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
UsernamePublicRestriction

Lilly and Daiichi Sankyo try to quash prasugrel panel meeting rumours

This article was originally published in Scrip

Executive Summary

Lillyand Daiichi Sankyoare attempting to damp down rumours over the progress of the US NDA for their novel antiplatelet agent prasugrel (Effient). In a joint statement, the companies, which are co-developing the potential blockbuster, say that they have not been notified of any regulatory action for the NDA or of any decision to have an advisory panel to review the drug. Speculation has mounted that the FDAwas contemplating taking the drug to a panel review, following its failure to complete a review of the product by the PDUFA user fee deadline of September 26th.

You may also be interested in...



US Approval For ViiV’s ‘Last Resort’ HIV Drug Rukobia

The US FDA has given the go-ahead for marketing of ViiV healthcare’s novel HIV drug just as the EMA removes the accelerated assessment status from its application there.

Executives On The Move: BioXcel Therapeutics Picks A Development Officer, A Finance Hire At RenovaCare And CANbridge Taps Takeda Talent

Immuno-oncology and neuroscience firm BioXcel Therapeutics picks a chief development officer, and stem-cell therapy company RenovaCare hires a CFO. Plus, CANbridge Life Sciences, developer of specialty health products, adds Takeda Pharma rare disease lead as global head, business development.

Genmab And Seattle Genetics Progress Cervical Cancer ADC

Topline Phase II data for the antibody-drug conjugate tisotumab vedotin put it on a swift path towards approval in cervical cancer.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1128165

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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