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Approvals

Merck KGaA/Pfizer Get Europe OK For Bavencio In Rare Skin Cancer

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.

Approvals ImmunoOncology Cancer
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EU Moves To RATIFY Novartis' Rydapt for AML

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.

Cancer Approvals

Trelegy Approval Boosts GSK's US Respiratory Business But Pressure Remains

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.

Approvals Respiratory

Pipeline Watch: Phase III Readouts For ADV7103, Pembrolizumab, Upadacitinib

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.

Pipeline Watch Approvals

Ocrevus Delay As CHMP Continues Assessment?

The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.

Companies Approvals

Samsung Bioepis’s Biosimilar Trastuzumab First To Take On Roche’s Herceptin In EU

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.

Biosimilars Approvals

J&J's Guselkumab Nears Crowded EU Psoriasis Market After CHMP OK

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.

Approvals Biologics
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