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The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023
In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…
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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…
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In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, we bring for our readers a concise yet thorough analysis of the drug Ocrevus
Ocrevus is a prescription medicine used to treat adults with relapsing or primary progressive multiple sclerosis including CIS, RRMS, and SPMS
PharmaShots presents…
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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…
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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…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars 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 patients
During the month of June, Samsung Bioepis presented results of SB12…
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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 2022
He also talked about Eisai’s collaboration with Biogen for the co-commercialization and co-promotion of Lecanemab
The interview gives an understanding of how Biogen develops and delivers innovative therapies…
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The second quarter of 2023 highlights multiple clinical trial results, approvals, and numerous deals. There are major alliances in this quarter which include Merck acquired Prometheus for ~$10.8B and Astellas entered into a definitive agreement to acquire Iveric Bio for ~$5.9B
The second quarter of the year also showcases multiple approvals of the therapies…
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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…
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The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023
In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

