|Aquestive Therapeutics Inc., of Warren, N.J.||Libervant (diazepam)||Buccal formulation of diazepam, a benzodiazepine||Seizure clusters||Resubmitted a revised weight-based dosing regimen along with modeling and simulations to FDA in December 2020 and expects to receive feedback and guidance in late January|
|Bayer AG, of Leverkusen, Germany||Nubeqa (darolutamide)||Androgen receptor inhibitor||Non-metastatic castration-resistant prostate cancer||FDA approved an sNDA to add overall survival and other secondary endpoint data to prescribing information, including additional guidance on drug interactions|
|Glaxosmithkline plc, of London, and Medicines for Malaria Venture||Kozenis (tafenoquine)||Antiparasitic||Plasmodium vivax malaria||Australian Therapeutic Goods Administration accepted submission of a category 1 application to extend indication of single-dose treatment to pediatric populations for radical cure (prevention of relapse)|
|Medicure Inc., of Winnipeg, Manitoba||MC-1||Pyridoxal 5′-phosphate||Seizures associated with pyridox(am)ine 5'-phosphate oxidase deficiency||Intends to file an IND application with the FDA and will proceed with the phase III trial|
|Merus NV, of Utrecht, the Netherlands||Zenocutuzumab||Bispecific antibody targeting HER2 and HER3 receptors||Neuregulin 1 fusion cancers||FDA granted fast track designation|
|Moderna Inc., of Cambridge, Mass.||COVID-19 Vaccine Moderna||mRNA vaccine||COVID-19||U.K.'s MHRA approved it for use under Regulation 174, a temporary authorization|
|Neoleukin Therapeutics Inc., of Seattle||NL-201||IL-2 and IL-15 mimetic||Relapsed or refractory solid tumors||Received a clinical hold letter from FDA related to its IND application to begin a phase I program, stating the company needs to develop a new assay that more precisely measures the amount of protein being administered and demonstrate that dose and administration procedures will accurately deliver the intended dose|
For more information about individual companies and/or products, see Cortellis.