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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 granted Merck’s new melanoma drug Keytruda accelerated approval and orphan drug status after a clinical trial indicated improved efficacy. Read More
Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions. Read More
The FDA has added flow charts and removed references to the now-defunct CDER Fax-On Demand system in its updated policy on how the agency goes about posting approval letters for new NDAs, ANDAs, BLAs and supplements. Read More