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Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s registration for human use quality standards Read More
A New Jersey federal judge Friday dismissed a pay-for-delay case involving a “no-authorized generic agreement” between GlaxoSmithKline and Teva, saying the Supreme Court’s landmark 2013 ruling in Federal Trade Commission v. Actavis applies antitrust scrutiny only to pay-for-delay deals that involve money. Read More
The European Medicines Agency (EMA) on Friday said it will investigate reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in some women who weigh more than 165 lbs. Read More
A new Tufts University report praises the FDA’s breakthrough therapy program for its potential to advance new drugs and biologics targeting unmet needs. Read More
FDA reviewers have unveiled the top five reasons for drug approval delays and denials over a twelve-year period, noting that many could be avoided if drugmakers submitted more accurate and useful information. Read More
The FDA is continuing its efforts to improve the ANDA approval process, this time asking generics makers to provide comments on what elements of the process are creating stumbling blocks and how the agency can help clear them away. Read More
Amag Pharmaceuticals’ regulatory woes deepened Wednesday as its bid to seek a new indication for its flagship iron deficiency drug Feraheme was rejected by FDA reviewers. Read More
The European Medicines Agency authorized 81 drugs in 2013, a 42 percent increase over the number of marketing authorizations in 2012, the agency reported Monday. Read More
The FDA has approved a new formulation of Nuvo Research and Mallinckrodt’s osteoarthritis drug Pennsaid for the treatment of osteoarthritis knee pain, but not the broader indication of signs and symptoms of the disease — adding a new wrinkle to the fight between the two partner companies co-developing the drug. Read More