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172 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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  • 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
  • Boehringer Ingelheim to seek approval for obesity injection survodutide after trial shows no added cardiovascular risk
    Boehringer Ingelheim announced it will file for regulatory approval of its investigational GLP-1 based obesity injection, survodutide, in the coming year. The move follows a phase 3 trial that dem…
    Endpoints · 6h agoApprovalNeutral↗ 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 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
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 8h agoLayoffsNegative↗ source
  • Novo and Novartis see heart drug setbacks as trials show minimal efficacy
    Novo's cardiovascular candidate failed to demonstrate meaningful benefit in its pivotal study, causing the company's shares to fall about 9% in July. The trial data showed the drug had little effe…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • Amgen's Repatha shows reduced heart attack risk while Satellos alters Duchenne trial endpoint
    Satellos Bioscience announced a change to the primary endpoint of its ongoing Duchenne muscular dystrophy trial of the investigational small‑molecule forazapadin, shifting focus to a measure of mus…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • AstraZeneca reportedly bids $10 billion for metabolic biotech Rhythm Pharmaceuticals
    AstraZeneca is said to have made a $10 billion offer to acquire Rhythm Pharmaceuticals, a biotech that develops treatments for rare neuroendocrine disorders. The proposal values Rhythm at $124 per…
    BioSpace · 4d agoDealPositive↗ source
  • Madrigal’s 2024 MASH drug sparks new wave of diagnosis and personalized treatment approaches
    The article argues that the field of metabolic dysfunction‑associated steatohepatitis (MASH) is entering a period of rapid innovation, and that the industry must broaden efforts in diagnosis, monit…
    BioSpace · 4d agoPositive↗ source
  • Novo claims 80% share of oral GLP-1 market as rivalry with Lilly intensifies
    Novo's CEO Mike Maziar Doustdar said the company leads the oral GLP-1 market, stating the Wegovy pill holds about 80% of prescriptions since its launch in January. Eli Lilly, however, reported tha…
    BioSpace · 5d agoEarningsNeutral↗ source
  • Amgen launches autoinjector study for GLP-1 candidate MariTide as Phase 3 readouts loom
    Amgen has begun a study of an autoinjector formulation of its GLP-1 drug candidate MariTide, as the company prepares for pivotal Phase 3 data expected next year. The candidate is marketed as havin…
    BioSpace · 5d agoNeutral↗ source
  • Neurocrine launches new safety study after another death linked to Prader-Willi drug Vykat
    Neurocrine Biosciences announced it will start a new study to evaluate dosing and safety of its rare disease drug Vykat in patients with Prader-Willi syndrome who have complex health issues. The m…
    BioSpace · 6d agoRegulatoryNegative↗ source
  • BridgeBio eyes first FDA approval for limb-girdle muscular dystrophy therapy
    BridgeBio Pharma is preparing for a potential launch of its experimental drug BBP-418 aimed at treating limb-girdle muscular dystrophy type 2I/R9, pending FDA decision. The agency has set a review…
    BioSpace · 7d agoRegulatoryPositive↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 7d agoDealNeutral↗ source
  • Alnylam shares tumble 25% as analysts flag uncertainties in its transthyretin franchise
    Alnylam Therapeutics saw its stock fall about a quarter on Thursday, closing near $174 after analysts highlighted a trio of uncertainties surrounding its transthyretin (TTR) franchise. The TTR fra…
    BioSpace · 10d agoEarningsNegative↗ source
  • AstraZeneca launches $1.5 billion cost-saving plan to fund growth, says no layoffs expected
    AstraZeneca announced a three-year cost‑saving initiative worth $1.5 billion during its third‑quarter earnings call. The program, called Reshaping for Sustainable Growth, aims to redeploy resource…
    BioSpace · 10d agoEarningsPositive↗ source
  • Merck projects continued investment and growth as Keytruda patent expires
    Merck reported third‑quarter results on an investor call, saying sales expectations were above forecasts thanks to strong performance of subcutaneous Keytruda and the pulmonary arterial hypertensio…
    BioSpace · 11d agoEarningsPositive↗ source
  • BMS shelves Prothena-partnered neuro drug after Phase 1 review, but raises full-year revenue outlook on 7% Q3 sales growth
    Bristol Myers Squibb announced it will not move forward with the neurodegeneration candidate BMS-986495 (PRX019), a monoclonal antibody licensed from Prothena. The decision follows a review of Phas…
    BioSpace · 11d agoNeutral↗ source
  • Big pharma holds $188 bn for M&A, J&J seen as most likely buyer, analysis shows
    The latest Leerink Partners analysis finds that the largest pharmaceutical companies collectively have about $188 billion in cash available for mergers and acquisitions. All but one of the firms su…
    BioSpace · 12d agoDealPositive↗ source
  • AstraZeneca’s heart drug Wainua fails late-stage trial, raising 2027 outlook concerns
    AstraZeneca announced that its experimental heart disease therapy, Wainua, did not meet primary endpoints in a Phase III trial conducted in July. The failure is a setback for the company, whose pi…
    Endpoints · 12d agoNegative readoutNegative↗ source
  • Lilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
    Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expect…
    BioSpace · 12d ago↗ source
  • Novartis takes $1.9B write-down after Avidity's del-desiran fails Phase 3 but reaffirms confidence in $12B acquisition
    Novartis announced a $1.9 billion partial impairment after the Phase 3 HARBOR study of del-desiran, an antibody‑oligonucleotide conjugate from its Avidity Biosciences acquisition, did not meet its…
    BioSpace · 13d agoNegative readoutNeutral↗ source
  • Australian clinical trials attract more U.S. sponsors amid regulatory uncertainty
    CROs are reporting faster startup timelines, predictable regulation, and tax incentives as reasons for increasing interest in conducting clinical trials in Australia. State-level incentives in Que…
    BioSpace · 14d agoNeutral↗ source