Formulation and Drug Delivery

GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate

July 29, 2014

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Study Shows Capsugel's Capsules as Suitable Excipients in QbD-based Product Development and Manufacturing

July 29, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Study provides first substantive reference data on key quality attributes of empty capsules

FDA Accepts First Biosimilar Filing

July 24, 2014

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

Dissolution Problems Spur Three Recalls

July 11, 2014

Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.

Biotech Industry Forms International Council

July 10, 2014

New International Council on Biotechnology Associations advocates biotechnology growth.

FDA Urged to Preserve Biosimilar Naming Conventions

July 02, 2014

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Biotage Launches Accelerated Chromatographic Isolation

June 30, 2014

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

PolySciTech's SpinSwiper Could Speed Up Production of Controlled-Release Microparticles

June 30, 2014

PolySciTech's new launch, SpinSwiper, has the potential to speed up microparticle production.

FDA Licenses First US Facility for Cell-Culture Influenza Vaccines

June 16, 2014

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

Research Firm Predicts Negative Impact of Biosimilars

June 12, 2014

A new report from GlobalData states that biosimilars will overtake the market share after 2019.