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VIEWPOINTS_Olivier Harari_2023
VIEWPOINTS

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…
July 17, 2023

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VIEWPOINTS_Dr. Mourad Farouk Rezk_2023
VIEWPOINTS

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on BLA Acceptance for BIIB800

Shots: Dr. Mourad spoke about the acceptance of aBLA for BIIB800, a Tocilizumab biosimilar candidate for several autoimmune diseases, including rheumatoid arthritis He briefed about the study design and results from the P-III trial which supported the BLA filing This interview focuses on Biogen's notable progress in addressing challenging immunologic conditions, offering potential solutions to…
July 10, 2023

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Top Performing Drug – Enbrel (June Edition)
INSIGHTS+

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…
June 28, 2023

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VIEWPOINTS_Dr. Mourad Farouk Rezk1_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…
June 27, 2023

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Thoughtspot_Saurabh_Chaubey
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…
June 22, 2023

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VIEWPOINTS_Gina Fusaro_2023
VIEWPOINTS

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…
May 16, 2023

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Top Performing Drug – Dupixent (April Edition)
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…
April 26, 2023

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thoughtspot_Adrian Wallace
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…
April 26, 2023

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VIEWPOINTS_Paul K Owens_2023
VIEWPOINTS

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…
April 20, 2023

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VIEWPOINTS_Scott Stout_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…
March 30, 2023

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