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Gilead Sciences is on track to launch another hepatitis C drug in Europe after an advisory panel of the European Medicines Agency recommended approval of Harvoni. Read More
AstraZeneca received good news Friday when a key European committee recommended approval of its new drug to treat opioid-induced constipation and a diagnostic test that can help identify patients for its cancer drug Iressa. Read More
Patients will be invited to participate in scientific discussions on the benefits and risks of certain drugs in Europe, under a new European Medicines Agency pilot project. Read More
The FDA is honing in on roughly eight to 10 quality metrics that the agency plans to collect from drugmakers starting in 2015, and expects to publish a guidance that names them by the end of the year. Read More
The FDA warned Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel, but the company says its labeling can back up the claims. Read More
British regulators have revised their recommendations on the reporting of pediatric adverse drug reactions to focus on severe or serious events, a change that addressed complaints that the previous system was overly burdensome. Read More
Clinical studies to evaluate drugs treating irritable bowel syndrome (IBS) should involve patients experiencing recurrent abdominal pain or discomfort at least three days per month in the previous 90 days, according to new final guidance issued by the European Medicines Agency. Read More
Boehringer Ingelheim won FDA approval Thursday for its chronic obstructive pulmonary disease (COPD) drug Spiriva Respimat and plans to launch the drug by the new year. Read More
With patent expirations looming, AbbVie secured a new indication for its blockbuster biologic Humira to treat children suffering from moderate to severe Crohn’s disease. Read More
Shire agreed to pay the federal government $56.5 million to settle allegations it peddled outlandish superiority claims for its attention deficit disorder drugs, including a sales pitch that Adderall XR could prevent poor school grades and traffic accidents. Read More