Company Product Description Indication Status
Acacia Pharma Group plc, of Cambridge, U.K. Barhemsys (amisulpride injection) Selective dopamine D2 and D3 antagonist Postoperative nausea and vomiting FDA approved drug for prevention and treatment of PONV in adults
Eli Lilly and Co., of Indianapolis Cyramza (ramucirumab) VEGF receptor 2 antagonist Non-small-cell lung cancer FDA’s Oncology Drugs Advisory Committee voted 6-5 that the drug plus erlotinib demonstrated a favorable benefit/risk profile for patients with untreated metastatic EGFR-positive disease based on results of the phase III Relay study
Glaxosmithkline plc, of London, and Innoviva Inc., of South San Francisco Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) Combination of inhaled corticosteroid, long-acting muscarinic antagonist and long-acting beta2-adrenergic agonist Asthma EMA accepted the regulatory submission seeking additional indication for the use of once-daily, single-inhaler triple therapy in adults
Glaxosmithkline plc, of London Zejula (niraparib) PARP inhibitor Advanced ovarian cancer EMA validated type II variation for use of drug as maintenance treatment in the first-line setting for women who responded to platinum-based chemotherapy regardless of biomarker status; formal review process for EMA’s CHMP begins
Harbour Biomed Therapeutics Ltd., of Cambridge, Mass. HBM-9167 Humanized IgG1 monoclonal antibody targeting PD-L1 Nasopharyngeal cancer FDA cleared the IND for a phase II study; agency also granted orphan designation
Steba Biotech SA, of Luxembourg Tookad (padeliporfin dipotassium) Vascular-targeted photodynamic therapy Prostate cancer FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of the NDA seeking use in men with localized early stage disease
Tessa Therapeutics Ltd., of Singapore CD30 CAR T CD30-directed autologous CAR T-cell therapy Relapsed/refractory CD30-positive classical Hodgkin lymphoma FDA granted regenerative medicine advanced therapy designation
Ultragenyx Pharmaceutical Inc., of Novato, Calif., and Kyowa Kirin Co. Ltd., of Tokyo Crysvita (burosumab) Recombinant fully human monoclonal IgG1 antibody FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia) FDA accepted for review supplemental BLA seeking use in patients whose disease cannot be curatively resected or localized; agency assigned priority review, with PDUFA date of June 18, 2020
Y-mabs Therapeutics Inc., of New York  Omburtamab Monoclonal antibody targeting B7-H3 CNS/leptomeningeal metastases from neuroblastoma Completed type B pre-BLA meeting with FDA and reached alignment on accelerated approval pathway, along with rolling BLA; company expects to complete rolling BLA within 10 weeks
Zogenix Inc., of Emeryville, Calif. Fintepla (ZX-008, fenfluramine oral solution) Antiseizure drug Dravet syndrome FDA extended review period for NDA seeking approval to treat seizures associated with Dravet syndrome by 3 months; new PDUFA date is June 25, 2020

Notes

For more information about individual companies and/or products, see Cortellis.

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