In Vivo 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

DMD In The Spotlight

Executive Summary

The FDA draft guidance for Duchenne’s muscular dystrophy drug development, which advocacy groups tried to push through to make sure the agency understood the complications of getting some of these drugs approved, is a good example of stakeholder interaction in the rare disease space.

You may also be interested in...



Orphans Should Live Alone

For larger organizations with interests in rare diseases, Bionest Partners believes it is necessary to maintain a separation from the rest of the company in order to keep the culture needed for successful product commercialization. Easier said than done.

BioMarin's Drisapersen 'Compete Response' Shows FDA Flexibility Still Limited

FDA wants another clinical trial for Duchenne muscular dystrophy treatment; focus moves to Sarepta's candidate, which gets committee review next week.

EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments

While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.

Topics

Related Companies

UsernamePublicRestriction

Register

MT003605

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