GVK BIO Newsletter, October 2013
October 2013

GVK BIO and US FDA Announced Drug Repositioning Collaboration – License to GVK BIO SAR Database GOSTARh

FDAGVK BIO licensed its popular SAR, PK and Toxicity Database (GOSTAR) to the US Food and Drug Administration (USFDA).

The Material Transfer Agreement formed the basis of collaboration in Drug Repositioning, wherein the initial focus would be to identify alternative therapeutic indications of marketed compounds for neglected and orphan diseases.

The platform will use data from GVKBIO proprietary databases such as SAR databases (GOSTAR), Biomarker database (GOBIOM) and other public databases. GOSTAR, a manually curated database, has been developed over the span of a decade by a team comprising of more than 200 scientists. The database and application is being used globally by pharmaceutical and biotechnology companies as well as academia and has been cited in numerous publications.

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Drug Discovery Unit (DDU), University of Dundee licensed GVK BIO Online SAR database (GOSTAR)

DUNDEEGVK BIO licensed its Online SAR Database – GOSTAR to the Drug Discovery Unit (DDU) at the University of Dundee. The product issued globally in various areas such as pharmaceuticals, academics, government sectors, apart from numerous publications that cite the data contained in GOSTAR.

GOSTAR contains over 6 million compounds manually curated through the screening of over 2 million patents and 400,000 journals and it also contains more than 18 million quantitative SAR points. It is envisaged that the GOSTAR database will greatly impact the drug discovery efforts underway within the DDU.

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GVK Biosciences Pvt. Ltd. Announced New Distributor in Taiwan

GVK BIO selected Genesis Genetics Asia Corp. as its distributor for its Informatics Database products and services in Taiwan. GGA is recognized as the premier distributor in the Life Sciences industry in Taiwan and the alliance would enable the company to work with a high caliber sales team that would help expand GVK BIO’s customer base in the region. GGA will be responsible for distribution of the SAR, Biomarker and Clinical Outcomes databases and would also promote the BioIT and Data Curation services offered by GVK BIO.

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GVK BIO Extends License of its Clinical Biomarker database to USFDA

US FDA & GOBIOMGVK BIO extended its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (USFDA). The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the USFDA in its Biomarker Qualification Process.

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GVK BIO Entered into a Research Collaboration with Endo Pharmaceuticals

GVK EndoGVK BIO entered into a collaboration agreement with U.S.-based Endo Pharmaceuticals focused on discovering novel small molecules targeting an exciting protein. Under this agreement, GVK BIO will use its discovery expertise to deliver a clinical candidate and Endo will develop and commercialize the product arising out of this collaboration. This collaboration arose out of a newly launched concept at GVK BIO named Early Discovery Assets (EDA™).

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  In this Issue  
GVK BIO and US FDA Announced Drug Repositioning Collaboration – License to GVK BIO SAR Database GOSTAR  
 
Drug Discovery Unit (DDU), University of Dundee licensed GVK BIO Online SAR database (GOSTAR)  
 
GVK Biosciences Pvt. Ltd. Announced New Distributor in Taiwan  
 
GVK BIO Extends License of the its Clinical Biomarker database to USFDA  
 
GVK BIO Entered into a Research Collaboration with Endo Pharmaceuticals  
 
GVK Biosciences and Onconova Therapeutics Established Novel Joint Development Partnership to Advance New Drugs for Cancern  
 
GVK BIO establishes the largest Isotope Labeling facility in India  
 
GVK Biosciences licensed its Biomarker Database to The Division of Cancer Prevention, National Cancer Institute  
 
Inogent Laboratories Clears the Pharmaceuticals and Medical Devices Agency (PMDA), Japan Audit  
 
Inogent

 

GVK Biosciences and Onconova Therapeutics Established Novel Joint Development Partnership to Advance New Drugs for Cancer

GVK & OnconovaGVK BIO and Onconova Therapeutics, a U.S. based biopharmaceutical company primarily focused on discovery and development of novel small molecules for Oncology, entered into a novel joint partnership to develop new drugs for Cancer. The joint partnership will be based in the U.S. and will align research priorities and technological expertise from both companies to facilitate moving certain Onconova oncology assets from early discovery to clinical development stage. Dr. E. Premkumar Reddy, the scientific founder and Director of Onconova and a world-renowned molecular oncologist, will oversee the biology and biomarker aspects of the Partnership. Onconova will provide two discovery targets with early chemical equity, while GVK BIO will use its multi-disciplinary discovery platform to advance these programs through lead optimization and IND candidate selection.

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GVK BIO establishes the largest Isotope Labeling facility in India

Atomic Energy Regulatory BoardGVK BIO received approvals from the Atomic Energy Regulatory Board (AERB), Government of India, to carry out 3H and 14C synthesis activities. This GLP compliant facility has state-of-the-art equipment to cater to the requirements of companies engaged in the fields of Drug Discovery and Development, Agro and Veterinary Chemicals, Cosmetics, Perfumery and Specialty Studies. This development is in response to the increasing demand from clients for enhancing chemistry services to include isotope labeling services. This state-of-the art facility is the largest such facility in India and has received all statutory approvals from the Atomic Energy Review Board of India.

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GVK Biosciences Licensed its Biomarker Database to the Division of Cancer Prevention, National Cancer Institute

National Cancer InstituteGVK BIO licensed its popular clinical biomarker database (GOBIOM) to the prestigious Division of Cancer Prevention (DCP), National Cancer Institute (NCI). The GOBIOM (GVK BIO Online Biomarker Database) is a comprehensive collection of all clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. GOBIOM covers over 100 different ethnicities, provides extensive information on approved assay methodologies & companion diagnostics and is a powerful tool for researchers and clinicians worldwide. Biomarker Research is growing exponentially in the area of Oncology. The GVK Database has over 6000 clinically evaluated markers in oncology and growing.

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Inogent Laboratories Clears the Pharmaceuticals and Medical Devices Agency (PMDA), Japan Audit

PMDAInogent’s GMP compliant facilities in Hyderabad were audited and approved by the Japanese regulator, Pharmaceuticals and Medical Devices Agency (PMDA). PMDA conducts scientific reviews of marketing authorization application of pharmaceuticals and medical devices and monitoring of their post-marketing safety. A four member team from PMDA, Japan visited and audited Inogent’s facility, processes and quality management system and approved it without any major observations.

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