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Boehringer Will Test How Pradaxa Stacks Up To The Competition In Real-World Study

 
• By Emily Hayes

Global observational study is assessing real-world experience with Pradaxa and other anticoagulants in patients with newly diagnosed atrial fibrillation who are at risk of stroke. Results are due in 2020.

Boehringer Ingelheim GMBH is gearing up to collect real-world, comparative data pitting its anticoagulant Pradaxa (dabigatran) against other treatments for stroke prevention in atrial fibrillation, including Johnson & Johnson/Bayer AG’s competing Xarelto (rivaroxaban) and long-time standard of care warfarin, in a massive global trial.

Boehringer’s GLORIA-AF registry program will look at long-term use of antithrombotic treatments for reducing risk of stroke in 56,000 patients newly diagnosed with non-valvular atrial fibrillation, the company announced May...

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
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ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
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The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

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Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
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Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.