Merry Christmas? Four US FDA approvals and a CRL
This article was originally published in Scrip
Executive Summary
The US FDA took action on five new drug and biologic license applications (NDAs and BLAs) during the two days before Christmas, approving four products or label updates and rejecting one combination therapy.
You may also be interested in...
Acne Pipeline Yields Three Disappointments, One Win So Far In 2017
The pipeline of acne therapeutics is packed with possibilities, but of four candidates to report data so far this year, only one was successful – Allergan's and Paratek's sarecycline, which may be a better antibiotic option, but doesn't give dermatologists a much-needed new mechanism of action.
Allergan Sees Growth From New Launches, Not Big M&A
Allergan PLC has $27.6m in cash after closing the $40.5bn sale of its generics business to Teva Pharmaceutical Industries Ltd. and paying down $9.3bn debt, but the company will rely on blockbuster sales gains and recent launches for revenue and earnings growth, not a big acquisition.
Finance Watch: A SPACtacular Week For Biopharma Deals And Dollars
Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.
Need a specific report? 1000+ reports available
Buy Reports