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


Vicuron dalbavancin 90-day extension

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Vicuron continues to plan a first-quarter 2006 launch of its lipoglycopeptide antibiotic dalbavancin despite FDA's 90-day extension of its original priority review user fee date of June 21. FDA reset the action date after deeming the company's responses to chemistry, manufacturing and controls questions to be a major amendment. The firm is seeking an indication for treatment of chronic skin and soft tissue infections. Vicuron has another antibiotic NME pending at FDA: anidulafungin has been "approvable" since May 2004 for esophageal candidiasis; the firm plans to respond in the second quarter...

You may also be interested in...

Pfizer dalbavancin "approvable"

Pfizer's lipoglycopeptide antibiotic dalbavancin is "approvable" Sept. 21 for treatment of chronic skin and soft tissue infections. The agent is receiving a priority review but FDA extended its action date by 90 days in May following a major amendment relating to chemistry, manufacturing & controls (1Pharmaceutical Approvals Monthly May 2005, In Brief). Pfizer's acquisition of innovator Vicuron closed Sept. 11...

Licensing In Brief

Pfizer expands anti-infective portfolio with Vicuron buy: Pfizer's $1.9 bil. acquisition of Vicuron includes the near-term antibiotic candidate dalbavancin, currently pending at FDA with a Sept. 21 user fee date . Vicuron has targeted an early 2006 launch for the once-weekly therapy for chronic skin and soft tissue infections (1Pharmaceutical Approvals Monthly May 2005, In Brief). Announced June 16, the merger builds on Pfizer's experience in the anti-infective market and extends its existing portfolio, which includes the antifungal agents Diflucan (fluconazole) and Vfend (voriconazole), and the antibiotics Zithromax (azithromycin) and Zyvox (linezolid). The Vicuron deal also gives Pfizer a new antifungal agent, anidulafungin, deemed "approvable" at FDA in May 2004. The firms' combination marks the culmination of a six-year collaboration to develop new antibiotic candidates…

Bristol/Exelixis Detail Survival Benefit For Opdivo/Cabometyx In Renal Cancer

Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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