Find disease awareness content and relevant supporting materials

Bayer announced  510(k) clearance from the FDA for its Medrad  Centargo CT Injection System, an innovative multi-patient injector that drives workflow efficiency with design features that integrate with Bayer’s portfolio of products, especially in high-volume CT suites

NDA Submission Under Accelerated Approval for Govorestat for the Treatment of SORD Deficiency Anticipated in Early Q1 2025

Gilead Sciences, Inc. announced data from a two-and-a-half-year interim analysis from the ongoing Phase III ASSURE study, which showed that 81% (30 out of 37) of participants with primary biliary cholangitis (PBC) treated with Livdelzi  (seladelpar) achieved a composite biochemical response (CBR), demonstrating significant improvements in a key measures of PBC progression. Additionally, 41% (15 out of 37) of participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker of liver function

Eisai Co., Ltd. and Biogen Inc. announced  a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology

Discover the potential of CRN04894, an ACTH receptor antagonist, in treating ACTH-dependent Cushing’s syndrome. This first-in-disease study explores its safety, tolerability, and pharmacokinetics over a 10-day treatment period.

Arbutus Biopharma Corporation and Barinthus Biotherapeutics plc announced new preliminary data from the Phase IIa IM-PROVE II clinical trial (AB 729202) of people with chronic hepatitis B virus (cHBV) at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting 2024

This Phase 2, randomized, placebo-controlled study explores the potential of SPI-62 in treating ACTH-dependent Cushing’s syndrome. Over 24 weeks, participants will receive SPI-62 or a placebo, with an option for long-term extension, to evaluate its efficacy, safety, and pharmacologic effects.

In a small Phase 1 study, Viking’s once-daily oral VK 2735 led to dose-dependent reductions in weight with greatest weight loss — an average 6.8% at 28 days — achieved in the highest of the eight doses tested. The results were presented  during the ObesityWeek conference in San Antonio. Viking said   it plans to start a Phase II test of the tablet by the end of this year.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the LAURA Phase III trial, which were published in The New England Journal of Medicine