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  • 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 · 13d 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 · 13d agoPositive↗ source
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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 · 13d 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 · 13d 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 · 13d agoDealPositive↗ source
  • FDA unveils transparency roadmap with plans for public NDA/BLA disclosures and inspection report publishing
    The FDA published a transparency roadmap that outlines its FY 2026 achievements and sets out priorities for FY 2027. One key priority is a proposal to require public disclosure of new drug applica…
    raps · 13d agoRegulatoryNeutral↗ 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 · 12d 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
  • Robotics biotech firm Multiply Labs raises $75M Series B as NorthStar secures up to $185M
    Multiply Labs, a robotics-driven biomanufacturing startup, announced a $75 million Series B financing round. The capital will be used to expand production capacity and hire additional staff as the…
    Endpoints · 12d agoDealPositive↗ source
  • WHO and biotech firms turn attention to preeclampsia, a leading cause of maternal and newborn complications
    Preeclampsia, a hypertension condition that develops during pregnancy, affects millions of mothers and their newborns each year, contributing to serious health complications. The World Health Orga…
    Endpoints · 12d agoNeutral↗ source
  • General Medicine secures $120 million to launch all-in-one healthcare marketplace
    General Medicine, a health‑tech startup, announced it has raised $120 million in a financing round. The capital will be used to develop a digital platform that functions as a one‑stop shop for med…
    Endpoints · 12d agoDealPositive↗ source
  • PhRMA sues Trump administration over Medicare price linking pilot program
    The pharmaceutical trade group PhRMA has filed a lawsuit against the Trump administration, challenging a pilot program that would tie Medicare drug prices to the levels seen in peer countries. The…
    STAT · 12d agoRegulatoryNegative↗ source
  • Rare disease biotech firms expand teams as FDA approvals boost pipelines
    Several biotech companies focused on rare diseases are actively hiring, offering opportunities for professionals interested in this niche therapeutic area. The article highlights four firms that ar…
    BioSpace · 13d agoPositive↗ source
  • Q3 biopharma layoffs drop 90% year-over-year, affecting about 1,800 workers
    Biopharma companies reduced their layoff activity in the third quarter, with the number of employees affected falling about 90% compared with the same period last year. According to BioSpace data,…
    BioSpace · 13d agoLayoffsNeutral↗ source
  • EU Commission urges EMA to fast-track Biotech Act preparations
    The European Commission has issued a statement urging the European Medicines Agency to accelerate work on the upcoming Biotech Act, which aims to streamline regulation of advanced therapies. The C…
    raps · 13d agoRegulatoryNeutral↗ source
  • Trump administration probes nine top universities over alleged J-1 visa misuse for postdocs
    The Trump administration announced an investigation into nine universities for alleged misuse of J-1 visas that support postdoctoral researchers. The schools named include Harvard, Yale, Stanford,…
    STAT · 12d agoRegulatoryNegative↗ source
  • Democrats eye key House committees as midterms approach, opening doors for new health policy influence
    Dozens of Democrats are competing for seats on the House Energy and Commerce and Ways and Means committees as they anticipate winning back control of the chamber. Several incumbents from both part…
    STAT · 12d agoRegulatoryNeutral↗ source
  • All 2026 Nobel laureates in science are men, highlighting ongoing gender gap
    The Nobel committees announced this year’s winners in physiology or medicine, physics and chemistry, and every recipient was male. Women have accounted for roughly 4% of laureates since the awards…
    STAT · 12d agoNegative↗ source
  • AI tool for breast cancer risk moves to direct-to-consumer amid regulatory scrutiny of Utah sandbox
    A startup featured in STAT's Health Tech newsletter is launching its breast cancer risk prediction algorithm directly to patients, bypassing traditional clinical pathways. The direct-to-consumer r…
    STAT · 12d agoNeutral↗ source
  • Grindr launches telehealth service offering erectile dysfunction and weight loss prescriptions
    Grindr has moved beyond its dating platform by introducing a telehealth service that connects users with clinicians for virtual consultations. The offering enables users to receive prescriptions f…
    Endpoints · 12d agoNeutral↗ source
  • Democrats compete for new seats on House Energy and Commerce and Ways and Means committees after midterms
    Washington reporters note that the House Energy and Commerce and Ways and Means committees are likely to welcome several new members following the 2026 midterm elections. A combination of a potent…
    STAT · 13d agoNeutral↗ source
  • Eli Lilly’s trillion-dollar market cap mirrors Dodgers’ big-spending dominance
    The piece draws a parallel between Eli Lilly and the Los Angeles Dodgers, noting that both organizations dominate their fields by spending heavily. Lilly recently became the first pharmaceutical co…
    BioSpace · 12d agoPositive↗ source
  • Mother and daughter seek community for ultra-rare Nicolaides-Baraitser syndrome
    In October 2020 a pediatric geneticist diagnosed an 11‑year‑old girl, Maya, with Nicolaides‑Baraitser syndrome, a condition documented in only 61 cases in the scientific literature. The doctor war…
    STAT · 13d agoNeutral↗ source
  • Merck barred from making subcutaneous Keytruda in 8 European countries
    With the patent court siding with Halozyme, Merck faces restrictions on a product that won approval in Europe last year.
    BioSpace · 12d ago↗ source
  • Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 13d ago↗ source