Pharmaceutical Technology Editors

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

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.

ETHOCEL HP is a solvent free advanced productivity technology for barrier membrane coating.

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.

OPKO’s newly approved extended-release capsule uses Catalent’s OptiShell softgel capsule technology.

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.

The assay, co-developed by Grifols and Hologic, will be used to test blood donations in the United States.

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

The OMCL Network met increasing market demand for testing quality of medicinal products, blood-derived medicinal products, and vaccines in Europe.

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

The agency provides quality, development, manufacturing, and labeling recommendations.

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

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

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

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

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

FDA cited a Las Vegas compounding pharmacy for sterility violations.

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

The company will be exhibiting at the 2016 International Fuel Ethanol Workshop and Expo.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.

At the conference, industry experts discussed regional trends and challenges for the Middle East and North Africa for 2016.

FDA approved Vaxchora intended for travelers who are at risk for the disease.