A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.
Home » FDA Advisory Panel Narrowly Recommends Genzyme HoFH Drug
FDA Advisory Panel Narrowly Recommends Genzyme HoFH Drug
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 9–6 Thursday to recommend approval of Genzyme and Isis Pharmaceuticals’ homozygous familial hypercholesterolemia (HoFH) drug Kynamro. The vote comes one day after the panel recommended approval of Aegerion’s HoFH treatment by a wider margin. As with Aegerion’s lomitapide, EMDAC panelists expressed numerous concerns over Kynamro’s (mipomersen) safety profile. Drug Industry Daily