Company Product Description Indication Status
Adocia SA, of Lyon, France BC Lispro Insulin Type 1 diabetes Cleared by FDA and German Federal Institute for Drugs and Medical Devices to initiate comparative study to demonstrate safety and efficacy of BC Lispro with insulin lispro manufactured by Tonghua Dongbao
Astrazeneca plc, of Cambridge, U.K. Tagrisso (osimertinib) EGFR antagonist Early stage EGFR-mutated non-small-cell lung cancer FDA granted breakthrough therapy designation for use in patients after complete tumor resection with curative intent
Aytu Bioscience Inc., of Englewood, Colo. Zolpimist (zolpidem tartrate oral spray) Benzodiazepine receptor agonist Sleep aid Sublicensee Suda Pharmaceuticals Ltd. received marketing approval from Australia’s Therapeutic Good Administration 
Bristol Myers Squibb Co., of New York, and Bluebird Bio Inc., of Cambridge, Mass. Idecabtagene vicleucel (bb-2121) BCMA-directed CAR T-cell immunotherapy Relapsed and refractory multiple myeloma Submitted BLA to FDA; submission provides further details on the CMC module to address outstanding regulatory requests from the agency's May 2020 refuse-to-file letter following original BLA submission in March 2020
Celltrion Group, of Incheon, South Korea CT-P59 Antiviral antibody COVID-19 U.K.’s Medicines and Healthcare products Regulatory Agency approved clinical trial authorization for phase I study in patients with mild symptoms of SARS-CoV-2 infection
Direct Biologics LLC, of Austin, Texas Exoflo Bone marrow-derived extracellular vesicle and exosome product COVID-19-associated acute respiratory distress syndrome FDA cleared IND for phase II Exit COVID-19 trial; patient enrollment expected to start in next 30 days
Diurnal Group plc, of London Ditest  Native oral testosterone formulation Male primary and secondary hypogonadism Received FDA feedback from pre-IND meeting, confirming that drug can progress to NDA via 505(b)(2) pathway
Dynacure SAS, of Strasbourg, France DYN-101 Antisense medicine designed to modulate expression of dynamin 2 Myotubular and centronuclear myopathies FDA granted rare pediatric disease designation
Edesa Biotech Inc., of Toronto EB-05 TLR4-targeting monoclonal antibody COVID-19 Filed IND with FDA for a phase II/III study in hospitalized patients
Eton Pharmaceuticals Inc., of Deer Park, Ill. Zonisamide oral suspension (ET-104) Calcium channel inhibitor; sodium channel inhibitor Epilepsy NDA for treatment of partial seizures submitted to FDA
Imago Biosciences Inc., of South San Francisco IMG-7289 (bomedemstat) LSD1 inhibitor Myelofibrosis EMA granted access to PRIME scheme for treating intermediate-2 and high-risk patients who have become intolerant of, resistant to or are ineligible or a JAK inhibitor
Imara Inc., of Boston IMR-687 Small-molecule PDE9 inhibitor Beta-thalassemia FDA granted fast track and rare pediatric disease designations
Marinus Pharmaceuticals Inc., of Radnor, Pa. Ganaxolone Positive allosteric modulator of GABAA receptors CDKL5 deficiency disorder FDA granted rare pediatric disease designation for rare, refractory form of epilepsy
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 antibody Triple-negative breast cancer FDA accepted for priority review the BLA seeking approval in combination with chemotherapy to treat patients with locally recurrent unresectable or metastatic disease whose tumors express PD-L1 
Poxel SA, of Lyon, France, and Sumitomo Dainippon Pharma Ltd., of Osaka, Japan Imeglimin Tetrahydrotriazine compound Type 2 diabetes Sumitomo submitted Japanese NDA
Siga Technologies Inc., of New York Oral tecovirimat Small-molecule antiviral Smallpox, monkeypox, cowpox, and complications from Vaccinia infection Filed MAA with EMA for same formulation approved under brand Tpoxx by FDA in July 2018
Synthetic Biologics Inc., of Rockville, Md. SYN-020 Oral formulation of recombinant intestinal alkaline phosphatase Multiple indications, including radiation enteropathy secondary to pelvic cancer therapy FDA cleared IND for phase I study in healthy volunteers
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Pevonedistat NEDD8-activating enzyme inhibitor Higher-risk myelodysplastic syndromes FDA granted breakthrough therapy designation

Notes

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

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