Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Stock Watch: Summit’s Stock Plummets

Surprise Changes In The Middle Of A Phase III Study Are Probably Bad

Executive Summary

What on earth would make a biotech company change the primary endpoint half way through a Phase III program and not discuss it with the FDA? There are at least two scenarios, neither of them good.

You may also be interested in...



Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says

Quarantines, travel restrictions and supply chain interruptions are likely to cause 'unavoidable protocol deviations' in ongoing clinical trials, FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by the coronavirus.

Stock Watch: Reinforcements Required As Darzalex Carries J&J

Loss of exclusivity and other competitive pressures will continue to offset J&J’s pharmaceutical growth as its former blockbusters accumulate in ex-growth "other" categories. Can the pipeline take up the slack?

Stock Watch: Spanners In The Works For Q4 Results

While the implications of the US Inflation Reduction Act are the focus of the sector’s concern this year, another regulatory development will impact earnings sooner.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC145133

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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