Ramsey Baghdadi
When it rains, it pours.
Rejected Out of Hand: FDA "Refuse-to-File" Letters Hit Five-Year High
Refuse-to-file letters used to be extremely rare events, but as FDA data show, that's not necessarily the case anymore. In fiscal years 2003 through 2005, FDA issued no more than four refuse-to-file letters, with three such actions taken in 2004. But in 2006 and 2007, the numbers rise sharply; FDA sent seven letters in 2006 and 11 letters, including one for a biologic application, last year.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
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The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.