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


Predictive Medicine Means "Ten Years of Bad News"

This article was originally published in RPM Report

Executive Summary

FDA expects pharmacogenomics to help turn around drug development. But one researcher says the first decade of applying the tenchonology will focus almost exclusively on limiting markets.

You may also be interested in...

Where Have All the New Drugs Gone

The drug approval drought keeps getting worse. FDA says it approved 20 new products during the year, one of the lowest totals in two decades. In fact, focusing on genuinely innovative medicines, the total was even worse. The good news is that 2006 should be a much better year. But focusing on 2006 misses the point: it's the long-term trend that matters. The hope for a turnaround relies on some leaps of faith. Industry is gambling that advances in drug development science will pay off-even though the first efforts to reap the fruits of the genomics revolution are one reason for the current drought.

End Of ‘Phase I’: The Case To Re-Name First-In-Human Oncology Trials

US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.

Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization

The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.





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