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Viewpoints_Dr. Robert Fogel_Janet Franklin_Dr. Dave Singh
VIEWPOINTS

ATS 2024: Robert Fogel, Janet Franklin, and Dave Singh from AstraZeneca & Amgen in Conversation with PharmaShots

Shots: Recently AstraZeneca and Amgen presented the results in late-breaking session from the COURSE trial, a proof-of-concept study evaluating tezepelumab in COPD The PoC study was carried out in people with moderately to very severe COPD with a broad range of eosinophil levels Today, at PharmaShots we have Robert Fogel from AstraZeneca, Janet Franklin from…
October 8, 20240Comments

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Teva
News

Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA 

Shots: The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25 Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as…
October 8, 20240Comments

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Viewpoints_Maria Belvisi_Dr. Sarah Doffman_Dr. Janet Franklin
VIEWPOINTS

ATS 2024: Maria Belvisi, Sarah Doffman, and Janet Franklin from AstraZeneca & Amgen in a Stimulating Conversation with PharmaShots

Shots: Jointly developed by AstraZeneca & Amgen, AZD8630/AMG targets Thymic stromal lymphopoietin (TSLP), an epithelial cytokine involved in Chronic Inflammatory Disorders Recently, AstraZeneca and Amgen released the P-I data evaluating AZD8630/AMG104 on three doses vs. placebo for 28 days. The data demonstrated linear PK at all three doses Today, at PharmaShots we have Prof. Maria…
October 7, 20240Comments

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Key Biosimilars Events of September 2024
INSIGHTS+

Key Biosimilars Events of September 2024

Shots:      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 patients       The major highlights were the US FDA’s approval of Samsung Bioepis and…
October 3, 20240Comments

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News

Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology 

  Shots: Teva and mAbxience have entered into a second global licensing agreement to develop an anti PD-1 biosimilar candidate in oncology As per the agreement, mAbxience will employ its state-of-the-art, cGMP-compliant facilities in Spain and Argentina for the development & production of biosimilar while Teva will handle its regulatory approvals & commercialization The agreement…
October 3, 20240Comments

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Viewpoints_Robert Fogel_Dave Singh
VIEWPOINTS

AstraZeneca at ATS’24: Robert Fogel & Dave Singh in a Stimulating Conversation with PharmaShots

Shots: Cardiopulmonary events associated with COPD are responsible for an increasing mortality rate in COPD patients. ETHOS trial, a posthoc analysis navigates BGF’s impact on a wide range of cardiopulmonary outcomes beyond COPD exacerbations The post-hoc analysis reveals that AstraZeneca’s Breztri led to a 20% reduction in the risk of severe cardiopulmonary events. AstraZeneca is currently…
September 30, 20240Comments

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Exclusive_Chris Heery_2024
EXCLUSIVE

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

Shots: Arcellx’s Anito-cel, a BCMA CAR-T therapy recently got the FTD, ODD, RMAT designations by the FDA for the treatment of patients with relapsed or refractory multiple myeloma (r/rMM) Today, at PharmaShots we have Chris Heery, Chief Medical Officer at Arcellx, shedding light on Anito-Cel therapy in advancing care for multiple myeloma In late 2022,…
September 30, 20240Comments

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Formycon and Fresenius Kabi
News

Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara) 

Shots: The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025 Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity…
September 30, 20240Comments

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