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Biogen’s Qalsody (tofersen) Receives CHMP’s Positive Opinion for the Treatment of Amyotrophic Lateral Sclerosis (ALS) 

Shots:  The opinion was based on the results from the P-III (VALOR) trial evaluating the safety & efficacy of Qalsody (100mg) vs PBO in ALS patients (n=108) associated with SOD1 mutations. The 1EPs of the study include changes in ALSFRS-R total score from baseline to wk.28 & 2EPs includes change in total cerebrospinal fluid SOD1…
February 23, 2024

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VIEWPOINTS_Kathleen Somera-Molina_2023
VIEWPOINTS

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 CongressShe 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 yearsThe interview also discusses Biogen’s advances…
August 7, 2023

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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

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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 arthritisHe briefed about the study design and results from the P-III trial which supported the BLA filingThis interview focuses on Biogen's notable progress in addressing challenging immunologic conditions, offering potential solutions to…
July 10, 2023

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Insights+ Key Biosimilars Events of June 2023
INSIGHTS+

Insights+ Key Biosimilars Events of June 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of June, Samsung Bioepis presented results of SB12…
July 5, 2023

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VIEWPOINTS_Michael Irizarry1_2023
VIEWPOINTS

Michael Irizarry, SVP, Clinical Research, Eisai Shared Insights on P-III Results from Clarity AD Study

Shots:Michael spoke about the P-III Clarity AD study evaluating Leqembi (lecanemab) for the treatment of mild cognitive impairment due to Alzheimer’s disease presented at CTAD 2022He also talked about Eisai’s collaboration with Biogen for the co-commercialization and co-promotion of LecanemabThe interview gives an understanding of how Biogen develops and delivers innovative therapies…
July 4, 2023

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