The biotech industry in 2024 has seen several high-profile patent disputes that have shaped the landscape of innovation and legal precedent. These cases have centered around cutting-edge technologies such as CRISPR gene editing, mRNA …
Earlier this year the FDA has introduced significant regulatory changes for Laboratory Developed Tests (LDTs) to enhance their oversight and ensure higher standards of safety and effectiveness. These changes align LDTs with the regulatory …
As of December 2023, 10 FDA-approved gene therapies were available. Based on existing development programs, 30-50 additional gene therapies are expected to be FDA-approved by 2030. The impact on treatment outcomes but also the …
With a focus on addressing a wide spectrum of diseases and conditions, US witnessed the most novel drug approvals in 6 years. Here we provide an overview of the key highlights in treatments that …
Drug development is a complex and resource-intensive process that involves significant investments in research, clinical trials, and regulatory activities. As pharmaceutical companies evaluate the potential of assets they employ various financial metrics. Two commonly …
When a company is in the process of strategizing the development and release of a new product, a notable concern arises, especially in technology-driven fields abundant with patents. The risk is the potential impedance …
The CEE region is home to some of the Europe's most complex clinical centres. Here we took a closer look at the largest ones of them, by bed number. 1. Clinical Centre of Serbia, …
American Society of Clinical Oncology (ASCO) Annual Meeting was held between the 2nd and 6th June in Chcago, USA. As the last year, here we look at the top 3 highlights we take from …
On 1st of June 2023, the Central & East European Health Policy Network (CEE HPN) organized an oncology workshop in Bratislava, Slovakia. The workshop theme was: ,Discussion on prevention, diagnosis and treatment of oncological …
The new managed entry agreement (MEA) and health technology assessment (HTA) regulations adopted in Ukraine over the course of 2020 and 2021 present significant step forward in improving access to treatment in the country. …
UAE has become one of the leading Middle Eastern countries in the biotechnology and pharmaceutical industry due to its heavy investment and development in the sector. In particular, the Dubai Free Zones and the …
It will soon be 25 years since the first CDx assay came to the market paving the way for the start of the era of personalized treatment. We have discussed the last 25 years …