BioSpace News Archive

Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted New Patient Population exclusivity for Nucynta®, an immediate release formulation of tapentadol.

Akeso Inc. announced today that the New Drug Application (NDA) for its fully human IgG1 monoclonal antibody, ebdarokimab (IL-12/lL-23, AK101) has been accepted by the National Center for Drug Evaluation of the State Drug Administration of the People’s Republic of China (NMPA CDE) for the treatment of adult patients with moderate-to-severe plaque-type psoriasis.

Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer.

Agilent Technologies Inc. announced the issuing of a companion diagnostic Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006.

Fresenius Kabi and Lupagen Inc. announced the companies have entered into a development and supply agreement for technologies designed to bring the delivery of cell and gene therapies to the bedside.

Biogenysis, Inc. (OTC PINK:ENZC) (or the “Company”). Biogenysis, a subsidiary of Enzolytics, Inc., announces the progress of its Patent Cooperation Treaty (PCT) application covering its inventions relating to Anti-SARS-CoV-2 Monoclonal Antibodies.

When it comes to raising crops, protecting them through harvest is often the toughest part of the job.

EmpiRx Health, the leading value-based PBM company, applauds Blue Shield of California for joining it in implementing a value-based pharmacy care model.

ALK’s revenue grew by 11% in Q2 2023, driven by 17% growth in tablet sales and double-digit growth in combined SCIT/SLIT-drops sales.

XNK Therapeutics AB announced that the company has entered into a research collaboration with the Karolinska University Hospital, Sweden, to evaluate the suitability of the company’s autologous natural killer cell therapy candidate XNK02 as a novel therapy for treatment of acute myeloid leukemia.