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Congress is considering new legislation to require the Drug Enforcement Agency to speed up the process of scheduling a drug as a controlled substance and give drugmakers a firm timeline for agency decisions. Read More
The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients. Read More
Zogenix Monday sought a temporary restraining order against Massachusetts Gov. Deval Patrick’s recent executive order prohibiting use of the prescription pain drug Zohydro ER in the state. Read More
Drugmakers decried the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
Amgen’s investigational metastatic melanoma candidate talimogene laherparepvec met its primary endpoint of durable response in a Phase III clinical trial, but missed the secondary endpoint of overall survival, the drugmaker said. Read More
Genzyme will resubmit its application for an expanded indication in relapsing multiple sclerosis for Lemtrada during the second quarter, following “constructive” talks with the FDA, the company said Monday. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
The FDA has lifted a February 2013 warning letter issued to Jubilant HollisterStier’s manufacturing facility located near Montreal, Canada, and deemed it acceptable after a follow-up inspection in September 2013. Read More
The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More