VIEWPOINTS

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Shots: Ahsan spoke about the US FDA acceptance for Priority Review of sBLAs for PADCEV and KEYTRUDA to treat patients with LA/mUC who are not eligible to receive cisplatin-containing CT He also talked about the study design and outcomes from the P-Ib/II (EV-103) clinical trial that supported the sBLA. The results from Dose Escalation/Cohort A…

August 17, 2023

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Shots: Marija spoke about the data on Migraine and Brain Health presented at the 75th Annual Meeting of the AAN 2023. The 12 abstracts included the data from post-hoc and real-world analyses of VYEPTI She also talked about a medical symposium sponsored by the company “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening…

August 14, 2023

Kathleen Somera-Molina, Head of SMA Global Medical Affairs at Biogen Shares Insights on New SPINRAZA (nusinersen) Long-Term Data in SMA

Shots: Kathleen spoke about new long-term SPINRAZA (nusinersen) data presented at the 3rd International Scientific Congress She then explained the new findings from individuals with infantile-onset SMA who were treated with SPINRAZA in the pivotal ENDEAR study followed by the long-term extension SHINE study for up to 7 years The interview also discusses Biogen’s advances…

August 7, 2023

Mary Rodgers, Principal Research Scientist at Abbott Shares Insights on its Partnership with CLIMADE Consortium to Predict Disease Outbreaks Caused by Climate Change

Shots: Mary talked about Abbott's partnership Climate Amplified Disease and Epidemics (CLIMADE) consortium will use data science to predict, track and control diseases that may be amplified by climate change She then spoke about how Abbott and its partners in the Abbott Pandemic Defense Coalition will provide viral sequencing and testing data as part of…

August 3, 2023

VIEWPOINTS_Tahi Ahmadi1_Asud Khaliq2_2023

Tahi Ahmadi and Asud Khaliq Share their Views on EPKINLY (epcoritamab) U.S. FDA Approval in DLBCL

Shots: Tahi and Asud initiated the conversation with an overview of EPKINLYTM (epcoritamab) and its approval by the U.S. FDA to treat R/R DLBCL They then spoke about the study design and results from the EPCORE NHL-1 P-I/II trial that served as the basis for the U.S. FDA approval of EPKINLY. EPKINLY is being co-developed and co-commercialized by Genmab and AbbVie. Both companies are evaluating…

August 2, 2023

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

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

Ivy Weng, Group VP, of Life Sciences at Komodo Health Shares Insights on its Collaboration with Intercept Pharmaceuticals

Shots: Ivy shared details of its collaboration with Intercept Pharmaceuticals and how Intercept is using Komodo’s tech platform and healthcare map for a retrospective real-world study on the long-term outcomes for Ocaliva She also talked about how pharma companies can utilize Komodo’s technology platform and how it supports rare disease research The interview gives an…

July 20, 2023

Nabil Abadir, CMO and Head of Global Medical Affairs at Amarin Corp Shares Insights from New Data Evaluating Vascepa/Vazkepa at ACC.23/WCC

Shots: Nabil spoke about the data evaluating Vascepa/Vazkepa and eicosapentaenoic acid in reducing cardiovascular events presented at the ACC.23/WCC He also told our readers about the new analysis from the REDUCE-IT trial showing the effectiveness of VASCEPA/VAZKEPA in patients with recent acute coronary syndrome The interview shows how Amarin is developing innovative therapies, increasing the…

July 18, 2023

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