ACRP blog

APRIL 30, 2023

Achieving a clinical research environment that is more diverse, equitable, and inclusive relies on all stakeholders deliberately moving from intention to action, attendees of the ACRP 2023 conference in Dallas, Texas, were told on Sunday morning (April 30). During a panel discussion moderated by Audrey Cavenecia, Chief Experience Officer for Reveles Clinical Services, thought leaders in the realm of increasing representation of persons of all types among both the members of the clinical research

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Clinical Research Research Medicine 98

Drug Patent Watch

APRIL 30, 2023

Annual Drug Patent Expirations for AGGRASTAT Aggrastat is a drug marketed by Medicure and is included in two NDAs. It is available from one supplier. There is one patent protecting… The post New patent expiration for Medicure drug AGGRASTAT appeared first on DrugPatentWatch - Make Better Decisions.

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Medical Xpress

APRIL 30, 2023

Researchers have found the "Eat, Sleep, Console" (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial.

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JAMA Internal Medicine

APRIL 30, 2023

This randomized clinical trial assesses the effect of Xuebijing injection vs placebo on 28-day mortality among patients with sepsis.

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Cloudbyz

APRIL 30, 2023

Clinical trials are complex and time-consuming endeavors, requiring efficient management and coordination between various stakeholders. Cloudbyz’s Unified Clinical Trial Management Solution, built on the Salesforce platform, offers a comprehensive, customizable, and secure platform for streamlining clinical trial operations. In this blog post, we will explore the unique value propositions of Cloudbyz’s solution that sets it apart in the clinical trial management software market, alon

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JAMA Internal Medicine

APRIL 30, 2023

This randomized clinical trial evaluates the effects of a transitional care intervention targeting higher-risk medical patients using a composite outcome of 30-day unplanned readmission or death.

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Clinical Trials Clinical Trials Trials 76

FDA Law Blog

APRIL 30, 2023

By Kurt R. Karst & Michael D. Shumsky — On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights i

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Drug Patent Watch

APRIL 30, 2023

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Romania. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating… The post Which pharmaceutical companies have the most SPCs in Romania? appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Trial Podcast

APRIL 30, 2023

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials. Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth. Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient ur

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