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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

European Pharmaceutical Review

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

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Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain

Legacy MEDSearch

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.