Announcements

Announcements

EDCTP    [to 16 Jun 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
14 June 2018
EDCTP holds ‘trainer-of-trainers’ workshop on GCP-GCLP in Johannesburg, South Africa
The EDCTP Africa Office organised a workshop on Good Clinical Practice/Good Clinical Laboratory Practice in Johannesburg, South Africa, from 12-14 June 2018. Participants of 26 EDCTP-funded projects – including from the four EDCTP-funded regional Networks of Excellence…
 
 
European Vaccine Initiative  [to 16 Jun 2018]
http://www.euvaccine.eu/news-events
14 June 2018
PREV_PKDL Kick-off meeting

14 June 2018
SEmalvac2 & SEmalvac Annual Meeting 2018
 
 
FDA [to 16 Jun 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
June 12, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
 
 
Fondation Merieux  [to 16 Jun 2018]
http://www.fondation-merieux.org/
June 11, 2018
The Mérieux Foundation is deeply saddened by the loss of Professor Ogobara Doumbo, who passed away June 9th. Our thoughts are with his family and loved ones.
 
 
Human Vaccines Project   [to 16 Jun 2018]
http://www.humanvaccinesproject.org/media/press-releases/
Public Release: 11-Jun-2018
Human Vaccines Project announces new partnership with Telethon Kids Institute in Australia
NEW YORK, JUNE 11, 2018 – The Human Vaccines Project, a nonprofit public-private partnership focused on decoding the immune system to improve human health, today announced its first international scientific hub through a partnership with Telethon Kids Institute. Based in Perth, Western Australia, Telethon Kids Institute is recognized as a world leader in addressing the health of pediatric and indigenous populations.
Telethon Kids brings extensive and complementary scientific capacity to the Project. As one of Australia’s leading systems biology centers, with a team of almost 600 dedicated researchers and support staff, the organization is focused on discovering how and why childhood diseases develop, and aims to prevent and cure them through better therapies and interventions. Telethon Kids also engages with global researchers in low-resource settings including extensive collaboration with researchers in Papua New Guinea.
“Telethon Kids is a rapidly growing research institute in Australia that brings exceptional expertise to the Human Vaccines Project,” said Wayne Koff, PhD, president and CEO of the Human Vaccines Project. “The Institute’s knowledge in pediatrics and indigenous populations will enhance our efforts toward better vaccines and immunotherapies, as well as our work towards a universal flu vaccine.”…
 
 
IAVI  [to 16 Jun 2018]
https://www.iavi.org/
June 11, 2018
IAVI Mourns the Passing of Dr. Adel A. F. Mahmoud, Vaccine Champion and Public Health Visionary
Adel A. F. Mahmoud, MD, PhD, was a member of the IAVI Board of Directors from 2012.  He was an important advocate for a global focus on vaccine development and equitable access, including the importance of advancing HIV R&D.
IAVI is deeply saddened by the recent death of Adel A. F. Mahmoud, MD, PhD, a highly respected physician, scientist, professor, IAVI board member, and cherished friend. Most recently, he had a joint appointment at Princeton University as Professor in the Woodrow Wilson School and the Department of Molecular Biology. He has served as a valued and dedicated member of the IAVI Board of Directors from 2012.
“Adel was a unique force of nature and a tireless champion of science, education, and public health,” said Dr. Mark Feinberg, MD, PhD, IAVI President and CEO. “He is remembered by all whose lives he touched as a warm, vibrant, generous, and compassionate physician scientist who sought to eradicate childhood illnesses and infectious diseases through the development of new vaccines. Adel was also an important advocate for a global focus on vaccine development and equitable access, including the importance of advancing HIV R&D. His work has contributed to saving countless lives around the world. For those of us who were fortunate to have Adel as a friend, we know how much joy and positive energy he shared with us and how much we will miss his very special presence.” …
 
 
IFFIm
http://www.iffim.org/library/news/press-releases/
04 June 2018
Bertrand de Mazières joins IFFIm Board
Director General for Finance at the European Investment Bank brings IFFIm over three decades of international finance experience.

IVAC  [to 16 Jun 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
June 2018
Press Release: 1.45 million children’s lives saved by Hib and pneumococcal vaccines since 2000
Researchers estimate that during 2000-2015 pneumococcal conjugate vaccine prevented a total of about 250,000 child deaths—mostly after 2010—while Hib vaccines prevented 1.2 million child deaths.
 
 
MSF/Médecins Sans Frontières  [to 16 Jun 2018]
http://www.msf.org/en/updates
11 June 2018
Jordan: Lack of patients forces closure of Ramtha surgical project
Amman – After more than four years of emergency lifesaving activities in which over 2,700 war-wounded Syrians underwent medical treatment, Médecins Sans Frontières (MSF) has taken the difficult decision to close the Ramtha surgical project in northern Jordan. The decision came in light of the sharp decrease in the number of wounded Syrians referred from southern Syria to Ramtha hospital since a de-escalation zone was established in July 2017.
 
 
NIH  [to 16 Jun 2018]
http://www.nih.gov/news-events/news-releases
June 14, 2018
Early-stage Respiratory Syncytial Virus vaccine trial begins
— Phase 1 study will enroll a small group of healthy adult volunteers.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched a clinical trial of an investigational vaccine designed to protect against respiratory syncytial virus (RSV). The Phase 1 study will enroll a small group of healthy adult volunteers to examine the safety of an experimental intranasal vaccine and its ability to induce an immune response. The study is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has launched a clinical trial of an investigational vaccine designed to protect against respiratory syncytial virus (RSV). The Phase 1 study will enroll a small group of healthy adult volunteers to examine the safety of an experimental intranasal vaccine and its ability to induce an immune response. The study is being conducted at the Cincinnati Children’s Hospital Medical Center, one of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs)…

June 13, 2018
New trans-NIH consortium aims to advance pediatric research on a global level
— Nearly all of the 27 NIH institutes and centers fund some aspects of child health research.
The National Institutes of Health has formed the Trans-NIH Pediatric Research Consortium to coordinate pediatric research programs across its institutes and centers. Nearly all of the 27 NIH institutes and centers fund some aspects of child health research. In fiscal year 2017, this support totaled more than $4 billion. The new consortium aims to harmonize these activities, explore gaps and opportunities in the overall pediatric research portfolio, and set priorities.
“NIH-funded research has resulted in tremendous advances against diseases and conditions that affect child health and wellbeing, including asthma, cancer, autism, obesity, and intellectual and developmental disabilities,” said Diana W. Bianchi, M.D., director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the lead NIH institute for the consortium. “This consortium aims to capitalize on this momentum by enhancing crosstalk between scientific disciplines to address the wide range of health conditions experienced by children in this country and around the world.”
The new consortium will be led by the NICHD Director. In addition to project-based interactions, the full consortium will meet several times a year to discuss scientific opportunities and potential new areas of collaboration, including efforts to enhance training for the next generation of pediatricians.
 
 
UNAIDS [to 16 Jun 2018]
http://www.unaids.org/en
Feature story
South Sudan: raising the profile of HIV in humanitarian contexts
15 June 2018
In South Sudan, 7 million people are in need of humanitarian assistance and 5 million people need access to health services, including HIV prevention and treatment services. In this context, AIDS does not stand in isolation; rather, it is an entry point for social transformation. This was the message of Michel Sidibé, UNAIDS Executive Director, during his recent visit to the country.

Feature story
Celebrating the life of Calle Almedal
13 June 2018
UNAIDS is remembering the life and work of Calle Almedal, UNAIDS Senior Adviser on Partnerships with Civil Society and Faith-Based Organizations from 1997 to 2007. He was born in Sweden in 1945 and died on 7 June 2018 following a long battle with cancer.
“Calle Almedal was an outstanding professional, a passionate advocate and a personal friend and colleague. His legacy lives on in the lives of people of faith and of no faith in every corner of the world,” said Michel Sidibé, the Executive Director of UNAIDS.

Feature story
Luxembourg committed to accelerating the AIDS response in western and central Africa
11 June 2018
The Government of Luxembourg has announced that it will renewal its €1 million contribution to UNAIDS for the western and central Africa catch-up plan, with the funds focused on paediatric care and treatment and human rights. Launched in December 2016, the western and central Africa catch-up plan aims to ensure that 4.5 million people living with HIV in the region will have access to HIV treatment by 2020
 
 
Wellcome Trust  [to 16 Jun 2018]
https://wellcome.ac.uk/news
Published: 14 June 2018
How to make sense of the body’s billions of cells
An ambitious international project is attempting to create a ‘Google map’ of the human body by making three-dimensional maps of every human cell. It could transform our understanding of many diseases and how to treat them.

Published: 12 June 2018
Contagious Cities: people and pathogens, microbes and migration
On the centenary of the 1918 flu pandemic, Wellcome is exploring the relationship between cities and infections through Contagious Cities, an international cultural collaboration.
Michael Regnier, a science writer at Wellcome who has written about urbanisation and health (opens in a new tab), considers why cities are hotspots for contagions – and sources of solutions.
 
 
The Wistar Institute   [to 16 Jun 2018]
https://www.wistar.org/news/press-releases
Press Release  Jun. 13, 2018
Older Melanoma Patients Have Better Response to Immune Checkpoint Blockade Therapy
Age variations are related to different T cell populations present in the tumor immune environment of younger and older patients

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Industry Watch   [to 16 Jun 2018]
:: FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL®9 in Women and Men Ages 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases
June 13, 2018 06:45 AM Eastern Daylight Time
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine. The application is seeking approval for an expanded age indication for GARDASIL 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine human papillomavirus (HPV) types covered by the vaccine. The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 6, 2018.
“Women and men ages 27 to 45 continue to be at risk for acquiring HPV, which can lead to cervical cancer and certain other HPV-related cancers and diseases,” said Dr. Alain Luxembourg, director, clinical research, Merck Research Laboratories. “We look forward to working with the FDA on the review of this application for GARDASIL 9, which, if approved, would enable more people to have access to the vaccine.”…

:: Themis Receives EMA PRIME Designation for Chikungunya Vaccine
June 11, 2018 05:00 AM Eastern Daylight Time
VIENNA–(BUSINESS WIRE)–Themis announced today that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to its most advanced program in development, a vaccine to prevent chikungunya fever. The PRIME scheme is designed to provide enhanced regulatory support for the development of medicines that target an unmet medical need. Chikungunya is a mosquito-transmitted disease that can have debilitating long-term effects and has no current treatment or prevention options. Themis’ vaccine candidate has shown excellent safety and immune-response data in clinical testing to date. Final results of a large dose-confirmation Phase 2 trial are expected in mid-2018. Additional Phase 2 trials are underway, totaling over 600 study volunteers in the US, EU and Central America…