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


FDA Drug Safety Changes Will Not Affect Oncology Therapies, Agency's Pazdur Says

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's safety overhaul "will not tamper with" drugs for life-threatening conditions, Office of Oncology Drug Products Director Pazdur tells the American Society of Clinical Oncology annual meeting. FDAer suggests the cancer community could provide insight into improved safety surveillance.

You may also be interested in...

AstraZeneca's Iressa Produces Effect In Subpopulation, ASCO Data Show

Initial Phase II study shows 62% response rate in Korean, non-smoking females with non-small cell lung cancer. Identification of Iressa (gefitinib) responders and the role of EGFR mutations are major themes at the American Society of Clinical Oncology annual meeting.

FDA "Drug Watch" Website To Include Three Categories Of Safety Information

The site will reflect information about serious adverse events, patient selection and monitoring, and risk minimization procedures, an FDA draft guidance states. Manufacturers will be notified "shortly before" information about a drug is first posted; agency suggests the site's information will not be used for promotional purposes.

Deal Watch: Vir Partnering With Alnylam, WuXi On Coronavirus Treatments

US biotech expands 2017 collaboration with Alnylam and inks collaboration with WuXi. Plus deals involving AbbVie, Allergan, Amazon, Thermo Fisher, Qiagen, Boehringer Ingelheim, Trutino, Taiho, Arcus, Eisai, Fuji Yakuhin, Hikma, Glenmark, Hanmi, GC, Bayer, GW.





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