Announcements
 

PATH [to 22 July 2017]
http://www.path.org/news/index.php
Announcement | July 21, 2017
Zambia and the BID Initiative celebrate commitment to close the immunization gap with better data
Today the BID Initiative is celebrating its partnership with the Ministry of Health (MOH) in Zambia to create a culture of data use in a showcase event. It will also mark the launch of Zambia’s electronic immunization registry (ZEIR). The celebration, which will include Zambia’s First Lady Esther Lungu, among other special guests, symbolizes both parties’ commitments to closing the immunization gap with timely, high-quality data.
Immunization is one of the best investments to improving health around the globe. Yet inaccurate or incomplete data about vaccine coverage rates, difficulties tracking patients who have missed a recent vaccine, labor-intensive reporting protocols, and poor visibility into vaccine stocks all make it difficult for health workers and health systems, particularly in low-resource settings, to protect their target population against life-threatening childhood diseases.
The BID Initiative, led by PATH, helps ensure that accurate data are both available and utilized, allowing health workers to make better decisions on how best to deliver care. Designed and implemented in partnership with the governments of Tanzania and Zambia, the BID Initiative enhances immunization and overall health service delivery by improving data collection, quality, and use. It holistically addresses immunization data challenges and strengthens evidence-based decisions through a package of interventions that build a culture of data use, including electronic immunization registries (EIR), barcodes or QR codes on child health cards, stock management tools, and peer support networks, among other data use tools. With better data, facilities can avoid stock-outs, identify defaulting patients, and better measure their performance against neighboring facilities…

Announcement | July 19, 2017
PATH welcomes $8.2 million grant from the Conrad N. Hilton Foundation to improve early childhood development in Mozambique, Kenya, and Zambia
PATH welcomes a four-year, $8.2 million grant from the Conrad N. Hilton Foundation to help thousands more children in Kenya, Mozambique, and Zambia develop to their full physical, cognitive, and social potential.
Children whose caregivers play and talk with them and are responsive to their needs show better education, health, social, and economic outcomes as adults. Yet globally, these activities, formally referred to as “nurturing care,” are often absent from children’s lives, especially during the critical window from birth until age three, when these activities have the greatest impact.
The investment builds on other PATH early childhood development (ECD) programs in sub-Saharan Africa, including the Hilton Foundation–supported Scaling Up Early Child Development project in Kenya and Mozambique, the Window of Opportunity project in South Africa and Mozambique (supported by BHP Billiton Sustainable Communities), and a US Agency for International Development-funded Public Private Partnership project in Mozambique.
PATH’s innovative approach integrates ECD services into the work of existing government health facilities and community-level health providers at a very low cost. The approach is particularly effective at reaching children younger than age three, who can benefit the most from ECD but are often missed by programs designed to reach children in school…

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European Vaccine Initiative [to 22 July 2017]
http://www.euvaccine.eu/news-events
20 July 2017
Role of vaccines in combatting anti-microbial resistance
 
19 July 2017
Current efforts in the development of effective Zika vaccines presented at the Zika Virus and other Mosquito-borne Viruses conference
 
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FDA [to 22 July 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
July 18, 2017 –
FDA approves Vosevi for Hepatitis C
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A.
“Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV. Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research…

What’s New for Biologics
Influenza Virus Vaccine for the 2017-2018 Season Updated: 7/20/2017
Recall of MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] Solution for intramuscular injection Posted: 7/18/2017
July 14, 2017 Approval Letter – Afluria and Afluria Quadrivalent (PDF – 32KB) Posted: 7/17/2017

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European Medicines Agency [to 22 July 2017]
http://www.ema.europa.eu/ema/
21/07/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
Eleven medicines recommended for approval, including five orphans
 
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EDCTP    [to 22 July 2017]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
21 July 2017
EC Call for Tender: burden of diseases preventable by maternal immunisation in sub-Saharan Africa
The European Commission Directorate-General for Research and Innovation issued a call for tender on 14 July 2017 on the topic…
 
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Wellcome Trust [to 22 July 2017]
https://wellcome.ac.uk/news
News / Published: 19 July 2017
Fiona Powrie joins our Board of Governors
Fiona Powrie, Director of the Kennedy Institute of Rheumatology at the University of Oxford, is joining Wellcome as a new Governor.
 
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Industry Watch
:: Jul 17, 2017 Sanofi Pasteur Ships First of its U.S. Influenza Vaccine Doses for 2017-2018 Season
:: Jul 14, 2017, 16:56 ETGSK ships 2017-18 seasonal influenza vaccines for US market

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PhRMA   [to 22 July 2017]
http://www.phrma.org/press-room
July 18, 2017
New Report Shows 74 Percent of Medicines in Development have Potential to be First-in-Class Treatments
Seventy-four percent of medicines in clinical development around the world are potentially first-in-class medicines, meaning they use a completely new approach to fighting a disease, according to a new report:
The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development
The biopharmaceutical pipeline contains thousands of significant and innovative new treatments with the potential to address unmet medical needs, save lives and improve patients’ health. A new report by the Analysis Group, “The Biopharmaceutical Pipeline: Innovative Therapies in Clinical Development,” examines the state of the drug development pipeline and provides insights into new approaches researchers are pursuing.
Key findings:
:: 74 percent of medicines in clinical development are potentially first-in-class medicines, meaning they represent a possible new pharmacological class for treating a medical condition.
:: 822 projects – defined as unique molecule-indication combinations – are designated by the U.S. Food and Drug Administration (FDA) as orphan drugs, which is critically important given only 5 percent of rare diseases have an approved medicine.
:: A range of novel scientific approaches are being pursued, including cell and gene therapies, DNA and RNA therapeutics and conjugated monoclonal antibodies.
PDF: http://phrmasubscribers.com/2017-pipeline-report?__hstc=99188225.961cb2d611680f482141e3df7aaa21f9.1487423286359.1500115909916.1500732104978.23&__hssc=99188225.3.1500732104978&__hsfp=1851132392