NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta
By Michael Mezher -
Published 22 June 2016
The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS).
Categories: News, Europe, NICE, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration
Tags: Zykadia, Mekinist, Praluent, Repatha, Humira, Benlysta, NICE, NHS
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
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