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Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19

The Pharma Data

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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Novartis Entresto receives positive CHMP opinion for pediatric heart failure

The Pharma Data

The positive opinion is based on final data from the 52-week Phase III PANORAMA-HF trial – the largest pediatric heart failure study ever conducted – and extrapolation of adult heart failure data from the Phase III PARADIGM-HF trial to pediatric patients 3,4.

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Novartis new analysis shows high consistency in lowering LDL-C in individual response with investigational inclisiran

The Pharma Data

Basel , August 30, 2020 — Novartis today announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.

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Are Statin Side Effects ‘All in Your Head’?

The Pharma Data

” Howard said that the researchers “noticed that in old trials of statins — when half the patients took statins and half the patients took placebo — the side effects were almost identical for both groups. 15 in the New England Journal of Medicine. This made no sense if statin side effects were so common.”

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Caelum and Alexion Announce Upcoming Data Presentations at the 62nd American Society of Hematology Annual Meeting and Exposition

The Pharma Data

Food and Drug Administration and European Medicine Agency as a potential therapy for patients with AL amyloidosis. Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines.

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Alexion Highlights Commercial, Clinical and Financial Progress at the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

Select pipeline updates, since third quarter results were reported in October 2020 , regarding promising individual programs and broader platform opportunities include: Completion of enrollment in the Phase 3 trial of ULTOMIRIS in gMG, with top-line data expected in the second half of 2021.

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Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

Progressed European regulatory review and commercial preparations : Continued to support regulatory review of VASCEPA by the European Medicines Agency (EMA) with the expectation of an early 2021 approval of VASCEPA for commercial sale in Europe. VASCEPA is contraindicated in patients with known hypersensitivity (e.g.,

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