Olivier Harari, VP, Early Clinical Development at Regeneron Shares his Views on Pozelimab’s BLA Acceptance for the US FDA Priority Review

Shots: Olivier highlighted the P-II/III data based on which Regeneron’s BLA for Pozelimab was accepted by the US FDA under priority review to treat adults and children with CHAPLE disease CHAPLE disease is driven by an overactivation of the complement system due to CD55 deficiency. Pozelimab blocks the activity of complement factor C5 and prevents…

BySenior EditorJuly 17, 2023

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Insights+: EMA Marketing Authorization of New Drugs in March 2023

Shots: The EMA approved 4 New Chemical Entity (NCE) and 5 Biologic Drugs in March 2023, leading to treatments for patients and advances in the healthcare industry In March 2023, the major highlights drugs were Reblozyl’s Approval for anemia in adult patients with non-transfusion-dependent beta thalassemia, Pombiliti for late-onset pompe disease PharmaShots has compiled a…

BySenior EditorApril 27, 2023

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Top Performing Drug – Dupixent (April Edition)

Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have selected Dupixent and prepared a curated analysis report for our readers Dupixent is an interleukin-4 receptor alpha antagonist used for the treatment of multiple indications including atopic dermatitis, asthma, eosinophilic esophagitis, etc. PharmaShots…

BySenior EditorApril 26, 2023

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Insights+: The US FDA New Drug Approvals in March 2023

Shots: The US FDA approved 6 NDAs and 1 BLA in March 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 26 novel products in 2023 In March 2023, the major highlights drugs were, Tafinlar + Mekinist approval for BRAF V600E low-grade glioma, Zynyz for metastatic or…

BySenior EditorApril 19, 2023

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Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots: The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome PharmaShots has compiled…

BySenior EditorMarch 23, 2023

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Insights+: The US FDA New Drug Approvals in February 2023

Shots: The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023 In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia A PharmaShots has compiled…

BySenior EditorMarch 15, 2023

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Insights+: EMA Marketing Authorization of New Drugs in January 2023

Shots: The EMA approved 3 New Chemical Entity (NCE) and 5 Biologic Drugs in January 2023, leading to treatments for patients and advances in the healthcare industry In January 2023, the major highlights drugs were Xofluza’s Approval for influenza, Dupixent for eosinophilic esophagitis PharmaShots has compiled a list of a total of 8 new drugs…

BySenior EditorFebruary 23, 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

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Insights+: EMA Marketing Authorization of New Drugs in December 2022

Shots: The EMA approved 6 New Chemical Entity (NCE) and 6 Biologic Drugs in December 2022, leading to treatments for patients and advances in the healthcare industry In December 2022, the major highlights drugs were Pluvicto’s approval for progressive PSMA+ metastatic castration resistant prostate cancer, Dupixent for Prurigo Nodularis PharmaShots has compiled a list of…

BySenior EditorJanuary 24, 2023

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Insights+: EMA Marketing Authorization of New Drugs in November 2022

Shots: The EMA approved 4 New Chemical Entity (NCE) and 4 Biologic Drugs in November 2022, leading to treatments for patients and advances in the healthcare industry In November 2022, the major highlights drugs were Skyrizi's approval for active crohn's disease, Beyfortus for RSV lower respiratory tract disease PharmaShots has compiled a list of a…

BySenior EditorDecember 28, 2022

Olivier Harari, VP, Early Clinical Development at Regeneron Shares his Views on Pozelimab’s BLA Acceptance for the US FDA Priority Review

Insights+: EMA Marketing Authorization of New Drugs in March 2023

Top Performing Drug – Dupixent (April Edition)

Insights+: The US FDA New Drug Approvals in March 2023

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Insights+: The US FDA New Drug Approvals in February 2023

Insights+: EMA Marketing Authorization of New Drugs in January 2023

Disease of the Month: Age-Related Macular Degeneration

Insights+: EMA Marketing Authorization of New Drugs in December 2022

Insights+: EMA Marketing Authorization of New Drugs in November 2022

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