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574 stories matching this filter · ← front page

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  • UniQure to submit UK marketing application for Huntington's gene therapy AMT-130
    UniQure announced it will file a marketing application in the United Kingdom later this year for its gene therapy AMT-130 aimed at Huntington's disease. The filing follows a positive meeting with…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • Avalyn Pharma raises $300M in IPO to fund inhalable lung-fibrosis drugs
    Avalyn Pharma completed a $300 million initial public offering, pricing 16.7 million shares at $18 each and exceeding its original $200 million target. The proceeds will be used to develop inhalab…
    BioPharma Dive · 4mo agoDealPositive↗ source
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Infectious Disease457
  • Chiesi to acquire KalVista for $1.9 billion, adding oral hereditary angioedema drug Ekterly to its rare-disease portfolio
    Chiesi Group announced it will purchase KalVista Pharmaceuticals for $1.9 billion, gaining ownership of Ekterly, an oral on‑demand treatment for hereditary angioedema (HAE). Ekterly received FDA a…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel
    The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review. AstraZeneca and Amgen have l…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Teva nabs experimental Tourette drug in $700M Emalex buyout
    A Jefferies analyst argued the deal — Teva’s largest in a decade — “makes sense” given the synergies between Emalex and the pharmaceutical giant’s neurology business.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Pfizer settles with generics to extend tafamidis patent until 2031, protecting revenue
    Pfizer announced settlements with three generic manufacturers-Dexcel Pharma, Hikma Pharmaceuticals and Cipla-to delay the launch of generic versions of tafamidis, the active ingredient in its rare‑…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Boehringer’s dual-acting obesity shot survodutide meets primary goal in Phase 3, showing strong weight loss and muscle-preserving effect
    Boehringer Ingelheim announced that its dual-acting injectable obesity therapy, survodutide, achieved its primary endpoint in a Phase 3 study. Participants receiving the drug lost significantly mo…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • FDA urges Amgen to withdraw Tavneos after alleging data manipulation by former developer
    The FDA has sent a formal letter to Amgen recommending that the company pull its drug Tavneos from the market. The agency says new information shows the original approval filings from ChemoCentryx…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • BridgeBio's heart drug Attruby exceeds sales expectations, shifting investor outlook
    BridgeBio prepared to sell its heart drug Attruby on its own, prompting skepticism from investors and analysts who doubted the company could compete with larger rivals. The drug far outperformed f…
    BioPharma Dive · 4mo agoPositive↗ source
  • Coultreon secures $125M Series A to advance oral immune drug into Phase 2 trials
    Coultreon Biopharma announced a $125 million Series A financing round to fund development of an oral drug it licensed from Galapagos. The round was led by Sofinnova Investments and included nine i…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Intellia’s CRISPR therapy cuts hereditary angioedema attacks by 87% in Phase 3 trial
    Intellia Therapeutics reported that its experimental CRISPR-based drug lonvo-z met the primary endpoint in a Phase 3 study for hereditary angioedema, a rare swelling disorder. The trial showed an…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Veradermics reports positive Phase 3 results for oral baldness pill
    Veradermics said its experimental oral formulation of minoxidil met the primary goal of its Phase 3 trial, showing significantly more new hair growth over six months compared with placebo. The dru…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Oruka’s experimental psoriasis drug achieves near-complete skin clearance in Phase 2 trial
    Oruka Therapeutics reported that its experimental IL-23 inhibitor ORKA-001 cleared the skin of 40 of 63 patients (about 63%) in a Phase 2 study, achieving a PASI 100 response at 16 weeks. A further…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Eli Lilly to acquire Ajax Therapeutics for up to $2.3 billion to develop improved JAK inhibitor
    Eli Lilly announced Monday it will purchase Ajax Therapeutics, a biotech based in New York and Cambridge, Massachusetts, in a deal valued at up to $2.3 billion. The transaction includes cash up fr…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • European regulators recommend Sanofi's MS drug tolebrutinib for approval after US rejection
    European Medicines Agency officials issued a positive recommendation for tolebrutinib, an experimental multiple sclerosis therapy from Sanofi, after the U.S. FDA rejected the drug earlier this year…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • Lilly shares slide as Foundayo prescriptions lag expectations, while Novo's Wegovy gains momentum
    Eli Lilly's stock fell nearly 5% after the latest weekly prescription count for its obesity drug Foundayo missed analysts' expectations. IQVIA data showed U.S. prescriptions for Foundayo reached 3…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • FDA approves Regeneron’s Otarmeni gene therapy for rare inherited hearing loss
    The FDA has approved Otarmeni, a gene therapy from Regeneron, marking the first therapy cleared under the agency’s national priority voucher program and will be provided to eligible patients at no…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • AbbVie to invest $1.4 billion in new 185-acre manufacturing campus in Durham, North Carolina
    AbbVie announced a $1.4 billion investment to build a large manufacturing campus in Durham, North Carolina. The 185-acre site will focus on producing small-volume parenteral medicines such as vial…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Sanofi beats Q1 sales forecasts, driven by strong Dupixent demand
    Sanofi reported first‑quarter results that exceeded Wall Street expectations, with net sales rising 6.2% to €10.5 billion (about $12.3 billion).\n\nThe growth was led by Dupixent, the anti‑inflamma…
    BioPharma Dive · 4mo agoEarningsPositive↗ source
  • Roche eyes up to $9 billion annual sales from breast cancer pill and obesity drug pipeline amid biosimilar pressure
    Roche reported first‑quarter earnings that showed a 5% dip in reported revenue, driven by a weaker U.S. dollar against the Swiss franc. On a constant‑currency basis, sales rose 6% to 14.7 billion S…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Revolution Medicines' early-stage pancreatic cancer drug shows tumor control in half of patients
    Revolution Medicines reported that its experimental therapy daraxonrasib helped control tumors in at least half of patients with early-stage pancreatic cancer, whether given alone or with chemother…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Moderna launches Phase 3 trial of mRNA bird flu vaccine after US funding cut
    Moderna has begun enrolling participants in a Phase 3 trial of its mRNA-1018 vaccine targeting H5 influenza (bird flu). The trial aims to include about 4,000 healthy adults in the United States and…
    BioPharma Dive · 4mo agoPositive↗ source
  • Merck commits up to $1 billion to Google Cloud partnership to accelerate AI across its operations
    Merck announced a multiyear partnership with Google Cloud, investing up to $1 billion to embed AI tools throughout its research, development, manufacturing, commercial and corporate functions. The…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Owkin launches autonomous AI scientist to accelerate drug discovery
    A new AI platform from Owkin, called K Pro, is designed to act as an autonomous "AI scientist," handling complex research questions that traditionally require teams of scientists. The system build…
    BioPharma Dive · 4mo agoPositive↗ source