Pharma | PQE Group

Fight against SARS-CoV-2: treatments and prevention. What are the pros and cons of drug therapies?

Fight against SARS-CoV-2: treatments and prevention. What are the pros and cons of drug therapies? by PQE Group’s Infodemic Research Team Topic: Science Researchers: Emanuele Volpe, Project Manager Valeria Famiglini, Consultant Abstract The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has recently emerged as the etiological agent of Coronavirus Disease 2019 (COVID-19), which causes serious […]

Smart Working: dealing with IT support implications

Smart Working: dealing with IT support implications by Dario Palese Current global health emergency situation is forcing the most of companies to maximize the smart working solution: In order to ensure the same performance whether working in the office or in smart working, IT services need to face this new reality. This means to refocus […]

Nitrosamines Risk Evaluation deadline postponed to october 1

Nitrosamines RA evaluation deadline extended to October 1st due to coronavirus spreading

European Medicines Regulatory Network agreed to proceed with the extension of the Step 1 (risk evaluation) deadline to October 1st, 2020, due to Covid-19 spreading.

Medical Cannabis: a fast-expanding market

Medical Cannabis: a fast-expanding market by Emanuele Bertea, Paola Cinquanta, Giampaolo Mazzuca Last year, the Cannabis global market has shown a rapid expansion. Canada was the first country to regulate its Medical Cannabis industry and market – meaning the production and commercialization of the plant and its derivatives – and now Europe is following Canada’s […]

CMDh raising risk awareness on Nitrosamine Impurities

On September 26th, 2019 the CMDh published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products. This includes generics and over-the counter (OTC) products.

FDA temporarily retreating on impurities for market shortage

FDA temporarily raising tolerance on impurities due to market shortage

FDA has issued setting temporary rules on a probable cancer-causing impurity formerly regulated. To avoid market shortage of Losartan, drugmakers will be able to make losartan with an impurity percentage above its prescribed level for six months while the supply of clean drugs is ramped up. A calculated risk, to preserve blood pressure drugs availability […]

Olive oil is a medicine according to FDA

Yes it is! Recently the U.S. Food and Drug Administration (FDA) has determined that there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary heart disease. For this reason FDA decided to exercise […]

EMA 2025 Regulatory Strategy

European Medicines Agency (EMA), has published its draft of ‘Regulatory Science to 2025’ strategy for a six-month public consultation, following the workshop organized last October. This “Reflection Paper” is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy will […]

Chinese e-commerce ready to conquer the health market

With a value of 122.6 billion dollars in 2017, which in 2022 will reach a figure of 145 and 175 billion dollars, the Chinese pharmaceutical market was the second largest in the world, after the US. A huge development that has not gone unnoticed by Alibaba, the Chinese colossus of e-commerce, who last June after […]