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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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Angelini Pharma to Acquire Catalyst Pharmaceuticals for $4.1 B, Expanding U.S. Rare-Disease Portfolio
    Angelini Pharma announced Thursday it will purchase Catalyst Pharmaceuticals, a Florida‑based company focused on rare‑disease medicines, for about $4.1 billion in cash. The transaction values Cata…
    STAT · 6mo agoDealPositive↗ source
  • Sanofi asks FDA to withdraw teplizumab from fast-track review after internal disagreement
    Sanofi has formally requested that the U.S. Food and Drug Administration remove its type 1 diabetes therapy, teplizumab, from the agency's new speedy review program. The request follows a disagree…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Entrada Therapeutics' next-gen Duchenne drug fails early trial, raising competitive concerns
    Entrada Therapeutics reported that its next-generation exon-skipping therapy for Duchenne muscular dystrophy did not meet efficacy endpoints in an early-stage study. The trial, which evaluated the…
    STAT · 6mo agoNegative readoutNegative↗ source
  • FDA staff cuts leave agency scrambling to rebuild workforce after 3,500 layoffs
    The Food and Drug Administration dismissed roughly 3,500 employees last year as part of a health‑policy push to reduce what officials called bureaucratic bloat. The mass layoffs have left the agenc…
    STAT · 6mo agoRegulatoryNegative↗ source
  • FDA reexamines previously rejected rare cancer therapy amid claims of political interference
    The FDA has opened a new review of a treatment for a rare form of cancer that it had turned down a few months earlier. The reconsideration arrives as the agency faces fresh allegations that politi…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • FDA agrees to revisit rare blood cancer drug Ebvallo after companies address concerns
    Two companies developing a therapy for a rare blood cancer have reached an agreement with the FDA to address the agency’s concerns about their drug Ebvallo. The FDA had previously rejected Ebvallo…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • AI-generated fake citations surge, study finds they are polluting scientific literature
    A new study published in The Lancet reports a sharp rise in fabricated citations that do not correspond to real papers, threatening the reliability of the scientific record. The researchers found…
    STAT · 6mo agoNegative↗ source
  • WHO briefs on hantavirus outbreak aboard cruise ship, Spain to allow docking in Canary Islands
    WHO held a press conference Thursday to update on a suspected hantavirus outbreak on the cruise ship MV Hondius. The vessel is expected to dock in Tenerife, Canary Islands, after Spain agreed to t…
    STAT · 6mo agoNeutral↗ source
  • Seaport Therapeutics goes public as obesity drug race heats up and FDA commissioner faces White House scrutiny
    Seaport Therapeutics announced a successful initial public offering, with CEO Daphne Zohar discussing the company’s next steps on the latest Readout LOUD podcast. The episode also highlighted the…
    STAT · 6mo agoNeutral↗ source
  • Analyst doubts gold-based ALS therapy from Clene, calling it ineffective
    Adam Feuerstein, a senior biotech writer, published a piece in his Biotech Scorecard newsletter questioning a new ALS treatment. The company Clene is developing CNM-Au8, which it describes as a hi…
    STAT · 6mo agoNegative↗ source