Company Product Description Indication Status Date
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

Notes

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.

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