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  • STAT+: Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, and more
    An FDA proposal to remove references to “gender” from its regulations sparked concerns about unintended consequences on research
    STAT · 2mo ago↗ source
  • 'Pharma, not really’: Top young AI talent shuns careers at big drugmakers
    RIO DE JANEIRO — Mazdak Abulnaga should be the poster child for the type of employee pharma companies want to hire this year. Abulnaga, a 33-year-old postdoctoral fellow at MIT and Harvard Medical…
    Endpoints · 2mo ago↗ source
  • Dr Gruenbaum on Where Alternative Options to BTK Inhibitors Stand in MCL
    Lore Gruenbaum, PhD, discusses alternative treatments to BTK inhibitors like bispecific antibodies and CAR T-cell therapy in mantle cell lymphoma.
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onclive · 2mo ago
↗ source
  • The PYNNACLE Phase 2 trial assessing rezatapopt, a selective p53 reactivator, in patients with advanced or metastatic solid tumors harboring a TP53 Y220C mutation: Interim analysis of patients with ovarian cancer
    Alison Schram, MD, discusses interim PYNNACLE phase 2 data showing that single-agent rezatapopt produced clinically meaningful responses and a manageable safety profile in heavily pretreated patien…
    onclive · 2mo ago↗ source
  • Characterization and Management of Sevabertinib induced Diarrhea in the SOHO 1 study
    This analysis from the SOHO-01 study evaluated the safety profile of sevabertinib in HER2-mutated non–small cell lung cancer, with a specific focus on treatment-related diarrhea. Diarrhea was frequ…
    onclive · 2mo ago↗ source
  • First-Line Danvatirsen Plus Pembrolizumab Fails to Improve Response Rates in Metastatic HNSCC
    Danvatirsen in combination with pembrolizumab did not result in an ORR improvement vs pembrolizumab alone in first-line recurrent/metastatic HNSCC.
    onclive · 2mo ago↗ source
  • Cumulative ADC Toxicities and Closing Reflections: Managing Edema, Fatigue, and Optimizing Long-Term Tolerability
    This concluding segment addresses cumulative toxicities affecting long-term antibody-drug conjugate tolerability, with Hope Rugo, MD and Aaron Lisberg, MD discussing edema, fatigue, and strategies…
    onclive · 2mo ago↗ source
  • The aging scientific workforce collides with rising fabricating citations in medical journals
    The latest in the hantavirus cruise ship saga, why these former officials left the FDA, and more health news from Morning Rounds
    STAT · 2mo ago↗ source
  • Natalie Holles' next move after Third Harmonic shutdown; Mark Alles passes the torch at ADC biotech
    → It didn’t take long for Natalie Holles to rebound after the decision to wind down operations at her previous company. She has replaced Elisabet de los Pinos as CEO of ...
    Endpoints · 2mo ago↗ source
  • Capricor sues Nippon Shinyaku over Duchenne drug 'pricing flaw' and launch prep
    Capricor Therapeutics said Thursday it has filed a lawsuit against Nippon Shinyaku over a distribution and commercialization agreement for deramiocel, a cell therapy candidate for Duchenne muscular…
    Endpoints · 2mo ago↗ source
  • Opinion: We need more men in nursing
    Men make up just 12% of nurses nationally. That needs to change.
    STAT · 2mo ago↗ source
  • Opinion: STAT+: Medicare’s new RAPID pathway is a breakthrough for adults. Children are still waiting
    “The pediatric and orphan pipeline is already the smallest, slowest, and least capitalized segment of the device industry,” writes Kolaleh Eskandanian.
    STAT · 2mo ago↗ source
  • Why we left the FDA: Six former officials share their stories
    In this week's STATus Report, hear from six former FDA officials on why they left the agency.
    STAT · 2mo ago↗ source
  • Odyssey raises more than $300M as biotech goes public
    Odyssey Therapeutics pulled together $279 million from its initial public offering, the autoimmune disease drug developer said Thursday night. Odyssey began trading on the Nasdaq on Friday. The bio…
    Endpoints · 2mo ago↗ source
  • Dr Sznol on Optimal Treatment Sequencing in Melanoma
    Mario Sznol, MD, discusses the challenges of determining whether to recommend adjuvant therapy for patients with melanoma based on current data.
    onclive · 2mo ago↗ source
  • Fraudulent citations, blamed on AI hallucinations, are becoming more common in research papers
    “Fabricated” citations that do not reference real academic papers are spreading in the literature, polluting the public record of science, a new study found
    STAT · 2mo ago↗ source
  • Astellas touts data from early test of stem cell-derived eye therapy
    Astellas reported promising results with its stem cell-derived therapy in an age-related eye disease, though data in a handful of high-dose patients in the early-stage study raised questions. The e…
    Endpoints · 2mo ago↗ source
  • Mentorship Is Key to Advance the Next Generation of Oncology Researchers
    Theresa A. Guise, MD, FASBMR, and Stephanie S. Watowich, PhD, discuss their elections as AAAS fellows and offer guidance for early-career investigators.
    onclive · 2mo ago↗ source
  • Dr Mauro on the Significance of Alternative TKI Formulations in CML
    Michael Mauro, MD, details the FDA approval of the small-molecule formulation of dasatinib and other alternate TKI formulations in chronic myeloid leukemia.
    onclive · 2mo ago↗ source
  • Key takeaways from WHO briefing on hantavirus cruise ship outbreak
    Here are key takeaways from a WHO briefing on the hantavirus outbreak aboard a cruise ship.
    STAT · 2mo ago↗ source
  • Women With Bladder Cancer Face Diagnostic Delays as Symptoms Mimic UTIs, Experts Warn
    Timothy N. Clinton, MD, and Stephanie A. Berg, DO, discuss gender differences in bladder cancer during Bladder Cancer Awareness Month.
    onclive · 2mo ago↗ source
  • Seaport’s IPO adventure, obesity pill battles, and Makary’s troubles
    This week on "The Readout LOUD" podcast: Seaport Therapeutics’ successful IPO, obesity pill battles, and the FDA commissioner's White House troubles.
    STAT · 2mo ago↗ source
  • Science is becoming less disruptive. Is an aging workforce to blame?
    Most researchers conduct their more disruptive work early in their careers, but as they age, they tend to abandon that groundbreaking energy
    STAT · 2mo ago↗ source
  • Amazon adds Ozempic pill to same-day prescription drug kiosks
    The Ozempic pill is coming to Amazon Pharmacy’s prescription drug kiosks. It’s an expansion for the kiosks, which operate like vending machines and have been stocking oral Wegovy since February. Am…
    Endpoints · 2mo ago↗ source
  • Dr Olawaiye on the FDA Approval of Relacorilant Plus Nab-Paclitaxel in PROC
    Alexander B. Olawaiye, MD, discusses the clinical significance of the FDA approval of relacorilant plus nab-paclitaxel in PROC.
    onclive · 2mo ago↗ source