Merck has today made public the launch of the company's Phase 3 clinical trials, labeled as CORALreef, for MK-0616, a potential oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor.
On August 8, 2023, Bavarian Nordic announced positive top-line results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of its Chikungunya virus candidate vaccine, CHIKV VLP (PXVX0317), in adults and adolescents aged 12 to 64.
On August 8, 2023, Vistagen announced the positive top-line results of the PALISADE-2 Phase 3 clinical trial, which assessed the efficacy and safety of its investigational fasedienol (PH94B, Aloradine) nasal spray in adult patients with social anxiety disorder (SAD).
On August 1, 2023, AstraZeneca has reached an agreement to pay $510 million to BMS to resolve patent lawsuit over its PD-L1 mAb Imfinzi (Durvalumab) and CTLA-4 mAb Imjudo (Tremelimumab).
On August 1, 2023, MyMD Pharmaceuticals announced that the oral Tumor Necrosis Factor-α (TNF-α) inhibitor MYMD-1 achieved statistically significant positive results in a Phase 2 randomized clinical trial (NCT05283486).
On July 31, 2023, Sumitomo Dainippon Pharma and Otsuka Pharmaceutical jointly announced that their two Phase III studies, DIAMOND 1 and DIAMOND 2, for ulotaront (SEP-363856) in the treatment of acute schizophrenia did not meet the primary endpoints.
On August 1, 2023, the official website of the Chinese Drug Evaluation Center (CDE) shows that the new drug application (NDA) for Zolbetuximab injection developed by Astellas has been accepted for review.
Dostarlimab is the first immunotherapy approved by the FDA to be used in combination with chemotherapy for the first-line treatment of this patient population.
Checkpoint Therapeutics announced the long-term data obtained in its key study on the PD-L1 inhibitor cosibelimab for the treatment of locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC).
On July 26, 2023, Astellas and PeptiDream announced that they have entered into a research collaboration and licensing agreement to discover innovative protein degradation drugs for two targets selected by Astellas.
On July 26, 2023, Tarsus Pharmaceuticals announced that the U.S. FDA has approved Xdemvy (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis.
Empagliflozin is the first Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitor to statistically significantly reduce the risk of hospitalization for any cause compared to a placebo in patients with CKD.