Regulatory matters figured prominently in the news last week, with the European approval of Kyowa Hakko Kirin and Ultragenyx Pharmaceuticals’ rare disease drug Crysvita and US clearance of a much awaited new indication for AstraZeneca’s immuno-oncology drug Imfinzi in lung cancer. Licensing news also attracted attention, with AbbVie’s Alzheimer’s disease collaboration with Voyager Therapeutics, Takeda’s accord with Wave Life Sciences, and Gilead Sciences’ new subsidiary Kite Pharma’s deal with Sangamo in the CAR-T space race. Merck & Co’s acquisition of Australian firm Viralytics, thus dipping its toe into the field of oncolytic virus, was a feature for M&A, and there were mixed reactions to Aimmune’s successful clinical trial in peanut allergy.
EU thumbs-up sets stage for burosumab’s more important test
Friday’s European approval for Ultragenyx’ burosumab marks the first green light for this rare disease drug and sets the stage for a more important event: a US Food and Drug Administration decision, due in April, that should bring with it the company’s second priority review voucher, opines EP Vantage, the editorial arm of the Evaluate group.
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