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

The Medicines Co. Prepares To Move Into New Commercial Territory

This article was originally published in The Pink Sheet Daily

Executive Summary

With the release of positive Phase III data on the antibiotic oritavancin, the hospital specialist soon could be making a commercial foray into an area outside its current expertise in cardiovascular disease.

You may also be interested in...



Oritavancin Phase III Results Support FDA’s New Endpoint, Sponsor Says

FDA’s new early endpoint for efficacy in ABSSSI had been criticized at the time it was released. But reporting positive results for a second Phase III study of oritavancin, The Medicines Co CEO says the agency’s ABSSSI endpoints are “appropriate” for industry.

Antibiotic Market Snapshot: In Exchange For Higher Prices, More Value

Drug developers face enormous regulatory and commercial hurdles in the antibiotics market, but industry is looking to challenge the current business model with new premium-priced drugs that deliver compelling pharmaco-economic benefits over generics.

With GAIN In Place, Antibiotic Improvements Depend On FDA Implementation

FDA and industry are turning their attention to implementation of the Generating Antibiotic Incentives Now provisions of PDUFA V, which include an additional five years of marketing exclusivity for certain products and new guidance aimed at streamlining the drug development process.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076046

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