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The FDA has accepted Apotex’s BLA for a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen, the Canadian generics maker said Tuesday, making it the fifth publicly disclosed biosimilar application in the U.S. Read More
The FDA gave tentative approval to Mylan’s ANDA for a generic Nexium earlier this month, 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.
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Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain bioequivalence testing batches for drugs protected by REMS product safety protocols. Read More
The UK’s health cost-effectiveness watchdog is recommending coverage of Norgine’s Targaxan to treat adults with a serious and potentially life-threatening brain condition caused by liver failure. Read More
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