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  • Vertex reports positive Phase 2b results for inaxaplin in APOL1-mediated kidney disease
    Vertex Pharmaceuticals announced positive Phase 2b data for its kidney disease candidate inaxaplin, which targets APOL1-mediated kidney disease (AMKD). The Amplified trial enrolled two cohorts: 2…
    Fierce Biotech · 29d agoPositive readoutPositive↗ source
  • Boston life-science lab vacancy climbs to 31% as new spaces sit empty
    Vacancy rates for laboratory and manufacturing space in Massachusetts have surged dramatically, rising from around 3% in 2021 to roughly 31% by mid-2026, according to recent data. One high-profile…
    Fierce Biotech · 29d agoNegative↗ source
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  • Siemens Healthineers partners with Novo to raise awareness and testing for fatty liver disease
    Siemens Healthineers and Novo have announced a collaboration aimed at increasing awareness and improving diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) and its progre…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Cordis receives FDA approval for first sirolimus drug-coated balloon for coronary in-stent restenosis
    The U.S. Food and Drug Administration has approved a new device from Cordis that delivers sirolimus via a drug-coated balloon. This is the first sirolimus-eluting balloon cleared for use in treatin…
    Fierce Biotech · 29d agoApprovalPositive↗ source
  • Iambic Therapeutics eyes IPO as it pushes HER2 inhibitor IAM1363 into early trials
    Iambic Therapeutics, a San Diego AI‑driven biotech, said it is preparing for an initial public offering after securing several large‑scale partnerships with major pharmaceutical companies. In its…
    Fierce Biotech · 29d agoPositive↗ source
  • Lexeo Therapeutics acquires Mantle Therapeutics for $8.3M to expand Friedreich ataxia pipeline
    Lexeo Therapeutics announced it will acquire Mantle Therapeutics for an upfront payment of $8.3 million, aiming to broaden its Friedreich ataxia pipeline. The transaction could rise to $21.3 milli…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Anaconda Biomed snares $56M in funding for endovascular tech
    Medtech startup Anaconda Biomed has hauled in $53 million to help finish off work on a pivotal trial for its endovascular project.
    Fierce Biotech · 29d agoNeutral↗ source
  • Boehringer Ingelheim partners with Envisagenics on $1 billion AI-driven oncology collaboration
    Boehringer Ingelheim and AI drug discovery firm Envisagenics have signed a potential $1 billion multi‑year agreement to validate tumor‑specific targets. The deal will see Boehringer use Envisagenic…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Telix to acquire ITM Isotope for $1.65 billion, targeting radioligand therapy market
    Telix Pharmaceuticals announced it will acquire ITM Isotope Technologies Munich for $1.65 billion upfront, securing a radiopharmaceutical supply network. The acquisition brings an R&D pipeline cen…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • White House considers executive order to politicize NIH grant approvals
    Senior officials met in the Oval Office on Friday to discuss an executive order that would establish an external panel with authority to reject NIH grant applications. The meeting, reported by The…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Novo Nordisk faces investor skepticism at Capital Markets Day as it outlines consumer and obesity growth plans
    Novo Nordisk held its Capital Markets Day in London, where CEO Mike Doustdar acknowledged the need to reassure a restless investor audience. The company has recently streamlined its brand after a p…
    Fierce Biotech · 1mo agoNeutral↗ source
  • China aims for 25% of global first-in-class drugs by 2030 under new five-year plan
    China's government has set an ambitious target to capture at least a quarter of the world’s first‑in‑class drug discoveries by 2030. The goal is part of a five‑year plan released by the National Me…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • NIH launches Linked Discoveries tool on PubMed to streamline finding related biomedical papers
    The National Institutes of Health’s National Library of Medicine has released a pilot version of a new tool called Linked Discoveries on PubMed. The feature adds a button to a paper’s page that op…
    Fierce Biotech · 1mo agoPositive↗ source
  • TRex Bio and Retension Pharma announce plans for IPOs, outlining biotech pipeline funding
    Biotech companies Retension Pharmaceuticals and TRex Bio have filed with the SEC indicating they intend to go public this year, adding to the current wave of biotech IPOs. TRex Bio said it will us…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Cue Biopharma's CUE-221 meets primary endpoint in phase 2 CSU trial, eyes phase 2b/3
    Cue Biopharma reported that its chronic spontaneous urticaria (CSU) candidate CUE-221 achieved the primary endpoint in a midstage study conducted in China. The trial enrolled 145 patients who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Beacon Therapeutics reports positive pivotal trial results for X-linked retinitis pigmentosa gene therapy
    Beacon Therapeutics said its gene therapy for X-linked retinitis pigmentosa (XLRP) met the primary endpoint in a phase 2/3 Vista study. The trial enrolled 85 male patients and compared two dose lev…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • FDA clears Aptitude’s latest Metrix molecular dx to test for COVID
    The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • Novo Nordisk acquires three early-stage obesity programs from Kallyope
    Novo Nordisk announced the purchase of three early-stage obesity drug programs from New York‑based biotech Kallyope, expanding its metabolic pipeline. The acquired assets are not GLP‑1 incretins.…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Alkermes reports promising Phase 1b results for orexin agonist ALKS 7290 in ADHD
    Alkermes presented data from a Phase 1b study that evaluated its orexin-based compound ALKS 7290 in adults with attention-deficit/hyperactivity disorder. The trial enrolled 50 participants who rece…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • AI's early, uneven impact on clinical trials sparks surprise
    The pharmaceutical industry is beginning to see artificial intelligence applied to clinical trial processes, though adoption is occurring in fits and starts. Early uses of AI are emerging in areas…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Medtronic secures FDA clearance for LigaSure vessel sealer on Hugo robotic platform
    Medtronic announced that the U.S. Food and Drug Administration has cleared its LigaSure RAS Maryland jaw vessel sealer-divider for use with the company's Hugo robotic-assisted surgery system. The…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Xenon pauses enrollment in phase 3 depression trials after reports of psychosis and other neuropsychiatric events
    Xenon Pharmaceuticals announced it has voluntarily stopped enrolling new patients in its two phase 3 studies of azetukalner for major depressive disorder and bipolar depression. The decision follo…
    Fierce Biotech · 1mo agoNegative↗ source
  • BMS abandons $100 million Orum degrader-antibody conjugate after early phase-1 results
    Bristol Myers Squibb has decided to stop development of the degrader‑antibody conjugate it purchased from Orum Therapeutics for $100 million after reviewing data from a phase‑1 trial. The experime…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • Electra Therapeutics raises $350 million in oversubscribed IPO
    Electra Therapeutics, a South San Francisco biotech focused on inflammation, completed its Nasdaq IPO, selling 23.3 million shares at $15 each and generating $350 million in gross proceeds. This a…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Biopharma prediction markets raise insider-info concerns, regulators weigh oversight
    Prediction markets are emerging as platforms where participants can wager on biopharma events such as clinical trial results and FDA approvals. The format allows crowds to aggregate expectations ab…
    Fierce Biotech · 1mo agoNeutral↗ source