Announcements

Announcements
November 29, 2019
FDA issues guidance for industry on adaptive designs for clinical trials of drugs and biologics – Drug Information Update
Today, the Food and Drug Administration (FDA) issued a final guidance for industry entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The guidance provides information to sponsors submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance also advises sponsors on the types of information to submit to facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design.

The Adaptive Design guidance is a revision of the 2018 draft guidance entitled “Adaptive Design Clinical Trials for Drugs and Biologics.” The final guidance contains revisions to the Bayesian subsection of the guidance, provides clarifications on the prespecification principle for adaptive design, and cross-references advice from the newly published draft guidance on Interacting with the FDA on Complex Innovative Trial Designs.

Fondation Merieux [to 30 Nov 2019]
http://www.fondation-merieux.org/
News, Events
December 3 – 4, 2019 – Geneva (Switzerland)
Mérieux Foundation co-organized event
6th GTFCC Working Group on Oral Cholera Vaccine

20 – 22 Jan 2020
Mérieux Foundation co-organized event
Dengue pre-vaccination screening strategies workshop
Les Pensières Center for Global Health, Veyrier-du-Lac (France)

 

Gavi [to 30 Nov 2019]
https://www.gavi.org/
No new digest content identified.

 

GHIT Fund [to 30 Nov 2019]
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 Nov 2019]
https://www.theglobalfund.org/en/news/
News & Stories
Feature Story
Communities Uniting Against HIV
29 November 2019

Voices
On World AIDS Day: Step Up the Fight Against HIV
29 November 2019

News
Global Fund Praises PEPFAR’s Leadership and Results
26 November 2019

Updates
Data Service: Grant Detailed Budgets
26 November 2019

Hilleman Laboratories [to 30 Nov 2019]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 30 Nov 2019]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
IAVI [to 30 Nov 2019]
https://www.iavi.org/newsroom
No new digest content identified.

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
No new digest content identified.

 

IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.

 

IFRC [to 30 Nov 2019]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
Media Advisory: World’s largest humanitarian network gathers in Geneva to shape its response to global challenges
Geneva, 29 November 2019 – The leaders of the International Red Cross and Red Crescent Movement will gather next week at the Centre International de Conferences (CICG) in Geneva, Switzerland, for a series of meetings that will shape the future of the w …

Democratic Republic of the Congo
Tragic attacks on responders and increased violence threaten to reverse positive gains in Ebola response, warns Red Cross
Goma/Kinshasa/Nairobi/Geneva, 28 November 2019 – Several violent attacks in the Democratic Republic of Congo (DR Congo) have killed, wounded and displaced many. Those killed included four Ebola responders. The President of DR Congo Red Cross, Grégoire …

 

IVAC [to 30 Nov 2019]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
No new digest content identified.

 

IVI [to 30 Nov 2019]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.

 

JEE Alliance [to 30 Nov 2019]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 30 Nov 2019]
http://www.msf.org/
Latest [Selected Announcements]
Niger
Fifteen years treating malnutrition and malaria around the cl…
Project Update 25 Nov 2019

DRC Ebola outbreaks
Crisis update – November 2019
Crisis Update 25 Nov 2019

 

National Vaccine Program Office – U.S. HHS [to 30 Nov 2019]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
February 13-14, 2020 NVAC Meeting
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)

 

NIH [to 30 Nov 2019]
http://www.nih.gov/news-events/news-releases
Selected News Releases
Investigational Drugs Reduce Risk of Death from Ebola Virus Disease
November 27, 2019 — Study Leaders Publish Results from NIH-DRC-WHO Clinical Trial of Four Experimental Therapies.
[See Milestones above for detail]

NIH Statement on World AIDS Day 2019
November 25, 2019 — NIH is playing a pivotal role in supporting the innovative science underpinning the effort to reduce the incidence of HIV domestically by 75% in 5 years, and by 90% by 2030.

 

PATH [to 30 Nov 2019]
https://www.path.org/media-center/
Selected Announcements
Review of one year of PrEP implementation in 11 provinces and rollout of PrEP in 15 new provinces in Vietnam
Ho Chi Minh City, November 27, 2019—Since the one year anniversary of the nationwide launch of the pre-exposure prophylaxis (PrEP) program in 11 provinces in Vietnam, the country is ready to roll out the program more widely due to global PrEP successes in reaching epidemic control for HIV. At the One-year PrEP Implementation Review Forum today, the Vietnam Administration for HIV/AIDS Control (VAAC) presented a review of the PrEP program’s progress to date and announced its expansion to an additional 15 provinces across Vietnam, as part of the country’s commitment to ending HIV by 2030…

 

Sabin Vaccine Institute [to 30 Nov 2019]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 30 Nov 2019]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
29 November 2019
United Republic of Tanzania lowers age of consent for HIV testing
The United Republic of Tanzania has approved a change to the law that lowers the age of consent for HIV testing from 18 years to 15 years. The amendment to legislation also makes self-testing for HIV legal, also from the age of 15 years.
“These amendments will significantly accelerate our intention to meet the 90–90–90 goals, which aim at ending the AIDS epidemic by 2030,” said Ummy Mwalimu, Minister of Health, Community Development, Gender, Elderly and Children. The ministry was instrumental in tabling the amendments to the legislation…

29 November 2019
HIV positive refugees support one another in Uganda

26 November 2019
Speech by UNAIDS Executive Director Winnie Byanyima at the World AIDS Day 2019 report launch

25 November 2019
Women are leading the response to HIV in their communities

 

UNICEF [to 30 Nov 2019]
https://www.unicef.org/media/press-releases
Selected Statements, Press Releases, Reports
News note
UNICEF delivers over 260,000 vaccines and medical supplies to fight measles outbreaks in Samoa, Fiji and Tonga
Delivers 115,500 doses of measles vaccines to worst-affected Samoa
28/11/2019

Statement
4,500 children under the age of five died from measles in the Democratic Republic of the Congo so far this year
Statement by UNICEF Representative in the DRC Edouard Beigbeder
27/11/2019

Press release
Over 300 children and adolescents die every day from AIDS-related causes
Only half of children living with HIV have access to life-saving treatment – UNICEF
26/11/2019

 

Vaccination Acceptance Research Network (VARN) [to 30 Nov 2019]
https://vaccineacceptance.org/news.html#header1-2r
No new digest content identified.

 

Vaccine Confidence Project [to 30 Nov 2019]
http://www.vaccineconfidence.org/
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 30 Nov 2019]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 30 Nov 2019]
https://wellcome.ac.uk/news
No new digest content identified.

 

The Wistar Institute [to 30 Nov 2019]
https://www.wistar.org/news/press-releases
No new digest content identified.

World Organisation for Animal Health (OIE) [to 30 Nov 2019]
https://www.oie.int/en/for-the-media/press-releases/2019/
No new digest content identified.

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ARM [Alliance for Regenerative Medicine] [to 30 Nov 2019]
https://alliancerm.org/press-releases/
No new digest content identified.

 

BIO [to 30 Nov 2019]
https://www.bio.org/press-releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 30 Nov 2019]
http://www.dcvmn.org/
News
Research and Development as the answer to vaccine shortages and low coverage
[Posted as 25 Nov 2019]
Rio de Janeiro, 22nd October 2019 – The Brazilian Minister of Health, Luiz Henrique Mandetta, addressed the delegates of the 20th DCVMN Annual General Meeting, affirming that vaccines represent a global public good, considering that their benefits are universal across countries, people and generations. He mentioned the challenges imposed by the reemergence of vaccine preventable diseases, due to low vaccination coverage, shortages of vaccines, vaccine hesitancy, anti-vaccination lobbying and the spreading of disinformation…

 

IFPMA [to 30 Nov 2019]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

PhRMA [to 30 Nov 2019]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.