Drug Development

Articles

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

FDA Approves First Drug for EGPA

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

WuXi Biologics Starts Up Large-Scale, Single-Use Biomanufacturing Facility

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

Gilead Sciences and Kite to Acquire Cell Design Labs

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

Phillips-Medisize Invests in Manufacturing Center of Excellence for Connected Health and Drug-Delivery Devices

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Orbis Biosciences’ Optimµm Platform delivers microparticulate dosage forms with controlled-release and taste-masked properties in a single manufacturing step. 

Manufacturing Microparticles in a Single Step

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

Aero Pump’s preservative-free Multidose Eye Dropper System with SideActuationDevice received the CPhI Pharma Award for Excellence in Pharma: Packaging.

Ophthalmic Drug-Delivery Device Improves Patient Experience

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

FDA Approves First Biosimilar to Roche’s Herceptin

Sean Milmo is a freelance writer based in Essex, UK.

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

Disputes Over Manufacturing Waiver and Other SPC Exemptions

Softgel capsules are a popular dosage form among patients but they also provide a number of manufacturing benefits over liquid-filled hardgel capsules.

Formulation and Drug Delivery