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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Biosimilars: 10 Drugs to Watch

New Drug Approvals

Genetic Engineering & Biotechnology News | www.genengnews.com

Biotechnology from bench to business

Biosimilars: 10 Drugs to Watch

Which innovator drugs are companies scrambling to copy?

read at




have a great reading

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Top 20 Best-Selling Drugs Approved and Launched During 2012

New Drug Approvals

Genetic Engineering & Biotechnology News | www.genengnews.com

Biotechnology from bench to business

Top 20 Best-Selling Drugs Approved and Launched During 2012

What new medicines are shaking things up?

read all this at http://www.genengnews.com/insight-and-intelligence/top-20-best-selling-drugs-approved-and-launched-during-2012/77899791/

have a good reading

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New Drug Approvals

Diabetes is one of the oldest known diseases. An Egyptian manuscript mentions the phrase “the passing of too much urine” to describe the prevalence of the disease then, while in India, the great physician Sushruta, identified the disease and classified it as Medhumeha. The ancient Indians tested for diabetes by observing whether ants were attracted to a person’s urine, and called the ailment “sweet urine disease”.

Of the estimated 346 million people worldwide that suffer from Diabetes, around 51 million are in India alone! According to a WHO report, an estimated 3.4 million people died from consequences of high blood sugar in 2004.

Many studies have shown how the use of certain plants has helped in lowering blood sugar levels and to some extent even curtailing it completely. This week we list down a few common and easily available plants that have proved to be very efficient in curbing this…

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New Drug Approvals


Erection of the penis in males is often a result of a state of sexual arousal. Erectile dysfunction occurs when it becomes difficult to produce erection even in a state of adequate arousal. Erectile dysfunction can occur at any age to any one and at any point of time. It can be due to a vast array of reasons, ranging from fatigue to serious diabetic or heart conditions. While causes like fatigue can be taken care of by simple rest and a good night’s sleep, serious causes like diabetes and cardiovascular diseases can be a little difficult to deal with. Erectile dysfunction does not necessarily mean that there is something physically wrong within the body, as it can also be a result of a vast number of psychological reasons. The loss of erection in itself can give rise to a vast number of psychological problems like loss of self…

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