Takeda Receives Positive CHMP Opinion for Crohn Disease drug Medical Dialogues Bureau8 March 2020 9:15 AM ISTTokyo: Takeda Pharmaceutical Company Limited had announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
Pfizer Oncology biosimilar Ruxience gets positive opinion from CHMP Medical Dialogues Bureau9 Feb 2020 9:30 AM ISTNew York: Pfizer Inc. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has...
Eli Lilly new insulin to improve glycemic control in diabetics get positive opinion from EMA Farhat Nasim3 Feb 2020 3:03 PM ISTThe CHMP opinion is now referred for final action to the European Commission, which grants approval in the European Union. Lilly plans to market the...
Bayer makes EMA application for a pre-filled syringe to administer eye medication Eylea MD bureau2 Feb 2020 10:00 AM ISTBerlin: Bayer has submitted an application to the European Medicines Agency (EMA) for a pre-filled syringe to administer Eylea® (aflibercept solution...
Roche Tecentriq, Avastin combo to increase overall survival, progression-free survival in HCC Medical Dialogues Bureau22 Oct 2019 9:50 AM ISTRoche, in its recent release, in 2018, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for Tecentriq in...
Tighter EU rules could trigger antibiotic shortage; says Fresenius Medical Dialogues Bureau9 Jun 2019 9:00 AM ISTFresenius said that under the draft proposals, the bulk-freeze-dryers that is used to produce the antibiotic would have to be sterilised more...
Pfizer acquires clinical-stage Biotech Therachon for $810 million Garima12 May 2019 9:45 AM ISTNEW YORK: Pfizer recently announced that it has entered into a definitive agreement to acquire all the shares of Therachon Holding AG, a privately...
Pfizer gets CHMP opinion for Talzenna for patients with metastatic breast cancer Farhat Nasim29 April 2019 9:35 AM ISTThe positive CHMP opinion of TALZENNA follows the medicine's approval by the U.S. Food and Drug Administration (FDA) in October 2018.New Delhi:...
GSK's severe pediatric asthma drug wins European panel thumbs-up Ruby Khatun Khatun30 July 2018 10:00 AM ISTGlaxoSmithKline (GSK) drug Nucala has won a key recommendation from a European Medicines Agency (EMA) panel for use in the treatment of children with...
Novo Nordisk wins EU panel's backing for key diabetes drug Ruby Khatun Khatun18 Dec 2017 10:30 AM ISTCOPENHAGEN: Danish drugmaker Novo Nordisk came closer to winning European approval for diabetes drug Ozempic, it's biggest growth prospect when a...
EMA accepts marketing authorization applications of Mylan and Biocon for 2 biosimilars Ruby Khatun Khatun2 Dec 2017 10:00 AM ISTHERTFORDSHIRE, England, PITTSBURGH and BENGALURU: Mylan N.V. and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for...
Mylan seeks EMA approval for 2 biosimilars Ruby Khatun Khatun9 Nov 2017 10:32 AM ISTNew Delhi: Biocon said that its partner Mylan has re-submitted marketing authorization applications with the European Medicines Agency for two...
