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Insights+ EMA Marketing Authorization of New Drugs in September 2022

Insights+: EMA Marketing Authorization of New Drugs in September 2022

The EMA approved 7 New Chemical Entity (NCE) and 4 Biologic Drugs in Sept 2022, leading to treatments for patients and advances in the healthcare industry In September 2022, the major highlights drugs were Imcivree approval for bardet-biedl syndrome, Opdualag for unresectable or metastatic melanoma, Ultomiris for generalised myasthenia gravis PharmaShots has compiled a list…

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Viewpoints_Garret Hampton

Garret Hampton, President, Clinical Sequencing & Oncology at Thermo Fisher Scientific Shares Insights from the Approval of the First NGS-Based Companion Diagnostic for HER2-Mutant NSCLC

Shots: Garret spoke about the approval of the first NGS-based companion diagnostic to aid in selecting NSCLC patients with HER2  activating mutations for treatment with ENHERTU Garret also talked about the Oncomine Dx Target Test and its availability for different targeted therapies in multiple geographies The interview highlights how Thermo Fisher is working to develop accessible CDx solutions…

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Viewpoints_Josh Rubel

Josh Rubel, CCO at MDClone, Shares Insights on the Partnership with MCI Onehealth to Accelerate Research through Global Clinical Intelligence Offering

Shots: Josh spoke about the collaboration with MCI Onehealth. The collaboration will provide access to high-value data insights as a service for an array of research, clinical, and data science needs Josh also talked about MDClone’s ADAMS platform which has a unique ability to convert datasets and cohorts of interest into synthetic files that are…

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Disease of the Month: Cerebral Palsy

Disease of the Month: Cerebral Palsy

INTRODUCTION Cerebral Palsy is a group of neurological disorders which affect motor and developmental skills. It causes disability in muscle tone, movement, balance, and posture. It is the most common motor disability in childhood with an estimated prevalence ranging from 1-4 per 1,000 live births. The incidence of CP is more in preterm or low…

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Viewpoints_Jonathan Wall

Jonathan Wall, Co-founder & Interim CSO at Attralus Share Insights from its New Data Presented across its Amyloidosis Portfolio at the 2022 International Symposium on Amyloidosis

Shots: Jonathan spoke about the data presented by Attralus at the XVIII International Symposium on Amyloidosis (ISA) as both oral and poster presentations Jonathan also talked about its lead candidate, AT-01. He discussed the study design of the P-I/II clinical trial evaluating AT-01 The interview highlights Attralus vision to develop innovative medicines to improve the…

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Viewpoints_Michael Scheffler

Michael Scheffler, Vice President, Head of Life Science PCR at QIAGEN Shares Insights on the Addition of New Biopharma Products to its Digital PCR Portfolio

Shots: Michael spoke about the addition of new biopharma products through QIAcuity series of digital PCR (dPCR) instruments to its digital PCR portfolio He also talked about how QIAGEN’s dPCR assays are quicker than systems as it was launched in four different master mixes allowing experiments leading to precise results The interview gives an understanding of…

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Viewpoints_Alex Zimmerman_Alexander Lin

Alex Zimmerman and Alexander Lin Share Insights on the FDA Breakthrough Device Designation Received for Non-Invasive Virtual Biopsy Technology

Shots: Alex Zimmerman talked about virtual biopsy technology using standard MRI scanners. The technology will allow doctors to understand brain imaging via chemical indicators more extensively Alexander Lin spoke about the data on which the BDD was granted by the FDA and the usage of Magnetic Resonance Spectroscopy (MRS) by this software BrainSpec is a…

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