BioSpace News Archive

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  Drug Development

  Clene Reports Improved Long-Term Survival for ALS Patients Treated with Drug Candidate

  The company’s experimental drug for amyotrophic lateral sclerosis reduced the risk of death by 49% compared to the largest U.S. database of previous ALS therapy trials.

  September 26, 2023

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  2 min read

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  Connor Lynch
• 

  Business

  Takeda Puts Nearly $600M on the Line for AcuraStem’s ALS Program

  The Japanese multinational pharma is pledging up to $580 million in a development and commercialization deal with AcuraStem for the latter’s PIKFYVE program for amyotrophic lateral sclerosis.

  September 26, 2023

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  2 min read

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  Tristan Manalac
• 

  Rethinking Chemical Procurement in Biopharmaceuticals

  Disruptions in the chemical supply chain can have severe consequences for R&D and drug manufacturing. Here’s how to avoid them.

  September 26, 2023

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  5 min read

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  Dave Haase
• 

  FDA

  Appili Gets FDA Approval for Liquid, Oral Reformulation of Antibiotic Metronidazole

  The FDA on Monday approved the Canadian biopharma’s liquid antibiotic metronidazole, an alternative for patients who are unable to use pills or injections.

  September 26, 2023

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  2 min read

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  Matt Olszewski
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  Drug Development

  Immunovant Stock Soars on Positive Phase I Autoimmune Antibody Data

  Shares were up over 60% in premarket trading on news that the company’s anti-FcRn antibody exhibited dose-dependent reductions in IgG levels, drivers of inflammation in many autoimmune diseases.

  September 26, 2023

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  2 min read

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  Kate Goodwin
• 

  Deals

  Alfasigma Buys Beleaguered Intercept Pharmaceuticals in $800M Cash Deal

  The Italian pharma company is acquiring what was once one of the hottest stocks in the biotech sector, just months after the FDA rejected Intercept’s non-alcoholic steatohepatitis candidate.

  September 26, 2023

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  2 min read

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  Connor Lynch
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  Drug Development

  mRNA Vaccine Manufacturing Comes to Africa

  The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.

  September 26, 2023

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  3 min read

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  Clemence Manyukwe
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  Drug Development

  Novartis’ Lutathera Clears Phase III as Frontline Treatment for Rare Neuroendocrine Cancer

  The Swiss pharma is one step closer to bringing Lutathera into the front-line setting, with data from the Phase III NETTER-2 study showing that the radiotherapy met its primary endpoint.

  September 26, 2023

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  2 min read

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  Tristan Manalac
• 

  Drug Development

  Ionis Notches Phase III Win in Rare Genetic Disease, Plans to Submit NDA

  The company’s olezarsen cleared a late-stage study, eliciting a sharp reduction in triglyceride levels in patients with familial chylomicronemia syndrome. Ionis plans to submit a New Drug Application to the FDA.

  September 26, 2023

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  2 min read

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  Tristan Manalac
• The Pancreatic Cancer Action Network Selects Oncolytics Biotech® Inc. To Receive $5 Million Therapeutic Accelerator Award to Develop Leading-Edge Treatments

  In an effort to continue accelerating new treatment options for people with pancreatic cancer, the Pancreatic Cancer Action Network announced Oncolytics Biotech, Inc. as the recipient of its second annual PanCAN Therapeutic Accelerator Award.

  September 26, 2023

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  9 min read