|Arcturus Therapeutics Holdings Inc., of San Diego, and Duke-NUS Medical School in Singapore||Lunar-COV19||Vaccine||COVID-19||Clinical trial application approved by Singapore Health Sciences Authority; dosing to begin shortly in up to 108 adults, including older adults, to evaluate several dose levels||7/21/20|
|Beigene Ltd., of Beijing||Pamiparib||PARP1 and PARP2 inhibitor||Third-line advanced ovarian, fallopian tube or primary peritoneal cancer with deleterious or suspected deleterious germline BRCA mutations||Center for Drug Evaluation of the China National Medical Products Administration granted a priority review||7/27/20|
|Can-Fite Biopharma Ltd., of Petach Tikva, Israel||Piclidenoson||A3 adenosine receptor agonist||Moderate COVID-19||Submitted IND to FDA for a 40-patient phase II study||7/27/20|
|Celltrion Healthcare, of Incheon, South Korea||Remsima (infliximab, CT-P13)||Subcutaneous biosimilar of Remicade (Johnson & Johnson)||Ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis||European Commission granted marketing application for the drug||7/27/20|
|Diffusion Pharmaceuticals Inc., of Charlottesville, Va.||Trans sodium crocetinate||Increases oxygen availability||COVID-19||FDA provided guidance on the IND for a phase Ib study, suggesting the company change endpoints and statistical considerations; company plans to submit the same changes to the Romanian National Agency for Medicines and Medical Devices for the Romanian part of the study; first patient now expected to be enrolled by the end of August||7/27/20|
|Generex Biotechnology Corp., of Miramar, Fla.||Ii-Key-SARS-CoV-2||Vaccine||COVID-19 prophylaxis||FDA accepted the pre-IND briefing package and is expected to issue a written response by Aug. 24, 2020||7/27/20|
|Genor Biopharma Co. Inc., of Hong Kong||Geptanolimab||PD-1 monoclonal antibody||Peripheral T-cell lymphoma||China’s NMPA accepted NDA||7/21/20|
|Inotrem SA, of Paris||Nangibotide||TREM receptor 1 antagonist||COVID-19 infection||French, Belgian and U.S. regulators authorized phase IIa trial in about 60 critically ill people showing features of systemic inflammation; outcome measures include impact on severity of respiratory failure, duration of mechanical ventilation, ICU length of stay and mortality||7/23/20|
|Kyowa Kirin Co. Ltd., of Tokyo||Crysvita (burosumab)||Fibroblast growth factor 23 ligand inhibitor||X-linked hypophosphatemia||EMA's Committee for Medicinal Products for Human Use recommended expanding label to include treatment of older adolescents and adults||7/24/20|
|Kyowa Kirin Co. Ltd., of Tokyo||Crysvita (burosumab)||Monoclonal antibody targeting phosphaturic hormone fibroblast growth factor 23||X-linked hypophosphatemia||EMA's Committee for Medicinal Products for Human Use issued a positive opinion for expanded use of the drug||7/27/20|
|Mesoblast Ltd., of Melbourne, Australia||Ryoncil (remestemcel-L)||Therapy comprising culture-expanded mesenchymal stem cells derived from bone marrow of unrelated donor||Steroid-refractory acute graft-vs.-host disease||U.S. FDA’s Oncology Drugs and Advisory Committee scheduled a meeting Aug. 13, 2020, to review data supporting the BLA, seeking approval for use in children; BLA has action date of Sept. 30, 2020||7/21/20|
|Neoimmunetech Inc., of Rockville, Md.||NT-I7 (efineptakin alfa)||Long-acting human IL-7||COVID-19||FDA cleared the IND for an investigator-initiated phase I study||7/27/20|
|Redhill Biopharma Ltd., of Tel Aviv, Israel||Opaganib (Yeliva, ABC-294640)||Sphingosine kinase-2 inhibitor||COVID-19 infection||CTA submitted to Mexican Federal Committee for Protection against Sanitary Risks, COFEPRIS, and submission process initiated with Brazilian Health Regulatory Agency, ANVISA, for phase II/III study in individuals hospitalized with severe infection and pneumonia||7/22/20|
The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found.
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