Category: North America

October 3, 2023 Off

J&J Patent Move Must be First of Many, says AHF

By BusinessWire

AIDS Healthcare Foundation (AHF) acknowledged today pharmaceutical company Johnson & Johnson’s (J&J) announcement that it will not enforce its patent for the multi-drug resistant tuberculosis treatment SIRTURO (bedaquiline) for 134 low- and middle-income countries—a significant step in ending the global TB crisis for a preventable, treatable, and curable disease.

August 23, 2023 Off

AiCuris Received 30 Million Euros Milestone Payment from Licensing Partner MSD Following U.S. FDA Approval of PREVYMIS

By Dino Mustafić

AiCuris Anti-infective Cures AG has received milestone payments in the amount of EUR €30 million from its licensing partner MSD (Merck) after the U.S. FDA’s approval for first-in-class antiviral agent PREVYMIS® in a new indication – the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients.

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.