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  • 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
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  • 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 · 12d 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
  • 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
  • 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 · 13d 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 · 13d agoPositive readoutPositive↗ source
  • Epkinly shows 51% lower risk of progression in frontline DLBCL trial, boosting hopes for expanded approval
    New Phase 3 data from the Epkinly and R-CHOP combination in diffuse large B cell lymphoma showed a 51% reduction in the risk of disease progression or death compared with standard therapy. The stud…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • ArriVent BioPharma's Phase 3 lung cancer trial misses primary endpoint, shares tumble
    ArriVent BioPharma reported that its investigational EGFR tyrosine kinase inhibitor firmonertinib did not achieve a statistically significant improvement in progression-free survival in the Phase 3…
    BioSpace · 13d agoNegative readoutNegative↗ source
  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 13d agoDealNegative↗ source
  • Caribou Biosciences to halt R&D and cut staff as financing for allogeneic CAR-T dries up
    Caribou Biosciences, co‑founded by Nobel laureate Jennifer Doudna, announced it will stop all clinical‑stage work and lay off staff because of a financing freeze in the allogeneic CAR‑T market. Th…
    BioSpace · 13d agoLayoffsNegative↗ source
  • Matchpoint Therapeutics raises $150M Series B to advance oral covalent therapies for autoimmune disease
    Matchpoint Therapeutics announced a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Digitalis Ventures, Invus, BB…
    Fierce Biotech · 13d agoDealPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 14d agoRegulatoryNeutral↗ source
  • Biotech VC Forbion raises record €2.3 bn ($2.6 bn) to back 30 high-potential life-science companies
    Forbion announced a record fundraising of €2.3 bn ($2.6 bn) across two new funds, bringing its assets under management to about €7.5 bn ($8.4 bn). The capital will be allocated through the Forbion…
    BioSpace · 13d agoDealPositive↗ source
  • ARPA-H launches Surpass program to speed and broaden clinical trials
    The U.S. Department of Health and Human Services announced a new initiative called Surpass, aimed at removing obstacles that slow clinical development and changing how trials are designed and run.…
    Fierce Biotech · 13d agoPositive↗ source
  • Bayer invests $2.2 billion in Ohio to build pharma manufacturing plant
    Bayer announced a $2.2 billion investment to construct a new pharmaceutical manufacturing complex in New Albany, Ohio. The plant will produce drug substances and finished products for oncology, ca…
    BioSpace · 13d agoDealNeutral↗ source
  • TCGX raises $600 million to fund Asian biotech startups
    Investment firm TCGX announced a new $600 million Asia Life Sciences Fund I aimed at supporting biotech companies across the region. The fund will operate separately but in close coordination with…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Atsena reports early efficacy signals for gene therapy ATSN-201 in X-linked retinoschisis trial
    Atsena Therapeutics presented data from the early parts of its Lighthouse gene therapy trial for X-linked retinoschisis (XLRS) at the American Academy of Ophthalmology meeting. The trial administe…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Venture capital continues to flow into biopharma in Q3 2026, favoring later-stage and AI-driven companies
    Venture capital funding into biopharma topped $16 billion in the first half of 2026 and kept rising in the third quarter, according to industry sources. Investors remain selective, directing money…
    BioSpace · 14d agoDealNeutral↗ source
  • Stryker appoints Spencer Stiles as CEO, Kevin Lobo to become Executive Chair
    Stryker announced a leadership change, naming Spencer Stiles as the new chief executive officer. Stiles, who has been president and COO, will also join the board. Kevin Lobo, who has led the compa…
    Fierce Biotech · 14d agoNeutral↗ source
  • Executive candidates need full truth, not a sales pitch, to address company challenges
    The article argues that candidates for senior roles must be given an honest picture of the company's problems rather than a polished sales narrative. It notes that during executive searches, infor…
    BioSpace · 13d agoNeutral↗ source
  • iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis Pigmentosa
    Following its Parkinson’s disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China.
    Fierce Biotech · 13d agoNeutral↗ source
  • Epkinly shows 51% PFS boost in frontline DLBCL, may become new standard of care
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a substantial gain in progression‑free survival when added to the standard R‑CHOP regimen in newly diagnosed diffuse large…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 14d agoNegative readoutNegative↗ source