Lane Labs supplement has "direct effect" on "tumor cell growth and cytokine production," in addition to previous findings showing agent enhances natural killer cell activity, according to a poster presented by Mamdooh Ghoneum, PhD, Charles Drew University and UCLA, et al., at American Association for Cancer Research annual meeting in New Orleans March 24-28. Lane Lab's Internet promotions for MGN-3, "a patented, Japanese compound consisting of hydrolyzed rice bran extracts modified by Shiitake mushroom enzymes," caused FDA and FTC to charge product is an unapproved drug. While FTC charges have been settled, FDA negotiations are ongoing, Lane Labs notes
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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.’
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
