During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more
An MIT group consisting of the CRISPR pioneer Feng Zhang and 18 of his colleagues recently published a paper in Science demonstrating a new platform for using CRISPR technology as a diagnostic tool for detecting nucleic...more
On March 13, 2017, the use of Novartis cell cycle inhibitor Kisqali® (ribociclib, LEE011) in combination with an aromatase inhibitor was approved by the U.S. Food and Drug Administration as a first-line treatment for...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
2/4/2017
/ Amgen ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Cross Motions ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
License Applications ,
Life Sciences ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remedies ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS