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  • Deals, deals, deals; Biohaven takes on Eli Lilly; and more
    Welcome back to Endpoints Weekly! Don’t miss Ryan Cross’ deep dive into the paranoia caused by competition with China. Ryan writes that US biotech companies are holding their cards close to the ...
    Endpoints · 14d ago↗ source
  • Apnimed files for IPO as FDA reviews its sleep apnea drug
    Apnimed is finally going forward with an IPO attempt after years of flirting with the milestone. The Cambridge, MA-based biotech revealed its Nasdaq plans on Friday night, following a strong six ...
    Endpoints · 14d ago↗ source
  • Nominee for key federal health role has a history of questioning vaccines
    Sean Kaufman's views on vaccines may put him at odds with Sen. Bill Cassidy during next week's confirmation hearing.
    STAT · 15d ago
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  • FDA returns to releasing pharma rejection letters with 14 new CRLs
    The FDA on Friday posted 14 new rejection letters to pharma companies online, days after HHS confirmed to Endpoints News that the agency had paused new CRL releases because of a pharma-backed ...
    Endpoints · 15d ago↗ source
  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time
    For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…
    Endpoints · 15d ago↗ source
  • CDER adds 100+ new employees in a quarter for first time since late 2024
    The FDA's drug center hired more new employees than it lost in a quarter for the first time since the Trump administration gutted the agency's ranks in April 2025. The FDA's
    Endpoints · 15d ago↗ source
  • US biotechs turn secretive as they fear competition from rising Chinese industry
    Janine Sengstack believes she may have found the next big breakthrough in diabetes and obesity. Her company, Junevity, has searched through hundreds of genes to discover ones that, when repressed,…
    Endpoints · 15d ago↗ source
  • German lawmakers pass cost-saving bill that drugmakers say will drive them out
    Germany’s federal parliament has voted to pass a bill designed to cut domestic healthcare spending that could negatively impact drugmakers, drawing sharp criticism from the country’s main pharmaceu…
    Endpoints · 15d ago↗ source
  • Hansoh meets Phase 3 SCLC goal; FDA approves Sanofi on-body injector
    Plus, news about Huntington's, Fate Therapeutics and Bausch + Lomb. 🇨🇳 Hansoh touts Phase 3 success for GSK-partnered ADC: The program, called risvutatug rezetecan or Ris-Rez, met its primary e…
    Endpoints · 15d ago↗ source
  • STAT+: Roche ends Huntington’s gene-silencing programs
    ARPA-H launches bespoke gene therapy push, Lilly and Novo to promote Bridge program, and more biotech news from The Readout
    STAT · 15d ago↗ source
  • STAT+: Pharmalittle: We’re reading about bigger drug discounts in Germany, drugmakers embracing secrecy, and more
    German lawmakers passed a bill that would more than double the discount on branded medicines drugmakers must provide the government
    STAT · 15d ago↗ source
  • FDA quietly pushes back deadline on electric shock ban
    Massachusetts' biggest nursing strike ever, tackling the male loneliness epidemic, and other health news for Morning Rounds
    STAT · 15d ago↗ source
  • The data that led Cellular Intelligence to pick up Novo's Parkinson's stem cell therapy
    MONTREAL — After Novo Nordisk closed its cell therapy unit, Cellular Intelligence contracted neurologist and drug developer Nuno Mendonça to conduct due diligence on the Danish pharma’s Parkinson’s…
    Endpoints · 15d ago↗ source
  • Pfizer appoints obesity discovery head; AI startup Xaira makes leadership adjustments
    → Danna Breen has been promoted to head of obesity discovery at Pfizer, according to a LinkedIn post. Breen succeeds Kendra Bence and gets this opportunity after nearly 14 years with ...
    Endpoints · 15d ago↗ source
  • Opinion: The primary care crisis paradox
    “Solving the health crisis in the United States will require confronting things far harder than readjusting a fee schedule.”
    STAT · 15d ago↗ source
  • New York boys club has a time-tested recipe to protect members’ mental health
    At a time when attention is deservedly being turned to the mental health crisis in boys, the Boys' Club of New York is a shelter from the storm for many…
    STAT · 15d ago↗ source
  • STAT+: How a Boston doctor built a following as a ‘loud and unafraid’ voice in the Trump era
    Jeremy Faust saves lives in the ER and breaks stories with his Inside Medicine newsletter. He’s also testing the bounds of news reporting.
    STAT · 15d ago↗ source
  • Whistleblower takes on health insurance and FDA commissioner candidates
    This week on "The Readout LOUD" podcast: Why does getting family health insurance through a job cost as much as buying a new car? And who might be the new…
    STAT · 16d ago↗ source
  • ARPA-H bookmarks $160M for custom gene editing treatments. Is it enough?
    After an infant last year was saved from a deadly disease thanks to a bespoke gene editing therapy that fixed an incredibly rare mutation in his DNA, the US government is hoping ...
    Endpoints · 16d ago↗ source
  • HHS advances plan to pay out Covid-19 vaccine injury claims
    A newly proposed HHS rule would establish a compensation mechanism for people who claim they were injured by Covid-19 vaccines, as a key panel that oversees broader vaccine injury payments remains…
    Endpoints · 16d ago↗ source
  • Roche ends work on tominersen after decade of trials, as well as early-stage Huntington’s asset
    After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen. The decision comes after tominersen did no better than placebo in a Phase…
    Endpoints · 16d ago↗ source
  • UK price watchdog recommends against Amgen's Lumakras in lung cancer
    The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institut…
    Endpoints · 16d ago↗ source
  • FDA criticizes Lundbeck for webpages on migraine treatment Vyepti
    The FDA has chastised Lundbeck Seattle Biopharmaceuticals for two promotional webpages that made allegedly inflated claims regarding the efficacy of its migraine drug. In an untitled letter sent…
    Endpoints · 16d ago↗ source
  • FDA quietly stops releasing CRLs
    The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information. The pause follows a law firm in April
    Endpoints · 16d ago↗ source
  • Outbreak of diarrhea-causing parasite grows to more than 1,000 cases
    An outbreak of diarrhea-causing parasite has grown to more than 1,000 cases, making it one of the nation’s largest such outbreaks in years.
    STAT · 16d ago↗ source