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2,692 stories matching this filter · ← front page

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  • 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
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  • 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
  • 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
  • Caribou Biosciences explores strategic alternatives, drawing interest as a reverse-merger candidate
    Caribou Biosciences, the cell‑therapy company co‑founded by CRISPR pioneer Jennifer Doudna, announced it is evaluating strategic alternatives as it faces a difficult financing environment. The com…
    BioPharma Dive · 12d agoDealNeutral↗ source
  • HHS unveils new vaccine injury surveillance plan with NIH clinic and reporting reimbursements
    The Department of Health and Human Services announced a comprehensive initiative to improve monitoring of vaccine-related injuries. The plan includes opening a new clinic at the National Institute…
    BioPharma Dive · 12d agoRegulatoryNeutral↗ 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
  • 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 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 · 14d agoPositive readoutPositive↗ source
  • Dutch court orders Merck to halt subcutaneous Keytruda sales in eight European countries
    A Dutch court has issued an injunction that requires Merck to stop manufacturing and selling the injectable, subcutaneous formulation of its cancer immunotherapy Keytruda in eight European countrie…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Zuckerberg’s Biohub secures $1.8 billion to expand AI-driven virtual cell platform with Meta and Google
    Mark Zuckerberg and Priscilla Chan's nonprofit Biohub announced an expansion of its virtual cell initiative, now backed by $1.8 billion in funding. The new capital comes from a coalition that incl…
    Endpoints · 13d agoPositive↗ source
  • Caribou Biosciences halts CAR-T programs and cuts staff amid funding shortfall
    Caribou Biosciences, a CRISPR gene-editing company co-founded by Nobel laureate Jennifer Doudna, announced it will stop work on its off-the-shelf CAR-T cancer therapies. The decision follows the c…
    BioPharma Dive · 13d agoLayoffsNegative↗ 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
  • 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
  • Cerevance reports positive Phase 3 results for Parkinson’s drug solengepras
    Cerevance, a Boston biotech spinout from Takeda, announced that its experimental Parkinson’s drug solengepras achieved its primary endpoint in a Phase 3 trial. The trial enrolled 341 patients with…
    BioPharma Dive · 14d agoPositive readoutPositive↗ 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
  • PhRMA files lawsuit against Trump administration over GLOBE drug pricing demonstration program
    PhRMA, the leading trade association for the pharmaceutical industry, has filed a lawsuit against the U.S. government challenging the Centers for Medicare & Medicaid Services' GLOBE drug pricing de…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Ultragenyx sells priority review voucher for $210 million, retains another to monetize
    Ultragenyx Pharmaceutical announced it has sold a priority review voucher to an undisclosed buyer for $210 million. The transaction is among the highest-priced voucher sales this year, providing a…
    Endpoints · 13d agoDealPositive↗ source
  • WHO advises against GLP-1 obesity drugs for children under 10, limits use in teens
    The World Health Organization issued guidance recommending that GLP-1 drugs not be used to treat obesity in children younger than ten years old. For adolescents aged 10 to 19, the WHO says these m…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda sales in eight European countries after Halozyme patent win
    A Netherlands court issued an injunction that stops Merck from marketing its subcutaneous formulation of Keytruda, known as Keytruda Qlex, in eight European markets. The ruling follows a patent in…
    BioPharma Dive · 13d agoRegulatoryNeutral↗ source