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  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 4mo agoRegulatoryPositive↗ source
  • 26 states file lawsuit to halt federal Medicaid work-requirement rule
    Five New England states joined 21 others in a lawsuit filed Monday to stop a federal rule that would add work requirements to Medicaid. The states argue the new guidelines create an unfair bureaucr…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • FDA adds peptide-focused physicians to advisory panel, raising conflict-of-interest concerns
    The FDA announced eight new members for a committee that will advise on whether compounding pharmacies can produce certain peptides. Most of the appointees are physicians or pharmacists who run bu…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Zymeworks CEO says $1 billion Theravance acquisition offers strong value despite recent setbacks
    Zymeworks chief executive Kenneth Galbraith explained why the company believes its near-$1 billion purchase of Theravance makes strategic sense. He noted that Theravance has faced operational diff…
    Endpoints · 4mo agoDealPositive↗ source
  • Evommune's lead drug fails in chronic hives trial, shares tumble over 30%
    Evommune reported its first major trial readout since going public last year, focusing on its lead candidate for chronic spontaneous urticaria, a condition where patients experience recurring hives…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Talawar Therapeutics merges with JATT II Acquisition to list on Nasdaq as AstraZeneca reports Phase 3 success in pediatric bone disease
    Talawar Therapeutics announced a combination with blank‑check company JATT II Acquisition Corp, a deal that will place Talawar on the Nasdaq exchange. The SPAC transaction gives Talawar public‑mar…
    Endpoints · 4mo agoDealPositive↗ source
  • Chinese partnerships are becoming the pharma industry's new tax inversion strategy
    The article notes that a decade after the wave of U.S. tax inversions, the pharmaceutical sector is now seeing a similar pattern with deals involving Chinese entities. Analysts argue that these tra…
    Endpoints · 4mo agoDealNeutral↗ source
  • Ipsen to acquire blood-cancer specialist Kartos Therapeutics for $450 million upfront
    Ipsen announced it will purchase Kartos Therapeutics, a company focused on blood cancers. The transaction includes a $450 million cash payment at closing, with the possibility of up to $1.75 billi…
    Endpoints · 4mo agoDealPositive↗ source
  • BioCryst to shut internal drug discovery and close Alabama research site
    BioCryst Pharmaceuticals announced it is winding down its internal drug discovery efforts. The company said it will seek future programs through external collaborations rather than in‑house resear…
    Endpoints · 4mo agoNegative↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • 5 takeaways from STAT’s investigation into microhospital operator Nutex Health
    Read the takeaways from STAT's investigation into Nutex, which used the No Surprises Act to fuel a stunning financial turnaround.
    STAT · 4mo agoRegulatoryNeutral↗ source
  • FDA’s top gene-therapy regulator Vijay Kumar steps down amid leadership shake-up
    Vijay Kumar, the acting director of the FDA office that reviews cell and gene therapies, has announced he will leave his position. In an email to staff, Kumar said he reflected on his tenure and de…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • AstraZeneca to Pay $34 Million Settlement Over Texas Medicaid Kickback Allegations
    AstraZeneca has agreed to a $34 million settlement with the Texas attorney general over allegations that it provided improper incentives to boost prescriptions covered by Texas Medicaid. The state…
    STAT · 4mo agoRegulatoryNegative↗ source
  • J&J EVP John Reed Discusses R&D Model, Oncology Deals and Pipeline Growth Potential
    John Reed, executive vice president of Innovative Medicine at Johnson & Johnson, brings more than a decade of experience overseeing drug pipelines at three of the world’s largest pharmaceutical com…
    Endpoints · 4mo agoNeutral↗ source
  • Over 200 biopharma investors urge EU governments to strengthen Europe's life-science sector
    More than 200 biopharma investors and companies have signed an open letter addressed to EU member states, calling for action to improve Europe's life‑science sector. The signatories argue that Eur…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • California hospital lawsuits reveal forced McKinsey ties and surprise ER chain profits
    Unredacted comments from recent California hospital lawsuits show that hospital executives admitted to a "forced" partnership with consulting firm McKinsey, raising questions about the influence of…
    STAT · 4mo agoRegulatoryNegative↗ source
  • European regulators give second chance approval to Acadia’s Daybu for Rett syndrome
    European Medicines Agency's CHMP has reversed its earlier negative vote and now recommends marketing authorization for Acadia Pharmaceuticals' drug Daybu (trofinetide) for Rett syndrome. The posit…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • FDA accepts resubmission of Replimune’s RP1 cancer therapy, decision due Aug. 2; Merck KGaA announces $11 B life-sciences spend
    The U.S. Food and Drug Administration has accepted Replimune's resubmitted application for its cancer drug RP1, with a final decision slated for August 2 and an advisory committee meeting planned f…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • US biotech faces regulatory push as China licensing deals spark security concerns
    A surge in licensing agreements between Chinese pharmaceutical firms and U.S. biotech companies has been noted, with nearly 100 deals announced since early 2025, prompting worry among investors and…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • Alkermes CEO targets orexin market after strong narcolepsy pill data
    Alkermes' incoming chief executive outlined a strategy to compete with larger rivals in the emerging orexin drug class. Recent mid-June trial results showed the experimental oral compound alixorex…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • La Ceiba Foods recalls Salvadoran and Mexican cottage cheese over possible Listeria contamination
    La Ceiba Foods Latin Market Inc. announced on June 26, 2026 that it is recalling its Requesón Salvadoreño (Salvadoran cottage cheese) and Requesón Mexicano (Mexican cottage cheese) products sold un…
    fda recalls · 4mo agoRegulatoryNegative↗ source
  • FDA proposes rule to require foreign tobacco makers to register and list products, aiming to curb illegal imports and protect youth
    The U.S. Food and Drug Administration announced on June 26, 2026 a proposed rule intended to strengthen its ability to identify illegal foreign tobacco products, including youth‑appealing e‑cigaret…
    fda press · 4mo agoRegulatoryPositive↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 4mo agoNeutral↗ source
  • Endpoints News celebrates ten years of bootstrapped growth and a 50/50 founder partnership
    John Carroll and Arsalan Arif launched Endpoints News a decade ago with no seed funding or investors, describing themselves as completely broke. They built the news service from scratch, relying on…
    Endpoints · 4mo agoPositive↗ source
  • STAT readers split on spelling of "health care" as industry leans toward single word
    STAT recently asked its audience whether to write the term as two words or one. Roughly 60% of respondents favored one spelling over the other. The discussion highlights a subtle but growing trend…
    STAT · 4mo agoNeutral↗ source