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

UsernamePublicRestriction
UsernamePublicRestriction

As Device Center Director Gets The Hook, Spotlight Turns To CDER's Woodcock

Executive Summary

For the pharmaceutical industry, the resignation of Center for Devices and Radiological Health Director Dan Schultz probably should be weighed in the context of what it means for interactions with CDER and CBER

You may also be interested in...



Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid

Jury verdict comes seven years after Momenta/Sandoz launched generic version of Lovenox; firms sought treble damages from Amphastar for willful infringement of manufacturing process patent.

Enoxaparin Generic Saga Continues: Momenta's Manufacturing Patent Invalid

Jury verdict comes seven years after Momenta/Sandoz launched generic version of Lovenox; firms sought treble damages from Amphastar for willful infringement of manufacturing process patent.

FDA Approves Momenta/Sandoz' Lovenox Generic Without Need For Clinical Studies

FDA approval of Momenta and Sandoz' generic version of Sanofi-Aventis' Lovenox (enoxaparin) suggests the agency is willing to find a way around requiring clinical efficacy and safety data for future biosimilar approvals

Related Content

Topics

UsernamePublicRestriction

Register

LL1133990

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