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

Broader Horizons For Advanced Biotech In 2022: New Targets, Settings For IO, Cell And Gene Therapy

Executive Summary

US FDA’s user fee goal calendar for 2022 already contains 45 applications for novel agents featuring a wide array of biologics, from cell therapy in cancer and hematology to bispecifics and new immuno-oncology targets that could move the field beyond PD-1/L1.

You may also be interested in...



Oncology Market Trends: Predictive Biomarkers, New IO Targets And Tougher Competition

Higher success rates in rare cancers, where biomarkers can better direct therapy, characterize the oncology treatment landscape. Deal-making is favoring alliances over acquisitions as drugmakers focus on establishing the clinical benefit of new targets, particularly for rare indications.

Janssen/Legend Plan Phased US Launch For BCMA-Targeting CAR-T Carvykti

Janssen priced the one-time autologous treatment at $465,000, well above the $419,500 list price for Bristol’s first-to-market CAR-T, but expects broad commercial and Medicare coverage. 

Keeping Track Of Rolling Submissions: Gamida Cell, Roche, Lilly And Reata Are Latest To Use Fast Track

Applications are underway for omidubicel, mosenutuzumab, pirtobrutinib and omaveloxolone.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS145614

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