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1,491 stories matching this filter · ← front page

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  • 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
  • Roche inks $1 billion deal with Dualitas to screen 300,000 bispecific combos for immunology and inflammation
    Roche has agreed to pay Dualitas Therapeutics an upfront $36.5 million as part of a broader agreement that could be worth up to $1 billion. The collaboration will use Dualitas’s DualScreen platfor…
    Fierce Biotech · 1mo agoDealPositive↗ source
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  • 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
  • Lisata acquires Marea Therapeutics, securing $225M financing to advance two mid-stage drugs
    Lisata Therapeutics completed a stock-for-stock acquisition of biotech startup Marea Therapeutics. The transaction includes a $225 million financing round led by existing backers such as Forbion,…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • ARPA-H launches SPECTRA program to advance autism diagnosis and precision care
    ARPA-H announced the launch of the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a new effort aimed at transforming autism diagnosis and precisio…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Lisata Therapeutics merges with Marea Therapeutics in reverse merger after failed Kuva deal
    Lisata Therapeutics, a solid tumor biotech, announced a stock-for-stock merger with cardiovascular specialist Marea Therapeutics after a previous merger attempt with Kuva Labs collapsed. The trans…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Roche partners with Dualitas Therapeutics in up to $1 billion deal to screen bispecific antibodies for immune diseases
    Roche has committed $36.5 million up front to biotechnology startup Dualitas Therapeutics under a research partnership that could total up to $1 billion in milestone payments and royalties. The agr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Rare inherited EGFR mutation raises lung cancer risk 62-fold in never-smokers, 25-fold in smokers
    Researchers examined genotyping data from 23andMe covering 3.37 million individuals and found the T790M germline mutation in about one out of every 15,850 people. The study reported that carriers…
    Fierce Biotech · 1mo agoNeutral↗ source
  • EU officials outline major pharmaceutical legislative reforms at RAPS Convergence 2026
    At RAPS Convergence 2026 in Charlotte, North Carolina, officials from the European Commission and the European Medicines Agency presented a set of reforms aimed at overhauling the European Union’s…
    raps · 1mo agoRegulatoryPositive↗ source
  • Goa Therapeutics launches with $15.5M funding to develop fast-acting alcohol sobering drug
    Goa Therapeutics announced its launch, backed by $15.5 million raised mainly from individual industry leaders, and has filed for an initial public offering that could raise up to $75 million. The…
    Fierce Biotech · 1mo agoPositive↗ source
  • North Immunology to go public via reverse merger, targeting eczema with bispecific antibody
    North Immunology, a private biotech incubated by ADAR1 Capital Management, announced it will become a public company through a reverse merger with Nasdaq‑listed Aethlon Medical. The merged entity…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • SK Biopharma signs $315 million deal with 1ST Biotherapeutics for preclinical Parkinson’s drug 1ST-104
    SK Biopharmaceuticals has entered a licensing agreement with South Korean biotech 1ST Biotherapeutics that could be worth up to $314.8 million. The deal includes an upfront payment of $1.8 million,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Longeveron’s pediatric heart stem-cell trial misses primary endpoint, prompting cost cuts
    Longeveron reported that its phase 2b Elpis II trial of the stem-cell product laromestrocel in infants with hypoplastic left heart syndrome failed to meet its primary efficacy endpoint. The study…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Senate schedules hearing for FDA nominee as Novo teams with Anthropic on AI drug development
    The Senate has announced a hearing to consider the nominee for the next FDA commissioner, signaling a forthcoming review of the agency's leadership. In parallel, biotech firm Novo has entered a pa…
    raps · 1mo agoRegulatoryNeutral↗ source
  • MHRA AI Commission Issues 44 Recommendations for Future UK Regulatory Framework
    A commission established by the Medicines and Healthcare products Regulatory Agency has released its findings. The group presented 44 recommendations aimed at shaping the United Kingdom’s regulato…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Novo signs $1.4 billion deal with Orbis Medicines to develop oral macrocycle cardiometabolic drugs
    Novo, which recently rebranded from Novo Nordisk, announced a partnership with Copenhagen‑based Orbis Medicines. The agreement could provide up to $1.4 billion in upfront payments and milestone pay…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Novartis halts ALS drug VHB937 after phase 2 trial fails to meet endpoints
    Novartis announced it is stopping development of its ALS candidate VHB937 after the phase 2 Astrals trial did not meet its primary or secondary endpoints. The study enrolled 251 patients with earl…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Skyhawk reports functional gains in Huntington's disease trial of RNA-splicing pill
    Skyhawk Therapeutics, a Boston biotech backed by Fidelity, released final data from a small mid-stage trial of its once-daily RNA-splicing pill for Huntington's disease. After 15 months, patients…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Senator Todd Young urges White House to appoint biotech leader amid rising Chinese innovation
    Senator Todd Young, chair of the National Security Commission on Emerging Biotechnology, told Fierce he is concerned about China’s expanding role in biopharma. The commission notes that Chinese co…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Novartis pays $125 million to acquire Sironax’s brain-delivery platform
    Novartis has exercised an option to buy Sironax’s platform for delivering large molecules across the blood‑brain barrier, with a $125 million payment due at closing. The technology is intended to…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Novo Nordisk partners with Anthropic to boost drug discovery using Claude Science AI
    Novo Nordisk announced a collaboration with Anthropic aimed at accelerating the discovery and development of new medicines through artificial intelligence. The two companies will test Anthropic's…
    BioPharma Dive · 1mo agoDealPositive↗ source