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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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Study Shows How Vitamin E Can Help Prevent Cancer


Ohio State's IDEA Studio for Healthcare and Design

Captured by The Ohio State University

Researchers have identified an elusive anti-cancer property of vitamin E that has long been presumed to exist, but difficult to find.

Many animal studies have suggested that vitamin E could prevent cancer, but human clinical trials following up on those findings have not shown the same benefits.

In this new work, researchers showed in prostate cancer cells that one form of vitamin E inhibits the activation of an enzyme that is essential for cancer cell survival. The loss of the enzyme, called Akt, led to tumor cell death. The vitamin had no negative effect on normal cells.

“This is the first demonstration of a unique mechanism of how vitamin E can have some benefit in terms of cancer prevention and treatment,” said lead author Ching-Shih Chen, professor of medicinal chemistry and pharmacognosy at The Ohio State University and an investigator in Ohio State’s Comprehensive…

View original post 135 more words

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Regenerative Medicine: Polymer coating could help stem cells target inflamed blood vessels to regrow healthy tissue


Mouse embryonic stem cells.jpg

People with chronic diseases like diabetes and multiple sclerosis have inflamed, leaky blood vessels, heightening their risk of heart attack and stroke. Some scientists envision using a patient’s own stem cells to regrow healthy tissue to plug the leaks and calm inflammation. A new polymer coating could help these stem cells find and adhere to inflamed endothelial tissue (J. Am. Chem. Soc., DOI: 10.1021/ja400636d).

read all at

http://cen.acs.org/articles/91/web/2013/04/Putting-Stem-Cells-Place.html

Chemical & Engineering News Serving The Chemical, Life Sciences & Laboratory Worlds

 

CVRx Gains Full FDA Approval for Barostim neo Hypertension Study


investigational device exemption (IDE) approval

Barostim neo

MINNEAPOLIS, April 29, 2013

CVRx, Inc., a private medical device company, received Food and Drug Administration (FDA) investigational device exemption (IDE) approval, allowing the company to proceed with its hypertension study

read all

http://www.stockrants.com/2013/04/29/cvrx-gains-full-fda-approval-for-hypertension-study.html

Barostim neo is designed to use the body’s own natural blood flow regulation system to treat hypertension.

http://www.cvrx.com/int/

 

The system works by electrically activating baroreceptors, the body’s natural blood pressure sensors that regulate cardiovascular function. When the Barostimneo is activated, signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, the heart to slow down and the kidneys to reduce fluid in the body, lowering excessive blood pressure and workload on the heart.

http://www.cvrx.com/int/  play video

Scioderm’s SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa


DURHAM, N.C., April 29, 2013 Scioderm announced its investigational product SD-101 has received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with inherited Epidermolysis Bullosa (EB). SD-101 is Scioderm’s investigational therapy that is being evaluated for the treatment of skin blistering and erosions associated with this disease, including facilitation of healing of skin lesions and reduction of the incidence and/or severity of new lesions.

read all at

http://www.stockrants.com/2013/04/29/scioderms-sd-101-receives-breakthrough-therapy-designation-from-fda-for-treatment-of-epidermolysis-bullosa.html

BioLineRx Enrolls First Patient in Phase I/II Clinical Trial for BL-8020, an Oral, Interferon-Free Treatment for Hepatitis C


BL-8020

read at

http://www.businesswire.com/news/home/20130429005754/en/BioLineRx-Enrolls-Patient-Phase-III-Clinical-Trial

FDA Approves Kcentra for the Urgent Reversal of Anticoagulation in Adults with Major Bleeding


April 29, 2013

The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

“The FDA’s approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation,” said Karen Midthun, M.D., director, Center for Biologics Evaluation and Research, FDA. “Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation.”

Kcentra is associated with the occurrence of blood clots when used as indicated, and carries a boxed warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and post marketing surveillance.

Kcentra is made from the pooled plasma of healthy donors. It is processed in a way to minimize the risk of transmitting viral and other diseases. The FDA approval of Kcentra was based on a study of 216 patients who had been receiving VKA anticoagulation and who had acute major bleeding along with a clotting test value indicative of anticoagulant use. Kcentra was demonstrated to be similar to plasma in terms of the ability to stop acute major bleeding.

The drug is manufactured by CSL Behring, Marburg, Germany.

GSK announces regulatory submission for umeclidinium monotherapy in European Union


 

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.

Daiichi Sankyo enrolls first patient in Nimotuzumab Phase 3 clinical trials


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 available onwww.clinicaltrials.jp/user/cteSearch.jsp.

About Phase 3 Clinical Trials for Gastric Cancer (ENRICH study)

The ENRICH study is a randomized, open-label, Japan-Korea collaborative study of previously treated patients with EGFR overexpressed advanced gastric and gastroesophageal junction cancer who will receive either nimotuzumab and irinotecan hydrochloride hydrate (hereafter, irinotecan) combination therapy or irinotecan monotherapy. The primary endpoint is overall survival (OS), and the secondary endpoints are progression free survival (PFS) and safety. Approximately 400 patients are planned to be enrolled at approximately 40 clinical centers in Japan and South Korea. In Korea, Kuhnil Pharmaceutical Company, Limited (hereafter, Kuhnil) is implementing this trial. Additional details of the trial are available on www.clinicaltrials.gov.

About Unresectable and Locally Advanced Squamous Cell Lung Cancer

In Japan, lung cancer is the first leading cause of cancer death, with about 70,000 deaths in 2011.i Non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, and large cell carcinoma) occupies more than 80 percent of lung cancer. Concurrent chemoradiotherapy for a radical cure is currently used as the standard treatment for patients with stage III locally advanced non-small cell lung cancer, in which radical surgery is not possible but radiotherapy is.ii Of these cases, between 30 and 40 percent are squamous cell carcinoma and EGFR is known to be overexpressed.iii

About Gastric Cancer

Half of the total number of gastric cancer cases worldwide occurs in Eastern Asia.iv In Japan, gastric cancer is the second leading cause of cancer death, with an estimated about 50,000 deaths. i In South Korea, about 10,000 gastric cancer deaths in 2011 were reported.v Numerous improvements have occurred in the management of gastric cancer; however, gastric cancer still has a poor prognosis. For patients with earlier stages of disease, more than 50% undergo surgery, but even after a curative resection, 60% of these patients eventually relapse locally or with distant metastases. vi

About Nimotuzumab and EGFR

Nimotuzumab is an intravenously administered recombinant humanized monoclonal antibody directed against human EGFR and is produced by CIMAB S.A. (Cuba). Nimotuzumab blocks the binding of EGF to its receptor interfering with the cell signaling pathway. Nimotuzumab has been approved for head and neck cancer, glioma, and esophageal cancer in several countries. EGFR is known to be overexpressed in a wide variety of human tumors.vii Overexpression of EGFR in tumors correlates with increased metastasis, decreased survival, and a poor prognosis. It is known that EGFR is activated by exposure to radiation.

In 2006, Daiichi Sankyo introduced nimotuzumab from CIMAB S.A. and CIMYM BioSciences Inc. (Canada) and has the rights to develop and commercialize in Japan. In Korea, Kuhnil has the rights to develop and commercialize.

15 top blockbuster drug contenders, compiled:Fiercebiotech, by John Carroll and Ryan McBride


15 top blockbuster drug contenders, compiled fiercebiotech, by John Carroll and Ryan McBride

read all this at

http://www.fiercebiotech.com/special-reports/top-15-blockbuster-contenders

FierceBiotech

Top 20 Best-Selling Drugs Approved and Launched During 2012


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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