Company Product Description Indication Status Date
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

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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