Company Product Description Indication Status
Abbvie Inc., of North Chicago Oriahnn (elagolix, estradiol and norethindrone; elagolix) Hormones Heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women FDA approved the drug
Abbvie Inc., of North Chicago Rinvoq (upadacitinib) Selective and reversible JAK inhibitor Active psoriatic arthritis Submitted applications to FDA and EMA for use in treating adults
Altimmune Inc., of Gaithersburg, Md. T-COVID Replication-deficient adenovirus 5 Early COVID-19 FDA cleared the IND for a 100-patient phase I/II study with a primary efficacy endpoint of patients with clinical worsening, defined as a 4% decrease in pulse oxygen saturation, or need for hospitalization; study scheduled to start in June with data in the fourth quarter of 2020
ANI Pharmaceuticals, of Baudette, Minn. Cortrophin Gel Repository corticotropin Undisclosed  Company forgoing a request for a type A meeting with the FDA and plans to address items identified in the refuse to file letter in a resubmission of its supplementary NDA
Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Lynparza (olaparib) PARP inhibitor Metastatic adenocarcinoma of the pancreas with BRCA1/2 germline mutations EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on use of the drug in patients who have not progressed after at least 16 weeks of a first-line platinum-based treatment
Astrazeneca plc, of Cambridge, U.K Brilinta (ticagrelor) P2Y12 receptor antagonist Coronary artery disease FDA approved the drug to reduce the risk of a first heart attack or stroke in high-risk patients
Aveo Oncology Inc., of Boston Tivozanib Next-generation VEGFR tyrosine kinase inhibitor Relapsed or refractory renal cell carcinoma FDA accepted for filing the NDA, assigning a PDUFA date of March 31, 2021; agency also indicated it does not plan to convene Oncology Drug Advisory Committee to discuss the application
Compugen Ltd., of Holon, Israel COM-701 Anti-PVRIG antibody Advanced solid tumors FDA cleared the IND for a study testing COM-701 plus Opdivo (nivolumab, Bristol Myers Squibb Co.) and BMS-986207; study scheduled to start in the second half of 2020
Cytodyn Inc., of Vancouver, Wash. Leronlimab (PRO 140) CCR5 antagonist HIV indication  Filed BLA with the FDA; requested a priority review
Eli Lilly and Co., of Indianapolis Cyramza (ramucirumab) Monoclonal antibody targeting VEGF receptor First-line metastatic non-small-cell lung cancer FDA approved the drug in combination with Tarceva (erlotinib)
Eli Lilly and Co., of Indianapolis Taltz (ixekizumab) Monoclonal antibody targeting IL-17A Active non-radiographic axial spondyloarthritis FDA approved the supplemental BLA
Genentech Inc., a unit of Roche Holding AG, of Basel, Switzerland Tecentriq (atezolizumab) Monoclonal antibody targeting PD-L1 Unresectable or metastatic hepatocellular carcinoma FDA approved the drug in combination with Avastin (bevacizumab)
Hutchison China Meditech Ltd., of London Surufatinib Angio-immuno kinase inhibitor Advanced neuroendocrine tumors FDA agreed that completed studies can form the basis to support an NDA submission; plans to start a rolling submission in late 2020
Longeveron LLC, of Miami Mesenchymal stem cells  Stem cells from bone marrow of young healthy adult donors Aging frailty Japan's Pharmaceutical and Medical Devices Agency approved the clinical trial notification for a phase II study
Mundipharma International Ltd., of Cambridge, U.K., and Janssen-Cilag International NV, a unit of New Brunswick, N.J.-based Johnson & Johnson Invokana (canagliflozin) Sodium glucose co-transporter 2 inhibitor Diabetic kidney disease EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the expanded indication
Myovant Sciences Ltd., of Basel, Switzerland  Relugolix/estradiol/norethindrone  Gonadotropin-releasing hormone receptor antagonist and hormones Heavy menstrual bleeding associated with uterine fibroids Submitted an NDA to the FDA
Myr Pharmaceuticals GmbH, of Bad Homburg, Germany Hepcludex (bulevirtide) Entry inhibitor Chronic hepatitis delta virus infection  EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of a conditional marketing authorization
Opko Health Inc., of Miami Rayaldee (calcifediol) Prohormone of calcitriol Mild to moderate COVID-19 FDA authorized the phase II study
Shanghai Henlius Biotech Inc., of Shanghai, and Accord Healthcare Ltd., of Durham, N.C. HLX-02   Biosimilar to Herceptin (trastuzumab) HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on the biosimilar
Shionogi & Co. Ltd., of Osaka, Japan Fetroja (cefiderocol) Cephalosporin antibiotic Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible gram-negative pathogens FDA accepted supplemental NDA, granting priority review; PDUFA date of Sept. 27, 2020
Vivet Therapeutics SAS, of Paris VTX-803 Gene therapy Progressive familial intrahepatic cholestasis type 3 Both FDA and European Commission granted orphan designation

Notes

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

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