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The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More
Following setbacks to its hepatitis C drug program, Idenix Pharmaceuticals has turned to the courts to try to delay Gilead’s competitor hepatitis C treatment, claiming the drug infringes several Idenix-owned patents. Read More
Teva and Mylan said Nov. 25 they had reached a confidential agreement to settle patent litigation over Teva’s multiple sclerosis drug Copaxone in three European courts. Read More
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction or postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying a citizen petition submitted by Square Pharmaceuticals. Read More
Eli Lilly and Acrux on Nov. 12 filed suit against Actavis to prevent the generic drugmaker from commercializing a generic version of the testosterone topical solution Axiron. Read More
The Drug Enforcement Administration has placed Eisai's seizure medication Fycompa into schedule III of the Controlled Substances Act, clearing the final regulatory hurdle on the drug's pathway to market. Read More
The White House Office of Management and Budget’s decision to sequester nearly $85 million of FDA user fees is wrong, and should be reversed immediately, lawmakers say. Read More
A group of lawmakers wants the FDA to strip Zogenix’s opioid painkiller Zohydro ER of its approval until the company creates an abuse-deterrent formulation of the product. Read More
The FDA has notified Biogen Idec that it needs more time to review its BLA for Alprolix after the drugmaker submitted additional data supporting the validation of a key manufacturing step. Read More
The FDA has agreed to review Purdue Pharma's NDA for its investigational Targiniq ER controlled-release tablets CII for the management of chronic pain. Read More
Despite not agreeing on primary endpoints with the FDA before beginning clinical trials for a new sleep disorder drug, Vanda was able to get an almost unanimous recommendation from an advisory committee earlier this month. Read More