Announcements

Announcements
 
EDCTP    [to 19 August 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
2 August 2017
Independent observer assesses Scientific Review Committee meetings
To ensure the integrity of its evaluation procedures and to find ways to improve quality, efficiency and transparency, EDCTP recently enlisted the assistance of independent experts to observe and critically examine its peer review evaluation process…

European Medicines Agency  [to 19 August 2017]
http://www.ema.europa.eu/ema/
08/08/2017
EMA supports regulatory harmonisation in East Africa
East African Community (EAC) envisages the creation of regional regulatory entity
01/08/2017
EMA encourages tailored development of medicines for older people
EMA invites comments on reflection paper by 31 January 2018
 
European Vaccine Initiative  [to 19 August 2017]
http://www.euvaccine.eu/news-events
14 August 2017
Medicines Evaluation Board (MEB) to join VAC2VAC
VAC2VAC is pleased to announce that one year after its start it has already created enough interest to have the Medicines Evaluation Board (MEB), a regulatory agency and an independent administrative body residing under the Government of the Netherlands, joining its membership.
For VAC2VAC, that aims to establish ‘Vaccine batch to vaccine batch comparison by consistency testing’, i.e. replacing animal test with non-animal assays, having regulatory agencies as partners is an important contribution towards its goal…

04 August 2017
VAC2VAC: Progress summary of first year
During the first year of the VAC2VAC project ample of process has been made.

31 July 2017
TRANSVAC2: Funding for European vaccine research infrastructure
The European Commission (EC), in the context of the Horizon 2020 Framework Programme, commits significant funding to TRANSVAC, , a European vaccine research and development (R&D) infrastructure…
 
FDA [to 19 August 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
What’s New for Biologics
Influenza Virus Vaccine for the 2017-2018 Season
Updated: 8/17/2017

CBER-Regulated Products: Resolved Shortages
Updated: 8/17/2017
August 3, 2017 Summary Basis for Regulatory Action – ZOSTAVAX (PDF – 102KB)
Posted: 8/9/2017
August 3, 2017 Approval Letter – ZOSTAVAX (PDF – 70KB)
Posted: 8/8/2017
 
Gavi [to 19 August 2017]
http://www.gavi.org/library/news/press-releases/
01 August 2017
Indonesian Government to immunise 70 million children against measles and rubella
The two-year campaign will aim to reach 95% immunisation coverage in Indonesia.
…Gavi is supporting the Government of Indonesia by contributing 50% of the total cost of vaccines. WHO is assisting with the preparation of immunisation activities, particularly in high-risk areas and among vulnerable populations, to ensure all children receive the vaccine…
 
Global Fund [to 19 August 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
The French Council of Investors in Africa and the Global Fund Create Innovative Partnership
31 July 2017
The French Council of Investors in Africa (CIAN) and the Global Fund to Fight AIDS, Tuberculosis and Malaria have entered into a cooperation agreement aimed at involving French companies in the fight against the three diseases in sub Saharan Africa.
CIAN is an organization of French companies operating in Africa, including multinational corporations, as well as small and medium-size businesses. The organization aims to accelerate private sector involvement in health issues through its network of 160 member companies and 10,000 establishments in Africa. CIAN recently created a Health Commission, an initiative that demonstrates its members’ growing interest in combating the AIDS, tuberculosis and malaria epidemics…

IVI   [to 19 August 2017]
http://www.ivi.int/
July 28, 2017
Former UN Secretary-General Ban Ki-moon visits IVI
SEOUL, KOREA – Prof. Ban Ki-moon, former Secretary-General of the United Nations, visited the International Vaccine Institute (IVI) at Seoul National University (SNU) Research Park on July 28.
The former UN chief is currently Honorary Dean of the Institute for Global Engagement and distinguished professor at Yonsei University in South Korea. He visited the Seoul-based non-profit international organization for the first time at the invitation of the Korea Support Committee for IVI (KSC)…
 
MSF/Médecins Sans Frontières  [to 19 August 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
FDA Reauthorization Act Passes U.S. House and Senate Without Fixes to Deliver Urgently Needed New Drugs, Vaccines for Neglected Diseases
August 03, 2017
Both chambers of U.S. Congress missed another opportunity to help people living with neglected diseases by passing the FDA Reauthorization Act (FDARA) of 2017 today without fixing the Food and Drug Administration’s Priority Review Voucher (PRV) program for neglected diseases. Language included in the bill makes changes to the neglected disease PRV program, but it doesn’t fix the major flaws that limit the program’s ability to help people most in need, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).
 
NIH  [to 19 August 2017]
http://www.nih.gov/news-events/news-releases
August 8, 2017
NIH accelerates the use of genomics in clinical care
— New funding awards focus on diverse and underserved populations.

August 7, 2017
NCI study identifies essential genes for cancer immunotherapy
— Researchers found more than 100 genes that may play a role in facilitating tumor destruction by T cells
 
PATH  [to 19 August 2017]
http://www.path.org/news/index.php
Announcement | August 18, 2017
PATH nominated for Saving Lives at Birth grants to accelerate diagnostic and device innovations that prevent maternal and infant deaths at birth

Announcement | August 10, 2017
PATH celebrates the extension of its digital health partnership with the Government of Tanzania
Second phase of the Data Use Partnership will strengthen Tanzania’s ability to use data to transform its health sector

Announcement | August 09, 2017
PATH partners with the Mahidol Oxford Tropical Medicine Research Unit on first study of the RTS,S malaria vaccine in Asia
Study is the first step toward understanding the vaccine’s potential role in elimination campaigns and combating drug resistance across Southeast Asia’s Greater Mekong Subregion

Press release | August 07, 2017
Versatile health innovator joins PATH to lead technology development and introduction efforts for low-income countries around the world
Dr. Praveen Raja brings passion, experience, and leadership in medical innovation, digital health, technology, pharmaceuticals, and entrepreneurship to new role
 
Sabin Vaccine Institute  [to 19 August 2017]
http://www.sabin.org/updates/pressreleases
Wednesday, August 2, 2017
Wendy Holman Joins Sabin Vaccine Institute Board of Trustees
WASHINGTON, D.C. – The Sabin Vaccine Institute (Sabin) is pleased to announce the election of Wendy Commins Holman to its Board of Trustees. Ms. Holman is the CEO and founder of Ridgeback Biotherapeutics, a biotechnology company focused on developing treatments and diagnostics for underserved patient populations primarily in pediatric orphan and emerging infectious diseases.
Prior to founding Ridgeback Biotherapeutics, Ms. Holman was a principal at Ziff Brothers Investments and director of research at ZBI Equities, a multi-billion dollar public equity investment fund where she spent 15 years guiding investments in healthcare and novel technology.
“We are very pleased to welcome Wendy to our board,” said Dr. Axel Hoos, chairman of Sabin’s Board of Trustees. “Her knowledge and experience of innovative technologies and deep interest in global health will be an important addition to the board as we advance our vision of a future free from vaccine-preventable diseases.”…

UNAIDS [to 19 August 2017]
http://www.unaids.org/en
Update  16 August 2017
Promoting HIV prevention among young people in El Salvador
…In El Salvador, there is a growing concern about the increase in new HIV infections reported since 2011 among adolescents aged between 15 and 19 years. Young people are not receiving the information they need to protect themselves from HIV: only 36.5% of young people aged 15–24 years know how to prevent HIV transmission.

UNICEF  [to 19 August 2017]
https://www.unicef.org/media/
1 August 2017
Babies and mothers worldwide failed by lack of investment in breastfeeding
GENEVA/NEW YORK, 1 August 2017 – No country in the world fully meets recommended standards for breastfeeding, according to a new report by UNICEF and the World Health Organization (WHO) in collaboration with the Global Breastfeeding Collective, a new initiative to increase global breastfeeding rates.
 
Wellcome Trust  [to 19 August 2017]
https://wellcome.ac.uk/news
News / Published: 10 August 2017
Danny Truell to become Emeritus Partner of Wellcome Investments
Danny Truell has led the Wellcome Trust’s Investment division with great distinction as Chief Investment Officer and more recently as Managing Partner, overseeing transformative growth of our endowment that has allowed us to more than double our charitable spending since his arrival in 2005.
 
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BIO    [to 19 August 2017]
https://www.bio.org/insights/press-release
August 18, 2017
BIO Applauds Signing of Food and Drug Administration Reauthorization Act (FDARA)
Washington, DC  Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement regarding President Trump’s signing of the Food and Drug Administration Reauthorization Act (FDARA) today:
“President Trump’s signature today on this landmark legislation is the culmination of a years-long collaborative process in which patients, industry, FDA, legislators and other stakeholders worked tirelessly to identify ways in which FDA’s human drug review programs can be improved to deliver better health care for every American and enhance the incorporation of the patient voice in drug development and review…
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 19 August 2017]
http://www.dcvmn.org/
25 September 2017 to 28 September 2017
DCVMN Annual General Meeting
Seoul / Korea
 
PhRMA    [to 19 August 2017]
http://www.phrma.org/press-room
August 14, 2017
Medicare Monday: Strengthening access to vaccines for seniors
Importance of access to vaccines for seniors
 
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MilliporeSigma and Baylor College of Medicine Advance Vaccine Development and Manufacturing for Neglected Diseases
MilliporeSigma today announced that it has formed a strategic alliance with Baylor College of Medicine, Houston, Texas, and its vaccine product development partnership, Texas Children’s
08 AUG 2017 | Billerica, Massachusetts, United States of America
:: Collaboration furthers both parties’ commitment to advance research and development for neglected diseases
:: Agreement focuses on optimizing vaccine process development and formulation and exchanging know-how
MilliporeSigma today announced that it has formed a strategic alliance with Baylor College of Medicine, Houston, Texas, and its vaccine product development partnership (PDP), Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD), to advance vaccine research and development for neglected and emerging infections.
The collaboration focuses on bringing vaccines through development to efficiently deliver them to societies in need. MilliporeSigma’s experts in process development and formulation are working with Texas Children’s CVD scientists at Baylor to optimize the vaccine manufacturing process to increase vaccine stability and yield. Initially, these activities are targeting schistosomiasis, a deadly parasitic disease that affects millions of people a year in tropical and subtropical regions…