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  • Revolution Medicines readies launch of experimental pancreatic cancer drug daraxonrasib as approval decision pending
    Revolution Medicines executives say they are preparing to launch daraxonrasib, an experimental therapy for metastatic pancreatic cancer. The drug is currently awaiting regulatory decisions in the…
    Endpoints · 3mo agoNeutral↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 3mo agoRegulatoryNeutral↗ source
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  • BioVie shares plunge as Parkinson’s trial results lack primary motor data
    BioVie reported results of its Phase 2 SUNRISE-PD study in early‑stage Parkinson’s disease. The double‑blind, placebo‑controlled trial enrolled 57 patients who had not yet received carbidopa/levodo…
    BioSpace · 3mo agoNegative readoutNegative↗ source
  • Sarepta delays Elevidys study readout while Emergent cuts 90 jobs
    Sarepta Therapeutics told investors that the readout for its non‑ambulatory Elevidys trial will not be available by the end of the year as previously expected. The company indicated the delay durin…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Podcast explores emerging rapid‑acting and psychedelic therapies for treatment‑resistant depression
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer C. Smith‑Parker talks with Hans Eriksson, chief medical officer of FundaMental Pharma, and Steve Levine, chief patient officer at…
    BioSpace · 3mo agoPositive↗ source
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 3mo agoDealPositive↗ source
  • Experts call for independent 9/11‑style commission to review U.S. Covid response
    In an opinion piece, IDSA President Ronald Nahass argues that the United States should create a nonpartisan, 9/11 Commission‑style body to examine the Covid‑19 response. He says such an inquiry wou…
    STAT · 3mo agoNeutral↗ source
  • Context Therapeutics drops CT-95 bispecific T-cell engager to stretch cash runway to 2027
    Context Therapeutics announced it is halting development of its bispecific T-cell engager CT-95. The company acquired CT-95 in 2024 for $3.7 million and began dosing patients in a phase 1 trial in…
    Fierce Biotech · 3mo agoNegative↗ source
  • Actimed regains full rights to S-oxprenolol, ends $126 million Faraday licensing deal
    Actimed Therapeutics announced it has reclaimed all worldwide rights to its experimental wasting disease drug S-oxprenolol, terminating the licensing agreement it had with Faraday Pharmaceuticals.…
    Fierce Biotech · 3mo agoDealNeutral↗ source
  • Vistagen's anxiety nasal spray fails to outperform placebo in phase 2 trial
    Vistagen Therapeutics reported that its experimental nasal spray fasedienol did not show a statistically significant advantage over placebo in a phase 2 study of social anxiety disorder. The trial…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • PacBio appoints COO Mark Van Oene as new CEO after Christian Henry steps down
    PacBio announced that its chief operating officer, Mark Van Oene, will become president and chief executive officer effective Aug. 5 and will join the company's board. Van Oene, who joined PacBio…
    Fierce Biotech · 3mo agoNeutral↗ source
  • Choosing Between CROs and Biotechs: How Company Size Shapes the Fit
    While biotechs and contract research organizations each have strengths, the article notes that the right choice depends on a company’s specific situation. Ali Pashazadeh, founder and CEO of Treehi…
    BioSpace · 3mo agoNeutral↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Medicare advances ACCESS pilot but leaves patients unaware of participating providers
    STAT's Health Tech newsletter reports that Medicare is promoting its ACCESS chronic‑care pilot, yet patients cannot see which providers are offering the program. A one‑month progress check highlig…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Merck KGaA to receive up to €40 million in US tariff refunds for life science business through 2026
    Merck KGaA announced that it expects to receive tariff refunds for its life‑science division after a US Supreme Court ruling. The company estimates the refunds will total roughly €40 million and w…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Centene reports strong enrollment growth but modest scale for its ICHRA offering
    Centene's chief executive Sarah London said the company's individual coverage health reimbursement arrangement (ICHRA) business is experiencing a strong enrollment growth rate, though the total num…
    Endpoints · 3mo agoEarningsPositive↗ source
  • US moves to shut Kentucky organ donation nonprofit over safety failures
    The U.S. Health Secretary announced that the federal government will begin the process to decertify Network for Hope, a Kentucky-based organ procurement organization, after allegations of safety la…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Senate committee votes to hold Dr. Fauci in contempt over Covid testimony
    A Senate committee voted along party lines to hold former health official Dr. Anthony Fauci in contempt of Congress after he refused to answer questions about his role in the Covid 19 pandemic resp…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Biotech leader Greg Verdine enjoys a successful year with multiple wins
    Greg Verdine, a scientist who moved into biotech leadership, is reported to be having a very good year. According to the source, Verdine has notched several wins in his role, though the specifics…
    STAT · 3mo agoPositive↗ source
  • U.S. experts to evaluate if measles elimination status still holds amid rising cases
    Noel T. Brewer, chair of the U.S. National Verification Committee, explains that his group will review the CDC’s annual measles report to decide if the United States continues to meet elimination c…
    STAT · 3mo agoNegative↗ source
  • Second child death reported in Chinese CRISPR trial for Duchenne muscular dystrophy raises safety concerns
    A second child death has been reported from a Chinese CRISPR gene-editing trial aimed at treating Duchenne muscular dystrophy, reviving concerns about the safety and transparency of such studies.…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Eli Lilly posts $23 B Q2 revenue, beats forecasts as Foundayo lags behind Novo's oral GLP-1
    Eli Lilly reported second‑quarter revenue of $23 billion, a 48% increase from the prior year and well above analysts' expectations. The strong top‑line helped the company deliver a sizable earnings…
    BioSpace · 3mo agoEarningsNeutral↗ source
  • Eli Lilly Q2 revenue hits $23 billion, topping forecasts as tirzepatide drives two-thirds of sales
    Eli Lilly reported second-quarter revenue of $23 billion, roughly $3 billion above analysts' estimates. Tirzepatide contributed about 64% of the total, highlighting its central role in the company…
    Endpoints · 3mo agoEarningsPositive↗ source
  • Lilly and FDA clash over retatrutide classification as company nears submission
    Eli Lilly is preparing to file its obesity drug candidate retatrutide for approval while a legal dispute with the FDA over the drug's classification intensifies. The agency has concluded that reta…
    BioSpace · 3mo agoRegulatoryNeutral↗ source
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source