Pharmaceutical Technology Editors

The company has launched new services for mammalian cell bank manufacturing under GMP conditions.

The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.

The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.

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.

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

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.

The new ready-to-use, packaging and production workflow solutions from DWK Life Sciences feature NextGen V and E-Z Ex-Traction vials to enhance security and minimize waste.

Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.

Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets because of concerns regarding product efficacy.

The first generics of Lyrica have been approved by the FDA for neuropathic pain management and adjunctive therapy.

Novartis, Amgen, and Banner have announced their decision to discontinue the investigation into the BACE1 inhibitor CNP520 (umibecestat) as a preventative therapy for Alzheimer’s disease.