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Latest From Kyowa Kirin Co., Ltd.
Japan has announced the latest evaluation results under its cost effectiveness assessment scheme. But how does it work and how much have prices been revised so far under the four-year-old program following discussions between pharma firms and authorities?
MSD and Kyowa Kirin have separately criticized England’s HTA body, NICE, for assessing their respective rare disease medicines Welireg and Crysvita using its standard appraisal pathway. Both medicines were provisionally rejected for reimbursement.
The 30+ year-old program, which monitors prenatal exposure to 164 drugs, should be the template for other efforts, US FDA officials say, because disease-based pregnancy registries ‘have a better track record.’
Endo’s Par has moved on the first FDA-approved generic version of Hikma’s Mitigare prevention of gout flares – weeks after another ANDA sponsor, Micro Labs, sought to clear its own path to market via a lawsuit.
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