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481 stories matching this filter · ← front page

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  • 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 · 4h 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 · 4h ago↗ source
  • 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.
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BioSpace · 4h 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 · 4h 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 · 4h 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 · 5h ago↗ source
  • Sarepta names former AbbVie R&D exec Michael Severino as next CEO
    After leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.
    BioSpace · 5h ago↗ source
  • Sarepta, in search of a turnaround, taps ex-AbbVie exec Severino as CEO
    <figure><div><img src="https://imgproxy.divecdn.com/WuH_AaE1tfJ0k6kCbc3Pl9229iGeCCh2cRL_fgDY5lg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TYXJlcHRhX1Bob3RvXzEuSlBH.webp"/><…
    BioPharma Dive · 6h ago↗ source
  • AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure
    AstraZeneca remains "very much on track" to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said durin…
    BioSpace · 7h ago↗ source
  • Otsuka’s ADHD approval opens up new drug class with $615M opportunity
    Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
    BioSpace · 7h ago↗ source
  • Argenx deepens immuno expertise with $2.2B Forte Biosciences buy
    The star of the takeover is Forte Biosciences' investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.
    BioSpace · 7h ago↗ source
  • [Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
    <p>This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.</p>
    BioPharma Dive · 8h ago↗ source
  • [Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus
    <p>This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.</p>
    BioPharma Dive · 8h ago↗ source
  • From confidence to capital: Positioning biotech for the next growth cycle
    <p>How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.</p>
    BioPharma Dive · 11h ago↗ source
  • Denmark’s foundation‑fueled biotech boom redraws the Nordic map
    Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
    BioSpace · 13h ago↗ source
  • Lilly, AbbVie climb aboard in vivo CAR T train—but safety remains a hurdle
    Safety will be the key determinant of in vivo CAR T therapies, according to H.C. Wainwright’s Mitchel Kapoor, who noted that convenience and efficacy won’t be enough to impress investors in this sp…
    BioSpace · 16h ago↗ source
  • Summit, Merck must navigate new regulatory terrain in China-first cancer landscape
    Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be requir…
    BioSpace · 16h ago↗ source
  • FDA has recommitted to adcomms—but to what end?
    The FDA will hold advisory committee meetings this week for previously rejected investigational therapies from Replimune and Capricor Therapeutics. Some industry leaders were surprised the meetings…
    BioSpace · 16h ago↗ source
  • Asia-Pacific Roundup: TGA adopts 23 international scientific guidelines
    <p>Australia’s Therapeutic Goods Administration (TGA) recently announced that it has adopted 23 international scientific guidelines from European Medicines Agency (EMA), the International Council f…
    raps · 20h ago↗ source
  • Amgen lays off around 40 employees
    Follow along as BioSpace tracks job cuts and restructuring initiatives.
    BioSpace · 20h ago↗ source
  • Sanofi halts development of troubled immune drug in eczema
    <figure><div><img src="https://imgproxy.divecdn.com/FBR1IQNmU9Hqatva496Zg2G8JMHsqV0UGsf4LMARqYo/g:nowe:189:144/c:1776:1003/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS80OTY5MDc4Mzc…
    BioPharma Dive · 3d ago↗ source
  • Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped
    Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.
    BioSpace · 3d ago↗ source
  • Scribe reels in nearly $129M in rare early-stage IPO for a gene editing biotech
    Jennifer Doudna–founded Scribe Therapeutics intends to use the proceeds from the public offering—the first for a gene editing outfit in over two years—to support development of its epigenetic silen…
    BioSpace · 3d ago↗ source
  • Amgen deploys patients to defend troubled Tavneos in FDA hearing request
    Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
    BioSpace · 3d ago↗ source
  • Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 3d ago↗ source