Medtech Insight 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

Corautus gets US fast track status angina gene therapy :

This article was originally published in Clinica

Executive Summary

The US FDA has designated Corautus Genetics' gene therapy treatment for severe angina fast track status, a classification designed to help companies accelerate a product's development to commercialisation. The vascular endothelial growth factor 2 (VEGF-2) treatment, which is being developed in collaboration with Boston Scientific, is intended to promote therapeutic angiogenesis in ischaemic muscle; trials are underway to assess VEGF-2 delivered percutaneously via Boston's Stiletto endocardial direct injection catheter system. Fast track-designated products are eligible for priority review - six months versus the average 12 months - and/or the review of portions of the marketing application prior to the completion of the final registration package.

You may also be interested in...



Unilever Hit With Class Action Over Mercury-Laced Pond’s Cream Originating In Mexico

According to the plaintiff, Unilever’s Pond’s Rejuveness Anti-Wrinkle Cream is defective insofar as tested product has been found to contain unlabeled mercury, constituting negligence that has resulted in user injuries. The plaintiff seeks certification of a transnational class and compensatory and punitive damages, among other relief.

HBW Product Launches: New Chapter Collagen, Alkamind Acid-Kicking, GNC China, Tetra Bio Canada, More

GNC, Harbin launch supplements in China following regulatory approval; Bee Gone expands with allergy swabs; Bed, Bath & Beyond expands distribution of CBDMedic personal care products promoted by Rob Gronkowski; Tetra Bio has Canadian OK For hemorrhoid and pain relief OTCs, US and European pending; Agrozen offers Urban Daze CBD products; New Chapter portfolio expansion also includes fermented vitamins, elderberry supplements and magnesium; and Alkamind’s Acid-Kicking Coffee Alkalizer creamers help neutralize acid from coffee.

Daraprim Drug Pricing Suit Against Shkreli And Vyera May Signal Future FTC Actions

In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.

Topics

UsernamePublicRestriction

Register

MT056935

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

Cancel