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Refillable Device for Drug Delivery Past the Blood-Brain Barrier: Interview with Mike Maglin, CEO at CraniUS

Medgadget

This layer of specialized endothelium significantly restricts which drug molecules can enter the brain, normally greatly limiting treatment options for patients with brain-based disease. In addition, it isn’t sustainable to have patients in-hospital for months at a time seeking this type of treatment.

Medicine 106
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How one pharma “family business” places patients first

pharmaphorum

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

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Develop and execute a winning drug launch strategy with an experienced contract packager

Pharmaceutical Technology

With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business. Navigating the complexities of pharma and biotech packaging services can be difficult.

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Shear-Thinning Biomaterial for Embolic Applications: Interview with Upma Sharma, President and CEO of Arsenal Medical

Medgadget

The market’s current leading liquid embolic contains a solvent, dimethyl sulfoxide (DMSO), which can cause pain upon injection, necessitating the use of anesthesia and special compatible catheters. Medgadget: Does the material require a specialized delivery device? How is it delivered, and how do you prevent device blockage?

Medical 69
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Advancement through adversity: how Covid-driven innovations are becoming best practices for pharmacovigilance

Pharmaceutical Technology

Before drugs are authorised, evidence of their safety and efficacy is limited to results from clinical trials, so it is essential that pharmacovigilance continues after a therapy has been approved. After AEs are recorded, they must be translated and put back out to doctors and scientists for processing.

Safety 52
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FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.

Legacy MEDSearch

The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with the potential to enhance diagnostic accuracy for patients with cardiovascular diseases and heart conditions. iTFlow® is an innovative software solution developed by Cardio Flow Design Inc.

FDA 52
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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.