February 2025 News and Resources

CDMO News

Xedev Enhances GMP Services with Liquid Formulation Capabilities

Xedev has successfully extended its Good Manufacturing Practice (GMP) authorization to cover the manufacturing and primary packaging of liquid formulations intended for internal use. The expansion broadens the company’s existing approval, which already includes non-sterile and biological medicinal products. With this

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CDMO News

Maravai LifeSciences Completes Acquisition of Officinae Bio’s DNA and RNA Business

Maravai LifeSciences has officially completed its acquisition of Officinae Bio’s DNA and RNA business, expanding its expertise in mRNA design and drug substance manufacturing. The deal integrates Officinae Bio’s AI-enabled mRNA sequence-optimization platform with Maravai and its subsidiary TriLink BioTechnologies‘ manufacturing capabilities, supporting a streamlined

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CDMO News

Chime Biologics and Mabgeek Advance MG-K10 to Phase III Trials

Chime Biologics has reaffirmed its commitment to Mabgeek in advancing MG-K10, a novel IL-4Rα-targeting antibody drug for atopic dermatitis and asthma, into Phase III clinical trials. This collaboration follows Mabgeek’s successful engagement with the U.S. Food and Drug Administration (FDA), paving the way

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Biotech News

atai Life Sciences Acquires Psilera’s DMT Patent Portfolio

Psilera, Inc., a biotechnology company focused on neurological disorders, has entered into a licensing agreement with atai Life Sciences, a clinical-stage biopharmaceutical company developing psychedelic-based therapies. Under the agreement, atai has acquired Psilera’s patent portfolio covering DMT and related psychedelics. Psilera’s

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CDMO News

Teva and Alvotech Launch SELARSDI, a Stelara Biosimilar, in the U.S.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech have announced the availability of SELARSDI (ustekinumab-aekn) in the United States. This biosimilar to Stelara (ustekinumab) is approved for multiple indications, including psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric

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