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  • Novartis scraps TREM2 ALS candidate after Phase 2 failure
    Novartis announced it is halting development of its TREM2-targeting drug VHB937, also known as lifonebart, after the Phase 2 trial in amyotrophic lateral sclerosis (ALS) did not meet its primary en…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Sling Therapeutics raises $123M to fund Phase 3 trial of former Astellas cancer drug for thyroid eye disease
    Investors have committed $123 million to Sling Therapeutics, a small Michigan biotech focused on eye‑disease treatments. The funding will support a Phase 3 clinical trial of a drug originally deve…
    Endpoints · 1mo agoDealPositive↗ source
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  • Skyhawk Therapeutics reports symptom improvement for Huntington's disease in Phase 1/2 extension study
    Skyhawk Therapeutics announced that its RNA-splicing candidate SKY-0515 showed a measurable improvement in symptoms for patients with Huntington's disease during an extension of its Phase 1/2 trial…
    Endpoints · 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
  • Yale and Harvard faculty question benefits of FDA's 'America First' user fee provisions
    Yale and Harvard medical school faculty have voiced concerns about the latest FDA user fee agreement, which includes a set of "America First" provisions. The provisions are designed to prioritize…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • 'Still a bull': Novo's CEO on honoring heritage and planning for the future amid corporate rebrand
    Novo CEO Mike Doustdar—tapped to breathe new life into the Danish drugmaker last year after losing GLP-1 marketing ground to chief rival Eli Lilly—isn’t one to make changes for the sake of change.
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ source
  • GSK licenses Chimagen trispecific T-cell engager for up to $750 million, targeting phase-1 multiple myeloma study
    GSK has entered a licensing agreement with China’s Chimagen Biosciences that could be worth as much as $750 million. The deal will allow GSK to begin phase‑1 testing of a trispecific T‑cell engager…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • RegCell secures multi-million dollar Series A to advance Nobel-winning regulatory T-cell therapy
    RegCell, a biotech founded by Nobel laureate Shimon Sakaguchi, announced a new financing round to move its regulatory T-cell (Treg) program toward clinical testing. The company’s CEO Michael McCul…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA approves Telix's Pixclara, first FET-PET imaging drug for glioma in the U.S.
    The U.S. Food and Drug Administration has granted approval to Telix Pharmaceuticals' Pixclara, a fluorine‑18 labeled amino acid PET tracer designed for imaging gliomas. This marks the first FDA‑cle…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Johnson & Johnson’s depression drug JNJ-5120 fails primary endpoint in phase 2 trial
    A phase 2 study of JNJ-5120, an M1 receptor antagonist developed by Johnson & Johnson with Contineum Therapeutics, did not meet its primary efficacy endpoint in patients with major depressive disor…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug into Phase 3
    Sling Therapeutics announced a $123 million Series C financing round aimed at moving its oral therapy for thyroid eye disease into a late‑stage trial and eventual market launch. The company has be…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA launches expedited IND pilot program, integrating public feedback into qualification criteria
    The FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday. Agency leaders Karim Mikhail and Michael Davis, new…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Axoltis reports Phase 2 failure of experimental ALS drug but notes small signal
    Axoltis Pharma, a French biotech, announced that its Phase 2 trial of an experimental ALS therapy did not meet its primary endpoints. The company said the data were noisy but observed a modest tre…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • FDA opens pilot to accelerate phase 1 trials with fast IND reviews
    The Food and Drug Administration announced a new pilot program aimed at speeding up early-stage clinical trials in the United States. The initiative pairs drug sponsors with qualified research inst…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • J&J and Contineum's oral M1 inhibitor fails second mid-stage depression trial
    Contineum Therapeutics and Johnson & Johnson reported that their oral M1 receptor inhibitor, known as PIPE-307 or JNJ-5120, did not meet its primary endpoints in a Phase II study for major depressi…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Mayo Clinic and Thermo Fisher launch Precure to build large biomedical data set
    Mayo Clinic has partnered with Thermo Fisher Scientific to form Precure LLC, a new group focused on creating one of the largest biomedical data sets using human multi‑omics data. Precure will inte…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Eli Lilly partners with QurCan Therapeutics, pledging up to $237 M per CNS genetic-medicine program
    Eli Lilly announced a collaboration with Canadian biotech QurCan Therapeutics to advance genetic medicines aimed at the central nervous system. Under the deal, Lilly will provide up to $237 millio…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Sionna Therapeutics cuts 46% of staff after cystic fibrosis trial miss
    Sionna Therapeutics announced it will lay off roughly half of its employees as it reassesses its strategy following a recent setback in its cystic fibrosis program. The company’s lead candidate, S…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • FDA approves first radioligand generic, pitting Curium against Novartis' Lutathera
    The U.S. Food and Drug Administration has granted approval to Curium’s radioligand product, the first generic in this therapeutic class. The approved drug is a direct equivalent of Novartis’ Lutat…
    Endpoints · 1mo agoApprovalNeutral↗ source
  • Centric Compounding initiates nationwide recall of three injectable drugs due to API contamination
    Centric Compounding, a Houston-based pharmacy, announced a nationwide recall of three injectable products after detecting contamination in an active pharmaceutical ingredient. The recall includes…
    Endpoints · 1mo agoCRLNegative↗ source
  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • GSK signs new agreement with China's Chimagen for trispecific T-cell engager targeting blood cancers
    GSK, the UK‑based pharmaceutical company, has entered into a fresh licensing agreement with Chinese biotech Chimagen Biosciences. The partnership focuses on a trispecific T‑cell engager designed fo…
    Endpoints · 1mo agoDealPositive↗ source