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Aegerion Pharmaceuticals said the FDA has closed out a warning letter stemming from overblown claims its CEO made on TV, but the company still faces a federal investigation and lawsuit surrounding its marketing practices. Read More
Taiwan-based TWi Pharmaceuticals has won final FDA approval for a generic version of Par Pharmaceutical’s AIDS drug Megace ES, but the product’s launch remains on hold as the brandmaker appeals its 2011 patent infringement lawsuit. Read More
Biogen Idec said it will launch its multiple sclerosis drug Tecfidera within three months in England and Wales following a final coverage recommendation this week from the UK healthcare pricing watchdog. Read More
Boehringer Ingelheim and Eli Lilly’s type 2 diabetes drug Jardiance has received a preliminary thumbs-down from the UK’s healthcare cost watchdog, which wants to see more cost-effectiveness data comparing the new product with other existing treatments. Read More
Drugmakers operating in Brazil must report all supply chain movements to regulatory authorities in real time, according a new guidance on the country’s drug tracking and tracing system. Read More
GlaxoSmithKline and the National Institutes of Health say they are fast-tracking clinical trials of their experimental Ebola vaccine candidates, and that the drugmaker will make up to roughly 10,000 additional doses of the vaccine so that stocks can be made available immediately if results are positive. Read More
Drugmakers are pushing back against an FDA plan to implement tough restrictions on distributing information about new, off-label benefits of a drug, while loosening restrictions on disseminating journal articles that present new risk information about their products. Read More
European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations for pharmaceuticals closer to those of the EU, although it may take another two years before the agreement is actually implemented. Read More
Canadian generics maker Apotex has lost a $520 million lawsuit the company brought in front of an international arbitration board against the FDA over import alerts on two of its facilities. Read More