Mallinckrodt Reports Completion of BLA Submission to the US FDA for StrataGraft to Treat Deep Partial-Thickness Thermal Burns in Adults

 Mallinckrodt Reports Completion of BLA Submission to the US FDA for StrataGraft to Treat Deep Partial-Thickness Thermal Burns in Adults

Mallinckrodt Signs an Agreement with Silence Therapeutics to Develop and Commercialize RNAi Therapeutics for Complement-Mediated Diseases

Shots:

  • In Apr 2020, Mallinckrodt’s Stratatech initiated StrataGraft’s BLA submission process which is a regenerative skin tissue therapy to develop therapies for deep partial-thickness thermal burns in adults
  • The BLA submission is based on P-III STRATA2016 clinical trial published in Journal of Burn Care & Research and is supported by STRATA2011 clinical trial (Published in Burns) further for presentation at the American Burn Association 52nd Annual Meeting
  • StrataGraft regenerative skin tissue therapy is targeted for the reduction of autograft in patients with severe thermal burns and is cryopreserved for delivering viable cells upon application. The therapy has also received the US FDA’s ODD and was a novel product designated as Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act

Click here to read full press release/ article | Ref: PRNewswire | Image: Behance

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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