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  • Legend Biotech CEO Ying Huang resigns, interim leader Alan Bash appointed
    Legend Biotech announced that its chief executive, Ying Huang, Ph.D., stepped down on Friday, with no permanent successor named yet. The board named Alan Bash as interim CEO on July 23, according…
    Fierce Biotech · 3mo agoNeutral↗ source
  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 3mo agoRegulatoryNeutral↗ source
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  • Medical schools add hands-on nutrition programs while avoiding broader HHS priorities
    When students return to McGovern Medical School at UT Health Houston, they will take part in hands‑on nutrition experiences such as cooking demonstrations, tours of a holistic garden, and a culinar…
    STAT · 3mo agoNeutral↗ source
  • E‑bikes and e‑scooters driving surge in severe pediatric injuries, say pediatric surgeons
    J. Todd R. Lawrence, a pediatric orthopedic surgeon, and Madison A. Kesler, a research associate at Children’s Hospital of Philadelphia, note a rapid rise in serious injuries among children using e…
    STAT · 3mo agoNegative↗ source
  • Midwives urge role in combating medical misinformation as patients reject blood based on vaccine myths
    Midwife Mara Evans, based in North Carolina and faculty at Georgetown University’s Berkley School of Nursing, writes about her experience in a Nevada delivery room. She describes the careful handli…
    STAT · 3mo agoNeutral↗ source
  • Sanofi scraps most atopic dermatitis trials after amlitelimab fails to outperform standard care
    Sanofi announced it is halting all but one ongoing trial for amlitelimab, an OX40‑ligand antibody acquired through its $1.4 billion purchase of Kymab. The decision follows the Phase 3 COAST‑1 stud…
    BioSpace · 3mo agoNegative readoutNegative↗ source
  • Scribe Therapeutics raises $129 million in rare early-stage IPO to fund epigenetic heart disease therapy
    Scribe Therapeutics, founded by Jennifer Doudna, completed an IPO raising nearly $129 million, selling 8.58 million shares at $15 each. It is the first gene‑editing company to go public in more tha…
    BioSpace · 3mo agoDealPositive↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 3mo agoRegulatoryNegative↗ source
  • Genetic markers linked to Yescarta toxicity identified, opening path to safer CAR-T designs
    Researchers analyzed data from patients who received Kite Pharma's Yescarta CAR-T therapy in clinical trials. The analysis uncovered specific genetic signatures that correlate with higher risk of…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • Merck grants royalty-free licenses for experimental HIV prevention pill to generic makers in 129 low-income countries
    Merck announced voluntary licensing agreements that let generic manufacturers produce its experimental HIV prevention pill, known as alimatravir, in low- and middle-income markets. The deals cover…
    STAT · 3mo agoDealPositive↗ source
  • FDA panel backs compounding of epitalon, rejects emideltide in narrow vote
    The FDA advisory committee voted to allow compounding pharmacies to produce the peptide epitalon, while narrowly voting against allowing the production of emideltide. The decision follows the pane…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Amgen cuts about 40 jobs, about 0.1% of workforce, amid ongoing challenges
    Amgen announced the layoff of roughly 40 employees, representing about 0.1% of its global staff, as part of organizational changes aimed at aligning operations with strategic objectives. The compan…
    Fierce Biotech · 3mo agoLayoffsNegative↗ source
  • Fatal gene-editing trial in China sparks ethics and oversight concerns
    A six-year-old girl in China died after receiving an experimental brain-directed CRISPR therapy, according to a report in Science. The tragedy has intensified calls for stronger ethical review and…
    STAT · 3mo agoRegulatoryNegative↗ source
  • FDA panel backs compounding pharmacies to produce four peptide drugs, amid insulin pen shortage and Merck HIV pill license
    An FDA advisory committee voted to allow compounding pharmacies to prepare four peptide-based medicines, a decision hailed by supporters of peptide therapeutics. The briefing also mentioned that M…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Summit Therapeutics faces under a year of cash runway as FDA decision on ivonescimab looms
    Summit Therapeutics reported that its cash and short-term investments total just over $690 million, which the company says is insufficient to fund operations for a full year. The biotech’s lead ca…
    BioSpace · 3mo agoRegulatoryNeutral↗ source
  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 3mo agoNeutral↗ source
  • Merck launches voluntary licensing for investigational monthly HIV PrEP pill ahead of approval
    Merck has signed voluntary licensing agreements to allow generic manufacturers to produce its investigational monthly HIV PrEP pill, alimatravir, before any regulatory submission. The agreements c…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • U.S. drug shortages stem from weak regulation, not China competition, says expert
    In 2025 the United States faced 216 active drug shortages, limiting access to lifesaving medicines for patients. While the White House and national‑security officials have framed the problem as a…
    STAT · 3mo agoRegulatoryNegative↗ source
  • White House science blueprint pushes billions toward AI firms, away from university life-science research
    The White House Office of Science and Technology Policy released a report titled “Science: A New Golden Age.” The document outlines a new direction for U.S. federal science funding. The plan calls…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Sanofi drops pursuit of eczema drug amlitelimab after failed Phase 3 trials
    Sanofi announced it will no longer seek regulatory approval for amlitelimab, an anti‑OX40 ligand antibody intended for atopic dermatitis, after recent Phase 3 data fell short of expectations. The…
    Fierce Biotech · 3mo agoRegulatoryNegative↗ source
  • Scribe Therapeutics upsizes IPO to $128.7 million to fund lipid-lowering gene therapy
    Scribe Therapeutics announced pricing its initial public offering at $128.7 million, surpassing the $96 million target it had set earlier in the week. The company sold 8.6 million shares at $15 ea…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 3mo agoDealNeutral↗ source
  • Senate moves forward bill to require warning labels on ultra-processed foods and ban child-targeted junk-food ads
    The Senate Health, Education, Labor and Pensions Committee voted to advance a bill that would require the FDA to place prominent warning labels on ultra-processed foods high in sugar, salt or satur…
    STAT · 3mo agoRegulatoryNeutral↗ source