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  • Novartis reports seven new tumor cases in children treated with Zolgensma gene therapy
    Novartis has disclosed that seven children who received its SMA gene therapy, Zolgensma, have been found to have tumors that were not previously reported. The cases were brought to light by an adv…
    STAT · 3d agoRegulatoryNegative↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 3d agoApprovalPositive↗ source
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  • Novartis Lp(a) drug pelacarsen shows no cardiovascular benefit, raising doubts on Amgen and Lilly programs
    Novartis disclosed that its phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide partnered with Ionis, failed to demonstrate any reduction in major cardiovascular events. The drug…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • Rezera targets $181 million IPO to fund phase-3 trial of NLRP3 inhibitor for peripheral artery disease
    Boston-based biotech Rezera, which rebranded from NodThera last September, said it will seek an initial public offering to raise about $181 million. The proceeds are intended to move its brain-pene…
    Fierce Biotech · 3d agoDealPositive↗ source
  • MetaVia's GLP-1/glucagon agonist cuts liver fat and weight in phase 1, eyes phase 2 in alcohol-related liver disease
    MetaVia reported that its dual GLP‑1/glucagon receptor agonist, DA‑1726, lowered liver fat and body weight in a small phase‑1 study of obese adults. After 16 weeks of once‑weekly dosing, the drug…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • AstraZeneca proposes $10 billion purchase of Rhythm Pharmaceuticals, sparking possible bidding war
    AstraZeneca has reportedly made an offer of about $10 billion to buy Rhythm Pharmaceuticals, a company focused on rare obesity disorders. Analysts from at least three research groups say the propo…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • Evommune pays $30 million to Hinova for rights to develop oral VAV1 molecular glue degrader EVO570 outside China
    Evommune announced a licensing agreement with Chinese firm Hinova Pharmaceuticals, paying $30 million upfront for access to a preclinical molecular glue program. The agreement gives Evommune the r…
    Fierce Biotech · 4d agoDealPositive↗ source
  • MIT defamation verdict awards $6 million to former star scientist, sparking campus debate over harassment claims
    A Boston jury awarded former MIT biologist David Sabatini $6 million in a defamation case against former colleague Kristin Knouse, a biology professor at the institute. The judgment stems from a la…
    STAT · 3d agoNegative↗ source
  • Sickle cell gene-editing therapy shows signs of revival as developers revisit trial after earlier safety halt
    A recent STAT+ article highlights that a sickle cell gene‑editing therapy, whose trial was stopped three years ago after a serious adverse event in the first patient, may be making a comeback. The…
    STAT · 3d agoNeutral↗ source
  • Novo names former Galderma exec as new CFO as eight-year finance chief departs; Alnylam and Amgen also seek senior replacements
    Novo's chief financial officer, who has served for eight years, will step down at the end of the year. The company has selected an executive from Galderma to take over the CFO role, signaling a le…
    Fierce Biotech · 3d agoNeutral↗ source
  • India proposes rule to instantly suspend drug manufacturing licenses that fail government quality tests
    India’s regulators have drafted new rules that would require an immediate suspension of any drug manufacturing license if the product does not meet quality standards in government testing. The prop…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Democrats’ midterm sweep positions Bernie Sanders to steer Senate health committee, raising hopes for major FDA reforms
    The recent midterm elections delivered a decisive victory for Democrats, giving the party control of Congress and setting the stage for sweeping health‑care changes. Among the anticipated shifts,…
    STAT · 3d agoRegulatoryNeutral↗ source
  • China clamps down on investigator-initiated biotech trials after patient deaths, halting rare-disease studies
    Chinese regulators have introduced new rules that sharply limit investigator‑initiated biotech trials after a series of patient deaths were reported this summer. The policy shift is intended to tig…
    STAT · 4d agoRegulatoryNegative↗ source
  • PhRMA spent roughly $59 million on search ads to shape public views on drug pricing
    PhRMA, the trade group for U.S. drug makers, spent about $59 million on search advertising over a recent seven‑year period to influence how Americans perceive prescription‑drug costs. Roughly $32…
    STAT · 3d agoNeutral↗ source
  • Democratic doctors celebrate gains as MAHA’s future remains uncertain after election
    The STAT+ D.C. Diagnosis newsletter reports that doctors aligned with the Democratic Party secured notable wins in recent political battles. At the same time, the Medicare for All (MAHA) initiativ…
    STAT · 3d agoNeutral↗ source
  • ProMis shares tumble after competitor's Alzheimer trial failure, CEO calls reaction overblown
    ProMis Neurosciences, developer of an amyloid‑targeting Alzheimer’s therapy, saw its stock plunge sharply last week. The decline came after Acumen Pharmaceuticals announced that its own amyloid‑ta…
    STAT · 3d agoNegative↗ source
  • Generate Biomedicines CEO touts AI-driven shrinkage of CAR-T cell engines as huge opportunity
    Generate Biomedicines' chief executive highlighted a "huge opportunity" after the company applied Anthropic's Claude AI platform to make its CAR‑T cell engines smaller. The Flagship‑founded biotec…
    Fierce Biotech · 4d agoPositive↗ source
  • Health systems grapple with AI chatbot use, some block tools while others consider in-house solutions
    Free AI chatbots designed for clinicians, such as OpenEvidence, Doximity Ask and ChatGPT for Clinicians, have become popular, with hundreds of thousands of doctors turning to them for clinical guid…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Agios to cut over 202 R&D positions as it awaits FDA decision on sickle cell drug
    Agios Pharmaceuticals said it will eliminate more than 100 research and development positions by the end of 2026, cutting its R&D workforce by roughly 35% from 2025 levels. The company entered the…
    Fierce Biotech · 4d agoLayoffsNegative↗ source
  • Cloudbreak Pharma’s Phase 3 Eye Drop Shows Significant Benefit in Pterygium Trial
    Cloudbreak Pharma reported that its phase 3 trial of CBT-001, a multi‑kinase inhibitor eye drop for pterygium, met both co‑primary endpoints. The study compared two doses of CBT-001 given twice da…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • STAT+: Beyond statins, one drug lowered heart attack risk by 20%
    A new study could help doctors figure out what medicine to prescribe for cholesterol when statins don't cut it: It's “answering a really challenging clinical question."
    STAT · 3d agoRegulatoryNeutral↗ source
  • Vivoryon reclaims Chinese rights to kidney disease drug amid cash crunch
    Vivoryon Therapeutics, a Munich-based biotech, has taken back the rights to develop its kidney disease candidate in China after a licensing arrangement with Simcere Pharmaceuticals. The original 2…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • Trump administration ends contracts with two No Surprises Act arbitrators over performance failures
    The federal government announced that two organizations that handle disputes under the No Surprises Act will no longer be allowed to accept new cases, saying they failed to meet required performanc…
    STAT · 3d agoRegulatoryNegative↗ source
  • Medicare postpones controversial rule that bars hospitals from using third-party remote patient monitoring services
    Medicare announced it will finalize a proposal that delays an update to its remote patient monitoring (RPM) rule, despite strong opposition. The rule would prohibit hospitals and other providers f…
    STAT · 3d agoRegulatoryNegative↗ source
  • Ballot measures on abortion, marijuana and transgender youth care highlight political divides in 2026 midterms
    Voters in the 2026 midterm elections faced a slate of state health policy ballot measures that addressed abortion rights, marijuana legalization, science funding bonds and care for transgender yout…
    STAT · 3d agoNeutral↗ source