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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients. We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.”

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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Worldwide Clinical Trials

Through the implementation of full automation in bioanalytical testing PK, immunogenicity, and biomarker assays we streamline trials, reduce costs, save time, and maintain the highest data quality standards. Biomarkers support adaptive trial designs, allowing modifications based on interim results to optimize study outcomes.

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LIB Therapeutics’ Cholesterol Lowering Med Lerodalcibep Receives FDA BLA Acceptance

XTalks

Current PCSK9 inhibitors on the market include Regenerons monoclonal antibody Praluent (alirocumab), Amgens Repatha (evolocumab) and Novartiss Leqvio (inclisiran), which is a small RNA interference (siRNA) therapy designed to lower LDL-C. Results from the trials demonstrated that lerodalcibep achieved significant reductions in LDL-C levels.

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Top 10 Heart and Vascular Medications Based on Recent Sales Data

XTalks

The heart and vascular medication market continues to be a critical focus area for pharma companies, with billions of dollars in sales generated annually. However, challenges such as patent expirations, generic competition and pricing pressures continue to shape the market landscape. Eliquis (Apixaban) Eliquis 2023 sales :$12.21

Sales 104
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Rapiblyk (Landiolol): A New Fast-Acting Option for AFib in the ICU

XTalks

The US Food and Drug Administration (FDA) has approved AOP Health’s landiolol injection, marketed as Rapiblyk, for the treatment of atrial fibrillation (Afib) and atrial flutter in critical care settings. This approval marks Rapiblyk’s introduction to the US market after being available in Europe.

Trials 104
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Top 10 Largest Publicly Traded Medical Device Companies by Market Cap in 2024

XTalks

This blog provides a comprehensive look at the medical device giants, ranked by market capitalization , leading the charge into the future of medicine. Abbott Laboratories (ABT) Market Capitalization : $267.1 Billion Abbott Laboratories leads the medical device industry in market capitalization. In Q2 2024, Intuitive posted $2.01

Marketing 105
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BridgeBio’s Attruby (Acoramidis): A New, More Potent TTR Stabilizer for ATTR-CM

XTalks

The trial demonstrated a 42 percent reduction in combined cardiovascular death and recurrent hospitalizations at Month 30, with cardiovascular-related hospitalizations reduced by half. A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025.