Announcements

Announcements

 

Paul G. Allen Frontiers Group    [to 11 Apr 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 11 Apr 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
 
 
Bill & Melinda Gates Medical Research Institute    [to 11 Apr 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 11 Apr 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.
No new digest content identified.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 11 Apr 2020]
http://cepi.net/
Latest News
CEPI publishes analysis of COVID-19 vaccine development landscape
115 vaccine candidates identified, 5 of which lead have progressed into phase 1
[See Milestones above for detail]
 
 
CEPI welcomes COVID-Zero initiative to fill R&D funding shortfall
09 Apr 2020
CEPI is a partner in the new COVID-Zero initiative, which aims to help raise at least $8 billion by the end of April to cover a global funding shortfall for vaccines, treatments and testing for coronavirus…
COVID-Zero is calling on business to form a coalition that can help bridge this funding shortfall and get our lives, businesses and economies back on track. The initiative is called COVID-Zero because by securing this funding, it aims to achieve zero deaths, zero new cases and zero lockdowns as soon as possible…
Belgium and Canada provide funding boost for CEPI’s COVID-19 vaccine research
06 Apr 2020
 
 Clinton Health Access Initiative, Inc. (CHAI)  [to 11 Apr 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 11 Apr 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
9 April 2020
EDCTP and Africa CDC collaborate to develop capacity for outbreak and epidemic response in sub-Saharan Africa
Reliable epidemiological data is often unavailable or severely limited in resource-limited settings in Africa. This knowledge gap is further aggravated by a shortage of skilled personnel in epidemiology and biostatistics to efficiently monitor, analyse and interpret epidemiological data to inform…
…On 10 April 2020, the European and Developing Countries Clinical Trials Partnership (EDCTP) and the Africa Centres for Disease Control and Prevention (Africa CDC) will launch a call for proposals with a total call budget of €5 million. The aim is to establish an African cohort of epidemiologists by supporting institutions in sub-Saharan Africa and Europe that provide Master’s degree training in epidemiology and biostatistics, as part of Africa CDC’s framework for public health workforce development…
 
 
Emory Vaccine Center    [to 11 Apr 2020]
http://www.vaccines.emory.edu/
No new digest content identified.
 
 
European Medicines Agency  [to 11 Apr 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Guidance on regulatory requirements in the context of the COVID-19 pandemic
Last updated: 10/04/2020
 
 
Press release: Update on EU actions to support availability of medicines during COVID-19 pandemic
Last updated: 10/04/2020
Press release: EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines
Last updated: 09/04/2020
Press release: Global regulators stress need for robust evidence on COVID-19 treatments
Last updated: 09/04/2020
News: Global regulators discuss observational studies of real world data for COVID-19 medicines
Last updated: 07/04/2020
 
 
European Vaccine Initiative  [to 11 Apr 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 11 Apr 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
April 10, 2020 – Coronavirus (COVID-19) Update: Daily Roundup April 10, 2020
 
April 10, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19
 
 
Fondation Merieux  [to 11 Apr 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
 
 
 
Gavi [to 11 Apr 2020]
https://www.gavi.org/
Top Stories
COVID-19: Gavi steps up response to pandemic
:: Up to US$ 200 million available to help lower-income countries to quickly respond to pandemic; US$ 29 million approved as first tranche of funds to protect health workers and boost surveillance, testing
:: More than 21,500 cases and 681 deaths have been officially reported in 66 lower-income countries; true numbers likely to be much higher
:: Seth Berkley: “Health systems across the developing world face their biggest test in living memory, and Gavi is helping them to meet it”
Geneva, 9 April 2020 – Gavi, the Vaccine Alliance, will provide US$ 29 million in urgent initial funding to 13 lower-income countries to support their response to COVID-19, helping them to protect health care workers with personal protective equipment (PPE), perform vital surveillance and training, and fund diagnostic tests. There are further requests or interest from 21 countries, meaning more support from a total of up to US$ 200 million is likely to be approved in the coming days and weeks. This early funding is designed to provide immediate support until more substantial support from other sources is unlocked…
 
 
GHIT Fund   [to 11 Apr 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 11 Apr 2020]
https://www.theglobalfund.org/en/news/
News & Stories
News
Global Fund Partners Unite to Fight
09 April 2020
GENEVA – The Board of the Global Fund to Fight AIDS, Tuberculosis and Malaria today unanimously approved a new response mechanism to support countries to respond to COVID-19 and mitigate the impact on programs to fight HIV, TB, malaria and systems for health, effectively doubling the amount of available funding to up to US$1 billion.
The COVID-19 Response Mechanism authorizes funding of US$500 million and comes in addition to up to US$500 million in grant flexibilities that were announced by the Global Fund on 4 March and are already being implemented by 54 countries…
 
Funding Model
COVID-19 Response: Technical Guidance
09 April 2020
 
Sourcing & Management of Health Products
Guidance for Countries Selecting a Logistics Management Information System
07 April 2020
 
Sourcing & Management of Health Products
Opportunity for Evaluation of Diagnostic Products
07 April 2020
 
Sourcing & Management of Health Products
COVID-19 Response: Impact on Health Product Supply
07 April 2020
 
Voices
The Threat to Africa
07 April 2020
By Peter Sands, Executive Director of the Global Fund
…Unless extremely fast action is taken, the prospect of an imminent catastrophe in Africa will become real. Current confirmed cases and deaths are still relatively low in Africa, and the continent may be four to six weeks behind Europe’s outbreak. But the trajectory and impact of Covid-19 could be far worse – much harder to contain and causing far more death and damage to communities…
 
 
Hilleman Laboratories   [to 11 Apr 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 11 Apr 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
 
 
IAVI  [to 11 Apr 2020]
https://www.iavi.org/newsroom
Press Releases
No new digest content identified.
 
 
International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
Global regulators stress need for robust evidence on COVID-19 treatments
International regulators have published a report today highlighting their considerations on the development of potential COVID-19 therapeutics, clinical trials and compassionate use programmes. The report presents the outcomes of a workshop on COVID-19 therapeutic medicine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
 
 
Second regulatory COVID-19 workshop – meeting report_April 2020
The following represents generally agreed positions among global regulators in attendance.
Regulators emphasised that within the current COVID-19 disease pandemic, no specific medicinal product has yet clearly demonstrated efficacy. With the threat affecting all countries, regulators expressed the need for collecting robust and reliable evidence to establish safety and efficacy for the proposed medicines, so as to serve the patients’ needs in the fastest fashion possible.

Various therapeutic candidates have been prioritised for inclusion in large well-designed randomized clinical trials aimed at evaluating the treatment of COVID-19 patients. They include, based on a WHO-initiated landscape analysis of therapeutics, remdesivir, lopinavir/ritonavir with or without interferon–𝛽, and chloroquine/hydroxychloroquine. Other antivirals (e.g. monoclonal antibodies, hyperimmune sera) and immunomodulating agents such as IL-6 and IL-1 inhibitors are likewise considered for development.

However, for all these medicines, the pharmacological rationale, potential benefits and risks even in context of clinical trials, e.g. increased risk of infection with use, require careful attention.

It was agreed that randomised controlled trials (RCTs) with an appropriate control arm (i.e. not including antivirals or immune modulators), appropriately designed to generate data that meet regulatory requirements for approval, could lead to timely regulatory decisions, and could guide clinicians in defining promptly the best treatment options for COVID-19.

To this effect, multi-arm clinical studies investigating different agents simultaneously have the potential to deliver results as rapidly as possible across a range of therapeutic options, according to the same evaluation criteria.

Participants acknowledged that small studies or compassionate use programmes are unlikely to be able to generate the required level of evidence to allow clear-cut recommendations.

Nevertheless, regulators concurred that compassionate use programmes, which allow access to potential therapies for patients in need, have a beneficial public health impact on the pandemic and should be allowed, as long as they do not pose a threat to clinical trials recruitment.

Regulators expressed concern due to the multitude of ongoing trials and access programmes, which may lead to shortages of investigational products, and recommended this to be carefully monitored. It was acknowledged that preservation of access to medicines approved in indications other than COVID-19 and used as well in COVID-19 investigations might be critical in these situations, posing ethical issues of equitable distribution.

It was agreed that as clinical trial data emerge from relevant studies, sharing of information would be of uttermost importance globally. This group will reconvene within 2-3 months to take stock of the evolving therapeutic landscape.
 
 
International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
IGBA Contributes to Global Discussion on Tailored Clinical Biosimilar Development with New Peer-Reviewed Scientific Paper
(10 April 2020)
The International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today announces the publication of its first peer-reviewed scientific paper on biosimilar medicines development: The Path Towards a Tailored Clinical Biosimilar Development (Biodrugs).

COVID-19: IGBA calls for urgent priority designation for medicines at custom controls and for cargo and freight
(6 April 2020)
The International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today requests urgent action by all governments to designate all medicines as PRIORITY ESSENTIAL PRODUCTS, including all critical goods needed to manufacture them…
 
 
IFFIm
http://www.iffim.org/
Press Releases
IFFIm stands ready to support COVID-19 vaccines
09 Apr 2020
… We already have a proven and trusted financing tool to make this possible: IFFIm, the International Finance Facility for Immunisation. Since its first Vaccine Bond issuance in 2006, IFFIm has enabled Gavi, the Vaccine Alliance to pay for pressing immunisation programmes, as well as for polio eradication, vaccine stockpiles and health system strengthening.
Now, subject to Gavi approval and additional donor pledges, IFFIm could be put to work to raise fast, flexible financing on a large scale to fund the development a COVID-19 vaccine as well as its rapid deployment to affected countries once available.

So far, ten countries have committed to pay out more than US$ 6.5 billion to IFFIm over 10 to 23 years. Against those pledges, IFFIm’s Vaccine Bonds have raised about $6.1 billion from private sector investors around the world and provided $2.6 billion of immediately available funding for Gavi. IFFIm then pays back those investors at a competitive rate of return…
 
 
 IFRC   [to 11 Apr 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.
 
 
IVAC  [to 11 Apr 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.
 
 
IVI   [to 11 Apr 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 11 Apr 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 11 Apr 2020]
http://www.msf.org/
Latest [Selected Announcements]
Yemen
Authorities in Yemen must do all they can to facilitate COVID-19 response
Press Release 10 Apr 2020
 
 
Coronavirus disease COVID-19
Spain must urgently improve the care of elderly in COVID-19 response
Press Release 9 Apr 2020
 
 
Coronavirus disease COVID-19
MSF responds to COVID-19 in Lebanon
Project Update 9 Apr 2020
 
 
 
National Vaccine Program Office – U.S. HHS  [to 11 Apr 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)
 
 
NIH  [to 11 Apr 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH begins study to quantify undetected cases of coronavirus infection
April 10, 2020 — Blood samples from healthy volunteers needed to inform public health decision making.

NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins
April 9, 2020 — Study is enrolling hospitalized adults with COVID-19.
 
 
PATH  [to 11 Apr 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 11 Apr 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
 
 
UNAIDS [to 11 Apr 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
9 April 2020
A tribute to Maeve Kennedy Townsend McKean

9 April 2020
When will men stop thinking that women’s bodies are their property?

8 April 2020
New innovations map to strengthen the response to COVID-19

8 April 2020
Ensuring that people living with HIV in the Philippines have access to treatment during COVID-19

7 April 2020
Living with HIV under lockdown

6 April 2020
Supporting transgender people during the COVID-19 pandemic

6 April 2020
HIV knowledge greater among women with higher incomes
 
 
UNICEF  [to 11 Apr 2020]
https://www.unicef.org/media/press-releases
Press release
New Ebola death confirmed in the DRC as country was close to declaring end of epidemic
10/04/2020

Statement
Don’t let children be the hidden victims of COVID-19 pandemic
Ninety-nine per cent of the world’s children live with some form of pandemic-related movement restrictions; Sixty per cent live in countries with full or partial lockdowns
09/04/2020

Press release
Children’s story book released to help children and young people cope with COVID-19
08/04/2020

Press release
UNICEF providing supplies to combat COVID-19 and support integrated response in Venezuela
08/04/2020

Press release
COVID-19: UNICEF Spain makes first delivery of health supplies to fight Coronavirus
08/04/2020

Press release
Debt relief for the poorest countries critical in fight against COVID-19
Statement by UNICEF Executive Director Henrietta Fore
07/04/2020

Statement
Launch of Global Multi-Religious Faith-in-Action Covid-19 Initiative
Faith and Positive Change for Children, Families and Communities
07/04/2020

Press release
UNICEF is providing supplies and technical support to fight COVID-19 in Lebanon
06/04/2020

Press release
Urgent need to secure learning for children across South Asia
06/04/2020
 
 
Unitaid  [to 11 Apr 2020]
https://unitaid.org/#en
Unitaid is a global development agency, hosted by the World Health Organization and its major donors are France, the United Kingdom, Brazil, Norway, Chile, the Republic of Korea, Spain and the Bill & Melinda Gates Foundation.
No new digest content identified.
 
 
Vaccination Acceptance Research Network (VARN)  [to 11 Apr 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 11 Apr 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
No new digest content identified.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 11 Apr 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
Coronavirus Updates
Frequently Asked Questions about Coronavirus Disease 2019 (COVID-19)
Last Updated: March 19, 2020
Get some fast facts about the coronavirus from CHOP and the CDC. The CDC will provide updated information as it becomes available.
 
 
Wellcome Trust  [to 11 Apr 2020]
https://wellcome.ac.uk/news
News | 6 April 2020
Wellcome Trust building to become respite centre for local NHS staff
 
 
The Wistar Institute   [to 11 Apr 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 11 Apr 2020]
https://www.wfpha.org/
Latest News
World Health Day
Tuesday, 07 April 2020
It’s World Health Day! It is the day to celebrate the work of Public Health Professionals, Nurses, Midwives, Doctors, and All Health Workers
 
 
World Organisation for Animal Health (OIE)   [to 11 Apr 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

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ARM [Alliance for Regenerative Medicine]  [to 11 Apr 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 11 Apr 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 11 Apr 2020]
http://www.dcvmn.org/
News
No new digest content identified.
 
 
IFPMA   [to 11 Apr 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Backgrounder – COVID-19
03 April 2020
[See COVID-19 above for detail]
 
 
PhRMA    [to 11 Apr 2020]
http://www.phrma.org/
Selected Press Releases, Statements
To the millions affected by COVID-19
Stephen J. Ubl and Giovanni Caforio, M.D.   |     April 9, 2020

Today, in the midst of this global pandemic, our industry is doing what we are uniquely positioned to do: testing new and existing treatments to determine what might work against COVID-19 and developing new vaccines to prevent it…
Merck’s Dr. Julie Gerberding on the threat of antimicrobial resistance and COVID-19
Andrew Powaleny   |     April 6, 2020
We recently spoke with Dr. Julie Gerberding, executive vice president and chief patient officer at Merck, about AMR and the biopharmaceutical industry’s efforts to combat the COVID-19 pandemic.
 
 
Industry Watch
::  Lilly Begins Clinical Testing of Therapies for COVID-19 Apr 10, 2020
:: Pfizer Advances Battle Against COVID-19 on Multiple Fronts
. Anti-viral compounds show activity against SARS-CoV-2 in preclinical screening
. Pfizer and BioNTech enter into collaboration agreement to co-develop potential COVID-19 vaccine
. Company shares additional data and analysis of azithromycin
. Launch of two new studies to provide insights on the interaction between S. pneumoniae and SARS-CoV-2
. Pfizer explores studies of JAK inhibitor tofacitinib in patients with COVID-19-related pneumonia
April 09, 2020