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European regulators are proposing changes to development guidelines of drugs treating the gastrointestinal disorders ulcerative colitis and Crohn’s disease to better understand how the products work in children as well as adults. Read More
Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
In a defeat for the pharmaceutical industry, a federal appeals court has upheld a California county ordinance that requires drug manufacturers to collect and dispose of unwanted medicines, a program that advocates say will serve as a national model. Read More
Salix Pharmaceuticals and Progenics Pharmaceuticals said they had received FDA clearance for a new indication on their opioid-induced constipation drug Relistor. Read More
The FDA has signed off on a new formulation of Otsuka and Lundbeck’s collaborative anti-psychotic Abilify Maintena to be delivered via pre-filled dual chamber syringe. Read More
The FDA will continue to combat abuse of central nervous system-stimulating drugs like Ritalin and Adderall on a case-by-case basis, the agency said, rejecting a long-standing citizen petition that had called for a reformulation of the entire drug class. Read More
Sponsors developing therapies for rare pediatric diseases must pay the FDA roughly $2.6 million to use a priority review voucher in the new fiscal year that starts today. Read More
Impax has agreed to pay shareholders $8 million to end a class action lawsuit alleging the brand and generics maker deliberately withheld the extent of its manufacturing practice violation problems. Read More
FDA investigators and their European counterparts are comparing training and auditing procedures as the first steps in a new push to increase mutual reliance on each other’s inspections. Read More