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New Drug Designations - August 2024

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…

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Pharmaceutical Automation and Digitalisation Congress - AUTOMA 2024

Pharmaceutical Automation and Digitalisation Congress – AUTOMA+ 2024

Pharmaceutical Automation and Digitalisation Congress (AUTOMA+ 2024 | Zurich, Switzerland, 18-19 November) is an annual event where attendees showcase their case studies and connect with industry experts, all with the goal of promoting effective digital transformation. The closed-door format of the Congress ensures that only decision-makers and key specialists are going to be there.  AUTOMA+ 2024…

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New Drug Designations - July 2024

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…

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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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PharmaShots' Key Highlights of Second Quarter 2024

PharmaShots’ Key Highlights of Second Quarter 2024

Shots: The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…

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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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Disease of the Month – Fabry Disease

Shots:  Fabry disease is a rare inherited neurological disorder that affects the body's ability to break down lipids into smaller components  In this reprise of our Disease of the Month report, we bring an illuminating account of Fabry Disease with deep dive analysis of epidemiology, market size, disease management, available therapies, patient advocacy groups, and…

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New Drug Designations - April 2024

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…

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New Drug Designations - March 2024

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…

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