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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
Pfizer has confirmed it made an aggressive bid to merge with AstraZeneca in an apparent attempt to gain a lower tax rate and shore up its pipeline in the face of costly patent expirations. Read More
Drugmakers providing postmarket benefit-risk assessments to Health Canada will soon need to follow rigid, standardized guidelines that provide both preapproval and postapproval data about a drug product’s efficacy. Read More
Drugmakers are enthusiastic supporters of the FDA’s plans to offer five years of market exclusivity for more fixed-dose combination products — but they want the agency to broaden its new policy so it will cover products already under review. Read More
The Arkansas Supreme Court declined to hear an appeal of its decision to reverse a $1.2 billion verdict against Johnson & Johnson over the practices the company used to market the antipsychotic Risperdal. Read More