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regulatory decisions

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Roche pulls EU Tecentriq/Avastin filing in kidney cancer

Another setback for Roche, but CHMP changes its mind on Opdivo/Yervoy

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CHMP delays decision on Kiadis’ GVHD immunotherapy

Medicines regulator issues out Day 180 List of Outstanding Issues

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New chair for Europe’s key medicines committee

Appointment comes amid Brexit-induced disruption and new era in medicines

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Alnylam’s amyloidosis drug heads latest crop of CHMP approvals

Three new biosimilars also gets the green light

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Daily Brief: Europe changes mind on Puma drug, Pfizer’s Healthcare Hub, AbbVie and Calico add $1bn to anti-ageing quest

The latest from pharma, biotech and healthcare

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CHMP backs first-line use for AZ’s Tagrisso in lung cancer

AstraZeneca, Roche and Gilead among companies one step closer to approval

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ViiV’s two-drug HIV combo backed by CHMP

The committee also backs two biosimilar medicines

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Bad news for Portola as CHMP considers Factor Xa drugs

The committee are ‘unlikely’ to adopt a positive opinion for betrixaban

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CHMP hands Santhera second ‘no’ in Duchenne muscular dystrophy

Swiss biopharma says it will re-file Raxone for the licence extension

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CHMP recommends Teva’s generic version of Astellas’ Advagraf

Committee backs the drug for transplant rejection prophylaxis

Roche Basel Switzerland

Roche wins CHMP nod for Alecensa licence extensions

Lung cancer monotherapy set for a broader European label

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CHMP backs three immuno-oncology drugs for solid tumours

Roche, MSD and Merck/Pfizer are all on course for new European approvals later this year

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