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  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 1mo agoDealPositive↗ source
  • Novo Nordisk sues Eli Lilly over alleged misleading obesity drug ads
    Novo Nordisk filed a lawsuit in a New Jersey federal court accusing Eli Lilly of deceptive advertising for its GLP-1 obesity medicines. The action follows a cease-and-desist request that asked Lil…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
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  • Novartis says it will keep seeking sub-$2 billion bolt-on deals worldwide, staying geography-agnostic
    Novartis CEO Vas Narasimhan told investors on the second‑quarter earnings call that the company will continue to pursue bolt‑on acquisitions below $2 billion and has no plans to overhaul its busine…
    BioSpace · 1mo agoDealNeutral↗ source
  • Agios halts development of sickle cell drug tebapivat after mid-stage trial failure
    Agios announced it will stop developing tebapivat for sickle cell disease after a mid-stage trial did not meet expectations. The drug, a next-generation pyruvate kinase activator related to the ap…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Agios drops next-gen sickle cell drug after Phase 2 data show no advantage over Novo’s candidate
    Agios Pharmaceuticals said it is halting development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a mid‑stage trial failed to demonstrate a benefit ove…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gains
    The FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Axiom Biosciences targets Hong Kong IPO to raise up to $200 million for regenerative therapy pipeline
    Axiom Biosciences, a San Diego‑based biotech, announced plans to list on the Hong Kong Stock Exchange rather than the traditional U.S. exchanges. The company aims to use the offering to secure new…
    BioSpace · 1mo agoDealPositive↗ source
  • Dimension raises $800 million for third fund to boost AI-driven biotech ventures
    Dimension, a venture capital firm focused on the intersection of technology and biotech, announced the closing of its largest fund to date, raising $800 million for its third fund, called Dimension…
    BioPharma Dive · 1mo agoDealPositive↗ 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
  • 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 AI to buy cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will acquire Personalis, a California-based company that offers a molecular residual disease test for cancer, in a transaction valued at $1.5 billion. The deal, priced at $1…
    BioPharma Dive · 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
  • Tempus AI to acquire cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will buy Personalis, a Fremont-based company that offers a molecular residual disease test for cancer, in a deal valued at $1.5 billion. The acquisition is expected to expan…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Latigo Biotherapeutics Announces Plans for Nasdaq IPO to Fund Non-Opioid Pain Drug Development
    Latigo Biotherapeutics, a Westlake BioPartners spin‑out founded in 2018, said it will seek a Nasdaq listing under the ticker LTGO. The company develops non‑opioid analgesics that block sodium ion…
    BioPharma Dive · 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
  • 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
  • Bristol Myers teams with Nvidia to launch large AI data center as Samsung Biologics bids $1.8 bn for Swiss peptide maker
    Bristol Myers Squibb announced expansion of its partnership with Nvidia, deploying two AI systems to create a powerful AI factory for life‑science research, aiming to tackle larger problems without…
    BioPharma Dive · 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
  • Yusol International expands recall of Ola-Ola Pounded Yam to include 2-, 4-, 5-, and 10-lb packages over undeclared milk allergen
    Fayus Inc., operating as Yusol International Foods in Sacramento, announced an expanded recall of its Ola-Ola Pounded Yam product line. The recall now covers 2‑lb, 4‑lb, 5‑lb and 10‑lb packages af…
    fda recalls · 1mo agoCRLNegative↗ source
  • Compounders still supply about 20% of US GLP-1 weight-loss market despite FDA crackdown and shortages
    A recent Gallup survey shows that while the number of Americans taking GLP-1 weight‑loss drugs has nearly quadrupled over the past two years, roughly one in five are using cheaper, non‑FDA‑approved…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 1mo agoNeutral↗ source