Pfizer's injectable COX-2 inhibitor parecoxib is "not approvable" a second time, the firm says Sept. 20. Pfizer plans to meet with FDA "as soon as possible" to discuss the agency's concerns. The company added that "it disagrees with the conclusions" stated in the letter. Parecoxib, the pro-drug of Pfizer's Bextra (valdecoxib), was first deemed not approvable in July 2001 (1Pharmaceutical Approvals Monthly December 2001, p. 26). Parecoxib is marketed outside the U.S. as Dynastat. Another Pfizer drug, the osteoporosis treatment Oporia (lasofoxifene), also was deemed not approvable recently; the company announced receipt of the latter letter Sept. 13...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
