TOKYO - Japan's Ministry of Health, Labor and Welfare has suspended Mitsubishi Tanabe Pharma's manufacturing and sales operations for 25 days because it was determined a subsidiary of the company fabricated data for Medway Injection 5%, the world's first genetically engineered transgenic human serum albumin, MHLW officials said April 13, and regulatory authorities may level additional administrative penalties against the company
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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