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Exclusive_Chris Heery_2024
EXCLUSIVE

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

Shots:  Arcellx’s Anito-cel, a BCMA CAR-T therapy recently got the FTD, ODD, RMAT designations by the FDA for the treatment of patients with relapsed or refractory multiple myeloma (r/rMM)  Today, at PharmaShots we have Chris Heery, Chief Medical Officer at Arcellx, shedding light on Anito-Cel therapy in advancing care for multiple myeloma  In late 2022,…
September 30, 2024

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New Drug Designations - April 2024
INSIGHTS+

New Drug Designations – April 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices   Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…
May 30, 2024

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New Drug Designations - March 2024
INSIGHTS+

New Drug Designations – March 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices    Trellis Bioscience's…
April 30, 2024

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VIEWPOINTS_Simon Portsmouth_2023
VIEWPOINTS

Simon Portsmouth Shares Insights from P-III Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Shots: Simon spoke about the enrollment of the first participant in Japan in the P-III (SCORPIO-PEP) study to evaluate the safety and efficacy of Ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection He mentioned how this study will supplement data from the pivotal SCORPIO-SR trial's P-III segment which showed ensitrelvir's effectiveness in treating mild-to-moderate COVID-19…
September 18, 2023

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New Drug Designations - August 2023
INSIGHTS+

New Drug Designations – August 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices  Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…
September 18, 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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New Drug Designations - June 2023
INSIGHTS+

New Drug Designations – June 2023

Shots:  PharmaShots' designation report provides a condensed overview of several drugs and their designations by the US FDA, the EU, China, and the UK. This month’s report includes 7 biological drugs, 13 small molecules and 9 cell and gene therapies  CellCentric’s Inobrodib, for multiple myeloma and Rocket Pharmaceuticals’ RP-A601, for PKP2-arrhythmogenic cardiomyopathy were the two…
July 17, 2023

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ThoughtSpot_Senior Editor
THOUGHTSPOT

ILAP and its nuance vs PRIME since BREXIT

Introduction PRIME (PRIority MEdicines) EMA launched PRIME on March 07, 2016, to support the development of medicines targeting unmet medical needs. The scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients faster. PRIME builds on the…
September 13, 2022

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