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

Gene Therapy Manufacturing Hurdle: Sponsors Unwilling To Share ‘Secret Sauce’

Executive Summary

US FDA’s Peter Marks says companies are not exchanging information about adenoviral factors, which is probably slowing down the field. He describes NIH's plans for a bespoke gene therapy consortium for vector generation and continued efforts for regulatory harmonization.

You may also be interested in...



Gilead/Kite Gain Second CAR-T Approval With Tecartus, Price On Par With Their First

As the first company with two approved chimeric antigen receptor T-cell therapies, Gilead’s Kite subsidiary has set a precedent by keeping the pricing the same as its first approved CAR-T, Yescarta. 

US DoJ Lets Biotechs Share Manufacturing Details To Speed Launch Of COVID-19 Therapies

Companies are shielded from antitrust concerns by Justice Department as they jointly prepare to manufacture whichever monoclonal-antibody-based coronavirus therapies emerge from development.

WHO Drafting Regulatory Convergence White Paper On Cell And Gene Therapies, US FDA's Marks Says

Regulators in high-income countries have a responsibility to help health authorities in low- and medium- income countries develop regulatory frameworks for cell and gene therapy products to ensure these treatments are available to all, asserts the US FDA’s biologics center’s director.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1122310

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

Cancel