Pink Sheet 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

Novartis files Tasigna, Aclasta ahead of schedule

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis announces the submission of NDAs for the oncologic Tasigna (nilotinib) and osteoporosis therapy Aclasta (zoledronic acid infusion) during its annual pipeline update Nov. 28 in London. The company had been predicting 2007 filings for both applications (1Pharmaceutical Approvals Monthly May 2006, p. 3). The Tasigna application, filed in both the U.S. and Europe, seeks an indication for treatment of chronic myeloid leukemia; Novartis also announced a global nilotinib expanded access program called ENACT that will be available to eligible patients in all phases of Philadelphia chromosome-positive CML who are resistant to or intolerant of Novartis' Gleevec (imatinib). Novartis seeks to differentiate Aclasta in the crowded osteoporosis market with its once-yearly administration and complete range of claims for "vertebral, both clinical and non-clinical vertebral diagnosed by x-ray, as well as hip and non-vertebral sites," Global Pharma Development Head James Shannon told investors...

You may also be interested in...



J&J Has A Plan B If Gamechanger Single Dose Vaccine Disappoints

If J&J’s gamble on a single dose pays off, it could rapidly advance the fight against SARS-CoV2 – but a second study will provide a safety net.

Woodcock To Be Acting US FDA Commissioner; Sharfstein Tops Biden's List Of Candidates For Post

Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.

Health And Wellness Trademark Review 12 January, 2021

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.

Topics

UsernamePublicRestriction

Register

ID1132542

Ask The Analyst

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

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