Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.
Cytomx Therapeutics Inc. has announced the nomination of the second clinical candidate under its Probody T-cell engaging bispecific (TCB) collaboration with Astellas Pharma Inc. The two companies are collaborating on multiple conditionally activated TCB programs, with T-cell engagers offering new possibilities for the treatment of solid tumors.
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
Japan’s Ministry of Health, Labor and Welfare approved Astellas Pharma Inc.’s Vyloy (zolbetuximab) to treat a type of advanced gastric cancer on March 26, making it the first anti-claudin 18.2 monoclonal antibody to gain regulatory clearance worldwide.
Astellas Pharma Inc. has patented new proteolysis targeting chimeras (PROTACs) comprising a cereblon E3 ubiquitin ligase-binding moiety coupled to GTPase KRAS (G12V mutant)-targeting agent through a linker.
San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in a novel immuno-oncology (I-O) drug discovery deal that could fetch more than $800 million. Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform.
San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in a novel immuno-oncology (I-O) drug discovery deal that could fetch more than $800 million. Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform.
Xyphos Biosciences Inc., a wholly owned subsidiary of Astellas Pharma Inc., and Kelonia Therapeutics Inc. have entered into a research collaboration and license agreement to develop novel immuno-oncology therapeutics.
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
Elpiscience Biopharma Ltd. is out-licensing to Astellas Pharma Inc. two preclinical bispecific macrophage engagers – ES-019, an anti-PD-L1/SIRPα bispecific antibody, and another unnamed program – in a deal worth up to $1.7 billion. The deal marks the Shanghai-based company’s first out-licensing deal, Elpiscience CEO Darren Ji told BioWorld, noting that Astellas will have global rights to both molecules with a potential to in-license two more.