Roche’s Kadcyla, Bayer’s Xofigo Head Latest Positive Opinions In Europe
This article was originally published in The Pink Sheet Daily
GSK’s once-daily combination inhaler Relvar Ellipta along with J&J’s diabetes therapy Invokana, Novo Nordisk’s hemophilia therapy NovoEight and Gilead HIV therapy Vitekta complete the list of six new medicines recommended for approval by the CHMP, Europe’s top scientific advisory panel.
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Roche has finally gained a positive recommendation from a health technology assessment body in the UK for its advanced breast cancer therapy, Kadcyla. The Scottish Medicines Consortium gave the product the all-clear after the quality-of-life benefits were highlighted by patients and doctors. It’s future in England is still unclear.
Pfizer’s Olivier Brandicourt, who has specialized in emerging markets and infectious diseases, inherits Bayer’s health care division, which is in the midst of several product launches and has few near-term patent expirations. Bayer has one of the largest exposures to emerging markets among large pharma companies.
With release of draft bioequivalence guidance for GSK’s blockbuster asthma and COPD treatment, generics seem more likely than ever, but there may be only a select number of companies who can meet the guidance’s requirements.