BioSpace News Archive

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  Drug Development

  Biogen Falls Back on Familiar Refrain as Tofersen Misses ALS Endpoint

  Biogen announced topline results from the Phase III VALOR trial of tofersen for superoxide dismutase 1 amyotrophic lateral sclerosis.

  October 18, 2021

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  3 min read

   · 

  Mark Terry
• 

  Policy

  Renewed Fears of mRNA Vaccine-Induced Heart Inflammation in Young Adults

  The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.

  October 18, 2021

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  2 min read

   · 

  Heather McKenzie
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  Drug Development

  Valneva Soars as COVID-19 Vaccine Bests AstraZeneca in Comparative Trial

  It proved itself superior to AZD1222 (ChAdOx1-S), the vaccine by Astrazeneca-Oxford, in terms of geometric mean titer for neutralization antibodies.

  October 18, 2021

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  2 min read

   · 

  Vanessa Doctor, RN
• 

  Drug Development

  FDA OKs Gilead’s Pediatric HIV Treatment and Boehringer’s Humira Biosimilar

  The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.

  October 18, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  Business

  Esperion to Cut 40% of Staff as Cholesterol Drugs Fail to Thrive

  Products getting regulatory approval and hitting the market doesn’t always spell success for companies, especially during a global pandemic. Michigan-based Esperion has learned that lesson all too well.

  October 18, 2021

   · 

  2 min read

   · 

  Ellen Camacho
• 

  FDA

  FDA Serves Omeros, MannKind-United and Revance with CRLs

  Omeros Corporation shares were down in premarket trading after the company received a CRL for its experimental hematopoietic stem cell transplant-associated thrombotic microangiopathy treatment.

  October 18, 2021

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  4 min read

   · 

  Alex Keown
• 

  Drug Development

  Vertex Shares “Unprecedented” Results in Early-Stage Type 1 Diabetes Trial

  Vertex Pharmaceuticals announced positive Day 90 data from the first patient in its Phase I/II study of VX-880 in type 1 diabetes.

  October 18, 2021

   · 

  4 min read

   · 

  Mark Terry
• 

  Drug Development

  FDA Approves Roche’s Tecentriq as First Adjuvant Treatment for NSCLC

  The FDA reviewed Tecentriq under Project Orbis, allowing the simultaneous submission and review of potential oncology treatments to international regulatory bodies.

  October 18, 2021

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Policy

  As COVID Surge Eases, Overall Viral Activity Up 23%

  Flu season is here and overall viral activity is up 23% across the United States, even as respiratory syncytial virus and COVID-19 infections continue to sweep across parts of the nation.

  October 18, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  Drug Development

  Atsena Unveils Gene Therapy for Retinal Eye Disease with Promising Profile

  While it has yet to reach clinical trials, preclinical results with the company’s specially-tailored adeno-associated virus have been fortuitously auspicious.

  October 18, 2021

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  2 min read

   · 

  Kaylei Whalen