Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir).
On the heels of the marketing OK in Europe, Protalix Biotherapeutics Inc. and the Chiesi Group’s global rare diseases unit scored approval of Elfabrio (pegunigalsidase alfa-iwxj) from the U.S. FDA for adults with Fabry disease.
A twisted, uncertain path has led to a U.S. FDA approval for Biogen Inc.’s Qalsody (tofersen), the first drug targeting a genetic cause of amyotrophic lateral sclerosis (ALS). Qalsody is for ALS associated with a mutation in the superoxide dismutase 1 (SOD1) gene. Patients with SOD-1 mutations account for 2% of ALS cases.
Providing a much-needed lift to struggling Gamida Cell Ltd., the U.S. FDA has approved the firm’s advanced cell therapy Omisirge (omidubicel-onlv) to reduce the risk of infection in patients with hematologic malignancies aged 12 years and older who are scheduled to have umbilical cord blood transplantation.
Amylyx Pharmaceuticals Inc. got good news when the Institute for Clinical and Economic Review posted a revised evidence report Aug. 4 that assessed the comparative clinical effectiveness and value of the company’s AMX-0035 and Mitsubishi Tanabe Pharma America Inc.’s Radicava (edaravone) in treating amyotrophic lateral sclerosis.
After showing power in its frequency of dosing and efficacy, Vabysmo (faricimab) has been approved by the FDA for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema. The bispecific monoclonal antibody was developed by Roche Holding AG units, Chugai Pharmaceutical Co. Ltd. and Genentech Inc.
Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022.
Celltrion Inc.’s Regkirona (regdanvimab), a monoclonal antibody treatment for COVID-19, received its latest approval from the European Commission (EC), making it the first Mab developed in South Korea to be approved there. The green light for Celltrion Healthcare Hungary Kft., the Hungarian arm of Korean biopharmaceutical company Celltrion, is for the treatment of adults with COVID-19 aged 18 and over who do not require supplemental oxygen and who are also at increased risk of severe disease.
