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What’s in Today’s Brief? (February 16th Preview)
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Ex‑FDA oncology chief says he was pressured to back trial cuts
Richard Pazdur, the long‑time FDA oncology veteran who stepped down last year, told the Wall Street Journal he was presented with a ready-made quote and asked to "just agree to it" amid agency moves to reduce clinical trial requirements. Pazdur said the change — shifting CDER to accept one pivotal trial instead of two — prompted his resignation and reflected an erosion of the historical separation between the commissioner's office and review staff. The report quotes HHS spokespeople defending Commissioner Marty Makary’s push as "urgent reform," while Pazdur warns of an uncertain regulatory future. The account names Pazdur’s prior roles, including founding director of the Oncology Center of Excellence, and cites internal friction when Makary tapped Pazdur to lead CDER. For industry readers, the episode signals potential shifts in evidentiary expectations, review autonomy, and the political exposure of senior reviewers — factors that could change trial design, regulatory timelines, and sponsor‑agency interactions.
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CBER director faces complaints as Moderna flu review stalls
Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, is the subject of internal complaints alleging misconduct while also overruling staff to return a refusal‑to‑file letter to Moderna for its seasonal influenza mRNA candidate, according to Wall Street Journal reporting. The dispute centers on trial design and choice of comparator; agency reviewers had disagreed with Prasad’s decision and some pushed to proceed with a formal review team. Moderna pushed back publicly, saying its comparator was agreed with CBER prior to the study; company CEO Stéphane Bancel called the decision unexpected. The episode highlights growing agency internal friction and shows how leadership disputes can directly disrupt vaccine review pathways, with potential downstream impacts on sponsor timelines and public‑private vaccine programs.
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FDA rejects Disc’s rare‑disease drug…fast‑track status didn’t help
The FDA issued a complete response letter to Disc Medicine, rejecting bitopertin for erythropoietic protoporphyria (EPP) and questioning the use of percent change in whole‑blood metal‑free PPIX as a surrogate endpoint, the company said in an SEC filing. The agency found the PPIX reductions modest and insufficiently linked to clinical benefit, and requested an adequate, well‑controlled study using clinical endpoints. Disc — which had received a Commissioner’s National Priority Voucher and was part of an accelerated review pilot — said the concerns are "readily addressable" and is running a Phase 3 APOLLO study that includes time‑in‑sunlight endpoints. Market reaction was swift: Disc shares fell and analysts expressed surprise given the drug’s selection for expedited review. The CRL underscores regulator skepticism about surrogate biomarkers in rare diseases and signals that rapid review pathways do not replace requirements for clear clinical benefit evidence.
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Fujifilm opens UK single‑use CDMO — £400m campus expansion
Fujifilm Biotechnologies inaugurated its expanded Teesside campus in the UK after a roughly £400 million investment, opening what it calls the country's largest single‑use biopharma CDMO facility. The 110,000 sq. ft. site adds 2,000 L and 5,000 L single‑use reactors with up to 19,000 L capacity and launches a Bioprocess Innovation Centre (BIC UK) for high‑throughput and continuous process development. Fujifilm said the expansion aligns with its kojoX modular manufacturing approach and will accelerate tech transfer with its Toyama site in Japan. For drug developers, the facility expands mid‑scale antibody manufacturing capacity and aims to shorten scale‑up timelines for oncology, neurodegenerative and rare‑disease programs; the site will be operational in H1 2026.
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China clears Gensci‑136 trials — dual APRIL/BAFF antagonist enters clinic
Changchun Genescience Pharmaceutical announced NMPA clearance to initiate clinical trials of Gensci‑136, a dual APRIL/BAFF antagonist for immunoglobulin A nephropathy (IgAN). The NMPA clearance authorizes first‑in‑human dosing of the injectable biologic, marking a regulatory milestone for a mechanism that targets B‑cell survival signals implicated in IgAN pathophysiology. For biotechs focused on kidney immunology, the move signals China’s ongoing emphasis on advancing novel biologics into clinical testing and could prompt competitive development updates from peers pursuing BAFF/APRIL biology.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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