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Latest From GlaxoSmithKline plc
If bad luck comes in threes, GSK will be delighted to see the end of this week with dostarlimab approval delayed, bintrafusp failing in lung cancer and a Phase II of an ulcerative colitis drug discontinued.
Approvals by FDA also include revised container and consumer information labeling for J&J's Men’s Rogaine to align with labeling for Women’s Rogaine; bonus-pack labeling for Bayer AG’s Aleve; and
Key cancer asset is still looking for a Phase III validation after failing to outperform Keytruda in challenging frontline NSCLC setting.
While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year.
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