Protocols

UK government backs $189M effort to bolster life sci; Bayer files hemophilia drug; Akcea files volanesorsen NDA

⇨ With Brexit looming, the UK government is particularly anxious about preserving and growing its big biopharma sector. With that in mind the government has come up with a near-term plan to invest $189 million in the sector, looking to spur new innovation in drug and vaccine development as well as pharmaceutical manufacturing. Bloomberg reports that Prime Minister Theresa May has selected the life sciences industry, which employs more than 235,000, as one of five vital to economic health.

Bayer AG has submitted its BLA for its long-acting site-specifically PEGylated recombinant human Factor VIII (BAY94-9027) for hemophilia A. The submission is based on the results from the PROTECT VIII trial, which demonstrated protection from bleeds with dosing intervals when used prophylactically once every seven days, once every five days, and twice per week.

⇨ Ionis affiliate Akcea has filed its NDA for volanesorsen, a therapy designed to treat familial chylomicronemia syndrome.

⇨ API manufacturer Cambrex is adding an 11,000-square-foot lab, with plans to hire a dozen scientists for its work.


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Biomanufacturing