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  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 21h agoDealPositive↗ source
  • EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
    raps · 1d agoRegulatoryNeutral↗ source
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  • Podcast debates FDA’s handling of Duchenne drugs and upcoming executive changes
    Allison DeAngelis, Adam Feuerstein and Elaine Chen host this week’s Readout Loud podcast, a STAT series that examines biotech trends and business moves. The trio questions whether the FDA is apply…
    STAT · 9h agoNeutral↗ source
  • Experts warn U.S. pharma reliance on China poses national security threat
    The authors of a recent Council on Foreign Relations report argue that the United States’ dependence on China for biopharmaceutical manufacturing creates a clear national security risk. They point…
    STAT · 20h agoNegative↗ source
  • Medicaid work rules spark confusion over medically frail exemption, risking coverage for chronically ill
    Nebraska will begin enforcing Medicaid work requirements next week, demanding that beneficiaries work, volunteer or attend school for at least 80 hours each month or risk losing their health covera…
    STAT · 20h agoRegulatoryNegative↗ source
  • Federal judge rejects 26 states' bid to delay Medicaid work requirement rollout
    A U.S. District Judge in Massachusetts issued an order Thursday refusing to grant a preliminary injunction that would have paused the new Medicaid work‑requirement rules. The decision leaves the fe…
    STAT · 14h agoRegulatoryNeutral↗ source
  • A decade after WHO recognition, mycetoma is still one of the world’s most neglected diseases
    Borna Nyaoke-Anoke, a physician leading mycetoma work at the Drugs for Neglected Diseases initiative, reflects on a decade since the World Health Organization formally acknowledged the disease. Sh…
    STAT · 20h agoNegative↗ source
  • Red Bull-funded studies downplay risks of mixing energy drinks with alcohol, shaping policy despite independent warnings
    An investigative report found that research funded by the energy‑drink maker contradicted the bulk of independent studies on the dangers of combining alcohol with caffeinated beverages. The funded…
    STAT · 1d agoRegulatoryNegative↗ source
  • FDA updates product-specific guidelines for injectable peptides
    The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide pr…
    raps · 1d ago↗ source
  • Researchers concerned by underutilization of accelerated approval in oncology
    Most adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than acc…
    raps · 1d ago↗ source
  • FDA unveils FY 2027 user fee rates
    The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. Th…
    raps · 1d ago↗ source
  • FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocel
    During an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…
    BioSpace · 1d agoApprovalNegative↗ source
  • Caldera and Vidya secure $478M via reverse mergers to go public
    Caldera Therapeutics, a U.S. bispecific antibody biotech, announced a reverse merger with Nasdaq-listed Synlogic to become a public company. The deal includes a $278 million private placement from…
    BioSpace · 1d agoDealPositive↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • Novo Nordisk faces shareholder fraud lawsuit over undisclosed dosing changes in CagriSema Phase 3 trial
    New Jersey federal judge Robert Kirsch ruled that shareholders can pursue claims that Novo Nordisk misled investors about its Phase 3 study of the weight‑loss drug CagriSema. The plaintiffs allege…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • FDA briefing hints tough road for Capricor and Replimune ahead of advisory committee meetings
    The FDA released briefing documents for upcoming advisory committee meetings concerning Capricor Therapeutics' Duchenne muscular dystrophy cell therapy and Replimune's advanced melanoma candidate.…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 1d agoPositive readoutPositive↗ source
  • Trump administration ends Medicare drug plan subsidies, raising cost concerns ahead of midterms
    The White House announced that subsidies for private Medicare prescription drug plans will be discontinued, a move expected to increase premiums for many seniors. The policy shift comes as Democra…
    STAT · 1d agoRegulatoryNegative↗ source
  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 1d agoDealPositive↗ source
  • Benchmarking Clinical LLMs Proves Complex After Recent Nature Medicine Study
    The STAT AI Prognosis newsletter, written by health‑tech reporter Brittany Trang, looks at why evaluating new clinical large language models is difficult. A recent Nature Medicine paper compared s…
    STAT · 1d agoNeutral↗ source
  • Incyte drops early-stage JAK2 inhibitor to prioritize next-generation pipeline
    Incyte announced it is terminating development of its early-stage oral JAK2 inhibitor, INCB160058, after a Phase 1 study in myeloproliferative neoplasms. The company said the decision reflects the…
    BioSpace · 1d agoNegative↗ source
  • Novo Nordisk loses bid to dismiss lawsuit over CagriSema trial readout
    U.S. District Judge Robert Kirsch in New Jersey refused to dismiss most of the securities lawsuit filed by investors after Novo Nordisk’s CagriSema readout. While the judge found the plaintiffs’ cl…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 1d agoNeutral↗ source