Archive for February 2023

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

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 70 percent and expanding its program that caps patient out-of-pocket costs at $35 per month. Source: Drug Industry Daily

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

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 Daily

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

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

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

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

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

A single infusion of BioMarin’s Roctavian (valoctocogene roxaparvovec) reduced bleeding rates by 84 percent for two years in patients with hemophilia A, according to a study published in The New England Journal of Medicine (NEJM). Source: Drug Industry Daily