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  • Novartis halts phase-2 radioligand therapy Lu-NeoB after disappointing data, but reaffirms commitment to RLT
    Novartis announced it is halting development of Lu-NeoB, a gastrin-releasing peptide receptor-targeting radioligand therapy, after phase-2 data failed to demonstrate sufficient efficacy. The candi…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • 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
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Infectious Disease369
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  • 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
  • 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
  • Eli Lilly’s $3.8 B bid for AtaiBeckley signals strong pharma endorsement of psychedelics
    Eli Lilly has announced a proposed acquisition of AtaiBeckley valued at up to $3.8 billion. Analysts at H.C. Wainwright described the move as the clearest strategic validation to date of psychedeli…
    BioSpace · 1mo agoDealPositive↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 1mo agoApprovalPositive↗ 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
  • Vertex’s IgA nephropathy drug povetacicept gains momentum as FDA reviews it after Novartis and Vera approvals
    Vertex Pharmaceuticals’ povetacicept is currently under FDA review with a target action date of Nov. 30 for the treatment of IgA nephropathy. The FDA recently granted full approval to Novartis’ Fa…
    BioSpace · 1mo agoRegulatoryPositive↗ 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
  • Baxter alerts users to potential air bubble risk in Duo-Vent IV solution sets
    The FDA’s Center for Devices and Radiological Health has issued an early alert about a possible high-risk issue with Baxter’s Duo-Vent intravenous solution sets. The devices may contain air bubbles…
    fda medwatch · 1mo agoRegulatoryNegative↗ 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
  • FDA’s push to publish complete response letters faces legal uncertainty and possible pause
    The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
    BioSpace · 1mo agoRegulatoryNegative↗ 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
  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Unique Pharma recalls 5 mg cetirizine tablets over possible ranitidine contamination
    Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., announced a voluntary nationwide recall of four lots of its 5 mg cetirizine hydrochloride tablets. The reca…
    fda medwatch · 1mo agoCRLNegative↗ 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