Category: Europe

Clinical trial labels across the globe – how to manage translations and country specific regulations
October 14, 2022 Off

Clinical trial labels across the globe – how to manage translations and country specific regulations

By Dino Mustafić

In recent years, there has been an industry-wide recognition of the need for speed and agility. Accelerating the trial processes for COVID-19 vaccine candidates required proactive and cooperative efforts from participants at all points in the supply chain. A sense of urgency and an expectation that trials should be completed more quickly and effectively emerged as a result of the realization that a drug can be approved and released to the market in a relatively short period of time. In light of this, improving the speed, accuracy, and agility of clinical trials labeling — and more specifically, the translation of label content — is one of the crucial areas that would help organizations to achieve this. 

Sanofi, Regeneron: first and only Phase 3 trial in children with EoE shows positive results
October 12, 2022 Off

Sanofi, Regeneron: first and only Phase 3 trial in children with EoE shows positive results

By Dino Mustafić

Dupixent presented detailed data at this year’s UEG Week conference in Vienna from from an investigational Phase 3 trial showing positive results in children ages 1 to 11 years old who are living with eosinophilic esophagitis (EoE). EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. Of the approximately 21,000 children under the age of 12 in the U.S. currently being treated for EoE, approximately 9,000 are most in need of new treatment options.

Vetter drives its sustainability campaign forward
October 12, 2022 Off

Vetter drives its sustainability campaign forward

By Dino Mustafić

Vetter, a globally leading contract development and manufacturing organization (CDMO) with long-term experience in supporting biotechnology and pharmaceutical customers, has in place a comprehensive sustainability strategy that has made it a pioneer in this energy-intensive industry.

ProBiotix Health with new CEO
June 14, 2022 Off

ProBiotix Health with new CEO

By Dino Mustafić

ProBiotix Health, a life sciences company developing clinically proven probiotic solutions to tackle chronic lifestyle diseases like high cholesterol, high blood pressure and atherosclerosis, has appointed Steen Andersen as Chief Executive Officer.

Novartis’ Kisqali the only CDK4/6 inhibitor consistent significant overall survival across entire Phase III program
June 3, 2022 Off

Novartis’ Kisqali the only CDK4/6 inhibitor consistent significant overall survival across entire Phase III program

By Dino Mustafić

Novartis today announced new overall survival (OS) and quality of life (QoL) analyses which evaluated Kisqali® (ribociclib) plus endocrine therapy for patients with hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) advanced or metastatic breast cancer. These data will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting,  Novartis said.

Novartis Announces Positive Phase III Results for its ESCC Drug
April 28, 2022 Off

Novartis Announces Positive Phase III Results for its ESCC Drug

By Author

Novartis has announced positive topline results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression.