BioSpace News Archive

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  BioCapital

  Study Indicates Sudden Hearing Loss Not Caused by COVID-19 Vaccines

  Researchers at John Hopkins made their preliminary conclusions that the vaccines produced by Pfizer-BioNTech and Moderna did not cause the hearing loss.

  May 21, 2021

   · 

  3 min read

   · 

  Mark Terry
• 

  FDA

  China’s CARsgen to Open CAR-T Manufacturing Facility in North Carolina

  CARsgen is building a new $157 million CAR-T manufacturing facility in Durham, that is expected to create approximately 200 new jobs.

  May 21, 2021

   · 

  2 min read

   · 

  Alex Keown
• 

  Drug Development

  FDA Accepts NDA for Takeda’s Maribavir

  If approved, Takeda said Maribavir would become the first and only treatment indicated for CMV infection in refractory patients.

  May 21, 2021

   · 

  3 min read

   · 

  Alex Keown
• 

  Drug Development

  Clinical Catch-Up: May 17-21

  It was another busy week for clinical trial announcement. Here’s a look.

  May 21, 2021

   · 

  4 min read

   · 

  Mark Terry
• 

  aptaTargets’ First-in-Human Data Shows Efficacy of Aptamers in Stroke

  Madrid-based aptaTargets S.L. announced data from its first-in-human trial using its ApTOLL aptamer to protect patients against the deleterious effects of acute ischemic stroke.

  May 21, 2021

   · 

  4 min read

   · 

  Gail Dutton
• 

  FDA

  FDA Action Alert: BMS, Eton, Provention and Lantheus

  It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.

  May 21, 2021

   · 

  4 min read

   · 

  Mark Terry
• 

  Business

  Tiny Beating Hearts Developed by Stem Cells Could Provide Insight Into Congenital Defects

  The tiny heart organoids, dubbed “cardioids,” even begun beating similarly as real miniature hearts, making them the most realistic heart organoids developed to date.

  May 21, 2021

   · 

  3 min read

   · 

  Brandon May
• 

  Business

  Cancer Biotech Janux Therapeutics Files for $100 Million IPO

  Janux plans to use the funds raised from the IPO to submit four Investigational New Drug applications to the U.S. FDA in the first half of 2022.

  May 21, 2021

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  Biogen and Ginkgo Bioworks Partner to Redefine AAV-Based Vector Manufacturing

  Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.

  May 21, 2021

   · 

  3 min read

   · 

  Mark Terry
• 

  FDA

  Iovance CEO Resigns Following Regulatory Delay for Melanoma Treatment Lifileucel

  Maria Fardis, who has been with the company since 2016, stepped down as CEO following FDA’s delay on its Biologics License Application.

  May 21, 2021

   · 

  2 min read

   · 

  Alex Keown