BioPharm International Editors

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

The company announced that Bioverativ will be the name of its new hemophilia spin-off business, which is expected to launch in early 2017.

NICE recommends secukinumab for the treatment of patients with ankylosing spondylitis.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

The company is voluntarily recalling one lot of product due to particulate matter.

The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.

The three-year report emphasizes the roll of collaboration in drug safety.

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

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

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.

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

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.

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

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

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

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

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

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.

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

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

The North Carolina-based company will expand Pfizer's capabilities in gene therapy research

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

John C. Lechleiter will step down from his post as CEO of Eli Lilly effective December 31, 2016.

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

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.