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433 stories matching this filter · ← front page

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  • Lupin spins out two phase-1 cancer candidates into US startup Kaveri, taking majority stake and providing seed funding
    Lupin, an Indian generics manufacturer, has created a U.S.-based spinout called Kaveri Therapeutics by transferring two clinical-phase cancer drug candidates. The assets are a PRMT5 inhibitor (LNP…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 1mo agoRegulatoryNeutral↗ source
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Infectious Disease360
  • Ashlins Pharma licenses interferon alpha-2b from Lee's, eyes $50M raise to pursue FDA approval for rare disease
    Ashlins Pharmaceuticals has signed a licensing agreement with Hong Kong‑based Lee’s Pharmaceutical to obtain the ex‑China rights to a Chinese formulation of interferon alpha‑2b. The deal, announced…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Roche appoints Dan Malarek as President and CEO of Diagnostics North America, creates new CCO role
    Roche announced that Dan Malarek, who has led Foundation Medicine since 2023, will become President and CEO of Roche Diagnostics North America. Malarek, a 19‑year veteran of Roche, will succeed Br…
    Fierce Biotech · 1mo agoPositive↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.
    Fierce Biotech · 1mo agoNeutral↗ source
  • PT Organics recalls select Pumpkin Tree banana‑strawberry puree pouches over possible soft plastic contamination
    PT Organics Limited of Lake Oswego, Oregon announced a voluntary recall of certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree pouches. The recall is due to an internal pack…
    fda recalls · 1mo agoCRLNeutral↗ source
  • Fresh & Ready Foods recalls Spicy Breakfast Burritos over undeclared soy
    Fresh & Ready Foods LLC announced a recall of its Sprig & Sprout and Fresh and Ready Spicy Breakfast Burritos because they may contain undeclared soy. The problem was traced to inadvertent inclusi…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Tempus acquires Personalis for $1.5 billion to expand cancer genomics and MRD testing
    Tempus announced it will purchase Personalis in a transaction valued at $1.5 billion, giving it full ownership of the cancer‑genomics firm. The deal builds on a 2023 partnership where Tempus inves…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Scribe Therapeutics targets $96 million IPO to fund PCSK9 gene-silencing program
    Scribe Therapeutics, a Bay Area biotech focused on genetic medicines, filed with the SEC outlining plans for an initial public offering on Nasdaq. The company aims to sell 7.1 million shares at $1…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 1mo agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 1mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 1mo agoRegulatoryPositive↗ source
  • Axiom Biosciences to launch IPO on Hong Kong exchange before Nasdaq co‑listing
    San Diego‑based Axiom Biosciences announced plans to go public with a primary listing on the Hong Kong Stock Exchange, followed later by a Nasdaq co‑listing, a structure it says is a first for a U.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Veteran scientists launch nonprofit Center for Therapeutic Genetics to advance personalized gene therapies
    A group of experienced researchers from top institutions has created the nonprofit Center for Therapeutic Genetics (CTG) to develop personalized genetic medicines. CTG will operate from a modest s…
    Fierce Biotech · 1mo agoPositive↗ source
  • BMS partners with Nvidia to build the largest AI supercomputer for drug research
    Bristol Myers Squibb announced an expanded partnership with Nvidia aimed at creating the biggest AI‑driven supercomputing platform for its drug discovery and development work. The new system will…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Kolon’s cell-based gene therapy misses key endpoints in phase 3 osteoarthritis trial
    Kolon TissueGene reported that its phase 3 study of TG‑C, a cell‑based gene therapy for knee osteoarthritis, failed to meet its co‑primary endpoints. Patients receiving the therapy showed no statis…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Latigo Biotherapeutics plans IPO to fund phase 3 trials of non-opioid pain drug LTG-001
    Latigo Biotherapeutics announced it is preparing an initial public offering to raise capital for its clinical-stage, non-opioid pain management pipeline. The company highlighted its oral Nav1.8 in…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Zen Principle Moringa Capsules Recalled Over Possible Salmonella Contamination
    Relay Peak Research LLC, operating as Zen Principle Naturals, announced a voluntary recall of its Zen Principle brand Moringa Leaf Powder Capsules. The recall was triggered by a potential contamin…
    fda recalls · 1mo agoCRLNegative↗ source
  • Geopolitical uncertainty dampens UK biotech IPO outlook despite record Q2 venture funding
    Geopolitical uncertainty continues to weigh on the sentiment around initial public offerings for British biotech companies, according to an industry leader speaking to Fierce. At the same time, th…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Abbott reports cyberattack on cancer diagnostics and LabCentral portal, says operations unaffected
    Abbott announced that a cyber incident on July 16 accessed a limited number of internal systems in its cancer diagnostics unit. The company said the breach does not affect product availability, ma…
    Fierce Biotech · 1mo agoNegative↗ source
  • Eli Lilly’s $2.8 bn purchase of AtaiBeckley adds psychedelic candidate BPL‑003, sparking optimism for broader mental‑health drug pipeline
    Eli Lilly announced it has acquired AtaiBeckley for $2.8 billion, bringing the privately held biotech’s lead psychedelic program into its portfolio. The deal gives Lilly access to BPL‑003, an intr…
    Fierce Biotech · 1mo agoDealPositive↗ source