In the ongoing saga of the Pasteur Act — a thus-far unsuccessful bill introduced in 2020 to encourage new treatments for fighting drug-resistant pathogens — a group of academics and…
GSK’s Blenrep (belantamab mafodotin), an antibody-drug conjugate that won accelerated approval in 2020, has failed its required confirmatory study as a treatment for relapsed or refractory multiple myeloma (RRMM), missing…
In the latest twist in an ongoing patent case with far-reaching implications, the U.S. Supreme Court will consider Amgen’s petition seeking review of an appeals court decision that invalidated the…
Before filing for an orphan medicinal product designation, says the European Medicines Agency (EMA) in a new guidance, sponsors should request a pre-submission meeting to discuss the prevalence of the…
The FDA has adopted the final version of an International Conference for Harmonisation (ICH) guidance on the validation of bioanalytical methods and studies. Source: Drug Industry Daily
New 24-month data will delay the FDA’s decision for Apellis Pharmaceuticals’ investigational therapy for the rare eye disease geographic atrophy (GA) until February, but — according to the company —…
The Centers for Disease Control and Prevention (CDC) has revamped its recommendations for prescribing opioids, nixing controversial dose and duration limits from 2016 that critics say hurt patients who needed…
The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled platforms. But at the moment it…
An FDA advisory committee voted 13-0 yesterday in favor of the agency’s long-term strategy for its Knowledge-Aided Assessment and Structured Application (KASA) program, including expanding it from just generic drugs…
Sovereign Pharmaceuticals, a contract development and manufacturing organization (CDMO) based in Fort Worth, Texas, has received an FDA warning letter citing multiple quality control issues that led to inconsistent tablet…