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VIEWPOINTS

Unlocking Approval: Sofie Berg from AbbVie in a Riveting Conversation with PharmaShots 

Shots: AbbVie adds an eighth indication to Rinvoq’s label with the European Commission’s approval for treating adult patients with giant cell arteritis (GCA) Sofie Berg, Therapeutic Area Head of International Immunology at AbbVie, in a conversation with PharmaShots, shares insights from the SELECT-GCA trial evaluating Rinvoq in GCA, highlighting both primary and secondary endpoints Rinvoq…
July 9, 2025

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Sanofi
NEWS

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots:The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…
January 22, 2025

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Key Biosimilars Events of November 2024
INSIGHTS+

Key Biosimilars Events of November 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 EC’s approval of Sandoz’ Afqlir for treating…
December 3, 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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Viewpoints_Dr. Med. Steven Hildemann
VIEWPOINTS

PharmaShots Interview: Ipsen’s Dr. Med. Steven Hildemann Shares Insight on the EC’s Approval of Cabometyx + Nivolumab for Advanced Renal Cell Carcinoma

In an interview with PharmaShots, Prof. Dr. Med. Steven Hildemann, Executive Vice President, Chief Medical Officer, Head of Global Medical Affairs, and Patient Safety of Ipsen share his views on the approval of the combination regimen for aRCC. He also shed light on the company's near-term goals in the coming years.Shots:The EC approval is based…
May 11, 2021

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