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  • Nobel-winning optogenetics sees growing biotech interest
    Karl Deisseroth, a Stanford psychiatrist and bioengineer, learned he had shared the 2026 Nobel Prize in Physiology or Medicine for pioneering optogenetics, a method that makes neurons responsive to…
    Fierce Biotech · 13d agoPositive↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 13d agoRegulatoryNeutral↗ source
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  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 13d agoNeutral↗ source
  • BD appoints Ferass Abuzaina as Worldwide President of Surgery
    Becton, Dickinson and Company announced that Ferass Abuzaina will serve as the new Worldwide President of its Surgery business unit, effective immediately. He will oversee the global strategy, oper…
    Fierce Biotech · 13d agoPositive↗ source
  • Endeavor BioMedicines reports positive phase 2b results for Hedgehog inhibitor taladegib in IPF
    Endeavor BioMedicines announced that its Hedgehog pathway inhibitor, taladegib, produced encouraging results in a phase 2b study of patients with idiopathic pulmonary fibrosis (IPF). The trial, nam…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Argenx halts late-stage Vyvgart trial in Sjogren’s disease after futility finding, shares tumble 13%
    Argenx announced it is ending the Phase 3 UNITY trial of its Vyvgart Hytrulo injection in Sjogren’s disease after an independent data monitoring committee concluded the study would not meet its pri…
    BioSpace · 13d agoNegative readoutNegative↗ source
  • Newron reports five deaths in schizophrenia trial as FDA keeps hold on evenamide study
    Newron Pharmaceuticals disclosed that five participants have died in its late-stage schizophrenia trial, with four deaths among those receiving the investigational drug evenamide and one death amon…
    BioSpace · 13d agoRegulatoryNegative↗ source
  • Zealand Pharma’s petrelintide shows 9% weight loss in Phase 2 but fails to improve blood sugar, analysts unimpressed
    Zealand Pharma, in partnership with Roche, reported results from the Phase 2 ZUPREME-2 trial of petrelintide, a long‑acting human amylin analog, in 220 obese or overweight patients with type 2 diab…
    BioSpace · 13d agoNegative readoutNeutral↗ source
  • Matchpoint Therapeutics raises $150 million Series B to move oral T-cell modulator MPT-062 toward clinical trials
    Matchpoint Therapeutics announced the closing of a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures and several exi…
    BioSpace · 14d agoDealPositive↗ source
  • ARM playbook proposes data reuse to slash gene-editing R&D costs and broaden rare-disease therapies
    The Alliance for Regenerative Medicine released a new playbook that outlines how developers of gene‑editing therapies can reuse existing data to lower research and development expenses. The guidanc…
    BioSpace · 13d agoRegulatoryPositive↗ source
  • Venture debt becomes central financing option for late-stage European biotech
    BioSpace’s Denatured podcast recently featured Jennifer McMahon of Seroba and Joey Mason of Claret Capital discussing the growing role of venture debt in European biotech. The guests explained tha…
    BioSpace · 14d agoPositive↗ source
  • Iambic Therapeutics targets $135M IPO to fund clinical trials of HER2 and KIF18A cancer drugs
    Iambic Therapeutics, a San Diego AI‑driven biotech, filed to raise $135 million in net proceeds through an initial public offering. The company plans to sell 9.4 million shares at $15 to $17 each,…
    Fierce Biotech · 14d agoDealNeutral↗ source
  • Ono Pharmaceutical pays $80 million for Asian rights to Biohaven IgG degrader trio, including phase-3 Graves disease candidate
    Japan's Ono Pharmaceutical has agreed to pay $80 million upfront for the rights to three Biohaven IgG degrader programs in Japan, South Korea, Taiwan and ASEAN markets. The agreement also includes…
    Fierce Biotech · 14d agoDealNeutral↗ source
  • Zealand's amylin analog shows strong weight loss but weak blood-sugar control in phase 2 trial
    Zealand Pharma, in partnership with Roche, released topline results from its mid‑phase Zupreme‑2 study of petrelintide, an amylin‑based candidate aimed at patients with overweight or obesity and ty…
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • Argenx’s FB102 meets primary endpoint in phase 2 celiac trial, paving way for pivotal study
    Argenx reported that its experimental antibody FB102 achieved a statistically significant improvement in villus height‑to‑crypt depth (Vh:Cd) compared with placebo in a phase 2 study of adults with…
    Fierce Biotech · 14d agoPositive readoutPositive↗ 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 · 14d agoRegulatoryNeutral↗ 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 · 14d 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 · 14d 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 · 14d agoRegulatoryNeutral↗ source
  • Vir Biotechnology appoints David Liu as chief medical officer to steer hepatitis D phase 3 and cancer programs
    Vir Biotechnology announced the appointment of David Liu, M.D., Ph.D., as its new chief medical officer. Liu comes from a recent stint as CMO at Nuvation Bio and has held senior roles at AstraZene…
    Fierce Biotech · 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 · 13d agoPositive↗ 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 · 13d 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 · 14d ago↗ source
  • Cerevance's solengepras cuts OFF time in phase 3 Parkinson's trial
    Cerevance reported that its oral non‑dopaminergic therapy, solengepras, produced meaningful improvements in both motor and non‑motor symptoms in a phase 3 Parkinson's disease study, rescuing the ca…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Cerevance's solengepras cuts Parkinson off-time by 0.6 hours in Phase 3, advancing toward FDA review
    Cerevance, a spinout from Takeda, reported that a high 150‑mg dose of its Parkinson's drug solengepras reduced daily "off time" by an average of 0.61 hours compared with placebo in the Phase 3 ARIS…
    BioSpace · 14d agoPositive readoutPositive↗ source