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Stock impact report

Novo's FDA voucher victory; biotech's rigid glass ceiling [Yahoo! Finance]

Sanofi - American Depositary Shares (SNY) 
US:NYSE Investor Relations: sanofi.com/en/investors
Company Research Source: Yahoo! Finance
Some of the biggest news and trends captured in PharmaVoice's newsletter this week. Sign up here to receive the newsletter daily. Novo scores an FDA win Drugs in the FDA's new review voucher program have been on a roll. Novo Nordisk scored the program's fourth approval last week when the FDA OK'd its higher-dose version of Wegovy. But the Commissioner's National Priority Voucher program has also picked up plenty of detractors. Unveiled last year with the aim of shrinking review timelines to a few months for drugs in the country's “national interests,” the details of the program and who wins a voucher remain “ shrouded in secrecy ,” according to one lawmaker. With Congressional pressure mounting on the FDA to provide answers, the agency will host a public meeting on the program in June. The voucher program is one of several regulatory factors causing unpredictability through the industry, including orphan drugs. This week, we looked at the outlook for the orphan market and the Show less Read more
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