Announcements

Announcements
 
 
BMGF – Gates Foundation  [to 15 Dec 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 15 Dec 2018]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.
 
 
CARB-X   [to 15 Dec 2018]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 15 Dec 2018]
http://cepi.net/
Press releases
CEPI partners with Imperial College to develop transformative rapid-response technology to create vaccines against emerging infectious diseases
Oslo, Norway, Dec 10, 2018 — The Coalition for Epidemic Preparedness Innovations (CEPI) and Imperial College London have announced a partnering agreement, worth up to USD8·4 million, to develop a self-amplifying RNA (saRNA) vaccine platform that enables tailored—just-in-time—vaccine production against multiple viral pathogens.
The idea behind this saRNA approach is to harness the body’s own cell machinery to make an antigen (ie, a foreign substance that induces an immune response) rather than injecting the antigen directly…
 
 
EDCTP    [to 15 Dec 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
No new digest content identified.
 
 
Emory Vaccine Center    [to 15 Dec 2018]
http://www.vaccines.emory.edu/
Woodruff Health Sciences Center | Dec. 11, 2018
National Academy of Inventors names Rafi Ahmed as Fellow
The National Academy of Inventors (NAI) has named Rafi Ahmed, PhD, as an NAI 2018 Fellow. Ahmed is director of the Emory Vaccine Center, a Georgia Research Alliance Eminent Scholar, Charles Howard Candler Professor of Microbiology and Immunology in Emory University School of Medicine, investigator in the Emory Center for AIDS Research (CFAR) and a member of the Winship Cancer Institute…
 
 
European Medicines Agency  [to 15 Dec 2018]
http://www.ema.europa.eu/ema/
News and press releases
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018
14/12/2018

Press release: EMA Management Board: highlights of December 2018 meeting
14/12/2018

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 December 2018
Press release 07/12/2018
[Excerpt]
…The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Evant, from LABORATORIOS HIPRA S.A, a new vaccine for the active immunisation of chicks from 1 day of age against coccidiosis….
 
European Vaccine Initiative  [to 15 Dec 2018]
http://www.euvaccine.eu/news-events
No new digest content identified.
 
FDA [to 15 Dec 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
No new digest content identified.
 
December 12, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice
 
December 11, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework
 
 
Fondation Merieux  [to 15 Dec 2018]
http://www.fondation-merieux.org/
Mérieux Foundation co-organized event
Dengue pre-vaccination screening based on serostatus: rapid tests and implementation strategies
January 14 – 16, 2019 – Les Pensières Center for Global Helath, Veyrier du Lac (France)
 
 
Gavi [to 15 Dec 2018]
https://www.gavi.org/
 
 
14 December 2018
Japan to send Junior Professional Officers to work at Gavi
Japanese government will fund placements for talented young professionals at the Vaccine Alliance.
 
12 December 2018
Coalition for Epidemic Preparedness Innovation turns to IFFIm to accelerate funding for new vaccine development
IFFIm’s frontloading capacity will boost CEPI’s efforts to fight the deadliest diseases.
 
Global health leaders hail immunisation as shortest path to healthy lives
Gavi Mid-Term Review closes with commitments to accelerate immunisation programmes in the poorest countries to reach more children with lifesaving vaccines.
11 December 2018
 
Gavi and Mastercard join forces to reach more children with lifesaving vaccines
Strengthening efficiency and reach of health services in developing countries with digital immunisation records.
11 December 2018
 
Serum Founder wins inaugural ‘Vaccine Hero’ award
Dr Cyrus Poonawalla congratulated for life-long commitment to boosting vaccine coverage in the world’s poorest countries.
11 December 2018
 
Gavi and Germany partner to harness blockchain technology
German government and the Vaccine Alliance to explore the application of blockchain technology to increase efficiency of immunisation programmes.
10 December 2018
 
Parsyl and Gavi announce supply chain strengthening partnership
Gavi to make Parsyl’s quality assurance platform available in Uganda and Senegal to address last mile distribution challenge.
10 December 2018
 
South Korea pledges US$15 million to immunise children in world’s poorest countries
New funding will help Gavi, the Vaccine Alliance, vaccinate millions of children against deadly diseases.
10 December 2018
 
UAE and Gavi convene leaders to focus on health for next generation
High-level meeting to review access to vaccines in low-income countries and how to accelerate impact.
 
GHIT Fund   [to 15 Dec 2018]
https://www.ghitfund.org/newsroom/press
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
December 13, 2018
GHIT Fund Announces New Investments in Vaccines for Dengue and Leishmaniasis, and Drug Screening for Malaria and Tuberculosis
TOKYO, JAPAN (December 13, 2018)—The Global Health Innovative Technology (GHIT) Fund announced today a total of 520 million yen (US$4.6 million*) to support four partnerships to develop new lifesaving drugs and vaccines for malaria, tuberculosis, dengue and leishmaniasis. This includes three new projects and one that will receive continued funding. (Appendix 1)
“At the GHIT Fund, we are delighted to accelerate open innovation between Japanese and non-Japanese R&D entities across the globe,” BT Slingsby, the CEO of GHIT said. “With the new partnerships developed through this investment, we are further strengthening our work through global collaboration to meet the needs of neglected populations worldwide.”
Including the investment projects announced today, GHIT has invested approximately 14.1 billion yen (US$124 million*) in 77 global product development partnerships that leverage Japanese science and capabilities in pharmaceutical research and development. Currently, 23 discovery projects, 13 preclinical projects, and eight clinical trials are under way in low- and middle-income countries.
 
 
Global Fund  [to 15 Dec 2018]
https://www.theglobalfund.org/en/news/
News
Making Uzbekistan Malaria Free is Major Achievement
11 December 2018
 
 
Hilleman Laboratories   [to 15 Dec 2018]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 15 Dec 2018]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 15 Dec 2018]
https://www.iavi.org/newsroom
December 10, 2018
Six Distinguished Leaders in Global Health Join IAVI Board of Directors
NEW YORK – December 10, 2018 – The International AIDS Vaccine Initiative (IAVI) today announced that David L. Blumberg, Jim Connolly, John Nkengasong, Ph.D., John Shiver, Ph.D., Anne Simonds, and Rajeev Venkayya, M.D., have been appointed to IAVI’s board of directors.
“IAVI is pleased that these accomplished leaders have joined our board. We look forward to their partnership as we work to translate scientific discoveries into affordable, accessible public health solutions,” said Mark Feinberg, M.D., Ph.D., president and CEO of IAVI. “Their deep expertise across the global health spectrum in the public, private, and nonprofit sectors will strengthen our organization as we explore new and better ways to address public health threats that disproportionately affect people living in poverty.”…
:: DAVID L. BLUMBERG, Vice President, Teva Global Operations and Portfolio Compliance, Teva Pharmaceuticals
:: JIM CONNOLLY, Former President and CEO of Aeras
:: JOHN NKENGASONG, Director, Africa Centres for Disease Control and Prevention
:: JOHN SHIVER, Senior Vice President, Global Vaccine Research and Development, Sanofi Pasteur
:: ANNE SIMONDS, Global Leader, Health, Development and Social Enterprise, Spencer Stuart
:: RAJEEV VENKAYYA, President, Global Vaccine Business Unit, Takeda Pharmaceuticals
 
 
IFFIm
http://www.iffim.org/library/news/press-releases/
11 December 2018
Islamic Development Bank and IFFIm announce plans to collaborate on private placement
Sukuk aims to build on Gulf Cooperation Council countries’ support for Gavi programmes.
 
 
IVAC  [to 15 Dec 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 15 Dec 2018]
http://www.ivi.int/
IVI News & Announcements
[Undated]
Nature Communications study addresses MDR typhoid
New study in Nature Communications reveals high burden of multi-drug resistant (MDR) typhoid fever in sub-Saharan Africa associated with two predominant genotypes
IVI epidemiologist Se Eun Park and collaborating scientists report data from Typhoid Fever Surveillance in Africa (TSAP) program and other sources
 
 
JEE Alliance  [to 15 Dec 2018]
https://www.jeealliance.org/
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 15 Dec 2018]
http://www.msf.org/
Selected News; Project Updates, Reports
Central American Migration
US asylum restrictions are deepening Mexican…
Press Release 13 Dec 2018
:: Migrants from Central America are exposed to extreme levels of violence transiting through Mexico, no longer considered a safe country
:: US migration policies are stranding migrants and asylum seekers in Mexico, leaving them vulnerable to further violence
:: MSF urges the US and Mexico to address the issues at the cause of the crisis along the border

Iraq
Iraq’s displaced see no hope on the horizon
Voices from the Field 12 Dec 2018

Refugees, IDPs and people on the move
“Migration is not a crime. Saving lives is not a crime”
Speech 11 Dec 2018

 
 
NIH  [to 15 Dec 2018]
http://www.nih.gov/news-events/news-releases
December 11, 2018
NIH to fund HIV care and prevention research in vulnerable southern U.S. communities
— New program leverages partnerships to discover sustainable, scalable interventions.
 
 
PATH  [to 15 Dec 2018]
https://www.path.org/media-center/
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 15 Dec 2018]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 15 Dec 2018]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
 
14 December 2018
Ireland to support HIV services for the most vulnerable in the United Republic of Tanzania
 
13 December 2018
UNAIDS Board calls for immediate implementation of UNAIDS agenda for change
 
12 December 2018
The need to scale up HIV programmes for key populations in western and central Africa
 
10 December 2018
Launch of a global partnership to eliminate HIV-related stigma and discrimination
Despite the existence of human rights obligations and policy commitments, HIV-related stigma and discrimination continues to be widespread around the world and in all sectors of society.
Following a call from civil society in 2017 to accelerate and scale up action to address stigma and discrimination, UNAIDS, UN Women, the United Nations Development Programme and the Global Network of People Living with HIV (GNP+) agreed to co-convene the Global Partnership to Eliminate All Forms of HIV-Related Stigma and Discrimination.
The global partnership was launched on 10 December on the 70th anniversary of the adoption of the Universal Declaration of Human Rights, during an event in Geneva, Switzerland…
…People living with HIV, adolescents, young people and key populations experience discrimination, including discrimination based on their gender and gender identity, race, ethnicity, age, drug use, sexual orientation and migration status. These added layers of stigma and discrimination increase their vulnerability to HIV and undermine their rights, including the right to health, work and education.
 
10 December 2018
Rwanda’s leadership provides model for advancing global agenda towards ending AIDS
 
 
UNICEF  [to 15 Dec 2018]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Statement
Yemen peace talks and Hudaydah ceasefire signal hope for country’s children
Statement by UNICEF Executive Director Henrietta Fore
13/12/2018

Press release
Nearly 30 million sick and premature newborns in dire need of treatment every year
Global coalition calls for better care and stronger legislation to save babies on the brink of death
13/12/2018

Press release
Children account for more than one third of Ebola cases in eastern Democratic Republic of the Congo – UNICEF
11/12/2018
[See Milestones above for detail]

Statement
UNICEF statement on the adoption of the Global Compact for Safe, Orderly and Regular Migration
Statement from UNICEF Director of Data, Research and Policy Laurence Chandy
10/12/2018
 
 
Vaccine Confidence Project  [to 15 Dec 2018]
http://www.vaccineconfidence.org/
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 15 Dec 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 15 Dec 2018]
https://wellcome.ac.uk/news
News
We’re changing the way we fund early career researchers
14 December 2018
We are extending our partnership with the Academy of Medical Sciences to £8.3 million to support early career researchers moving into an independent role. Alongside this, we’re going to close our Seed Awards in Science in March 2019.

Opinion
Why we’re supporting public engagement beyond the UK
12 December 2018
The case for good public engagement in low- and middle-income countries is strong. But why, and what is Wellcome doing to ensure that our public engagement work makes a difference outside the UK?

News
Sir David Weatherall, 1933-2018
11 December 2018
A doctor and scientist of great compassion and intellect, Sir David Weatherall died on 8 December 2018. He was a member of Wellcome’s Board throughout the 1990s, helping to shape our support for science, particularly research in tropical medicine and genetics.

Explainer
With a mandate to develop new vaccines, CEPI needs global funding
10 December 2018
Vaccines are a vital part of fighting epidemics, but developing new ones is challenging, costly and complex. The Coalition for Epidemic Preparedness Innovation (CEPI) is a new model for funding vaccine development which could drastically change the way we tackle epidemics. Global partnerships between government, industry and philanthropy are at the heart of it. 

 
The Wistar Institute   [to 15 Dec 2018]
https://www.wistar.org/news/press-releases
Press Release   Dec. 13, 2018
Nikon Small World: An Up-close Look at the Unseen World
Wistar hosts top winners of the 2018 Nikon Small World Photomicrography Competition.

World Organisation for Animal Health (OIE)   [to 15 Dec 2018]
http://www.oie.int/en/for-the-media/press-releases/2018/
No new digest content identified.
 
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BIO    [to 15 Dec 2018]
https://www.bio.org/insights/press-release
Dec 14 2018
BIO Statement on Hatch-Waxman Integrity Act of 2018 [Introduction]
“For almost 40 years, the groundbreaking law known as the Hatch-Waxman Act (HWA) has been highly successful in spurring the development of life-saving new treatments while at the same time vastly broadening the availability of low-cost generic pharmaceuticals.”
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 15 Dec 2018]
http://www.dcvmn.org/
No new digest content identified.
 
IFPMA   [to 15 Dec 2018]
http://www.ifpma.org/resources/news-releases/
10 December 2018
Unjela Kaleem joins global pharma association as Director of Communications
 
PhRMA    [to 15 Dec 2018]
http://www.phrma.org/press-room
No new digest content identified.
 
 
Industry Watch    [to 15 Dec 2018]
:: Pfizer Initiates Phase 3 Program for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
December 14, 2018 08:00 AM Eastern Standard Time
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today the initiation of a Phase 3 program for its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older.
“While the full extent of Prevenar 13 protection of adults is still being realized, we anticipate our 20vPnC vaccine candidate will be the next important step to help protect adults from a substantial invasive pneumococcal disease and pneumonia burden, including disease caused by serotypes not yet covered by any available conjugate vaccine,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As the industry leader in pneumococcal conjugate vaccination, we are proud to start the Phase 3 trials of our third generation pneumococcal vaccine, which received Breakthrough Therapy Designation by the FDA in September 2018.”…

:: Merck and Instituto Butantan Announce Collaboration Agreement to Develop Vaccines to Protect Against Dengue Infections
December 12, 2018 10:30 AM Eastern Standard Time
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Instituto Butantan, Sao Paulo, Brazil, a non-profit producer of immunobiologic products for Brazil today announced a collaboration agreement to develop vaccines to protect against dengue virus disease, the mosquito-borne infection. Instituto Butantan and Merck have licensed certain rights from National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH), for the development of live attenuated tetravalent vaccines (LATV). Instituto Butantan’s dengue vaccine candidate, TV003, is currently being evaluated in a large Phase 3 study in Brazil.
“By sharing data from our ongoing vaccine development programs, Instituto Butantan and Merck are better positioned to achieve our goal of reducing the significant human and economic toll of dengue virus in Brazil and around the world,” said Dr. Dimas Covas, director, Instituto Butantan. “We look forward to collaborating with Merck, an established global leader in vaccine development.”
Under the agreement, Merck and Instituto Butantan have agreed to collaborate to share clinical data and other learnings from their respective dengue vaccine development programs, both derived from licensed materials from the NIAID. Instituto Butantan will receive a $26 million upfront payment from Merck and is eligible to receive up to $75 million for the achievement of certain milestones related to the development and commercialization of Merck’s investigational vaccine as well as potential royalties on sales. Instituto Butantan will retain responsibility for the manufacturing and commercialization of their investigational vaccine, TV003, in Brazil…