Announcements

Announcements

European Medicines Agency  [to 11 November 2017]
http://www.ema.europa.eu/ema/
10/11/2017
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7–9 November 2017

10/11/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
Ten medicines recommended for approval, including two orphans ..
 
 
FDA [to 11 November 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
November 08, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to improve FDA review of shared Risk Evaluation and Mitigation Strategies to improve generic drug access

November 06, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency’s streamlined development and review pathway for consumer tests that evaluate genetic health risks
 
 
Global Fund [to 11 November 2017]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Malawi Accelerating Progress against HIV, TB and Malaria
09 November 2017
Malawi and the Global Fund strengthened their partnership by signing four grants today worth a total of US$460 million. The funds seek to expand interventions for HIV, tuberculosis and malaria, including efforts to reach more than 800,000 people in Malawi with treatment for HIV by 2020.

IFFIm
http://www.iffim.org/library/news/press-releases/
10 November 2017
IFFIm issues US$ 300 million in 3-year floating rate Vaccine Bonds
Funding to support immunisation of children in the poorest countries
London, 9 November 2017 – The International Finance Facility for Immunisation Company (IFFIm) today priced a US dollar floating rate benchmark bond issuance. The US$ 300 million, 3-year Vaccine Bonds provide investors an opportunity to fund immunisation programmes by Gavi, the Vaccine Alliance (Gavi), helping protect millions of children in the world’s poorest countries against preventable diseases.
This marks IFFIm’s first visit to the international US dollar benchmark market this year, and it re-establishes IFFIm as regular borrower in the market, following its US$ 500 million 3-year floating rate note issued in October 2016. Today’s issuance was lead managed by Citi, Crédit Agricole and Goldman Sachs International. The issue maturing on 16 November 2020 has a re-offer of 100% and carries a quarterly coupon of +13 basis points over the 3-month USD Libor rate.
IFFIm funds – approximately US$ 2.6 billion to-date — have accelerated delivery of vaccines, helping vaccinate 640 million children and saving more than nine million lives in communities across Africa and Asia. Gavi uses economies of scale to drive down the prices of vaccines for the world’s poorest countries. Gavi-supported countries pay less than US$ 40 for the full recommended course of 11 vaccines, compared with the U.S. market price of more than US$ 900.
“This transaction is yet another opportunity in IFFIm’s 11-year history for investors to put their money to work in support of Gavi’s efforts to increase access to life-saving vaccines in developing countries,” said IFFIm Board Chair René Karsenti. “IFFIm’s Vaccine Bonds are the consummate example of how investors can do good for the world, even as they do well with a solid investment.”…

 
MSF/Médecins Sans Frontières  [to 11 November 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Yemen: Saudi-Led Coalition Must Allow Access for Humanitarian Organizations
SANA’A, YEMEN/NEW YORK, NOVEMBER 8, 2017—The Saudi-led coalition has not allowed Doctors Without Borders/Médecins Sans Frontières (MSF) flights into Yemen for the past three days, directly hindering the organization’s ability to provide life-saving medical and humanitarian assistance to a population already in dire need.
MSF is calling on the Saudi-led coalition to immediately allow unhindered access so that humanitarian assistance can reach those most in need in Yemen.

Press release
DRC: Aid Urgently Needed in Rural Areas of Kasai
November 07, 2017
KINSHASA, DEMOCRATIC REPUBLIC OF CONGO—More aid is urgently needed in rural areas of Kasai province, Democratic Republic of Congo (DRC), as people come out of hiding a year after conflict flared in the region, according to the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).
Alarming levels of malnutrition among young children indicate the severity of this neglected crisis.
 
 
NIH  [to 11 November 2017]
http://www.nih.gov/news-events/news-releases
November 6, 2017
NIH awards to test ways to store, access, share, and compute on biomedical data in the cloud
— NIH Data Commons Pilot Phase to seek best practices for developing and managing a data commons.
 
 
PATH  [to 11 November 2017]
http://www.path.org/news/index.php
Announcement | November 06, 2017
PATH convenes global partners to improve access to safe oxygen delivery
Government delegations from nine countries will join industry leaders, financiers, and global health partners in Dubai from November 7-9

UNAIDS [to 11 November 2017]
http://www.unaids.org/en
Press release
UNAIDS launches 2017 World AIDS Day campaign—My Health, My Right
GENEVA, 6 November 2017—In the lead-up to World AIDS Day on 1 December, UNAIDS has launched this year’s World AIDS Day campaign. The campaign, My Health, My Right, focuses on the right to health and explores the challenges people around the world face in exercising their rights…

UNICEF  [to 11 November 2017]
https://www.unicef.org/media/
10 November 2017
Geneva Palais Briefing Note: The impact of the closure of all air, land and sea ports of Yemen on children
This is a summary of what was said by Meritxell Relano, UNICEF Representative in Yemen  – to whom quoted text may be attributed – at today’s press briefing at the Palais des Nations in Geneva.
[See Emergencies above for more detail]
 
Bangladesh steps up vaccination for new Rohingya arrivals as measles cases rise
COX’S BAZAR, Bangladesh, 10 November 2017 – An increase in the number of suspected measles cases among the newly arrived Rohingya and their host communities in southern Bangladesh has prompted the Government and UN partners to step up immunization efforts in overcrowded camps and makeshift shelters close to the border with Myanmar.
[See Emergencies above for more detail]

Wellcome Trust  [to 11 November 2017]
https://wellcome.ac.uk/news
News / Published: 8 November 2017
WHO changes guidance on averting maternal deaths after WOMAN trial results
The WHO has published new guidance strongly recommending that intravenous tranexamic acid (TXA) is given to women diagnosed with severe bleeding within three hours of them giving birth.
Bethan Hughes, from our Innovations team, explains how the WOMAN trial, which was co-funded by Wellcome, has prompted the new WHO guidelines.

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November 9, 2017
New report and event examine the new era of vaccines
Vaccines play a vital role in protecting public health and preventing deadly disease.
For decades, vaccines and immunizations have played a critical role in protecting public health. A new report released today examines the integral value of vaccines in preventing the spread of illness and, in many places around the world, eliminating deadly infectious diseases. Smallpox has been eliminated and 16 diseases are now preventable in the United States as a result of childhood vaccines.
In order to develop vaccines, researchers must work together with stakeholders to overcome unique scientific, clinical and logistical challenges. America’s biopharmaceutical companies are committed to advancing a new era of both preventative and therapeutic vaccines for patients.      Our 2017 Medicines in Development: Vaccines update, released today, highlights the more than 260 vaccines in development to treat and prevent disease. These groundbreaking discoveries could alleviate the suffering of millions of people around the world…
Report: VACCINES: HARNESSING SCIENCE TO DRIVE INNOVATION FOR PATIENTS. 2017: 18 pages
PDF:  http://phrma-docs.phrma.org/files/dmfile/Vaccines_ReportLong_2017.pdf

 
Industry Watch  [to 11 November 2017]
:: One Year Later: Pfizer Update On Progress Of Humanitarian Assistance Program
6 November 2017