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744 stories matching this filter · ← front page

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  • In second reversal, FDA gives uniQure a green light to seek accelerated approval
    Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad. At the center of the debate, once again, is the ...
    Endpoints · 1mo ago↗ source
  • Jazz turns to AbCellera for T cell engagers in up to $4.1B partnership
    For much of its first decade, Canadian antibody developer AbCellera signed partnership after partnership, securing 40 biopharma alliances that led to more than a dozen clinical-stage drug candidate…
    Endpoints · 1mo ago↗ source
  • Update: Spot Bio launches with $40M to study non-viral gene therapy for muscular dystrophy
    A startup with operations in California and China has quietly begun tests of a genetic medicine that could restore dystrophin, the vital muscle protein that is broken or missing in people born with…
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Endpoints · 1mo ago
↗ source
  • Triveni Bio raises $65M ahead of upcoming readouts on eczema drugs
    Triveni Bio announced a $65 million Series C after its second asset for eczema entered clinical studies last month. The Series C was co-led by Ascenta Capital and Janus Henderson Investors and in…
    Endpoints · 1mo ago↗ source
  • Migraine biotech Vedana Therapeutics makes its debut with $46M Series A
    Vedana Therapeutics has emerged from stealth with $46 million in Series A proceeds with the goal of developing treatments that could free patients from migraines entirely. Available treatments fo…
    Endpoints · 1mo ago↗ source
  • Health groups say HHS is trying to 'rush reinstatement' of ACIP
    A group of health organizations has accused HHS of trying to use a “self-created crisis” to “rush reinstatement” of the CDC’s frozen vaccine advisory panel. The committee and its recommendations…
    Endpoints · 1mo ago↗ source
  • B cell therapy maker Be Bio stops hemophilia trial
    Be Biopharma disclosed in a federal clinical trials listing that it has terminated its study of a hemophilia B therapy made by editing a patient’s own cells. It was one of ...
    Endpoints · 1mo ago↗ source
  • FDA raises no major red flags with Moderna's flu shot
    The FDA provided tepid support of Moderna’s flu vaccine ahead of an advisory meeting but, more importantly, didn't appear to raise any major concerns that could hinder its prospects. In briefing…
    Endpoints · 1mo ago↗ source
  • FDA greenlights Colorado's drug import proposal
    The FDA gave the go-ahead for Colorado to try importing cheaper drugs from Canada, but it remains to be seen how or when this would actually begin. In a letter Monday ...
    Endpoints · 1mo ago↗ source
  • Edgewise to advance heart drug into Phase 3 following mid-stage data update
    Edgewise Therapeutics has shared plans to advance its drug candidate for a genetic heart disease into a registrational study on the back of updated Phase 2 data. The biotech said Tuesday ...
    Endpoints · 1mo ago↗ source
  • How to launch a telehealth business in one day
    Want to prescribe GLP-1s online? OpenLoop Health says it can get your virtual care company up and running in as little as 24 hours. OpenLoop provides the behind-the-scenes medical group powering…
    Endpoints · 1mo ago↗ source
  • Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill
    Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies. 💸 Eli Lilly acquires another pain biotech: The Indianapolis pharma giant has made its 11t…
    Endpoints · 1mo ago↗ source
  • UCSF spinout Kopra Bio raises $9.1M to test virus therapy in brain cancer
    Glioblastoma is notoriously good at evading the immune system, making it particularly resistant to immunotherapy, but now researchers may have found a clever workaround. Scientists at the Universi…
    Endpoints · 1mo ago↗ source
  • CMS seeks to close Medicare negotiation 'loophole'
    CMS has proposed a policy change that clarifies its stance on how products are grouped together for Medicare negotiations. Under the Inflation Reduction Act, biologics become eligible for Medicar…
    Endpoints · 1mo ago↗ source
  • FDA plans to keep Makary priorities on trials, China, deputy says
    PHILADELPHIA – Following the recent departures of FDA Commissioner Marty Makary and both of his center directors for drugs and biologics, the Trump administration will continue pushing their priori…
    Endpoints · 1mo ago↗ source
  • Takeda fortifies orexin potential with more Phase 3 data
    With a formidable new competitor set to enter the orexin development race, Takeda is out with new data that it hopes will reinforce market-leading potential. The additional results from Takeda’s…
    Endpoints · 1mo ago↗ source
  • Elicio’s KRAS cancer vaccine fails in Phase 2, shares plummet
    Elicio Therapeutics’ pancreatic cancer vaccine failed to improve outcomes in a mid-stage study, but the company is seeking funds to move ahead to a larger Phase 3 trial anyway. Elicio reported ...
    Endpoints · 1mo ago↗ source
  • Gan & Lee's Phase 3 obesity successes; J&J touts multiple myeloma data
    Plus news about Sanofi, PharmaMar, Jazz, Rhythm Pharmaceuticals, Spyre and Zymeworks 🇨🇳 Another obesity readout from China: Gan & Lee Pharmaceuticals, a China-based insulin specialist, anno…
    Endpoints · 1mo ago↗ source
  • Neumora drug fails two more Phase 3 trials, biotech to lay off 35% of staff
    The Really Big Neuroscience Company is proving to be a Really Big Flop with each passing update. Neumora Therapeutics will discontinue its lead depression drug after it failed another two Phase 3…
    Endpoints · 1mo ago↗ source
  • Six leaders working on LGBTQ+ inclusion in biopharma
    It’s been a tough 18 months for the LGBTQ+ community. The American Civil Liberties Union tracked 530 anti-LGBTQ bills across dozens of states this year. Nearly 40% of US workers say ...
    Endpoints · 1mo ago↗ source
  • Lilly puts its stamp at #EHA26 with Jaypirca combo data in CLL, first clinical data from Ajax buyout
    Eli Lilly made a push in blood cancer at this year’s European Hematology Association meeting in Stockholm over the weekend. The drugmaker presented data for Jaypirca combined with the standard of…
    Endpoints · 1mo ago↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health has secured $50 million in a Series B fundraise designed to support two psychiatry programs into mid-stage studies. The family-owned German drugmaker Medice led the Series B, wh…
    Endpoints · 1mo ago↗ source
  • Biopharma’s 2025 industry pay report; Parabilis sets industry record IPO; and more
    Welcome back to Endpoints Weekly! This week, we opened nominations for our eighth annual Women in Biopharma report. We’re looking to profile 20 scientists, executives, founders and other enterprisi…
    Endpoints · 1mo ago↗ source
  • Merck brings Welireg-Keytruda combo to treat kidney cancer
    Merck’s Welireg and Keytruda combination won approval as an adjuvant treatment for kidney cancer patients after surgery to remove all or part of the organ. The combination was approved Friday for…
    Endpoints · 1mo ago↗ source
  • Amgen and the FDA want two different outcomes for Tavneos. What will patients do?
    Amgen has asked the FDA to review evidence that its drug Tavneos (avacopan), which treats a rare form of vasculitis, is worth keeping on the market, as the future of the drug remains in flux. ...
    Endpoints · 1mo ago↗ source