Blog
RSS FeedPosted by Michael Wonder on 14 Jul 2016
Gormley’s take: road to launching ‘biosimilar’ drugs just got longer
13 July 2016 - Small companies developing lower-cost copies of expensive biotechnology drugs already faced a tough road launching their products. ...
Posted by Michael Wonder on 13 Jul 2016
Amgen biosimilar gets thumbs up from FDA panel
13 July 2016 - ABP 501 designed to be a lower-cost alternative to AbbVie’s blockbuster Humira. ...
Posted by Michael Wonder on 13 Jul 2016
Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases
13 July 2016 - Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the ...
Posted by Michael Wonder on 13 Jul 2016
Pfizer receives FDA approval for Prevnar 13 in adults age 18 through 49
12 July 2016 - Prevnar 13 is the only pneumococcal vaccine approved in the U.S. for patients 6 weeks through adulthood. ...
Posted by Michael Wonder on 12 Jul 2016
FDA approves new medication for dry eye disease
12 July 2016 - The U.S. FDA approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry ...
Posted by Michael Wonder on 11 Jul 2016
FDA approves first and only single monthly injection for a PCSK9 inhibitor
10 July 2016 - Repatha (evolocumab) Pushtronex system available to U.S. patients in early August. ...
Posted by Michael Wonder on 11 Jul 2016
FDA approves first MRI-guided focused ultrasound device to treat essential tremor
11 July 2016 - The U.S. FDA today approved the first focused ultrasound device to treat essential tremor in patients who ...
Posted by Michael Wonder on 08 Jul 2016
FDA approves first HPV test for use with SurePath Preservative Fluid
7 July 2016 - The U.S. FDA today approved the Roche cobas HPV Test as the first test for human papilloma ...
Posted by Michael Wonder on 08 Jul 2016
FDA approves Differin Gel 0.1% for over-the-counter use to treat acne
8 July 2016 - First retinoid approved for over-the-counter use. ...
Posted by Michael Wonder on 08 Jul 2016
Idalopirdine granted fast track designation by U.S. FDA
7 July 2016 - Designation provides the opportunity for more frequent interactions with FDA during clinical development and potential eligibility for ...
Posted by Michael Wonder on 08 Jul 2016
Novartis announces FDA approval of Xolair (omalizumab) for paediatric allergic asthma
7 July 2016 - Extension of indication makes Xolair the first and only approved biologic for pediatric patients six years and ...
Posted by Michael Wonder on 06 Jul 2016
Biosimilar makers lose second shot at shortening biologics exclusivity
6 July 2016 - In a blow to biosimilar developers and consumers, the federal appeals court has again ruled that biosimilar ...
Posted by Michael Wonder on 05 Jul 2016
FDA should stand firm on stem-cell treatments
5 July 2016 - You may have heard that regulators in the United States are too strict when it comes to ...
Posted by Michael Wonder on 05 Jul 2016
FDA approves treatment for AIDS symptoms
5 July 2016 - Insys says agency OKs Dronabinol oral solution after earlier application was rejected in 2014. ...
Posted by Michael Wonder on 05 Jul 2016
Accelerated drug approval and health inequality
5 July 2016 - This Viewpoint argues that the acceleration of the drug approval process could unequally distribute the costs and ...