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Technological advances are aiding manufacturers to streamline aseptic processes.
Quality Considerations for Using AI in Bio/Pharma
Sterile filtration and use of sterile single-use materials provide the best solutions depending on vector size.
This research focuses on refining the clarification step by assessing the performance of various depth filters.
June 26, 2024
Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.
The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.
June 25, 2024
FDA has granted expanded approval to Sarepta Therapeutics for Elevidys to treat DMD in non-ambulatory patients, in addition to ambulatory patients.
Immunology company argenx gets its third FDA-approved indication for VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy.
A new initiative will advance access to quality medicines and vaccines in Africa.
This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.
June 21, 2024
The transaction, announced June 20, follows Bora’s purchase of Minnesota-based Upsher-Smith Laboratories earlier in 2024.
The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.
June 20, 2024
Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.
June 19, 2024
The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.
The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.
The collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.