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1,270 stories matching this filter · ← front page

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  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Bipartisan House bill would require security review of U.S. biotech investments in China
    A bipartisan group of Representatives introduced legislation on Tuesday that would expand the Committee on Investment and National Security (COINS) Act to cover biotechnology. The bill, called the…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
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  • Eli Lilly partners with Ascidian Therapeutics on $1.9 b RNA exon-editing collaboration for kidney disease
    Eli Lilly and Boston-based Ascidian Therapeutics announced a research collaboration aimed at discovering medicines for genetically driven kidney diseases. The partnership leverages Ascidian’s RNA e…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • NewLimit raises $435M Series C to launch epigenetic anti-aging therapy, while Lilly signs GLP-2 obesity drug deal
    Longevity startup NewLimit announced a $435 million Series C financing, one of the largest biotech rounds this year. The round was led by Founders Fund and included investors such as Thrive Capital…
    BioPharma Dive · 3mo agoNeutral↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • AbiVax shares plunge as safety concerns shadow strong ulcerative colitis trial results
    AbiVax reported Phase 3 data for its experimental therapy obefazimod in patients with moderately to severely active ulcerative colitis. Two dose levels achieved placebo‑adjusted clinical remission…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • ASCO 2026 Highlights Bispecific Antibodies, ADCs and New Advances in RAS-Targeted and Prostate Cancer Therapies
    The meeting featured a lively comparison of bispecific antibodies and antibody-drug conjugates as leading modalities in oncology. Researchers presented data suggesting that targeting mutant RAS pr…
    BioPharma Dive · 3mo agoPositive↗ source
  • Celcuity's gedatolisib trial cuts death risk but misses investor expectations
    Celcuity reported data from its Phase 3 VIKTORIA-1 trial evaluating gedatolisib in HR‑positive, HER2‑negative breast cancer with PIK3CA mutations. The trial enrolled 350 patients who had progresse…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Eli Lilly gives 340B hospitals a week to share data or lose drug discounts
    Eli Lilly has told hospitals and medical groups that participate in the 340B drug discount program that they must submit claims data for all Lilly medications by the coming Monday, or they will be…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • US-made packaging equipment offers faster lead times and regulatory alignment for pharma manufacturers
    As pharma firms upgrade their packaging lines, the source of the equipment is becoming a strategic factor rather than a simple purchasing decision. Domestic production shortens lead times and redu…
    BioPharma Dive · 3mo agoPositive↗ source
  • Servier to acquire Edgewise's experimental muscular dystrophy drug in $2.7B deal
    Servier, a French pharmaceutical company, announced it will acquire the muscular dystrophy business of Colorado biotech Edgewise Therapeutics. The deal centers on sevasemten, an experimental oral…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Orphan drug sales projected to exceed 21% of prescription market by 2032, driven by strong pipeline and policy support
    Orphan drug developers continue to see robust sales growth even as the broader pharmaceutical industry faces pricing and policy turbulence. The latest Evaluate Orphan Drugs Report highlights that s…
    BioPharma Dive · 3mo agoPositive↗ source
  • RallyBio pursues second reverse merger, this time with cancer drug developer Avenzo Therapeutics
    RallyBio announced on Monday that it will merge with cancer-focused Avenzo Therapeutics in a reverse‑merger transaction. The combined entity will operate under the Avenzo Therapeutics name. The de…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Revolution Medicines' daraxonrasib nearly doubles survival in pancreatic cancer trial
    Data presented at the American Society of Clinical Oncology meeting showed that Revolution Medicines' experimental drug daraxonrasib significantly extended survival for patients with metastatic pan…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Ivonescimab cuts death risk by one-third in Chinese lung cancer trial, adds four-month survival
    A trial in China evaluated ivonescimab combined with chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer. The study was presented at the American Society of Clinical O…
    BioPharma Dive · 3mo agoPositive readoutNeutral↗ source
  • Bristol Myers reports Phase 3 data showing mezigdomide extends survival in relapsed multiple myeloma
    Bristol Myers Squibb presented Phase 3 results for its experimental multiple myeloma drug mezigdomide at the American Society of Clinical Oncology meeting. The study evaluated mezigdomide combined…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Pfizer partners with China's Innovent Biologics on $10 billion cancer drug collaboration
    Pfizer announced a major partnership with Chinese biotech Innovent Biologics, valued at over $10 billion, to develop cancer therapies. The agreement covers up to 12 antibody-based candidates, incl…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Merck touts promising ADC sacituzumab tirumotecan as potential cornerstone therapy at ASCO
    Merck highlighted a new antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), licensed from Chinese biotech Kelun-Biotech, at the ASCO meeting. The company said early clinical data have give…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • Former FDA official says leadership turnover won’t derail push for faster US drug trials
    The Food and Drug Administration has faced a wave of leadership changes this year, creating uncertainty about its ability to keep drug development moving quickly. Industry leaders and regulators, h…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • CVS adds Lilly’s Foundayo and Zepbound to formularies, leveling GLP-1 market with Novo
    CVS Caremark announced it will place Eli Lilly’s new oral GLP-1 drug Foundayo on its formulary starting June 1 and will restore the injectable Zepbound as a preferred option from Oct 1. The change…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 3mo agoDealPositive↗ source