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239 stories matching this filter · ← front page

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  • 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 · 1d 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 · 2d agoPositive readoutPositive↗ source
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  • 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 · 2d agoLayoffsNegative↗ 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 · 3d 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
  • Alethio Therapeutics secures $90 million to develop treatments for rare blood cancers
    Alethio Therapeutics, a UK based biotechnology startup, announced it has raised $90 million in new financing. The capital will be used to advance its pipeline targeting myeloproliferative neoplasm…
    BioPharma Dive · 4d agoDealPositive↗ source
  • Novo Nordisk lifts 2026 profit outlook after Wegovy obesity pill beats forecasts
    Novo Nordisk announced on Wednesday that it is raising its full-year profit and sales guidance after the third-quarter results for its Wegovy obesity pill came in above analysts' expectations. The…
    BioPharma Dive · 4d agoEarningsPositive↗ 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 · 4d 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 · 4d 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 · 5d agoRegulatoryNegative↗ source
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 5d agoRegulatoryNeutral↗ source
  • AstraZeneca outlines restructuring as earnings show cost cuts, while Alnylam slides and Regeneron posts record quarter
    AstraZeneca said it will redeploy resources through a new restructuring program aimed at cutting costs while staying on track to hit its long‑term revenue goal of $80 billion by 2030. The company h…
    BioPharma Dive · 6d agoEarningsNeutral↗ 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 · 6d agoDealNeutral↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 9d agoEarningsPositive↗ 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 · 9d 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 · 9d 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 · 10d 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 · 10d 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 · 11d 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 · 11d 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 · 12d 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
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 16d ago↗ source