Search Results for Regeneron

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Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance By Zachary Brennan - Published 16 March 2017

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday.

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

Tags: GlaxoSmithKline, Regeneron, Novartis, Teva, BIO, Celgene, AstraZeneca, clinical trial endpoints

Why Don’t People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss By Zachary Brennan - Published 01 December 2016

At the end of Thursday's Forbes healthcare summit in New York, some of the pharmaceutical and biotech industries’ top executives – from Pfizer, Regeneron, Eli Lilly, Gilead and Astellas – sat down and were presented with a simple question: Why don’t people like you?

Categories: News

Tags: Regeneron, Eli Lilly, Pfizer, Astellas, Gilead, Forbes

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