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2,131 stories matching this filter · ← front page

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  • Lilly's oral GLP-1 Foundayo cuts sleep apnea severity in Phase 3, paving way for second FDA filing
    Lilly said it will submit its oral GLP-1 drug Foundayo for FDA approval in obstructive sleep apnea after a late‑stage trial showed strong efficacy. The Phase 3 ATTAIN-OSA study enrolled about 712…
    BioSpace · 4h agoPositive readoutPositive↗ source
  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 7h agoDealPositive↗ source
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Nephrology757
  • Novartis' Phase 3 HORIZON trial shows pelacarsen lowers Lp(a) but fails to cut cardiovascular events
    Novartis and Ionis reported that the Phase 3 HORIZON trial of the antisense drug pelacarsen did not improve major adverse cardiovascular events despite markedly lowering lipoprotein(a) levels. The…
    BioSpace · 7h agoNegative readoutNegative↗ source
  • Vir Biotechnology reports 44% undetectable hepatitis delta virus in Phase 3 trial, eyes mid-2027 filing
    Vir Biotechnology announced results from its Phase 3 Eclipse 1 trial of a monthly subcutaneous combination of siRNA therapy elebsiran and monoclonal antibody tobevibart for chronic hepatitis delta.…
    BioSpace · 5h agoPositive readoutPositive↗ source
  • Argenx to acquire Unnatural Products' macrocyclic peptide platform for $550 million upfront
    Argenx announced that it will acquire the California-based protein specialist Unnatural Products, paying $550 million upfront for its macrocyclic peptide platform. The deal could rise to more than…
    BioPharma Dive · 6h agoDealPositive↗ source
  • Delix Therapeutics raises $100M Series C to advance non-hallucinatory psychedelic for depression
    Delix Therapeutics announced a $100 million Series C financing round, led by Johnson & Johnson’s venture arm JJDC and joined by investors such as SV Health Investors’ Dementia Discovery Fund, RA Ca…
    Fierce Biotech · 13h agoDealPositive↗ source
  • Windward Bio targets $204M Nasdaq IPO to fund Chinese respiratory drug program
    Windward Bio, a biotech backed by Sanofi, announced plans to go public on Nasdaq with an offering of 10.3 million shares priced between $16 and $18 each. The company expects net proceeds of about $…
    Fierce Biotech · 14h agoDealNeutral↗ source
  • AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain
    AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…
    BioSpace · 18h agoDealNeutral↗ source
  • FDA launches Rare Disease Framework to embed patient input early in drug development
    FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
    BioSpace · 18h agoRegulatoryPositive↗ source
  • Argenx acquires Unnatural Products for up to $1.15 billion to boost oral peptide platform
    Argenx announced it will buy biotech Unnatural Products, paying $550 million upfront with the total deal value potentially reaching $1.15 billion through development and regulatory milestones. The…
    Fierce Biotech · 19h agoDealNeutral↗ source
  • FDA mandates label update for all GLP-1 drugs to warn of rare eye disease risk
    The FDA issued a class‑wide labeling requirement for all approved GLP‑1 receptor agonists, adding a warning about non‑arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that…
    BioSpace · 4h agoRegulatoryNeutral↗ source
  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 7h agoRegulatoryNeutral↗ source
  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 7h agoPositive readoutNeutral↗ source
  • Merck's efinopegdutide shows strong MASH resolution in phase 2b trial
    Merck & Co. reported results from a phase 2b trial (MK-6024-013) evaluating efinopegdutide, a GLP-1 and glucagon receptor co-agonist, in patients with metabolic dysfunction-associated steatohepatit…
    Fierce Biotech · 7h agoPositive readoutPositive↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 8h agoNegative readoutNeutral↗ source
  • Phase II success does not guarantee easy Phase III launch, says Thermo Fisher
    Positive Phase II data often signals the start of Phase III planning, but the transition involves far more than simply adding patients and sites. When a trial expands into new countries, differenc…
    BioPharma Dive · 13h agoNeutral↗ source
  • State incentives can shape site decisions for commercial-stage life sciences firms
    The article advises commercial-stage life-science companies to consider state and local incentives early in expansion planning to improve site selection and preserve capital. Incentives most relev…
    BioPharma Dive · 13h agoNeutral↗ source
  • Zura Bio halts hidradenitis suppurativa program after tibulizumab fails phase 2 trial
    Zura Bio announced it is ending development of tibulizumab for hidradenitis suppurativa after the drug did not meet the primary endpoint in a phase 2 study. The trial, called Tibushield, compared t…
    Fierce Biotech · 13h agoNegative readoutNegative↗ source
  • Vir Biotechnology's Phase 3 Trial Shows Primary Endpoint Success in Chronic Hepatitis Delta
    Vir Biotechnology reported that its phase 3 Eclipse 1 trial in chronic hepatitis delta met the primary endpoint. At week 48, 44% of patients who began treatment immediately showed undetectable HDV…
    Fierce Biotech · 18h agoPositive readoutPositive↗ source
  • Valneva's Shigella vaccine cuts infection rates in phase 2 trial
    Valneva reported that its Shigella vaccine reduced the number of intestinal infections in a phase 2 controlled human infection model study conducted in the United States. The trial enrolled 120 he…
    Fierce Biotech · 18h agoPositive readoutPositive↗ source
  • Phase 3 trial shows Zealand-Boehringer obesity drug survodutide does not raise cardiovascular death risk
    The Phase 3 SYNCHRONIZE-CVOT study found that survodutide, the joint obesity therapy from Zealand and Boehringer Ingelheim, was non‑inferior to placebo for cardiovascular death, indicating no added…
    BioSpace · 4h agoPositive readoutNeutral↗ source
  • Kyorin signs $140M deal for Japan rights to Edesa's ARDS antibody
    Kyorin Pharmaceutical will pay $12 million up front and up to $134 million in milestones, plus royalties, for exclusive Japan rights to Edesa Biotech’s anti‑TLR4 antibody, paridiprubart, intended f…
    Fierce Biotech · 15h agoDealPositive↗ source
  • Gene therapy sponsors urged to address six GMP manufacturing considerations early
    SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
    BioSpace · 18h agoNeutral↗ source
  • Early technical expertise key to tackling complex life-science construction projects
    Life‑science construction projects often present problems that lack obvious solutions, such as retrofitting existing buildings, using unconventional materials, or fitting large process equipment in…
    BioPharma Dive · 13h agoPositive↗ source
  • Biotech controversies cloud Vivek Ramaswamy’s Ohio governor campaign
    Vivek Ramaswamy, a former biotech entrepreneur, was defeated in Ohio’s governor race, a loss that coincided with heightened scrutiny of his industry background. Six biotech leaders publicly asked…
    BioPharma Dive · 7h agoNegative↗ source