Company Product Description Indication Status
Beigene Ltd., of Beijing Brukinsa (zanubrutinib) BTK inhibitor Chronic lymphocytic leukemia/small lymphocytic lymphoma Approved by China’s NMPA for use in patients who have received at least 1 prior therapy
Beigene Ltd., of Beijing Brukinsa (zanubrutinib) BTK inhibitor Mantle cell lymphoma Approved by China’s NMPA for use in patients who have received at least 1 prior therapy
Clarity Pharmaceuticals Pty Ltd., of Sydney 67Cu-Sartate Radiopharmaceutical Neuroblastoma FDA granted rare pediatric disease designation
FSD Pharma Inc., of Toronto FSD-201 (ultramicronized palmitoylethanolamide) Analgesic and anti-inflammatory molecule COVID-19 FDA cleared firm to submit IND to test FSD-201’s ability to avoid cytokine storm associated with acute lung injury in hospitalized COVID-19 patients
Genmab A/S, of Copenhagen, and Novartis AG, of Basel, Switzerland Subcutaneous ofatumumab Fully human monoclonal antibody targeting CD20 Relapsing forms of multiple sclerosis FDA notified Novartis that agency extended review of supplemental BLA; action now anticipated in September 2020
Pierre Fabre SA, of Castres, France Braftovi (encorafenib) Small-molecule BRAF kinase inhibitor BRAFV600E-mutant metastatic colorectal cancer European Commission approved for use in combination with Erbitux (cetuximab) for treating adults who have received prior systemic therapy
Revive Therapeutics Ltd., of Toronto Bucillamine Cysteine derivative COVID-19 Filed a CTA with Health Canada and is finalizing IND with FDA for proposed phase III confirmatory trial in patients with mild to moderate COVID-19 due to the SARS-CoV-2 infection
Specialised Therapeutics Asia Pty Ltd., of Singapore, a unit of Specialised Therapeutics Lurbinectedin (PM-1183) Synthetic compound that inhibits oncogenic transcription in tumor-associated macrophages Solid tumors, including small-cell lung cancer Australia’s TGA granted provisional designation; drug will now be reviewed concurrently by FDA and other international regulators, including TGA, under Project Orbis initiative
Treadwell Therapeutics Inc., of New York CFI-402411 HPK1 inhibitor Solid tumors FDA accepted IND; Health Canada issued no objection letter to CTA; phase I/II study to test drug as monotherapy and in combination with PD-1 pathway blockade set to start in 2020
Trevena Inc., of Chesterbrook, Pa. I.V. oliceridine  Mu receptor G protein pathway selective modulator Moderate to severe acute pain Chinese partner Jiangsu Nhwa Pharmaceutical Co. Ltd. said NMPA cleared start of clinical trials

Notes

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

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