PharmTech Europe News

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.

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.

MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.

As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?

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.

MHRA has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.

Development and manufacturing machine specialists, groninger, have opened a new showroom at its headquarters based in Crailsheim, Germany.

Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. 

Process Automation Solutions becomes the latest partner to join the TrendMiner ecosystem.

Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.

The Bosch packaging machinery business, including the pharma unit, will remain intact in the transfer to private equity firm CVC.

Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.

Industry has responded positively to the United Kingdom government’s new pharmaceutical payment system to incentivize development of new drugs to tackle AMR.

The Native Antigen Company has revealed its appointment of Biozol and Shanghai Bioleaf as its distributors in Germany, Switzerland, Austria, and China

Certara has unveiled the formation of a new product development innovation practice area that will be focused on global health.

CatSci has received two accolades from Welsh organizations, demonstrating its contributions to the Welsh economy in the field of process R&D.

Oncology drug discovery and development company, ADC Therapeutics, has closed its Series E financing expansion, in which it raised $103 million.

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.

Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.

CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.

The Bittium Wearable Platform with Philips EmoGraphy & CardioSense solution has been unveiled as one of five winners of GSK’s “Transform the Future of Self-Care” innovation content.

Cegedim has announced the launch of its Health Data Business in support of pharmaceutical companies, clinical research organizations, and academic institutions.

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

German-based company, Velabs Therapeutics, has closed its Series B financing round, raising EUR3 million (US$3.4 million).

New figures published by the ABPI have revealed the continuation of significant investment by the pharmaceutical industry into R&D in the United Kingdom.

Pfizer has successfully completed its acquisition of Therachon, a privately held clinical-stage biotechnology company.

Fujifilm Irvine Scientific has announced plans to open a third manufacturing facility in Tilburg, The Netherlands.