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  • Sarepta Therapeutics appoints Michael Severino, former Tessera CEO, as new chief executive
    Sarepta Therapeutics announced that Michael Severino will become its chief executive, effective Tuesday. Severino previously led Tessera Therapeutics. He replaces Doug Ingram, who said he will ret…
    STAT · 3mo agoNeutral↗ source
  • Gossamer ends $486M PAH partnership with Chiesi after phase 3 miss
    Gossamer Bio announced it is terminating its collaboration and licensing agreement with Italy's Chiesi, regaining worldwide development and commercial rights to its pulmonary arterial hypertension…
    Fierce Biotech · 3mo agoDealNegative↗ source
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  • AstraZeneca says it remains confident in its ADC pipeline after dropping two underperforming candidates
    AstraZeneca executives told Fierce they are very confident in their internally developed antibody‑drug conjugate (ADC) program despite recent setbacks. The company has discontinued two ADC candida…
    Fierce Biotech · 3mo agoNegative readoutNeutral↗ source
  • Labcorp unveils direct-to-consumer genetic health panel covering 163 genes and 100+ conditions
    Labcorp announced the launch of a new direct-to-consumer test called the Marker by Labcorp Genetic Health Panel. The panel examines 163 genes to assess risk for more than 100 hereditary conditions…
    Fierce Biotech · 3mo agoPositive↗ source
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 3mo agoNeutral↗ source
  • FDA panel backs compounding pharmacies to make two peptides, rejects third
    The U.S. Food and Drug Administration’s advisory committee met on Friday and issued recommendations on the manufacturing of certain peptide drugs by compounding pharmacies. Committee members voted…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • AstraZeneca says Wainua failure won’t alter M&A plans, stays on track for $80B 2030 goal
    AstraZeneca said during its Q2 earnings presentation that the late‑stage failure of the antisense therapy Wainua in ATTR‑cardiomyopathy does not derail its goal of reaching $80 billion in revenue b…
    BioSpace · 3mo agoDealNeutral↗ source
  • Sarepta appoints Michael Severino as CEO to steer company beyond a turbulent year
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer, taking over from longtime leader Doug Ingram. Severino is slated to start on Tuesday and joins the com…
    Endpoints · 3mo agoNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns, Carvykti head Max Gelman appointed interim chief
    Legend Biotech announced that its chief executive officer, Ying Huang, has stepped down after serving in the role since November 2020. Huang's resignation was reported on Friday, marking the end o…
    Endpoints · 3mo agoNeutral↗ source
  • 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
  • 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
  • Upcoming Q2 earnings from Moderna, AstraZeneca, GSK and others highlighted in weekly pharma preview
    The Endpoints Weekly newsletter signals a busy earnings week for major pharmaceutical companies, with Q2 results slated from Moderna, AstraZeneca, GSK, Bristol Myers Squibb and several others. It…
    Endpoints · 3mo agoEarningsNeutral↗ source
  • Biogen's Alzheimer's trial data ignites excitement and uncertainty over tau-targeting therapies
    Biogen recently shared results from a late-stage Alzheimer's trial that tested a therapy aimed at the tau protein, a key hallmark of the disease. The findings have sparked enthusiasm among researc…
    Endpoints · 3mo agoNeutral↗ source
  • Amgen submits new analysis to FDA to defend continued availability of Tavneos
    Amgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
    Endpoints · 3mo agoRegulatoryNeutral↗ 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