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  • Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trial
    Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.
    BioPharma Dive · 1mo ago↗ source
  • Lilly gives hospitals deadline to comply with 340B claims data policy
    Eli Lilly is giving a group of hospitals five days to comply with its new claims data policy or risk losing their 340B discounts. Some health centers aren’t cooperating with Lilly's recent push to…
    Endpoints · 1mo ago↗ source
  • FDA details flexibilities for new cell and gene therapies to leverage past data
    The FDA is further explaining to cell and gene therapy developers the types of prior knowledge companies can leverage for clinical, nonclinical and manufacturing-related work, according to new CBER…
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Endpoints · 1mo ago
↗ source
  • Anti-aging biotech NewLimit raises $435M at $3B+ valuation
    The Bay Area startup NewLimit has closed one of biotech's largest private financings of 2026 and expects to start human testing next year for its first anti-aging drug candidate. NewLimit said Tues…
    Endpoints · 1mo ago↗ source
  • Eli Lilly issues data sharing ultimatum to 340B hospitals
    Select hospitals have refused to share data to prove they’re not double-dipping drug discounts, Lilly said. Hospitals, which have until Monday to comply, are urging the government to intervene.
    BioPharma Dive · 1mo ago↗ source
  • Fulcrum exploring a potential sale after FDA sidelined its sickle cell drug
    Fulcrum’s setback is the latest in a series of stumbles for the developers of sickle cell medicines, among them Pfizer, Novartis and Intellia Therapeutics.
    BioPharma Dive · 1mo ago↗ source
  • What’s next for VEGF? #ASCO26 offered clues, but answers will have to wait
    CHICAGO — Not long ago, there were hopes that a new class of cancer drugs would repeat the success of Keytruda. Instead, it seems more likely they could end up making up for its weaknesses. Many ...
    Endpoints · 1mo ago↗ source
  • Male contraception startup closes $92.5M Series B; Novartis bets on actinium
    💸 Funding male contraception: Contraline closed a $92.5 million Series B financing to support a Phase 3 study of a male contraceptive dubbed NES/T. The daily treatment is a gel rubbed on the shoul…
    Endpoints · 1mo ago↗ source
  • Travere pays Everest $112M upfront to grow rare kidney disease pipeline
    Travere Therapeutics is enlisting the help of China-based Everest Medicines to bolster its rare kidney disease pipeline beyond its approved medicine Filspari. The San Diego biotech is doling out $1…
    Endpoints · 1mo ago↗ source
  • Legend Biotech shares first in vivo CAR-T data, its next act after Carvykti
    Legend Biotech’s long-awaited first showing of in vivo CAR-T data is here, fueling momentum in the growing field. Legend reported results Tuesday on 12 lymphoma patients from an investigator-initia…
    Endpoints · 1mo ago↗ source
  • AbiVax falls as safety worries cloud ‘landmark’ immune drug results
    A handful of cancer cases reported among treatment recipients overshadowed efficacy results analysts described as “best-in-disease” and sent shares down more than 30%.
    BioPharma Dive · 1mo ago↗ source
  • #ASCO26: Celcuity plans another FDA filing after positive breast cancer readout
    Celcuity said a combination regimen with its experimental drug gedatolisib doubled patients' likelihood of survival without disease progression or death in a late-stage breast cancer trial. Executi…
    Endpoints · 1mo ago↗ source
  • Citing 'dangerous deals,' lawmakers propose China restrictions
    A bipartisan group of Michigan lawmakers released a new bill that could greatly stifle the booming cross-border deals spree between Chinese and American biotechs. Rep. John Moolenaar (R-MI) and Rep…
    Endpoints · 1mo ago↗ source
  • #ASCO26: Roche details narrow failure of breast cancer pill trial
    Back in March, Roche revealed that the breast cancer pill on which it had pinned billion-dollar sales expectations had failed in a pivotal Phase 3 trial. Data presented Tuesday at ASCO reveal ...
    Endpoints · 1mo ago↗ source
  • Fulcrum ends sickle cell ambitions following regulatory feedback, will seek exit
    Fulcrum Therapeutics is scrapping its sole clinical-stage medicine after feedback from the FDA that referenced a recently pulled cancer drug from Ipsen. Fulcrum had planned to enter a registrationa…
    Endpoints · 1mo ago↗ source
  • Cancer cases weigh down Abivax’s Phase 3 maintenance data in ulcerative colitis
    Abivax has proclaimed that its maintenance trial in ulcerative colitis delivered “landmark” results, and the drug's safety profile has previously been one of its main potential selling points. But…
    Endpoints · 1mo ago↗ source
  • Praxis sinks on late-stage study fail for seizure pill, halts second trial
    Praxis Precision Medicines has had a decent run over the past eight months or so, with two major clinical wins. But on Monday, the company disclosed a late-stage failure for its investigational sei…
    Endpoints · 1mo ago↗ source
  • ASCO ‘26: Bispecifics vs. ADCs, a ‘RAS’ revolution and a step change in prostate cancer
    At the year’s biggest cancer meeting, a high-stakes clash between two popular drug classes erupted, and scientists made headway against a once-insurmountable foe.
    BioPharma Dive · 1mo ago↗ source
  • Obesity care startup Ilant Health raises $15M
    Ilant Health has raised $15 million in a Series A funding round to expand its personalized approach to treating obesity. Ilant is one of many virtual care companies competing to help employers and…
    Endpoints · 1mo ago↗ source
  • Why US-manufactured pharmaceutical packaging equipment matters
    As manufacturers modernize operations, the origin of their equipment is a strategic consideration.
    BioPharma Dive · 1mo ago↗ source
  • Updated: Allen Institute launches $400M effort to turn brain atlas lessons into medicines
    A Seattle-based nonprofit known for basic brain research is launching a $400 million initiative to translate its knowledge into drug development for neurodegenerative diseases, including Alzheimer'…
    Endpoints · 1mo ago↗ source
  • RallyBio tries again for reverse merger, this time with Avenzo
    It's the second attempt for the rare disease company, which initially announced plans to merge with Candid Therapeutics before the immune drug developer was bought by UCB.
    BioPharma Dive · 1mo ago↗ source
  • The cost of a PRV is twice as high as it was three years ago — and it’s likely to stay that way
    How much is a regulatory shortcut worth? The cost of a priority review voucher, which shortens the FDA’s standard review time by about four months, has roughly doubled in the last few years. The FD…
    Endpoints · 1mo ago↗ source
  • Epigenetic editing shows promise against chronic hep B infections
    A new method of CRISPR-based gene editing shows promise in curtailing chronic hepatitis B infections. Its twist is to silence disease-causing genes without altering the underlying DNA. Tune Therape…
    Endpoints · 1mo ago↗ source
  • Shionogi wins US approval for first pill to prevent Covid following exposure
    Japan's Shionogi on Monday said it won FDA approval for its oral antiviral to prevent Covid‑19 in adults and children older than 12 years who have been in contact with someone ...
    Endpoints · 1mo ago↗ source