FTC is reviewing advertising for ephedra-free weight-loss product, previous marketer Cytodyne told the National Advertising Division of the Council of Better Business Bureaus in response to an inquiry, according to a recent NAD release. As a result, the firm declined to take part in NAD's request for substantiation of a number of claims including the statement that Xenadrine-EFX "was clinically tested against two leading ephedra-based thermogenic supplements and outperformed them for both the boosting of metabolism, and resulting caloric expenditure." Marketer of the supplement is now known as Nutraquest...
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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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Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.
Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.