FDAnews Drug Daily Bulletin

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.

Manufacturers withdrawing their drugs from any market in the EU will now have to notify competent authorities of the reason, according to amended pharmacovigilance rules adopted by the Council of the European Union Oct. 4.

The FDA reclassified its clinical hold on Repros Therapeutics’ Proellex and will now allow the company to conduct a Phase II trial of low-dose Proellex as a treatment for endometriosis.

A New York federal judge on Wednesday narrowed claims brought by a proposed class of indirect purchasers of the anti-diuretic drug DDAVP who allege Ferring BV and a Sanofi SA unit suppressed generic competition by fraudulently acquiring a patent on the medication.

German drugmaker Bayer said its Xarelto blood-thinning pill was recommended for approval by the European drugs regulator for the treatment of dangerous blood clots of the lung, a condition known as pulmonary embolism.

More than two years after Vladimir Putin promised to transform his nation into a biotech heavyweight by 2020, Russia is achieving a measure of success by one important barometer, namely a steadily growing volume of clinical trial activity.

Savient Pharmaceuticals and its wholly owned subsidiary, Savient Pharma Ireland, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has completed its scientific assessment and has issued a positive opinion recommending approval of a marketing authorization in the European Union for Krystexxa (pegloticase) for the treatment of severe debilitating chronic tophaceous gout in adult patients.

The Drug Regulatory Agency of Pakistan (DRAP) has decided to establish a committee to resolve the long outstanding issues being faced by the pharmaceutical sector, including a considerable increase in fee structure of services offered by DRAP, huge number of pending registration applications, and finalisation of contract manufacturing policy.

Vertex Pharmaceuticals, maker of the hepatitis C drug Incivek (telaprevir), has received interest from other companies to collaborate on tests of one of its experimental medicines for the liver disease, CEO Jeffrey Leiden said.