BioSpace News Archive

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• 

  Drug Development

  BMS’s Busy Week: a Milestone Approval, Reblozyl Delay and Action in Japan

  The FDA delayed Bristol Myers Squibb’s (BMS) target date for Reblozyl, approved the company’s melanoma drug and Japan accepted BMS’ NDA for Breyanzi.

  March 25, 2022

   · 

  3 min read

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  Mark Terry
• 

  A Bone-afied Discovery: Researchers Develop Universal Skeleton Key for Druggable Targets

  Many drugs work by matching up to a pocket or molecular receptor on a protein, like a key into a lock. Dr. David Baker may have found a kind of “skeleton key” to unlock these proteins.

  March 25, 2022

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  Icosavax Shares Crater as COVID-19 Vaccine Disappoints

  Seattle-based Icosavax’s stock plunged 50% after the company reported topline interim data from its ongoing Phase I/II COVID-19 vaccine trial.

  March 25, 2022

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  FDA Action Alert: A Very Busy Week for Drug Application Decisions

  The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.

  March 25, 2022

   · 

  4 min read

   · 

  Mark Terry
• 

  Drug Development

  DMT-Assisted Therapy May Address Root Cause of Major Depressive Disorder

  Small Pharma Inc. is developing a new approach to treat major depressive disorder (MDD) without using SSRIs or standard medications. Here’s what they are using.

  March 25, 2022

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  5 min read

   · 

  Gail Dutton
• 

  Business

  Nobel Laureate Helms New Immunotherapy Research Institute at MD Anderson

  James P. Allison will helm an innovation hub at The University of Texas MD Anderson Cancer Center that is focused on developing new immunotherapy breakthroughs in oncology.

  March 25, 2022

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  3 min read

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  Alex Keown
• 

  Pharm Country

  More Good News in HIV Space as FDA Greenlights Cabenuva Optional Oral Lead-In

  Janssen Pharmaceutical’s treatment for people living with human immunodeficiency virus (HIV-1) has received a label update to now include injectable administration.

  March 25, 2022

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  2 min read

   · 

  Vanessa Doctor, RN
• 

  Pharm Country

  Merck to Close Cherokee API Manufacturing Plant, Cut 300 Jobs

  Pharmaceutical giant Merck & Co. has announced the company will shutter the doors of its Cherokee Plant, located in Riverside, Penn.

  March 25, 2022

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  2 min read

   · 

  Jazmine Colatriano, M.S.
• 

  Drug Development

  FDA Concerns Over P13K Inhibitors Snag MEI Pharma, Kyowa Kirin

  The FDA recommends a randomized trial to adequately assess drug efficacy and safety of P13K inhibitor drug candidates.

  March 25, 2022

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  2 min read

   · 

  Alex Keown
• 

  Drug Development

  Clinical Catch-Up: Moderna COVID-19 Vaccine for Kids and Much More

  Although it was relatively quiet in COVID-19-related clinical trials, there was plenty of other clinical trial news. Here’s a look.

  March 25, 2022

   · 

  10 min read

   · 

  Mark Terry