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  • BioNTech appoints Guido Oelkers as new CEO, succeeding cofounder Ugur Sahin
    BioNTech announced that Guido Oelkers will become its chief executive officer, taking over from cofounder Ugur Sahin. Oelkers comes from Swedish biopharma Sobi, where he led the company, and bring…
    STAT · 3h agoNeutral↗ source
  • Biotech leaders urge faster IND process as FDA launches TrialBlazer pilot
    The U.S. Department of Health and Human Services has introduced Operation TrialBlazer, a pilot program aimed at simplifying the investigational new drug (IND) application and approval process. The…
    BioSpace · 11h agoRegulatoryNeutral↗ source
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  • BioNTech picks Sobi CEO Oelkers to lead as founders plot new mRNA biotech
    BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will tak…
    BioSpace · 2h ago↗ source
  • ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever
    If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.
    BioSpace · 3h ago↗ source
  • BlossomHill eyes $112M IPO harvest to bankroll potential Tagrisso challenger
    BlossomHill Therapeutics plans to raise $111.7 million to fund the clinical journey of its potential challenger to Tagrisso.
    Fierce Biotech · 5h ago↗ source
  • After 6-month wait, BioNTech announces Sobi CEO will take on top job at mRNA company
    One of the most closely watched vacancies in biopharma has now been filled, with Sobi CEO Guido Oelkers, Ph.D., moving across to take up the top job at mRNA pioneer BioNTech.
    Fierce Biotech · 8h ago↗ source
  • Editor’s Corner: Why an AstraZeneca-Bristol Myers Squibb merger is a bad idea
    Combining the two drugmakers would trigger severe regulatory concerns and significant pipeline disruptions, cost numerous jobs, all while damaging the broader biopharma ecosystem and hurting patien…
    Fierce Biotech · 14h ago↗ source
  • AbbVie shares slip 4% as Q2 immunology earnings beat falls short of lofty expectations
    AbbVie’s stock fell about 4% on Friday after the company reported second‑quarter results that modestly exceeded analyst forecasts, disappointing investors who had set very high expectations. The f…
    BioSpace · 2d agoEarningsNegative↗ source
  • UniQure prepares for FDA advisory committee on Huntington’s gene therapy amid rare-disease regulatory jitters
    UniQure said it is ready to present its Huntington's disease gene therapy, AMT-130, to an FDA advisory committee, as discussed in its Q2 earnings call. The company expects the FDA may schedule the…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 3d agoRegulatoryNeutral↗ source
  • Analysts say Daiichi Sankyo’s ADC pipeline lags rivals as cash flow peaks, cutting expectations
    Jefferies analysts warned that Daiichi Sankyo's early‑stage antibody‑drug conjugate (ADC) pipeline is falling behind competitors, even as the company approaches a peak in cash flow from its existin…
    BioSpace · 4d agoNegative↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 4d agoNegative readoutNegative↗ source
  • FDA advisory panel backs Replimune’s melanoma immunotherapy combined with Opdivo
    The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10-3 to recommend Replimune’s RP1 immunotherapy, used together with Bristol Myers Squibb’s Opdivo, for patients with advanced…
    BioSpace · 3d agoRegulatoryPositive↗ source
  • Replimune's melanoma virus therapy wins FDA advisory committee vote after two rejections
    Replimune's oncolytic virus RP1, also called vusolimogene oderparepvec and Tudriqev, has been rejected twice by the FDA. Today an advisory committee voted 10 to 3 that the candidate shows enough ef…
    Fierce Biotech · 3d agoRegulatoryPositive↗ source
  • BMS CEO says firm not pressured to pursue acquisitions despite quiet M&A year
    BMS chief executive Chris Boerner told analysts on the second‑quarter earnings call that the company’s robust late‑stage pipeline means it does not feel any compulsion to chase deals. The firm has…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • Labcorp reports Q2 sales of $3.73 billion, lifts full-year revenue outlook despite missing consensus
    Labcorp announced second‑quarter revenue of $3.73 billion, up from $3.53 billion a year earlier, driven by strong performance across its core businesses. The Diagnostics division grew 5.5% to $2.9…
    Fierce Biotech · 4d agoEarningsNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 4d agoNegative↗ source
  • Arvinas CEO outlines strategy to rebuild pipeline after lead asset departure
    In a recent episode of the Denatured podcast, Arvinas President and CEO Randy Teel discussed how the company is shifting focus to an early‑stage pipeline after its lead asset was out‑licensed or di…
    BioSpace · 4d agoPositive↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 4d agoDealPositive↗ source
  • Podcast debates FDA’s handling of Duchenne drugs and upcoming executive changes
    Allison DeAngelis, Adam Feuerstein and Elaine Chen host this week’s Readout Loud podcast, a STAT series that examines biotech trends and business moves. The trio questions whether the FDA is apply…
    STAT · 3d agoNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns abruptly, board taps interim leader
    Legend Biotech announced that its chief executive, Dr. Ying Huang, has stepped down unexpectedly, leaving the role vacant. Huang, who moved from chief financial officer to CEO in 2020 after a cust…
    Fierce Biotech · 3d agoNeutral↗ source
  • Medicaid work rules spark confusion over medically frail exemption, risking coverage for chronically ill
    Nebraska will begin enforcing Medicaid work requirements next week, demanding that beneficiaries work, volunteer or attend school for at least 80 hours each month or risk losing their health covera…
    STAT · 4d agoRegulatoryNegative↗ source
  • FDA briefing hints tough road for Capricor and Replimune ahead of advisory committee meetings
    The FDA released briefing documents for upcoming advisory committee meetings concerning Capricor Therapeutics' Duchenne muscular dystrophy cell therapy and Replimune's advanced melanoma candidate.…
    BioSpace · 5d agoRegulatoryNeutral↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 4d agoPositive readoutPositive↗ source