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NEWS

ADC Therapeutics Reports Enrollment Completion in P-III (LOTIS-5) Study of Zynlonta Plus Rituximab for 2L+ Diffuse Large B-Cell Lymphoma

Shots: The patient enrollment in confirmatory P-III (LOTIS-5) study assessing Zynlonta + rituximab for treating 2L+ r/r DLBCL has been completed. Zynlonta was previously approved in 2021 under accelerated pathway for the same The study aims to convert accelerated approval & support label expansion to 2L+ with rituximab. Part 1 enrolled 20 patients for…
January 1, 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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Pharmaceutical Automation and Digitalisation Congress - AUTOMA 2024
EVENTS

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…
September 23, 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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INSIGHTS+

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…
June 12, 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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