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  • 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
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  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 1mo agoPositive readoutNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo agoNegative readoutNegative↗ source
  • Eli Lilly inks $3.35 B China partnership as Immunovant halts lupus drug trial
    Eli Lilly announced a new alliance with Beijing‑based InnoCare Pharma that could be worth up to $3.35 billion. The deal includes an upfront payment of $100 million and up to five target programs fo…
    BioPharma Dive · 1mo agoDealNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNeutral↗ source
  • Senate Finance Committee Advances Chris Klomp’s HHS Deputy Nomination
    The Senate Finance Committee voted Thursday to move Chris Klomp’s nomination for deputy secretary of the Department of Health and Human Services forward to the full Senate. The 15-12 vote saw all…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • AI doomsday warnings may curb health-tech innovation, Epic cautions
    Recent commentary warns that sensational AI doomsday predictions could slow the pace of health‑technology innovation. Epic, the large electronic health‑record company that provides AI tools to hos…
    Endpoints · 1mo agoNegative↗ source
  • Measles deaths rise as U.S. sees worst outbreak since 1991, CDC reports four fatalities in Pennsylvania
    The Centers for Disease Control and Prevention has added a measles death to its online counter, highlighting a recent increase in fatalities. State officials in Pennsylvania say four unvaccinated…
    STAT · 1mo agoNegative↗ source
  • Physician who survived measles warns of rising U.S. cases and deaths
    Jewel Mullen, an associate professor at Dell Medical School, recalls surviving a near-fatal measles infection as a kindergartener in 1961, before a vaccine existed. Her personal ordeal and decades…
    STAT · 1mo agoNegative↗ source
  • Radiology practices increasingly develop and market in-house AI, branding themselves as AI-native
    Radiology groups, especially outpatient and teleradiology firms, are moving beyond using third‑party AI tools and are building their own algorithms within the practice. By keeping development in‑h…
    STAT · 1mo agoPositive↗ source
  • EMA leaders say single pivotal trial should not be default, decision must match evidence needed
    EMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
    raps · 1mo agoRegulatoryNeutral↗ source