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  • Former FDA oncology chief says political turmoil opens chance to reshape agency amid rising Chinese competition
    Rick Pazdur, who led oncology reviews at the FDA, told a STAT audience at the American Society of Clinical Oncology meeting that recent political appointments have caused significant disruption at…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Trump administration abandons Biden Ebola response plan, opting for new strategy
    The Biden administration completed a multi-hundred-page set of guidelines in early 2025 outlining how federal agencies should handle future disease threats, including protocols for Ebola outbreaks…
    STAT · 5mo agoRegulatoryNegative↗ source
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  • Experts say Grail’s multi-cancer blood test not yet ready for routine screening
    At the ASCO 2026 meeting in Chicago, Grail presented its multi-cancer early detection blood test, which the company markets as a tool to identify several cancers at an early stage. Independent exp…
    Endpoints · 5mo agoNegative↗ source
  • Endpoints Weekly previews ASCO coverage, discusses AI in research and shifting immunotherapy strategies
    The weekly newsletter returns with a team of reporters stationed in Chicago for the upcoming ASCO meeting. It promises on‑the‑ground insights from the conference. One focus will be the role of art…
    Endpoints · 5mo agoNeutral↗ source
  • Bristol Myers reports 52% reduction in progression risk for next-gen multiple myeloma drug in Phase 3 trial
    Bristol Myers Squibb said its next-generation multiple myeloma therapy, positioned as a successor to Pomalyst, lowered the risk of disease progression or death by 52% when added to a standard combi…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Pfizer partners with China's Innovent Biologics on $10.5 billion deal for 12 early-stage cancer programs
    Pfizer announced a collaboration with Innovent Biologics of China to develop a suite of cancer therapies. The agreement covers up to 12 early-stage antibody‑drug conjugates and multi‑specific anti…
    Endpoints · 5mo agoDealPositive↗ source
  • Positive data from Bristol Myers in multiple myeloma and Pfizer in lung cancer unveiled at ASCO
    At the American Society of Clinical Oncology (ASCO) meeting, Bristol Myers Squibb presented early-stage results that showed a favorable response in a multiple myeloma trial. The data suggest the in…
    STAT · 5mo agoPositive readoutPositive↗ source
  • Trump administration proposes overhaul of federal grant rules, sparking researcher concerns
    The White House released a more than 400-page proposal that would rewrite the core regulation governing all federal grants. The administration says the changes are meant to curb waste and increase…
    STAT · 5mo agoRegulatoryNegative↗ source
  • White House reviews FDA's new prescription drug user fee agreement for 2028-2032
    The White House is currently reviewing a recently negotiated agreement between the FDA and the biopharma industry that determines the level of prescription-drug user fees for the period 2028 throug…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Eli Lilly stops disclosing Phase 1 pipeline, making early-stage projects invisible in earnings decks
    Eli Lilly has become more opaque as its size grows, choosing to stop public disclosure of its early-stage research efforts. The shift was noted earlier this year when the company removed Phase 1 pr…
    Endpoints · 5mo agoNegative↗ source
  • AstraZeneca explores options after anselamimab fails Phase 3, while Imfinzi and Tremfya receive label expansions
    AstraZeneca announced that its experimental monoclonal antibody anselamimab failed to meet the primary endpoint in two Phase 3 trials for a specific patient group. The company said it will explore…
    Endpoints · 5mo agoNegative readoutNeutral↗ source
  • Agios halts development of tebapivat for low-risk MDS after disappointing Phase 2b data
    Agios Pharmaceuticals announced it will discontinue development of its pyruvate kinase activator tebapivat for patients with low-risk myelodysplastic syndromes (MDS). The decision follows the relea…
    Endpoints · 5mo agoNegative↗ source
  • FDA releases draft guidance to trim animal testing in cancer drug development
    The FDA's Oncology Center of Excellence announced a draft guidance aimed at reducing unnecessary animal studies in the nonclinical safety assessment of certain oncology drugs. The guidance suggest…
    fda press · 5mo agoRegulatoryPositive↗ source
  • US says Ebola patients will be evacuated to Europe, not treated in America, as outbreak grows
    The World Health Organization is reviewing which vaccines could help curb the expanding Ebola outbreak in Africa. The U.S. government announced it will no longer bring Americans infected with Ebol…
    STAT · 5mo agoRegulatoryNegative↗ source
  • XPRIZE Healthspan launches $101 million competition to test anti-aging therapies in older adults
    Jamie Justice, former Wake Forest professor, now leads XPRIZE Healthspan, a global contest aimed at finding treatments that can restore muscle, cognition and immune function in older people. The c…
    STAT · 5mo agoPositive↗ source
  • Replimune seeks third FDA approval attempt, Pfizer signs China deal, panel backs updated Covid vaccine
    Replimune is pursuing a third attempt to secure FDA approval for its investigational therapy, after two prior submissions did not succeed. Pfizer has entered into a new agreement to expand its pre…
    STAT · 5mo agoNeutral↗ source
  • Allogene announces CEO David Chang will step down
    Allogene Therapeutics disclosed that its chief executive, David Chang, will be leaving the company. The firm indicated that a succession plan is in place, though it did not provide a specific timel…
    STAT · 5mo agoNeutral↗ source
  • Massachusetts sues UnitedHealth over alleged Medicaid fraud targeting seniors
    Massachusetts Attorney General Andrea Joy Campbell filed a lawsuit against UnitedHealth Group's UnitedHealthcare subsidiary, alleging the insurer deliberately over‑coded health conditions of low‑in…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Allogene CEO David Chang to step down after eight years; former Esperion chief joins Phlow
    Longtime Allogene chief executive David Chang announced he will leave the role at the end of June, concluding an eight‑year tenure leading the cell‑therapy developer. The company said a successor…
    Endpoints · 5mo agoNeutral↗ source
  • Replimune to resubmit melanoma therapy RP1 to FDA after two prior rejections
    Replimune announced on Friday that it will again submit its advanced melanoma candidate, RP1, to the U.S. Food and Drug Administration for review. The company says the filing follows new discussion…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Kenyan court halts U.S. plan for Ebola quarantine facility for Americans
    A Nairobi High Court on Friday ordered a stop to a U.S. proposal to build a quarantine center in Kenya for Americans who might have been exposed to a rare Ebola strain circulating in northeastern C…
    STAT · 5mo agoRegulatoryNegative↗ source
  • Weight-loss doctor warns against unproven GLP-1 microdosing for cosmetic use
    Dr. Jody Dushay, a Harvard‑affiliated weight‑loss specialist, says patients are asking about tiny doses of GLP‑1 drugs for cosmetic slimming. She notes there is no scientific definition of “microd…
    STAT · 5mo agoNegative↗ source
  • GC Therapeutics appoints former BlueRock executive Stefan Irion as chief scientific officer
    GC Therapeutics announced that Stefan Irion has joined the company as its new chief scientific officer. Irion previously served in the same capacity at BlueRock Therapeutics. Irion brings experien…
    STAT · 5mo agoNeutral↗ source
  • GSK reports strong Phase 3 results for Ionis-licensed chronic hepatitis B therapy
    GSK disclosed data from two late‑stage trials of a chronic hepatitis B treatment it licensed from Ionis Pharmaceuticals. The studies evaluated the drug’s efficacy and safety in patients with chroni…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Eli Lilly's obesity drugs Foundayo and Zepbound added to CVS Caremark formulary
    Eli Lilly announced that its two flagship obesity treatments, the oral agent Foundayo and the injectable Zepbound, will be listed on CVS Caremark's drug formularies. The inclusion comes as the GLP…
    Endpoints · 5mo agoRegulatoryPositive↗ source