It was reported yesterday that the US Food and Drug Administration (USFDA) has granted breakthrough therapy designation to United States-based Celgene's Pomalyst (pomalidomide) intended for the treatment of HIV.
The designation has been granted for the product to treat patients with HIV-positive Kaposi sarcoma who have earlier received systemic chemotherapy, in addition to patients with HIV-negative Kaposi's sarcoma.
Pomalyst is one of the firm's IMiD agents for the treatment of some blood cancers. It is a thalidomide analogue indicated, in combination with dexamethasone, to treat patients with multiple myeloma who have received at least two prior therapies including lenalidomide and proteasome inhibitor.
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
ECO Animal Health Group secures EU approval for ECOVAXXIN MS
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin