Regulatory
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
Principal Scientist Anders Cai Holm Hansen explains how CDMO AGC Biologics uses its global, single-use network and a strategy emphasizing “scale-out” manufacturing, to derisk demand uncertainty, speed timelines and conserve cash for emerging drug developers.
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to treat cerebral folate deficiency with “autistic features.”
A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.
The approval of Eli Lilly’s oral obesity drug officially ignites an intense competition with Novo Nordisk’s oral Wegovy; Gilead Sciences and Neurocrine Biosciences keep the M&A train chugging; Trump hits pharma with his long promised tariffs, and the FDA proposes many changes with 2027 budget.
If the Trump administration’s proposal passes, the FDA’s budget will be more than $200 million bigger in 2027, with plans to launch new programs that expedite drug development, boost national security and promote “radical transparency.”
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.
Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early testing, smart IP and regulatory planning, and scalable CMC choices can help founders reach first-in-human faster.
PRESS RELEASES