2011 Leads Safety 
European Pharmaceutical Review
DECEMBER 14, 2023
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
Pharmaceutical Technology
JUNE 19, 2023
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 Technology
NOVEMBER 14, 2022
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.
European Pharmaceutical Review
JANUARY 29, 2024
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.
European Pharmaceutical Review
JULY 4, 2024
The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).
Healthcare Success
JANUARY 25, 2023
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?
European Pharmaceutical Review
JULY 13, 2023
A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 2011; 117(11): 2993–3001. References Alduaij W, Illidge T. Salvaris R, Ong J, Gregory GP.
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