Category: Regions

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

Rentschler Biopharma, Cell and Gene Therapy Catapult and Refeyn in collaboration
August 23, 2023 Off

Rentschler Biopharma, Cell and Gene Therapy Catapult and Refeyn in collaboration

By Dino Mustafić

Rentschler Biopharma, a leading global contract development and manufacturing organisation (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), announces a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of cell and gene therapies, and Refeyn Ltd., the Oxford based mass photometry pioneer.

BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC
June 29, 2023 Off

BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC

By Dino Mustafić

BioNTech and US based OncoC4 today announced that the first patient with non-small cell lung cancer (NSCLC) has been treated in a pivotal Phase 3 trial evaluating the companies’ next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart). The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024, the companies said in a press release Thursday.

June 29, 2023 Off

NetScientific in board changes

By Dino Mustafić

NetScientific, the deep tech and life sciences VC investment group, announces that all resolutions set out in the 2023 Notice of Annual General Meeting sent to shareholders were duly passed at the Company’s Annual General Meeting held earlier today. Resolutions 1 to 9 were passed as Ordinary Resolutions and Resolution 10 was passed as a Special Resolution. 

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.