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FDA grants AbbVie breakthrough therapy designation for venetoclax in combination with rituximab for the treatment of relapsed/refractory chronic lymphocytic leukemia.

AbbVie Receives Breakthrough Therapy Designation for Venetoclax and Rituximab

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

Samsung Bioepis Receives Approval in EU for Enbrel Biosimilar

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

US Patent Office Denies Amgen’s Petition to Review Humira Patents

Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.

Stem Cell Treatment Centers Receive FDA Warning for Not Following cGMP Procedures

Takeda Pharmaceutical Company and enGene have entered into a strategic alliance to develop novel therapies for specialty gastrointestinal diseases.

Takeda and enGene Enter into Strategic Alliance

Cell Therapy Catapult and Synpromics announced a collaboration to increase scale and efficiency of viral vector manufacturing.

Cell Therapy Catapult and Synpromics to Collaborate on Viral Vector Manufacture

Adimab and Merck have entered into a definitive agreement to transfer Adimab’s antibody technology to Merck Research Laboratories.

Adimab Announces Technology Transfer Agreement with Merck

Shire’s acquisition of Baxalta creates a leading company for rare disease drugs.

Shire Acquires Baxalta in $32 Billion Deal

AstraZeneca and Moderna Therapeutics set to collaborate on mRNA therapeutic candidates for the treatment of cancer.

AstraZeneca and Moderna Therapeutics Announce Collaboration

Novartis enters into alliance and licensing agreement with Surface Oncology.

Bio/Pharma News