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The EMA is recommending the European Commission suspend sales of more than 300 generic drug formulations approved using flawed bioequivalence studies conducted at two Micro Therapeutic Research Labs’ facilities in India. Read More
The EU Court of Justice has denied the European Medicines Agency appeals to allow the agency to release three documents as part of its transparency efforts. Read More
The Drug Controller General of India asked manufacturers twice last year to submit Phase IV trial protocols— once in June and again in September — but most drugmakers have still not fulfilled the regulatory requirement. Read More
Despite the Senate defeat of a measure allowing drug importation earlier this year, House and Senate Democrats are trying again: they’ve introduced new legislation that would allow imports of prescription drugs from Canada. Read More
Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis, which stemmed from Chinese manufacturing facilities. Read More
The EMA’s Committee for Medicinal Products for Human Use is recommending EU approval of six drugs for treating a range of conditions from rare forms of cancer to chronic heart failure. Read More
In a complaint filed in the District Court of the Central District of California, Immunex asserts Sanofi and Regeneron infringed on the Immunex patent for Dupixent, which the FDA approved in March to treat atopic dermatitis, a form of eczema. Read More