From Breakthroughs Blog: FDA

 
PATH/Patrick McKern
Research Roundup: WHO releases findings from malaria eradication report, two-month HIV injection could be on its way, and refrigerator to protect vaccines against power outages

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Matthew Dakin
Research Roundup: The first chlamydia vaccine passed a major test, a new drug approved for drug-resistant tuberculosis, and two new Ebola treatments prove highly effective in the DRC

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Gabe Bienczycki
Research Roundup: Wiping out mosquitoes on two Chinese islands, betting on biometrics to boost vaccination rates, and J&J to test HIV vaccine in US and Europe

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Matthew Dakin
Research Roundup: FDA advisory panel recommends approval of TB Alliance's TB treatment, innovation in women's health, and British syringe-free vaccine maker set to shake up the industry

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Georgina Goodwin
Research Roundup: An experimental Ebola cure may also protect against Nipah virus, gender inequality in clinical trials, and FDA authorizes first Zika diagnostic test for marketing

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Georgina Goodwin
Research Roundup: Warning to address drug-resistant TB, a new Ebola vaccine strategy in DRC, and FDA takes step to bolster research on pregnant and lactating women

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Wendy Stone
Research Roundup: Study finds drugs stop HIV transmission, polio endgame strategy includes new technologies and vaccines, and FDA approves first ever vaccine for dengue fever

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Mike Wang
Research Roundup: Study finds safer & shorter treatment for Chagas, Trumps budget proposes cuts to biomedical research, and FDA accepts new drug application for pretomanid in combination TB regimen

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Mike Wang
Research Roundup: CEPI invests in vaccine printer tech, new bednet strategy to fight malaria, and Themis' chikungunya vaccine nabs FDA Fast Track

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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PATH/Doune Porter
President signs spending bill boosting funding for global health

On February 15, President Trump signed into law a bipartisan spending bill—averting another partial government shutdown and ensuring full-year funding for the government for the remainder of fiscal year 2019. The months-long saga ended with some great news for global health and research and development.

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PATH/Wendy Stone
How the partial government shutdown is affecting global health, R&D

As the partial government shutdown stretches into a fifth week – the longest in United States history – news of its impact on agencies essential to global health broadly, and research and development in particular, is taking clearer shape.

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PATH/Satvir Malhotra
Research Roundup: Vaccines without chemicals, FDA fast track for Vanelva's chikungunya vaccine, and Marburg virus found in bats in West Africa

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

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Photo: White house/Shealah Craighead
Medical research, global health programs face steep cuts in Trump budget

On Tuesday, the Trump Administration released its full fiscal year 2018 budget proposal. This budget proposes significant cuts to programs that support global health and medical research at the National Institutes of Health, Centers for Disease Control and Prevention, and the US Agency for International Development.

GHTC
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Architect of the Capitol
Global health and medical research saved from spending cuts in FY17 budget agreement

What global health R&D advocates need to know about the FY2017 budget agreement.

GHTC
GHTC
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Office of Management and Budget
Trump budget proposes steep cuts to research and foreign assistance that will threaten global health research

What global health advocates need to know about the President's "skinny" budget.

GHTC
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Architect of the Capitol
Research Roundup: HIV drug resistance, the 21st Century Cures Act, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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CDC/James Gathany
Research Roundup: Clinical trial data, Mayaro virus, antimicrobial resistance, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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National Institute of Allergy and Infectious Diseases
Research Roundup: Update on Zika R&D

In this regular feature on Breakthroughs, we highlight the most promising Zika virus vaccine, drug, and diagnostic candidates as well as vector control approaches. 

GHTC
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Architect of the Capitol
Research Roundup: Priority Review Voucher legislation, Toxic Shock Syndrome vaccine, and repurposing existing drugs

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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Research Roundup: kid-friendly malaria medicine, Zika fever, priority review vouchers, and more

After four successful Phase 3 clinical trials enrolling more than 3,500 patients in 18 countries, the European Medicines Agency (EMA) has granted Pyramax® Granules, a pediatric malaria medicine, a positive opinion under Article 58—a mechanism through which the EMA reviews and issues a scientific opinion on products that are not intended for use in Europe.

GHTC
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CDC/Dr. Scott Smith
Research Roundup: an HIV/AIDS vaccine candidate, inflatable incubator for premature babies, and US government R&D

Dr. Robert Gallo co-discovered the HIV virus and subsequently led the development of the first HIV/AIDS blood test.

GHTC
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Research Roundup: genetic protection against malaria, the vaccine pipeline, and counterfeit drugs and the FDA

A new study conducted by the Malaria Genomic Epidemiology Network (MalariaGEN)—a community of researchers across malaria-endemic regions—reveals a formerly unknown genetic variations that make people less susceptible to malaria.

GHTC
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PATH/Evelyn Hockstin
Research Roundup: a promising Ebola treatment, access to drugs for NCDs, a new approach to treating a deadly bacterium, and the perception of breakthrough drugs

The US Department of Health and Human Services (HHS) is partnering with New York–based Regeneron Pharmaceuticals, Inc. for the development of an Ebola treatment.

GHTC
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PATH/James Gathaney
Research Roundup: antibiotic and reproductive health R&D, leadership at the FDA, and a potential new strain of dengue fever.

The US Department of Health and Human Services (HHS) announced last week a partnership with pharmaceutical company AstraZeneca for the research and development (R&D) of antibiotics.

GHTC
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PATH/Aaron Joel Santos
Research Roundup: priority review vouchers, diagnosing drug resistance, and oral and universal flu vaccines

Pharmaceutical company AbbVie is paying United Therapeutics US$350 million for its priority review voucher (PRV)—which expedites the US Food and Drug Administration’s (FDA) review of a product by four months—and EP Vantage speculates on their motive.

GHTC
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Research Roundup: 3D-printed drugs, R&D in emergency settings, a universal flu vaccine, and more

The US Food and Drug Administration (FDA) approved the first 3D-printed drug last week, paving the way for the technology to be used to customize medical care to individual patients.

GHTC
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Research Roundup: a dengue vaccine, a breakthrough HIV treatment, antimicrobial R&D, and more

Later this year, French pharmaceutical company Sanofi plans to launch a vaccine for dengue fever, the first on the market for an infection for which nearly half of the world’s population is at risk.

GHTC
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Research Roundup: Drug-resistant TB, regulatory reform in India, a malaria vaccine, and more

A new study published in PLOS Medicine indicates that multi-drug resistant tuberculosis (TB) is less contagious than drug-susceptible TB.

GHTC
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PATH/Nguyen Ba Quang
Research Roundup: Middle East Respiratory Syndrome R&D, G7 support for antimicrobial and neglected tropical disease R&D, patient safety and the 21st Century Cures Act, and the contraceptive pipeline

The zoonotic Middle East Respiratory Syndrome (MERS), which World Health Organization (WHO) Director-General Dr. Margaret Chan called “a threat to the entire world” has spread to South Korea. More than 100 cases and 10 deaths have been reported, making it the largest outbreak outside of the Arabian Peninsula.

GHTC
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Research Roundup: priority review voucher sells for record price, WHO action to address antimicrobial resistance, and more

The French pharmaceutical company Sanofi purchased a priority review voucher (PRV)—which entitles the owner to an expedited review of a future product by the US Food and Drug Administration (FDA)—for US$245 million last week.

GHTC
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21st Century Cures Act: What the global health community needs to know

Last week, the House Energy and Commerce Committee unanimously voted to approve the 21st Century Cures Act—a bill that aims to speed the development, approval, and introduction of new health technologies.

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Will Boase
Research Roundup: inclusion of women in clinical trials, the future of vaccines, and diagnostics for counterfeit medicines and parasitic worms

United States Representatives Jim Cooper (D-TN) and Cynthia Loomis (R-WO) introduced the Research for All Act last week which calls for the inclusion of more women in clinical trials for products submitted for US Food and Drug Administration (FDA) approval.

GHTC
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PATH/Gabe Bienczycki
Research Roundup: India to expand list of essential medicines, China’s emerging leadership in the pharmaceutical industry, WHO paves the way for hepatitis C generics, and more

India is expected to add all of the drugs currently used in the government’s HIV/AIDS and tuberculosis (TB) control programs to its list of essential medicines within the next six months.

GHTC
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PATH/Wendy Stone
Research Roundup: FDA Commissioner to step down, a Grand Challenge for neglected diseases, funding for reproductive health research and development, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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PATH/Heng Chivoan
Research Roundup: Intellectual property awards, FDA priorities, Australia R&D, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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PATH/Satvir Malhotra
Research Roundup: R&D in the post-2015 agenda, TB vaccines, the Global Innovation Fund, intellectual property, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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PATH/Dan Chang
Research Roundup: Funding global health R&D, the neglected disease pipeline, Ebola vaccines, FDA approvals, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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PATH/Robin Biellik
Research Roundup: SFOPS, new FDA guidance, top trends in global health, new report on global health R&D, and more

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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PATH/Will Boase
Congress acts on FY 2015 funding; shows lukewarm support for global health R&D

As the DC summer kicks into full swing, Congress has had a busy month moving forward fiscal year (FY) 2015 funding legislation for a variety of government programs including global health research and development (R&D).

GHTC
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Impact of PCAST recommendations on advancing global health R&D

Recently, there has been a surge of interest in evaluating progress made on the 2012 President’s Council of Advisors on Science and Technology’s (PCAST) recommendations that aim to accelerate research and development (R&D) of new therapeutics.

GHTC
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PATH/Evelyn Hockstein
Research Roundup: What we’re reading this week

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

GHTC
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Ken Kistler
Congressional budget justifications shed light on FY 2015 global health R&D priorities

As more detailed information about the President’s fiscal year (FY) 2015 budget requests to Congress is released, the results continue to be a mixed bag for global health research and development (R&D).

GHTC
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Obama Administration’s FY 2015 budget request sends mixed signals on global health R&D

Yesterday, the White House released President Obama’s much-anticipated budget request for fiscal year (FY) 2015.

GHTC
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What we’re looking forward to in 2014

As 2014 gets into full swing, the GHTC is looking ahead to many exciting developments on both the global health research and development (R&D) and policy landscapes:

GHTC
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Ken Kistler
Congress passes FY 2014 Omnibus package: Mixed results for global health research

In an increasingly rare show of bipartisanship, Congress has moved forward an appropriations agreement that should finally settle the issue of fiscal year (FY) 2014 funding levels.

GHTC
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New fact sheet outlines the global health R&D pipeline and why US support is so important

In the past, the United States has contributed to important breakthroughs in global health—from the eradication of smallpox to a 74 percent drop in measles deaths worldwide.

GHTC
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New tool to understand global health regulatory requirements

In this guest post, Tricia Aung—the GHTC’s regulatory associate—writes about a new database that provides easy access to information on global health regulatory information.

GHTC
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New GHTC resources highlight FDA’s critical role in global health

The GHTC has long stressed that the US Food and Drug Administration (FDA) plays a critical part in efforts to improve global public health.

GHTC
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