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Mass. Board of Pharmacy director fired for not investigating complaint about NECC
James D. Coffey, RPh, director of the Massachusetts Board of Registration in Pharmacy, has been removed from his position after allegedly failing to follow up on a complaint about the New England Compounding Pharmacy (NECC) from the Colorado Board of Pharmacy in July. In addition, Susan Manning, the Massachusett’s Board attorney has been placed on administrative leave, according to a statement from the Massachusetts Department of Public Health.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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