Skip to content Skip to footer
Subscribe Now
VIEWPOINTS_Boaz Hirshberg_2023
VIEWPOINTS

Boaz Hirshberg, SVP, Clinical Development at Regeneron Shares Insights from the US FDA Approval of Evkeeza (evinacumab-dgnb)

Shots: Boaz spoke about the US FDA approval of Evkeeza (evinacumab-dgnb) to treat children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH) Boaz also talked about the study design of the pivotal pediatric trial evaluating Evkeeza(evinacumab-dgnb) . He then extended his talk on HoFH and how Regeneron is creating awareness about the disease The…
July 31, 2023

Read more

VIEWPOINTS_Kathleen Somera-Molina1_2023
VIEWPOINTS

Kathleen Somera-Molina, Head of SMA Global Medical Affairs at Biogen Shares Insights on New Data Published about SPINRAZA

Shots: Kathleen spoke about the results of a new study published in Advances in Therapy evaluating real-world adherence to SPINRAZA (nusinersen) with its unique dosing schedule among people with spinal muscular atrophy (SMA) She also talked about the overall adherence rates to nusinersen. She highlighted that adherence was higher during the maintenance phase than the loading phase…
July 24, 2023

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

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

Read more

Load more