Samsung BioLogics approved to make first mAb for US market
Samsung BioLogics announced license-approval by the US FDA to create a mAb drug product at its Plant 1 facility.
Archives for July 27, 2018
US FDA puts gene-therapy on hold after DNA fragment found in plasmids
Sarepta’s gene therapy clinical trial is put on hold by the US FDA after DNA fragment was found in plasmids during quality assurance testing.
Dr. Reddy’s launches Herceptin biosimilar in India
Dr. Reddy’s Laboratories has announced its biosimilar version of Roche’s Herceptin, Hervycta (trastuzumab), is now available on the Indian market.
Rubius to pay $8m for ex-Soliris plant with troubled past
Rubius has announced plans to acquire Alexion’s manufacturing facility in Rhode Island, where the latter made immunosuppressant Soliris before exiting the site last year.