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New Drug Designations - June 2024

New Drug Designations – June 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 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices   This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…

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New Drug Designations - May 2024

New Drug Designations – May 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 12 small molecules, 7 biologics, 9 cell & gene therapies, 1 vaccine, 1 peptide, 1 RNA candidate, 1 recombinant fusion protein, 1 imaging agent and 6 devices  This…

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VIEWPOINTS_Jeffrey Lengyel_2024

Increasing Accessibility: Jeffrey Lengyel from Thermo Fisher Scientific, in an Enlightening Conversation with PharmaShots

Shots:   Advances in Cryo-EM help better understand biological molecules and complexes at atomic resolution. Thermo Fisher Scientific’s recently launched Glacios 2 Cryo-TEM with E-CFEG offers promising potential in reducing the workflow complexities with automation  Today, we have Jeffrey Lengyel Director of Life Sciences, Cryo-EM, at Thermo Fisher Scientific shedding light on Glacios 2 Cryo-TEM with E-CFEG  Jeffrey highlights the significance of the…

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New Drug Designations - February 2024

New Drug Designations – February 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, and EC. This month’s report includes designations allotted to 13 small molecules, 20 biologics, and 2 devices  SN Bioscience’s SNB-101 received ODD from the US FDA for the treatment of pancreatic cancer based on preclinical results. It…

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New Drug Designations - January 2024

New Drug Designations – January 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 13 small molecules, 7 devices, 3 biologics ADC, 3 gene therapy, 1 antineoplastics, 1 protein, 1 peptide, 1 recombinant enzyme & 1 vaccine   NRx Pharmaceuticals’ NRX-101 small molecule, focused…

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Know Your Investor (January Edition): RA Capital Management LLC  

Know Your Investor (January Edition): RA Capital Management LLC  

Shots:   New Year, New Us! Our hand-curated “Know Your Investor” reports will now be exploring leading investors of 2023   Founded in 2002, RA Capital forged ahead to become a key investor in life science and healthcare companies. In 2023, RA Capital closed 40 major investments in biopharma companies, devices, manufacturing, service offering firms, and diagnostics  …

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New Drug Designations - September 2023

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…

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New Drug Designations - July 2023

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…

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