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…

BySenior EditorApril 30, 2024

INSIGHTS+

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…

BySenior EditorOctober 16, 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…

BySenior EditorSeptember 18, 2023

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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…

BySenior EditorAugust 21, 2023

THOUGHTSPOT

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

Shots: With the healthcare sector moving ahead with its technological advances, there is still an unexplored section in therapeutics that requires much more attention. Through innovations, life science companies have evolved to make breakthrough discoveries in many focus areas, but when it comes to the rare disease segment, all our endeavors seem to be bleak…

BySaurabh ChaubeyMarch 14, 2023

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Disease of the Month: Age-Related Macular Degeneration

Introduction: AMD, an eye disease that can cause of loss of eyesight/blur vision mostly in people ≥50 years of age and it is the leading cause of visual impairment worldwide. It occurs when the part of the retina (macula) is damaged. Patients lose their central vision and cannot see fine details The three stages of…

BySenior EditorFebruary 9, 2023

INSIGHTS+

Top Performing Drug of 2021 – Opdivo (December Edition)

Active Ingredient: Nivolumab Strength: 40 mg/4 mL, 100 mg/10 mL, & 240 mg/24 mL solution in a single-dose vial Dosage Form: Injection Mechanism of Action: Programmed cell death-1 receptor antagonists (PD-1) First Approval: US (22 Dec 2014), EU (19 Jun 2015)  Revenue Analysis of Opdivo BMS’ Opdivo gives tough competition to other drugs in the…

BySenior EditorDecember 22, 2022

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Disease of the Month: AIDS

“Putting Ourselves to the Test: Achieving Equity to End HIV” -Theme of the year 2022 Introduction: HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system. HIV, a type of retrovirus that isn't…

BySenior EditorDecember 20, 2022

INSIGHTS+

Top Performing Drug of 2021 – Biktarvy (October Edition)

Active Ingredient: bictegravir, emtricitabine, and tenofovir alafenamide Strength: 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF/ 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF Dosage Form: Tablet Mechanism of Action: HIV reverse transcriptase inhibitors First Approval: US (07 Feb 2018), EU (25 Jun 2018) Revenue1 Gilead's HIV drug, Biktarvy has…

BySenior EditorOctober 27, 2022

INSIGHTS+

Top Performing Drug of 2021 – Eylea (September Edition)

Active Ingredient: Aflibercept Strength: 2 mg (0.05 mL) Dosage Form: Injection (intravitreal) Mechanism of Action: VEGF-A and PlGF inhibitors First Approval: US (18 Nov 2011), EU (27 Nov 2012) Revenue1 EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in…

BySenior EditorSeptember 22, 2022

New Drug Designations – March 2024

New Drug Designations – September 2023

New Drug Designations – August 2023

New Drug Designations – July 2023

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

Disease of the Month: Age-Related Macular Degeneration

Top Performing Drug of 2021 – Opdivo (December Edition)

Disease of the Month: AIDS

Top Performing Drug of 2021 – Biktarvy (October Edition)

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