A bill that would prevent pharma companies from blocking generic competition by patenting their drugs’ Risk Evaluation and Mitigation Strategy (REMS) programs is making a return appearance in the 118th…
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,…
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…
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…
An FDA advisory committee has cleared the way for Pfizer’s investigational respiratory syncytial virus (RSV) vaccine, Abrysvo (RSVpreF) — a likely blockbuster product for Pfizer if approved. Source: Drug Industry…
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…
In the midst of swirling controversy about high insulin prices, Eli Lilly has announced that it’s reducing the cost of its most commonly prescribed — and older — insulins by…
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…
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…
The FDA outlines drug trial options for developers of neovascular age-related macular degeneration drugs in a newly published draft guidance. Source: Drug Industry Daily