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

View original post

Daiichi Sankyo enrolls first patient in Nimotuzumab Phase 3 clinical trials

New Drug Approvals

Nimotuzumab

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…

View original post 435 more words

GSK announces regulatory submission for umeclidinium monotherapy in European Union

New Drug Approvals

 

Umeclidinium bromide

http://www.ama-assn.org/resources/doc/usan/umeclidinium-bromide.pdf

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.

View original post

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

http://www.news-medical.net/news/20130420/Ceregene-announces-top-line-data-from-CERE-12-Phase-2b-clinical-study-for-Parkinsons-disease.aspx

 

View original post

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.

read more at pharmalive

http://www.pharmalive.com/fda-oks-sun-pharma-for-generic-januvia-glumetza

View original post

The Pakistan Political Palette

Pakpotpourri2's Blog

This is a Pkpotpourri Exclusive

By: Yasmeen Ali

The Pakistan Political Palette is dotted with multi hues. Parties that have been there, seen it, done all, the wannabes waiting for their turn, individuals who have returned from yonder wanting to grab a part of the action. You name it, Pakistan has it. The trailer promises an action packed thriller. Grab your bag of pop corns everyone!

NS & AZFirst there are the traditional arch rivals: PPP and PML-N. The five years of PPP governance have been marred by increase in terrorism, inflation, energy crisis. There are charges of widespread corruption. Whereas it is true that PPP could have improved upon its governance, it is also true that after the 18th Amendment- a number of issues laid at the federation door were the responsibility of the provincial governments. PML-N and MQM cannot today, legitimately claim to oppose PPP after having governed their…

View original post 1,008 more words

Parveen Rehman. Keep the Torch Alight

Journeys to democracy

The cold-blooded murder of Perween Rehman on March 13 this year came as no great surprise —  in the lawless concrete jungle that is Karachi, one always expects the worst. That doesn’t mitigate the shock and  immense grief at the gunning down of the gentlest of human beings, someone who had devoted her life to helping the poor, empowering the under-privileged. Below, my article on Perween in Economic and Political Weekly, India, written on March 19, 2013. Also see the these beatuiful tributes by K. B. Abro (with audio), Zameen Kha Gayi Asmaan Kaise Kaise; Zubeida Mustafa, Rest in peace little sister; and Masuma Hasan, Perween Rahman: the legend lives on

View original post 2,286 more words

Pakistan Goes to the Oscars

CHUP! - Changing Up Pakistan

Tomorrow is Oscar day. If you are anything like me, you watch as many Oscar-nominated films as humanly possible (while still, of course, maintaining some semblance of a life) and hope your favorite movies walk away with the coveted trophy.

The Oscars are it, the last pit stop in the awards season, the culmination of all that was brilliant in film that year. This year, filmmaker Sharmeen Obaid Chinoy became the first Pakistani to ever garner an Academy Award nomination. Her documentary, Saving Face, co-directed with Daniel Junge, is up for the Oscar in the short documentary category. The film delves into the issue of acid attacks through the lens of the women affected by tragedy and the doctor trying to help them. In Pakistan, there are 100 acid attacks reported each year, but many cases go unreported, the victims instead relegated to the shadows…

View original post 851 more words