Biologic Drugs in Development

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

Antibodies in research should be standardized and categorized using a barcode-like classification system, according to research published in Nature.

Amgen announced that it met primary and secondary endpoints in its biosimilar evaluation of adalimumab for the treatment of rheumatoid arthritis, when compared to Humira.

The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of the prescription drug user fee goal date.

Developing intellectual property standards for biological products is a point of conflict as negotiations on the Trans-Pacific Partnership continue.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.

The move represents Hospira’s first biosimilar submission in the United States.

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.