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The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for “significant deviations” of current good manufacturing practices (cGMPs), including failures to ensure adequate environmental monitoring and employee training. Read More
One of the leading manufacturers of painkillers is calling for leniency from the Drug Enforcement Administration (DEA) if it decides to adopt new restrictions for hydrocodone combination products. Read More
Mylan and Actavis are challenging the FDA’s April 24 decision to grant 180-day marketing exclusivity to Teva for a generic version of the blockbuster arthritis drug Celebrex. Read More
The FDA on Monday approved UK-based NOVA Laboratories’ oral suspension drug for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Read More
The European Medicines Agency (EMA) says the EU’s EudraVigilance database received more than 1 million post-marketing expedited adverse-drug-reaction (ADR) reports in 2013. Read More
Manufacturers estimate that a medium-sized drugmaker would have to pay roughly $36 million to implement a serialization and traceability system required under the new federal track-and-trace law. Read More
A European Medicines Agency committee on Friday recommended approval of GlaxoSmithKline’s melanoma drug Mekinist, the first of its kind treatment that selectively targets the MEK protein kinase. Read More
The European Medicines Agency (EMA) is considering new trial designs using pathologic complete response (pCR) as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early stage breast cancer. Read More