BioSpace News Archive

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• 

  89bio
• 

  PBMs

  Deep Dive: Biopharma in the 2024 Presidential Election

  On election day, Tuesday, November 5, Americans will choose between former President Donald Trump and current Vice President Kamala Harris for their next president. The election will also see the rearrangement of Congress.

  October 23, 2024

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  2 min read

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  Annalee Armstrong
• 

  Neuroscience

  Alto Depression Therapy Fails Mid-Stage Trial, 9 Months After IPO

  Alto Neuroscience’s depression treatment failed to beat placebo just nine months after the biotech went public. The stunning failure called to mind Acelyrin, which faced a similar fate last year.

  October 23, 2024

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  4 min read

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  Annalee Armstrong
• 

  Podcast

  Trodelvy’s Bladder Cancer Withdrawal, Sage Therapeutics Layoffs, Sanofi’s Radiopharma Investment, More

  Yet another therapy with FDA accelerated approval suffers a setback; Sage’s tough year continues; Sanofi drops $326 million in radiopharma while selling its consumer health unit; Novo Nordisk’s positive Rybelsus results in cardiovascular disease; and more.

  October 23, 2024

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  1 min read

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  Heather McKenzie
• 

  RSV

  Pfizer Wins FDA Approval of RSV Vaccine for Broader Adult Population

  Pfizer’s Abrysvo is the first respiratory syncytial virus vaccine that can be used for adults less than 50 years of age. Tuesday’s label expansion covers younger adults who are deemed at higher risk of RSV-related lower respiratory tract disease.

  October 23, 2024

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  2 min read

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  Tristan Manalac
• 

  Regulatory

  Novo Makes Case to FDA That Semaglutide Is Too Complex for Compounders to Produce

  Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.

  October 23, 2024

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  2 min read

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  Tristan Manalac
• 

  Regulatory

  Sangamo’s Fabry Gene Therapy Could Hit Market 3 Years Earlier With FDA Accelerated Approval Pathway

  The regulator agreed to allow Sangamo Therapeutics to use data to seek accelerated approval for its Fabry gene therapy candidate, eliminating the need for an additional registrational study and potentially shortening the time-to-market by three years.

  October 23, 2024

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  2 min read

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  Tristan Manalac
• 

  IN PARTNERSHIP WITH PATSNAP

  Webinar: Revolutionizing Biologics Discovery: Harnessing the Power of AI and Patent Data

  This webinar explores the pivotal role of patent data in overcoming the data challenges faced by generative AI models in drug discovery, particularly for biologics. Watch now.
  

  October 23, 2024

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  1 min read

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  BioSpace Insights
• 

  Earnings

  Roche Beats Q3 Sales Estimates as CEO Voices Opposition to Novo Holdings’ Catalent Buyout

  Jefferies analyst Peter Welford noted that Roche’s pharma group came just slightly ahead of consensus expectations, driven by strong performance of its multiple sclerosis therapy Ocrevus and eye injection Vabysmo.

  October 23, 2024

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  3 min read

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  Tristan Manalac
• News

  Circle Pharma’s First-in-Class Oral Macrocycle Cyclin A/B RxL Inhibitor, CID-078, Preclinical Data Highlighted at the 36th EORTC-NCI-AACR Symposium

  October 23, 2024

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  2 min read