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2,582 stories matching this filter · ← front page

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  • Boehringer Ingelheim boosts Variant Bio partnership with $250 million for cardiovascular research
    Boehringer Ingelheim announced an expansion of its collaboration with Variant Bio. The partnership will now include cardiovascular disease research, broadening its original scope. The deal value…
    Fierce Biotech · 28d agoDealPositive↗ source
  • FDA shift sparks renewed pharma and VC focus on osteoporosis drug development
    The FDA recently altered its regulatory framework for osteoporosis medicines, prompting a wave of renewed interest across the pharmaceutical sector. Earlier, drugs from Eli Lilly, Merck, Novartis…
    STAT · 28d agoRegulatoryPositive↗ source
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  • Insurers UnitedHealth, CVS, and Kaiser oppose Medicare's contractor ban on remote patient monitoring
    Major insurers including UnitedHealth Group, CVS Health and Kaiser Permanente have formally objected to a new Medicare proposal that would change billing for remote patient monitoring (RPM). The p…
    STAT · 28d agoRegulatoryNeutral↗ source
  • White House plan to tighten control over NIH grants stalls after bipartisan opposition
    A proposed executive order that would have given the White House significant authority over National Institutes of Health grant awards is now considered dead. The plan called for a commission of p…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Human‑centric testing methods promise safer, cheaper drug development but repeatability remains a key obstacle
    Regulators such as the FDA, EMA and ICH are urging drug developers to replace animal safety studies with New Approach Methodologies that use human‑relevant models. Early research shows these models…
    Fierce Biotech · 28d agoNeutral↗ source
  • Immunovant halts cutaneous lupus program after phase 2 failure
    Immunovant announced it is discontinuing development of its anti-FcRn antibody IMVT-1402 for cutaneous lupus erythematosus. The decision follows a mid-phase trial that did not meet its primary end…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source
  • Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementation
    Industry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
    raps · 28d agoRegulatoryNeutral↗ source
  • US to End Personal Medication Import Loophole as New Customs Rule Takes Effect
    A new regulation will begin next month that ends the longstanding loophole allowing Americans to import prescription drugs by mail. The rule, reported by the Wall Street Journal, requires any medic…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Quorum Health moves to nonprofit status as its rural hospital chain faces insolvency
    Quorum Health, a chain of mostly rural hospitals owned by private-equity investors, is in the process of converting all 11 of its facilities to nonprofit status after years of financial strain that…
    STAT · 28d agoRegulatoryNegative↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 27d agoRegulatoryNegative↗ source
  • STAT AI Prognosis newsletter tackles AI doomerism and offers guidance for health professionals
    The latest web edition of STAT’s AI Prognosis newsletter, authored by health tech reporter Brittany Trang, focuses on the growing chatter around AI doomerism. It aims to help readers cut through th…
    STAT · 28d agoNeutral↗ source
  • Trump's Department of War bets $47M on Flagship biotechs to develop countermeasures
    The Department of War has awarded Flagship Pioneering $47 million to develop medical countermeasure technologies against emerging threats.
    Fierce Biotech · 28d agoNeutral↗ source
  • Opinion: Mentally ill women need stronger support to become mothers
    Meg LeDuc writes in an opinion piece that maternal mental-health needs of women with serious psychiatric conditions have been largely ignored in the United States. She recounts her own history of…
    STAT · 28d agoPositive↗ source
  • Roche’s dual GLP-1/GIP drug enicepatide lowers HbA1c in phase 2 trial, sparking best-in-disease hopes
    Roche reported that its dual GLP-1/GIP receptor agonist, enicepatide, met the primary goals of a phase 2 study in patients with type 2 diabetes. The top 24‑mg weekly dose reduced HbA1c by 2.65% ove…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • GSK pursues China-centric growth after successful Hansoh licensing deals show promise
    GSK says it is following a "balance West and East" strategy, increasingly looking to China for drug licensing opportunities. In 2023 the company paid a combined $270 million upfront to Hansoh Phar…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Celldex reports dual Phase 3 successes for barzolvolimab in refractory chronic spontaneous urticaria
    Celldex Therapeutics announced that its monoclonal antibody barzolvolimab achieved positive results in two Phase 3 studies of patients with treatment-refractory chronic spontaneous urticaria. The E…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Otsuka and Ionis report ALS drug ulefnersen meets primary endpoint in phase 3 trial
    Otsuka and Ionis have completed the Fusion phase 3 trial of ulefnersen, an RNA‑targeted therapy for ALS patients with mutations in the FUS gene. The study enrolled 89 participants, with 73 forming…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Novartis licenses preclinical radioligand from China's BoomRay in up to $900 million deal
    Novartis has expanded its radiopharmaceutical pipeline by signing a licensing agreement with Chinese biotech BoomRay Therapeutics. The deal could be worth up to $900 million, including an upfront…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Amgen’s Horizon-acquired drug dazodalibep meets primary endpoint in phase 3 Sjögren’s trial
    Amgen announced that its investigational fusion protein dazodalibep, acquired through Horizon Therapeutics, achieved its primary goal in a phase 3 study of patients with moderate to severe Sjögren’…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Vertex reports positive Phase 2b results for inaxaplin in APOL1-mediated kidney disease
    Vertex Pharmaceuticals announced positive Phase 2b data for its kidney disease candidate inaxaplin, which targets APOL1-mediated kidney disease (AMKD). The Amplified trial enrolled two cohorts: 2…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IV
    Consumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines. The g…
    raps · 29d agoRegulatoryNegative↗ source
  • HHS rolls out new FDA rule to allow non-animal testing methods in drug development
    The Department of Health and Human Services announced a new set of strategies aimed at shifting drug development away from animal testing toward human-based research methods. The FDA issued a fina…
    STAT · 28d agoRegulatoryPositive↗ source
  • Former FDA Commissioners Endorse Heidi Overton as Strong Choice to Lead Agency
    Two former FDA commissioners, Scott Gottlieb and Mark B. McClellan, wrote an opinion piece supporting Heidi Overton’s nomination to lead the agency. They note her confirmation hearing is set before…
    STAT · 28d agoRegulatoryPositive↗ source
  • Boston life-science lab vacancy climbs to 31% as new spaces sit empty
    Vacancy rates for laboratory and manufacturing space in Massachusetts have surged dramatically, rising from around 3% in 2021 to roughly 31% by mid-2026, according to recent data. One high-profile…
    Fierce Biotech · 29d agoNegative↗ source
  • Novo Nordisk may secure more favorable terms under Medicare’s Bridge obesity drug program
    Novo Nordisk and Eli Lilly have been profiting from a Medicare pilot that caps obesity drug prices for seniors at $245 a month. Recent analysis suggests Novo could negotiate an even better arrangem…
    STAT · 29d agoRegulatoryPositive↗ source