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EC approves Bristol Myers Squibb’s Opdivo as adjuvant for melanoma
The approval was based on the findings from the Phase 3 CheckMate -76K trial in which Opdivo lowered the risk of recurrence or death in patients with stage IIB or IIC melanoma by 58% compared to placebo
Novavax’s updated Covid shot shows immune response against new Covid subvariants
The American biotechnology company is now submitting applications for its XBB.1.5 Covid vaccine candidate to regulatory agencies all around the world to become the only protein-based non-mRNA vaccine
Cabozantinib combo met one of two primary endpoints in Phase 3 mCRPC trial
The late-stage trial evaluated cabozantinib combination against a second hormonal therapy in mCRPC patients which showed a statistically significant improvement in progression-free survival at the primary analysis
CARsgen, Moderna partner to assess CT041 and mRNA cancer vaccine combination
The partnership intends to test satricabtagene autoleucel in combination with Claudin18.2 mRNA cancer vaccine through preclinical research and a phase 1 clinical trial
China’s NMPA approves AstraZeneca’s Forxiga for heart failure patients
The approval was based on positive results from the DELIVER Phase 3 trial in which Forxiga met its primary endpoint in reducing the composite outcome of CV death or worsening HF by 18%
Neurocrine Biosciences gets FDA approval for Ingrezza to treat chorea
FDA granted the approval based on the data from the KINECT-HD Phase 3 study and the ongoing KINECT-HD2 open-label extension trial which were conducted in collaboration with the Huntington Study Group
European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI
Teclistamab, the first BCMA-targeting bispecific antibody to receive approval in Europe, maintained deep and durable responses, with reduced onset of Grade 3 or higher infections, in eligible patients with relapsed and refractory multiple myeloma (RRMM) switching from weekly to reduced, biweekly dosing schedule
Alzheimer’s Drug Discovery Foundation Joins Astrocyte Pharmaceuticals’ $6M+ Pre-Series B Financing Round to Expand Development of Cerebroprotectant AST-004
he funding will accelerate the clinical development of AST-004, a highly promising therapeutic candidate aimed at treating a broad array of acute brain injuries including stroke and traumatic brain injury (TBI), and further assess its potential in preclinical models of Alzheimer’s disease
Moderna’s updated Covid-19 vaccine shows positive response against new Covid variants
According to Moderna, these findings imply that the updated Covid-19 vaccine can successfully combat the Covid-19 variations that are anticipated to circulate throughout the upcoming vaccination season
Boehringer Ingelheim to move survodutide in three global Phase 3 obesity studies
This decision was supported by newly released data from a Phase 2 dose discovery study in overweight or obese individuals in which survodutide after 46 weeks of treatment, showed a 19% of weight reduction