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Keryx Biopharmaceuticals said it will launch its renal disease drug ferric citrate within 12 weeks, following FDA approval Friday of the product that controls phosphorus levels in dialyzed chronic kidney disease (CKD) patients. Read More
A federal judge has tossed out all claims in a consolidated class-action antitrust lawsuit alleging that brandmaker Warner Chilcott executed a “reverse payment” to generics firms Watson (now Actavis) and Lupin Pharmaceuticals to delay generic competition on its contraceptive Loestrin 24. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is leading a three-year initiative that seeks to harness the power of social media to report adverse drug events. Read More
Drugmaker OncoMed expects to resume enrollment and dosing of new patients for its experimental cancer drug ipafricept in the coming weeks, after the FDA lifted a partial hold on its clinical trials. Read More
Johnson & Johnson and NewLink Genetics are the latest companies to seek Ebola treatments through accelerated human trials of vaccine candidates, an effort that is getting a boost from a collaboration of international regulatory agencies. Read More
The UK’s drug pricing watchdog is recommending Alexion’s blood disease drug Soliris for a life-threatening blood disorder that affects roughly 200 people in England, although the agency is urging the National Health Service and the company to find ways of reducing the high cost of treatment. Read More
Canada’s health regulators have approved Boehringer Ingelheim’s blood thinner Pradaxa for new indications to treat and prevent blood clots deep in the legs and in the lungs. Read More
The FDA denied Teva its 180-day exclusivity period for a version of Warner Chilcott’s osteoporosis drug Actonel 150 mg because the agency itself didn’t tentatively approve Teva’s ANDA fast enough, according to an internal agency document. Read More
Israeli firm Teva has launched the first generic version of Bristol-Myers Squibb’s hepatitis B drug Baraclude in both its 0.5 mg and 1 mg tablet strengths. Read More
Compounding pharmacies are asking the FDA to overhaul its guidance for interim good manufacturing practices, contending the recommendations for such things as the cleanliness of air filters and presence of particulates are unclear and subjective. Read More