If you are looking for evidence that the regulatory climate has improved at FDA since 2007, look no farther than FDA's handling of Vivus' weight loss drug Qnexa: FDA's review team was ready to take a risk on the drug despite a number of safety signals that would most likely have killed a product three years ago. But if you want to know how fundamentally the regulatory model has changed, listen to what the committee said in rejecting the application.
Michael McCaughan
If you are looking for evidence of how much the regulatory climate at the Food & Drug Administration has changed...
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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.’
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.
