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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, 2024

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NEWS

Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio) 

  Shots:  Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease  The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active…
September 25, 2024

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Viewpoints_Sofie Berg
VIEWPOINTS

Unlocking Approval: Sofie Berg from AbbVie in an Illuminating Dialogue Exchange with PharmaShots

Shots:  Recently, the European Commission approved AbbVie’s Skyrizi for the treatment of adults with moderate to severe active Ulcerative Colitis  The approval was based on positive data from the P-III INSPIRE induction trial and COMMAND maintenance study   Today, at PharmaShots we have Sofie Berg, the therapeutic area head of international immunology, International Medical Affairs, at…
September 23, 2024

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Abbvie
NEWS

AbbVie Reports the CHMP’s Positive Opinion of Skyrizi (Risankizumab) to Treat Ulcerative Colitis 

     Shots:  The CHMP grants a positive opinion to Skyrizi for treating moderate to severely active UC in adults with inadequate or lost response and were intolerant to conventional or biologic therapy. Final decision is anticipated in Q3’24  The positive opinion was based on the P-III (INSPIRE) study, assessing Skyrizi (induction treatment: 1200mg, IV, 0,4…
May 31, 2024

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Pfizer New
NEWS

Pfizer’s Velsipity (etrasimod) Receives the European Commission’s Approval for the Treatment of Severely Active Ulcerative Colitis 

Shots:   The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma   Patients in the trial have previously received 1-3 prior lines of therapy,…
February 19, 2024

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Insights+ Key Biosimilars Events of December 2023
INSIGHTS+

Insights+ Key Biosimilars Events of December 2023

Shots:  Stay up to date with PharmaShots Biosimilars Report, a monthly digest designed to keep you familiarized with the recent developments in biologics  Biosimilars are cost-effective alternatives to branded drugs but are very much alike when it comes to safety and efficacy  Check out the developments in the Biosimilars with PharmaShots’ illuminating report. PharmaShots has…
January 9, 2024

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Insights+ Key Biosimilars Events of November 2023
INSIGHTS+

Insights+ Key Biosimilars Events of November 2023

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   During November, Amgen received US FDA approval for Wezlana, biosimilar of ustekinumab &…
December 6, 2023

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Disease of the Month - Ulcerative Colitis
INSIGHTS+

Disease of the Month – Ulcerative Colitis

Shots:  To keep our readers acquainted with several disease conditions, ongoing trials, and available treatment options, PharmaShots brings every month a detailed take on a particular disease after thorough research   Continuing the series for the disease of the month, PharmaShots presents a condensed report on Ulcerative Colitis, which causes inflammation and sores (ulcers) in the digestive…
November 28, 2023

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Thoughtspot_Adam_Ferraresi_2023
THOUGHTSPOT

Easing the Storm: Tackling Ulcerative Colitis Flare-ups Effectively

Did you know that 1 in 250 people globally grapple with ulcerative colitis? You're not alone in this fight. This article provides you with practical strategies to manage flare-ups effectively. You'll identify your triggers, explore nutritional strategies, understand medication options, and learn about stress's role. We'll also delve into the benefits of regular exercise and…
November 10, 2023

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