Santhera secures FDA approval for Duchenne muscular dystrophy therapy
Agamree has been approved in the US for treating patients aged two years or older with Duchenne muscular dystrophy.
30 October 2023
30 October 2023
Agamree has been approved in the US for treating patients aged two years or older with Duchenne muscular dystrophy.
The FDA rejected Omvoh’s (mirikizumab) BLA over manufacturing concerns in April 2023.
UK Prime Minister Rishi Sunak has announced new investment in the life sciences and healthcare fields.
The world’s most expensive drug, Hemgenix, has been granted authorisation in Canada after being approved in other regions.
The MAA has been accepted based on data from the Phase III MIRASOL study of ELAHERE in platinum-resistant ovarian cancer.
The immunology portfolio of the company generated Q3 global net revenues of $6.78bn, a year-on-year decline of 11.3%.
Lowering barriers to participation could boost the diversity of patients in clinical trials. We analyze gender, race and ethnicity data to understand the differences that mobile visits from a certified mobile research nurse can make.
Patients who have used the products should consult their healthcare provider or seek medical advice.
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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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