract disease associated with respiratory syncytial virus (RSV) infections in people age 60 years and older. Source: Drug Industry Daily

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OGD Reports Uptick in Generic Approvals for 2022

The FDA’s Office of Generic Drugs (OGD) approved 742 abbreviated new drug applications (ANDA) in 2022 compared with 663 the previous year, according to OGD’s latest annual report. Source: Drug Industry Daily

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Controversial FDA Official Behind Aduhelm Approval Departs FDA

Billy Dunn, director of the FDA’s Office of Neuroscience (ON) and a key figure in the FDA’s controversial June 2021 approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), is officially leaving the agency after nearly two decades. Source: Drug Industry Daily

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Jazz Pharmaceuticals Loses Narcolepsy Drug Patent Appeal

A federal appeals court has rejected Jazz Pharmaceuticals’ attempt to overturn a lower court ruling invalidating a patent claim covering the company’s Risk Evaluation and Mitigation Strategies (REMS) distribution system for its blockbuster narcolepsy therapy Xyrem (oxybate). Source: Drug Industry Daily

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FDA Hiring Ethicists to Help Agency Frame Difficult Issues, Says Califf

The FDA is bringing in ethicists to help the agency better frame issues around gene editing as well as data generation using patients with rare diseases that have no cure, said FDA Commissioner Robert Califf, speaking during the agency’s Rare Diseases Day 2023 virtual public meeting on Monday. Source: Drug Industry Daily

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California OTC Drugmaker Rapped for Lacking Written Procedures

Cosmoceutical Research Center was hit with a five-observation Form 483 following an inspection of its Panorama City, Calif., facility for lack of written quality control procedures, failing to test incoming components and several other lapses. Source: Drug Industry Daily

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Coalition of States Sues FDA Over Abortion Pill REMS

Attorneys general from a dozen states have filed a lawsuit against the FDA over its Risk Evaluation and Mitigation Strategies (REMS) for the abortion pill, mifepristone, arguing that the restrictions are not necessary and create burdens for patients. Source: Drug Industry Daily

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