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  • Personalized mRNA melanoma vaccine shows clinical success, reviving optimism for the platform
    Moderna and Merck reported positive results from a personalized mRNA vaccine designed to treat melanoma in a recent clinical study. The outcome is being hailed as a boost for mRNA technology, whic…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance
    A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders. Indu…
    raps · 2mo agoRegulatoryNeutral↗ source
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  • Trump announces nine voluntary drug pricing agreements with mid-size biotech firms
    On August 31, 2026, the White House announced that President Donald Trump has secured nine new voluntary drug-pricing agreements with mid-size biotechnology companies. The companies entered the de…
    Endpoints · 2mo agoDealNeutral↗ source
  • Radiopharmaceutical experts urge pharma to adopt bolder dosing despite safety concerns
    Louise Emmett and a group of radiopharmaceutical specialists argue that these modern radiation‑based drugs could dramatically improve cancer outcomes if used more aggressively. They say the therapi…
    STAT · 2mo agoNeutral↗ source
  • Industry insiders invited to take Q3 BioPharma Sentiment Survey
    Signal's Endpoints team is launching the third quarterly BioPharma Sentiment Index (BPSI) survey, a three minute questionnaire that captures industry views. The survey asks participants to share p…
    Endpoints · 2mo agoNeutral↗ source
  • Pregnancy hormone explored as possible guide for cardiovascular drug development
    The STAT+ newsletter preview highlights a discussion about whether a hormone that regulates pregnancy could be leveraged to direct a new cardiovascular therapy. The piece also notes that researche…
    STAT · 2mo agoNeutral↗ source
  • Industry and patient groups urge FDA to revise master protocol guidance
    Industry groups and patient advocacy organizations have written to the U.S. Food and Drug Administration asking for several revisions to its recently updated draft guidance on master protocols for…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Highlights from the European Society of Cardiology meeting and updates on radiopharmaceutical research
    The newsletter reports that the European Society of Cardiology convened in Munich, with Europe correspondent Andrew Joseph providing coverage of the event. The author contrasts the ESC’s rotating…
    STAT · 2mo agoNeutral↗ source
  • Ana Salazar Modela Tu Cuerpo recalls Lipofit Extreme Fat Burner 2.0 after FDA finds undeclared fluoxetine and DNP
    Ana Salazar Modela Tu Cuerpo Inc. announced a voluntary nationwide recall of its Lipofit Extreme Fat Burner 2.0 on August 27, 2026, targeting the lot with expiration in September 2027. FDA laborat…
    fda medwatch · 2mo agoCRLNegative↗ source
  • India streamlines regulations for outsourced medical device sterilization
    The Indian government announced a simplification of the regulatory framework governing outsourced sterilization of medical devices. The move is part of a broader effort to make it easier for busine…
    raps · 2mo agoRegulatoryPositive↗ source
  • Study reports up to 25% of sampled NFL players had CTE at death, sparking calls for league-wide action
    Researchers in the Boston area examined the brains of a sample of former NFL players and found that about one quarter showed signs of chronic traumatic encephalopathy at death. The authors noted th…
    STAT · 2mo agoNegative↗ source
  • FDA approves Mimrylo, a weekly injection for polycythemia vera, developed by Protagonist and sold by Takeda
    The Food and Drug Administration has approved a new therapy for polycythemia vera, a rare blood cancer that causes an overproduction of red blood cells. The drug, known as rusfertide, will be mark…
    STAT · 2mo agoApprovalPositive↗ source
  • AstraZeneca’s oral relaxin drug shows partial success in mid-stage heart-failure trial
    AstraZeneca reported that its oral relaxin agonist improved cardiac function in a subset of patients enrolled in a mid-stage heart‑failure study. The trial demonstrated measurable benefits for some…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Alnylam defends its heart failure silencers after AstraZeneca's ATTR-CM trial miss
    AstraZeneca reported that its experimental drug Wainua failed to meet its primary endpoints in a study of transthyretin amyloid cardiomyopathy (ATTR-CM). The setback raised concerns about the thera…
    STAT · 2mo agoNeutral↗ source
  • Arrowhead's RNAi drug Redemplo shows safety advantage over Ionis in late-stage triglyceride trials
    At the European Society of Cardiology meeting in Munich, Arrowhead Pharmaceuticals presented new data on its RNA interference candidate Redemplo. Redemplo was evaluated in two late-stage studies i…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • FDA grants approval to Revolution Medicines' Rasonque for pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque, a new therapy from Revolution Medicines, for the treatment of pancreatic cancer. The decision follows data that showed the drug nearly…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Novartis IL-6 antibody pacibekitug cuts inflammation markers in Phase 2 study
    A Phase 2 trial called TRANQUILITY showed that pacibekitug, an IL-6‑targeting antibody acquired by Novartis, reduced several biomarkers of inflammation in participants. The reductions were sustain…
    STAT · 2mo agoPositive readoutPositive↗ source
  • Novartis launches Phase 3 trial of IL-6 antibody to test cardiovascular benefit despite Novo's setback
    Novartis announced it will begin a Phase 3 study evaluating its anti-IL-6 monoclonal antibody in patients at high cardiovascular risk. The trial aims to determine whether reducing inflammation thr…
    Endpoints · 2mo agoNeutral↗ source
  • FDA approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 2mo agoApprovalPositive↗ source
  • Eli Lilly’s Mounjaro receives FDA approval to lower cardiovascular risk; Teva announces acquisition of approved drug
    Eli Lilly’s once‑a‑diabetes blockbuster tirzepatide, marketed as Mounjaro, was granted FDA approval on Friday for an indication that reduces the risk of major cardiovascular events. The approval e…
    Endpoints · 2mo agoApprovalPositive↗ source
  • AstraZeneca’s ATTR-CM Silencer Trial Fails to Show Benefit Over Existing Stabilizer Therapy
    AstraZeneca announced that its Phase 3 trial of a silencer drug for transthyretin amyloid cardiomyopathy (ATTR-CM) did not meet its primary endpoints. The study showed no additional clinical benefi…
    STAT · 2mo agoNegative readoutNegative↗ source
  • AstraZeneca and Ionis gene silencer Wainua fails trial after patients also took Pfizer heart drug
    At the ESC Congress in Munich, a high‑profile trial of the gene‑silencing therapy Wainua, developed by AstraZeneca and Ionis, was reported to have failed. The failure was linked to participants co…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Cytokinetics reports positive pivotal trial results for aficamten in non-obstructive hypertrophic cardiomyopathy
    Biotech Cytokinetics disclosed full data from a pivotal study of its drug aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The trial met both primary endpoints, showin…
    STAT · 2mo agoPositive readoutPositive↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 2mo agoApprovalPositive↗ source
  • BioNTech and Genentech halt Phase 2 trial of personalized mRNA cancer vaccine
    BioNTech and its partner Genentech announced the termination of a Phase 2 study evaluating a personalized mRNA cancer vaccine. The decision was made shortly after the trial had entered its second s…
    Endpoints · 2mo agoNegative↗ source