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The Merkel cell carcinoma area is very niche but getting approval means that Merck and Pfizer can now prepare to compete with the likes of Opdivo and Keytruda in the European PD-1/PD-L1 space.
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Latest From Approvals
Rydapt represents the first major development in targeted acute myeloid leukaemia treatment in more than 25 years as Novartis plots its commercial launch in Europe.
With the FDA approval of Trelegy Ellipta, GlaxoSmithKline will enjoy first-to-market status with a LABA/LAMA/ICS triple combination therapy to treat COPD in the US. However, it faces the challenge of convincing payers.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.
Samsung Bioepis’s Ontruzant is likely to be the first biosimilar to take on Roche’s Herceptin in the EU market after it was recommended for marketing authorization by the EMA’s CHMP on Sept 15.
Janssen-Cilag/MorphoSys's potential first-in-class psoriasis therapy has received a positive approval recommendation from Europe's top scientific advisory panel, and could become a blockbuster product despite the cluttered and changeable state of the dermatology sector.
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