FDA grants approval for Novartis’ hidradenitis suppurativa treatment
The latest approval was based on findings from the Phase III SUNSHINE and SUNRISE trials of Cosentyx.
01 November 2023
01 November 2023
The latest approval was based on findings from the Phase III SUNSHINE and SUNRISE trials of Cosentyx.
Revenues saw a decline of 42% to $13.23bn from $22.63bn in the same quarter of the previous year.
Sellas will be meeting with the FDA in Q4 2023 to discuss Breakthrough Therapy Designation for SLS009 as a treatment for r/r PTCL.
Roche and Sarepta’s DMD drug failed to meet its primary endpoint in patients with patients with DMD aged 4-7 years.
The acquisition of the oral methotrexate solution, marketed as Jylamvo, marks the second FDA-approved oncology product in Shorla’s portfolio.
The laboratory will be operational by Q3 2024, and the first manufacturing suite is expected to be operational in Q3 2025.
Genentech is one of many companies using Sosei Heptares GPCR know-how, with AbbVie, Eli Lilly and Pfizer all on the company’s books.
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Despite challenging business conditions in 2021 and 2022, large CMOs were still involved in acquisitions to enhance their capabilities or scale of production. Catalent and Recipharm were particularly active in acquiring companies during this period, and these acquisitions had a focus on advanced biologic capabilities related to cell and gene therapies. CMOs are increasingly targeting companies with sophisticated (biologic and specialized) capabilities to manufacture modern drugs and seek high-value contracts.
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