NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Generex, Immuron, Karyopharm, Molecular Partners, Neoimmunetech, Orchard, Orphazyme, Osmotica, Sanifit, Sorrento.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, BMS, Botanix, Denovo, Nabriva, Puma, Specialised Therapeutics, Sunovion.
With an Aug. 22 PDUFA date set, Tricida Inc. said it received an FDA notification regarding the NDA for veverimer (TRC-101) for treating metabolic acidosis in chronic kidney disease (CKD) patients, noting that it had identified deficiencies precluding discussion of labeling and postmarketing requirements/commitments.
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.
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