BrainSpec, the web-based software platform that intends to use existing MRI machines to enable virtual biopsies of the brain, has received FDA designation as a breakthrough device for estimating isocitrate dehydrogenase (IDH) status in glioma patients in whom biopsy is inadvisable.
FDA issued a revised draft guidance for industry, “Charging for Investigational Drugs Under an IND: Questions and Answers,” which responds to frequently asked questions about FDA’s processes, policies, and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use.
MD Anderson Cancer Center and Empyrean Medical Systems Inc. formed an exclusive license and joint development agreement to advance novel technologies and products in the fields of radiation oncology and cancer therapeutics.
MD Anderson Cancer Center and Erasca formed a strategic research and development collaboration to evaluate multiple agents from Erasca’s pipeline targeting the RAS/MAPK pathway as either single-agent or combination therapies.
Lynparza (olaparib) was approved by the European Commission as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have HER2-negative, high-risk, early-stage breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
The University of Texas MD Anderson Cancer Center and TransCode Therapeutics Inc. form an alliance to advance TransCode’s pipeline of RNA-targeted oncology therapeutic and diagnostic candidates.
Poseida Therapeutics Inc. entered into a collaboration and license agreement with Roche to develop allogeneic CAR T-cell therapies directed to hematologic malignancies.
FDA accepted for review a Biologics License Application from ImmunityBio, Inc. for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.
Merck has paid $35 million Kelun-Biotech to Merck for the exclusive rights to develop, manufacture and commercialize an investigational antibody drug conjugate for treatment of solid tumors.
Mission Bio Inc. has created the first assay capable of determining measurable residual disease in cancer down to the level of individual cells.
