Archive for March 2023

The pandemic has exposed longstanding vulnerabilities in the U.S. medical supply chain as well an overreliance on China and other countries, according to a new report on drug shortages by the majority staff on the Senate Committee on Homeland Security and Governmental Affairs. Source: Drug Industry Daily

The Biden administration’s fiscal 2024 budget request dedicates a total of $59 million for new efforts to increase drug and device supply chain security, HHS Secretary Xavier Becerra told Congress last week. Source: Drug Industry Daily

The International Council for Harmonization (ICH) has finalized a new guideline covering nonclinical considerations for gene therapies, setting the stage for individual ICH member nations to accept and release their own versions of the guideline. Source: Drug Industry Daily

The FDA has told Incyte that it can’t review the company’s new drug application (NDA) for Janus kinase inhibitor Jakafi (ruxolitinib) extended-release (XR) tablets without more supporting data. Source: Drug Industry Daily

Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week. Source: Drug Industry Daily

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations — including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Source: Drug Industry Daily

The Federal Trade Commission (FTC) has filed an amicus brief urging the U.S. District Court for the District of Delaware not to dismiss the suit brought by Sage Chemical and its marketing partner TruPharma against Supernus Pharmaceuticals over alleged blocking of generic competition. Source: Drug Industry Daily

The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development. Source: Drug Industry Daily

The FDA said it could not approve AbbVie’s new drug application (NDA) for ABBV-951 (foslevodopa/foscarbidopa), an investigational therapy for advanced Parkinson’s disease, because of concerns about the delivery device. Source: Drug Industry Daily

Members of an FDA advisory committee agreed in a 5-3 vote yesterday that clinical data on Biogen’s tofersen — a first-in-class drug candidate for a rare type of amyotrophic lateral sclerosis (ALS) — didn’t support a full approval, but said it might pass muster for an Accelerated Approval. Source: Drug Industry Daily