Early lung-specific response to atezolizumab plus bevacizumab was associated with longer overall survival in patients with hepatocellular carcinoma with pulmonary metastases.
Higher-cost therapies for age-related macular edema (ARMD) were significantly more likely to be prescribed by ophthalmologists accepting manufacturer payments.
After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”