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  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 1mo ago↗ source
  • UK waitlist for Novo's Wegovy pill triples in week after approval, major online pharmacy says
    The waiting list at a UK online pharmacy for Novo Nordisk’s Wegovy pill now stands at 30,000 people a week after approval, in a sign of dramatic demand for the weight loss drug among patients ...
    Endpoints · 1mo ago↗ source
  • Hackers claim they stole Novo Nordisk AI models, manufacturing recipes
    Novo Nordisk got robbed and is in the unenviable position of being extorted by the thieves. At stake, according to a group that has claimed responsibility for a cyberattack, are some of Novo's most…
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Endpoints · 1mo ago↗ source
  • 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 zeroes in on next-gen T cell engagers with AbCellera deal
    The potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.
    BioPharma Dive · 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…
    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 incl…
    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 for…
    Endpoints · 1mo ago↗ source
  • A new Westlake-backed biotech takes aim at migraines
    Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.
    BioPharma Dive · 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 ar…
    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 do…
    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
  • Lilly buys non-opioid pain drugmaker 4E
    It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.
    BioPharma Dive · 1mo ago↗ source
  • Express Scripts, PCMA sue to block Tennesee law breaking up PBMs and pharmacies
    Express Scripts and the PBM lobby are following in CVS Caremark’s footsteps in filing complaints challenging the FAIR Rx Act, which was passed earlier this year despite vehement opposition from PBMs.
    BioPharma Dive · 1mo ago↗ source
  • FDA staff scrutinizes evidence supporting Moderna’s flu vaccine
    Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year.
    BioPharma Dive · 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 a…
    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 11th…
    Endpoints · 1mo ago↗ source
  • Edgewise heart drug passes key trial test
    Still, the results leave somewhat unclear how different the company’s drug is than marketed hypertrophic cardiomyopathy medicines from Bristol Myers Squibb and Cytokinetics.
    BioPharma Dive · 1mo ago↗ source
  • Neumora depression drug fails; EnGene to cut 50% of staff
    Neumora’s stumble is the latest setback for a once-promising class of brain drugs. Elsewhere, a cell therapy manufacturing specialist took steps toward an IPO and J&J made its latest U.S investment.
    BioPharma Dive · 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 Universit…
    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 Medicare…
    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