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  • BD appoints Ferass Abuzaina as Worldwide President of Surgery
    Becton, Dickinson and Company announced that Ferass Abuzaina will serve as the new Worldwide President of its Surgery business unit, effective immediately. He will oversee the global strategy, oper…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
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  • Endeavor BioMedicines reports positive phase 2b results for Hedgehog inhibitor taladegib in IPF
    Endeavor BioMedicines announced that its Hedgehog pathway inhibitor, taladegib, produced encouraging results in a phase 2b study of patients with idiopathic pulmonary fibrosis (IPF). The trial, nam…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Iambic Therapeutics targets $135M IPO to fund clinical trials of HER2 and KIF18A cancer drugs
    Iambic Therapeutics, a San Diego AI‑driven biotech, filed to raise $135 million in net proceeds through an initial public offering. The company plans to sell 9.4 million shares at $15 to $17 each,…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Ono Pharmaceutical pays $80 million for Asian rights to Biohaven IgG degrader trio, including phase-3 Graves disease candidate
    Japan's Ono Pharmaceutical has agreed to pay $80 million upfront for the rights to three Biohaven IgG degrader programs in Japan, South Korea, Taiwan and ASEAN markets. The agreement also includes…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Zealand's amylin analog shows strong weight loss but weak blood-sugar control in phase 2 trial
    Zealand Pharma, in partnership with Roche, released topline results from its mid‑phase Zupreme‑2 study of petrelintide, an amylin‑based candidate aimed at patients with overweight or obesity and ty…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Argenx’s FB102 meets primary endpoint in phase 2 celiac trial, paving way for pivotal study
    Argenx reported that its experimental antibody FB102 achieved a statistically significant improvement in villus height‑to‑crypt depth (Vh:Cd) compared with placebo in a phase 2 study of adults with…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Vir Biotechnology appoints David Liu as chief medical officer to steer hepatitis D phase 3 and cancer programs
    Vir Biotechnology announced the appointment of David Liu, M.D., Ph.D., as its new chief medical officer. Liu comes from a recent stint as CMO at Nuvation Bio and has held senior roles at AstraZene…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Cerevance's solengepras cuts OFF time in phase 3 Parkinson's trial
    Cerevance reported that its oral non‑dopaminergic therapy, solengepras, produced meaningful improvements in both motor and non‑motor symptoms in a phase 3 Parkinson's disease study, rescuing the ca…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 1mo agoDealNegative↗ source
  • Matchpoint Therapeutics raises $150M Series B to advance oral covalent therapies for autoimmune disease
    Matchpoint Therapeutics announced a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Digitalis Ventures, Invus, BB…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • ARPA-H launches Surpass program to speed and broaden clinical trials
    The U.S. Department of Health and Human Services announced a new initiative called Surpass, aimed at removing obstacles that slow clinical development and changing how trials are designed and run.…
    Fierce Biotech · 1mo agoPositive↗ source
  • TCGX raises $600 million to fund Asian biotech startups
    Investment firm TCGX announced a new $600 million Asia Life Sciences Fund I aimed at supporting biotech companies across the region. The fund will operate separately but in close coordination with…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Atsena reports early efficacy signals for gene therapy ATSN-201 in X-linked retinoschisis trial
    Atsena Therapeutics presented data from the early parts of its Lighthouse gene therapy trial for X-linked retinoschisis (XLRS) at the American Academy of Ophthalmology meeting. The trial administe…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Stryker appoints Spencer Stiles as CEO, Kevin Lobo to become Executive Chair
    Stryker announced a leadership change, naming Spencer Stiles as the new chief executive officer. Stiles, who has been president and COO, will also join the board. Kevin Lobo, who has led the compa…
    Fierce Biotech · 1mo agoNeutral↗ source
  • iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis Pigmentosa
    Following its Parkinson’s disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China.
    Fierce Biotech · 1mo agoNeutral↗ source
  • MimiVax’s cancer vaccine fails phase 2 glioblastoma study, but CEO still sees data as ‘inspiring’
    MimiVax has reports a phase 2b miss in newly diagnosed glioblastoma patients, but remains positive about a significant survival benefit in a subset of patients 65 years and under.
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Forbion raises record €2.3 billion to back 30 European biotech firms
    Forbion Capital Partners announced it has closed two new funds, the Growth Opportunities Fund IV and Ventures Fund VIII, together raising €2.3 billion, a record for the European life‑sciences ventu…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • TRex Bio targets $111M IPO as Retension and Lycia also prepare public listings
    TRex Bio, backed by Eli Lilly, filed with the SEC to raise about $111.3 million by offering 8.3 million shares priced between $14 and $16. If the midpoint price is achieved, the company expects net…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • UK regulator to shift from one-off checks to continuous monitoring of AI medical devices
    The UK’s Medicines and Healthcare products Regulatory Agency announced a new policy that will require continuous monitoring of AI‑driven medical devices, replacing the current one‑time review model…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
  • Caribou Biosciences halts pipeline and announces major workforce cut
    Caribou Biosciences, a Bay Area biotech that develops off-the-shelf CAR-T cell therapies, said it will stop all clinical development and begin a substantial workforce reduction. The company, which…
    Fierce Biotech · 1mo agoLayoffsNegative↗ source
  • ArriVent’s phase 3 EGFR inhibitor trial misses primary endpoint, shares plunge 57%
    ArriVent BioPharma reported results from its phase 3 Furvent trial, which evaluated firmonertinib, a brain-penetrant EGFR inhibitor, in patients with exon 20 insertion-mutated non-small cell lung c…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Kairos pushes prostate cancer drug ENV-105 into earlier treatment line after promising mid-phase data
    Kairos Pharma announced a change to its phase 2 trial of ENV-105, a prostate cancer candidate, moving it to an earlier line of therapy. The modified protocol will enroll patients whose PSA rises a…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Abbott receives FDA clearance for CardioMEMS HF System updates enabling home pressure monitoring via smartphone app
    Abbott announced that the U.S. Food and Drug Administration has cleared updated software for its CardioMEMS HF System. The changes add a patient facing component through the CardioGuide HF mobile a…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • AstraZeneca opens 570,000-sq-ft Kendall Square R&D hub to boost cancer and biotech research
    AstraZeneca inaugurated a 570,000-square-foot research and development facility in Kendall Square, Cambridge, Massachusetts. The 18-story building will host roughly 2,000 scientists working on chr…
    Fierce Biotech · 1mo agoPositive↗ source