Company Product Description Indication Status
Adaptimmune Therapeutics plc, of Philadelphia ADP-A2M4 SPEAR T cells targeting MAGE-A4 Soft tissue sarcomas EMA’s Committee for Orphan Medicinal Products adopted a positive opinion for orphan designation
Bioeclipse Therapeutics Inc., of Mountain View, Calif. CRX-100 Immunotherapy Therapy-refractory solid tumors FDA cleared IND for a phase I study expected to start in 2020
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
Moleculin Biotech Inc., of Houston Annamycin Next-generation anthracycline Acute myeloid leukemia Authorized by Polish Department of Registration of Medicinal Products to accelerate phase I dose-escalation portion of trial
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
Retrotope Inc., of Los Altos, Calif. RT-001 Chemically stabilized fatty acid Progressive supranuclear palsy FDA cleared the IND for a phase II/III trial
Roche Holding AG, of Basel, Switzerland Rozlytrek (entrectinib) Tumor-agnostic treatment targeting NTRK Extracranial solid tumors Approved by Health Canada for use in patients with unresectable locally advanced or metastatic disease, including brain metastases, that have a NTRK gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options
Sanofi SA, of Paris Menquadfi  Meningococcal (groups A, C, Y, W) conjugate vaccine Prevention of invasive meningococcal disease FDA approved BLA for use in persons 2 and older
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
Zambon SpA, of Milan, Italy Liposomal cyclosporine A for inhalation Calcineurin inhibitor Bronchiolitis obliterans syndrome FDA granted fast track designation

Notes

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

No Comments