World Health Organization
TB Alliance, Takeda enter pact for novel TB therapies
TB Alliance and Takeda Pharmaceutical Company Limited have entered into an agreement that further explores hits generated from a high-throughput screening programme conducted to find novel compounds to improve treatment of tuberculosis (TB). The joint research programme is funded through the Global Health Innovative Technology (GHIT) Fund, established for the purpose of promoting research and development of pharmaceutical products, vaccines and diagnostics needed for communicable diseases.
In June 2013, TB Alliance and Takeda initiated a programme to screen Takeda’s library of 20,000 proprietary compounds to identify potential candidates that showed promise to be further developed into new TB treatments. This new collaboration advances the successful hits from the screening program, which was also funded by GHIT Fund. This partnership complements TB Alliance’s existing work in advancing the pipeline for new TB drugs. For Takeda, this programme with TB Alliance is an excellent opportunity to leverage, as part of Takeda’s corporate social responsibility programme, the company’s drug discovery expertise for communicable diseases, in addition to Takeda’s focus on the oncology, gastroenterology and central nervous system therapeutic areas.
TB is the leading infectious disease killer in the world. According to the World Health Organization (WHO), 9.6 million people were infected with TB in 2014. In the same year, 1.5 million people lost their lives to the disease, 95% of whom lived in low- to middle-income countries.
Today’s existing TB treatments are complicated and require a minimum of six months of treatment, imposing a heavy burden on patients, families, and healthcare systems. Treatment for drug-resistant tuberculosis can take two years or longer and is much more expensive and complicated. Given this global health threat, new TB drugs and regimens that are simpler to administer, are of shorter duration, and can overcome drug resistance are urgently needed.
The collaboration will leverage both TB Alliance’s and Takeda’s experience, knowledge and technology to discover and pursue optimal lead compounds for intervention against TB. Through these initiatives, TB Alliance and Takeda aim to contribute to the eradication of TB and improve the health and quality of life for millions of people.
WHO frames Global Regulatory Norms for Medical Devices and IVD
The World Health Organization (WHO)has issued a set of draft guidelines for a global model regulatory framework for medical devices including in-vitro diagnostic devices. The regulator is seeking industry comments for the same before July 12. Indian medical device companies see the move as a step in the right direction.
According to Manoj Menon, medical device consultant who was earlier with GE Healthcare said that the guidelines were anticipated for a long time and is a welcome move. The move will help improve quality of devices and solutions substantially; remove sub-standard devices and bring in transparency. However, the regulatory body should be also geared up for speedy and quality inspections through build up of appropriate tools, infrastructure and trained manpower. A step by step approach is required to manage the large pool of devices marketed.
Medical devices require the highest material and manufacturing standards. Without medical devices, routine medical procedures from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial hip or any surgical intervention would not be possible, noted WHO in its draft guidance.
The medical devices are used in many diverse settings. It could either be on a lay person at home, paramedical staff, clinicians in remote locations and highly trained medical professional in advanced medical facility. Even for opticians and dentists, medical devices are indispensable. Such health technologies are used to diagnose illness, to monitor treatments, assist disabled persons, or intervene and treat illnesses, both acute and chronic. Today there are an estimated 5,00,000 different kinds of medical devices in the world market, separated into more than 10,000 generic devices groups.
The resources people, funds, technology and facilities available in any country for regulatory control of medical devices are limited. Generally, such resources will be allocated to support overall government policy objectives and priorities but it also reflects the characteristics of the national market for medical devices. Medical devices are barometer of public health needs, burden of disease, demographic trends, economic development among others. It also indicates the industry structure on sources of supply which covers imported versus domestic manufacture.
The WHO has pointed out that regulation of medical devices does not take place in isolation and it should be coordinated with regulation of other products like medicines, vaccines, and government policy objectives.
The WHO model recommends guiding principles, harmonized definitions and the essential elements required for effective and efficient regulation. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).
“The model is particularly relevant for WHO member states with no or limited regulation for medical devices in place. Yet it foresees that countries will progress from basic controls towards an expanded level as their resources allow. It will also describe circumstances in which a regulatory authority may rely upon, or recognize, the work products from trusted regulatory systems providing scientific assessments, audit and inspection reports or WHO pre-qualification,” stated the draft guidance.
The draft also indicated that there are limitations to the Global Model Regulatory Framework for Medical Devices including IVDs. Therefore the model provides a general approach and cannot provide country -specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it provides references to relevant documents. It does not detail responsibilities of manufacturers, distributors and healthcare professionals, who have roles to assure quality, safety and performance of medical devices.
Source : Pharmabiz
DCGI sets up Independent Expert Committee on Oncology for trial deaths caused by cancer drugs
The Drugs Controller General of India (DCGI) has constituted an Independent Expert Committee on Oncology for examination of reports of serious adverse events (SAEs) of deaths occurred during clinical trials in the country. Dr Arun Agarwal, Professor of ENT, Maulana Azad Medical College, New Delhi is the chairman of the expert committee.
The committee will function under the provisions as specified in Appendix XII of the Schedule Y of the Drugs & Cosmetics Rules.
The chairman of the committee will receive reports of serious adverse events of death from investigators, sponsors or his representatives whosoever had obtained permission from the DCGI for conducting the clinical trial and the ethics committee. The committee will examine the reports of serious adverse events of death, to determine the cause of death and if the cause is due to reasons which are considered as clinical trial related death , then it will give its recommendation to the DCGI.
The committee will examine whether the death has been happened due to adverse effect of investigational products; due to violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator; whether it is due to the failure of investigational product to provide intended therapeutic effect; due to use of placebo in a placebo-controlled trial; due to adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol; for injury to a child in-utero because of the participation of parent in clinical trial; and due to any clinical trial procedures involved in the study.
In case of clinical trial related death, the committee will also give recommendation to the DCGI the quantum of compensation to be paid by the sponsor or his representative.
Dr YK Gupta of AIIMS New Delhi; Dr Renuka Kulkarni-Munshi of TN Medical College and BLY Nair Charitable Hospital, Mumbai; Dr Hemant Malhotra of SMS Medical College, Rajasthan; Dr SD Banavali of Tata Memorial Hospital, Mumbai; Dr TN Sagar of Cancer Institute, Adayar, Chennai; Dr Kishore Singh of Maulana Azad Medical College, New Delhi; and Dr S Kataria of Safdarjung Hospital are the other members of the 8-member expert committee.
Source: PharmaBiz
Mosquitoes kill more people yearly than crocodiles and sharks do
Gates and his wife Melinda have dedicated many philanthropic endeavors to help eradicate malaria and other mosquito-borne diseases through the Bill and Melinda Gates Foundation.
Report on antibiotic resistance reveals worldwide threat to public health
The planet may be headed toward a “post-antibiotic era” in which common infections once easily controlled by antimicrobial medicines are lethal, the World Health Organization reported Wednesday in its first look at antibiotic resistance that has developed in all parts of the world.
“The problem is so serious that it threatens the achievements of modern medicine,” the organization said, adding that “a very real possibility for the 21st century” is a time when standard treatments no longer work, the chances of death from infection rise and the risk of disease spreading to others will increase.
“Effective antibiotics have been one of the pillars allowing us to live longer, live healthier and benefit from modern medicine,” Keiji Fukuda, WHO’s assistant director-general for health security, said in a news release. “Unless we take significant actions to improve efforts to prevent infections and also change how we produce, prescribe and use antibiotics, the world will lose more and more of these global public health goods and the implications will be devastating.”
Such alarm in the health-care community and elsewhere about resistance to antibiotics is not new. In September, the US Centers for Disease Control and Prevention warned of “potentially catastrophic consequences” of drug-resistant microorganisms, saying they now kill an estimated 23,000 people in this country every year, and other public health groups have been clamoring about them for years.
But WHO reported that “very high rates of resistance” have been observed around the world to common bacteria that cause urinary tract, wound and bloodstream infections, as well as pneumonia. Multi-drug-resistant tuberculosis is a growing and under-reported concern, and rising resistance to anti-HIV drugs has been detected. At the same time, surveillance of the growing threat by officials worldwide is not coordinated.
In a region-by-region breakdown, WHO reported that in some settings in the Americas, up to 90 percent of Staphylococcus aureus infections are resistant to methicillin, a situation that has come to be abbreviated as MRSA. The bacteria that causes pneumonia is now less susceptible to penicillin throughout the world and exceeds 50 percent of cases in some places. In 36 countries, the last-resort treatment for gonorrhea is proving less effective.
Source: Arab News
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