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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, 20240Comments

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Pharmaceutical Automation and Digitalisation Congress - AUTOMA 2024
EVENTS

Pharmaceutical Automation and Digitalisation Congress – AUTOMA+ 2024

Pharmaceutical Automation and Digitalisation Congress (AUTOMA+ 2024 | Zurich, Switzerland, 18-19 November) is an annual event where attendees showcase their case studies and connect with industry experts, all with the goal of promoting effective digital transformation. The closed-door format of the Congress ensures that only decision-makers and key specialists are going to be there. AUTOMA+ 2024…
September 23, 20240Comments

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Henlius and Intas
News

Henlius and Intas’ Hetronifly (Serplulimab) Receives the CHMP’s Positive Opinion to Treat Extensive-Stage SCLC 

     Shots:   The positive opinion of Hetronifly (anti-PD-1 mAb) was supported by ASTRUM-005 study assessing it with CT vs PBO as a 1L treatment of ES-SCLC patients (n=585) in various regions. It is approved in China under the brand name Hansizhuang for the same Henlius partnered with Intas in 2023 to develop & commercialize…
September 21, 20240Comments

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Pfizer
News

Pfizer Reports the CHMP’s Positive Opinion of Hympavzi (Marstacimab) to Treat Hemophilia A and B 

      Shots:   The CHMP has recommended Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively  The opinion was based on data of 116 subjects (12-75yrs.) from a pivotal P-III (BASIS) study treated with marstacimab (300mg loading dose followed by…
September 20, 20240Comments

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News

AbbVie Reports the CHMP’s Positive Opinion of Elahere (Mirvetuximab Soravtansine) to Treat Ovarian Cancer 

      Shots:   The CHMP has granted positive opinion to Elahere for treating FRα+, Pt-resistant & high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults who have received 1 to 3 prior therapies. The decision is anticipated in Q4’24, with other reviews underway The opinion was based on P-III (MIRASOL) study assessing Elahere…
September 20, 20240Comments

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Zevra Therapeutics
News

Zevra Therapeutics Receives the US FDA’s Approval of Miplyffa (Arimoclomol Citrate) for Treating Niemann-Pick Disease Type C (NPC) 

Shots:    The US FDA has awarded priority review voucher & approved Miplyffa (47mg to 124mg, oral, TID) + miglustat to treat neurological manifestations in adults & pediatrics (≥2yrs.) with NPC, with its launch planned within 8-12wks.   Approval was based on trial of Miplyffa + miglustat vs PBO in NPC patients (2-19yrs.), showing halted disease progression…
September 20, 20240Comments

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