Biotechnology from bench to business
Top 20 Best-Selling Drugs Approved and Launched During 2012
What new medicines are shaking things up?
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15 top blockbuster drug contenders, compiled fiercebiotech, by John Carroll and Ryan McBride
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25 April 2013
Daiichi Sankyo Company, Limited announced today that the first patient has been enrolled in two pivotal phase 3 clinical trials of nimotuzumab (DE-766), a recombinant humanized monoclonal antibody targeting the Epidermal Growth Factor Receptor (EGFR), which is being evaluated for the treatment of patients diagnosed with lung cancer and with gastric cancer.
The phase 3 clinical trial is a multicenter, randomized, double-blind, placebo-controlled study investigating nimotuzumab for the first-line therapy in patients with unresectable and locally advanced squamous cell lung cancer. The patients will receive either nimotuzumab in combination with concurrent chemoradiotherapy or placebo in combination with concurrent chemoradiotherapy. The primary endpoint is overall survival (OS), and the secondary endpoints are progression free survival (PFS) and safety. Approximately 420 patients are planned to be enrolled at approximately 60 clinical centers in Japan. Additional details of the trial are…
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26 April 2013
GlaxoSmithKline plc today announced the submission of a regulatory application in the European Union for the investigational once-daily medicine, umeclidinium bromide (UMEC), for patients with chronic obstructive pulmonary disease (COPD).
UMEC is an investigational bronchodilator molecule (formerly known as GSK573719), a long-acting muscarinic antagonist (LAMA), administered using the ELLIPTA™ inhaler.
A Marketing Authorisation Application (MAA) for UMEC monotherapy (55 mcg delivered dose) has been submitted to the European Medicines Agency (EMA), for a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
Regulatory filings for UMEC monotherapy are imminent in the US and planned in other countries during the course of 2013.
Ceregene, Inc. today announced the top-line data from its double-blind, randomized, controlled Phase 2b clinical study of CERE-120 (AAV-neurturin), a gene therapy product designed to deliver the neurotrophic factor neurturin, for Parkinson’s disease……………read more at
Sun Pharma announces tentative USFDA approvals for generic Januvia® and generic Glumetza®
SUNPHARMA, BSE: 524715) announced that the US FDA has granted its subsidiary, two tentative approvals for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia®, Sitagliptin Tablets and generic version of Glumetza®, Metformin HCl Extended-release tablets.
read more at pharmalive
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