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Medtronic Is Back at Renal Denervation
Apr 3, 2015Symplicity Spyral Multi-electrode Renal Denervation Catheter (Image courtesy of Medtronic) The medtech giant isn’t giving up yet on renal denervation, if a new announcement is any indication. Chris Newmarker Medtronic is ...
Tags: Medtronic, Chris Newmarker, Medicine
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BMS Received Breakthrough Therapy Designation for Its Investigational DCV Dual Regimen
Feb 26, 2014Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
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Boehringer Ingelheim Has Submitted European Marketing Authorization Applications
Nov 15, 2013Boehringer Ingelheim has submitted European marketing authorization applications (MAA) to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and over. The MAA is based on results ...
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Helsinn Gives Rights to Their Ghrelin Receptor Agonist to Chugai Pharma Marketing
Nov 14, 2013Switzerland-based Helsinn group has granted Chugai Pharma Marketing, a wholly-owned subsidiary of Chugai Pharmaceutical, exclusive commercialization rights to their ghrelin receptor agonist, anamorelin, for the three major European pharma ...
Tags: Helsinn group, Pharma Marketing
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Boehringer Ingelheim Has Obtained Marketing Approval for Striverdi Respimat
Oct 23, 2013Boehringer Ingelheim has obtained marketing approval for Striverdi Respimat (olodaterol), a long-lasting bronchodilator indicated for chronic obstructive pulmonary disease (COPD), in the UK, Denmark and Iceland. This approval is based ...
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Japan-Based Takeda Pharma Has Received Positive CHMP Opinion
Jul 30, 2013Japan-based Takeda Pharma has received positive CHMP opinion for its three new type 2 diabetes therapies from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The therapies include Vipidia ...
Tags: Therapies, CHMP Opinion
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GSK Has Reached Settlement with The Attorneys
Jul 29, 2013British drug-maker GlaxoSmithKline (GSK) has reached settlement with the attorneys general of eight US states over misleading marketing of the diabetes treatment drug, Avandia, and even agreed to pay $229m to settle the lawsuits. Without ...
Tags: Avandia Lawsuits, Medicine
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FDA Accepted to Review Bristol-Myers and Pfizer's Eliquis Supplemental New Drug
Jul 12, 2013The US FDA has accepted to review Bristol-Myers Squibb Company and Pfizer's Eliquis (apixaban) supplemental new drug application for prophylaxis of deep vein thrombosis (DVT) subsequent to hip or knee replacement surgery. The application ...
Tags: Drug Application, Medicine
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Takeda Pharmaceutical Company Has Submitted MAA Seeking Approval From The EMA
Mar 11, 2013Takeda Pharmaceutical Company has submitted marketing authorisation application (MAA) seeking approval from the European Medicines Agency (EMA) for its investigational, gut-selective humanized monoclonal antibody for the treatment of adults ...
Tags: Takeda, IBD Disease Drug, MAA, EMA
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Bristol-Myers Squibb and Pfizer Have Announced The US FDA's Approval for Eliquis
Jan 4, 2013Bristol-Myers Squibb and Pfizer have announced the US FDA's approval for Eliquis (apixaban), used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In 2007, Pfizer and Bristol-Myers ...
Tags: US, FDA, Eliquis, patients, nonvalvular atrial fibrillation
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Takeda Receives Response From FDA Regarding Its New Drug Applications
Dec 4, 2012Takeda Pharmaceutical has received a complete response letter from the US Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin and the fixed-dose combination therapy alogliptin and pioglitazone. ...
Tags: FDA, alogliptin, clinical trial program
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Use of Ocular Nsaid in Diabetic Cataract Patients Be Approved By smc
Nov 15, 2012The Scottish Medicines Consortium (SMC) has approved the use of Alcon's Nevanac in patients suffering from diabetes to minimize the possibility of postoperative macular oedema (MO) coupled with cataract surgery. The approval allows the ...
Tags: The Scottish Medicines Consortium, diabetic cataract patients, Medicine