Tags : Decision

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to

Shots:  The independent DSMB recommended pausing the enrollment of the ACTIV-3 clinical trial. The trial is evaluating Lilly’s bamlanivimab (LY-CoV555, 7000mg) + remdesivir as a treatment for COVID-19 in hospitalized patients, and is sponsored by the NIAID Lilly trusts the judgment & supports independent DSMB decisions to exercise caution in ensuring the safety of the […]Read More

The US FDA Delays its Decision on Roche’s Risdiplam for

Shots: The US FDA has extended the PDUFA date for its review of risdiplam’s NDA with the expected decision by Aug 24, 2020. The extension is based on the submission of additional data, including SUNFISH Part 2 study The company has submitted filing applications for in seven countries with submission in China imminent and currently […]Read More

Roche and GE Healthcare Launch NAVIFY Tumor Board 2.0 for

Shots: The NAVIFY Tumor Board 2.0 with medical imaging capabilities brings a personalized treatment in patients with cancer with its initial availability in the US & Canada The tumor board enables radiologists to upload their patient records to the same dashboard where the patient’s previous treatment details are stored, helping the clinicians to have a […]Read More