BioSpace News Archive

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  Drug Development

  Eliem in Hot Water Following Disappointing Trial Data

  Eliem Therapeutics could be in trouble following the announcement that its drug candidate ETX-810, intended to treat diabetic peripheral neuropathic pain, did not meet its primary endpoint.

  April 25, 2022

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  3 min read

   · 

  Hayley Shasteen
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  Drug Development

  Ocugen Sees Ray of Light with Gene Therapy for Retinitis Pigmentosa

  The DSMB for Ocugen’s Phase I/II trial of OCU400, a gene therapy in development for Retinitis Pigmentosa (RP), recommended the study proceed with enrolling more patients.

  April 25, 2022

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  3 min read

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  Mark Terry
• 

  Drug Development

  Gilead’s Veklury Becomes First FDA-Approved COVID-19 Treatment for Young Children

  The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.

  April 25, 2022

   · 

  3 min read

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  Mark Terry
• 

  Drug Development

  LAG-3 Pioneer Discusses BMS Milestone and Potential of the New Checkpoint

  Triebel holds the distinction of having discovered LAG-3 in 1990. Today, the company he founded is leveraging the handy molecule against cancer and autoimmune disease.

  April 25, 2022

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  6 min read

   · 

  Heather McKenzie
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  Drug Development

  CMC Issues Could Spell Setback for Axsome as Shares Plunge

  Shares of Axsome Therapeutics have fallen more than 20% in trading this morning after the company announced the FDA is unlikely to approve its acute migraine treatment AXS-07 due to unresolved quality control issues.

  April 25, 2022

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  2 min read

   · 

  Alex Keown
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  Drug Development

  AstraZeneca Moves Toward Approval of CTLA-4 Antibody Combo for HCC

  Final analysis of the Himalaya trial demonstrated safety as well as a statistically relevant 22% improvement of overall survival (OS) without exposing the patient to an increase in liver toxicity.

  April 25, 2022

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  2 min read

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  Jazmine Colatriano M.S.
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  UK Researchers Uncover 58 New Mutational Signatures of Cancer

  Scientists from the U.K. may have identified several more environmental causes for cancer after evaluating genetic data of over 12,000 cancer patients from the NHS files.

  April 25, 2022

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  2 min read

   · 

  Vanessa Doctor, RN
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  Drug Development

  Ardelyx Continues Battle to Secure Approval for Chronic Kidney Disease Drug Tenapanor

  Ardelyx announced the FDA’s OND, CDER, provided an interim response to the company’s second level of appeal for tenapanor. Here’s what you need to know.

  April 25, 2022

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  3 min read

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  Mark Terry
• 

  Policy

  How to Navigate Family Medical Leave in the Workplace

  One of the most common types of leave is family leave, and navigating it can be a long, arduous process. To help, we’ve created a guide to answer your questions about family medical leave.

  April 25, 2022

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  3 min read

   · 

  Rosemary Scott
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  Policy

  Mysterious Illness Related to Liver Claims Life of Pediatric Patient

  WHO is raising flags against the concerns surrounding a mysterious illness (related to pediatric liver disease) that is increasing following a reported death.

  April 25, 2022

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  2 min read

   · 

  Alex Keown