News

An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.

A US District Court in Washington, DC upheld FDA’s interpretation of clinical need when choosing which substances are approved to use for drug compounding.

The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.

Under an agreement, Colorcon will incorporate TruTag’s edible microtag technology in its coatings.

Fifty years after the man walked on the Moon, space-based science is benefiting Earth.

As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

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.

Fujifilm has bought Biogen ApS’ Copenhagen facility for US$890 million.

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

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.