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  • Swiss biotech Windward Bio raises $175 million in IPO to fund lung-drug development and test Tezspire competitor
    Windward Bio, a Swiss immune‑drug developer, completed a $175 million initial public offering, selling about 10.3 million shares at $17 each. The company began trading on the exchange under the tic…
    BioPharma Dive · 17h agoDealPositive↗ source
  • Windward Bio launches on Nasdaq after $175 million IPO, secures $50 million from Sanofi
    Windward Bio, a biotech developing drugs for respiratory diseases, completed its initial public offering and began trading on Nasdaq. The offering raised $175 million, with the stock opening at $1…
    Endpoints · 2h agoDealPositive↗ source
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  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 1d agoNeutral↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 7d agoApprovalPositive↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 7d agoApprovalPositive↗ source
  • Medicare to slash 340B drug payments and expand site-neutral rules in 2027
    Medicare finalized a rule that will cut payments for drugs covered by the 340B discount program and broaden site-neutral payment policies beginning in 2027. The rule is expected to reduce Medicare…
    BioPharma Dive · 7d agoRegulatoryNegative↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 10d agoRegulatoryNeutral↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 11d agoDealNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 13d agoApprovalPositive↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 14d agoEarningsPositive↗ source
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 14d agoDealPositive↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 16d agoNeutral↗ source
  • Melanoma vaccine shows 42% risk reduction at ESMO 2026, but shares tumble on early data release
    Moderna and Merck presented Phase 3 results for their melanoma vaccine intismeran autogene at the European Society for Medical Oncology meeting. The trial reported a 42% reduction in the relative r…
    BioPharma Dive · 18d agoPositive readoutNeutral↗ source
  • SystImmune/BMS and Hengrui showcase ADC data for EGFR-mutant lung cancer at ESMO
    At the European Society for Medical Oncology (ESMO) meeting in Madrid, Li Zhang of Sun Yat-sen University Cancer Center presented early data from the HERON‑Lung01 study, highlighting an antibody‑dr…
    Endpoints · 18d agoNeutral↗ source
  • Patient dies after receiving Bristol Myers experimental autoimmune CAR-T therapy zola-cel
    A participant in Bristol Myers Squibb’s multiple sclerosis trial died 44 days after being infused with the experimental cell therapy known as zola-cel. The company disclosed that the patient develo…
    BioPharma Dive · 18d agoNegative readoutNegative↗ source
  • BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study
    The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.
    BioPharma Dive · 18d ago↗ source
  • Roche's KRAS G12C inhibitor cuts death risk by 44% versus Amgen and BMS in lung cancer trial
    At the European Society for Medical Oncology meeting in Madrid, Roche presented data on its next‑generation KRAS G12C inhibitor in non‑small cell lung cancer. In a head‑to‑head study against compa…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Pfizer shifts focus after lung cancer trial setback, cites early signals in earlier-line patients; BioNTech and BMS report initial activity
    Pfizer’s late‑stage trial in non‑small cell lung cancer did not meet its primary endpoint, prompting the company to highlight a post‑hoc analysis that suggests benefit for patients treated earlier…
    Endpoints · 19d agoNeutral↗ source
  • AstraZeneca reports Tagrisso-Orpathys combo could prolong treatment for EGFR-mutant lung cancer
    At the European Society for Medical Oncology meeting, AstraZeneca said early data suggest that adding Orpathys to Tagrisso may let patients with mutant non‑small cell lung cancer continue therapy a…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Amgen's Imdelltra plus AstraZeneca's Imfinzi cuts death risk by 58% in small cell lung cancer Phase 3 trial
    Amgen reported results from a Phase 3 trial evaluating its investigational therapy Imdelltra in combination with AstraZeneca’s immunotherapy Imfinzi in patients with small cell lung cancer. The st…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 21d agoPositive readoutNeutral↗ source
  • Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication
    Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness…
    BioPharma Dive · 23d agoRegulatoryPositive↗ source
  • ICER reports two-thirds of new drugs launched 2022-2025 priced well above cost-effectiveness thresholds
    ICER’s latest analysis of launch prices for new prescription medicines shows a sharp rise in net costs between 2022 and 2025. After adjusting for inflation, the median price climbed from $190,000 i…
    BioPharma Dive · 24d agoNegative↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 24d agoApprovalPositive↗ source