Paradoxically, in a place not exactly known for its digital legacy, in 2019, a major change in the approach towards the reimbursement of digital health solutions has been put forward. The German Digital Healthcare …
Recently, the FDA has requested Sarepta Therapeutics, Inc., a Massachusetts-based biopharmaceutical company, to suspend all distribution of its DMD gene therapy Elevidys (delandistrogene moxeparvovec), following the deaths of three patients—two non‑ambulatory teenagers and one …
ambiom is helping to make the European tech transfer more effective. We are very glad the EIT Higher Education Initiative has awarded IMPACTWHEEL funding as part of their Call for Proposals 2024. IMPACTWHEEL is …
Introduction If you asked us (and many other industrial consultants) what one of the most common commercial strategy mistakes we see in otherwise well-positioned early-stage companies is, without a doubt, it would be the …
We spoke in detail about our activities at BeyondBiotech podcast, you can listen to the episode here: https://podcast.labiotech.eu/1995493/episodes/16219760-cracking-the-code-of-biotech-valuations
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 …
On the 20th of February 2024, we had the opportunity to present our experience and know-how on the online webinar hosted by the BioCentre in Zagreb, to the audience of early-stage life science entrepreneurs, …
With a focus on addressing a wide spectrum of diseases and conditions, the US witnessed the most novel drug approvals in 6 years. Here we provide an overview of the key highlights in treatments …
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 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, Belgrade, …
ambiom · asco · breast cancer · companion · drug development · NGS · pancreatic cancer · rectal cancer · Uncategorized
American Society of Clinical Oncology (ASCO) Annual Meeting was held between the 2nd and 6th June in Chicago, 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 a significant step forward in improving access to treatment in the …
The 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 …
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 …
In 2019, Novartis’s gene therapy Zolgensma made news as the „most expensive single-dose drug ever“ with $2.125 million. Just 3 years later, as of November 2022, bluebird bio’s Skysona, with the price tag of …
Next-generation sequencing (NGS)—a form of DNA sequencing that can examine millions of DNA molecules simultaneously—is proving to be crucial to the successful execution of the concept of precision medicine in oncology, but its utility …
