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India’s medicines authority has released a set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
Global drug regulators have reduced drug approval times over the last 10 years, and while the U.S. Food and Drug Administration remains the fastest at approving new drugs, other regulators are closing the gap. Read More
The European Medicines Agency has extended a pilot program that allows generics manufacturers to make joint submissions to the agency and regulators in Australia, Canada, Taiwan and Switzerland. Read More
India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies — a continuation of the rebounding number of studies in the country. Read More
The FDA gave tentative approval to Mylan’s ANDA for a generic Nexium last week, but denied final approval due to lasting exclusivity protections — almost guaranteeing Teva the only generic version of the blockbuster heartburn drug on the market for months to come. Read More
An FDA advisory committee will meet next month to consider Celltrion’s biosimilar version of Janssen’s Remicade, putting the agency on track to meet a goal of reviewing five biosimilar applications a year. Read More