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


McClellan evaluates ephedra

This article was originally published in The Tan Sheet

Executive Summary

FDA Commissioner Mark McClellan, MD/PhD, asks RAND Corp.'s Paul Shekelle, MD/PhD, if "the available evidence supports a causal relationship at a somewhat less certain level of scientific proof" than the "95% certainty" standard often used in studies, according to an April 4 email correspondence. Shekelle replies that although "95% certainty" level does not exist to link ephedra with adverse events, "we judge that it is much more likely than not that such a relationship exists" and "we are much more than 50% confident that it exists." McClellan also asks whether evidence of a causal relationship "is more certain for the special circumstances suggested in FDA's proposed warning label," such as strenuous exercise or consumption of other stimulants. Shekelle notes RAND report "did not find sufficient evidence to reach firm conclusions," but adds that does not mean the risk is not increased...

You may also be interested in...

Bharat Biotech Plans Coronavirus Vaccine

After two Indian vaccine makers, Serum Institute of India and Cadila Healthcare joined the fight against COVID-19, Bharat Biotech may follow suit. Others like Hilleman have decided against it for the moment while Panacea Biotech is weighing the pros and cons of developing a SARS-CoV-2 vaccine after a sour experience with H1N1.

HLB Takes First Expansion Step Via Immunomic Acquisition

South Korea’s HLB has begun a new growth phase by taking over US-based clinical stage biotech firm Immunomic Therapeutics. Through the acquisition, it is poised to add new pipeline assets including a Phase II vaccine therapy for glioblastoma and proprietary lysosomal targeting technology.

QUOTED. 20 February 2020. Steven Raman.

Less-invasive technologies to treat benign prostatic hyperplasia are fast becoming viable alternatives to medication and surgery. Here's what one researcher in the area, Steven Raman, had to say about the new options.





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