BioVoice News June 2016 Issue 2 Volume 1 - Page 44

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BIOTECH PATENTS DECLINE GLOBALLY , CRUCIAL TIMES AHEAD : THOMSON REUTERS STUDY
Biotech was the only technology area of the 12 studied that decreased its year-over-year innovation output , experiencing a 2 percent decline over 2014 . This is after having had a 7 percent overall increase from 2013 . And all but one of the subsectors , general biotechnology , declined from the earlier period , with the steepest drops in the Diagnosis of Diseases ( 20 percent ) and Drug Discovery ( 13 percent ). This has been revealed in the latest annual Thomson Reuters State of Innovation 2016 Report .
While going into the details , report mentions that the China , France , Germany , South Korea and the US lead the world in biotech innovation . China and the US each have three of the top 10 spots , followed by France with two , while Germany and South Korea split the remaining two .
ACHIRA LABS GETS ' NATIONAL AWARD ' FOR INDIGENOUS PRODUCT COMMERCIALIZATION
The President of India , Mr Pranab Mukherjee awarded the Bangalore based startup , Achira Labs , a pioneer in developing advanced microfluidics-based solutions for applications in diagnostics , with the National Award for Indigenous Product Commercialization on the occasion of Technology Day event on May 11th at New Delhi . The event , held at Vigyan Bhavan convention centre was attended by Dr Harsh Vardhan , Union Minister for Science and Technology and Mr Y S Choudhry , Minister of State for Science and Technology .
The award instituted by the BIRAC carries a citation , trophy and a cash prize of Rs 1 lakh . It was given to Achira Labs this year for developing advanced technology in the field of point of care medical diagnostics . The concept involves the discipline of microfluidics and optics to analyze chemical constituents in blood samples , providing for accurate and immediate analysis .
OCIMUM UNVEILS NEW SOFTWARE PRODUCT TO MANAGE QUALITY PROCESSES
Ocimum Biosolutions , a leading provider of life sciences Laboratory Information Management Systems ( LIMS ), has announced the release of PharmaTracker , which supports QA / QC process and data management in pharmaceutical companies for regulatory markets . It supports exhaustive tracking and robust management of quality control and assurance process and the data generated in an API or drug manufacturing environment
According to Mr Subash Lingareddy , President , Ocimum Biosolutions , “ The software is priced under Rs 100,000 ( US $ 1,500 ) per site per month for unlimited licenses for Indian companies and can be accessed on the cloud enabling managers to keep control of the system remotely ”.
BIRAC PLEDGES SUPPORT TO AMR CAUSE
The Biotechnology Industry Research Assistance Council ( BIRAC ) and the UK based innovation foundation , Nesta are jointly funding the initiative to find a point of care diagnostic solution for anti-microbial resistance . Launched in November 2014 , the Longitude Prize is a fiveyear challenge with a £ 10 million prize fund . It aims to conserve antibiotics for future generations , revolutionizing global healthcare .
To help ensure as many teams as possible enter the Prize , the funding organizations , BIRAC from India and Nesta from United Kingdom , have launched the Longitude Prize Discovery Awards . These are small seed grants to help individuals or teams to further develop their ideas to win the Prize . Objective is to look for a transformative , accurate , affordable , rapid , point of care diagnostic test that is easy to use , anywhere in the world . While the applications have opened up on 16 May and will close on 26 August , the winners will be announced on 21 November . Find out more about the Longitude Prize Discovery Awards at www . longitudeprize . org / discovery awards .
FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF SANOFI ' S TYPE 2 DIABETES CURE
Sanofi announced on May 26 , 2016 that the Endocrinologic and Metabolic Drugs Advisory Committee ( EMDAC ) of the U . S . Food and Drug Administration ( FDA ) recommended the approval of the New Drug Application ( NDA ) for the investigational fixed-ratio combination of basal insulin glargine 100 Units / mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes . The 15-member panel voted 12 to 2 ( 1 panelist did not vote due to travel ) to approve the fixedratio combination of basal insulin glargine 100 Units / mL and GLP-1 receptor agonist lixisenatide .
" We are pleased by the Advisory Committee ' s recommendation for approval of this investigational diabetes therapy ,” said Elias Zerhouni , President , Global R & D , Sanofi . “ By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose , both of which can contribute to HbA1c lowering , this fixed-ratio product may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin .”
STRIDES SHASUN RECEIVES USFDA TENTATIVE APPROVAL FOR EFAVIRENZ
Strides Shasun Limited on May 26 , 2016 announced that it has received tentative approval from the United States Food & Drug Administration ( USFDA ) for Efavirenz Tablet USP , 600 mg . Efavirenz Tablet is indicated for the treatment of Human Immunodeficiency Virus Type 1 ( HIV-1 ) infected adults and adolescents . The final approval will be received after Patent Expiry in August 2018 .
According to IMS data , the US market for Efavirenz 600 mg Tablet is approximately USD 150 Million . The product will be manufactured at the Company ’ s Oral dosage facility at Bangalore and marketed by Strides in the US Market .
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BioVoiceNews | June 2016
news bytes BIOTECH PATENTS DECLINE GLOBALLY, CRUCIAL TIMES AHEAD: THOMSON REUTERS STUDY Biotech was the only technology area of the 12 studied that decreased its year-over-year innovation output, experiencing a 2 percent decline over 2014. This is after having had a 7 percent overall increase from 2013. And all but one of the subsectors, general biotechnology, declined from the earlier period, with the steepest drops in the Diagnosis of Diseases (20 percent) and Drug Discovery (13 percent). This has been revealed in the latest annual Thomson Reuters State of Innovation 2016 Report. While going into the details, report mentions that the China, France, Germany, South Korea and the US lead the world in biotech innovation. China and the US each have three of the top 10 spots, followed by France with two, while Germany and South Korea split the remaining two. ACHIRA LABS GETS 'NATIONAL AWARD' FOR INDIGENOUS PRODUCT COMMERCIALIZATION The President of India, Mr Pranab Mukherjee awarded the Bangalore based startup, Achira Labs, a pioneer in developing advanced microfluidics-based solutions for applications in diagnostics, with the National Award for Indigenous Product Commercialization on the occasion of Technology Day event on May 11th at New Delhi. The event, held at Vigyan Bhavan convention centre was attended by Dr Harsh Vardhan, Union Minister for Science and Technology and Mr Y S Choudhry, Minister of State for Science and Technology. The award instituted by the BIRAC carries a citation, trophy and a cash prize of Rs 1 lakh. It was given to Achira Labs this year for developing advanced technology in the field of point of care medical diagnostics. The concept involves the discipline of microfluidics and optics to analyze chemical constituents in blood samples, providing for accurate and immediate analysis. OCIMUM UNVEILS NEW SOFTWARE PRODUCT TO MANAGE QUALITY PROCESSES Ocimum Biosolutions, a leading provider of life sciences Laboratory Information Management Systems (LIMS), has announced the release of PharmaTracker, which supports QA/QC process and data management in pharmaceutical companies for regulatory markets. It supports exhaustive tracking and robust management of quality control and assurance process and the data generated in an API or drug manufacturing environment According to Mr Subash Lingareddy, President, Ocimum Biosolutions, “The software is priced under Rs 100,000(US$ 1,500) per site per month for unlimited licenses for Indian companies and can be accessed on the cloud enabling managers to keep control of the system remotely”. 44 BioVoiceNews | June 2016 BIRAC PLEDGES SUPPORT TO AMR CAUSE The Biotechnology Industry Research Assistance Council (BIRAC) and the UK based innovation foundation, Nesta are jointly funding the initiative to find a point of care diagnostic solution for anti-microbial resistance. Launched in November 2014, the Longitude Prize is a fiveyear challenge with a £10 million prize fund. It aims to conserve antibiotics for future generations, revolutionizing global healthcare. To help ensure as many teams as possible enter the Prize, the funding organizations, BIRAC from India and Nesta from United Kingdom, have launched the Longitude Prize Discovery Awards. These are small seed grants to help individuals or teams to further develop their ideas to win the Prize. Objective is to look for a transformative, accurate, affordable, rapid, point of care diagnostic test that is easy to use, anywhere in the world. While the applications have opened up on 16 May and will close on 26 August, the winners will be announced on 21 November. Find out more about the Longitude Prize Discovery Awards at www.longitudeprize.org/discovery awards. FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF SANOFI'S TYPE 2 DIABETES CURE Sanofi announced on May 26, 2016 that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of the New Drug Application (NDA) for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The 15-member panel voted 12 to 2 (1 panelist did not vote due to travel) to approve the fixedratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. "We are pleased by the Advisory Committee's recommendation for approval of this investigational diabetes therapy,” said Elias Zerhouni, President, Global R&D, Sanofi. “By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose, both of which can contribute to HbA1c lowering, this fixed-ratio product may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin.” STRIDES SHASUN RECEIVES USFDA TENTATIVE APPROVAL FOR EFAVIRENZ Strides Shasun Limited on May 26, 2016 announced that it has received tentative approval from the United States Food & Drug Administration (USFDA) for Efavirenz Tablet USP, 600 mg. Efavirenz Tablet is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults and adolescents. The final approval will be received after Patent Expiry in August 2018. 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