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FDA Authorizes Pfizer COVID-19 Vaccine for Children 5 to 11 + Genentech’s Ocular Implant for Macular Degeneration – Xtalks Life Science Podcast Ep. 35

XTalks

The authorization was based on trial data that showed the vaccine was safe, well-tolerated and induced robust immune responses among children in this age group; side effects were generally mild to moderate. Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game Changer.

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Nemolizumab Approved for Adults with Prurigo Nodularis

XTalks

The US Food and Drug Administration (FDA) has approved Galderma’s monoclonal antibody Nemluvio (nemolizumab) for the treatment of adult patients with the chronic skin condition prurigo nodularis. A significant percentage of patients also reported reduced sleep disturbances by Week 16 in both clinical trials.

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Meeting global demand for patient independence: SHL Medical expands production in Charleston, US

Pharmaceutical Technology

SHL Medical is a world-leading solutions provider for advanced drug delivery systems with a unified purpose to further enable patient independence. As it establishes these new operations, SHL Medical will be welcomed into a growing community of life sciences companies expanding in and around Charleston.

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FDA Approves AbbVie’s Vuity as the First Eyedrop for Presbyopia

XTalks

Related: Genentech’s New Ocular Implant Drug Delivery System for Macular Degeneration Could Be a Game Changer. In May, New York biotech Eyenovia announced positive trial results for its drug-device combo called MicroLine for the treatment of presbyopia. Vuity is available by prescription.

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Vornov, the use of intrathecal delivery in drug development is unexplored for small molecules and peptides besides what has already been proved.

Trials 83
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PCI Pharma Services Invests Over $365 Million in EU, US Facilities to Drive Clinical and Commercial Supply of Advanced Drug Delivery and Drug Device Combination Products

XTalks

This initiative focuses on enhancing infrastructure to support the clinical and commercial-scale final assembly and packaging of drug-device combination products, emphasizing advanced drug delivery systems, particularly injectable formats. For more information, visit pci.com.

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Skin Cancer Awareness Month 2024 and Insights from Medicus Pharma

XTalks

For healthcare and life sciences industries, Skin Cancer Awareness Month helps highlight the importance of preventive measures and early detection. is a biotech and life sciences company dedicated to advancing the clinical development of innovative and groundbreaking therapeutic assets.