Announcements

Announcements
 
 
Paul G. Allen Frontiers Group    [to 30 May 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
 
 
BARDA   [to 30 May 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 30 May 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 30 May 2020]
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 30 May 2020]
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.
05.28.2020
CARB-X funds Microbion to develop inhaled drug to treat cystic fibrosis-related lung infections
CARB-X is awarding Microbion Corporation of Bozeman, MT, USA, up to $6.1 million plus up to $5.4 million more if certain project milestones are met, to develop its anti-infective drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 30 May 2020]
http://cepi.net/
Latest News
Novavax COVID-19 vaccine candidate begins clinical trials
The Novavax vaccine candidate is the fourth CEPI-funded COVID-19 vaccine to enter the clinic.
Blog
26 May 2020
 
 
Clinton Health Access Initiative, Inc. (CHAI)  [to 30 May 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 30 May 2020]
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
25 May 2020
EDCTP-co-funded visceral leishmaniasis treatment trial completes recruitment
 
 
Emory Vaccine Center    [to 30 May 2020]
http://www.vaccines.emory.edu/
[Undated]
No new digest content identified.
 
 
European Medicines Agency  [to 30 May 2020]
http://www.ema.europa.eu/ema/
News & Press Releases ·
Press release: COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
Last updated: 29/05/2020
Press release: New vaccine for prevention of Ebola virus disease recommended for approval in the European Union
CHMP, Last updated: 29/05/2020
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020
Press release: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
Last updated: 28/05/2020
 
 
European Vaccine Initiative  [to 30 May 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 30 May 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
May 29, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020
May 29, 2020 – Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
May 28, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
May 26, 2020 – FDA Approves Only Drug in U.S. to Treat Severe Malaria
Today, the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate     oral antimalarial regimen.
Prior to this approval, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the U.S. Centers for Disease Control and Prevention (CDC) to provide IV artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol. There has been no FDA-approved drug for treatment of severe malaria in the United States since the marketing of quinine was discontinued by the manufacturer in March 2019…
May 26, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020
 
 
Fondation Merieux  [to 30 May 2020]
http://www.fondation-merieux.org/
News, Events
Appui aux laboratoires RESAOLAB
COVID-19: RESAOLAB mobilized and reinforced to contend with the epidemic in West Africa
May 27, 2020 – West Africa
The West African Network of Biomedical Analysis Laboratories (RESAOLAB), of which the third phase was launched end 2019, has set up a special Covid-19 unit to reinforce the diagnostic capacities of its member countries and to prevent the spread of the virus, with the support of the Agence française de développement (AFD) and the Mérieux Foundation.
 
 
Gavi [to 30 May 2020]
https://www.gavi.org/
News releases
Virtual Conference
4 June 2020
The UK government will host Gavi’s third donor pledging conference to mobilise at least US$ 7.4 billion in additional resources to protect the next generation with vaccines, reduce disease inequality and create a healthier, safer and more prosperous world.
26 May 2020
New Zealand announces NZ$ 7 million pledge to Vaccine Alliance
 
 
GHIT Fund   [to 30 May 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.
 
 
 
Global Fund  [to 30 May 2020]
https://www.theglobalfund.org/en/news/
Sourcing & Management of Health Products
Updates
Strategy Development Open Consultation
29 May 2020
The Global Fund has launched an open consultation to develop the next Global Fund Strategy.
We strongly encourage all stakeholders to contribute to this consultation by identifying the most pressing challenges and opportunities in the fight against the three diseases; building resilient and sustainable systems for health; promoting and protecting human rights and gender equality; and mobilizing resources. We also want your views as to how these priorities are affected by the COVID-19 pandemic and broader changes in the health and development landscape. We have prepared a series of framing questions to answer.

See how to contribute and read background information on our new Strategy Development page.
Voices
On the Front Lines: Responding to COVID-19
28 May 2020
Sourcing & Management of Health Products
COVID-19 Response: Diagnostics Procurement
27 May 2020
Voices
COVID-19 Threatens to Derail Fight Against HIV, TB and Malaria
27 May 2020
Updates
Search for Independent Members of the Inspector General Nomination Committee
25 May 2020
 
 
Hilleman Laboratories   [to 30 May 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 30 May 2020]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 30 May 2020]
https://www.iavi.org/newsroom
Press Releases
May 26, 2020
IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2

KENILWORTH, N.J., and NEW YORK, N.Y., MAY 26, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, today announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO® (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans. Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, to provide initial funding support for this effort.
Under the agreement IAVI and Merck will work together to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved…
 
 
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
ICMRA meeting on international alignment during COVID-19 pandemic #4 (27 May 2020)
… Participants of the high-level meeting exchanged information about the growing number of medicines that are in development or in clinical trials to assess their safety and efficacy for the treatment or prevention of COVID-19…
 
 
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Statement // Solidarity Call to Action: To realize equitable global access to COVID-19 health technologies through sharing of knowledge, intellectual property and data (29 May 2020)
[See Milestones above for detail]
 
 
IFFIm
http://www.iffim.org/
Press Releases
No new digest content identified.
 
 
IFRC   [to 30 May 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
International Red Cross and Red Crescent Movement appeals for 3.1 billion Swiss francs (3.19 billion US dollars) to curb COVID-19’s spread and assist world’s most vulnerable amid the pandemic
Geneva, 28 May 2020 –-The International Red Cross and Red Crescent Movement is appealing for 3.1 billion Swiss francs (3.19 billion US dollars) to urgently scale up its global response to curb COVID-19’s rapid spread and assist the world’s most vulnerable people amid the pandemic.
28 May 2020
 
 
IVAC  [to 30 May 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.
 
 
IVI   [to 30 May 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 30 May 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 30 May 2020]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
MSF opens COVID-19 centre in Venezuela
Project Update 29 May 2020
Coronavirus COVID-19 pandemic
Continuing essential medical services during COVID-19
Project Update 28 May 2020
Coronavirus COVID-19 pandemic
Unregulated market for personal protective equipment puts lives at r…
Press Release 28 May 2020
Brazil
MSF responds to the COVID-19 pandemic in Amazonas
Press Release 27 May 2020
Coronavirus COVID-19 pandemic
Offering extra protection against COVID-19 to Lebanon’s most vulnera…
Project Update 26 May 2020
 
 
Coronavirus COVID-19 pandemic
MSF concludes COVID-19 response in Spain
Press Release 25 May 2020
 
 
National Vaccine Program Office – U.S. HHS  [to 30 May 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting (Virtual)
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 30 May 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH releases strategic plan to accelerate nutrition research over next 10 years
May 27, 2020 — With a focus on precision nutrition, the plan reflects the wide range of nutrition research supported across the agency.
 
 
PATH  [to 30 May 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 30 May 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 30 May 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
29 May 2020
Caribbean community organizations call for decisive action to end homophobic abuse and cyberbullying
28 May 2020
“My biggest concern is to get my antiretroviral medicines”: HIV and COVID-19 in Latin America
27 May 2020
Pia Wurtzbach on how she is helping the response to COVID-19
26 May 2020
“When people are asked to isolate themselves, we also need to make sure that they have food and medicine”
25 May 2020
“We are in this together”: Uganda Young Positives respond to COVID-19
25 May 2020
Modelling the extreme—COVID-19 and AIDS-related deaths
 
 
UNICEF  [to 30 May 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
COVID-19: Number of children living in household poverty to soar by up to 86 million by end of year
New analysis from Save the Children and UNICEF reveals that without urgent action, the number of children living in poor households across low- and middle-income countries could increase by 15 per cent, to reach 672 million
27/05/2020
Press release
Countries failing to stop harmful marketing of breast-milk substitutes, warn WHO and UNICEF
Agencies encourage women to continue to breastfeed during the COVID-19 pandemic
27/05/2020
 
 
Unitaid  [to 30 May 2020]
https://unitaid.org/
Featured News
29 May 2020
Unitaid backs WHO and Costa Rica call to action on pooling of knowledge and rights for COVID-19 global public goods

Geneva — Unitaid welcomes the call by WHO and the President of Costa Rica for the voluntary pooling of knowledge, intellectual property and data for COVID-19 health technologies to help ensure equitable access to global public goods.

WHO Director-General Dr Tedros Adhanom Ghebreyesus and President Carlos Alvarado Quesada of Costa Rica launched the initiative at a digital event on Friday 29 May, together with the support of a large number of Member States and international organisation. The ‘Solidarity Call to Action’ targets governments, public and private sector funders of research, pharmaceutical industry, as well as researchers themselves.

Marisol Touraine, Chair of the Unitaid Executive Board and former French health minister said, “Equitable access to better medicines, tests and preventive methods is at the heart of Unitaid’s work – not just for COVID-19 but for HIV, tuberculosis, malaria and other diseases.” She continues, “We very much support the call for non-exclusive and global voluntary licensing through the Unitaid-established and supported Medicines Patent Pool, as well as through other mechanisms such as the UN Technology Bank-WHO TechAccess Partnership.”

Speaking at the launch, Dr Philippe Duneton, Unitaid Executive Director a.i., said. “Voluntary pooling is an important step in towards equitable access to COVID-19 medicines and tests. Intellection property rights are not the problem here, it is the way in which they are used. We expect the pharmaceutical industry to turn IP rights into solutions. Unitaid has created and supported MPP, and it has shown the way for the HIV response; this model is also key for the COVID-19 response”. He continues, “Global threats need global solutions. Equitable access to vaccines, diagnostics and therapeutics is  key to ending this pandemic, and what’s more they also need to be affordable.”…
25 May 2020

Unitaid greets new Korean-led initiative to improve the global response to infectious diseases

Geneva –  Unitaid welcomes the launch of the Support Group for Global Infectious Disease Response (G4IDR), an initiative led by the Republic of Korea that seeks to capitalize on lessons learned from the COVID-19 pandemic. The Geneva-based group convenes several countries and will collaborate with the World Health Organization (WHO) and global health organizations including Unitaid.
Is it part of the wider ‘Group of Friends of Solidarity for Global Health Security’ launched on 12 May 2020 at the UN Headquarters in New York, USA.

The Geneva G4IDR initiative was launched by H.E. Mrs Kang Kyung-wha, Minister of Foreign Affairs of the Republic of Korea. Mrs Kang emphasised the role of global institutions in tackling global challenges and said that she hoped the G4IDR Support Group, “will play an important role in facilitating and coordinating cooperation between countries and health organizations, eventually strengthening the global response not only to COVID-19 but to future global health crises that can strike next.”…
 
 
Vaccination Acceptance Research Network (VARN)  [to 30 May 2020]
https://vaccineacceptance.org/news.html#header1-2r
Annoucements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 30 May 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Feature
First measles, now COVID-19 – are outbreaks finally moving the dial on vaccine hesitancy?
May 2020
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 30 May 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 30 May 2020]
https://wellcome.ac.uk/news
Explainer | 29 May 2020
How can we get effective treatments for COVID-19?
From repurposed drugs to new therapies – researchers are working at incredible speed to find the best ways to treat COVID-19 patients.
 
 
The Wistar Institute   [to 30 May 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 30 May 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 30 May 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.
 
 
ARM [Alliance for Regenerative Medicine]  [to 30 May 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 30 May 2020]
https://www.bio.org/press-releases
Press Releases
Dr. Anthony Fauci, Dr.Moncef Slaoui and Top COVID-19 Thought Leaders Take Stage During BIO Digital Week
May 28, 2020
Anthony Fauci, M.D., National Institute of Allergy and Infectious Diseases Director and Moncef Slaoui, Ph.D., U.S. Operation Warp Speed Chief Advisor will speak on a special plenary session on Tuesday, June 9 during BIO Digital, a virtual conference…
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 30 May 2020]
http://www.dcvmn.org/
No new digest content identified.
 
 
IFPMA   [to 30 May 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Pharma partners in efforts to give coronavirus vaccine for everyone
28 May 2020
Geneva, 28 May 2020. IFPMA has today updated the world’s media on the biopharmaceutical industry’s unprecedented efforts, many of them in collaboration with others, to speed up research and development for a new COVID-19 vaccine. The body representing the global biopharmaceutical industry also highlighted at the briefing that plans are underway to scale up manufacturing at risk even though it is not sure yet which, if any, vaccines in development will be found to be safe and effective. Such investments decisions are unprecedented and demonstrate companies are not taking a “business as usual” approach in their response to the global pandemic.
The industry reaffirmed its acute awareness of the enormous responsibility it has to patients and society to bring its knowledge and expertise to bear, in collaboration and in partnership with others, in finding a coronavirus vaccine and thereby live up to the commitment it is giving to deliver safe, quality, effective, and affordable COVID-19 vaccines to all.
A new vaccine to protect people from COVID-19 holds the greatest promise of ending the pandemic, but there are no guarantees that one will be found. The biopharmaceutical industry is working at unparalleled speed and sparing no resources to develop safe and effective COVID-19 vaccines in record time. As of 27 May 2020, the WHO reports there are currently 10 candidate vaccines in clinical evaluation and 115 candidate vaccines in pre-clinical evaluation. Several biopharmaceutical companies are researching vaccine candidates and are collaborating in the sharing of existing technologies that can be leveraged to allow a rapid upscale of production once a vaccine candidate is identified. Companies are also sharing technologies that act as an adjuvant which can boost the effectiveness of a potential vaccine. [Overview of industry activities].

Thomas Cueni, IFPMA Director General, is acutely aware of the challenges: “Not only does the science have to be on our side if we are to quickly find a coronavirus vaccine, but we also have to find ways of being able to produce hundreds of millions, possible billions of doses of the new vaccine. Then people need to be vaccinated in sufficient numbers to protect whole communities. And, all the while, we should continue to produce existing vaccines”.

He admits the task in hand is larger than any attempted before and beyond the power of any single entity. Cueni explains: “The only way to deliver on our promise of safe, equitable, affordable coronavirus vaccines is for science and collaboration on a global scale to prevail. Be in no doubt, our member companies are fully engaged in the race to find a vaccine. We are fully committed to playing our full role within existing partnerships, such as ACT Accelerator and Gavi, on the basis that we wholeheartedly embrace the goal of providing new coronavirus vaccines for all”.

Looking to the upcoming Global Vaccine Summit on 4 June, and Gavi, the Vaccine Alliance replenishment, Cueni declared: “While we should give our undevoted attention to ending the COVID-19 pandemic, we must not fall into the trap of forgetting the need for ongoing immunization efforts to continue as well as being very vigilant in tracking any future virus”. He confirms that the biopharmaceutical industry will continue its 20-year history of working in partnership with Gavi, founded in 2000, that has led to nearly half the world’s children being protected against deadly and debilitating infectious diseases”.
Pharma industry updates advice on engaging with healthcare professionals as countries emerge from COVID-19 lockdown
28 May 2020
Geneva, 28 May 2020: As countries lift lockdown restrictions, the international pharma industry body, IFPMA, provides its members with ethical considerations on when and how to resume in-person meetings with healthcare practitioners and other stakeholders within the healthcare system.

During the COVID-19 pandemic, biopharmaceutical companies proactively interrupted face-to-face interactions between their representatives and physicians, in order to protect patients, healthcare professionals, and their own employees, and have replaced in-office visits and face-to-face congresses with online platforms, virtual meetings, webinars, etc.
Maintaining dialogue and scientific exchange with the medical community is critical to inform physicians about new possible treatments, alternative treatment protocols, product supply or safety/efficacy data. This meaningful engagement is even more critical during the COVID-19 pandemic, as physicians contend with the many medical questions of how the virus could affect their patients’ existing treatments and at the same time need to remain informed about general scientific information and treatment options. “During the lockdown, employees have stepped away from healthcare sites to limit the spread of the virus and protect patients, while maintaining remote interactions to continue to share scientific knowledge” explains Rady Johnson, Chair of the IFPMA Ethics and Business Integrity Committee, and Chief Compliance, Quality and Risk Officer at Pfizer. Looking to the future, he adds: “Maintaining productive dialogue and scientific exchange with the medical community is central to ensuring that all patients, COVID and non-COVID, receive the treatments needed to support their overall health and well-being. But even as doors open up, we want to preserve that dialogue and partnership without risk to the safety of patients, customers, our employees and communities. We remain committed to appropriately engaging healthcare professionals in-person when it is safe to do so, alongside our continued use of remote interaction channels”.
In these unprecedented times and the high level of unpredictability, the biopharmaceutical industry has found that its recently launched Ethos[1] has been indispensable in helping provide the necessary framework to anchor ethical decision-making, where no specific rules could have previously been anticipated. This principles-driven approach will continue to guide IFPMA members’ conduct as they adapt to the evolving COVID-19 operating environment…
 
 
ICBA – International Council of Biotechnology Associations   [to 30 May 2020]
https://internationalbiotech.org/
News
No new digest content identified.
 
 
PhRMA    [to 30 May 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.
 
 
Industry Watch   [to 30 May 2020]
:: Moderna Announces First Participants in Each Age Cohort Dosed in Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 29, 2020
:: Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Investigational Preventive Ebola Vaccine Regimen
May 29, 2020
 
Announcements
 
 
Paul G. Allen Frontiers Group    [to 30 May 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
 
 
BARDA   [to 30 May 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 30 May 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 30 May 2020]
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 30 May 2020]
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.
05.28.2020
CARB-X funds Microbion to develop inhaled drug to treat cystic fibrosis-related lung infections
CARB-X is awarding Microbion Corporation of Bozeman, MT, USA, up to $6.1 million plus up to $5.4 million more if certain project milestones are met, to develop its anti-infective drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 30 May 2020]
http://cepi.net/
Latest News
Novavax COVID-19 vaccine candidate begins clinical trials
The Novavax vaccine candidate is the fourth CEPI-funded COVID-19 vaccine to enter the clinic.
Blog
26 May 2020
 
 
Clinton Health Access Initiative, Inc. (CHAI)  [to 30 May 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 30 May 2020]
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
25 May 2020
EDCTP-co-funded visceral leishmaniasis treatment trial completes recruitment
 
 
Emory Vaccine Center    [to 30 May 2020]
http://www.vaccines.emory.edu/
[Undated]
No new digest content identified.
 
 European Medicines Agency  [to 30 May 2020]
http://www.ema.europa.eu/ema/
News & Press Releases ·
Press release: COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
Last updated: 29/05/2020
Press release: New vaccine for prevention of Ebola virus disease recommended for approval in the European Union
CHMP, Last updated: 29/05/2020
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020
Press release: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
Last updated: 28/05/2020
 
 
European Vaccine Initiative  [to 30 May 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 30 May 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
May 29, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020
May 29, 2020 – Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

May 28, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020
May 27, 2020 – Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection
May 26, 2020 – FDA Approves Only Drug in U.S. to Treat Severe Malaria
Today, the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate     oral antimalarial regimen.
Prior to this approval, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the U.S. Centers for Disease Control and Prevention (CDC) to provide IV artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol. There has been no FDA-approved drug for treatment of severe malaria in the United States since the marketing of quinine was discontinued by the manufacturer in March 2019…
May 26, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020
 
 
Fondation Merieux  [to 30 May 2020]
http://www.fondation-merieux.org/
News, Events
Appui aux laboratoires RESAOLAB
COVID-19: RESAOLAB mobilized and reinforced to contend with the epidemic in West Africa
May 27, 2020 – West Africa
The West African Network of Biomedical Analysis Laboratories (RESAOLAB), of which the third phase was launched end 2019, has set up a special Covid-19 unit to reinforce the diagnostic capacities of its member countries and to prevent the spread of the virus, with the support of the Agence française de développement (AFD) and the Mérieux Foundation.
 
 
Gavi [to 30 May 2020]
https://www.gavi.org/
News releases
Virtual Conference
4 June 2020
The UK government will host Gavi’s third donor pledging conference to mobilise at least US$ 7.4 billion in additional resources to protect the next generation with vaccines, reduce disease inequality and create a healthier, safer and more prosperous world.
26 May 2020
New Zealand announces NZ$ 7 million pledge to Vaccine Alliance
 
 
GHIT Fund   [to 30 May 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.
 
 
Global Fund  [to 30 May 2020]
https://www.theglobalfund.org/en/news/
Sourcing & Management of Health Products
Updates
Strategy Development Open Consultation
29 May 2020
The Global Fund has launched an open consultation to develop the next Global Fund Strategy.
We strongly encourage all stakeholders to contribute to this consultation by identifying the most pressing challenges and opportunities in the fight against the three diseases; building resilient and sustainable systems for health; promoting and protecting human rights and gender equality; and mobilizing resources. We also want your views as to how these priorities are affected by the COVID-19 pandemic and broader changes in the health and development landscape. We have prepared a series of framing questions to answer.
See how to contribute and read background information on our new Strategy Development page.
Voices
On the Front Lines: Responding to COVID-19
28 May 2020
Sourcing & Management of Health Products
COVID-19 Response: Diagnostics Procurement
27 May 2020
Voices
COVID-19 Threatens to Derail Fight Against HIV, TB and Malaria
27 May 2020
 
 
Search for Independent Members of the Inspector General Nomination Committee
25 May 2020
 
 
Hilleman Laboratories   [to 30 May 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 30 May 2020]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 
 
IAVI  [to 30 May 2020]
https://www.iavi.org/newsroom
Press Releases
May 26, 2020
IAVI and Merck Collaborate to Develop Vaccine Against SARS-CoV-2
KENILWORTH, N.J., and NEW YORK, N.Y., MAY 26, 2020 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, and IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, today announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO® (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans. Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, to provide initial funding support for this effort.
Under the agreement IAVI and Merck will work together to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved…
 
 
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
ICMRA meeting on international alignment during COVID-19 pandemic #4 (27 May 2020)
… Participants of the high-level meeting exchanged information about the growing number of medicines that are in development or in clinical trials to assess their safety and efficacy for the treatment or prevention of COVID-19…
 
 
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Statement // Solidarity Call to Action: To realize equitable global access to COVID-19 health technologies through sharing of knowledge, intellectual property and data (29 May 2020)
[See Milestones above for detail]
 
 
IFFIm
http://www.iffim.org/
Press Releases
No new digest content identified.
 
 
IFRC   [to 30 May 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
International Red Cross and Red Crescent Movement appeals for 3.1 billion Swiss francs (3.19 billion US dollars) to curb COVID-19’s spread and assist world’s most vulnerable amid the pandemic
Geneva, 28 May 2020 –-The International Red Cross and Red Crescent Movement is appealing for 3.1 billion Swiss francs (3.19 billion US dollars) to urgently scale up its global response to curb COVID-19’s rapid spread and assist the world’s most vulnerable people amid the pandemic.
28 May 2020
 
 
IVAC  [to 30 May 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.
 
 
IVI   [to 30 May 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 30 May 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 30 May 2020]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
MSF opens COVID-19 centre in Venezuela
Project Update 29 May 2020
Coronavirus COVID-19 pandemic
Continuing essential medical services during COVID-19
Project Update 28 May 2020
Coronavirus COVID-19 pandemic
Unregulated market for personal protective equipment puts lives at r…
Press Release 28 May 2020
Brazil
MSF responds to the COVID-19 pandemic in Amazonas
Press Release 27 May 2020
Coronavirus COVID-19 pandemic
Offering extra protection against COVID-19 to Lebanon’s most vulnera…
Project Update 26 May 2020
 
 
Coronavirus COVID-19 pandemic
MSF concludes COVID-19 response in Spain
Press Release 25 May 2020
 
 
National Vaccine Program Office – U.S. HHS  [to 30 May 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting (Virtual)
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 30 May 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH releases strategic plan to accelerate nutrition research over next 10 years
May 27, 2020 — With a focus on precision nutrition, the plan reflects the wide range of nutrition research supported across the agency.
 
 
PATH  [to 30 May 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 30 May 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 30 May 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
29 May 2020
Caribbean community organizations call for decisive action to end homophobic abuse and cyberbullying
28 May 2020
“My biggest concern is to get my antiretroviral medicines”: HIV and COVID-19 in Latin America
27 May 2020
Pia Wurtzbach on how she is helping the response to COVID-19
26 May 2020
“When people are asked to isolate themselves, we also need to make sure that they have food and medicine”
25 May 2020
“We are in this together”: Uganda Young Positives respond to COVID-19
25 May 2020
Modelling the extreme—COVID-19 and AIDS-related deaths
 
 
UNICEF  [to 30 May 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
COVID-19: Number of children living in household poverty to soar by up to 86 million by end of year
New analysis from Save the Children and UNICEF reveals that without urgent action, the number of children living in poor households across low- and middle-income countries could increase by 15 per cent, to reach 672 million
27/05/2020
Press release
Countries failing to stop harmful marketing of breast-milk substitutes, warn WHO and UNICEF
Agencies encourage women to continue to breastfeed during the COVID-19 pandemic
27/05/2020
 
 
Unitaid  [to 30 May 2020]
https://unitaid.org/
Featured News
29 May 2020
Unitaid backs WHO and Costa Rica call to action on pooling of knowledge and rights for COVID-19 global public goods
Geneva — Unitaid welcomes the call by WHO and the President of Costa Rica for the voluntary pooling of knowledge, intellectual property and data for COVID-19 health technologies to help ensure equitable access to global public goods.
WHO Director-General Dr Tedros Adhanom Ghebreyesus and President Carlos Alvarado Quesada of Costa Rica launched the initiative at a digital event on Friday 29 May, together with the support of a large number of Member States and international organisation. The ‘Solidarity Call to Action’ targets governments, public and private sector funders of research, pharmaceutical industry, as well as researchers themselves.
Marisol Touraine, Chair of the Unitaid Executive Board and former French health minister said, “Equitable access to better medicines, tests and preventive methods is at the heart of Unitaid’s work – not just for COVID-19 but for HIV, tuberculosis, malaria and other diseases.” She continues, “We very much support the call for non-exclusive and global voluntary licensing through the Unitaid-established and supported Medicines Patent Pool, as well as through other mechanisms such as the UN Technology Bank-WHO TechAccess Partnership.”
Speaking at the launch, Dr Philippe Duneton, Unitaid Executive Director a.i., said. “Voluntary pooling is an important step in towards equitable access to COVID-19 medicines and tests. Intellection property rights are not the problem here, it is the way in which they are used. We expect the pharmaceutical industry to turn IP rights into solutions. Unitaid has created and supported MPP, and it has shown the way for the HIV response; this model is also key for the COVID-19 response”. He continues, “Global threats need global solutions. Equitable access to vaccines, diagnostics and therapeutics is  key to ending this pandemic, and what’s more they also need to be affordable.”…
25 May 2020
Unitaid greets new Korean-led initiative to improve the global response to infectious diseases
Geneva –  Unitaid welcomes the launch of the Support Group for Global Infectious Disease Response (G4IDR), an initiative led by the Republic of Korea that seeks to capitalize on lessons learned from the COVID-19 pandemic. The Geneva-based group convenes several countries and will collaborate with the World Health Organization (WHO) and global health organizations including Unitaid.
Is it part of the wider ‘Group of Friends of Solidarity for Global Health Security’ launched on 12 May 2020 at the UN Headquarters in New York, USA.
The Geneva G4IDR initiative was launched by H.E. Mrs Kang Kyung-wha, Minister of Foreign Affairs of the Republic of Korea. Mrs Kang emphasised the role of global institutions in tackling global challenges and said that she hoped the G4IDR Support Group, “will play an important role in facilitating and coordinating cooperation between countries and health organizations, eventually strengthening the global response not only to COVID-19 but to future global health crises that can strike next.”…
 
 
Vaccination Acceptance Research Network (VARN)  [to 30 May 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 30 May 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Feature
First measles, now COVID-19 – are outbreaks finally moving the dial on vaccine hesitancy?
May 2020
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 30 May 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 30 May 2020]
https://wellcome.ac.uk/news
Explainer | 29 May 2020
How can we get effective treatments for COVID-19?
From repurposed drugs to new therapies – researchers are working at incredible speed to find the best ways to treat COVID-19 patients.
 
 
The Wistar Institute   [to 30 May 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 30 May 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 30 May 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.
::::::
 
 
ARM [Alliance for Regenerative Medicine]  [to 30 May 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 30 May 2020]
https://www.bio.org/press-releases
Press Releases
Dr. Anthony Fauci, Dr.Moncef Slaoui and Top COVID-19 Thought Leaders Take Stage During BIO Digital Week
May 28, 2020
Anthony Fauci, M.D., National Institute of Allergy and Infectious Diseases Director and Moncef Slaoui, Ph.D., U.S. Operation Warp Speed Chief Advisor will speak on a special plenary session on Tuesday, June 9 during BIO Digital, a virtual conference…
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 30 May 2020]
http://www.dcvmn.org/
No new digest content identified.
 
 
IFPMA   [to 30 May 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Pharma partners in efforts to give coronavirus vaccine for everyone

28 May 2020
Geneva, 28 May 2020. IFPMA has today updated the world’s media on the biopharmaceutical industry’s unprecedented efforts, many of them in collaboration with others, to speed up research and development for a new COVID-19 vaccine. The body representing the global biopharmaceutical industry also highlighted at the briefing that plans are underway to scale up manufacturing at risk even though it is not sure yet which, if any, vaccines in development will be found to be safe and effective. Such investments decisions are unprecedented and demonstrate companies are not taking a “business as usual” approach in their response to the global pandemic.

The industry reaffirmed its acute awareness of the enormous responsibility it has to patients and society to bring its knowledge and expertise to bear, in collaboration and in partnership with others, in finding a coronavirus vaccine and thereby live up to the commitment it is giving to deliver safe, quality, effective, and affordable COVID-19 vaccines to all.

A new vaccine to protect people from COVID-19 holds the greatest promise of ending the pandemic, but there are no guarantees that one will be found. The biopharmaceutical industry is working at unparalleled speed and sparing no resources to develop safe and effective COVID-19 vaccines in record time. As of 27 May 2020, the WHO reports there are currently 10 candidate vaccines in clinical evaluation and 115 candidate vaccines in pre-clinical evaluation. Several biopharmaceutical companies are researching vaccine candidates and are collaborating in the sharing of existing technologies that can be leveraged to allow a rapid upscale of production once a vaccine candidate is identified. Companies are also sharing technologies that act as an adjuvant which can boost the effectiveness of a potential vaccine. [Overview of industry activities].

Thomas Cueni, IFPMA Director General, is acutely aware of the challenges: “Not only does the science have to be on our side if we are to quickly find a coronavirus vaccine, but we also have to find ways of being able to produce hundreds of millions, possible billions of doses of the new vaccine. Then people need to be vaccinated in sufficient numbers to protect whole communities. And, all the while, we should continue to produce existing vaccines”.

He admits the task in hand is larger than any attempted before and beyond the power of any single entity. Cueni explains: “The only way to deliver on our promise of safe, equitable, affordable coronavirus vaccines is for science and collaboration on a global scale to prevail. Be in no doubt, our member companies are fully engaged in the race to find a vaccine. We are fully committed to playing our full role within existing partnerships, such as ACT Accelerator and Gavi, on the basis that we wholeheartedly embrace the goal of providing new coronavirus vaccines for all”.

Looking to the upcoming Global Vaccine Summit on 4 June, and Gavi, the Vaccine Alliance replenishment, Cueni declared: “While we should give our undevoted attention to ending the COVID-19 pandemic, we must not fall into the trap of forgetting the need for ongoing immunization efforts to continue as well as being very vigilant in tracking any future virus”. He confirms that the biopharmaceutical industry will continue its 20-year history of working in partnership with Gavi, founded in 2000, that has led to nearly half the world’s children being protected against deadly and debilitating infectious diseases”.

Pharma industry updates advice on engaging with healthcare professionals as countries emerge from COVID-19 lockdown

28 May 2020
Geneva, 28 May 2020: As countries lift lockdown restrictions, the international pharma industry body, IFPMA, provides its members with ethical considerations on when and how to resume in-person meetings with healthcare practitioners and other stakeholders within the healthcare system.

During the COVID-19 pandemic, biopharmaceutical companies proactively interrupted face-to-face interactions between their representatives and physicians, in order to protect patients, healthcare professionals, and their own employees, and have replaced in-office visits and face-to-face congresses with online platforms, virtual meetings, webinars, etc.

Maintaining dialogue and scientific exchange with the medical community is critical to inform physicians about new possible treatments, alternative treatment protocols, product supply or safety/efficacy data. This meaningful engagement is even more critical during the COVID-19 pandemic, as physicians contend with the many medical questions of how the virus could affect their patients’ existing treatments and at the same time need to remain informed about general scientific information and treatment options. “During the lockdown, employees have stepped away from healthcare sites to limit the spread of the virus and protect patients, while maintaining remote interactions to continue to share scientific knowledge” explains Rady Johnson, Chair of the IFPMA Ethics and Business Integrity Committee, and Chief Compliance, Quality and Risk Officer at Pfizer. Looking to the future, he adds: “Maintaining productive dialogue and scientific exchange with the medical community is central to ensuring that all patients, COVID and non-COVID, receive the treatments needed to support their overall health and well-being. But even as doors open up, we want to preserve that dialogue and partnership without risk to the safety of patients, customers, our employees and communities. We remain committed to appropriately engaging healthcare professionals in-person when it is safe to do so, alongside our continued use of remote interaction channels”.

In these unprecedented times and the high level of unpredictability, the biopharmaceutical industry has found that its recently launched Ethos[1] has been indispensable in helping provide the necessary framework to anchor ethical decision-making, where no specific rules could have previously been anticipated. This principles-driven approach will continue to guide IFPMA members’ conduct as they adapt to the evolving COVID-19 operating environment…
 
 
ICBA – International Council of Biotechnology Associations   [to 30 May 2020]
https://internationalbiotech.org/
News
No new digest content identified.
 
 
PhRMA    [to 30 May 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.
 
 
Industry Watch   [to 30 May 2020]
:: Moderna Announces First Participants in Each Age Cohort Dosed in Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 29, 2020
:: Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Investigational Preventive Ebola Vaccine Regimen
May 29, 2020