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1,444 stories matching this filter · ← front page

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  • Agios halts sickle cell drug program after disappointing phase 2 results
    Agios announced it is stopping development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a phase 2 trial failed to meet expectations. The study enrolle…
    Fierce Biotech · 23d agoNegative readoutNegative↗ source
  • Biotech firms rally to defend FDA's mifepristone approval in Louisiana lawsuit
    Biotech companies, executives and investors filed an amicus brief supporting the FDA in the Louisiana case that seeks to limit access to the abortion pill mifepristone. The brief is signed by 61 e…
    Fierce Biotech · 23d agoRegulatoryPositive↗ source
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  • Broad Institute, Boston Children’s Hospital and Jackson Laboratory launch nonprofit to advance affordable gene therapies for rare diseases
    The Broad Institute, Boston Children’s Hospital and Maine’s Jackson Laboratory announced a new collaboration to develop gene‑based treatments for rare genetic disorders. The three institutions will…
    STAT · 23d agoDealPositive↗ source
  • Anthropic expands rare disease collaborations as Novo sues Lilly and Agios halts sickle cell drug
    Anthropic, a biotech firm, announced it is expanding its partnership portfolio focused on rare disease therapeutics, deepening collaborations with several companies to advance pipeline candidates.…
    STAT · 23d agoDealNeutral↗ source
  • Novo Nordisk sues Eli Lilly over allegedly deceptive obesity and diabetes ads
    Novo Nordisk has filed a federal lawsuit against Eli Lilly, accusing the rival of running misleading advertisements for its obesity and diabetes medicines. The company claims Lilly's ads rely on ou…
    STAT · 23d agoRegulatoryNegative↗ source
  • Novo Nordisk sues Eli Lilly, alleging deceptive ads that misrepresent GLP-1 drug efficacy
    Novo Nordisk filed a lawsuit in federal court in New Jersey accusing Eli Lilly of running a deceptive advertising campaign. The complaint says Lilly’s ads compare the highest doses of its weight‑l…
    STAT · 23d agoRegulatoryNegative↗ source
  • Jupiter Neurosciences signs $100M deal for U.S. rights to PharmAla's MDMA therapy ALA-002
    Jupiter Neurosciences announced a licensing agreement with Canadian biotech PharmAla Biotech to obtain U.S. rights to an MDMA‑based drug, ALA‑002, aimed at treating neuropsychiatric conditions. Th…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Rare-disease biotech coalition urges Trump admin to carve out orphan drugs from Medicare price-cut pilots
    Biotech firms formed the Rare Disease Company Coalition and met with the White House Office of Management and Budget to discuss excluding orphan drugs from two Medicare price‑cut pilot programs. T…
    STAT · 23d agoRegulatoryNeutral↗ source
  • Novartis halts phase-2 radioligand therapy Lu-NeoB after disappointing data, but reaffirms commitment to RLT
    Novartis announced it is halting development of Lu-NeoB, a gastrin-releasing peptide receptor-targeting radioligand therapy, after phase-2 data failed to demonstrate sufficient efficacy. The candi…
    Fierce Biotech · 23d agoNegative readoutNegative↗ source
  • Lupin spins out two phase-1 cancer candidates into US startup Kaveri, taking majority stake and providing seed funding
    Lupin, an Indian generics manufacturer, has created a U.S.-based spinout called Kaveri Therapeutics by transferring two clinical-phase cancer drug candidates. The assets are a PRMT5 inhibitor (LNP…
    Fierce Biotech · 23d agoDealNeutral↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 23d agoRegulatoryNeutral↗ source
  • Ashlins Pharma licenses interferon alpha-2b from Lee's, eyes $50M raise to pursue FDA approval for rare disease
    Ashlins Pharmaceuticals has signed a licensing agreement with Hong Kong‑based Lee’s Pharmaceutical to obtain the ex‑China rights to a Chinese formulation of interferon alpha‑2b. The deal, announced…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Rare disease drugmakers brace for potential Trump administration price cuts amid GOP push on health‑care fraud
    Rare disease drugmakers are watching the Trump administration closely as proposals emerge that could force lower prices for their specialty therapies. The companies are exploring strategies to miti…
    STAT · 23d agoRegulatoryNeutral↗ source
  • Advocates warn federal HIV prevention funding cuts could force community groups to close
    Community-based organizations that deliver HIV testing and prevention tools are urging federal health officials to restore a key funding program that recently expired. Advocates say the lapse thre…
    STAT · 23d agoRegulatoryNegative↗ source
  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 23d agoDealNeutral↗ source
  • THC-infused drinks found on New York shelves near schools, often sold without ID and breaching state law
    A variety of cannabis-infused beverages are now stocked in grocery stores, bodegas and delis across New York City. Brands such as Oasis, Cann, Milonga, Cycling Frog, Tempters, Gigli and Mighty Kind…
    STAT · 23d agoRegulatoryNegative↗ source
  • Proposed OMB Rule Threatens NIH Grant Independence, Experts Warn
    The Office of Management and Budget has issued a proposed rule that would require political appointees to review NIH research grants and certify that the projects "demonstrably advance the Presiden…
    STAT · 23d agoRegulatoryNegative↗ source
  • Roche appoints Dan Malarek as President and CEO of Diagnostics North America, creates new CCO role
    Roche announced that Dan Malarek, who has led Foundation Medicine since 2023, will become President and CEO of Roche Diagnostics North America. Malarek, a 19‑year veteran of Roche, will succeed Br…
    Fierce Biotech · 23d agoPositive↗ source
  • Trump administration defers over $1 billion in Medicaid payments to California and Minnesota over fraud concerns
    The Trump administration announced it is holding back more than $1 billion in Medicaid funds for California and Minnesota, saying the states have suspected fraud and non‑compliance. Health Secreta…
    STAT · 23d agoRegulatoryNegative↗ source
  • Urologist warns that Defense Dept's testosterone screening for servicemembers fuels outdated masculinity myths
    Dr. Elizabeth Dray, a urologist, criticizes Defense Secretary Pete Hegseth's recent plan to screen all service members aged 30 and older for testosterone, describing it as a modern echo of ancient…
    STAT · 23d agoNegative↗ source
  • Epic Systems sees senior leadership exits amid speculation of broader exodus
    Epic Systems is experiencing notable executive turnover, highlighted by the recent departure of President Sumit Rana, who had been expected to succeed CEO Judy Faulkner. Rana told a reporter last…
    STAT · 23d agoNegative↗ source
  • Nabla appoints former Bamboo Health president Brian Manning as CEO to boost US market push
    Nabla, the Paris‑based maker of ambient AI scribes for clinical documentation, announced that Brian Manning will take over as chief executive officer. Manning comes from a background in care‑coord…
    STAT · 23d agoNeutral↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 23d agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 23d agoRegulatoryNeutral↗ source
  • Right-wing groups intensify campaign to limit abortion pills amid ongoing health news
    Advocates on the political right are renewing efforts to restrict access to medication abortions, according to the latest Morning Rounds newsletter. The piece notes that the campaign is gaining mom…
    STAT · 23d agoNegative↗ source