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


Astellas gets fifth action letter on modified-release tacrolimus

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Astellas Pharma receives another "approvable" letter for its once-daily formulation of its immunosuppressant Prograf (tacroliumus), dashing hopes of approval before a substance patent for the twice-daily formulation expired April 8. Prograf MR is under review for prophylaxis of organ rejection in both kidney and liver transplant patients. The Japanese firm received the second approvable letter for the liver transplant indication April 30; the kidney transplant indication got its second approvable letter in March. A heart transplant indication was deemed "not approvable" in January 2007. Astellas said it is "examining the future strategy" and working closely with FDA to better understand the issues raised. More time needed for Entereg review: After a three-month delay pushed back the user fee date for GlaxoSmithKline/Adolor's Entereg (alvimopan), FDA will not meet the scheduled May 10 action date, Adolor announces. After the Gastrointestinal Drugs Advisory Committee called the risk management plan inadequate in January, the firms submitted a new program in February. Entereg, indicated for postoperative ileus, has received two "approvable" letters since the NDA submission in 2004 (1Pharmaceutical Approvals Monthly November 2006, In Brief)

You may also be interested in...

GSK/Adolor Entereg approvable again

GlaxoSmithKline and Adolor plan to continue development of Entereg (alvimopan) after the NDA for management of post-operative ileus was deemed "approvable" a second time, the companies said Nov. 6. FDA noted a potential increased risk of cardiovascular events and requested additional 12-month safety data from GSK's ongoing Phase III safety study (76905/014) in opioid-induced bowel dysfunction in chronic cancer pain patients, as well as a risk management plan. The first approvable letter, issued in July 2005, requested additional efficacy data in patients following bowel resection surgery (1Pharmaceutical Approvals Monthly February 2006, p. 9). The response to the first approvable letter was submitted in May 2006; a response to the second letter appears unlikely before the second quarter of 2007, when final data from the 014 study is expected...

Centessa ‘Creates Pharma Pipeline Overnight’ Using Novel R&D Approach

With $250m in series A funding, Cambridge, MA-based Centessa is looking to upend traditional biopharma R&D models. The new company was created through the merger of 10 private biotechs, which will sit under the Centessa umbrella as subsidiaries.

Mining The Deep Tech Seam Of Innovation For Healthtech Gold

Singapore-based SGInnovate has a unique multi stakeholder business model focused on identifying and funding Deep Tech start-ups. CEO Jui Lim now plans to increase the group’s activity in advanced manufacturing and “wetware”  ̶   drugs and diagnostics – as firms increasingly are able to revert to pre-COVID business plans.





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