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Bayer-Monsanto deal one step closer, after EU nod pharmafile
March 23, 2018
The merger between Bayer and agricultural giant, Monsanto, is inching closer to completion after the EU Commission won EU antitrust approval.
Progress Prospects for Regulations in China, U.S. and EU in 2018 zhulikou431
March 15, 2018
The drug administration of each country has introduced their work plan for 2018 legislation or regulation revision and update, etc. in the spring of 2018.
EU expands scope of GSK/Innoviva’s asthma inhaler pharmatimes
March 12, 2018
The European Commission has approved a label update to GlaxoSmithKline/Innoviva’s Relvar Ellipta, expanding the asthma therapy’s reach.
EU clears MSD’s Prevymis for CMV prevention pharmatimes
January 31, 2018
European regulators have approved MSD’s Prevymis for the prevention of cytomegalovirus (CMV) reactivation and disease in prone adults who have received an allogeneic haematopoietic stem cell transplant (HSCT).
Brexit may disrupt medicines supply, warns British alliance pharmaceutical-technology
January 31, 2018
The alliance cited an example that around 120,000 prostate cancer patients across Europe might be affected if Brexit negotiations fail to secure a future collaboration on regulation and trade of medicines and medical devices.
Seven medicines leap closer to EU approval pharmatimes
January 30, 2018
The European Medicines Agency’s Committee for Medicinal Products for Human Use has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
Eli Lilly's Taltz get EU approval in psoriatic arthritis subgroup pharmafile
January 25, 2018
Eli Lilly revealed that its IgG4 monoclonal antibody Taltz (ixekizumab) has been approved by the European Commission for the treatment of patients with active Psoriatic Arthritis (PsA)
Roche's Star MS Drug Snags EU Approval biospace
January 15, 2018
Roche’s OCREVUS (ocrelizumab) approved in the European Union for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis
EU Follows US and Approves Chugai's ALK Inhibitor "Alecensa®" as First Line Therapy for ALK-Positive biospace
December 22, 2017
Alecensa Now Available in Japan, the United States and Europe for the Treatment of Advanced Lung Cance
EU invests €6.3m into cancer project led by Philips biospectrumasia
November 27, 2017
The project complements the €18.3m Cancer-ID project.

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