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

Lilly’s EUA Timeline For COVID-19 Combo Antibody Depends On Safety Data, Manufacturing

Executive Summary

Single neutralizing antibody moves to US FDA with data showing reduced hospitalization, while Lilly’s EUA filing for two-antibody combo awaits safety data and more certainty about production capabilities.

You may also be interested in...



US COVID Antibody Drug Supply: Regeneron, Lilly, AstraZeneca To Contribute To 1M Dose Goal For 2020

Precise amounts to be supplied by each company will depend in part on whether the monoclonal antibody drugs are used for prevention or treatment because dosage strengths will be different.

COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says

Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.

Executive Privilege: How Giving Trump Special Access To Experimental COVID Treatment Could Backfire

Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1133145

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