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New Drug Designations - September 2023
INSIGHTS+

New Drug Designations – September 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, and China. This month’s report includes 10 biological drugs, 15 small molecules, 5 cell and gene therapies, 4 devices, 1 vaccine and 1 microbiota  MicuRx’ Contezolid and Contezolid acefosamil, focused on the treatment of Diabetic…
October 16, 2023

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Thoughtspot_Saurabh_Chaubey
THOUGHTSPOT

Health Equity: A Pressing Need

Shots:  With half of the World's population devoid of primary healthcare facilities, health equity is indeed an indispensable need of the present. With health equity instated, potentially everyone can attain the highest level of health. It means no more deaths from vaccine-preventable diseases, and a healthy equilibrium in the physical, mental, and social aspects of…
October 10, 2023

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VIEWPOINTS_Samantha Kerr_2023
VIEWPOINTS

Samantha Kerr shares insights from the topline data of Xeomin P-III studies and pivotal study evaluating Belotero Balance (+)

Shots: Samantha Kerr, Chief Scientific Officer, Merz Aesthetics shares insights from the topline data of Xeomin P-III studies and pivotal study evaluating Belotero Balance (+) Samantha says, for Belotero Balance (+), Merz Aesthetics has already submitted the data as a supplemental Premarket Approval Application (sPMA) with the FDA and plans to submit the data as…
October 5, 2023

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VIEWPOINTS_Dr. Christopher Piorkowski_2023
VIEWPOINTS

Dr. Christopher Piorkowski Shares His Views on the US FDA Approval of TactiFlex Ablation Catheter to Treat Abnormal Heart Rhythm

Shots: Christopher started by highlighting the working of the TactiFlex Ablation Catheter and how it can be used for the treatment of patients with Atrial Fibrillation He also talked about the study design and the key findings from the TactiFlex AF IDE trial. He later gave a comparative view of the TactiFlex catheter vs. conventional…
September 11, 2023

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New Drug Designations - July 2023
INSIGHTS+

New Drug Designations – July 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test  MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…
August 21, 2023

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