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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
A UK cost-effectiveness watchdog doesn’t plan to recommend national reimbursement of three treatments that treat severe ulcerative colitis because of unclear effectiveness data. Read More
Drugmakers, importers, marketers and distributors in India must report company details, production sources and product lists in an online database by next month, according to the country’s drug regulatory authority. Read More
An HHS watchdog has urged the Centers for Medicare and Medicaid to work with manufacturers to ensure copayment coupons aren’t used on drugs covered under federal programs; a violation of anti-kickback laws. Read More
Pharmaceutical companies developing new pediatric vaccines for diphtheria, tetanus and pertussis (DTaP) should conduct clinical trials using a single dosing schedule as a means to streamline the process, according to a new guidance from the European Medicines Agency. Read More
Drugmakers should develop assays, tests and other processes to identify and mitigate any impurities in their products that may cause cancer, according to a European Medicines Agency guideline set to take effect January 2016. Read More
Celgene’s psoriasis drug Otezla will soon be available to a new group of patients following the FDA’s approval this week of an extended indication. Read More