Top Performing Drug – Enbrel (June Edition)

Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have covered Enbrel as the top-performing drug of the month Enbrel is a biologic drug classified as a TNF inhibitor used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other autoimmune diseases PharmaShots…

BySenior EditorJune 28, 2023

VIEWPOINTS

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

Shots : Dr. Mourad talked about the positive P-III data showing results for BIIB800, a Tocilizumab biosimilar candidate presented at the Annual European Congress of Rheumatology (EULAR 2022) He also spoke about the results of the 48-week analysis of the PROPER trial evaluating adalimumab biosimilar, Imraldi, in patients with autoimmune diseases The interview highlights Biogen's…

BySenior EditorJune 27, 2023

THOUGHTSPOT

FDA Launches a Pilot Program to Regulate the Safety Standards Associated with In vitro Diagnostic Tests to Identify Cancer Biomarkers

In a landmark decision, FDA on June 20th, 2023 launched a new pilot program to mitigate the risks involved with certain Laboratory Developed Tests (LDTs) used to develop certain oncology products. It is an important initiative by FDA to address the safety standards associated with unregulated or poorly performing in vitro diagnostic tests. With an…

BySaurabh ChaubeyJune 22, 2023

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Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

Shots: Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanoma She also spoke on the epidemiology of melanoma and…

BySenior EditorMay 16, 2023

INSIGHTS+

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

THOUGHTSPOT

4 Steps To Ensure Clinical Trial Compliance

When performing research studies, clinical trial compliance plays a vital part in ensuring the safety and effectiveness of the research. It means adhering to ethical and regulatory requirements established by governing bodies that guarantee the well-being of study participants and the legitimacy of study results. Sponsors, investigators, and study sites could face considerable legal and…

ByAdrian WallaceApril 26, 2023

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Paul K Owens, VP of Global Brand Development, Insulins & Glucagon at Eli Lilly & Company Shares Insights from the US FDA Approval of Lyumjev

Shots: Paul talked about the approval of the Lyumjev Injection for the improvement of glycemic control in children and adolescents with diabetes. He also shared various details about Lyumjev Paul further discussed the study design and the key findings from the registrational PRONTO-Peds study The interview also talks about Lilly’s Diabetes Solution Center which helps eligible…

BySenior EditorApril 20, 2023

VIEWPOINTS

Scott Stout, CEO of MedVector his Views on the Misunderstood FDA’s Guidance on DCTs at 2023 J.P. Morgan Healthcare Conferences

Shots: Scott gave a brief about the MedVector and shared his personal experience from his treatment of arthritis by participating in the clinical trial He also elaborated on how MedVector clarified the misunderstanding on FDA’s guidance on DCTs by the clinical research industry at the 41st Annual J.P. Morgan Health Care Conference 2023 The interview…

BySenior EditorMarch 30, 2023

INSIGHTS+

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

VIEWPOINTS

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

Shots: Volker spoke about the granting of marketing authorization by EC to treat adults with active lupus nephritis.The approval was based on the results of the P-III AURORA study Volker also talked about the collaboration between Aurinia and Otsuka Pharmaceutical for the development and commercialization of LUPKYNIS The interview gives an understanding of how Aurinia…

BySenior EditorDecember 7, 2022

Top Performing Drug – Enbrel (June Edition)

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

FDA Launches a Pilot Program to Regulate the Safety Standards Associated with In vitro Diagnostic Tests to Identify Cancer Biomarkers

Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

Top Performing Drug – Dupixent (April Edition)

4 Steps To Ensure Clinical Trial Compliance

Paul K Owens, VP of Global Brand Development, Insulins & Glucagon at Eli Lilly & Company Shares Insights from the US FDA Approval of Lyumjev

Scott Stout, CEO of MedVector his Views on the Misunderstood FDA’s Guidance on DCTs at 2023 J.P. Morgan Healthcare Conferences

Disease of the Month: AIDS

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

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