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2,223 stories matching this filter · ← front page

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  • 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 · 12d agoDealPositive↗ source
  • Argenx halts Phase 3 Sjögren's trial as celiac disease data brings mixed results
    Argenx disclosed on Thursday that it is ending its Phase 3 trial in Sjögren's syndrome after the study failed to meet its primary endpoint. The decision came alongside the release of encouraging r…
    Endpoints · 12d agoNegative readoutNegative↗ source
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Nephrology634
  • 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 · 12d agoRegulatoryPositive↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion, expanding its non‑opioid pain portfolio
    Viatris, a maker of generic and branded medicines, announced a cash purchase of commercial‑stage Pacira BioSciences for $1.65 billion. The deal adds Pacira’s non‑opioid pain treatments to Viatris’…
    Endpoints · 12d agoDealPositive↗ source
  • Ono Pharmaceutical pays Biohaven $80 million for protein degrader as UK pulls Valneva's chikungunya vaccine
    Tokyo-based Ono Pharmaceutical announced it will pay Biohaven $80 million upfront to license a pan‑IgG protein degrader technology. The agreement gives Ono rights to develop the degrader, while Bi…
    Endpoints · 12d agoDealNeutral↗ source
  • Endeavor BioMedicines reports mid-stage trial success for IPF drug, suggests disease reversal potential
    Endeavor BioMedicines announced that its experimental therapy for idiopathic pulmonary fibrosis has met its primary goals in a Phase 2 study. The company said the mid‑stage trial showed signs that…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Zealand and Roche report positive Phase 2 results for amylin drug petrelintide in obesity and diabetes
    Zealand Pharma and Roche announced topline results from a Phase 2 trial of their amylin analogue petrelintide in patients with obesity and type 2 diabetes. The interim data showed that participant…
    Endpoints · 12d agoPositive readoutPositive↗ 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 · 12d agoPositive↗ 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 · 12d 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 · 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
  • 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 · 12d 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 · 12d 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 · 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 · 12d 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 · 13d 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