This PSD-3, the first pharmaceutical spray dryer built by GEA for OEB-5 products, sets new standards for high-containment pharmaceutical spray drying
Replicate will receive research funding and could potentially receive up to approximately US$550 million
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit
Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)
Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market
Triggering global regulatory submissions this year for the treatment of obesity
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