All articles by
CENTENE CORPORATION SIGNS DEFINITIVE AGREEMENT TO DIVEST CIRCLE HEALTH GROUP
Centene to sell Circle Health Group to Pure Health at an enterprise value of approximately $1.2B
Janssen files sBLA with US FDA for Rybrevant combo approval in NSCLC treatment
The application was based on the results from the Phase 3 PAPILLON trial in which the Rybrevant combination showed a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy alone
Novo Nordisk’s semaglutide 2.4mg reduces HF-related symptoms in Phase 3 trial
The semaglutide 2.4mg caused a mean reduction in body weight of 13.3% compared to a placebo’s 2.6% loss, resulting in an estimated treatment difference of 10.7% weight reduction
Akeso’s ivonescimab obtains NDA priority review from China NMPA
The recent priority review procedure will help validate the clinical significance of the PD-1/VEGF bi-specific antibody and will accelerate the drug’s approval and marketing procedures
Exelixis to halt Phase 3 Cabozantinib trial of pancreatic tumour after efficacy concerns
In an interim analysis, cabozantinib significantly prolonged the time without disease progression or death in both cohorts of the trial, which included patients with either advanced pNET or advanced extra-pancreatic NET
Sandoz’s Tyruko gets FDA approval as first biosimilar for multiple sclerosis treatment
The approval was based on a strong data package that included functional, analytical and clinical data which showed no clinically meaningful differences between the two products in terms of safety, purity and potency
New Shingrix data demonstrate 100% vaccine efficacy in the prevention of shingles in adults aged 50 and over in China
No cases of shingles (herpes zoster) reported among the participants who received Shingrix (Recombinant Zoster Vaccine or RZV) in the randomised clinical trial
FDA Approves Veklury to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment
This Approval Supports Veklury’s Strong Safety Profile and Makes Veklury the Only Approved COVID-19 Antiviral Treatment Across all Stages of Liver Disease
US FDA grants ODD to Immix Biopharma’s NXC-201 for multiple myeloma
With ODD, NXC-201 is now eligible for seven years of US market exclusivity in the US upon regulatory approval and will also get tax credits for qualified clinical testing and a waiver of the Prescription Drug User Fee
Vaxxas Awarded US$3.67m from global charitable foundation, Wellcome, for Human Clinical Study of Typhoid Vaccination using Needle-Free Vaccine Patch
Funding from Wellcome will further broaden Vaxxas’ diverse clinical pipeline of next-generation vaccines to include Typhoid fever