Plavix Settlement Outcome May Make Industry Overly Cautious, Legal Experts Say
Collapse of Bristol/Sanofi generic settlement with Apotex will likely impact future brand-generic negotiations, attorneys predict.
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The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.
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Companies have until 17 March to respond to an EU consultation on a new strategy that will seek to simplify the regulatory framework and make it easier for innovative small and medium-sized enterprises to “access the capital they need” to scale up in the bloc.
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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.