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- Read more about EMA grant marketing authorisation for Vabomere
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vabomere (meropenem trihydrate/vaborbactam), a new treatment option against the following infections in adults: Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection causing the kidneys to swell and which may permanently damage them; Complicated intra-abdominal infection; Hospital-acquired pneumonia, including ventilator associated pneumonia; Bacteria in the blood associated with any of the infections listed above; Infections due to aerobic Gram-negative organisms in adults with limited treatment options.
- Read more about EMA committee recommend grant marketing authorisation for Emgality (galcanezumab)
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.
- Read more about WHO is developing Benchmark Documents for practice in traditional medicine
World Health Organisation is developing Benchmark Documents for practice in Ayurveda, Panckarma and Unani system as part of its global strategy to provide safe, effective and accessible Traditional Medicine to global community. Development of these benchmarks documents is included in the Project Collaboration Agreement (PCA) between WHO and Ministry of AYUSH. WHO Working Group Meetings for three WHO benchmark documents scheduled 17 -19 September, 2018, was inaugurated at Jaipur. The three days programme containing four sessions on each day has been organized by Ministry of AYUSH and coordinated by National Institute of Ayurveda (NIA), Jaipur.
- Read more about FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications
U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting.
- Read more about Health ministry initiate Empanelment of Independent National Monitors
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
- Read more about National AIDS Control Organization (NACO) releases HIV Estimations 2017
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).
- Read more about NIH announce the launch of initiative to accelerate genetic therapies to cure sickle cell disease
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.
- Read more about Sun Pharma and SPARC Announce US FDA Approval of XELPROS™
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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- Read more about FDA is issuing new warning letters to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom
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.

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