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3,167 stories matching this filter · ← front page

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  • 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 · 26d 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 · 27d agoNeutral↗ source
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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 · 26d 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 · 26d 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 · 26d 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 · 26d 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 · 26d 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 · 28d agoRegulatoryPositive↗ source
  • Eli Lilly partners with China’s InnoCare on drug development deal worth up to $3.35 billion
    Eli Lilly has signed a partnership agreement with Beijing-based InnoCare to co-develop new medicines. InnoCare will apply its internal drug discovery platform while Lilly will contribute its devel…
    Endpoints · 28d agoDealPositive↗ source
  • FDA nominee Heidi Overton avoids taking positions in Senate hearing on vaccines, China and abortion
    Heidi Overton, President Trump’s pick to lead the Food and Drug Administration, appeared before the Senate health committee for a two hour hearing. Senators focused their questions on China, vaccin…
    STAT · 27d agoRegulatoryNegative↗ source
  • Roche signs discovery partnerships with Atavistik Bio and Earendil Labs
    Roche announced new collaborations with the drug discovery companies Atavistik Bio and Earendil Labs to develop early-stage candidates. The agreements continue a recent wave of dealmaking by the S…
    Endpoints · 27d agoDealNeutral↗ source
  • Indonesian court strikes down patent evergreening amendment, signaling pushback on drug pricing tactics
    An Indonesian Constitutional Court ruled that a recent amendment allowing patent evergreening was unconstitutional, reinstating the original restriction that balances patent rights with public heal…
    STAT · 27d agoRegulatoryPositive↗ source
  • Acadia’s Alzheimer’s psychosis drug misses Phase 2 goals, but moves to revised Phase 3
    Acadia Pharmaceuticals announced that its experimental treatment for psychosis linked to Alzheimer’s disease failed to meet the primary endpoints in a Phase 2 trial. The company said the data stil…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Kyverna reports durable responses in early cell therapy trial for autoimmune disease
    Kyverna Therapeutics announced new data from its cell therapy candidate targeting an autoimmune condition, marking progress toward a potential first‑in‑class product. The results showed that a not…
    STAT · 27d agoPositive readoutPositive↗ source
  • FDA nominee Heidi Overton pledges faster, more efficient regulation to keep pace with China
    During a Senate hearing, Heidi Overton was confirmed as the nominee to lead the U.S. Food and Drug Administration. She outlined her priorities for the agency. Overton said the FDA must move faster…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Merck's $1.3B EyeBio investment yields first ophthalmology success
    Merck's strategic move to re-enter ophthalmology has begun to show results after its 2024 acquisition of EyeBio. The company committed $1.3 billion upfront for EyeBio, aiming to broaden its pipeli…
    Endpoints · 27d agoDealPositive↗ source
  • Gilead pushes further into immunology, touts inflammation drug pipeline
    Gilead Sciences’ senior leadership has repeatedly emphasized the company’s long‑term ambition to expand beyond its virology roots into the inflammatory and autoimmune space. The messaging, delivere…
    STAT · 27d agoPositive↗ source
  • Kyverna reports positive one-year CAR-T results for rare stiff person syndrome, supporting FDA filing
    Kyverna Therapeutics announced that its CAR-T therapy for stiff person syndrome showed positive results after one year of treatment. The trial involved patients with the rare autoimmune disorder,…
    Endpoints · 28d agoPositive readoutPositive↗ source
  • Novartis and Novo Nordisk trials lower biomarkers but fail to cut heart events, prompting preventive cardiology rethink
    The article discusses two recent Phase 3 trials that achieved their biological goals but did not improve clinical outcomes. Novartis reported that pelacarsen in the Lp(a) HORIZON study successfull…
    STAT · 28d agoNegative readoutNegative↗ source
  • Heidi Overton, Trump’s FDA nominee, to appear before Senate committee for confirmation hearing
    Heidi Overton, a 37‑year‑old preventive‑medicine physician, is the Trump administration’s pick to lead the Food and Drug Administration and will face a Senate committee this morning. Lawmakers hav…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Congress mulls linking Medicare doctor pay to medical inflation under Patients First Act
    Congress is debating a major overhaul of Medicare physician payments, proposing to tie rates to a medical inflation index. The plan, part of the Patients First Act, would give doctors automatic an…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Senators question FDA nominee as agency issues rule to cut animal testing
    The latest FDA briefing highlighted two key developments: a Senate hearing on the agency’s next leader and a new regulation targeting animal testing. During the confirmation hearing, senators pres…
    raps · 28d agoRegulatoryNeutral↗ source
  • FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory review
    The U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.…
    raps · 28d agoRegulatoryNeutral↗ source
  • Elevar Therapeutics receives FDA approval for Lyrfigtu as second-line treatment for bile duct cancer
    The U.S. Food and Drug Administration has approved Elevar Therapeutics' drug Lyrfigtu as a second‑line option for patients with bile duct cancer who meet specific criteria. Bile duct cancer is dia…
    Endpoints · 27d agoApprovalPositive↗ source
  • STAT's The Readout LOUD podcast goes international with a Shanghai dispatch on China's biotech surge
    The Readout LOUD podcast, part of STAT's weekly biotech series, is expanding its reach beyond the United States this week. Host Jason Mast reports from Shanghai, where he examines how China's growi…
    STAT · 27d agoNeutral↗ source