Evotec entered into a strategic collaboration and license agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration focuses on the development of first-in-class targeted immune-based therapies for oncology, which will ultimately be commercialized by Janssen. The agreement was facilitated by Johnson & Johnson Innovation.
FDA granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive, unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
FDA issued a draft guidance for industry, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.”
Gilead Sciences, Inc. agreed to collaborate on the Strata Precision Indications for Approved THerapies (PATH) trial by providing Trodelvy (sacituzumab govitecan-hziy) for eligible patients with cancer.
Elicio Therapeutics has entered into a definitive merger agreement with Angion Biomedica Corp under which Elicio will merge with a wholly-owned subsidiary of Angion in an all-stock transaction.
FDA has accepted Genentech’s Biologics License Application and granted priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
Foundation Medicine Inc. and Natera Inc. launched an early access program for clinical use of FoundationOne Tracker, a personalized circulating tumor DNA monitoring assay.
Kronos Bio Inc. and Genentech entered into a discovery collaboration focused on discovering and developing small-molecule drugs that modulate transcription factor targets selected by Genentech.
FDA granted accelerated approval to Lunsumio (mosunetuzumab-axgb), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.
