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Latest From Kyowa Kirin Co., Ltd.
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.
Advanz has acquired exclusive rights to register and commercialize a Phase III candidate from Dimerix in multiple territories, alongside agreements with Kyowa Kirin, Bayer and GP Pharm.
Institute for Clinical and Economic Review continues to assign high values to novel gene therapies, suggesting that Orchard’s pending ‘arsa-cel’ for MLD could be cost effective at a price as high as $4 million per treatment.
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