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The French major and partner Regeneron expect to file Dupixent for the rare skin disease next year after a Phase III trial of the blockbuster hit its primary and secondary endpoints.
From the latest COVID-19 advances to the emergence of a game changer for heart failure, Scrip’s editor in chief Eleanor Malone reviews the big stories of the past three months. Safety issues around JAK inhibitors and AAV vector-based gene therapy were also to the fore, while biopharma financing continued apace.
The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.
The company created two new divisions focused on the new disease areas, bringing in former executives from Bristol Myers Squibb and Sanofi Pasteur.
Deucravacitinib is an oral drug in development for a wide range of autoimmune conditions, including psoriasis and psoriatic arthritis.
Emerging Company Profile: Switzerland-based Anjarium Biosciences AG has successfully raised $61m in a series A financing that will fund expansion of its novel proprietary platform and development of a nascent pipeline of non-viral gene therapies.
MoonLake of Switzerland is heading to the NASDAQ armed with $230m to take its tri-specific IL17A/IL-17F nanobody sonelokimab, acquired from Merck KGaA, into the highly competitive spaces of psoriatic arthritis, ankylosing spondylitis and hidradenitis suppurativa.
As the European Academy of Dermatology and Venerology congress closed its doors, two OX40 atopic dermatitis drugs from Sanofi and Amgen/Kyowa Kirin caught the eye.
The Swiss group believes that remibrutinib, as well as its investigational IgE antibody ligelizumab, will complement standard of care Xolair and help it build a strong franchise for chronic spontaneous urticaria.
The deal could nevertheless give Incyte a competitive edge, especially with combination potential between its JAK inhibitors and Syndax’s axatilimab.
Analysts say biotech’s EDP1815 may offer similar efficacy to Amgen’s Otezla, with better safety. Evelo says data offer new proof for its small intestinal axis approach to inflammatory disease.
The Oxford university spin-out MiroBio has a senior leadership team in place, and aims to have its first checkpoint agonists in the clinic in 2022. Scrip spoke to its CEO about its plans.
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