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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
December 14, 2022
Under the collaboration between Vertex and Entrada, the companies will work on discovering and developing intracellular endosomal escape vehicle therapeutics for myotonic dystrophy type 1.
Thermo Fisher Scientific’s new facility in Hangzhou, China, is designed to boost biologics and sterile development and manufacturing capabilities in the Asia-Pacific region.
The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.
December 13, 2022
Amgen’s $27.8 billion acquisition of Horizon Therapeutics, an Irish biotechnology company, is one of the largest of 2022.
Takeda will purchase the rights to Nimbus Pharmaceuticals candidate, NDI-034858, which is currently being evaluated for treating multiple autoimmune diseases.
The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.
mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.
December 12, 2022
Generate Biomedicines published a preprint describing technology that can generate novel proteins towards desired functional or other properties.
PictorLabs, a digital pathology company developing an AI-powered virtual staining platform, formally announced its launch at the start of December.
The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.