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Mallinckrodt Announces U.S. FDA Approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen


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DUBLIN, June 15, 2021 /PRNewswire/  Mallinckrodt plc (OTCMKTS: MNKKQ), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved StrataGraft
® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). Please see Important Safety Information for StrataGraft below.
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This project was funded in part with $86 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), under contract HHSO100201500027 for Stratatech Corporation, a Mallinckrodt company, to develop Str ....

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Investegate |MeiraGTx Announcements | MeiraGTx: MeiraGTx Reports First Quarter 2021 Financial and Operational Results


MeiraGTx Reports First Quarter 2021 Financial and Operational Results
LONDON and NEW YORK, May 11, 2021 (GLOBE NEWSWIRE) MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2021 and provided an update on recent progress.
“During the first quarter of 2021, we continued to advance our clinical and preclinical programs, as well as our proprietary cGMP manufacturing process. We are progressing rapidly with our riboswitch gene regulation technology platform and we are excited to share
in-vivo data later this year,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “This will be an important year for MeiraGTx as the Company prepares for the initiation of two Phase 3 pivotal trials in X-linked retinitis pigmentosa and ....

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MeiraGTx Reports First Quarter 2021 Financial and Operational Results


MeiraGTx Reports First Quarter 2021 Financial and Operational Results
LONDON and NEW YORK, May 11, 2021 (GLOBE NEWSWIRE) MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2021 and provided an update on recent progress.
During the first quarter of 2021, we continued to advance our clinical and preclinical programs, as well as our proprietary cGMP manufacturing process. We are progressing rapidly with our riboswitch gene regulation technology platform and we are excited to share
in-vivo data later this year, said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. This will be an important year for MeiraGTx as the Company prepares for the initiation of two Phase 3 pivotal trials in X-linked retinitis pigmentosa and ....

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