Pink Sheet 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

Choice Of Regulatory Pathway Is Key Inflection Point In Drug Reviews

Executive Summary

A year of Drug Review Profiles in the Pink Sheet shows how important the choice of regulatory pathway has become to drug development and approval.

You may also be interested in...



Antibiotic Incentives Helped Spero Get Where It Is Today

The firm is developing a novel class of antibacterials that could enable shelved agents for Gram-positive infections to reach and kill Gram-negative bacteria.

Patient Voices Swayed FDA's Imlygic Review Team

Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.

Chin Fat Not A 'Serious Condition' Worthy Of Priority Review, FDA Says

Deoxycholic acid offers safe and effective alternative to 'unapproved and unregulated' pharmacy compounded products, Kythera asserted in unsuccessful bid for shorter review.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS057635

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