Friday, December 6, 2019 Daily Archives

Merck plans $57m NC investment to support rotavirus vaccine

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The investment at the facility in Wilson, North Carolina comes on the back of several expansion across Merck & Co’s vaccine manufacturing network. Merck (known as MSD outside of North America) announced just five months ago plans to invest $680 million (€613 million) to ramp up its vaccine production capabilities in North Carolina to support human papillomavirus (HPV) vaccines Gardasil and Gardasil 9. The expansion plans included a $30 million investment to add packaging lines and warehouse space at Merck’s…

December 6, 2019

Enzyvant hit with CRL due to regenerative therapy manufacturing concerns

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The US FDA has cited manufacturing concerns in a complete response letter (CRL) rejecting Enzyvant’s regenerative tissue therapy RVT-802. RVT-802 is a tissue-based therapy in development for congenital athymia. While the candidate has been granted Breakthrough Therapy designation, Rare Pediatric Disease designation, Orphan Drug designation, and Regenerative Medicine Advanced Therapy (RMAT), the US Food and Drug Administration (FDA) has rejected the therapy due to manufacturing concerns. Roivance Sciences subsidiary Enzyvant received the CRL this week and while there were no…

December 6, 2019