Announcements

Announcements

EDCTP    [to 17 March 2018]
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 March 2018
EDCTP contribution to epidemic preparedness: consortia ALERRT and PANDORA-ID-NET
At the 1st International Conference on (Re-)Emerging Infectious Diseases(ICREID) which took place in Addis Ababa on 12-14 March 2018, a symposium was dedicated to two EDCTP-funded epidemic research preparedness consortia: the African coaLition for Epidemic Research, Response and Training (ALERRT), and the Pan-African Network for Rapid Research, Response, Relief and Preparedness for Infectious Diseases Epidemics (PANDORA-ID-NET).

European Medicines Agency  [to 17 March 2018]
http://www.ema.europa.eu/ema/
16/03/2018
EMA Management Board: highlights of March 2018 meeting
Board adopts 2017 report on veterinary medicines for minor use minor species and hears update on clinical trial portal and database
…Review of clinical trial portal and database
The Board received an update on progress with the development of the European Union (EU) portal and database. Based on the experience with this complex development so far, the developer has submitted a revised project plan with improved project management, development and testing processes and resources. It also contains increased contingency…
Advanced therapies: achievements and challenges
Dr Martina Schüssler-Lenz, chair of EMA’s Committee for Advanced Therapies (CAT), also deputy head of advanced therapy medicinal products at the Paul-Ehrlich Institute (PEI) in Germany, presented the achievements and ongoing challenges in the area of advanced therapies, i.e. medicines that are based either on cells, genes or tissues. These medicines offer new treatment options for rare diseases and patients with high unmet medical need.
Ten advanced therapies have been granted an EU-wide marketing authorisation since the creation of the CAT in 2009. Four advanced therapies are currently under evaluation, including one cell-based and three gene-based therapies. In 2018, the CAT expects to start evaluating four additional medicines.
“We are observing rapidly evolving scientific and technical innovation entering the field of advanced therapies,” explained Dr Schüssler-Lenz, “but the Committee is well set up to cope with the scientific and regulatory challenges ahead due to its expertise and the way members interact and learn from each other.”
Dr Schüssler-Lenz also noted that requests for scientific advice for advanced therapies have increased significantly between 2012 and 2017 and that the CAT is now routinely involved in all scientific advice procedures for these medicines.
 
FDA [to 17 March 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
March 14, 2018 Approval Letter – Trumenba (PDF – 96KB)
Posted: 3/15/2018
 
 
Fondation Merieux  [to 17 March 2018]
http://www.fondation-merieux.org/
March 14, 2018  Bamako, Mali
A new mobile laboratrory to combat epidemics more efficiently I the G5 Sahel
A second mobile laboratory was inaugurated on March 1, 2018 at the Charles Mérieux Center for Infectious Disease. It joins a first mobile laboratory that was provided to Malian authorities in 2014. It will benefit all G5 Sahel member countries: Burkina Faso, Chad, Mali, Mauritania and Niger. The lab will enable health professionals in these countries to rapidly diagnose outbreaks of highly pathogenic diseases with potentially serious consequences for the health and safety of the local communities.
 
JEE Alliance  [to 17 March 2018]
https://www.jeealliance.org/
16.3.2018
Meeting of the Alliance Advisory Group on 27 February 2018
On 27 February, the Advisory Group of the Alliance met at the OIE Headquarters in Paris. The aim of the meeting was to discuss the role of the Alliance in the changing health security landscape, the strategic targets for health security capacity building, and the programme and working methods in 2018…

 
NIH  [to 17 March 2018]
http://www.nih.gov/news-events/news-releases
March 15, 2018
H7N9 influenza vaccine clinical trials begin
Two new clinical trials testing an experimental vaccine to prevent influenza caused by an H7N9 influenza virus are now enrolling volunteers at sites across the United States. The Phase 2 studies, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will test different dosages of the inactivated influenza vaccine candidate (called 2017 H7N9 IIV) as well as different vaccination schedules. The studies also will evaluate whether an adjuvant boosts the immune responses of people receiving the vaccine…

NIDA’s 2018 Avant-Garde awards highlight immune response and killer cells
March 13, 2018 — NIH’s awards support groundbreaking approaches to HIV prevention and treatment.
With diverse proposals focused on everything from natural killer cells to therapeutic vaccines to treat HIV, three recipients have been selected for the 2018 Avant-Garde Award for HIV/AIDS Research from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The awards will each provide $500,000 per year for up to five years (subject to the availability of funds) to support the research of three scientists, Drs. Catherine Blish, Nathaniel Landau, and Sara Sawyer. NIDA’s annual Avant-Garde Award competition, now in its 11th year, is intended to stimulate high-impact research that may lead to groundbreaking opportunities for the prevention and treatment of HIV/AIDS in drug users…

 NIH scientists describe potential antibody approach for treating multidrug-resistant Klebsiella pneumoniae
March 13, 2018 — Promising concept may lead to an alternative to antibiotics.

NIH experts call for transformative research approach to end tuberculosis
March 9, 2018 — A more intensive biomedical research approach is necessary to control and ultimately eliminate tuberculosis (TB), according to a perspective published in the March 2018 issue of The American Journal of Tropical Medicine and Hygiene. In the article, authors Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and Robert W. Eisinger, Ph.D., special assistant for scientific projects at NIAID, discuss the need to modernize TB research by applying new diagnostic, therapeutic, and vaccine approaches. The perspective is based on a lecture delivered by Dr. Fauci on Nov. 17, 2017 in Moscow at the first World Health Organization Global Ministerial Conference, “Ending TB in the Sustainable Development Era: A Multisectoral Response.”…
 

UNAIDS [to 17 March 2018]
http://www.unaids.org/en
14 March 2018
Feature story
Improving data on key populations
14 March 2018
UNAIDS has relaunched its Key Populations Atlas. The online tool that provides a range of information about members of key populations worldwide—sex workers, gay men and other men who have sex with men, people who inject drugs, transgender people and prisoners—now includes new and updated information in a number of areas. And in addition to data on the five key populations, there are now data on people living with HIV.
Chief among the new data is information on punitive laws, such as denial of the registration of nongovernmental organizations, and on laws that recognize the rights of transgender people. The overhaul of the site was undertaken in consultation with representatives of civil society organizations, including the International Lesbian, Gay, Bisexual, Trans and Intersex Association, which supplied some of the new data on punitive laws…

UNICEF  [to 17 March 2018]
https://www.unicef.org/media/
Selected Press Releaases
Geneva Palais briefing note on UNICEF Rohingya Joint Response Plan
GENEVA, 16 March 2018 – This is a summary of what was said by Marixie Mercado, UNICEF spokesperson in Geneva – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.

Briefing note on the situation of children in Afrin and Eastern Ghouta, Syria
GENEVA, 16 March 2018 – This is a summary of what was said by Marixie Mercado, UNICEF spokesperson in Geneva – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.

No end in sight to seven years of war in Syria: children with disabilities at risk of exclusion
BEIRUT/AMMAN/DAMASCUS, 12 March 2018 – With no end in sight to the war in Syria, children with disabilities risk being excluded and forgotten.

Wellcome Trust  [to 17 March 2018]
https://wellcome.ac.uk/news
News / Published: 13 March 2018
Wellcome’s goals: support global research to tackle global challenges
News / Published: 13 March 2018
Cell and developmental biology
Genetics, genomics and molecular biology
Infectious disease and the immune system
Influencing policy
Population health
In March 2017, Wellcome announced five ambitious goals to support research globally. Today we look at what we have achieved so far and what we are working towards in 2018.
Throughout 2017 we have worked towards these goals by working with colleagues from across the world.
Collaboration brings fresh ideas and new perspectives. Bringing people together from diverse backgrounds, often across borders, leads to new ways of thinking, better solutions and faster progress.
In 2016/17, Wellcome made 939 awards worth £1.1 billion, more than ever before and double what we supported a decade ago. We currently fund research activity in more than 100 countries and our non-UK funding continues to increase, largely driven by our commitment to major initiatives such as CEPI (opens in a new tab), CARB-X (opens in a new tab), GARD-P (opens in a new tab), DELTAS and H3Africa (opens in a new tab), and by increased investments in our Africa and Asia Programmes
 
News / Published: 9 March 2018
Sir Damon Buffini to stand down from our Board of Governors
News / Published: 13 March 2018
After six years as a Wellcome Governor, Sir Damon Buffini will step down later this year.
Sir Damon joined Wellcome in September 2012. He was awarded a knighthood in the Queen’s Birthday Honours 2016 for voluntary and charitable services.
He is a founding partner of Permira, a private equity firm with global reach. He was managing partner from 1997 to 2007 and Chair from 2007 to 2010…

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BIO    [to 17 March 2018]
https://www.bio.org/insights/press-release
Mar 12 2018
International Council of Biotech Associations Launches New Website
Washington, D.C. (March 12, 2018) – The International Council of Biotech Associations (ICBA) today announced the launch of internationalbiotech.org, a new website to support the organization’s mission of growing and connecting the innovative biotechnology industry worldwide.
The website unites publicly available resources of ICBA members, providing a virtual library of materials ranging from economic and employment data to issue specific whitepapers. The site’s interactive map demonstrates the distribution of the biotechnology industry around the world, enabling users to easily contrast key economic data markers, including the percent of GDP spent by businesses and governments on research and development.
“The increasingly global biotechnology industry provides breakthrough products and technologies that combat debilitating and rare diseases, reduce our environmental footprint, feed the hungry, use less and cleaner energy, and have safer, cleaner and more efficient industrial manufacturing processes,” said Andrew Casey, Chair of the ICBA and President & CEO, BIOTECanada. “The challenges and opportunities faced by the biotechnology industry cross borders. This website demonstrates the steps our industry is taking to better coordinate, organize and face these issues around the world together.”

DCVMN – Developing Country Vaccine Manufacturers Network  [to 17 March 2018]
http://www.dcvmn.org/
5 April 2018
Webinar: The new Future Vaccine Manufacturing Hub, collaborating with DCVMN
Prof Robin Shattock, Professor of Mucosal Infection and Immunity, Imperial College, London
Thursday, April 5, 2018 9:00 am
Europe Summer Time (Paris, GMT+02:00)