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  • US proposes new biotech investment limits on China, but licensing deals remain allowed
    The U.S. Treasury announced a proposal to curb outbound investments in Chinese biotechnology, citing national‑security concerns. The plan would limit U.S. persons from funding certain bio‑derived c…
    BioSpace · 20d agoRegulatoryNeutral↗ source
  • FDA lifts hold on Aardvark Therapeutics' ARD-101 after safety study shows no cardiac events
    FDA has lifted the clinical hold on Aardvark Therapeutics' ARD-101 after the company completed an additional safety study. The new data showed no cardiac events, addressing the concerns that prompt…
    BioSpace · 20d agoCRLPositive↗ source
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  • Star Therapeutics raises $200 million to build new drug pipeline after Vega and Electra wins
    Star Therapeutics announced it has secured $200 million in financing. The capital will be used to develop its own pipeline of medicines, aiming to replicate the success of its earlier Vega and Ele…
    Endpoints · 20d agoDealPositive↗ source
  • New Medicare rules could restrict pain medication access for many patients, doctor warns
    A recent Medicare policy proposal would tighten coverage criteria for certain pain‑relief treatments, potentially limiting their availability to patients who rely on them for daily functioning. Ph…
    STAT · 20d agoRegulatoryNegative↗ source
  • Alnylam to launch larger study of RNA therapy for Huntington’s disease
    Alnylam Therapeutics announced it will expand its clinical program for an RNA‑based drug aimed at treating Huntington’s disease. The decision comes amid a challenging landscape for neurodegenerati…
    Endpoints · 20d agoNeutral↗ source
  • Alnylam's experimental Huntington's therapy reduces mutant protein in early trial
    Alnylam Pharmaceuticals reported early data from a small study of its gene‑silencing drug for Huntington's disease. The investigational agent, brezosiran, was administered at several dose levels.…
    STAT · 20d agoPositive readoutPositive↗ source
  • Bristol Myers Squibb identifies cause of safety signal in lupus CAR‑T trial
    Bristol Myers Squibb's cell therapy division is confronting ongoing safety challenges with its autoimmune CAR‑T program. The company says it has pinpointed the underlying cause of the safety signa…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • Biotech M&A slows sharply in Q3 as deal activity cools
    The third quarter saw a noticeable slowdown in biotech mergers and acquisitions after a busy first half of the year. Large upfront licensing agreements were fewer, and venture capital firms reduce…
    Endpoints · 20d agoDealNegative↗ source
  • Roche bets up to $813M on Zymeworks’ lung cancer trispecific T cell engager
    Roche will pay Zymeworks $55 million upfront plus another $40 million once the partnership asset enters Phase 1b development and up to $718 million in additional milestones.
    BioSpace · 20d agoDealNeutral↗ source
  • State officials scramble to roll out Medicaid work requirements, exchange strategies at NAMD conference
    At the National Association of Medicaid Directors (NAMD) conference, state officials gathered to discuss the rollout of Medicaid work requirements. Officials described the effort as a scramble, no…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Swiss biotech Windward Bio files for Nasdaq IPO to raise funds for China-derived assets and R&D
    Windward Bio, a Basel-based European biotech founded two years ago, announced it has filed its registration statements to list on Nasdaq. The company plans to use the proceeds to support two clini…
    Endpoints · 19d agoDealPositive↗ source
  • Tango combo clears Rasonque bar and Takeda's Innovent sees early returns as ESMO data leaks dampen hype
    The first day of the European Society for Medical Oncology (ESMO) congress opened in Madrid with several notable updates from the oncology field. Tango's combination therapy cleared the Rasonque r…
    Endpoints · 20d agoRegulatoryNeutral↗ source
  • Voyager Therapeutics CEO Al Sandrock to resign next year, remains on board; Insmed appoints Paul Hudson as director
    Voyager Therapeutics announced that its chief executive, Al Sandrock, will step down in the first quarter of next year. Sandrock will continue to serve on Voyager's board after his resignation, pr…
    Endpoints · 20d agoNeutral↗ source
  • Star raises $200 million after successful spinouts of Electra and Vega Therapeutics
    Star, a biopharma company, announced it has secured $200 million in new funding. The capital follows the recent exits of its subsidiaries Electra Therapeutics and Vega Therapeutics, which were spu…
    BioPharma Dive · 20d agoDealPositive↗ source
  • Family reflects on extra months gained from new pancreatic cancer drug daraxonrasib
    Bobby Senaha was among the first patients to receive daraxonrasib, a new medicine aimed at extending survival for people with pancreatic cancer. The drug is described as life extending, offering p…
    STAT · 20d agoPositive↗ source
  • Lung cancer patient credits targeted therapy for 15-year survival, notes limited benefit for others
    A lung cancer patient described how a targeted drug allowed her to live for 15 years after diagnosis. She highlighted that while her own quality of life improved, many of her peers who received th…
    STAT · 20d agoNeutral↗ source
  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 20d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 20d agoNeutral↗ source
  • ADA admits unclear policies after ejecting members, sparks boycott and journal shutdown
    The American Diabetes Association ejected five members from a scientific session in New Orleans on June 5 and later issued two explanations, an apology and a summary of its internal review. The org…
    STAT · 19d agoNegative↗ source
  • Callio Therapeutics appoints Chris Hassig as chief scientific officer, coming from Boundless Bio
    STAT+ regularly highlights personnel changes across the pharmaceutical sector. In its latest column the outlet reports a new senior appointment at Callio Therapeutics. The company has hired Chris…
    STAT · 20d agoPositive↗ source
  • States Challenge New Medicaid Work Requirements in Boston Court
    A federal judge in Boston heard arguments from about two dozen states contesting the Biden administration’s new Medicaid work-requirement rule. The states claim Health Secretary Robert F. Kennedy…
    STAT · 20d agoRegulatoryNegative↗ source
  • Opioid Overdose Deaths Have Plummeted, Experts Call for Deeper Investigation
    Recent data indicate a steep drop in opioid overdose deaths. The decline is notable compared with previous years. Three health experts argue that influences beyond medical treatment and public hea…
    STAT · 20d agoPositive↗ source
  • STAT honors late infectious disease reporter Helen Branswell on The Readout LOUD podcast
    The Readout LOUD podcast dedicated an episode to remembering Helen Branswell, a well‑known infectious disease journalist who passed away last week. Colleagues, family, and public health leaders sh…
    STAT · 20d agoNegative↗ source
  • Writer empathizes with Christina Applegate’s MS misdiagnosis, recalling her own 13-year diagnostic journey
    The author of the piece shares a personal connection to actress Christina Applegate’s recent revelation that she was told she no longer had multiple sclerosis, only to discover the news was a misdi…
    STAT · 19d agoNeutral↗ source
  • STAT reporters share reactions to new Elizabeth Holmes documentary
    STAT reporters attended the newly released documentary "You Can See Everything," which chronicles the rise and fall of Elizabeth Holmes and her company Theranos. The reporters offered a range of h…
    STAT · 20d agoNeutral↗ source