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The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended 11 medicines for approval, including one new cell therapy, four new drugs and four biosimilars. Read More
The U.S. Trade Representative flagged China and India on its latest priority watch list of countries with lax intellectual property protections for drugs. Read More
Health Canada is proposing changes to its prescription drug pricing regulations with the establishment of a risk-based approach, applying new economic factors in the decision framework, and updating the list of countries it uses for average price comparisons. Read More
The European Medicines Agency plans to launch an improved version of its adverse event monitoring system, EudraVigilance, in November, with new methods for reporting and analyzing suspected reactions to investigational and authorized products. Read More
The PTO’s Patent Trial and Appeal Board invalidated a patent for AbbVie’s flagship drug Humira, saying its claims were unpatentable following a challenge by Coherus Biosciences. Read More
Astellas Pharma filed suit against generics makers Roxane Laboratories, West-Ward Pharmaceuticals and Hikma Pharmaceuticals over their copycat version of Xtandi. Read More
Fifty-two representatives and nine senators sent letters to HHS Secretary Tom Price and CMS Administrator Seema Verma, urging them to reverse current Medicare policy for the reimbursement for biosimilar products. Read More
The FDA approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit hyperactivity disorder in pediatric and adult patients, including multiple strengths manufactured by Apotex, Teva, Aurobindo Pharma and Glenmark Pharmaceuticals. Read More