Takeda Receives Positive CHMP Opinion for Crohn Disease drug Medical Dialogues Bureau8 March 2020 3:45 AM GMTTokyo: Takeda Pharmaceutical Company Limited had announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
Roche Tecentriq, Avastin combo to increase overall survival, progression-free survival in HCC Medical Dialogues Bureau22 Oct 2019 4:20 AM GMTRoche, 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 3:30 AM GMTFresenius 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 4:15 AM GMTNEW 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 4:05 AM GMTThe 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 4:30 AM GMTGlaxoSmithKline (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 5:00 AM GMTCOPENHAGEN: 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 4:30 AM GMTHERTFORDSHIRE, 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 5:02 AM GMTNew Delhi: Biocon said that its partner Mylan has re-submitted marketing authorization applications with the European Medicines Agency for two...
Biocon up 5 per cent as Malaysia arm gets GMP compliance certificate Ruby Khatun Khatun10 Sep 2017 5:49 AM GMTNew Delhi: Shares of biopharmaceutical firm Biocon surged over 5 per cent after the company said its Malaysian arm Biocon Sdn Bhd has received EU GMP...
Novartis hopeful for novel heart drug, despite modest benefit Ruby Khatun Khatun28 Aug 2017 7:35 AM GMTZURICH: Novartis will seek regulatory approval this year for a new kind of anti-inflammatory heart drug, though some experts fear fatal infection...
Europe ready to embrace first copies of biotech cancer drugs supriya kashyap kashyap17 Feb 2017 6:55 AM GMTLondon : Treatment with two important cancer drugs is about to get much cheaper in Europe with a cut-price copy of Roche's blood cancer drug Rituxan...
