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  • 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 · 8d agoRegulatoryPositive↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 8d agoApprovalNeutral↗ source
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  • U.S. bioscience jobs up 7% from 2021 to 2025: Report
    Bioscience employment rose in 41 states, though not in California, according to a new report from the Biotechnology Innovation Organization and the Council of State Bioscience Associations.
    BioSpace · 7d agoRegulatoryNeutral↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 8d agoRegulatoryNeutral↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 8d agoRegulatoryNeutral↗ source
  • Brad's Raw Chips recalls kale chips over potential thallium contamination
    Snack Right Super Foods, doing business as Brad's Raw Chips, announced a recall of certain Brad's Plant Based Crunchy Kale (2 oz) and Brad's Veggie Chips Kale (3 oz) products because they may conta…
    fda recalls · 7d agoCRLNegative↗ source
  • Regeneron posts $5.1 billion Q3 revenue, beating forecasts and highlighting strong sales of Dupixent, Eylea HD and Libtayo
    Regeneron reported third‑quarter revenue of $5.1 billion, well above the consensus range of $4.61‑$4.65 billion and representing a 36% increase from the same period last year. The company attribut…
    BioSpace · 10d agoEarningsPositive↗ source
  • AbbVie beats Q3 expectations, lifts full-year EPS outlook as immunology and neuroscience drive growth
    AbbVie reported third-quarter results that exceeded analysts' sales and earnings per share forecasts. The company posted $17.4 billion in revenue, driven largely by its immunology franchise which…
    BioSpace · 10d 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 · 11d agoEarningsNegative↗ source
  • Early-stage data show promise for targeting Wnt/β-catenin pathway across cancers
    Early-stage clinical results from the company and several peers indicate that the Wnt/β-catenin signaling pathway could become a viable target for treating a range of tumor types. The pathway has…
    BioSpace · 11d agoPositive readoutPositive↗ 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
  • Sanofi eyes late-stage and commercial acquisitions to counter upcoming Dupixent revenue drop
    Sanofi said on its third‑quarter earnings call that it is looking to acquire late‑stage and commercial medicines to sustain growth after Dupixent loses exclusivity. CEO Belén Garijo highlighted th…
    BioSpace · 10d agoDealPositive↗ source
  • Setara Biosciences raises $90 million Series A to advance Jazz-spun rare disease programs
    Setara Biosciences has been created to focus on a set of rare-disease assets that Jazz Pharmaceuticals retained after acquiring Actio Biosciences. The new company secured $90 million in Series A f…
    BioSpace · 11d agoDealPositive↗ source
  • FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides
    FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities. A U.S. senator introduced draft legislation…
    raps · 11d agoRegulatoryNeutral↗ source
  • Acumen scraps sole asset after Alzheimer’s fail, plunging stock 80%
    Acumen will implement cash-saving strategies and assess its options after sabirnetug failed to beat placebo, leaving the biotech without a clinical program.
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Vitality Works recalls 365 Whole Foods Ashwagandha capsules over possible Salmonella contamination
    Vitality Works Inc., based in Albuquerque, NM, announced a recall of one lot of its 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha capsules, 120-count, due to potential Salmo…
    fda recalls · 10d agoRegulatoryNegative↗ source
  • Once Upon a Farm recalls all Tractor Wheels toddler bars over choking risk
    Once Upon a Farm announced a recall of every lot and variety of its Tractor Wheels Organic Toddler Soft-Baked bars. The company said the snack can quickly turn into a dense, dry and sticky mass whe…
    fda recalls · 10d agoCRLNegative↗ 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
  • Eli Lilly lifts guidance by $10 billion as GLP‑1 sales outpace expectations
    Eli Lilly said its latest financial guidance is $10 billion higher than previously forecast, driven by strong sales of its GLP‑1 medicines. The company’s commercial performance has repeatedly excee…
    BioSpace · 11d agoEarningsPositive↗ source
  • Dren Bio raises $350 million to advance rare blood cancer antibody
    Dren Bio, a California biotech, announced a $350 million financing round to fund late‑stage development and commercial preparation of its lead therapy, a CD94‑targeting monoclonal antibody known as…
    BioSpace · 11d agoDealPositive↗ source
  • Biopharma manufacturing cuts slated to affect over 4,000 workers, with BioNTech leading layoffs
    Companies investing billions to reshore drug production are trimming staff at manufacturing sites, with ten biotech and pharma firms planning cuts that could affect more than 4,000 employees. BioN…
    BioSpace · 12d agoLayoffsNegative↗ source
  • Ono Pharma halts ONO-1110 development for depression and anxiety after five Phase 2 failures, continues pain studies
    Ono Pharma announced that its endocannabinoid modulator ONO-1110 failed to demonstrate efficacy in five Phase 2 trials, prompting the company to stop development for depression and social anxiety.…
    BioSpace · 12d agoNegative readoutNegative↗ source
  • Australia emerges as a hub for early-stage clinical trials thanks to speed, clear regulations and tax incentives
    A recent episode of BioSpace’s Denatured podcast featured Jerome Barley of Avion Medical and Ryan Klein of Resolian discussing Australia’s growing appeal for early-stage clinical development. The…
    BioSpace · 12d agoPositive↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 12d agoApprovalPositive↗ source
  • EMA and African regulator issue joint guidance to accelerate Ebola vaccine trials
    The European Medicines Agency and its African counterpart have released a joint position paper aimed at facilitating Ebola vaccine research. The guidance is intended to help launch clinical trials…
    raps · 12d agoRegulatoryPositive↗ source