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ABPI Chief warns of Brexit impact on EU pharmafile
August 13, 2018
The head of the Association of the British Pharmaceutical Industry (ABPI) has warned that European governments have failed to recognise the impact a no-deal Brexit would have on medical supply chains between Europe and the UK.
EU Commission grants market authorisation for Sandoz’ Humira biosimilar pharmafile
July 31, 2018
The European Commission has granted marketing authorisation to Sandoz’ biosimilar Hyrimoz for use in all indications, including rheumatoid arthritis, plaque psoriasis, Crohn's disease, uveitis and ulcerative colitis.
Merck’s formulation steps further for approval in 21 EU countries biospectrumasia
July 30, 2018
BfArM is acting as a representative of all 21 EU countries involved in the EU worksharing procedure
FDA joins EU in seeking recall of certain Chinese-made valsartan products over potential cancer risk fiercepharma
July 17, 2018
Recalls of certain drugs containing heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the U.S., as the FDA sought voluntary actions to take some affected drugs off the shelves due to the potential cancer risk.
Clovis’ PARP inhibitor Rubraca under EU review in maintenance setting pharmatimes
July 16, 2018
European regulators have agreed to review Clovis’ application to expand the use of its PARP inhibitor Rubraca in the region.
Pfizer's Xeljanz scores EU approval for active psoriatic arthritis pharmafile
July 06, 2018
With the decision, Xeljanz becomes the first and only oral Janus kinase inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA.
CAR-T therapies leap towards EU approval pharmatimes
July 03, 2018
The stage has been set for approval of the first chimeric antigen T-cell therapies (CAR-T) in Europe, after Novartis’ Kymriah and Gilead’s Yescarta both won backing from the Committee for Medicinal Products for Human Use (CHMP).
Amgen’s Blincyto gets full EU approval for rare leukaemia pharmatimes
June 21, 2018
European regulators have awarded Amgen’s Blincyto full approval for Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow thought to aff
EU filing for Clovis’ Rubraca in ovarian cancer maintenance setting pharmatimes
June 06, 2018
Clovis Oncology is seeking to expand use of its PARP inhibitor Rubraca in Europe to include maintenance treatment of certain adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
ViiV's two-drug regimen gets EU approval for HIV-1 pharmafile
May 25, 2018
ViiV Healthcare has announced that its HIV therapy Juluca (dolutegravir/rilpivirine) has been awarded marketing authorisation in the EU from the European Commission, making it the first available two-drug regimen, daily single pill solution for the type 1

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