Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Sanofi Files LixiLan For Diabetes, Gambles Expensive Priority Review Voucher

This article was originally published in Scrip

Executive Summary

Sanofi has filed a new drug application (NDA) with the US FDA for LixiLan, its investigational fixed-ratio combination of insulin glargine (Lantus) and the GLP-1 receptor agonist lixisenatide (Lyxumia). Sanofi also revealed that it redeemed a priority review voucher (PRV) with the filing, giving the NDA an expedited 6-month review if the submission is accepted by the FDA, instead of the standard 10-month review.

You may also be interested in...



1Q Earnings Preview: What To Expect From US, EU Big Hitters

The slow drip of pharma industry earnings announcements that began on April 19 with Roche and Johnson & Johnson will turn into a veritable stream over the next couple of weeks. Scrip takes a look at expectations around some of the main firms due to report.

UK Reimbursement Decisions Focus Mostly On Cancer

The UK's main reimbursement bodies made a series of decisions this week that were broadly favorable and largely focused on oncology medicines.

Deal Watch: Valeant Sells Off iNova To Finance Debt-Reduction Efforts

While troubled Valeant was divesting iNova to private equity investors, Novartis announced a pair of oncology-focused deals, out-licensing a brain cancer drug to Midatech and partnering with IBM Watson Health to optimize breast cancer treatment.

Topics

UsernamePublicRestriction

Register

SC064064

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel