Biopharma News
FDA Issues Complete Response Letter to Allergan, Molecular Partners for Ocular Therapeutic BLA
July 1st 2020The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.
uniQure, CSL Behring Collaborate on Hemophilia B Gene Therapy in Over $1.6-Billion Deal
June 29th 2020The companies are entering into a license agreement to provide CSL Behring with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B.
Oxford Biomedica Signs Agreement with Vaccines Manufacturing and Innovation Centre
June 12th 2020Oxford Biomedica, has signed a collaboration agreement with the not-for-profit organization, the Vaccines Manufacturing and Innovation Centre, to provide the UK with its first strategic vaccine development and advanced manufacturing capability.
EC Grants Marketing Authorization for Subcutaneous Formulation of Daratumumab
June 5th 2020The European Commission has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous formulation to treat adults with multiple myeloma.
TAE Life Sciences to Launch Drug Delivery Program After $30-Million Investment
June 4th 2020The investment will give the company the opportunity to accelerate the development of proprietary boron-10 target drugs while it develops its neutron beam accelerator technology for Boron Neutron Capture Therapy.