Biologic Drugs in Development

The decision to skip an FDA panel advisory may allow the medication to be approved more quickly.

The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.Roche Acquires Bispecific Antibody Developer Dutalys

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

FDA gives orphan drug designation to Merrimack Pharmaceuticals' MM-141 for the treatment of pancreatic cancer.

FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.

Lilly1s Cyramza is the first FDA-approved treatment for advanced gastric cancer after prior chemotherapy.

Sanofi and Genzyme to resubmit FDA application for approval of Lemtrada, for the treatment of relapsing forms of multiple sclerosis.

Rentschler Biotechnologie will manufacture GMP material for advanced clinical studies and market supply of Apeiron's lead program, APN311.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.