Archive for October 2022

In a new draft guidance released Thursday, the FDA laid out its thinking on developing drugs that treat Clostridioides difficile infection (CDI), as well as those that prevent and reduce recurrence of the condition. Source: Drug Industry Daily

The FDA scolded Jubilant Pharma for failing to properly investigate batch discrepancies and keep written records, among other deficiencies, during an inspection of its Indian facility in Sikanderpur Bhainswal, Uttaranchal conducted from July 20 to Aug. 1. Source: Drug Industry Daily

Acadia Pharmaceuticals has filed three separate patent infringement suits in an attempt to block generic formulations of its only approved drug, Nuplazid (pimavanserin). Source: Drug Industry Daily

As part of its commitments under the recently reauthorized Generic Drug User Fee Amendments (GDUFA), the FDA has set out a list of eight science and research priorities for generics for fiscal year 2023 with a focus on impurities and bioequivalence. Source: Drug Industry Daily

The FDA is pushing off or rescheduling several advisory committee meetings this week — including one to consider what could become of the first over-the-counter (OTC) daily oral contraceptive in the U.S., Opill. Source: Drug Industry Daily

Drug manufacturer and outsourcer Nephron SC failed to adequately investigate incidents of cross-contamination between its outsourced operations and its conventional manufacturing line, said the FDA in an especially lengthy and detailed warning letter that cautioned the company against sharing equipment between the two operations. Source: Drug Industry Daily

AstraZeneca’s blockbuster Fasenra (benralizumab) has stumbled in its quest to become a therapy for eosinophilic esophagitis, failing to hit the clinical target of its dual-primary endpoints in a critical phase 3 trial. Source: Drug Industry Daily

The World Health Organization (WHO) should include drugs on its essential medicines list regardless of their cost, according to a group of researchers that advocates separating reviews of comparative effectiveness, safety and public health priority from consideration of the price of medicines and their cost-effectiveness. Source: Drug Industry Daily

On the heels of a recent FDA write-up, another Catalent facility drew a Form 483 from the agency for multiple quality lapses following an inspection of its Brussels, Belgium, plant. Source: Drug Industry Daily

The Centers for Medicare and Medicaid Services (CMS) should require clinical trial participation of patients seeking coverage for many new drugs, particularly those that have accelerated approval. Source: Drug Industry Daily