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EU approves post-chemo option for patients with ovarian cancer pharmatimes
November 23, 2017
European regulators have cleared Tesaro’s Zejula, offering a new option for the maintenance treatment of certain adults with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
EMA grants marketing authorisation for Zubsolv for opioid dependence pharmatimes
November 22, 2017
The European Medicines Agency (EMA) has granted a Marketing Authorization (MA) for Zubsolv (buprenorphine and naloxone), a novel rapidly-disintegrating treatment option for opioid dependence to Orexo AB (publ.) .
EU nod for first Herceptin biosimilar pharmatimes
November 21, 2017
European regulators have approved the first biosimilar of Roche’s blockbuster biologic Herceptin, issuing a green light for Samsung Bioepis’ Ontruzant.
EU OKs low-dose Xarelto to prevent recurrent VTE pharmatimes
November 03, 2017
A lower dose formulation of Bayer and Janssen’s bloodthinner Xarelto has been approved by European regulators for preventing recurrent venous thromboembolism, expanding treatment options for patients.
Novartis receives EU approval for ribociclib europeanpharmaceuticalreview
August 25, 2017
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
EMA unveils business continuity plan ahead of UK exit from EU firstwordpharma
August 02, 2017
The European Medicines Agency on Tuesday revealed its business continuity plan ahead of its relocation from the UK as part of the country's decision to leave the EU.
Eleven medicines leap closer to EU approval pharmatimes
July 25, 2017
Eleven therapies, including five targeting rare diseases, have taken a giant leap towards being approved in Europe after winning backing from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Brexit Health Alliance welcomes collaborative EU relationship europeanpharmaceuticalreview
July 18, 2017
Niall Dickson responds to the commitment by the secretaries of state to seek a collaborative relationship with the EU in medicines regulation and supply…
Gilead’s new HIV therapy under EU review pharmatimes
July 17, 2017
European regulators are now reviewing Gilead’s fixed-dose combination of bictegravir (BIC), emtricitabine and tenofovir alafenamide as a treatment for HIV-1 infection.
EU regulators review Novartis’ migraine drug pharmatimes
June 23, 2017
An experimental therapy being developed by Amgen and Novartis to prevent migraine has been accepted for review in the European Union.

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