BioPharm International Editors

Califf appointed Richard Pazdur as acting director of the Oncology Center of Excellence under the Cancer Moonshot Initiative.

The drug received breakthrough therapy and orphan drug designation as a monotherapy for the treatment of chronic graft-versus-host-disease.

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

The monoclonal antibody for the treatment of two forms of multiple sclerosis has a target action date of December 28, 2016.

The facility will be built in approximately 18 months using GE Healthcare’s KUBio modular facility solution.

Charles River acquired Blue Stream Laboratories, an analytical contract research organization.

The companies agree to exchange ownership of Sanofi’s animal health and Boehringer Ingelheim’s consumer healthcare businesses.

A new facility in Marlborough, MA, will house laboratories to support GE Healthcare Life Sciences’ biomanufacturing and development operations.

ICH detailed the highlights of the council’s June 2016 meeting.

The cell lines have the potential to provide new medical applications for patients suffering from Alzheimer’s disease, Parkinson’s disease, spinal cord injury, diabetes, and muscular dystrophy.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.

The agency publishes draft reference material for implementation of FDA’s quality metrics guidance.

Thermo will provide access to its instruments to NIBRT so that the Dublin-based group can generate helpful characterization data.

China’s State Council issued a notice authorizing a trial plan for a new drug marketing authorization holder system for 10 provinces.

Langer will work with the company to develop its portfolio of cannabidiol candidates for bone health.

The 10-year agreement augments Adaptimmune’s license and supply relationship with Thermo Fisher for the Dynabeads CD3/CD28 Cell Therapy System for use in the manufacture of Adaptimmune’s SPEAR T-cell therapies.

The Pharmacopoeial Discussion Group approved monographs and plans to harmonize several others.

The agency cited the company for sterile manufacturing violations.

The annual CPhI Pharma Awards honor companies and individuals driving the pharmaceutical industry forward through innovation, new approaches, technologies, and strategies.

The two agencies have set up a working group on involving patients in drug development.

Pending regulatory approval, Sandoz plans to release biosimilars to etanercept, adalimumab, pegfilgrastim, infliximab, and rituximab.

Emergent is seeking approval for the manufacture of BioThrax at the company’s large-scale manufacturing facility.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

The ambr 250 is a mini bioreactor system for parallel fermentation or cell culture.

Lonza will continue to sponsor the conservation of horseshoe crabs, which are used in endotoxin testing.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.