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

Hemispherx Ampligen chronic fatigue data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A 40-week Phase III trial of Hemispherx Biopharma's chronic fatigue syndrome agent Ampligen showed a statistically significant increase vs. placebo for the primary endpoint of physical performance, the firm announces May 3. Ampligen patients improved treadmill performance 19.4% compared to 5.1% for placebo (p=0.022); the minimum medically significant performance change is 6.5%. Trial design was "reviewed by a specially convened panel of the FDA's Antiviral Advisory Committee," Hemispherx said. The results may offer the first hard evidence to support Ampligen's approval in CFS; Hemispherx has been studying the double-stranded RNA drug in CFS for over a decade, but without convincing results. The immunomodulator/antiviral is also in Phase IIb for HIV/AIDS...

You may also be interested in...



Signs Of Hope But Obstacles Remain For Swiss Device MRA With EU

Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having to find ways of limiting the damage that newly erected barriers will cause after the MDR comes into force.

Amneal Ready To Go Head-To-Head With Mylan’s Xulane In US

Amneal is set to benefit from 180 days of US exclusivity for its norelgestromin and ethinyl estradiol contraceptive patch product after receiving FDA approval with a competitive generic therapy designation. The generic will be the only competitor to Mylan’s Xulane version.

Demand For Supplements Helps Bayer Outpace Global Market In 2020

Enjoying a 5% sales rise, Bayer Consumer Health grew faster than the global market last year, with the company keen to repeat the performance in 2021.

Topics

UsernamePublicRestriction

Register

OM004078

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