Top 20 Best-Selling Drugs Approved and Launched During 2012

New Drug Approvals

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Top 20 Best-Selling Drugs Approved and Launched During 2012

What new medicines are shaking things up?

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Daiichi Sankyo enrolls first patient in Nimotuzumab Phase 3 clinical trials

New Drug Approvals


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.

About Phase 3 Clinical Trials for Lung 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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GSK announces regulatory submission for umeclidinium monotherapy in European Union

New Drug Approvals


Umeclidinium bromide

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.

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Ceregene announces top-line data from CERE-120 Phase 2b clinical study for Parkinson’s disease

New Drug Approvals




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


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FDA OKs Sun Pharma for Generic Januvia, Glumetza

New Drug Approvals

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.

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