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An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
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As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistically significant.
With Phase 3 data showing what analysts called a “potentially best-in-class profile,” Arrowhead Pharmaceuticals plans to submit for FDA approval of plozasiran by the end of the year—hoping to follow to market Ionis Pharmaceuticals’ Tryngolza, which got the regulator’s nod in severe hypertriglyceridemia last month.
Top-selling cell therapies from BMS, J&J and Gilead depend on a BioLife product, positioning Repligen to use the takeover to increase its exposure to the modality.
A Congressional advisory panel recommends the U.S. government put supportive policies in place for rare disease drug development, such as a finalized platform designation from the FDA and the allowance of novel trial designs for small patient populations.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
The discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.
Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues.
Working at a Big Pharma has its benefits, but there are limitations too. SERB Pharmaceuticals’ Thomas Kolaras discusses how moving to a midsize company creates new opportunities for sharpened thinking and leadership.
With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the indication.