Drug Development

Articles

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

Amneal Purchases Manufacturing Site in Ireland

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

FDA Approves First 3D-Printed Drug Product

Michelle Frisch, MBA, is senior manager, Global Technical Systems, Powder Systems Limited, and a member of the AGS Standards Committee; michelle.frisch@powdersystems.com.

Brian G. Ward, PhD, CChem, FRSC, is the owner of Barrier Concepts and a member of the AGS Standards Committee; briangward@me.com.

Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.

Environmental Containment Performance—Is There Accountability?

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

The Potential of Perfusion

Vetter’s Vetter-Ject closure system for prefilled syringes has an integrated needle hub and shield and is designed for sensitive compounds, such as biologics.

Syringe Closure System Allows Use of Highly Sensitive Compounds

Agnes Shanley is senior editor of Pharmaceutical Technology.

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Recovering the Value of Repurposed Drugs

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

Xcelience Makes Investment in Powdersize

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

The Generic Pharmaceutical Association and the Biosimilars Council wrote an open letter to President Barack Obama protesting the patent protections outlined in the Trans-Pacific Partnership.

Biosimilars Council Opposes IP Provisions in Trans-Pacific Partnership

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

FDA Approves Praluent, the First PCSK9 Inhibitor in the US

EMA gives GSK’s malaria candidate vaccine a positive opinion for the prevention of malaria in young children in sub-Saharan Africa.

Formulation and Drug Delivery