Pharmaceutical Technology Editors

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process of polypropylene and thermoplastic elastomer.

This collaboration is said to be the first established between the Crick and a pharmaceutical company.

The investment will help strengthen biotech spin-offs from the United Kingdom’s leading research-intensive universities

The company has doubled its pharmaceutical sciences capacity through the acquisition of a second GMP manufacturing facility and the construction of new formulation development and pharmaceutical analysis laboratories.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.

The agency requires early notification of potential drug shortages.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.

CDMO for semi-solid and liquid manufacturing realigns operations at Texas facility.

Teva has launched the generic version of almotriptan malate (Axert), 6.25 mg and 12.5 mg, in the United States.

Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.

Vacuum-conveying conditions for powders and other free-flowing solid forms can be simulated in Volkmann's new laboratory.

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.

The agreement gives Allergan a foothold in migraine drug development.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Keith Moore will support Metrics Contract Services as vice president of analytical services.

FDA orders unapproved prescription ear drop products with active ingredients removed from the market.

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.

Hovione is installing a new large-scale spray-drying unit in Loures, Portugal, specifically designed to handle high potency APIs and a wide variety of organic solvent systems.

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

FDA has accepted for review Pfizer’s new drug application for its modified-release formulation of tofacitinib citrate tablets (Xeljanz).

The addition of a new manufacturing line at Lonza’s Portsmouth, NH site enables Alexion to add dedicated product supply for 10 years.

CPhI is calling on all its attendees, exhibitors, and the wider pharma community to support this initiative.

The Latvian government and Pharma have signed a letter of intent on June 29, 2015, agreeing on measures and a mutual cooperation in projects that will help improve medicines access and health outcomes in Latvia.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

US Court orders New Jersey drug manufacturer and its president to stop distribution of unapproved and misbranded drugs.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.