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Fresenius Kabi
News

Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025 FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…
May 20, 2025

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ALPCO
News

ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU

Shots: ALPCO has launched its Calprotectin Immunoturbidimetric Assay for the diagnosis of IBD, incl. Crohn's disease & ulcerative colitis in the EU ALPCO has also enrolled 1st pts in its pivotal trial for FDA clearance of its automated chemiluminescent calprotectin assay on the KleeYa system, following completion of the FDA pre-submission in Mar 2025, with…
May 9, 2025

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Akesobio
News

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots: Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adult Clinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…
April 18, 2025

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Sanofi
News

Sanofi Enters a ~$1.84B Global License Agreement with Earendil Labs for HXN-1002 & HXN-1003

Shots: Earendil Labs has granted Sanofi exclusive global rights to develop HXN-1002 & HXN-1003 bispecific antibodies for autoimmune & inflammatory bowel diseases As per the deal, Earendil Labs will receive $125M upfront, ~$1.72B in development & commercial milestones, incl. a near-term $50M payment, & tiered royalties ranging from high-single to low-double digits Developed using Earendil…
April 17, 2025

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Viewpoints_Anabela Cardoso_Mark Genovese
VIEWPOINTS

Lilly at ACG 2024: Anabela Cardoso and Mark Genovese in Conversation with PharmaShots

Shots:  Lilly presented results from two long-term studies evaluating sustained efficacy in patients treated with mirikizumab for both moderately to severely active Ulcerative Colitis and Crohn’s Disease at ACG 2024  At three years, more than 80 percent of patients with moderately to severely active ulcerative colitis who were on remission sustained long-term remission and relief  …
March 24, 2025

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Viewpoints_Chris Gasink
VIEWPOINTS

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Shots: Johnson & Johnson’s (J&J) Tremfya recently received its third approval from the US FDA, supported by the pivotal QUASAR study, which demonstrated significant remission after one year of treatment in adults with moderately to severely active ulcerative colitis Tremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammation At…
February 3, 2025

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News

Key Biosimilars Events of December 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 A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
January 7, 2025

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Key Biosimilars Events of December 2024
INSIGHTS+

Key Biosimilars Events of December 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        A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek…
January 7, 2025

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Viewpoints_Marcelo Freire
VIEWPOINTS

Takeda at UEG Week 2024: Marcelo Freire from Takeda in an Enlightening Conversation with PharmaShots

Shots:  Recently, Takeda shared 32-week interim results from the VERDICT study, which evaluated Entyvio (vedolizumab) for the treatment of patients with ulcerative colitis (UC)  Entyvio achieved a stringent endpoint of disease clearance, a new concept in UC clinical research, which is a combination of clinical, endoscopic, and histologic remission  Today at PharmaShots, we are joined…
December 2, 2024

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