BioSpace News Archive

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  Business

  ReCode Enlists New CEO to Drive Assets into the Clinic

  Suliman anticipates filing an Investigational New Drug application with the FDA for the PCD asset this year, and next year filing one for the cystic fibrosis asset.

  January 24, 2022

   · 

  5 min read

   · 

  Alex Keown
• 

  Drug Development

  Merck Remains Committed to Chronic Cough Drug Following FDA Rejection

  The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.

  January 24, 2022

   · 

  2 min read

   · 

  Mark Terry
• 

  Drug Development

  Oncopeptides Withdraws Withdrawal of First Marketed Drug Pepaxto

  Oncopeptides has discontinued the marketing of Pepaxto drug in the US. But, in a recent turnaround, they decided to withdraw this decision of stopping the production.

  January 24, 2022

   · 

  2 min read

   · 

  Jill Gartz
• 

  Drug Development

  MaaT Pharma on Accelerated Development Plan as Proof of Engraftment Attained

  MaaT Pharma decided today to end the Phase Ib CIMON study for MaaT03, the company’s second drug candidate and first oral formulation in Phase 1b clinical trial, following positive interim engraftment data of the drug.

  January 24, 2022

   · 

  2 min read

   · 

  Alvin Clavines
• 

  Learn Dealing With A Micromanager At Work

  Dealing with a micromanager boss or coworker can be challenging. Read the full article on Biospace to find out how to deal with a micromanager at work.

  January 24, 2022

   · 

  6 min read

   · 

  Alina Zahid
• 

  Drug Development

  AbbVie’s SKYRIZI Offers New Option for Psoriatic Arthritis Sufferers

  The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).

  January 24, 2022

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Drug Development

  Pfizer and OPKO’s Growth Hormone Deficiency Drug Denied by FDA

  FDA rejected OPKO’s once-weekly human growth hormone, somatrogon, which it co-developed with Pfizer for the treatment of growth hormone deficiency (GHD) in pediatric patients.

  January 24, 2022

   · 

  2 min read

   · 

  Alex Keown
• 

  Drug Development

  Six Companies Hit the Clinic with Innovative Therapeutic Candidates

  TScan Therapeutics, Lyell, SQZ Biotech and others secured clearance from the U.S. Food and Drug Administration for their Investigational New Drug Application.

  January 24, 2022

   · 

  4 min read

   · 

  Alex Keown
• 

  Drug Development

  Algernon Adds Sub-Psychedelic Stroke Rehabilitation Drug to IP Roster

  The company submitted its application for AP-188 in early 2021, covering dosage details, formulation, and method of stroke rehabilitation.

  January 24, 2022

   · 

  2 min read

   · 

  Vanessa Doctor, RN
• 

  Pharm Country

  Clinical Catch-Up: January 17-21

  Last week was a relatively quiet week for clinical trial news, particularly around COVID-19. Here’s a look.

  January 24, 2022

   · 

  4 min read

   · 

  Mark Terry