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The European Commission has blessed the first biosimilar of Amgen’s blockbuster drug Enbrel, clearing the way for Samsung Bioepis to release the biosimilar in select EU countries in the coming weeks. Read More
Titan Pharmaceuticals won positive news from an FDA advisory committee Jan. 12, with panelists voting in favor of approving its implant to treat opioid addictions. Read More
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for following the law. Read More
The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More