A March 2 lawsuit filed in California state court alleges dietary supplements with omega-3 fatty acids have "undisclosed and unnecessarily high levels of contamination with polychlorinated biphenyl compounds." Environmental advocates and the Mateel Environmental Justice Foundation name as defendants: CVS Pharmacy Inc., General Nutrition Corp., Now Health Group Inc., Omega Protein Inc., Pharmavite LLC, Rite Aid Corp., Solgar, Inc. and TwinLab Corp. The lawsuit alleges the supplements have PCB levels above the "safe harbor" limit set for human consumption under California's Proposition 65, which requires warnings about such exposures on product labels. The Council for Responsible Nutrition says the levels of PCBs found in the majority of the products do not appear to exceed the Prop 65 limit of 90 ng per day
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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 treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
