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Daiichi Sankyo will pay the federal government $39 million to resolve allegations it used lavish dinners and other kickbacks to persuade physicians to prescribe more of the company’s drugs. Read More
The European Medicines Agency approved a record number of orphan drugs in 2014, a milestone it says is likely due to increasing early collaboration with sponsors. Read More
A federal appeals court is expected to rule next month in a dispute over Actavis’s plan to pull an older formulation of its blockbuster Alzheimer’s drug Namenda from the market and replace it with a newer version. Read More
Mylan and Abbott have submitted proposed commitments to the European Commission’s competition oversight body to allay anti-competitive concerns over a proposed merger that would reincorporate Mylan in the Netherlands. Read More
The FDA approved Impax Labs’ Parkinson’s disease drug Rytary after the drugmaker agreed to not use a troubled manufacturing facility for production. Read More
China’s FDA is pledging to impose stronger drug safety regulations, with efforts focused on risk assessments and a risk grading and classification system, as well as initiatives to effectively detect and solve problems. Read More
Drug sponsors are expected to expand their investments in developing new cancer therapies this year, spurred by a growing understanding of tumors’ molecular bases and immunotherapy techniques, according to a new report that projects pharma and biotech trends for 2015. Read More
An FDA advisory committee may have given its unanimous approval for a biosimilar application this week, but industry and patient groups contend the regulatory pathway still has many potholes, including unanswered questions on naming, labeling, testing requirements and interchangeability of the products. Read More