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Biosimilar competition saves US healthcare $21 billion

European Pharmaceutical Review

Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. In Q2, savings in drug spend due to biosimilar availability is estimated to be a substantial $3.2

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Novel haemophilia B gene therapy approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

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ESG Top Trends: Technology trends

Pharmaceutical Technology

Listed below are the key technology trends impacting the ESG performance in the healthcare sector, as identified by GlobalData. AI also speeds up the drug development process, which could translate into cheaper drugs for patients. 3D bioprinting offers an alternative to animal testing in drug development. 3D printing.

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Realising milestones with gene therapy for SMA

European Pharmaceutical Review

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. percent of Europe’s annual healthcare spend. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach. Stakeholder education is critical to achieving this.

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FDA raises alarm about weight-gain supplement apetamin

Pharmaceutical Technology

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).

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The potential of tryptamines in treatment-resistant depression

European Pharmaceutical Review

Psilocybin therapy in mental healthcare. Mental healthcare should promote optimal quality of life through preventing, treating and managing mental health illnesses, such as depression, with the aim of facilitating sustained recovery. The introduction of psilocybin therapy could provide a potential step-change in mental healthcare.

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The US federal drug GMP regulations that first became official in 1977 and their European counterparts will need to be re-interpreted for this new generation of products.