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  • 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 · 5mo 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 · 5mo agoNeutral↗ source
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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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo agoNegative↗ source
  • Hospital shootings have risen steadily since 2000, according to new data
    A new analysis shows that incidents of gunfire inside U.S. hospitals have been climbing each year since 2000. The report notes a clear upward trend in the frequency of these events, raising concer…
    STAT · 5mo agoNeutral↗ source
  • Study finds researchers become less disruptive as they age, favoring incremental work
    A new study published in Science reports that scientists tend to produce their most disruptive work early in their careers, but shift toward less groundbreaking research as they get older. The ana…
    STAT · 5mo agoNeutral↗ source
  • CDC’s cruise ship health chief Luis Rodríguez retires amid hantavirus outbreak on MV Hondius
    The Centers for Disease Control and Prevention announced that Luis Rodríguez, who has been with the Vessel Sanitation Program since 2010 and its chief since 2023, will retire. His departure comes…
    STAT · 5mo agoNeutral↗ source
  • STAT Health Tech newsletter highlights OpenAI health policy ideas and Dexcom CGM updates
    The latest STAT Health Tech newsletter, edited by Mario Aguilar, offers a roundup of recent technology developments in health care. OpenAI proposes a set of health policy recommendations aimed at…
    STAT · 5mo agoNeutral↗ source
  • Eugene Braunwald, the "father of modern cardiology," remembered for pioneering heart-attack prevention and a lab scandal
    Eugene Braunwald, widely called the father of modern cardiology, died at 96 on April 22. His career reshaped how doctors treat heart disease and he is celebrated as the most influential cardiologis…
    STAT · 5mo agoNeutral↗ source
  • Experts caution limited knowledge of hantavirus after outbreak on African offshore cruise ship
    Health officials are monitoring a hantavirus outbreak on the MV Hondius, a cruise ship that was moored off the western coast of Africa. The situation has drawn attention because passengers were con…
    STAT · 5mo agoNeutral↗ source
  • Novo Nordisk shares rise as Wegovy updates improve earnings outlook
    Novo Nordisk reported that recent data on its obesity drug Wegovy were less negative than expected, helping the company’s earnings. The improved outlook lifted Novo Nordisk’s share price, narrowin…
    STAT · 5mo agoEarningsPositive↗ source
  • Trump executive order accelerates psychedelic drug development with priority review vouchers, funding and expanded right-to-try
    President Trump signed an executive order that aims to speed the development and approval of psychedelic medicines. The order directs the FDA to issue priority review vouchers, expands right-to-tr…
    STAT · 5mo agoRegulatoryPositive↗ source
  • Gene therapy leaders in Rome flag FDA regulatory shifts as key challenge
    Gene therapy manufacturers gathered in Rome to discuss the sector’s outlook in Europe, with the U.S. Food and Drug Administration’s recent actions dominating conversation. Speakers highlighted rec…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • White House drug strategy endorses treatment but tightens funding for fentanyl test strips
    The White House released a new drug‑policy document on May 4 that lists public‑health measures such as wider access to the overdose‑reversal drug naloxone, medication‑assisted treatment, and the di…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Administration releases detailed report on most-favored-nation drug pricing, projects $529 billion savings
    The White House Council of Economic Advisers released its most detailed analysis yet of the administration's most-favored-nation drug pricing policy. The report defines the MFN pricing approach, w…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Sanofi requests removal of teplizumab from FDA fast-track voucher program after director dispute
    Sanofi has formally asked the Food and Drug Administration to withdraw its type 1 diabetes therapy, teplizumab, from the new speedy review voucher program overseen by Commissioner Marty Makary. Th…
    STAT · 5mo agoRegulatoryNegative↗ source