Alexion shoots for fast review of Soliris successor using a PRV; Sandoz wades into medical cannabis business

→ Anxious to get their Soliris successor to the FDA, Alexion $ALXN is using one of its two priority review vouchers to shave four months off the regulatory process for ALXN1210. Hailed as the next standard of care for the rare blood disorder paroxysmal nocturnal hemoglobinuria, ALXN1210’s files come with data showing it is non-inferior — though not exactly superior — to the blockbuster Soliris, while carrying an easier dosing schedule. Just weeks ago, the New Haven, CT-based biotech also highlighted successful switching of Soliris patients to the new drug. Now that the US application is in, the company will ready its pitch for the EU and Japan later this year.

NovartisSandoz Canada is getting into the medical cannabis business, but nobody will be smoking their products. They struck a deal with Tilray on a range of oil- and capsule-based weed products designed for specific ailments.

Pierre Fabre Research Institute has tapped San Diego-based Crown Bioscience to collaborate on their immuno-oncology drug discovery pipeline.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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