Drug Development

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

Articles

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Ensuring the Quality of Biologicals

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

FDA Releases Final Biosimilar Guidance

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

Catalent Awarded Vaccine Research Grant

The agency has recommended granting marketing authorization for Opdivo.

EMA Recommends Authorization of Melanoma Treatment

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

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

A presentation by Jim Miller will offer a detailed review of the contract services landscape.

Reviewing the Contract Services Market

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

GSK Recalls Flu Vaccine

The acquisition expands Sartorius Stedim Biotech’s service portfolio.

Sartorius Stedim Biotech Acquires BioOutsource

The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.

European Pharmacopoeia Seeks Comments on Eye Preparations Monograph

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

Formulation and Drug Delivery