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How Can You Manage the Complexity of Early Phase Clinical Development?

XTalks

Today, there’s been a shift towards more complex, large molecules or biologics like monoclonal antibodies, antibody-drug conjugates (ADCs) and advanced therapies like RNA-based treatments and cell and gene therapies. In the past, the majority of drugs evaluated in the clinical pharmacology space were small molecules.

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

XTalks

Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies. Ancillary services are also needed, such as a pharmacy to store, prepare and deliver the IP and labs such as a CSF lab to prepare samples.”. All facilities (such as lab, pharmacy, MRI, etc.)

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U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

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COVID-19 Pandemic Coverage

XTalks

The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. That said, the percentage of all COVID-19 deaths that occurred in nursing homes, standing at 81 percent, is the highest in the world followed by Spain at 66 percent.