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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Researchers at Northeastern University in Boston have developed a gene therapy approach that may one day stop Parkinson’s disease (PD) in it tracks, preventing disease progression and reversing its symptoms

New Drug Approvals

Glial cell derived neurotrophic factor structure (credit: Wikimedia Commons)


A noninvasive avenue for Parkinson’s disease gene therapy

Nanoparticles bypass the blood-brain barrier to treat Parkinson’s disease
April 26, 2013

Researchers at Northeastern University in Boston have developed a gene therapy approach that may one day stop Parkinson’s disease (PD) in it tracks, preventing disease progression and reversing its symptoms.

The novelty of the approach lies in the nasal route of administration and nanoparticles containing a gene capable of rescuing dying neurons in the brain.

Parkinson’s is a devastating neurodegenerative disorder caused by the death of dopamine neurons in a key motor area of the brain, the substantia nigra (SN). Loss of these neurons leads to the characteristic tremor and slowed movements of PD, which get increasingly worse with time.

Currently, more than 1% of the population over age 60 has PD and approximately 60,000 Americans are newly diagnosed every…

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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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South African Party Favors

Adventuressetravels Blog

Now everyone has done things they wouldn’t dream of doing sober under the influence of a drink or 10.  Sailors are a notoriously drunken lot and the WARC crew take that notoriety to a whole new level.  The WARC parties were a force to be reckoned with.

Umineko’s,  or “sea cat” in Japanese, motto was: have Karaoke Machine, will travel.”  Sato San, the cat’s ebullient skipper was a born showman.  The svelte man was a dyed-in-the-wool extrovert.  He had lived in Detroit for 20 years and easily made friends with all nationalities on the ARC.  It was impossible not to like the man who always had a joke ready and a story to share.   When he joined WARC in Australia he told everyone that Umineko had a karaoke machine on board and invited everyone to karaoke and “Hiroshima Pizza.”

Thus many a WARC party made fellow mariners wish there were some actual…

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