(IN BRIEF) Sandoz has announced the US availability of TYRUKO® (natalizumab-sztn), the first FDA-approved biosimilar to Tysabri® for treating relapsing forms of multiple sclerosis and Crohn’s disease. Developed by Polpharma Biologics, TYRUKO® is clinically equivalent to its reference product and … Read the full press release
Posted in Business, Healthcare, Marketing, News, Pharma & Biotech, Switzerland
Tagged affordable biologics, biosimilar growth, Crohn's disease, FDA approval, JCV antibodies, Keren Haruvi, Labcorp partnership, multiple sclerosis, natalizumab-sztn, neurology portfolio, PML risk, Polpharma Biologics, REMS program, Sandoz, TYRUKO, TYRUKO Availability Marks Major Milestone in Affordable MS Care and Sandoz Biosimilar Leadership, Tysabri biosimilar, US launch
London, United Kingdom, 10-10-2013 — /EuropaWire/ — AstraZeneca today announced that the US Court of Appeals for the Federal Circuit (CAFC) lifted a temporary injunction against the US launch of Hanmi’s 505(b)2 NDA esomeprazole strontium product. AstraZeneca’s CAFC appeal of claim construction … Read the full press release
Posted in Business, Government, Healthcare, Law, Pharma & Biotech, United Kingdom
Tagged 192, 5, 504, 714, 877, Amneal Pharmaceuticals, Anthony Brown, AstraZeneca, CAFC, Colleen Proctor, Court of Appeals for the Federal Circuit, Ed Seage, Esra Erkal-Paler, Hanmi, Hanmi Pharmaceutical, Hanmi's 505(b)2 NDA esomeprazole strontium, Jacob Lund, Jens Lindberg, Karl Hård, Michele Meixell, New Jersey, Nexium, patent-infringement damages, Temporary injunction, US launch, Vanessa Rhodes
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