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BioMarin Pharmaceutical Inc.

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Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.
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Provention Bio’s teplizumab, a potentially game-changing treatment for preventing or delaying type 1 diabetes, is one of three investigational products to be newly accepted onto the European Medicines Agency’s popular priority medicines scheme.

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Gilead Hopes Selectivity Will Ease Safety Labeling For Filgotinib

On pace to file selective JAK1 inhibitor filgotinib for US approval in RA by year’s end, Gilead says the drug’s safety profile may allow for a labeling advantage compared with other drugs in the class.

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Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster

Amarin’s cardiovascular risk reducing drug, Vascepa, is among four new products being considered for accelerated assessment by the European Medicines Agency.

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