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703 stories matching this filter · ← front page

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  • Novo signs €1.2 bn deal with Nanexa for long-acting injectables as Acadia’s Alzheimer trial misses target
    Novo has agreed to pay Nanexa up to about €1.165 bn for its PharmaShell delivery platform, which enables long-acting injectable medicines. The partnership will apply the technology to up to five c…
    BioPharma Dive · 26d agoDealNeutral↗ source
  • FDA advisory panel finds Grail's Galleri multicancer blood test benefits outweigh risks
    A Food and Drug Administration advisory panel voted 7-2, with one abstention, to conclude that the probable benefits of Grail's Galleri multicancer blood test outweigh its risks. The panel unanimou…
    BioPharma Dive · 26d agoRegulatoryPositive↗ source
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  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 26d agoPositive readoutNeutral↗ source
  • Eli Lilly inks $3.35 B China partnership as Immunovant halts lupus drug trial
    Eli Lilly announced a new alliance with Beijing‑based InnoCare Pharma that could be worth up to $3.35 billion. The deal includes an upfront payment of $100 million and up to five target programs fo…
    BioPharma Dive · 27d agoDealNeutral↗ source
  • FDA nominee Overton parries vaccine questions at Senate hearing
    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
    BioPharma Dive · 26d ago↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 27d agoPositive readoutPositive↗ source
  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 27d agoNegative↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 27d agoDealPositive↗ source
  • Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome
    Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Celldex shares drop as Phase 3 data for barzolvolimab show efficacy but raise anaphylaxis safety concerns
    Celldex reported Phase 3 results for barzolvolimab in chronic spontaneous urticaria, showing strong efficacy against hives and itching. Two cases of life-threatening anaphylaxis were observed amon…
    BioPharma Dive · 28d agoNegative readoutNegative↗ source
  • Alkermes reports early proof-of-concept for orexin-2 drug in ADHD
    Alkermes announced early-stage trial results for ALKS 7290, an orexin‑2 receptor agonist originally being developed for narcolepsy, showing proof of concept in ADHD. The study reported dose‑depend…
    BioPharma Dive · 29d agoPositive readoutPositive↗ source
  • Viking Therapeutics reports obesity drug maintains weight loss after dosing switch, shares jump 36%
    Viking Therapeutics said its Phase 2 trial of the dual-acting obesity candidate VK2735 showed participants largely kept the weight they had lost when the dosing schedule changed from a weekly injec…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Trump administration’s MFN drug pricing deals may cut projected Medicare savings by up to 80%
    The White House announced "most-favored-nation" pricing agreements with 26 pharmaceutical companies, saying the contracts would lower drug costs for federal programs. The deals require companies to…
    BioPharma Dive · 29d agoRegulatoryNegative↗ source
  • Telix to acquire Germany's ITM for $1.65 billion, aiming to dominate radiopharmaceutical market
    Telix, an Australian radiopharmaceutical diagnostics company, announced it will purchase German developer ITM in a cash transaction valued at $1.65 billion upfront. The agreement gives Telix the o…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Novo outlines plan for multiple new drugs to regain market share as shares dip 8%
    At a capital markets day in London, Novo executives presented a roadmap to launch more than five multi-blockbuster drugs by 2030 and target $23 billion in annual sales by 2035, aiming to offset the…
    BioPharma Dive · 29d agoNegative↗ source
  • Walgreens Specialty Pharmacy highlights holistic support to boost oncology medication adherence
    Advances in oncology are moving care out of the clinic and into patients' homes, with treatments becoming more personalized. This shift means patients often manage complex drug schedules themselves…
    BioPharma Dive · 1mo agoPositive↗ source
  • Healthcare systems lag behind rapid expansion of GLP-1 therapies, raising care and trust challenges
    GLP-1 drugs have demonstrated that pharmacological treatment can effectively reduce obesity, and regulators have now approved them for additional uses such as cardiovascular risk reduction, metabol…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Compass eyes J&J’s Spravato playbook for upcoming psychedelic drug COMP360 launch
    Compass executives told BioPharma Dive that, if the FDA approves their treatment, they plan to follow the commercial strategy Johnson & Johnson used for its ketamine spray Spravato. When Spravato…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Beacon eye gene therapy hits mark in late-stage study
    Beacon claimed the findings represent the first time a treatment for X-linked retinitis pigmentosa, a rare and potentially blinding condition, met its main goal in a pivotal trial.
    BioPharma Dive · 29d agoRegulatoryNeutral↗ source
  • Xenon shares tumble up to 30% after pausing depression trial over neuropsychiatric events
    Xenon Pharmaceuticals announced it is pausing enrollment in its depression trial for the drug azetukalner after neuropsychiatric adverse events emerged that were not observed in earlier testing. A…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Electra Therapeutics raises $350M in biotech IPO, fueling rare disease drug development
    Electra Therapeutics completed a $350 million initial public offering, becoming the 21st biotechnology company to go public in 2026. The strong demand for its shares highlights continued investor a…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • GSK adds two China cancer-therapy licensing deals, keeping pace with industry partnership surge
    BioPharma Dive's new visualization series recapped recent activity, spotlighting GSK's licensing agreements in China and the market response. Since the start of 2025, GSK has signed five deals wit…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Ultragenyx prices Sanfilippo gene therapy at $4 million as it gains a second FDA approval; Bristol Myers halts Orum cancer drug
    The FDA approved Fayuvi, the first gene therapy for Sanfilippo syndrome Type A, with a list price of $3.95 million. This marks Ultragenyx's second gene‑therapy approval since August, earning sella…
    BioPharma Dive · 1mo agoApprovalNeutral↗ source
  • North Immunology to go public via reverse merger with Aethlon, targeting eczema market
    North Immunology, an early-stage biotech developing a dual-acting antibody for eczema, announced plans to become a public company through a reverse merger with Aethlon Medical. The transaction wil…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Novo and Orbis strike up to $1.4 billion partnership to develop oral peptide macrocycles for cardiometabolic disease
    Novo Pharmaceuticals has entered a partnership with fellow Danish firm Orbis Medicines that could be worth as much as $1.4 billion. The agreement includes upfront payments, downstream payouts and r…
    BioPharma Dive · 1mo agoDealPositive↗ source