Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Bayer, Kiniksa, Mallinckrodt, MC2, Merck, Redhill, Tetra, Tracon and Tricida.
While members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee all recognized the severity of hepatorenal syndrome type 1 (HRS-1) and the significant unmet need in the space, they were divided on whether the FDA should follow the decades-old lead of regulators in 60 other countries in approving Mallinckrodt plc’s terlipressin as an HRS-1 treatment.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Bioaegis, Boehringer, GSK, Knopp, Lintonpharm, Neoimmunetech, Oramed.
Patients with triple-refractory multiple myeloma who are running out of options may soon have a new lifeline. That’s if the FDA follows the unanimous vote of its Oncologic Drugs Advisory Committee (ODAC) and grants accelerated approval to Glaxosmithkline plc’s (GSK) belantamab mafodotin as a fifth-line therapy for adults with relapsed or refractory multiple myeloma.
The U.S. FDA has a number of draft guidances in queue thanks to the COVID-19 pandemic, but released two final guidances in mid-July, including the guidance for clinical investigations for prostate tissue ablation devices. Stakeholders pressed the agency to avoid a fixed period of follow-up for such studies due to variability in the elapsed time for device-related adverse events, but the agency stuck to the draft’s mandate for at least a year of follow-up.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA, International Coalition of Medicines Regulatory Authorities.
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