Announcements

Announcements
 
AERAS  [to 20 Oct 2018 ]
http://www.aeras.org/pressreleases
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 20 Oct 2018 ]
http://www.gatesfoundation.org/Media-Center/Press-Releases
OCTOBER 16, 2018
Bill & Melinda Gates Foundation opens new European office in Berlin 
Foundation also announces a new Grand Challenges partnership with the African Academy of Sciences and the German Federal Ministry of Education and Research (BMBF) 
…In addition, the German Federal Ministry of Education and Research (BMBF), the African Academy of Sciences and the Bill & Melinda Gates Foundation have announced today a joint Grand Challenges Partnership. The new partnership will strengthen scientific cooperation between Germany and African countries, supporting African investigators to pursue scientific innovations in maternal, neonatal and child health.
Germany is currently the world’s second largest donor to international health and development programmes. The Gates Foundation has been extending and diversifying its cooperation with both the Federal Government and civil society over many years. In 2017, the Federal Ministry for Economic Cooperation and Development and the Gates Foundation signed a Memorandum of Understanding, seeking to strengthen their collaboration on multilateral and bilateral projects under the overarching objective of significantly reducing poverty and transforming the lives of those most in need.
Dr. Sue Desmond-Hellmann, CEO of the Bill & Melinda Gates Foundation, said: “We are excited to deepen our partnerships in Europe as we pursue our mission to give everyone the chance to lead a healthy, fulfilling life. Europe continues to show strong commitment to reducing global inequity, and our new Berlin office will allow us to tap into Germany’s thriving life sciences sector and its growing role as a global health and development hub to help meet the challenges faced by the world’s poorest people.”…
 
 
Bill & Melinda Gates Medical Research Institute    [to 20 Oct 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 20 Oct 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 20 Oct 2018 ]
http://cepi.net/
No new digest content identified.
 
 
EDCTP    [to 20 Oct 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
18 October 2018
EDCTP co-sponsors ‘TB Science 2018’ – the 49th Union’s research preconference
TBScience2018 is the official pre-conference event for the 49th Union World Conference on Lung Health. The scientific conference focuses on basic and translational tuberculosis research. The event takes place at the Marriot Hotel The Hague on 23-24 October 2018.
 
 
Emory Vaccine Center    [to 20 Oct 2018 ]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 20 Oct 2018 ]
http://www.ema.europa.eu/ema/
News and press releases
19/10/2018
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018
The CHMP recommended six medicines for approval, three extensions of indications and elected its new vice-chair at its October 2018 meeting.
… The CHMP recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), the first vaccine in the EU for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a prior dengue virus infection. For more information, please see the press release in the grid below.
The Committee adopted a positive opinion for Flucelvax Tetra (influenza vaccine surface antigen inactivated prepared in cell cultures), intended for the prevention of influenza in adults and children from 9 years of age.
CHMP elects new vice-chair
The Committee elected Professor Bruno Sepodes from Portugal as its new vice-chair, for a three-year mandate, starting on 15 October 2018. Professor Sepodes replaces Dr Harald Enzmann, who was elected as CHMP Chair at the September 2018 CHMP meeting. Bruno Sepodes is a member of the evaluation board of medicines at the Portuguese national competent authority – the National Authority for Medicines and Health Products (INFARMED). He has been a member of the CHMP since 2012. In parallel to his involvement in the CHMP, he was also the Chair of EMA’s Committee for Orphan Medicinal Products (COMP) from 2012 to 2018.

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18 October 2018
EMA/CHMP/666423/2018   Committee for Medicinal Products for Human Use (CHMP)
Summary of opinion1 (initial authorisation)
Dengvaxia – Dengue tetravalent vaccine (live, attenuated)
On 18 October 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dengvaxia, intended for prophylaxis against dengue disease. The applicant for this medicinal product is Sanofi Pasteur.
Dengvaxia will be available as a powder and solvent to be made into a suspension for injection. The active substance of Dengvaxia is made of chimeric yellow fever-based live attenuated viruses, which contain 2 surface dengue proteins from each of serotypes 1 to 4 of dengue virus. Following administration, the viruses replicate locally and induce neutralizing antibodies and cell-mediated immune responses against the four dengue virus serotypes.
The benefits with Dengvaxia are its ability to protect against symptomatic dengue infection, including severe forms of the disease, in individuals who have had dengue infection before. The most common side effects are headache, injection site pain, malaise, myalgia, asthenia and fever.
The full indication is: “Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with prior dengue virus infection and living in endemic areas. The use of Dengvaxia should be in accordance with official recommendations”.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
 
 
European Vaccine Initiative  [to 20 Oct 2018 ]
http://www.euvaccine.eu/news-events
16 October 2018
4th Call for TRANSVAC Vaccine Development Services
New call launched on 15 October.
 
 
FDA [to 20 Oct 2018 ]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
October 15, 2018
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
The FDA continues to advance new policies, modernize our programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a disease, and potentially arrest and even reverse its progress. Our efforts are aimed at making sure that our regulatory framework is adapted to these challenges and opportunities, allows for the efficient development of these innovations and the robust demonstration of their safety and efficacy. Our comprehensive efforts are aimed at improving every stage of drug development. We’re focused on making the process of generating pre-clinical and clinical evidence required for making risk-based regulatory decisions more modern, more scientifically rigorous, and more efficient.

The scientific opportunities we’re seeing today demand that we make sure our policies are as sophisticated as the treatments that are being developed. As the nature of drug discovery and development has become more focused on basic mechanisms of disease, targeted at specific genetic or molecular dysfunctions, science is bringing forward more novel opportunities to meaningfully address human disease.

In response, we’re developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway. We also want to ensure that the development processes are efficient enough to support multiple therapeutic options, not just first-in-class innovations. We need to facilitate second-and-third-to-market innovation as a way to promote more competition within drug classes. This competition can offer important therapeutic differentiation along with opportunities for price competition that can lower costs and broaden patient access…

… Today we’re issuing two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

The first is the draft guidance, Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment, which the FDA is developing to assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials of drugs or biologics to treat specific blood cancers…

…Additionally, the agency today issued the final guidance, Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease, which was issued as draft guidance in December 2017. This final guidance addresses the topic of finding treatments that address the underlying molecular changes (e.g., genetic variants) that often cause or contribute to diseases, including uncommon, or rare molecular changes that are present in a small subset of patients…
 
 
Fondation Merieux  [to 20 Oct 2018 ]
http://www.fondation-merieux.org/
Mérieux Foundation co-organized event
Case Management working group / Global Task Force on Cholera Control (GTFCC)
November 5 – 6, 2018 – Les Pensieres Center for Global Health, Veyrier-du-Lac (France)
 
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 20 Oct 2018 ]
https://www.gavi.org/
16 October 2018
Global health organisations commit to new ways of working together for greater impact
[See Milestones above for details]
 
 
GHIT Fund   [to 20 Oct 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
October 15, 2018
GHIT Fund welcomes Ono Pharmaceutical Co., Ltd. as New Funding Partner
TOKYO, JAPAN (October 15, 2018)–The Global Health Innovative Technology (GHIT) Fund today welcomed Ono Pharmaceutical Co., Ltd. (Ono) to join GHIT as a new affiliate partner. Ono, headquartered in Osaka, Japan, is a research and development (R&D)-oriented pharmaceutical company and a pioneer in the field of immuno-oncology. With the addition of Ono, GHIT now counts 21 public and private organizations as funding partners.
“Ono’s partnership with GHIT underscores the strong commitment of industry to global health R&D. GHIT’s inception was led by industry and now 16 life science companies are GHIT funding partners together with the Government of Japan, the United Nations Development Programme, the Bill and Melinda Gates Foundation, and the Wellcome Trust. Ono’s engagement increases GHIT’s momentum toward accelerated product development for patients worldwide afflicted with infectious diseases.” said Dr. BT Slingsby, CEO of the GHIT Fund…
 
 
Global Fund [to 20 Oct 2018 ]
News
Global Health Organizations Commit to New Ways of Working Together for Greater Impact
16 October 2018
Eleven heads of the world’s leading health and development organizations signed a landmark commitment to find new ways of working together to accelerate progress towards achieving the United Nations’ Sustainable Development Goals.
[See Milestones above for more detail]
 
 
Hilleman Laboratories   [to 20 Oct 2018 ]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 20 Oct 2018 ]
http://www.humanvaccinesproject.org/media/press-releases/
Event
Towards a Universal Influenza Vaccine: Lessons from the Great Influenza Pandemic of 1918 to Now
November 15-16, 2018 I Nashville, TN
The Human Vaccines Project is hosting a scientific summit featuring prominent researchers and thought leaders to discuss cutting-edge influenza research. The 2-day meeting will bring together leading scientists, clinicians and public health specialists including: John Barry, James E. Crowe, Jr., Senator Bill Frist, and Laurie Garrett.  Find a full agenda at:
www.humanvaccinesproject.org/talks/universalinfluenzavaccinesummit
 
 
IAVI  [to 20 Oct 2018 ]
https://www.iavi.org/
No new digest content identified.
 
 
IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.
 
 
IVAC  [to 20 Oct 2018 ]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 
 
IVI   [to 20 Oct 2018 ]
http://www.ivi.int/
No new digest content identified.
 
 
JEE Alliance  [to 20 Oct 2018 ]
https://www.jeealliance.org/
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 20 Oct 2018 ]
http://www.msf.org/
Selected Press Releases/Statements
Nauru
Information on patient files transfer by MSF to Nauruan health authority
Statement 17 Oct 2018
 
 
NIH  [to 20 Oct 2018 ]
http://www.nih.gov/news-events/news-releases
October 18, 2018
Genomic analysis offers insight into 2018 Nigeria Lassa fever outbreak
— Findings helped inform Nigeria’s public health response.
 
 
PATH  [to 20 Oct 2018 ]
https://www.path.org/media-center/
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 20 Oct 2018 ]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 
UNAIDS [to 20 Oct 2018 ]
http://www.unaids.org/en
News  
19 October 2018
Race to ensure that people living with HIV get treatment after Central Sulawesi earthquake
 
19 October 2018
Defending opioid substitution therapy services in Kazakhstan
 
16 October 2018
Germany: taking a human-rights based approach to injecting drug use
 
15 October 2018
UNAIDS revises its policy on adoption, paternity and surrogacy leave
NAIDS has revised its internal adoption and paternity leave policy and introduced new rules on surrogacy leave, marking an important step in ensuring a more inclusive working environment.
The revised policy includes the extension of adoption leave from eight to 16–18 weeks, depending on the number of children being adopted, the extension of paternity leave from four to 16 weeks and the introduction of 16 weeks of leave for a single birth by surrogacy and 18 weeks for multiple births by surrogacy.
The new policy is the result of concerted advocacy efforts by the UNAIDS Secretariat Staff Association (USSA), in collaboration with UNAIDS management, and is one of the commitments made in the recently launched UNAIDS Gender Action Plan 2018–2023
 
 
UNICEF  [to 20 Oct 2018 ]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Statement
In Yemen, millions of children could soon be without food or water as economic crisis deepens and Hudaydah violence drags on
Statement by UNICEF Executive Director Henrietta Fore
18/10/2018
 
Press release
Global health organizations commit to new ways of working together for greater impact
16/10/2018
[See Milestones above for more detail]
 
Press release
UNICEF announces arrival of education material for Sulawesi earthquake and tsunami affected communities
16/10/2018
 
 
Vaccine Confidence Project  [to 20 Oct 2018 ]
http://www.vaccineconfidence.org/
Vaccine Confidence Project – Confidence Commentary
The biggest pandemic risk? Viral misinformation
Heidi Larson | 18 Oct, 2018
published in Nature 562, 309 (2018)
A century after the world’s worst flu epidemic, rapid spread of misinformation is undermining trust in vaccines crucial to public health.
A hundred years ago this month, the death rate from the 1918 influenza was at its peak. An estimated 500 million people were infected over the course of the pandemic; between 50 million and 100 million died, around 3% of the global population at the time.
A century on, advances in vaccines have made massive outbreaks of flu — and measles, rubella, diphtheria and polio — rare. But people still discount their risks of disease. Few realize that flu and its complications caused an estimated 80,000 deaths in the United States alone this past winter, mainly in the elderly and infirm. Of the 183 children whose deaths were confirmed as flu-related, 80% had not been vaccinated that season, according to the US Centers for Disease Control and Prevention.
I predict that the next major outbreak — whether of a highly fatal strain of influenza or something else — will not be due to a lack of preventive technologies. Instead, emotional contagion, digitally enabled, could erode trust in vaccines so much as to render them moot. The deluge of conflicting information, misinformation and manipulated information on social media should be recognized as a global public-health threat…
read full article in Nature : click here
 
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 20 Oct 2018 ]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 20 Oct 2018 ]
https://wellcome.ac.uk/news
19 October 2018
Photographer Adrienne Surprenant commissioned to focus on dengue
We’re proud to announce that this year’s Wellcome Photography Prize Commissioned photographer is Adrienne Surprenant, who will be creating a new photographic series focusing on the mosquito-borne tropical disease Dengue https://wellc.me/2RWZEuc  #WPP19 #OnAssignment
 
 
The Wistar Institute   [to 20 Oct 2018 ]
https://www.wistar.org/news/press-releases
Press Release   Oct. 15, 2018
Function of Neutrophils During Tumor Progression Unraveled 
Neutrophils isolated from the bone marrow of mouse models and patients with early stage tumors exhibit increased spontaneous migration to tissues and promote tumor cell seeding.
 
 
World Organisation for Animal Health (OIE)   [to 20 Oct 2018 ]
http://www.oie.int/en/for-the-media/press-releases/2018/
No new digest content identified.
 
 
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BIO    [to 20 Oct 2018 ]
https://www.bio.org/insights/press-release
No new digest content identified.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 20 Oct 2018 ]
http://www.dcvmn.org/
29 October 2018 to 31 October 2018
19th DCVMN Annual General Meeting
Kunming / China
 
 
IFPMA   [to 20 Oct 2018 ]
http://www.ifpma.org/resources/news-releases/
No new digest content identified.
 
 
PhRMA    [to 20 Oct 2018 ]
http://www.phrma.org/press-room
No new digest content identified.