Search Results for Zika

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Doctors Without Borders Appeals Exclusive License Granted to Sanofi for Zika Vaccine By Zachary Brennan - Published 19 May 2017

Doctors Without Borders (MSF) on Friday appealed the US Department of Defense’s decision to grant an exclusive, royalty-bearing license to Sanofi Pasteur for patents to a Zika vaccine developed with US government funds.

Categories: News, US, Biologics and biotechnology, Drugs, Research and development

Tags: Doctors Without Borders, MSF, Zika vaccine, Sanofi

FDA Offers 2016 Report on Medical Countermeasure Activities By Zachary Brennan - Published 20 March 2017

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Quality

Tags: medical countermeasures, Ebola, Zika, flu vaccine

Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine By Zachary Brennan - Published 24 January 2017

Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi on Tuesday explained the risks of developing such a vaccine.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Government affairs, Manufacturing

Tags: Zika, MSF, Sanofi Pasteur, Zika vaccine

FDA Form 483: Theranos Initiated Trials Without IRB Approval By Zachary Brennan - Published 09 September 2016

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in two Zika-related trials without approval of an institutional review board (IRB).

Categories: News, US, FDA, Ethics, Government affairs, In vitro diagnostics, Medical Devices

Tags: Theranos, Elizabeth Holmes, Zika, Form 483

Senate Advances $1.1B in Emergency Zika Funds as House Fight Looms By Zachary Brennan - Published 17 May 2016

The Senate on Tuesday voted in favor of providing $1.1 billion in new funds to fight the Zika virus, which continues to spread in Central and South America and is expected to hit the US soon.

Categories: News, US, Crisis management, Government affairs

Tags: Zika funds, emergency HHS funding, Zika virus, Hal Rogers

Democrats Renew Call for $1.9 Billion to Fight Zika By Michael Mezher - Published 27 April 2016

House and Senate Democrats are calling on their Republican counterparts to support a new standalone bill, supported by President Barack Obama, calling for $1.9 billion to fund efforts to combat the Zika virus.

Categories: News, Latin America and Caribbean, US, FDA, Government affairs

Tags: Zika

Additional Funding to Combat Zika Denied in House Markup of FDA Spending Bill By Zachary Brennan - Published 19 April 2016

The House Appropriations Committee on Tuesday marked up the FY 2017 spending bill for the US Food and Drug Administration (FDA) and decided not to include an amendment adding $1.9 billion in additional funding requested by President Barack Obama to combat the Zika virus.

Categories: News, US, FDA, Clinical, Government affairs, Regulatory intelligence, Submission and registration

Tags: e-cigarettes, vaping, Zika funding, FDA appropriations

FDA Authorizes Use of Investigational Diagnostic to Screen Blood Donors for Zika By Michael Mezher - Published 30 March 2016

The US Food and Drug Administration (FDA) on Wednesday said it will permit the use of an investigational blood test to screen donated blood for the Zika virus.

Categories: News, FDA, Blood, In vitro diagnostics

Tags: Zika virus, Roche Diagnostics

Congressional Support for Priority Review Vouchers Presses On Despite FDA Qualms By Zachary Brennan - Published 18 March 2016

Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun.

Categories: News, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: generic competition, priority review voucher, PRV program, Zika PRV, generic PRV

FDA Sends Three Letters Over Unapproved Zika Diagnostics By Michael Mezher - Published 14 March 2016

The US Food and Drug Administration (FDA) is taking steps to enforce its oversight of diagnostic tests used to detect the Zika virus, with three new letters to two laboratories and two Texas hospitals for marketing what it says are "high risk" unapproved diagnostics.

Categories: News, US, FDA, In vitro diagnostics

Tags: Zika, Zika virus, Emergency use authorization

Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills By Zachary Brennan - Published 09 March 2016

The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Quality, Research and development

Tags: Zika, priority review voucher, pediatric PRV program

FDA Issues Guidance on Zika in Human Cell and Tissue Products By Michael Mezher - Published 02 March 2016

The US Food and Drug Administration (FDA) on Tuesday announced new measures to prevent transmission of Zika virus via human cell and tissue products (HCT/Ps) by recommending a six-month deferral for at-risk donors.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Human cell and tissue

Tags: Zika, Zika virus, Human cell and tissue products, HCT/P

Genetically Engineered Mosquitoes to Aid Zika Response? FDA Plans to Release More Info By Michael Mezher - Published 02 March 2016

The US Food and Drug Administration's (FDA) acting chief scientist told members of the House Energy and Commerce Committee on Wednesday that FDA is investigating all avenues to combat Zika, including a proposal to release genetically engineered mosquitoes in Florida.

Categories: News, Latin America and Caribbean, US, Anvisa, FDA, Biologics and biotechnology, In vitro diagnostics

Tags: Zika, Zika virus, MAC-ELISA, CDC, NIAID, Oxitec

FDA Clears First Zika Diagnostic for Emergency Use By Michael Mezher - Published 26 February 2016

The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency.

Categories: News, Latin America and Caribbean, US, FDA, In vitro diagnostics

Tags: Zika, Zika diagnostic, Zika test, Zika MAC-ELISA, Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay, CDC

Zika: FDA Recommends Deferring At-Risk Blood Donors for Four Weeks By Michael Mezher - Published 16 February 2016

The US Food and Drug Administration (FDA) is recommending blood banks defer donations from recent travelers to Zika-affected countries.

Categories: News, Latin America and Caribbean, US, FDA, Blood

Tags: Zika, Blood donor screening

Congress Considers Priority Review Vouchers for Medical Countermeasures By Michael Mezher - Published 12 February 2016

Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, In vitro diagnostics, Regulatory strategy, Research and development, Submission and registration

Tags: Biodefense, Blue Ribbon Study Panel on Biodefense, Medical Countermeasures, MCMs, Priority Review Voucher, PRV, Zika Virus, Ebola, Bioterrorism

CDC, NIH 'Working Closely' With FDA on Zika Response By Michael Mezher - Published 10 February 2016

At a Congressional hearing in Washington, DC on Wednesday, officials from the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) say they are working closely with the US Food and Drug Administration (FDA) in their response to the Zika virus.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Communication, Government affairs, Submission and registration

Tags: Zika virus, Accelerated approval, CDC, NIH, Anthony Fauci, Tom Frieden

Obama’s FY 2017 Budget Request: $5.1B for FDA, New Ways to Tackle High Drug Prices By Zachary Brennan - Published 09 February 2016

President Barack Obama unveiled his final budget request on Tuesday, and though Republicans have said it’s dead on arrival, the US Food and Drug Administration (FDA) would receive an 8 percent increase in funds to help further address drug compounders, device submissions and supply chain security. New ways to combat high prescription drug prices were also included in the request.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Combination products, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Zika, Cancer Moonshot, FDA 2017 budget, Obama budget, device regulations

US, EU & WHO Launch Efforts to Accelerate Zika R&D By Michael Mezher - Published 08 February 2016

One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease.

Categories: News, Europe, Latin America and Caribbean, US, EC, EMA, FDA, WHO, In vitro diagnostics, Regulatory strategy, Research and development, Submission and registration

Tags: Zika virus, Emergency Use Assessment and Listing, EUAL, Priority Review Voucher, PRV

WHO Declares Public Health Emergency Over Microcephaly, Zika Suspected as Cause By Michael Mezher - Published 01 February 2016

The World Health Organization (WHO) on Monday declared a public health emergency in response to clusters of microcephaly and Guillain-Barré Syndrome (GBS) in Brazil and French Polynesia suspected to be caused by the Zika virus.

Categories: News, Africa, Latin America and Caribbean, WHO, Crisis management, Government affairs

Tags: Zika virus, Microcephaly, Guillain-Barré Syndrome, GBS, Public Health Emergency of International Concern, PHEIC