After the Federal Circuit’s denial last month of Regeneron’s motion for an injunction pending appeal, seeking to prevent Amgen from launching its aflibercept biosimilar, Amgen announced on its Q3 earnings call last...more
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
9/3/2024
/ Biologics ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Moderna Inc. ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Vaccinations
On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more
5/23/2024
/ Administrative Review ,
Appeals ,
Double Patent ,
Final Written Decisions ,
Indefiniteness ,
Jepson Claims ,
Life Sciences ,
Means-Plus-Function ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under...more
As we previously reported, Magistrate Judge Hall issued a Report and Recommendation (“R&R”) on February 10, 2023 denying Amgen’s motion to dismiss Regeneron’s antitrust claims in Regeneron Pharmaceuticals, Inc. v. Amgen Inc.,...more
As we previously reported, on March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and...more
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s...more
Bio-Thera Solutions and Intract Pharma announced at the end of last month that they had entered into a global collaboration and licensing agreement that gives Bio-Thera access to two oral delivery technologies for monoclonal...more