Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.

Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.

To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.

European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.

Much has changed in the bio/pharma industry over three decades. In this special feature, the editors take a trip down memory lane, highlighting some of the major happenings of the past 30 years.

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.

FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.

Researchers in China are playing a role in advancing gene therapy development.

CPhI will host the CPhI Korea Conference to focus on the international nature of South Korea’s growth in exports.

Alizé Pharma 3 completed a €67 million Series A financing round led by LSP to boost its product portfolio in rare endocrine and metabolic diseases.

Phenomenex’s Zebron Gas Management filters and click-on inline gas traps can reduce gas chromatography (GC) system downtime and column damage.

NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.

Daiichi Sankyo Europe has revealed the results of a Phase III study assessing the efficacy, safety, and tolerability of bempedoic acid/ezetimibe fixed-dose combination (FDC) tablet.

Neuraxpharm Group has announced it is launching its first products in the United Kingdom.

CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.

Orion Corporation announced it has received approval from the US Food and Drug Administration for darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC).

Cannuba has announced its support of the first national pilot study in the United Kingdom aimed at assessing patients on prescription medical cannabis.

Cambrex has revealed that it is expanding its solid form screening and crystallization process development facility in Edinburgh, Scotland.

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.

Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.

EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.

Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.

Olon began construction of a GMP facility for biologic APIs in Capua, Italy.

Cure Pharmaceutical secured a patent that lets the company load higher drug amounts to its proprietary drug delivery system, CUREfilm.

Hikma will supply 14 essential medicines to US hospitals and patients.