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Merck acquires Prometheus Biosciences

Express Pharma

Prometheus is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialisation of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases.

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Ichnos Glenmark Innovation presents first clinical data from phase 1 study of Trispecific TREAT Antibody, ISB 2001

Express Pharma

Ichnos Glenmark Innovation (IGI), a clinical-stage biotech company developing multispecifics in oncology, presented first-time clinical data from the early dose-escalation portion of its Phase 1 study of ISB2001 for the treatment of relapsed or refractory multiple myeloma (RRMM). The median duration of CRS was 2 days (range: 18).

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Boehringer’s spesolimab data raises hope for serious skin disease

pharmaphorum

Biologic drugs used to treat plaque psoriasis are used off-label in GPP, but there’s little data on their effectiveness. In some cases the consequences are fatal, and at the moment there are no approved therapies in the US or Europe for GPP flares.

Labelling 103
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Phase III trial shows tislelizumab improves outcomes for liver cancer patients

European Pharmaceutical Review

Despite improvements in screening, surveillance rules, and imaging, more than two-thirds of patients with HCC present with advanced disease at diagnosis, BeiGene said. The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia. About tislelizumab.

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September 2023 Newsletter

Safe Biologics

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. Read the new FDA’ Guidance here.

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Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Furthermore, participants who switched from placebo to atacicept in the open-label extension had similar results at 72 weeks as those initially randomised to atacicept in the first 36 weeks.

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Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. Furthermore, participants who switched from placebo to atacicept in the open-label extension had similar results at 72 weeks as those initially randomised to atacicept in the first 36 weeks.