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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

Myelofibrosis is a rare bone marrow cancer that causes the dysfunctional production of blood cells, leading to extensive bone marrow scarring, causing severe anaemia. Novartis and Incyte Corp’s Jakafi was the first FDA-approved drug for the treatment of myelofibrosis in November 2011. people per every 100,000 individuals in the US.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. 16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. However, there were some notable differences.

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Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics. About Hip Innovation Technology, LLC.

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure.

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Why Are Patients So Angry? Plus, Frontliner Tips for Health Leaders

Healthcare Success

The rate of injuries from violent attacks against medical professionals grew by 63% from 2011 to 2018. Porath also found that technology overuse leads to increased exposure to negativity and misinformation. To be clear, workplace violence experienced by healthcare workers predates the pandemic. Why are people so angry and rude?

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UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Legacy MEDSearch

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. SUI significantly impacts quality of life, as it can be debilitating, and often leads to depression, low self-esteem and social stigma. Food and Drug Administration).