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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
The FDA granted Merck’s new melanoma drug Keytruda accelerated approval and orphan drug status after a clinical trial indicated improved efficacy. Read More
Pharmaceutical companies want to maintain the current exemption on reporting financial support for continuing medical education (CME) programs under the Physician Payment Sunshine Act, a position that is under threat from a new proposed rule. Read More
Both PhRMA and public health advocacy group Pew Charitable Trusts want CMS to account for its delay in publishing one-third of the data that manufacturers must submit on payments to physicians and teaching hospitals. Read More
Teva is clear to market its version of AstraZeneca’s chronic obstructive pulmonary disorder drug Symbicort in the United Kingdom, after the High Court there struck down an AZ indication patent on grounds of obviousness. Read More
Johnson & Johnson is pulling its OTC nausea and vomiting drug domperidone from the UK market following a decision by regulators that the medicine must require a prescription to obtain due to risks of serious cardiac effects. Read More