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  • Pharma groups urge FDA to clarify criteria for approving drugs based on a single pivotal trial
    Pharmaceutical companies and industry associations are asking the U.S. Food and Drug Administration for more detailed guidance on when a single pivotal clinical trial, supported by additional confi…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Anew Labs, ByteDance’s biotech spinout, raises $290M to build a China AI bio rival
    Anew Labs, a biotech spinout from ByteDance, announced it has secured $290 million in funding. The capital came from a mix of Chinese investors such as HSG, IDG Capital and Hillhouse Investment, a…
    Endpoints · 1mo agoDealPositive↗ source
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  • Vivodyne’s Human Tissue Factory Wins Endpoints 11 2026, Promising Faster Drug Testing
    Vivodyne was announced as the winner of the Endpoints 11 2026 competition for its human tissue factory technology. The platform creates human tissue constructs that can be used in preclinical drug…
    Endpoints · 1mo agoPositive↗ source
  • Veteran Russell Shilling leads new federal autism research initiative
    Russell Shilling, a Navy veteran and father of two sons with autism, has been appointed to lead the Advanced Research Projects Agency for Health's new autism project. The initiative is described a…
    STAT · 1mo agoPositive↗ source
  • Tobacco companies submitted 175,000 largely duplicate comments to block FDA menthol cigarette ban
    Researchers at Rutgers University analyzed the public comment period for the FDA’s 2022 proposal to ban menthol cigarettes and found that out of 175,000 submissions, 97% were form letters and only…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Jury awards Nektar $90 million in lawsuit against Eli Lilly over licensing dispute
    A federal jury in a US District Court awarded Nektar Therapeutics $90 million after finding Eli Lilly breached a licensing agreement. The verdict ends a dispute that began when the parties' licens…
    Endpoints · 1mo agoPositive↗ source
  • Medici wins Endpoints 2026 award, touts personalized cancer therapy
    Medici was announced as the winner of the Endpoints 2026 competition. The company said its approach focuses on tailoring cancer treatments to individual patients. The award highlights growing int…
    Endpoints · 1mo agoPositive↗ source
  • Endpoints 11 showcases top biotech startups, signaling renewed optimism and funding
    The Endpoints 11 awards highlight the most promising biotech startups of 2026, offering a snapshot of emerging trends in the sector. According to the summary, the awards illustrate that biotech ap…
    Endpoints · 1mo agoPositive↗ source
  • Kali Therapeutics pivots from Chinese drug acquisitions to focus on its own growing pipeline
    Kali Therapeutics, the winner of the Endpoints 11 2026 competition, initially explored the possibility of purchasing drug candidates from China. The company ultimately chose to rely on its own res…
    Endpoints · 1mo agoPositive↗ source
  • Stipple Bio wins Endpoints 2026 award for precision pancreatic cancer therapy
    Stipple Bio was announced as the winner of the Endpoints 2026 competition, recognized for its work in precision medicine. The company’s approach focuses on developing targeted treatments for pancr…
    Endpoints · 1mo agoPositive↗ source
  • Medra, 2026 Endpoints 11 winner, aims to build self-driving labs
    Medra, the recent winner of the Endpoints 11 2026 competition, announced plans to develop autonomous laboratory systems. The company's founder, who just completed a PhD in robotics, said the goal…
    Endpoints · 1mo agoPositive↗ source
  • Corsera wins Endpoints 11 2026 award, marking a major bet by veteran biotech leaders Meanwell and Maraganore
    Corsera was announced as the winner of the Endpoints 11 2026 competition, a recognition of its scientific progress. The win highlights the involvement of veteran biotech executives Clive Meanwell…
    Endpoints · 1mo agoPositive↗ source
  • Travere names former Amicus CEO Bradley Campbell as new leader; Roche eyes board seat for ex‑Takeda chief Alex Hoffman
    Travere Therapeutics announced that its long‑time chief executive Eric Dube will step down at the start of December, ending an almost eight‑year tenure. The board has selected Bradley Campbell, wh…
    Endpoints · 1mo agoNeutral↗ source
  • Novo signs development deal with Swedish biotech Nanexa to license long-acting delivery technology
    Novo Nordisk has entered a new development agreement with the Swedish biotech Nanexa. Under the pact, Nanexa will license its long-acting drug delivery platform to Novo, expanding the larger compa…
    Endpoints · 1mo agoDealNeutral↗ source
  • Experts say measles death counts are muddled by 'with' vs 'of' debate
    Public health scientists note that Pennsylvania reported two measles‑related deaths in August, but the county coroner described one infant as having died "with" measles rather than "from" the disea…
    STAT · 1mo agoNeutral↗ source
  • Legend's five-year data suggests Carvykti could be a cure; Addex, Indivior split
    Plus news about Amberstone, Henlius and Boehringer Ingelheim. Legend adds to argument for Carvykti as a cure: J&J and Legend Biotech said Friday that 10 of 20 relapsed/refractory multiple myeloma p…
    Endpoints · 1mo agoNeutral↗ source
  • Rakuten Medical appoints Hassan Danesi as chief medical officer, coming from Coherus Biosciences
    Rakuten Medical announced that Hassan Danesi will join the company as its new chief medical officer. The appointment was disclosed in a recent industry column. Danesi previously served as vice pre…
    STAT · 1mo agoNeutral↗ source
  • Opinion: RFK Jr.’s use of the National Center for Health Statistics will add confusion to measles deaths count
    “A discrepancy between how federal and state public health officials determine measles deaths will only increase public confusion,” write Denys T. Lau and Jennifer D. Schoendorf.
    STAT · 1mo agoNeutral↗ source
  • K2 Therapeutics seeks to blend China’s speed with global expertise after winning Endpoints 2026 award
    K2 Therapeutics, a small drug development company, was named the winner of the Endpoints 2026 award. The company said it will try to combine the rapid development pace found in China with its own…
    Endpoints · 1mo agoNeutral↗ source
  • Federal judge overturns key disability protection law
    A federal judge has reversed a longstanding disability protection ruling, reducing the legal safeguards that favored community-based living over institutional care. The Justice Department had anno…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Opinion: FDA commissioner nominee Heidi Overton is ignoring the science on abortion drug
    “With this latest appointment, mifepristone has a new boss but an old problem,” writes Julie F. Kay, founder and CEO of Reproductive Futures.
    STAT · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about a reticent FDA commish nominee, a Novo deal, and more
    President Trump’s nominee to lead the FDA was grilled by senators on hot button topics like China, vaccines, and abortion access
    STAT · 1mo ago↗ source
  • Alnylam alumni lead RNAi biotech City Therapeutics to IPO filing
    Biotechs are rushing into the IPO queue. City Therapeutics submitted its public pitch late Thursday, the same night ADARx Pharmaceuticals priced its $446 million Nasdaq debut. Kendall Square-based ...
    Endpoints · 1mo ago↗ source
  • Heidi Overton, a New Mexico-born physician, nominated as FDA commissioner
    Heidi Overton grew up in Gallup, New Mexico, and as a college freshman expressed a desire to become a doctor and return to her small hometown. Her early ambition was highlighted in a 2007 intervie…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA advisory panel finds Grail's Galleri multicancer blood test benefits outweigh risks
    A Food and Drug Administration advisory panel voted 7-2, with one abstention, to conclude that the probable benefits of Grail's Galleri multicancer blood test outweigh its risks. The panel unanimou…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source