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901 stories matching this filter · ← front page

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  • Biopharma must pair innovation with operational readiness to scale therapies
    The article argues that breakthrough science alone no longer guarantees success in biopharma. Companies now face pressure to turn discoveries into reliably manufactured, delivered, and scalable pro…
    BioPharma Dive · 3mo agoNeutral↗ source
  • Logistics firms tackle time-critical delivery of radiopharmaceuticals for cancer care
    Radiopharmaceuticals are emerging as a key tool in oncology, offering cell‑level targeting that spares healthy tissue while delivering radiation directly to tumors. Because the radioactive isotope…
    BioPharma Dive · 3mo agoPositive↗ source
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Lundbeck advances PACAP-targeting migraine drug after mid-stage trial shows reduction in migraine days
Lundbeck reported new data from a mid-stage study of its experimental migraine prevention therapy, bocunebart, which targets the PACAP protein involved in headache pathways. The trial enrolled hun…
BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Supreme Court rules generic Vascepa copy does not infringe patents, boosting skinny-label pathway
    The U.S. Supreme Court issued a decision that Hikma Pharmaceuticals’ generic version of Amarin’s heart drug Vascepa does not infringe the brand’s patents. The ruling clarified that the generic make…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Analysts warn that PD-1/VEGF bispecific drugs may be better suited for liver cancer than lung cancer
    Many drugmakers have poured billions into PD-1/VEGF bispecific antibodies after ivonescimab beat Keytruda in a 2024 lung‑cancer trial, sparking a wave of deals and development programs. A recent C…
    BioPharma Dive · 3mo agoNeutral↗ source
  • ADC Therapeutics shares plunge as Phase 3 trial of Zynlonta shows high death rate despite efficacy gain
    ADC Therapeutics reported Phase 3 data for Zynlonta combined with rituximab in a hard-to-treat blood cancer. The trial met its primary endpoint by extending progression-free survival versus standar…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Alnylam partners with Inceptive Nucleics on AI deal that could reach $2 billion
    Alnylam Pharmaceuticals announced a partnership with Inceptive Nucleics to apply artificial‑intelligence tools to its RNA‑based drug discovery program. The agreement provides an upfront $30 millio…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Spanish biotech Ona Therapeutics secures $86.6 million Series B to advance new ADCs for breast and colorectal cancer
    Ona Therapeutics, a Barcelona‑based biotechnology startup, announced a Series B financing round that raised roughly $86.6 million. The new capital will fund the launch of two antibody‑drug conjuga…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • 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
  • 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