News

The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

On July 25, 2016 Kite Pharma entered into an agreement with the University of California, Los Angeles,  (UCLA) to advance development of off-the-shelf allogenic T-cell therapies from renewable pluripotent stem cells. The company entered into an exclusive license agreement with UCLA for an artificial thymic organoid (ATO) cell culture system. The ATO replicates the human thymic environment to support efficient ex vivo differentiation of T-cells from primary and reprogrammed pluripotent stem cells.

The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

The companies will test the efficacy of Rova-T in combination with Opdivo, and Opdivo + Yervoy as a treatment for extensive-stage small cell lung cancer.

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

The company opened a new service center in San Juan, Puerto Rico.

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

The conference will return to the COEX center in Seoul for the third year from August 23¬–25, 2016.

Curida will manufacture PCI Biotech’s Amphinex, a drug used to treat bile duct cancer.

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

Thirty percent of current Remicade patients could be eligible for a switch to competitors such as Inflectra, according to estimates, although J&J doubts this will occur in the United States in 2016.

The company announced that it will be relaunching its customer collaboration centers.

The company plans to purchase and develop an 18-acre site in Des Plaines, Illinois.

The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

On July 19, 2016, Pfizer announced that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). According to the company, WHO prequalification allows for the global use of Prevenar 13 MDV by the United Nations agencies and countries worldwide that require WHO prequalification.The MDV presentation of Prevenar 13 offers benefits to developing countries, including a 75% reduction in:

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

GE further ramps up its cellular and gene therapy offerings with its acquisition of Biosafe, a cell processing solutions company.