Research & Development November 17, 2023 Q32 Bio to merge with Homology Medicines By PBR Staff Writer Homology Medicines will issue shares of its common stock to Q32 Bio stockholders as part of the merger deal, in return for cancelling Q32 Bio’s capital stock. Pre-merger
ApprovalsResearch & Development November 16, 2023 Xentria receives ODD from EMA for anti-TNFα monoclonal antibody By PBR Staff Writer The company has also enrolled the first US patient in a Phase Ib/IIa clinical study to assess XTMAB-16 for the treatment of patients with pulmonary sarcoidosis. Pulmonary sarcoidosis
Approvals November 15, 2023 Kesin Pharma receives approval from FDA for LIKMEZ By PBR Staff Writer The first and only FDA-approved ready-to-use oral liquid metronidazole in the country, LIKMEZ is intended for patients who may struggle with dysphagia, difficulty swallowing, or high taste sensitivities.
Manufacturing November 14, 2023 Otsuka Pharmaceutical submits NDA for voclosporin in Japan By PBR Staff Writer The company filed the application to manufacture and sell the second-generation oral calcineurin inhibitor, voclosporin, in Japan. In January 2021, voclosporin along with a background immunosuppressive therapy regimen
Approvals November 13, 2023 Lipella Pharmaceuticals gets ODD for LP-310 to treat GvHD By PBR Staff Writer A clinical stage pipeline asset for the company, LP-310 is intended to be indicated for inflammatory diseases of the oral cavity, including oral lichen planus and oral GvHD.
Approvals November 10, 2023 Valneva Austria receives FDA approval for chikungunya vaccine By PBR Staff Writer Ixchiq is approved to be used for individuals aged 18 years and above at increased risk of exposure to the virus. Administered as a single dose by injection
RegulationHaematologyOncology November 9, 2023 Juventas receives NMPA market approval for cell therapy By PBR Staff Writer The investigational CD19 CAR-T cell therapy received approval to treat patients with relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel uses CMC manufacturing
Research & Development November 8, 2023 OrsoBio raises $60m to advance treatment for obesity and associated disorders By PBR Staff Writer This latest funding round has increased the company’s total capital raised to $97m. Co-led by Longitude Capital and Enavate Sciences, this round saw participation from existing investors Samsara
Research & Development November 7, 2023 Halozyme, Acumen partner for ENHANZE drug delivery technology By PBR Staff Writer Halozyme’s ENHANZE is a recombinant human hyaluronidase PH20 enzyme (rHuPH20) for quick subcutaneous drug delivery. Acumen plans to evaluate the potential application of this technology in the development
Approvals November 6, 2023 Mirati receives approval from UK’s MHRA for NSCLC therapy By PBR Staff Writer Krazati has been approved as a monotherapy to treat adult patients with advanced NSCLC with KRASG12C mutation and who have progressive disease after previous therapy with, or intolerance