BioSpace News Archive

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  Drug Development

  4D’s Fabry Gene Therapy on Ice After FDA-Mandated Pause

  The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.

  February 6, 2023

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  2 min read

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  Tristan Manalac
• 

  Business

  Astellas Taps New CEO in Nod to Accelerated Growth

  Astellas named a new president and CEO and announced additional changes to its leadership structure in an effort to accelerate growth and chart its long-term business trajectory.

  February 6, 2023

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  2 min read

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  Tristan Manalac
• 

  Confidentiality Agreements and Severance Pay: a Comprehensive Guide

  If you’ve recently lost your job, BioSpace has provided a guide to confidentiality agreements and severance packages so you can feel confident making your next career move.

  February 6, 2023

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  3 min read

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  Christie Adams
• 

  Drug Development

  Biogen’s $1.5B Bet for Depressive Disorders Heads to FDA (Updated)

  Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.

  February 6, 2023

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  2 min read

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  Kate Goodwin
• 

  Drug Development

  Janssen Posts Positive HDFN Data Amid Reports of Global Overhaul

  Janssen reported positive topline data from a Phase II proof of concept study assessing nipocalimab in severe hemolytic disease of the fetus and newborn.

  February 6, 2023

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  2 min read

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  Heather McKenzie
• 

  Drug Development

  GEN2 NASH Therapies Near the Finish Line

  Industry leaders say the second generation of interventions for nonalcoholic steatohepatitis is likely to succeed where first-generation approaches stumbled.

  February 6, 2023

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  4 min read

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  Gail Dutton
• Drug Development

  Daewoong Pharmaceutical begins the first administration of the Bersiporocin, new treatment for idiopathic pulmonary fibrosis, as Phase II clinical trial

  The world’s first-in-class candidate substance against idiopathic pulmonary fibrosis, ‘Bersiposocin’, which is under development Daewoong Pharmaceutical, has entered its Phase II clinical administration.

  February 6, 2023

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  3 min read
• Drug Development

  Ground-breaking results in Phase 2 scleroderma study by Certa Therapeutics demonstrates improvement in more than 60% of patients

  Certa Therapeutics announces ground-breaking clinical trial data for FT011, its novel therapy for the treatment of serious inflammatory and fibrotic diseases.

  February 6, 2023

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  9 min read
• Alvotech Enters Into Commercialization Agreement With Advanz Pharma for Proposed Biosimilar to Xolair® (Omalizumab)

  Alvotech announced that it has entered into an exclusive agreement with Advanz Pharma, for the commercialization of AVT23, a proposed biosimilar to Xolair®.

  February 6, 2023

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  7 min read
• Business

  Bioweg and Ginkgo Bioworks Announce Partnership to Develop Cost Effective and Efficacious Bio-Based Materials to Reduce the Use of Microplastic Pollutants

  Bioweg and Ginkgo Bioworks announced a collaboration to optimize the production of bacterial cellulose and to produce novel variants of cellulose with improved performance to serve a variety of end markets.

  February 6, 2023

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  6 min read