We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Drugmaker Eisai says it is outraged by NHS England’s decision to remove its cancer therapy Halaven from a special fund that reimburses cancer drugs not considered cost-effective by the UK’s pricing watchdog. Read More
Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product based on the actual amount of active ingredient in a dose rather than a proposed standard that compares dosages and routes of administration. Read More
India’s drug pricing authority wants manufacturers of fixed-dose combination products that are less than four years old to confirm that the products have been approved and are not prohibited under the country’s drug laws. 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
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More