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New Drug Designations: July 2025
INSIGHTS+

New Drug Designations: July 2025

Shots:       PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.    The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…
August 26, 2025

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NEWS

Skyhawk Therapeutics Enters a ~$2B Deal with Merck KGaA to Identify RNA-Targeting Small Molecules for Neurological Disorders

Shots: Skyhawk Therapeutics has entered into a strategic research collaboration with Merck KGaA to discover novel RNA-targeting small molecules for neurological diseases with limited treatment options Skyhawk will receive ~$2B incl. upfront, milestones, & potential tiered royalties, leading discovery & preclinical development, while Merck KGaA gains exclusive global rights & handles further development & commercialization upon…
August 19, 2025

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NEWS

XtalPi and Pfizer Expand Partnership to Advance AI-Driven Drug Discovery and Materials Simulation

XtalPi has expanded its collaboration with Pfizer to develop an advanced AI-powered molecular modeling platform, aiming to improve the speed and accuracy of small-molecule drug discovery by combining physics-based methods with scalable AI tools Under the expansion, XtalPi and Pfizer will develop predictive models tailored to Pfizer’s chemical space, enhancing small-molecule drug discovery. XtalPi will…
June 30, 2025

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NEWS

Deep Apple Therapeutics Enters a Research Collaboration and Licensing Deal with Novo Nordisk to Advance Oral Small Molecules

Shots: Deep Apple & Novo have partnered to discover, develop, & commercialize oral small molecules targeting novel non-incretin GPCRs for cardiometabolic diseases, incl. obesity, using Deep Apple’s drug discovery tech Novo will gain exclusive global rights to develop, manufacture, & commercialize assets discovered & optimized by Deep Apple for ~$812M in upfront, research costs, &…
June 12, 2025

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Novo Nordisk and Septerna
NEWS

Novo Nordisk Enters a ~$2.2B Deal with Septerna to Develop Oral Small Molecules for Cardiometabolic Diseases

Shots: Septerna & Novo Nordisk to identify, develop & market oral small molecules for obesity, T2D & other cardiometabolic diseases under an exclusive global collaboration & license agreement As per the deal, Septerna will receive ~$2.2B, incl. over $200M in upfront & near-term milestones, plus research, development, & commercial milestones, along with net sales-based tiered…
May 15, 2025

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New Drug Designations - August 2024
INSIGHTS+

New Drug Designations – August 2024 

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. August month’s report includes designations allotted to 10 small molecules, 9 biologics, 7 cell & gene therapies, 1 vaccine, 2 radiopharmaceutical, 1 peptide, 1 antineoplastic and 2 devices   In August 2024, Invenra’s INV724 received the…
September 25, 2024

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New Drug Designations - July 2024
INSIGHTS+

New Drug Designations – July 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 16 small molecules, 5 biologics, 11 cell & gene therapies, 1 recombinant protein, 1 vaccine, 1 immunotherapy, 1 radiopharmaceutical, 1 antisense oligonucleotide, 3 RNA therapies 1 herbal medicine…
August 27, 2024

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New Drug Designations - June 2024
INSIGHTS+

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 &…
July 30, 2024

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New Drug Designations - May 2024
INSIGHTS+

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…
June 25, 2024

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VIEWPOINTS_Jeffrey Lengyel_2024
VIEWPOINTS

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…
May 22, 2024

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