Category: North America

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. 

October 12, 2022 Off

Ginkgo in a deal with Merck

By Dino Mustafić

Enzyme biocatalysts can reduce costly synthesis and purification steps, thereby decreasing production costs. Through this collaboration, we aim to optimize…

April 29, 2022 Off

FDA Approves BMS’s Camzyos for the Treatment of Adults With Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy (HCM)

By Author

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos™ (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.

April 20, 2022 Off

Moderna: Clinical update on bivalent COVID-19 booster platform

By Author

Moderna has announced new clinical data on its bivalent COVID-19 booster platform including data on the company’s first bivalent booster candidate, mRNA-1273.211, which includes mutations found in the Beta variant of concern, several of which have been persistent in more recent variants of concern including Omicron.