Search Results for Priority Review Voucher

Showing 1 – 25  of 36

FDA Approves First Treatment for a Form of Batten Disease By Zachary Brennan - Published 27 April 2017

The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Batten disease, priority review voucher, PRV, Stivarga, Brineura, Bayer, Biomarin

Sarepta Sells Priority Review Voucher for $125M to Gilead By Zachary Brennan - Published 21 February 2017

Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Sarepta, Gilead, priority review voucher, PRV, Cures

Priority Review Voucher Fees to Decline in FY 2017 By Zachary Brennan - Published 29 September 2016

The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs

Tags: priority review vouchers, PRV, rare pediatric disease voucher, golden ticket, tropical disease priority review voucher

Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program By Zachary Brennan - Published 28 September 2016

The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December.

Categories: News, US, FDA, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: rare pediatric priority review voucher, PRV program, PRV extension, Bob Casey

House E&C Committee Clears New Priority Review Voucher Program By Zachary Brennan - Published 14 July 2016

The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset.

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

Tags: PRV, priority review voucher, FDA priority review, user fees for priority drug reviews

House Looks to Reform Tropical Disease Priority Review Voucher Program By Zachary Brennan - Published 08 June 2016

The House Energy and Commerce Committee on Wednesday passed by voice vote an amendment (to an unrelated bill on hospital preparedness for dangerous threats) that would significantly change the priority review voucher (PRV) program for tropical diseases.

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

Tags: priority review voucher, tropical disease voucher, FDA expedited review, new drugs for rare disease

Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US By Zachary Brennan - Published 21 April 2016

As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US.

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, US, EMA, FDA, WHO, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Government affairs, Manufacturing, Medical Devices

Tags: Global Health Technologies Coalition, FDA scientific opinions, FDA task force, priority review voucher

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

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

More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program By Zachary Brennan - Published 03 March 2016

In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics.

Categories: News, US, FDA, Generic drugs, Government affairs, Research and development, Submission and registration

Tags: generic drugs, priority review voucher, Janet Woodcock, Susan Collins

FDA Calls for End to Priority Review Vouchers as GAO Says Too Early to Gauge Effectiveness By Zachary Brennan - Published 02 March 2016

The US Government Accountability Office (GAO) said Wednesday in a new report that it’s still too early to assess whether the Food and Drug Administration’s (FDA) three-year-old pediatric priority review voucher (PRV) program has stimulated the development of drugs to treat or prevent rare pediatric diseases.

Categories: News, US, FDA, Active pharmaceutical ingredients, Clinical, Drugs, Government affairs, Manufacturing, Research and development, Submission and registration

Tags: PRV, priority review voucher, pediatric rare diseases

Sanofi Redeems $245M Priority Review Voucher for Type 2 Diabetes Treatment By Zachary Brennan - Published 22 February 2016

The US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for Sanofi’s investigational type 2 diabetes treatment on Monday and granted the use of another Priority Review Voucher (PRV), which speeds up FDA’s decision by four months.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: priority review voucher, PRV, tropical disease, rare pediatric disease, orphan drugs

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

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

Health Advocacy Groups Call for Changes to Priority Review Voucher Program By Michael Mezher - Published 19 November 2015

A group of health advocacy organizations are calling on the Senate Committee on Health, Education, Labor and Pensions (HELP) to tighten requirements for obtaining priority review vouchers for drugs for tropical diseases.

Categories: News, Africa, Asia, Latin America and Caribbean, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Research and development

Tags: Neglected Tropical Disease, NTD, Priority Review Voucher, PRV, Senate HELP Committee, MSF, DNDi

Senators Propose New Exclusivity Voucher, Priority Review Voucher Programs By Zachary Brennan - Published 22 October 2015

Senators on both sides of the aisle are trying to incentivize the development of new drugs for newborn babies and medical countermeasures via a new exclusivity voucher and a priority review voucher system that are similar to the voucher programs already linked to tropical and rare pediatric disease treatments.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: priority review voucher programs, PRV, pediatric disease, neonatal drug development, medical countermeasures, Senator Bob Casey

FDA Raises Fee Rate for FY16 Tropical Disease Priority Reviews By Zachary Brennan - Published 11 September 2015

The US Food and Drug Administration (FDA) has raised the tropical disease priority review fee rate for fiscal year 2016 to about $2.73 million, which is effective from the beginning of next month through 30 Sept, 2016.

Categories: News, US, FDA, Prescription drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Priority Review voucher, FDA, tropical disease priority review, malaria, dengue, PDUFA

Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers By Alexander Gaffney, RAC, Michael Mezher, Zachary Brennan - Published 02 October 2017

Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Research and development, Submission and registration

Tags: Priority Review Voucher, PRV, Neglected Tropical Disease, Neglected Tropical Disease Priority Review Voucher, Rare Pediatric Disease Voucher, Rare Pediatric Disease, FDASIA, FDAAA, Voucher, FDA Voucher, Guidance, AbbVie, United Therapeutics, Praluent

Sanofi Bets Nearly a Quarter Billion on Voucher for Faster Drug Approval By Alexander Gaffney, RAC - Published 28 May 2015

An unusual regulatory incentive used to accelerate the review of a small number of drug products has just sold to the French pharmaceutical giant Sanofi for the record-setting sum of $245 million.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Priority Review Voucher, PRV, Rare Pediatric Priority Review Voucher, Sanofi

Bill Would Make Permanent FDA's Rare Pediatric Voucher Program By Alexander Gaffney, RAC - Published 24 March 2015

New legislation introduced this week would reauthorize the US Food and Drug Administration's (FDA) rare pediatric disease priority review voucher program, which is currently set to end after triggering a sunset clause in its authorizing statute.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Priority Review Voucher, Advancing Hope Act, Rare Pediatric Disease Priority Review Voucher

Pediatric Priority Review Voucher Program Set to End After FDA Approves New Drug By Alexander Gaffney, RAC - Published 18 March 2015

The US Food and Drug Administration's (FDA) rare pediatric disease priority review voucher program is slated to end in one year, after the agency awarded its third-ever rare pediatric voucher, thereby triggering a little-known provision in the voucher program.

Categories: News, US, CDER, Drugs, Regulatory strategy

Tags: Priority Review Voucher, PRV, Asklepion, Retrophin, Rare Pediatric Disease Priority Review Voucher

With New Data in Hand, Could Sanofi and Regeneron Use a Regulatory Shortcut? By Alexander Gaffney, RAC - Published 16 March 2015

A new drug being co-developed by drugmakers Sanofi and Regeneron could, according to new data, dramatically decrease low-density lipoprotein (LDL) cholesterol in patients and lessen cardiac events. But it's a reduction in something else that could be most important for Sanofi and Regeneron: the time it might take the US Food and Drug Administration (FDA) to review the new drug, Praluent.

Categories: News, US, CDER, Biologics and biotechnology, Regulatory strategy, Submission and registration

Tags: Sanofi, Regeneron, Praluent, Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher

For Second Time Ever, FDA Awards Special Voucher Meant to Accelerate Drug Reviews By Alexander Gaffney, RAC - Published 11 March 2015

Drugmaker United Therapeutics has become just the second company in US history to obtain a new type of voucher which allows a company to potentially get its drug approved by the US Food and Drug Administration (FDA) in 40% less time than it normally takes.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: PRV, Priority Review Voucher, Rare Pediatric Disease Priority Review Voucher, Voucher

Obama Signs Special Ebola Incentive Program Into Law By Alexander Gaffney, RAC - Published 18 December 2014

President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Submission and registration

Tags: Ebola, Priority Review Voucher, PRV, Neglected Tropical Disease Priority Review Voucher, Bill, Legislation, Congress, President Barack Obama, Adding Ebola to the FDA Priority Review Voucher Program Act

Legislation to Increase Regulatory Incentives to Fight Ebola Awaits Obama's Signature By Alexander Gaffney, RAC - Published 04 December 2014

The US House has quickly passed legislation making changes to the Neglected Tropical Disease Priority Review Voucher (PRV) system in the hopes of making it more enticing to pharmaceutical companies, and in particular to those developing new treatments for the Ebola virus.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Ebola, PRV, Priority Review Voucher, Neglected Tropical Disease Priority Review Voucher, Bill, Legislation, House, Congress