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The Central government initiated empanelling independent individual and institutional monitors across the country.
The main objective is to undertake regular monitoring of major national programmes and special monitoring of specific interventions under the NHM, to identify areas for improvement following the review and to provide suggestions for addressing the gaps identified
The National AIDS Control Organisation (NACO) released the report HIV Estimations 2017 at a function. The HIV Estimations 2017 is the 14th round in the series of HIV Estimations under National AIDS Control Programme (NACP).
The National Institutes of Health announced the launch of a new initiative to help speed the development of cures for sickle cell disease, a group of inherited blood disorders affecting at least 100,000 people in the United States and 20 million worldwide. The Cure Sickle Cell Initiative will take advantage of the latest genetic discoveries and technological advances to move the most promising genetic-based curative therapies safely into clinical trials within five to 10 years.
Sun Pharma Advanced Research Company Ltd. announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of XELPROSTM (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat, India) facility.
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Epidemics don’t occur overnight. U.S. Food and Drug Administration must remain vigilant and aggressive against trends that threaten to reverse our progress, or substances that have the potential to cause new epidemics of abuse.
The U.S. Food and Drug Administration announced that it has awarded five grants totaling up to USD 6 million per year over the next five years to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children's medical devices. The program aims to enhance the development, production and distribution of pediatric medical devices and has awarded USD 37 million to various consortia since 2009.
The PDC grant recipients and their principal investigators for 2018 are the following:
• Philadelphia Pediatric Medical Device Consortium, Matthew Maltese, Ph.D.
• National Capital Consortium for Pediatric Device Innovation 2.0, Kolaleh Eskandanian, Ph.D., M.B.A.
• Southwest National Pediatric Device Consortium, Chester Koh, M.D.
• University of California San Francisco-Stanford Pediatric Device Consortium, Michael Harrison, M.D.
• West Coast Consortium for Technology and Innovation in Pediatrics, Juan Espinoza, M.D.
Specific areas of expertise provided by the consortia to medical device innovators include advising on issues related to: intellectual property, prototyping, engineering, laboratory and animal testing, grant-writing and clinical trial design to help foster and guide the advancement of medical devices specifically for children.
Of the estimated USD 6 million granted this year, approximately USD 1 million will be used for the Real World Evidence (RWE) Demonstration Project, in which three of the consortia will conduct RWE projects in the pediatric space that develop, verify and operationalize methods of evidence generation, data use and scalability across device types, manufacturers and the health care system. The FDA intends to use the information gathered through this initiative to further efforts to incorporate RWE into the agency’s work.
Legislation passed by Congress in 2007 established funding to be distributed as grants for nonprofit consortia to help stimulate projects to promote the development and availability of pediatric medical devices. This legislation was re-authorized as part of the FDA Safety and Innovation Act of 2012 and again in the FDA Reauthorization Act of 2017 to run through fiscal year 2022.
The PDC Grants Program was launched in 2009, and this is the fourth time the FDA has awarded grants. Each group’s grant runs for five consecutive years. Funding for fiscal year 2018 is approximately USD 1 million to USD 1.35 million per consortium. Support for the four additional years will be contingent upon annual appropriations, availability of funding and satisfactory awardee performance.
The consortia have assisted or advised more than 1,000 medical device projects since the program began. There are now 19 pediatric medical devices available to patients as a result of this grants program, including a needle-free blood collection device that attaches to peripheral IV systems for use as a direct blood draw device; a surgical vessel sealing system for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles and a rapid infusion device that delivers fluids to a patient’s vascular system.
The Ministry of Health and Family Welfare has issued a notification for bringing the Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017 in force from 10th September, 2018.
The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.
NITI Aayog, Intel, and Tata Institute of Fundamental Research (TIFR) announced on 7th September that they are collaborating to set up a Model International Center for Transformative Artificial Intelligence (ICTAI) towards developing and deploying AI-led application-based research projects. This initiative is part of NITI Aayog’s ‘National Strategy for Artificial Intelligence’ Discussion Paper that focuses on establishing ICTAI in the country through private sector collaboration.
Aurobindo Pharma Limited a world-leading marketer and manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, announces the signing of a definitive agreement to acquire certain assets from Sandoz Inc., USA ("Sandoz"), a Novartis Division, comprising a market leading dermatology business and a portfolio of oral solid products along with commercial and manufacturing infrastructure in the US. The acquisition will be on debt free and cash free basis and will be made through its wholly owned subsidiary, Aurobindo Pharma USA Inc. Aurobindo and Sandoz will enter into a transitional services agreement to support the ongoing growth plans of the businesses being acquired by Aurobindo.
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