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  • Q32 Bio appoints José Trevejo as chief medical officer, coming from Enveda Therapeutics
    STAT+ ran its regular "up and down the ladder" column highlighting recent personnel moves in the pharma sector. The feature invites readers to share hiring, promotion and departure news for broader…
    STAT · 11d agoNeutral↗ source
  • Viking Therapeutics commercial chief exits after nine months; Gilead eyes BeOne executive for China growth
    Viking Therapeutics' chief commercial officer Neil Aubuchon left the company after only nine months in the role, according to Peer Review. His brief tenure has sparked speculation about the compan…
    Endpoints · 11d agoNeutral↗ source
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Krasnyi Oktyabr Recalls Starfish Seafood Trio Over Listeria Risk
Krasnyi Oktyabr Inc. of Brooklyn, New York announced a voluntary recall of its Starfish Seafood Trio, which includes cold smoked salmon, halibut and trout packaged in 8‑oz vacuum‑sealed packs. The…
fda recalls · 11d agoCRLNegative↗ source
  • Acting HHS General Counsel Bob Foster Departs Agency
    The acting general counsel for the U.S. Department of Health and Human Services, Bob Foster, is no longer employed by the agency. Endpoints News attempted to reach him via his government email and…
    Endpoints · 11d agoRegulatoryNeutral↗ source
  • MAHA movement fades as midterms approach, lacking visibility and funding
    Health secretary Robert F. Kennedy Jr.'s Make America Healthy Again (MAHA) movement entered the political arena promising to rally an unlikely coalition of activists and deliver significant gains f…
    STAT · 11d agoNegative↗ source
  • Krasnyi Oktyabr Inc. Recalls Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced (227g/8oz) Because of Possible Health Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York, is voluntarily recalling STARFISH SEAFOOD PREMIUM COLD SMOKED NORWEGIAN SALMON SLICED (227g/8oz) packages, because the product has the potential to be co…
    fda recalls · 11d ago↗ source
  • Roche partners with Chinese biotech Defand Therapeutics to co-develop new medicines
    Roche announced a partnership with Chinese biotech startup Defand Therapeutics aimed at joint discovery of new drug candidates. Unlike the typical licensing deals where companies obtain rights to…
    STAT · 12d agoDealPositive↗ source
  • Par Health recalls two lots of Brevital Sodium injection over cellulose particles
    Par Health announced a voluntary recall of two lots of its Brevital® Sodium 500 mg/vial for injection after detecting particulate matter identified as cellulose. The recall is being executed at th…
    fda recalls · 12d agoRegulatoryNegative↗ source
  • Argenx's Vyvgart fails to beat placebo in Phase 3 Sjögren's disease trial
    Argenx announced that its marketed antibody therapy Vyvgart did not show superiority over placebo in a Phase 3 study involving patients with Sjögren's disease, a chronic autoimmune condition. The…
    STAT · 12d agoNegative readoutNegative↗ source
  • Roche partners with China's Defand Therapeutics to discover molecular glue medicines
    Roche announced a collaboration with Chinese biotech Defand Therapeutics aimed at discovering new molecular glue medicines for oncology and immune‑mediated diseases. Unlike typical licensing deals…
    STAT · 12d agoDealPositive↗ source
  • Argenx halts Phase 3 Sjögren's trial as celiac disease data brings mixed results
    Argenx disclosed on Thursday that it is ending its Phase 3 trial in Sjögren's syndrome after the study failed to meet its primary endpoint. The decision came alongside the release of encouraging r…
    Endpoints · 12d agoNegative readoutNegative↗ source
  • CMS proposes changes to curb 340B drug discount program’s costly subsidies to safety-net hospitals
    Casey B. Mulligan, chief economist and chief regulatory officer at HHS, wrote an opinion piece outlining a major flaw in the 340B drug discount program. The program, created in 1992, gives steep di…
    STAT · 12d agoRegulatoryNegative↗ source
  • NIH funding uncertainty clouds US research, dampens biotech investor sentiment
    The latest episode of STAT’s “The Readout LOUD” podcast examined how the National Institutes of Health is allocating its budget and the growing uncertainty surrounding future funding. Hosts Elaine…
    STAT · 12d agoNegative↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion, expanding its non‑opioid pain portfolio
    Viatris, a maker of generic and branded medicines, announced a cash purchase of commercial‑stage Pacira BioSciences for $1.65 billion. The deal adds Pacira’s non‑opioid pain treatments to Viatris’…
    Endpoints · 12d agoDealPositive↗ source
  • Ono Pharmaceutical pays Biohaven $80 million for protein degrader as UK pulls Valneva's chikungunya vaccine
    Tokyo-based Ono Pharmaceutical announced it will pay Biohaven $80 million upfront to license a pan‑IgG protein degrader technology. The agreement gives Ono rights to develop the degrader, while Bi…
    Endpoints · 12d agoDealNeutral↗ source
  • Endeavor BioMedicines reports mid-stage trial success for IPF drug, suggests disease reversal potential
    Endeavor BioMedicines announced that its experimental therapy for idiopathic pulmonary fibrosis has met its primary goals in a Phase 2 study. The company said the mid‑stage trial showed signs that…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • FDA extends safety review of mifepristone into next year, report due by March 2027
    The FDA announced that its ongoing safety evaluation of mifepristone, the primary medication used for medical abortions, will not be completed until next year. The agency expects to finish the saf…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Zealand and Roche report positive Phase 2 results for amylin drug petrelintide in obesity and diabetes
    Zealand Pharma and Roche announced topline results from a Phase 2 trial of their amylin analogue petrelintide in patients with obesity and type 2 diabetes. The interim data showed that participant…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Tailored breast cancer care for older women gains momentum as researchers highlight age-specific tumor differences
    Older women represent a large share of breast cancer diagnoses, with nearly half of cases occurring in patients 65 or older and about one-fifth in those 75 and older. Despite these numbers, clinic…
    STAT · 12d agoPositive↗ source
  • Everlywell launches AI tool to predict breast cancer risk directly to consumers
    Everlywell, a digital health company known for offering at-home lab tests, has introduced a new artificial intelligence algorithm that evaluates breast cancer risk from medical images. The company…
    STAT · 12d agoPositive↗ source
  • Experts say U.S. must step up to match Europe’s progress in eliminating hepatitis C
    The authors argue that England and several other nations are nearing hepatitis C elimination, while the United States lags behind. They point to recent public attention, such as Pamela Anderson’s…
    STAT · 12d agoNeutral↗ source
  • Smaller biotech firms face uncertainty over U.S. tariff exemptions as new import taxes take effect
    A broad 100% tariff on imported pharmaceuticals introduced at the end of September under the Trump administration has created confusion for many biotech companies. While large drugmakers can use e…
    STAT · 12d agoRegulatoryNegative↗ source
  • Roche signs near-$1 billion partnership with Chinese biotech Defand on degrader therapies
    Roche has entered into a new collaboration with Defand, a relatively unknown biotech based in Hangzhou, China. The agreement is the fourth China-focused deal the Swiss drugmaker has signed since Au…
    Endpoints · 12d agoDealPositive↗ source
  • Congressional Bill Aims to End Arbitration in No Surprises Act, Shifting Payments to Median In-Network Rates
    Rep. Frank Pallone introduced the Lower Premiums, Faster Payments Act, which would eliminate the arbitration system used under the No Surprises Act and replace it with a payment model based on medi…
    STAT · 11d agoRegulatoryNeutral↗ source
  • New PDUFA agreement earmarks funds to rehire FDA reviewers after recent layoffs
    Trade groups report that the latest PDUFA reauthorization includes a specific funding pool for the FDA. The money is intended to replace reviewers who were let go after recent HHS staffing reducti…
    Endpoints · 12d agoRegulatoryPositive↗ source