Product Approvals In Brief: Xalkori Gets Full Approval, H5N1 Flu Vaccine Approved
Pfizer gains full approval for its lung cancer treatment Xalkori, following accelerated approval in 2011; also updates on ID Biomedical’s adjuvanted H5N1 flu vaccine; a new indication for Bayer/Onyx’s cancer treatment Nexavar; a new formulation for Merck’s antifungal Noxafil; and BTG’s new varicose vein product Varithena.
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The addition of Onyx’s cancer drugs to Amgen’s portfolio will fill a near-term sales gap for the big biotech and reinforce the company as a major oncology player. But Amgen will need to execute expertly on the merger if it is to transform itself into a high-growth biotech.
Pfizer says that it won’t challenge NICE’s final rejection of Xalkori on cost-effectiveness and survival uncertainty grounds.
Vaccines and Related Biological Products Advisory Committee also said that more data is needed to determine the groups that potentially could receive more than one periodic vaccine booster.