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Indian pharma sees immense importance in US FDA guidance on aluminum content and labelling in parenteral nutrition

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharma sees immense value in US FDA’s insistence for aluminum content and labelling recommendations for the Small Volume Parenterals Drug Products and Pharmacy Bulk Packages. Pharma companies in the country have increasingly made a shift to nutritional based prescription and over the counter products.

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Warning of counterfeit ivermectin tablets sold via social media

Sciensano

In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day. It is also being promoted as a low-cost medicine via social media, but there is no clinical evidence to confirm that ivermectin is an effective treatment of COVID -19.

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MindMed Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

The Pharma Data

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

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RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

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FluMist Nasal Flu Vaccine Gets FDA Consideration for Self-Administration

XTalks

XTALKS WEBINAR: Accelerating Vaccines to Clinical Trials — A Toolkit for Efficacy, Safety and Bioanalytical Studies Live and On-Demand: Wednesday, November 15, 2023, at 11am EST (4pm GMT/UK) Register for this free webinar to gain insights into the challenges and innovations in mRNA vaccines in clinical trials.

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Are microtaggants the key to making medicines smarter?

pharmaphorum

This technology can also play an important role in supporting virtual clinical trials. The threat of illegal online pharmacies. Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain.

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,