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3,581 stories matching this filter · ← front page

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  • Roche to acquire PathAI for $750 million to boost AI pathology
    Roche announced it will acquire Boston based PathAI for an upfront payment of $750 million. The acquisition follows a partnership that began in 2021 and is intended to speed the use of artificial i…
    STAT · 6mo agoDealPositive↗ source
  • Former FDA officials and pharma groups weigh in as Supreme Court considers mifepristone regulation
    The Supreme Court is expected to act on a case involving the abortion pill mifepristone after a pause on a federal appeals court order that halted mail‑order distribution. The decision could resha…
    STAT · 6mo agoRegulatoryNeutral↗ source
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  • Medicare’s new RAPID coverage pathway speeds adult device access, but pediatric devices still lag
    The Centers for Medicare and Medicaid Services and the FDA introduced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. The new process promises Medicare natio…
    STAT · 6mo agoRegulatoryPositive↗ source
  • Trump reportedly plans to dismiss FDA Commissioner Marty Makary
    Multiple media outlets report that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The reports say the decision has not been finalized and could still be…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • WSJ reports Trump plans to fire FDA Commissioner Marty Makary, decision not yet final
    The Wall Street Journal reported that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The report said the administration has not yet made a final decisi…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • Daiichi Sankyo writes off $950 million after abandoning ADC manufacturing plan
    Daiichi Sankyo announced it will abandon its planned antibody-drug conjugate (ADC) manufacturing facility. The company said the decision follows a serious over-estimate of third-party demand for AD…
    Endpoints · 6mo agoEarningsNegative↗ source
  • FDA pushes Leqembi subcutaneous decision to Aug. 24; Artiva secures $300M and Pharvaris sets pricing
    The U.S. Food and Drug Administration has postponed its review of the subcutaneous formulation of Leqembi. The original target date earlier this month has been moved to August 24, as Biogen and Eis…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • Capricor sues Japanese partner over botched Duchenne therapy launch and pricing concerns
    Capricor Therapeutics has filed a lawsuit against its Japanese collaborator Nippon Shinyaku and its subsidiary NS Pharma. The biotech alleges the partners mishandled preparations for the launch of…
    STAT · 6mo agoNegative↗ source
  • Odyssey Therapeutics raises $279 million in IPO, begins Nasdaq trading
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, announced that its initial public offering generated $279 million. The company sold about 15.5 million shares and priced the IPO at…
    Endpoints · 6mo agoDealPositive↗ source
  • Trump reportedly moves to dismiss FDA Commissioner Marty Makary
    President Trump is said to have approved a plan to remove FDA Commissioner Marty Makany, according to several news outlets. The proposed ouster would add to recent turnover in the agency’s senior l…
    STAT · 6mo agoRegulatoryNegative↗ source
  • Capricor sues Nippon Shinyaku over delayed Duchenne drug rollout and pricing formula flaw
    Capricor Therapeutics has filed a lawsuit in New Jersey alleging that Nippon Shinyaku and its US subsidiary NS Pharma have failed to execute agreed upon marketing plans for the company's Duchenne m…
    STAT · 6mo agoRegulatoryNegative↗ source
  • FDA proposes stripping gender references from regulations, prompting research concerns
    The U.S. Food and Drug Administration has issued a proposal to eliminate references to gender in its regulatory language. The change is intended to modernize the rules but has drawn attention from…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Aging scientific workforce grapples with rising fabricated citations as hantavirus cruise ship outbreak drags on
    A new analysis highlights that an increasingly senior scientific workforce is coinciding with a surge in fabricated citations across medical journals, raising concerns about research integrity. Th…
    STAT · 6mo agoNeutral↗ source
  • Top young AI researchers avoid careers at large pharmaceutical companies
    Mazdak Abulnaga, a 33‑year‑old postdoctoral fellow at MIT and Harvard Medical School, is highlighted as the type of employee pharmaceutical companies hope to attract this year. Despite the demand,…
    Endpoints · 6mo agoNegative↗ source
  • Natalie Holles appointed CEO after Third Harmonic shutdown; Mark Alles steps down at ADC Biotech
    Natalie Holles quickly found a new role after the decision to wind down operations at Third Harmonic. She has taken over as chief executive, succeeding Elisabet de los Pinos. At the same time, Mar…
    Endpoints · 6mo agoNeutral↗ source
  • Six former FDA officials explain why they left the agency during the Trump era
    STAT's weekly video series STATus Report recently featured a road-trip edition in which reporter Lizzy Lawrence traveled to the Washington suburbs to talk with former FDA staff. The interviews inc…
    STAT · 6mo agoNeutral↗ source
  • Spain prepares to isolate over 140 cruise passengers amid hantavirus outbreak
    Spanish authorities are ready to receive more than 140 passengers and crew from a cruise ship flagged with a hantavirus outbreak as it approaches Tenerife. The vessel is expected to dock on Sunday…
    STAT · 6mo agoNegative↗ source
  • Capricor sues Nippon Shinyaku over pricing dispute for Duchenne cell therapy candidate
    Capricor Therapeutics announced it has filed a lawsuit against its Japanese partner Nippon Shinyaku. The suit alleges a flaw in the pricing terms of the distribution and commercialization agreemen…
    Endpoints · 6mo agoNegative↗ source
  • Calls grow for increased recruitment of men into nursing to address workforce shortages
    Men make up only about 12% of the nursing workforce in the United States. The demand for nurses is rising, with roughly 200,000 job openings expected each year as many current nurses retire. The…
    STAT · 6mo agoPositive↗ source
  • Epidemiologist highlights surge of hantavirus misinformation after cruise ship outbreak
    An outbreak of hantavirus tied to the cruise ship MV Hondius has generated serious health concerns, but online discussion has taken a different turn. Social media users quickly began sharing false…
    STAT · 6mo agoPositive↗ source
  • Immunic appoints Michael Panzara as chief medical officer, coming from Neurvati Neurosciences
    STAT+ columnist Ed Silverman's weekly feature highlights recent personnel changes in pharma. This edition notes a new appointment at Immunic. Immunic has named Michael Panzara its new chief medica…
    STAT · 6mo agoNeutral↗ source
  • Met Gala outfits whimsically matched to biotech logos in annual tradition
    The piece highlights an annual tradition of pairing Met Gala attire with the logos of biotech companies, a playful feature in the STAT newsletter The Readout. For this year’s event, whose theme wa…
    STAT · 6mo agoNeutral↗ source
  • Angelini Pharma to acquire Catalyst Pharmaceuticals for $4.1 billion, adding three rare-neurology drugs
    Angelini Pharma announced a $4.1 billion acquisition of Catalyst Pharmaceuticals, a U.S. company that develops treatments for rare neurological disorders. The purchase adds three FDA‑approved medi…
    Endpoints · 6mo agoDealPositive↗ source
  • EnGene shares tumble 80% after Phase 2 bladder cancer data raise safety concerns
    EnGene, a Canadian biotech firm, released updated Phase 2 results for its experimental therapy aimed at a specific group of bladder cancer patients. The company said the new data fell short of expe…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Political appointee stalls Sanofi drug approval, raising concerns about FDA interference
    STAT's D.C. Diagnosis newsletter reports that a political appointee is impeding the approval of a Sanofi drug, suggesting direct political interference at the FDA. The article notes that the appoi…
    STAT · 6mo agoRegulatoryNegative↗ source