Announcements  

Announcements

EDCTP    [to 18 November 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
15 November 2017
EU action against antimicrobial resistance: EDCTP’s contribution
Antimicrobial resistance and improper use of antibiotics are a potential global threat to healthcare. During the European Antibiotic Awareness Week…

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European Medicines Agency  [to 18 November 2017]
http://www.ema.europa.eu/ema/
17/11/2017
Towards a single development programme for new antibiotics in EU, Japan and US
EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development …

16/11/2017
Improving the availability of vaccines for animals within the EU
CVMP agrees proposals to increase clarity for when field efficacy trials are needed in the development of veterinary vaccines
The Committee for Veterinary Medicinal Products (CVMP), at its November meeting, accepted recommendations to clarify the need for conducting field efficacy trials, i.e. trials in animals under real-life conditions in the field, to support the authorisation of veterinary vaccines. Improving clarity on this topic will facilitate the availability of veterinary vaccines in the European Union (EU).

These recommendations were made by the joint European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) Steering Group on veterinary vaccine availability on the basis of the outcome of a joint EMA/HMA stakeholder focus group meeting held in June 2017, which brought together regulators, industry and academic experts.

According to EU legislation, the efficacy and safety of veterinary vaccines should be demonstrated in laboratory trials, and then supplemented by data from field trials, unless an acceptable justification can be provided for not providing this data. The role of veterinary field trials is primarily to confirm that the performance of the product observed under controlled experimental conditions is verified under actual conditions of use.

According to veterinary vaccine developers, field trials can be challenging to carry out because of practical matters and due to issues related to trial design whilst adding only limited value to an authorisation dossier. A common issue encountered is connected to trials where animals are not exposed to the disease under real-life conditions, leading to inconclusive outcomes, while conducting these trials can be very costly…

15/11/2017
EMA to work with stakeholders to improve the product information for EU medicines
Stakeholder feedback sought on ongoing electronic initiatives …
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FDA [to 18 November 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
November 16, 2017 –
FDA announces comprehensive regenerative medicine policy framework
[See Milestones above for more detail]
 
November 16, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
[See Milestones above for more detail]
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Fondation Merieux  [to 18 November 2017]
http://www.fondation-merieux.org/
November 13, 2017
African countries launch framework to tackle the threat of antibiotic resistant infections
Annecy, 07 November 2017- Africa CDC launched its framework to fight antibiotic resistant infections during the eighth edition of the Advanced Courses on Diagnostics convened by the Fondation Mérieux.
The Advanced Course on Diagnostics (ACDx) was organized October 29-November 3 at Les Pensières Center for Global Health by the Mérieux Foundation and the London School of Hygiene & Tropical Medicine (LSHTM). This eighth edition trained more than 38 scientists and decision-makers from 20 countries…
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Gavi [to 18 November 2017]
http://www.gavi.org/library/news/press-releases/
12 November 2017
Pneumonia vaccine saves 500,000 lives in world’s poorest countries
Over 109 million children in the developing world have now received pneumococcal conjugate vaccine (PCV).
Geneva – The rollout of pneumonia vaccine has prevented the deaths of over half a million children in developing countries over the past decade, Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, said today.

Since 2007, 109 million children have received pneumococcal conjugate vaccine (PCV), which protects against the leading cause of pneumonia, with the support of Gavi. Vaccination coverage in Gavi-supported countries has now reached 41%, up from 35% in 2015 and almost equaling the global average of 42%.

“Hundreds of thousands of children in the world’s poorest countries are alive today thanks to pneumococcal vaccine,” said Dr Berkley. “I’m immensely proud of the role Gavi has played in expanding access to this lifesaver over the past ten years, but millions of children remain unprotected. This is an entirely preventable, treatable disease that still takes the lives of more children than any other illness, causing untold needless suffering. We cannot afford to lose focus in the fight against pneumonia.”

This year marks the tenth anniversary of the launch of the Advance Market Commitment (AMC). Children in the poorest countries typically received newly developed vaccines more than a decade later than children in the richest countries. With help from the AMC developing countries began to introduce the latest formulations of PCV as soon as a year after they were first made available.

Funded by Italy, UK, Canada, Russia, Norway and the Bill and Melinda Gates Foundation, this unique financing mechanism has allowed eligible countries to access affordable PCV vaccines at a cost of less than 10% of the US market price. Gavi has now helped 58 countries across Africa and Asia to introduce the vaccine into their routine immunisation programmes…
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Global Fund [to 18 November 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund Appoints Peter Sands as Executive Director
14 November 2017
The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria today appointed a new Executive Director: Peter Sands, a former chief executive of Standard Chartered Bank who after a distinguished career in banking immersed himself in a range of global public health projects.
[See Milestones above for more detail]
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IAVI  [to 18 November 2017]
https://www.iavi.org/
November 13, 2017
IAVI’s Fran Priddy Talks Scientific Challenges at AtlanticLIVE’s Vaccines + Immunity
What’s missing in HIV vaccine development? If you guessed political will or buy-in from pharmaceutical companies, you’d be wrong.
According to Fran Priddy, IAVI’s Chief Medical Officer, it’s actually the virus itself, she explained at AtlanticLIVE’s Vaccines + Immunity event on November 9 in Philadelphia. The event convened top health officials and vaccine experts from both the private and public sectors.
That’s not to say that HIV vaccine research efforts are deficient, however. Priddy’s point is that HIV is an extraordinarily challenging and elusive virus and why, 30 years later, scientists are still trying to understand how the body produces HIV antibodies and how to harness that knowledge in a vaccine.
“The science is really key for HIV,” she said. “That’s really why it’s been such a long road.”
Priddy joined Leonard Friedland of GSK and David B. Weiner of the Wistar Institute for a panel on the latest science, which includes a roster of 260 new vaccines in development by America’s biopharmaceutical companies. She highlighted the last decade’s HIV vaccine progress, such as the discovery of broadly neutralizing antibodies, which has led to a renaissance in the field. As important, she discussed the hurdles facing vaccine product development in light of these successes…

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IVAC  [to 18 November 2017]
http://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Latest IVAC News  [Undated]
Mathu Santosham, MD, MPH, wins the 2017 Prince Mahidol Award
IVAC’s Senior Advisor recognized for landmark scientific contribution to controlling Hib, pneumococcal disease
Mathu Santosham, MD, MPH, has received the Prince Mahidol Award 2017 in the field of Public Health, which recognizes “outstanding contribution in the field of public health for the sake of the well-being of the peoples.”
Santosham, who serves as Director Emeritus of the Johns Hopkins Center for American Indian Health and Special Advisor in the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, has been recognized for his landmark scientific contribution to the control of Hib and pneumococcal disease around the world.
The Prince Mahidol Award was established in 1992 to honor the late Prince Mahidol of Songka, the Royal Father of His Majesty the King of Thailand. Prince Mahidol modernized medical services and education in Thailand and is known to the country as the “Father of Modern Medicine and Public Health.” Dr. Santosham will jointly receive the award with Professor Porter Warren Anderson Jr., Dr. Rachel Schneerson, and Dr. John B. Robbins…
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MSF/Médecins Sans Frontières  [to 18 November 2017]
http://www.doctorswithoutborders.org/news stories/press/press-releases
Press release
Yemen: Blockade by Saudi-Led Coalition Hindering Medical Aid
SANA’A, YEMEN/NEW YORK, NOVEMBER 17, 2017—The Saudi-led coalition’s continuing blockade of Yemen’s ports and airports is significantly hindering the efforts of Doctors Without Borders/Médecins Sans Frontières (MSF) and other humanitarian organizations to provide lifesaving assistance to people in the war-torn country.
For the past 12 days, MSF has not received authorization from the Saudi-led coalition to fly into Yemen’s capital, Sana’a, which is essential to bring medical supplies and staff to patients in need.

Press release
Doctors Without Borders Brings Interactive Exhibition on Refugee Crisis to the Santa Monica Pier
November 15, 2017
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières brings its exhibition on the plight of more than 65 million refugees and internally displaced people to Santa Monica this week. Forced From Home illustrates individual stories of the world’s displaced people, and helps visitors better understand the medical humanitarian consequences of the global refugee crisis.

Press release
MSF Welcomes Suspension of Harmful Intellectual Property Measures in New TPP Trade Deal
November 14, 2017
Ministers from the eleven countries assessing the Trans-Pacific Partnership (TPP) trade deal have suspended many of the damaging provisions that would have restricted access to medicines and vaccines, a victory for millions of people who rely on affordable medicines worldwide.
 
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NIH  [to 18 November 2017]
http://www.nih.gov/news-events/news-releases
November 16, 2017
National organizations support outreach efforts for NIH’s All of Us Research Program
— Groups will help raise awareness about the initiative to engage 1 million or more volunteers in health research.

November 14, 2017
Three decades of responding to infectious disease outbreaks
— NIAID director Anthony S. Fauci, M.D., highlights lessons from AIDS to Zika.
Article : CI Paules, et al. What recent history has taught us about responding to emerging infectious disease threats. Annals of Internal Medicine DOI: 10.7326/M17-2496 (2017).

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PATH  [to 18 November 2017]
http://www.path.org/news/index.php
Press release | November 15, 2017
A Structural Clue to Attacking Malaria’s ‘Achilles Heel’
TSRI and PATH collaboration provides blueprint for design of a next-generation vaccine
Washington DC, and La Jolla California, November 15, 2017—Researchers from The Scripps Research Institute (TSRI) and PATH’s Malaria Vaccine Initiative (MVI) have shed light on how the human immune system recognizes the malaria parasite through investigation of antibodies generated from the RTS,S malaria vaccine—work that could boost the development of a more potent vaccine against the global killer.
In a study published this week in the journal Proceedings of the National Academy of Sciences, the researchers provide an atomic-level view of how human antibodies bind to an important malarial surface protein, the circumsporozoite protein [CSP], to protect against the malaria parasite. These new structures could potentially help scientists enhance the efficacy and duration of RTS,S, the world’s most advanced malaria vaccine to date, which has shown partial protection against the disease in a large-scale Phase 3 clinical trial.
The RTS,S vaccine was the outcome of a long-standing collaboration between PATH and GSK that began in 2001 and involved research institutions in Africa and around the world. RTS,S is the first and, to date, the only vaccine to show a protective effect against malaria among young children in Phase 3 clinical trials.
Efforts continue to enhance the vaccine’s efficacy and duration of protection against malaria, a major public health problem that infects millions of people each year. An estimated 429,000 people died from the mosquito-borne illness in 2015 and 212 million people were infected…

Press release | November 14, 2017
Multi-sector partnership supports detection and treatment of childhood tuberculosis in Vietnam
Nghe An, Vietnam, November 14, 2017—Increasing numbers of children in four districts of Vietnam’s Nghe An province are being protected against tuberculosis (TB) through a partnership focused on strengthening detection, treatment, and management of the deadly disease.
The Breath for Life project, a partnership between PATH, the Nghe An Tuberculosis and Lung Disease Hospital, and Johnson & Johnson, has supported public and private health care workers and facilities to increase the detection and early treatment of children with TB, and to increase the number of children taking preventive treatment due to being in close contact with people who have contracted the illness.
Through the Breath for Life project’s focus on improved detection, 148 children were diagnosed with TB in the districts of Dien Chau, Quynh Luu, Nam Dan, and Yen Thanh in 2016, double the 74 diagnosed in these districts in 2015. In the first nine months of 2017, an additional 87 children were diagnosed with TB. The increased number of diagnoses means that more children with previously undetected TB are now being treated…

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UNAIDS [to 18 November 2017]
http://www.unaids.org/en
Update
China focuses on strengthening HIV prevention
16 November 2017
The International Symposium on the Prevention and Control of HIV in China was held in Beijing, China, on 13 and 14 November to discuss China’s evolving HIV epidemic. The symposium was sponsored by China’s National Health and Family Planning Commission and the Ministry of Science and Technology, with the support of UNAIDS, the World Health Organization and the United States Centers for Disease Control and Prevention.
The meeting aimed to put forward new strategies for preventing HIV through sexual transmission…

Update
United Nations Deputy Secretary-General and Geneva-based leaders discuss the future of global health in 2030 Agenda
15 November 2017

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UNICEF  [to 18 November 2017]
https://www.unicef.org/media/
16 November 2017
   UN Leaders appeal for immediate lifting of humanitarian blockade in Yemen – Millions of lives at imminent risk
NEW YORK/GENEVA, 16 November 2017 – “While the Saudi-led military coalition has partially lifted the recent blockade of Yemen, closure of much of the country’s air, sea and land ports is making an already catastrophic situation far worse. The space and access we need to deliver humanitarian assistance is being choked off, threatening the lives of millions of vulnerable children and families.

Statement by UNICEF South Asia Regional Director, Jean Gough, from Afghanistan and Pakistan border
SPIN BOLDAK, Afghanistan, 11 November 2017 – “The town of Spin Boldak on Afghanistan’s southern border with Pakistan is at the epicentre of the global effort to eradicate polio.
[See Polio above for more detail]

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Wellcome Trust  [to 18 November 2017]
https://wellcome.ac.uk/news
News / Published: 16 November 2017
Ayurvedic Man: our new exhibition exploring ‘the knowledge of long life’
‘Ayurvedic Man: Encounters with Indian medicine’, Wellcome Collection’s latest exhibition, shines a light on some of the treasures in our archives, from intricate anatomical diagrams and surgical tools, to erotic manuals and spiritual manuscripts