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  • STAT+: GSK lays out plans to cut costs, pursue more late-stage drug trials
    New GSK CEO Luke Miels outlined his strategy to help the company navigate a patent cliff and get on a path toward long-term growth.
    STAT · 26m ago↗ source
  • STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
    Regulators at the FDA have reiterated concerns that Replimmune does not have adequate data to support an approval of its investigational skin cancer treatment.
    STAT · 57m ago↗ source
  • STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more
    The FDA said a Capricor stem cell treatment for Duchenne muscular dystrophy did not meet a Phase 3 trial's objectives — contrary to company claims
    STAT
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· 1h ago
↗ source
  • STAT+: Three questions with Whoop’s new CMO
    In this edition of STAT Health Tech: A chat with Whoop's new chief medical officer, an update on CMS health tech initiative, and more.
    STAT · 1h ago↗ source
  • FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
    The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
    BioSpace · 1h ago↗ source
  • Altimmune rises as GLP-1/GIP drug curbs heavy drinking in mid-stage study
    Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics in this sp…
    BioSpace · 1h ago↗ source
  • An eye drug biotech banks $118M and stocks its executive suite
    <figure><div><img src="https://imgproxy.divecdn.com/cIH1PfJposjsKezbbrmwTwtzNlhqTiIaZ_OaEGGTHE8/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNjE5NzI0MTUxLmpwZ…
    BioPharma Dive · 2h ago↗ source
  • The FDA was all in on AI. Will that change?
    <figure><div><img src="https://imgproxy.divecdn.com/SbY7pjJU5zpd9fYni9dr5J14qHlA98Kk2ofoQajpOLE/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9UVFIyNUguanBn.webp"/></div></figur…
    BioPharma Dive · 2h ago↗ source
  • Anthony Fauci’s pandemic-era diary entries
    New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds
    STAT · 2h ago↗ source
  • Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch
    If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
    BioSpace · 3h ago↗ source
  • Oak Hill takes SPAC track to Nasdaq with Roche asset in tow
    Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
    BioSpace · 3h ago↗ source
  • STAT+: Preliminary trial results suggest a path to a safer Alzheimer’s treatment
    ProMIS Neurosciences is trying to design a safer amyloid-clearing drug for Alzheimer's. Early results suggest it might be on to something.
    STAT · 4h ago↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 6h ago↗ source
  • Opinion: STAT+: Dementia finally has a business model
    The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.
    STAT · 6h ago↗ source
  • STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD
    Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.
    STAT · 6h ago↗ source
  • STAT+: CMS evaluates one year of health tech progress, announces eight new pledge categories
    One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.
    STAT · 6h ago↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 10h ago↗ source
  • STAT+: HIV resurgence is feared as global funding to combat the disease falls 18%
    The world risks a resurgence of the HIV epidemic after international financing to combat the disease suffered a “profound shock” last year, according to a new report from UNAIDS.
    STAT · 17h ago↗ source
  • STAT+: Pharma’s drug spending deflection
    Job lock, surging prescription drug costs, No Surprises Act update, and more from STAT's Health Care Inc.
    STAT · 20h ago↗ source
  • MapLight dives despite positive data for schizophrenia drug
    <figure><div><img src="https://imgproxy.divecdn.com/hE3SUiWFPTXu78esitpkGlFwKNqX19ie92vbcO82d5g/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDQ5MjI0OTcwXzIua…
    BioPharma Dive · 22h ago↗ source
  • Argenx to acquire Forte in $2.2B deal for ‘differentiated’ immune drug
    <figure><div><img src="https://imgproxy.divecdn.com/nnTWCzHBd9_O2uNBVPF6xmxcO0M-nRFDpca5z-2Xchs/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDMwNzQzODA0LmpwZ…
    BioPharma Dive · 22h ago↗ source
  • UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy
    In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.
    BioSpace · 22h ago↗ source
  • MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout
    While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb's Cobenfy is likely to hold its market share.
    BioSpace · 23h ago↗ source
  • Gossamer regains rights to lung disease asset from Chiesi after Phase 3 fail
    Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.
    BioSpace · 23h ago↗ source
  • FDA scientists question Capricor data; Legend CEO steps down
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 23h ago↗ source