Announcements

Announcements

EDCTP    [to 9 December 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
8 December 2017
EDCTP 2018 Prizes: Call for nominations
EDCTP opens the call for nominations for its 2018 Prizes today…The EDCTP prizes recognise outstanding individuals and research teams from Africa and Europe who have made significant contributions to health research. In addition to their scientific excellence, the awardees will have made major contributions to the EDCTP objectives of strengthening clinical research capacity in Africa and supporting South-South and North-South networking.

8 December 2017
EDCTP and Global Health Innovative Technology Fund partnership
The Global Health Innovative Technology Fund (GHIT) and the European & Developing Countries Clinical Trials Partnership (EDCTP) announced a new partnership today, 8 December 2017, to support product development research. The partners’ first action will be co-funding the PZQ4PSAC phase III clinical study, which is sponsored by Merck KGaA and conducted by the Pediatric Praziquantel Consortium…

European Medicines Agency  [to 9 December 2017]
http://www.ema.europa.eu/ema/
04/12/2017
Call for patient organisation representatives to join the Committee for Orphan Medicines
Deadline for applications is 20 December 2017 …

European Vaccine Initiative  [to 9 December 2017]
http://www.euvaccine.eu/news-events
05 December 2017
New Project Manager vacancy at EVI
EVI has an exciting new Project Manager position. Deadline for applications: 15th January 2018, 17:00 CET.
 
 
FDA [to 9 December 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
December 07, 2017 –
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation

December 07, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation

 
Fondation Merieux  [to 9 December 2017]
http://www.fondation-merieux.org/
December 4, 2017
The Center on Infectiology Lao Christophe Merieux Hosts Workshops on HIV and Viral Hepatitis, Organized by Merieux Foundation
The Mérieux Foundation organized two workshops in Vientiane, Laos: one on viral hepatitis, November 22-24, and the other on HIV, November 29-30. They brought together nearly 150 people to address these major public health issues in Laos and neighboring countries.
 
 
GHIT Fund   [to 9 December 2017]
https://www.ghitfund.org/
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical ·
Press Room
EDCTP and Global Health Innovative Technology Fund partnership for the development of a paediatric formulation for schistosomiasis
2017.12.08
The European & Developing Countries Clinical Trials Partnership (EDCTP) and The Global Health Innovative Technology Fund (GHIT) announced a new partnership today, 8 December 2017, to support product development research. The partners’ first action will be co-funding the PZQ4PSAC phase III clinical study, which is sponsored by Merck KGaA and conducted by the Pediatric Praziquantel Consortium. This study will provide clinical data and support for registration of a new praziquantel (PZQ) tablet formulation to treat schistosomiasis in preschool-aged children (PSAC). EDCTP will be contributing €1,99M1 and GHIT €3,22M2 to the study consortium for a total project value of €12,10M including in-kind and cash contributions by all related parties.
“The joint investment in this project reflects the true value of global partnership with a noble goal of creating local solutions in disease endemic countries.  Moreover, this pivotal study aims to generate valuable evidence and support for registration of a paediatric formulation for preschool-aged children against schistosomiasis, thus addressing a neglected population and disease – the EDCTP programme embraces populations often excluded from clinical studies but with major unmet medical needs.” said, Dr Michael Makanga, EDCTP Executive Director…

 
Global Fund [to 9 December 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Global Fund, ADB Sign MOU to Help Countries in Asia Strengthen Health Systems to Fight HIV, Tuberculosis and Malaria
08 December 2017
NAY PYI TAW, Myanmar – The Global Fund and the Asian Development Bank (ADB) have signed a memorandum of understanding to support the financing, design and implementation of country-led programs to fight HIV, tuberculosis and malaria, and build resilient health systems in ADB member countries eligible for Global Fund financing.
Through a framework of mutual cooperation, ADB and the Global Fund can complement each other’s contributions to health programs in the Asia and Pacific region.
“The agreement exemplifies the Global Fund’s commitment to strategic partnerships with multilateral development banks,” said Marijke Wijnroks, Interim Executive Director of the Global Fund. “Development finance institutions like ADB can augment the impact and footprint of Global Fund grants by leveraging additional investment, building financial sustainability, and reinforcing transparency.”…
 
 
IVI   [to 9 December 2017]
http://www.ivi.int/
[Undated]
International Vaccine Institute joins the JEE Alliance
The International Vaccine Institute (IVI) joined the JEE Alliance (Alliance for Country Assessments for Global Health Security and IHR Implementation) on November 14, 2017.
The JEE Alliance is a multi-sectoral platform for international cooperation to promote political, financial and technical support for implementation of the International Health Regulations (2005), which was launched in Geneva, Switzerland in May 2016. The alliance brings together like-minded players from relevant sectors in countries, organizations and other stakeholders involved in health security. As of November 2017, the alliance had 65 members including governments, international organizations, financial institutions, NGOs and a group of private sector organizations.
“IVI’s experience in and commitment to health security is a valuable contribution to the JEE Alliance. We look forward to IVI’s active participation in the JEE Alliance initiatives” co-chairs Ambassador Blair Exell and Dr Päivi Sillanaukee of the Alliance said in a letter to IVI.
Dr. Jerome Kim, Director General of IVI, said, “As an organization concerned with the development of vaccines for global health security, we are pleased to join the JEE Alliance and have a chance to promote vaccine R&D and vaccination as a critical component of global health security, and partner with other parties to contribute to health security.”
 
 
JEE Alliance  [to 9 December 2017]
https://www.jeealliance.org/
1.12.2017
International Vaccine Institute (IVI) joins the JEE Alliance
 
 
MSF/Médecins Sans Frontières  [to 9 December 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Yemen: Warring Parties Show New Level of Disregard for Suffering Civilians
December 06, 2017
SANA’A/HAJJAH, YEMEN—The warring parties in Yemen are showing a whole new level of disregard for civilians, as heavy street fighting and airstrikes have paralyzed Sana’a, leaving the wounded without safe access to medical care. Meanwhile, a crippling blockade prevents vital supplies from entering the country, the international medical humanitarian organization Doctors Without Borders Médecins Sans Frontières (MSF) said today.
 
 
NIH  [to 9 December 2017]
http://www.nih.gov/news-events/news-releases
December 4, 2017
Gene-based Zika vaccine is safe and immunogenic in healthy adults
— Vaccine developed by NIH scientists shows promise in Phase 1 testing
Results from two Phase 1 clinical trials show an experimental Zika vaccine developed by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is safe and induces an immune response in healthy adults. The findings will be published on Dec. 4 in The Lancet. NIAID is currently leading an international effort to evaluate the investigational vaccine in a Phase 2/2b safety and efficacy trial…

Trials show inactivated Zika virus vaccine is safe and immunogenic
December 4, 2017 — Results support further clinical development.
 

UNAIDS [to 9 December 2017]
http://www.unaids.org/en
Press statement
Message on the occasion of Human Rights Day
10 December 2017
Michel Sidibé
Executive Director of UNAIDS

Under-Secretary-General of the United Nations
The advances in the response to HIV have been unprecedented. In South Africa in 2000, just 90 people had access to antiretroviral therapy. Today, South Africa has the largest treatment programme in the world, with 4.2 million people living with HIV in the country now on treatment. We have exceeded global targets and today around the world 20.9 million people have access to life-saving HIV medicines.
However, we cannot be complacent—AIDS is not over in any part of the world and the challenges ahead remain significant. Studies from 19 countries show that approximately one in five people living with HIV had been denied health care (including dental care, family planning services or sexual and reproductive health services). Data from eight countries show that 25% of people living with HIV avoided going to hospital because they feared stigma or discrimination related to their HIV status, and one in three women living with HIV had experienced at least one form of discrimination in health-care settings related to their sexual and reproductive health…

Press release
UNAIDS and IOM renew partnership agreement to promote access to HIV services for migrants and crisis-affected populations
GENEVA, 8 December 2017—UNAIDS and the International Organization for Migration (IOM) today signed a new cooperation agreement to promote access to HIV prevention, treatment, care and support services for migrants, mobile populations and people affected by humanitarian emergencies.
“Migrants and people displaced through conflict or emergencies must be supported and enabled through their journeys to exercise their right to health,” said Michel Sidibé, Executive Director of UNAIDS. “This new partnership agreement between UNAIDS and the International Organization for Migration will be essential in strengthening our efforts to make sure that no one is left behind.”

6 December 2017
PEPFAR announces continued progress against HIV

UNICEF  [to 9 December 2017]
https://www.unicef.org/media/
5 December 2017
West and Central Africa left behind in Global HIV response
ABIDJAN/DAKAR/NEW YORK/GENEVA, 5 December 2017 – More than four decades into the HIV epidemic, four in five children living with HIV in West and Central Africa are still not receiving life-saving antiretroviral therapy, and AIDS-related deaths among adolescents aged 15-19 are on the rise, according to a new report released today.

Wellcome Trust  [to 9 December 2017]
https://wellcome.ac.uk/news
News / Published: 5 December 2017
Six new partnerships to translate research into treatments
Today, we’re announcing collaborations with six institutions to find new ways to translate scientific discoveries into real world impact.
We are committing £6 million to these first translational partnerships with the universities of Bristol, Cambridge, Edinburgh, Manchester, Imperial College and Oxford through the Mahidol Oxford Tropical Medicine Research Unit (MORU) in Bangkok.
Researchers can face a number of barriers to taking the first step to translating their research – and often need more than financial support, including mentorship and regulatory advice.
Making the transition between discovery science and translation easier is one of the core aims of Wellcome’s Innovation for Impact [PDF 200KB].
Earlier this year, we set out a series of commitments – Transforming UK translation [PDF 99KB] – together with the Royal Society, Academy of Medical Sciences and Royal Academy of Engineering.
How we will work together
Through our new translational partnerships we will work closely with partners to explore new ways of supporting transition and to share best practice.
By working at institutional level, we can work with each university to develop support which will best suit its own researchers.
Support through the new partnerships will be primarily, but not exclusively, for Wellcome-supported scientists. It will include a portfolio of activities, for example:
:: developing seed funds, identifying mentors and entrepreneurs in residence
:: access to Wellcome’s network of advisers, experts and mentors
:: introductions to potential partners to take promising advances forward…

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Industry Watch    [to 9 December 2017]
:: Bioethics International Releases the “Good Pharma Scorecard” in BMJ Open, Ranking the Top 20 Largest Pharmaceutical Companies on Clinical Trial Transparency
NEW YORK, Dec. 5, 2017 /PRNewswire/ — Bioethics International announced today the second publication of its Good Pharma Scorecard (“GPS”), an annual index ranking large pharmaceutical companies and new drugs on their clinical trial transparency, in BMJ Open. Bioethics International is a not-for-profit organization dedicated to raising the bar on ethics, trustworthiness, and patient-centricity in pharma.
Two of eleven ranked companies—Johnson & Johnson and Sanofi—achieved the highest overall clinical trial transparency scores, both scoring 100%. AbbVie, Celgene, Merck and Astra Zeneca all scored at or above the industry median.
The 2017 GPS ranking evaluates clinical trial registration, results reporting, clinical study report synopsis sharing, and journal article publication rates for new drugs approved by the Food and Drug Administration (FDA) in 2014 that were sponsored by large drug companies. Bioethics International is the first organization to consistently measure large pharma companies and their FDA-approved drugs on their clinical trial transparency performance. This learning system helps advance high-quality, patient-centric, and ethical healthcare innovation, medical evidence, and drug development…

:: Sanofi ends development of Clostridium difficile vaccine
Paris, France – December 1, 2017 – Following a planned interim analysis, the Independent Data Monitoring Committee (IDMC) for the phase III Cdiffense clinical trial program concluded that the probability that the study will meet its primary objective is low. Based on this, Sanofi has therefore decided to discontinue clinical development of its experimental Clostridium difficile vaccine, to focus on six key vaccine projects currently in development….

:: Boehringer Ingelheim Invests $80 Million to Expand Animal Vaccine Manufacturing Capacity in the U.S.
DULUTH, Ga., Dec. 4, 2017 /PRNewswire/ — Boehringer Ingelheim, a leading provider of animal health products for pets and livestock, today announced investments totaling more than $80 million to expand its existing facilities in Athens, GA and St. Joseph, MO to accommodate increased production of animal vaccines.
Boehringer Ingelheim’s facility in Athens, GA will grow from its current footprint of approximately 350,000 square feet to 400,000 square feet and will nearly double its filling capacity for companion animal and avian vaccine…