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145 stories matching this filter · ← front page

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  • 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 · 19h agoRegulatoryPositive↗ source
  • Pharma pours billions into bispecifics, ADCs and cell therapies despite limited clinical proof
    The article notes that emerging drug formats such as bispecific antibodies, antibody‑drug conjugates and cell therapies have yet to demonstrate clear clinical success, yet pharmaceutical firms cont…
    BioPharma Dive · 1d agoNeutral↗ source
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  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, adding Phase-2 RNAi drug for polycythemia vera
    Merck KGaA announced it will purchase UK‑based Silence Therapeutics for about $1.3 billion, paying $20 in cash per share, representing a 130 % premium. The deal gives Merck control of an RNA‑inter…
    BioPharma Dive · 2d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • Saudi Arabia rolls out biotech partnerships to support its $34.6 billion non‑oil growth plan
    Saudi Arabia’s National Biotechnology Strategy, launched in early 2024, aims to add $34.6 billion to non‑oil GDP by 2040 and create 11,000 jobs by 2030. The plan is now moving beyond policy into co…
    BioPharma Dive · 3d agoPositive↗ source
  • City Therapeutics raises $200 million in IPO to fund next-gen RNAi programs
    City Therapeutics, a biotech focused on RNA interference, completed a $200 million initial public offering, selling about 11.1 million shares at $18 each. The proceeds will back three drug candida…
    BioPharma Dive · 6d agoDealPositive↗ source
  • FDA launches Rare Disease Framework Initiative to overhaul review process
    The FDA announced a new Rare Disease Framework Initiative aimed at redesigning how therapies for rare conditions are regulated. The initiative will move away from a one-size-fits-all model, instea…
    BioPharma Dive · 6d agoRegulatoryPositive↗ source
  • FDA launches rare disease framework initiative
    A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases…
    raps · 7d ago↗ source
  • FDA review flags limited efficacy of Revolution's pancreatic cancer drug Rasonque, shares drop 6%
    Shares of Revolution Medicines fell about 6% after the Food and Drug Administration released review documents that suggest its pancreatic cancer therapy Rasonque may not work as well in all patient…
    BioPharma Dive · 12d agoRegulatoryNegative↗ source
  • HHS unveils new vaccine injury surveillance plan with NIH clinic and reporting reimbursements
    The Department of Health and Human Services announced a comprehensive initiative to improve monitoring of vaccine-related injuries. The plan includes opening a new clinic at the National Institute…
    BioPharma Dive · 13d agoRegulatoryNeutral↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda sales in eight European countries after Halozyme patent win
    A Netherlands court issued an injunction that stops Merck from marketing its subcutaneous formulation of Keytruda, known as Keytruda Qlex, in eight European markets. The ruling follows a patent in…
    BioPharma Dive · 14d agoRegulatoryNeutral↗ source
  • ArriVent shares tumble as lung cancer trial of furmonertinib misses primary goal
    ArriVent BioPharma reported that its late-stage study of furmonertinib in patients with EGFR exon 20 insertion-mutated non-small cell lung cancer did not achieve its primary endpoint. The trial, w…
    BioPharma Dive · 15d agoNegative readoutNegative↗ source
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 16d agoDealPositive↗ source
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 16d agoDealPositive↗ source
  • Diagnostic-driven therapies face patient loss due to workflow gaps, new commercialization model proposed
    The sponsored article from Diaceutics highlights that while diagnostic-driven therapies are being developed faster than ever, many patients who could benefit never receive them. The authors attribu…
    BioPharma Dive · 17d agoNeutral↗ source
  • PhRMA appoints former congressman Eric Cantor as CEO as Pierre Fabre resubmits Ebvallo approval request
    PhRMA announced that former U.S. House member Eric Cantor will become its president and chief executive on Nov 9, taking over from longtime leader Steve Ubl. Cantor served Virginia from 2000 to 201…
    BioPharma Dive · 21d agoRegulatoryNeutral↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
    The U.S. Food and Drug Administration has granted approval to Egetis' Emcitate, a therapy targeting a rare genetic disorder. This marks a regulatory milestone for the company and patients awaiting…
    raps · 23d agoDealPositive↗ source
  • Beam Therapeutics sues YolTech and Serapha Bio over alleged theft of base editing trade secrets
    Beam Therapeutics has filed a lawsuit in U.S. District Court in Massachusetts accusing Chinese biotech YolTech Therapeutics and its U.S. partner Serapha Bio of using confidential information to dev…
    BioPharma Dive · 22d agoNegative↗ source
  • UniQure tumbles with latest data for Huntington’s gene therapy
    Analysts guessed that investors wanted to see stronger durability results at a four-year check-in of the key trial supporting a potential approval of "AMT-130."
    BioPharma Dive · 22d ago↗ source
  • Adicet's off-the-shelf CAR-T shows 50% kidney response in early lupus trial
    An early-stage study of Adicet Bio's off-the-shelf gamma-delta CAR-T cell therapy reported encouraging results in patients with lupus nephritis. After a year of follow-up, half of the evaluable pa…
    BioPharma Dive · 23d agoPositive readoutPositive↗ source
  • FDA advises early engagement and error prevention for BLA submissions, says CBER expert
    A CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…
    raps · 24d agoRegulatoryNeutral↗ source
  • RNAi biotech ADARx raises $446 million in IPO, secures $89 million from AbbVie
    ADARx Pharmaceuticals priced its initial public offering at $17 per share, selling more than 26 million shares to raise about $446.3 million. The company also received an additional $89 million th…
    BioPharma Dive · 27d agoDealPositive↗ source
  • 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
  • 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
  • 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 · 1mo agoRegulatoryNeutral↗ source