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.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

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

Pressure is mounting to reduce costs and spending on prescription drugs.

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

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.

In a lawsuit against Celltrion, Janssen alleges the GE subsidiary infringed one of Janssen’s patents covering the method of making the cell-culture media that HyClone later supplied to Celltrion.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Keytruda was shown to be superior to chemotherapy in the treatment of patients with non-small cell lung cancer.

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.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

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.