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  • Novo Nordisk halts two IL-6 heart trials as Novartis suffers Phase 3 setbacks; Ionis wins first Alexander disease approval
    Novo Nordisk announced it has ended two late‑stage studies of its investigational IL‑6 inhibitor ziltivekimab, which was being evaluated for cardiovascular disease. The decision follows an earlier…
    BioSpace · 2mo agoNegative↗ source
  • ARPA-H commits $62.7 million to develop FDA-authorized AI for heart-failure treatment
    ARPA-H announced a $62.7 million investment to create artificial-intelligence systems that can assist in treating heart failure. The program, called ADVOCATE, seeks to develop partially autonomous…
    STAT · 2mo agoDealPositive↗ source
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  • Scientists who discovered orexin receive Lasker Award as FDA appoints permanent heads of key drug and biologics centers
    The team that identified the orexin system has been honored with a Lasker Award, one of the nation’s most prestigious biomedical recognitions. The award highlights the impact of their work on under…
    STAT · 2mo agoPositive↗ source
  • AstraZeneca's COPD drug cuts flare-ups in late-stage trials, offering new option for patients
    In two late-stage studies, an AstraZeneca therapy showed a statistically significant reduction in acute exacerbations that worsen chronic obstructive pulmonary disease. The data, released on Tuesda…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Sandoz to invest $1 billion in European biosimilar hub, targeting 100 biosimilars by 2040
    Sandoz announced at its investor day that it will spend roughly $1 billion to build a fully integrated European biosimilar hub as part of a plan to bring more than 100 biosimilars to market by 2040…
    BioSpace · 2mo agoPositive↗ source
  • Solstice Oncology secures $225M Series A to launch FDA-cleared Phase 2 CTLA-4 antibody trial
    Solstice Oncology, a cancer-focused startup that emerged from stealth in February, announced a $225 million Series A financing round to fund its early-stage programs. The capital will be used to a…
    BioSpace · 2mo agoDealPositive↗ source
  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • UK commission proposes new framework to regulate AI-driven medical tools
    A UK commission released a report on Thursday outlining 44 recommendations for how artificial intelligence should be governed in the medical sector. The guidance aims to capture AI's promise, such…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Tyra Biosciences’ bladder cancer pill misses expected response rate in Phase 2 trial
    Shares of Tyra Biosciences dropped about 20% after data from its Phase 2 study of a bladder cancer pill fell short of market expectations. The experimental drug, dabogratinib, is taken daily and t…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • Encoded Therapeutics raises $275 million in Series F round for Dravet syndrome program
    Encoded Therapeutics announced closing a Series F financing round that brought in $275 million. The round was led by GV with participation from an undisclosed healthcare investor. The new capital…
    Endpoints · 2mo agoDealPositive↗ source
  • Kura Oncology launches Caspian Therapeutics to develop menin-inhibitor diabetes drug with $50M funding
    Kura Oncology has spun out a new biotech called Caspian Therapeutics to focus on menin inhibitors for diabetes and other cardiometabolic diseases. The company’s lead candidate, code-named KO-7246,…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Research on orexin and narcolepsy earns Lasker Award for Yanagisawa and Mignot
    Masashi Yanagisawa and Emmanuel Mignot were honored with the Lasker Award for their work uncovering the role of orexin in narcolepsy. The award was announced on September 9, 2026. Their research b…
    Endpoints · 2mo agoPositive↗ source
  • Compass Pathways reports positive one-year data for its psilocybin therapy COMP360
    Compass Pathways released results from a one-year study of its psilocybin‑based therapy COMP360. The company described the data as positive, indicating continued promise for the investigational tre…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • FDA appoints permanent heads of CDER and CBER, adding AI deputy role
    The Trump administration announced permanent appointments to two key FDA centers after a period of turnover. Michael Davis, who had been acting director of the Center for Drug Evaluation and Resea…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • Webinar explores how GLP-1 obesity drugs are reshaping US healthcare and market dynamics
    The upcoming webinar titled "The Massive Scale of GLP-1s: Evolving Health, Healthcare and Markets" will examine how GLP-1 receptor agonists used for obesity are altering the U.S. health-care landsc…
    BioSpace · 2mo agoNeutral↗ source
  • BMS reports positive mid-stage results for arlo-cel in heavily pre-treated myeloma patients
    BMS said its CAR T therapy arlo-cel, formally arlocabtagene autoleucel, achieved positive results in a registrational mid-stage study for relapsed and refractory multiple myeloma. The open-label,…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • TwoStep Therapeutics raises $62.5 million Series A backed by Pfizer and Merck KGaA venture groups
    TwoStep Therapeutics, a cancer biotech, announced a $62.5 million Series A financing to advance its novel approach to antibody-drug conjugates and radioligand therapies. The round was supported by…
    Endpoints · 2mo agoDealPositive↗ source
  • Kura Oncology spins out diabetes program into new company with $50M funding and Lilly support
    Kura Oncology, known for its leukemia menin inhibitor Komzifti, announced it is separating its diabetes research into a newly formed company. The new entity will receive $50 million in financing,…
    Endpoints · 2mo agoDealPositive↗ source
  • Tyra Biosciences reports Phase 2 success in low-risk bladder cancer, plans pivotal trial
    Tyra Biosciences announced that its experimental therapy for low‑risk bladder cancer has produced encouraging results in a Phase 2 study. The company said the data, released on Wednesday, represen…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Caspian Therapeutics launches with $50M to develop menin inhibitors for diabetes and cardiometabolic disease
    Caspian Therapeutics, a spin‑out from Kura Oncology, announced it is starting operations with $50 million in financing. The capital, led by BVF Partners and joined by Eli Lilly and Kura leadership,…
    STAT · 2mo agoDealPositive↗ source
  • Caspian Therapeutics launches with $50M funding and Eli Lilly backing to develop menin inhibitor for diabetes
    Caspian Therapeutics has been created as a spin-out from Kura Oncology to advance a menin-targeting drug for diabetes. The company received $50 million in initial capital, led by BVF Partners with…
    BioSpace · 2mo agoDealPositive↗ source
  • AMA chief says AI will augment, not replace, physicians
    John Whyte, the chief executive of the American Medical Association, wrote an opinion piece asserting that artificial intelligence should work alongside doctors rather than take their place. He po…
    STAT · 2mo agoPositive↗ source
  • Opinion: Autonomous AI could surpass AI-assisted doctors on key tasks by 2030
    The piece, authored by Ezekiel J. Emanuel and Abe Baker-Butler, argues that autonomous artificial intelligence is likely to outpace both unaided physicians and those using AI assistance on five cor…
    STAT · 2mo agoNeutral↗ source
  • Biopharma looks beyond China to five alternative overseas markets amid rising geopolitical tensions
    Geopolitical tensions between the United States and China are prompting biopharma companies to look beyond the Chinese market for growth. China remains the leading destination, with licensing deal…
    BioSpace · 2mo agoNeutral↗ source
  • Biotech crossover rounds projected to exceed $4.2 billion in 2026, supporting IPO pipeline
    PitchBook forecasts that biotech crossover rounds could surpass $4.22 billion across roughly 28 rounds in 2026. The surge follows a market bottom after COVID and a rise in investor confidence, wit…
    BioSpace · 2mo agoDealPositive↗ source