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  • Allogene announces CEO David Chang will step down
    Allogene Therapeutics disclosed that its chief executive, David Chang, will be leaving the company. The firm indicated that a succession plan is in place, though it did not provide a specific timel…
    STAT · 5mo agoNeutral↗ source
  • Replimune to resubmit melanoma therapy RP1 to FDA after two prior rejections
    Replimune announced on Friday that it will again submit its advanced melanoma candidate, RP1, to the U.S. Food and Drug Administration for review. The company says the filing follows new discussion…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
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  • Kenyan court halts U.S. plan for Ebola quarantine facility for Americans
    A Nairobi High Court on Friday ordered a stop to a U.S. proposal to build a quarantine center in Kenya for Americans who might have been exposed to a rare Ebola strain circulating in northeastern C…
    STAT · 5mo agoRegulatoryNegative↗ source
  • GC Therapeutics appoints former BlueRock executive Stefan Irion as chief scientific officer
    GC Therapeutics announced that Stefan Irion has joined the company as its new chief scientific officer. Irion previously served in the same capacity at BlueRock Therapeutics. Irion brings experien…
    STAT · 5mo agoNeutral↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • AbbVie receives FDA approval for ultra-rare blood cancer ADC acquired from ImmunoGen
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for an antibody-drug conjugate targeting an ultra-rare, aggressive form of blood cancer. The therapy was obtained t…
    Endpoints · 5mo agoApprovalPositive↗ source
  • U.S. policy bars Ebola patients from entering country, plans overseas evacuation
    U.S. health officials announced that any American who contracts Ebola will not be taken to the United States for care. Instead, patients will be moved to undisclosed locations in Europe for treatme…
    STAT · 5mo agoRegulatoryNegative↗ source
  • FDA delays AstraZeneca breast cancer drug camizestrant PDUFA date
    The U.S. Food and Drug Administration has extended the PDUFA target date for AstraZeneca’s breast cancer candidate camizestrant, pushing the review timeline back by a few days. No new deadline was…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 5mo agoApprovalPositive↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Relay Therapeutics' zovegalisib shows 60% response in mid‑stage trial for rare vascular anomalies
    Relay Therapeutics reported early data from a phase 2 trial of its experimental drug zovegalisib in patients with vascular anomalies, a group of rare disorders characterized by abnormal blood vesse…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • Relay Therapeutics' zovegalisib meets efficacy endpoint in Phase 2 vascular anomalies trial
    Relay Therapeutics reported that its PI3Kα inhibitor zovegalisib achieved the predefined efficacy threshold in a Phase 2 study of a rare genetic vascular anomaly. The data readout exceeded Wall Str…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Merck's China-sourced ADC shows survival benefit in Phase 3 endometrial cancer trial
    Merck & Co., in partnership with Chinese biotech Kelun-Biotech, reported that its experimental antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoint in a global Phase 3…
    BioPharma Dive · 5mo agoPositive readoutPositive↗ source
  • FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan
    The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…
    BioPharma Dive · 5mo agoRegulatoryNegative↗ source
  • Merck and Kelun-Biotech's ADC sac-TMT secures first global Phase 3 win ahead of schedule
    Merck and China-based Kelun-Biotech reported that their experimental antibody-drug conjugate sac-TMT achieved a positive outcome in a global Phase 3 study, marking the first such success for the ca…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Regeneron signs up to $125 million deal with Parabilis to target difficult drug targets
    Regeneron announced a deal with Parabilis Medicines valued up to $2.2 billion, with an upfront payment of $125 million. The agreement aims to give Regeneron access to Parabilis’s platform that dis…
    Endpoints · 5mo agoDealNeutral↗ source
  • Regeneron's LAG-3 inhibitor fianlimab fails Phase 3 skin cancer trial
    Regeneron announced that its experimental LAG-3 inhibitor fianlimab did not meet its primary endpoint in a late-stage trial for a skin cancer indication. The Phase 3 study was designed to evaluate…
    Endpoints · 5mo agoNegative readoutNegative↗ source
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 5mo agoRegulatoryNeutral↗ source
  • Texas launches clinic to support individuals seeking detransition services
    Texas health officials announced the opening of a clinic dedicated to people who want to reverse a gender transition, marking a new service in the state. The facility will provide counseling, medi…
    STAT · 5mo agoNeutral↗ source
  • Americans in Congo May Have Been Exposed to Ebola; One Shows Possible Symptoms, Tests Pending
    Several Americans traveling in the Democratic Republic of the Congo are believed to have had high risk exposure to suspected Ebola cases, according to sources familiar with the situation. At least…
    STAT · 5mo agoNeutral↗ source
  • Conflicting guidelines leave women unsure when to start routine mammograms
    Deciding when to begin routine mammograms is confusing because major health groups recommend different starting ages-some say 40, others 45, and a recent recommendation pushes the start to 50. They…
    STAT · 5mo agoNeutral↗ source
  • Preoperative intravesical mitomycin C cuts NMIBC recurrence risk by 77% over five years
    A recent study evaluated giving two doses of intravesical mitomycin C before transurethral resection of bladder tumor (TURBT) in patients with non‑muscle‑invasive bladder cancer (NMIBC). Compared…
    onclive · 5mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary Resigns, Prompting Concerns Over Agency Direction
    FDA Commissioner Marty Makary stepped down on Tuesday, leaving the agency without a permanent leader as it already faces turnover in its drug and biologics divisions. Makary had recently appeared…
    STAT · 5mo agoNegative↗ source
  • High TMB, GBD and PD-L1 Levels Linked to Better Response in Neoadjuvant Gem-iDRS or Cetrelimab Trial for Bladder Cancer
    The SunRISe-4 trial evaluated neoadjuvant gemcitabine‑based immunotherapy with or without cetrelimab in patients with muscle‑invasive bladder cancer. A biomarker sub‑analysis showed that patients…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Expert reviews real-world data on BCG retreatment after failure in non-muscle-invasive bladder cancer
    Dr Joshua J. Meeks, MD, PhD, provided an overview of a real-world study that examined the use of BCG retreatment in patients with non‑muscle‑invasive bladder cancer (NMIBC) who had previously faile…
    onclive · 5mo agoNeutral↗ source