Cloudbyz

AUGUST 16, 2024

Introduction to Electronic Case Report Forms (eCRF) In the ever-evolving landscape of clinical trials, the transition from traditional paper-based case report forms to electronic Case Report Forms (eCRFs) has marked a significant advancement in how clinical data is collected, managed, and analyzed.

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The Pharma Data

OCTOBER 14, 2020

Michael Felker, MD, MHS, FACC, FAHA, FHFSA is Professor of Medicine with tenure in the Division of Cardiology at Duke University School of Medicine. He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. Source link.

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Pharma Marketing Network

FEBRUARY 27, 2025

Creating content that is informative, engaging, and compliant with industry regulations. Pharma brands can develop: Whitepapers on clinical trials showcasing drug effectiveness. Scientific blogs discussing new advancements in oncology, cardiology, or rare diseases. Engaging HCPs Through Thought Leadership 1.

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XTalks

JULY 10, 2023

Xtalks spoke with Kaushik Gune, Head of Healthcare (US) at Huma, a global digital health technology company, to learn more about SaMD and what it looks like to create a regulated health app. What are some examples of software as a medical device (SaMD) and how is this software regulated? Tier one devices represent the low risk.

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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The Pharma Data

OCTOBER 29, 2020

We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinical trials. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials.

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The Pharma Data

JANUARY 12, 2021

Dosing is underway in Phase 3 trials of ULTOMIRIS in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), ALXN2060 (AG10) in ATTR cardiomyopathy in Japan , CAEL -101 in AL amyloidosis and ALXN2040 in paroxysmal nocturnal hemoglobinuria (PNH) patients with extravascular hemolysis (EVH).

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Pharmaceutical Technology

JUNE 21, 2023

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. 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.

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The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee.

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The Pharma Data

NOVEMBER 4, 2020

Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. This press release and further information about Alexion can be found at: www.alexion.com.

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XTalks

FEBRUARY 8, 2024

According to AstraZeneca, the drug had strong demand across all of its approved indications and was further supported by recent guideline updates from cardiology societies. The efficacy and safety of Rybelsus in reducing blood sugar in patients with type 2 diabetes were investigated in various clinical trials. billion in 2022.

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The Pharma Data

AUGUST 29, 2020

Presented at the ESC Congress 2020, the annual meeting of the European Society of Cardiology, the analysis evaluated the efficacy and tolerability of inclisiran on top of a maximally tolerated dose of statins, in two studies of more than 2,300 patients (of which 1,164 were on inclisiran) from the Phase III trials.

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The Pharma Data

AUGUST 30, 2021

Results were presented at the ESC Congress 2021, organized by the European Society of Cardiology (ESC). In three clinical trials, patients taking Leqvio maintained LDL-C reduction throughout each six-month dosing interval 8,10. In the first analysis, patients with established CeVD treated with Leqvio achieved an average 55.2%

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The Pharma Data

NOVEMBER 4, 2020

Expanded m edical society recommendations in support of the efficacy and safety of VASCEPA : The European Society of Cardiology expanded their guidelines to recommend use of VASCEPA in treating acute coronary syndrome patients. Securities and Exchange Commission Regulation G. commercial team. “In

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The Pharma Data

AUGUST 17, 2021

Following a topline presentation at the ESC Heart Failure Congress in June, the updated European Society of Cardiology and Heart Failure Association Guidelines on Acute and Chronic Heart Failure will also be presented during the ESC Congress and made available for use. About Vericiguat Verquvo 2.5

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pharmaphorum

JANUARY 5, 2021

An IQVIA survey to Neurology, Cardiology, Rheumatology, Dermatology and Ophthalmologists in June 2020 across the lead five European countries showed an average of 30% of patients either “no shows” or still waiting for treatment that was delayed.

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XTalks

AUGUST 2, 2023

In September 2022, Roche acquired Good Therapeutics for an upfront payment of $250 million, and has access to their PD-1-regulated IL-2 program. The TPO receptor agonist regulates blood platelet production by binding to and activating TPO receptors on megakaryocyte cells and inducing signalling cascades that increase platelet production.

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The Pharma Data

APRIL 26, 2021

At present, drug development operations are continuing with manageable disruptions (see the Innovation Review Section of the Condensed Interim Financial Report for further information), with our range of digital technologies allowing us to proactively manage our clinical trials portfolio and rapidly mitigate any disruptions.

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Pharma Marketing Network

MARCH 19, 2025

Introduction In the highly regulated pharmaceutical industry, audience engagement is more than just a marketing goalit is a necessity for building trust with healthcare professionals (HCPs) and patients. But how can pharma brands create meaningful connections in a digital landscape crowded with content?

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The Pharma Data

MAY 13, 2021

The trans-fat ban–food regulation and long-term health. based weight loss intervention in adults with obesity: A randomized clinical trial. Regulation of glucose metabolism from a liver-centric perspective. Journal of the American College of Cardiology. Biochem Cell Biol. 2015 Oct;93(5):466-71. N Engl J Med.

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FDA Law Blog

NOVEMBER 8, 2022

By Véronique Li, Senior Medical Device Regulation Expert — At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF).

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