Pharmaceutical Technology Editors

Catalent Pharma Solutions teamed with Zumutor Biologics to develop antibodies with enhanced ADCC activity.

Opdivo did not meet primary endpoints in Phase III trials investigating the drug as a monotherapy for untreated advanced non-small cell lung cancer in patients whose tumors expressed PD-L1.

MilliporeSigma will provide support to Y-mAbs for the development of its monoclonal antibody for the treatment of pediatric brain cancer.

The report addressed how the agency might support medicine development for patients’ unmet medical needs.

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.

Sanofi Pasteur will deliver the first of more than 65 million influenza vaccines to the United States throughout the 2016–2017 flu season.

The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

The manufacturing subsidiary of Astellas Pharma in Oklahoma has been transferred to CMO Avara and renamed Avara Pharmaceutical Technologies.

The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.

After divesting 79 generics businesses, the company completed its acquisition of Actavis Generics, including its over-the-counter business, on August 2. The following day, it bought Anda, Inc., the fourth largest generics distributor in the United States.

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

The company will install new vial-filling and lyophilization capacity, including an isolator-based filling machine. The new filling equipment will result in a five-fold increase in the company's current filling capacity.

The collaboration will focus on methods to eradicate cancer stem cells

The acquisition will add to the company's cell therapy base and potential impact in treating rare diseases.

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

The new materials handling laboratory will be used for storage, dispensing, inventory management, and distribution of non-GMP materials.

Galvani Bioelectronics will be based in Stevenage, UK, and headed by Kris Famm, GSK's vice president of bioelectronics R&D

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

The investment will be spread across three sites: Barnard Castle in County Durham; Montrose, Scotland; and Ware, Hertfordshire.

On July 27, 2016, John C. Lechleiter, PhD, chairman, president, and CEO of Eli Lilly, announced his retirement from the company. This decision is effective December 31, 2016, however, Lechleiter will remain on the company’s board of directors until May 31, 2017 as a non-executive chairman. Lechleiter joined the company in 1979 as a senior organic chemist in process R&D. He has served as CEO of Eli Lilly since April 2008.

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 project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

CDMO Saneca Pharma has sold registration dossiers for more than 20 pharmaceutical products to Xantis Pharma and will hold an exclusive five-year contract manufacturing agreement for the products with Xantis Pharma.

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 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.