The week began with PDUFA-delaying news for Regeneron Pharmaceuticals Inc. The company said it received two complete response letters (CRLs) from the U.S. FDA regarding the priority BLA for its bispecific antibody to treat lymphoma, odronextamab.
Parvus Therapeutics Inc. has entered into an exclusive worldwide collaboration and option agreement with Abbvie Inc. for the development and commercialization of novel treatments for inflammatory bowel disease (IBD), utilizing Parvus’ Navacim regulatory T-cell (Treg) immune tolerization platform technology.
Abbvie Inc. has prepared and tested new antibody-drug conjugates comprising an antibody targeting seizure protein 6 homolog (SEZ6) covalently linked to DNA topoisomerase I inhibitors through a linker.
OSE Immunotherapeutics SA disclosed a $713 million deal with Abbvie Inc. for preclinical-stage monoclonal antibody OSE-230, a potentially first-in-class therapy for treating a range of inflammatory diseases, while Idorsia Ltd. found a partner for two phase III-stage assets in Viatris Inc., as dealmaking continues strong in 2024.
Abbvie Inc.’s blockbuster drug Humira is getting a 10th challenger that could give all the other adalimumab biosimilars a run for their money – depending on pricing and formulary coverage, of course. After delays caused by the COVID-19 pandemic and manufacturing issues, the U.S. FDA approved Simlandi, previously known as AVT-02, as a Humira biosimilar and interchangeable Feb. 23.
Abbvie Inc. and Tentarix Biotherapeutics Inc. have established a multiyear collaboration focused on the discovery and development of conditionally active, multispecific biologic candidates against one target in oncology and another in immunology.
In its second big collaboration of the past six months, privately held Tentarix Biotherapeutics LP plans to discover and develop biologics for treating oncology and immunology indications with Abbvie Inc. The deal comes at a time of change at Abbvie, which is getting a new CEO, watching the marketplace erosion of bestselling Humira (adalimumab) and digesting two major acquisitions at a cost of billions.
Despite Vertex Pharmaceuticals Inc.’s mostly positive phase III study results of a non-opioid for treating moderate to severe acute pain, the data for a key secondary endpoint show VX-548 is not as effective as Vicodin (hydrocodone, Abbvie Inc.).
Abbvie Inc. and Umoja Biopharma Inc. have announced two exclusive option and license agreements to develop multiple in situ generated chimeric antigen receptor (CAR)-T cell therapy candidates in oncology using Umoja's proprietary Vivovec platform.
Umoja Biopharma Inc.’s gene delivery platform that combines a third-generation lentiviral vector gene approach with a novel T-cell targeting and activation surface complex brought Abbvie Inc. to the table for a pair of deals that could be worth as much as $1.44 billion.
