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

   · 

  3 min read

   · 

  Mark Terry
• 

  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

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  BioCapital

  Overcoming Myths that Slow Investment in Biotech and Pandemic Companies

  Peter Adams and Dave Harris at Rockies Venture Club (the oldest angel investment group in the U.S.) explored those myths and offered strategies to counter them.

  October 18, 2021

   · 

  5 min read

   · 

  Gail Dutton
• 

  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
• 

  Drug Development

  Phathom Ready to Run Third NDA for Acid-Blocking Drug Vonoprazan

  Phathom announced positive results from its Phase III trial, PHALCON-EE, comparing vonoprazan against lansoprazole in patients with moderate to severe erosive esophagitis.

  October 18, 2021

   · 

  2 min read

   · 

  Kate Goodwin
• 

  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

   · 

  2 min read

   · 

  Heather McKenzie
• 

  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
• 

  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

   · 

  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
• 

  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