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Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara) 

Shots:  Following the MAA submission by Accord Healthcare (Intas’ subsidiary) in 2023, the EMA’s CHMP has granted positive opinion to Imuldosa, a biosimilar version of Stelara (ustekinumab)  Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide…
October 21, 2024

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News

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara) 

Shots:  Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023  Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…
October 11, 2024

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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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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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VIEWPOINTS_Dr. Lotus Mallbris_2023
VIEWPOINTS

Dr. Lotus Mallbris Discusses Positive Results from the VIVID-1 P-III Study of Mirikizumab for the Treatment of Crohn’s Disease in Adults

Shots:    Dr. Lotus Mallbris shares the positive endpoint results of the VIVID-1 P-III study, evaluating the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn’s disease    While shedding light on the mechanism of mirkizumab, Lotus highlights that available therapies to treat Crohn’s disease often fail to achieve clinical…
December 19, 2023

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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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VIEWPOINTS_Jennifer Davidson_2023
VIEWPOINTS

Jennifer Davidson Highlights the Data from the Phase 3 QUASAR Induction Study 1

Shots:  Jennifer Davidson, VP, of Medical Affairs Immunology, Johnson & Johnson Innovative Medicine shares insights from the data of the Phase III QUASAR induction study presented at the DDW'23  P-III QUASAR induction study 1 demonstrated positive results in patients who received TREMFYA 200 mg vs Placebo, with most of the patients achieving remission at week…
November 13, 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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