Lilly may be able to offer an alternative fibromyalgia treatment to Pfizer's Lyrica (pregabalin) by June 2008 if its sNDA for Cymbalta (duloxetine) is approved within a standard 10-month review. The filing was announced by the company Aug. 21. Cymbalta is approved for treatment of major depressive disorder, management of diabetic peripheral neuropathic pain and treatment of generalized anxiety disorder in adults. Separately, Lilly released clinical trial data for the serotonin-norepinephrine reuptake inhibitor showing greater reductions in pain severity one week after starting treatment compared to placebo. The sNDA is based on data from 1,400 patients across five clinical trials, the firm said. Pfizer has estimated the fibromyalgia indication could add $1 billion in incremental sales for Lyrica (1"The Pink Sheet" July 2, 2007, p. 17)...
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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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As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.