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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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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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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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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. In subsequent years, up to 2022, half this number or less were issued.

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Digital health tech: a solution to substance use disorders?

Pharmaceutical Technology

Healthcare providers are under pressure to address the growing issue of substance use disorders. A recent study in the Journal of the American Medical Association found that between 2015 and 2019 as high as one in eight deaths in the US could be attributable to excessive alcohol consumption.

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Advamedica Inc announces FDA clearance for Ax-Surgi Surgical Hemostat

Legacy MEDSearch

a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. As the healthcare costs continue to rise, surgeons are looking for effective measures to reduce the duration of surgeries. Advamedica Inc., Advamedica Inc.

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Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for Limiflex™ Dynamic Sagittal Tether™

Legacy MEDSearch

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The concept was developed to meet healthcare systems’ increasing demands for improved long-term outcomes with a lower cost of care. Empirical Spine, Inc., “But attempts up to now have fallen short.

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