Category: Europe

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

IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated sustained overall survival benefit in advanced liver cancer with an unprecedented one in four patients alive at four years in HIMALAYA Phase III trial

By Dino Mustafić

Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at four years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment.

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. 

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

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.

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.