Mylan N.V. and Biocon Ltd. said FDA has accepted Mylan's biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway.
FDA released the final guidance for industry "Nonproprietary Naming of Biological Products."
The American Association for Cancer Research announced the first public release of cancer genomic data aggregated through its initiative known as AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE).
Strata Oncology today announced launch of the Strata Trial, a nationwide observational study providing no-cost tumor sequencing and clinical trial matching for 100,000 advanced cancer patients, to study the impact of tumor sequencing on clinical trial enrollment.
FoundationFocus CDxBRCA received FDA approval for use as a companion diagnostic to aid in identifying women with ovarian cancer.
Ionis Pharmaceuticals Inc. announced that it has earned $28 million from AstraZeneca following AstraZeneca's completion of IND-supporting studies and license of IONIS-KRAS-2.5, or AZD4785. IONIS-KRAS-2.5x is a Generation 2.5 antisense drug discovered by Ionis designed to directly target KRAS, one of the most frequently mutated genes in cancer.
MaxCyte Inc. and Washington University in St. Louis announced a collaboration to develop unique immunotherapy drug candidates based on MaxCyte's proprietary cell engineering platform technology, CARMA.
MD Anderson and German-based Affimed N.V., announced an exclusive strategic clinical development and commercialization collaboration to evaluate Affimed's TandAb technology in combination with MD Anderson's natural killer cell product.
Gradalis Inc. and the Icahn School of Medicine at Mount Sinai established a research alliance to advance the scientific understanding of the Gradalis Vigil Engineered Autologous Tumor Cell therapy.
Phylogica Ltd. said Genentech has extended its exclusivity period for the research collaboration and license agreement to discover novel antibiotics utilizing Phylogica's Phylomer drug discovery platform, including its proprietary cell penetrating peptide discovery technology.
