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336 stories matching this filter · ← front page

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  • GSK shares rise as $2.5B cost-cutting plan unveiled
    As GSK records $2.4 billion in impairment charges for the second quarter, the U.K. pharma has announced a sweeping restructure designed to save about the same amount of money over the next few years.
    BioSpace · 4h 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 · 6h 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, among oth…
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Hematology6
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Infectious Disease4
Ophthalmology3
Dermatology2
BioSpace · 6h 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 · 8h 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 · 8h ago↗ source
  • Incyte ditches phase 1-stage JAK inhibitor to pursue next-gen options
    Incyte has ditched a JAK2 inhibitor in phase 1 development for a rare blood cancer in favor of “next-generation” replacements.
    Fierce Biotech · 8h ago↗ source
  • Altimmune’s next-gen GLP-1 curbs heavy drinking in ‘unequivocal’ ph. 2 alcohol use disorder win
    An experimental drug targeting both GLP-1 and glucagon receptors has curbed heavy drinking in a phase 2 trial, providing hope that the ubiquitous weight loss meds can be effectively harnessed again…
    Fierce Biotech · 8h ago↗ source
  • GSK unveils 3-year cost-saving plan to fund late-stage R&D, move research HQ to AZ's backyard
    GSK has unveiled an ambitious three-year plan to divert resources to its late-stage R&D programs and shift its research headquarters—but CEO Luke Miels is being tight-lipped about the extent of…
    Fierce Biotech · 9h ago↗ source
  • Atea’s hepatitis C asset matches Gilead’s Epclusa in phase 3 trial
    Atea Pharmaceuticals’ hepatitis C prospect has matched Gilead’s Epclusa in a phase 3 trial, keeping the biotech barreling toward a second readout for its shorter, simpler treatment regimen.
    Fierce Biotech · 10h ago↗ source
  • Acrosian debuts as AI-focused biometrics CRO
    The founders of contract research organization Quartesian have reunited to form Acrosian, a CRO designed to be purpose-built for the AI era.
    Fierce Biotech · 10h ago↗ source
  • Guardant Health taps Patrick Dempsey for emotional colorectal cancer awareness video
    Colorectal cancer blood test maker Guardant Health has teamed up with “Grey’s Anatomy” star Patrick Dempsey for a new, highly emotional video.
    Fierce Biotech · 10h ago↗ source
  • GSK partner Hansoh reports another phase 3 win for priority ADC
    Hansoh Pharmaceutical has guided its GSK-partnered, B7-H3-directed antibody-drug conjugate to another phase 3 win in China.
    Fierce Biotech · 11h 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 · 14h ago↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 17h ago↗ source
  • ‘This could be a large market’: Novo Holdings-backed Claris secures $118M for corneal disease drug
    A new biotech has come into view with a $118 million series B and a vision for making the front of the eye front-of-mind.
    Fierce Biotech · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d ago↗ source
  • RA Capital launches rare disease company Oak Hill Bio onto Nasdaq via SPAC
    Rare disease biotech Oak Hill is headed to the Nasdaq through a SPAC merger with RA Capital-sponsored Research Alliance Corporation III (RACC) to fund a rare genetic disease candidate.
    Fierce Biotech · 1d 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 · 1d 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 · 1d 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 · 1d ago↗ source
  • Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears
    Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill.
    Fierce Biotech · 1d ago↗ source
  • MapLight shares sink on mixed phase 2 schizophrenia readout
    MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.
    Fierce Biotech · 1d ago↗ source