|Akarx Inc., unit of Dova Pharmaceuticals Inc., of Durham, N.C., a Swedish Orphan Biovitrum AB company||Doptelet (avatrombopag)||Thrombopoietin receptor agonist||Thrombocytopenia||China NMPA approved drug to treat adults with chronic liver disease scheduled to undergo a procedure||4/30/20|
|Algernon Pharmaceuticals Inc., of Vancouver, British Columbia||NP-120 (ifenprodil)||NMDA receptor antagonist||COVID-19||Received no objection letter from Health Canada for phase IIb/III trial; same study protocol being prepared for submission to U.S. and Australian regulators||4/29/20|
|Ascentage Pharma Group International, of Suzhou, China||HQP-1351||BCR-ABL inhibitor||Chronic myeloid leukemia||FDA granted orphan drug designation||5/4/20|
|Capricor Inc., of Los Angeles||CAP-1002||Allogeneic cardiac cell therapy||COVID-19||Following a review of available data, FDA approved expanded access protocol to treat up to 20 additional patients||4/29/20|
|Combioxin SA, of Geneva||CAL-02||Liposomes that bind bacterial virulence effectors||COVID-19 at high risk of secondary bacterial infections||FDA reviewed the pre-IND||5/4/20|
|Cytodyn Inc., of Vancouver, Wash.||Leronlimab (PRO-140)||CCR5 antagonist||COVID-19||Submitted a request to the FDA to grant compassionate use for patients not eligible for 2 ongoing studies||5/4/20|
|Junshi Biosciences Co. Ltd., of Shanghai||Toripalimab||PD-1-targeting monoclonal antibody||Recurrent/metastatic nasopharyngeal carcinoma||China’s NMPA accepted a supplemental NDA seeking approval for use in patients who failed at least 2 lines of systemic therapy||4/30/20|
|Moderna Inc., of Cambridge, Mass.||mRNA-1273||mRNA vaccine candidate||COVID-19||Submitted IND to FDA to evaluate vaccine in phase II and late-stage studies if supported by safety data from phase I study led by NIH’s National Institute of Allergy and Infectious Diseases; phase II study expected to begin in second quarter of 2020||4/28/20|
|Pharmamar SA, of Madrid, Spain||Aplidin (plitidepsin)||Compound extracted from ascidian Aplidium albicans||COVID-19||Started trial authorized by Spanish Medicines and Healthcare Products Agency||4/28/20|
|Remegen Ltd., of Yantai, China||RC-48 (disitamab vedotin)||Anti-HER2 antibody-drug conjugate||HER2-positive metastatic or unresectable urothelial cancer||FDA cleared the IND for a phase II trial||4/29/20|
|Shionogi & Co. Ltd., of Osaka, Japan||Cefiderocol||Antibiotic||Infections due to aerobic gram-negative bacteria||European Commission granted approval for use in adults with limited treatment options||4/28/20|
|Telix Pharmaceuticals Ltd., of Melbourne, Australia||TLX591-CDx||68 Ga-PSMA-11 injection||Prostate cancer imaging||Submitted an MAA in the EU||5/1/20|
The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.
For more information about individual companies and/or products, see Cortellis.