Written by: Adam Marťák
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Gene therapy reimbursement status in CEE – 5/2024

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 …
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May 13, 2024
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ambiom has presented the practical experience in technology transfer at the BioCentre in Zagreb, Croatia

On the 20th of February 2024, we have 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 …
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March 2, 2024
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FDA has approved 55 new molecules in 2023

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 …
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January 15, 2024
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Pharma Valuation 101: NPV vs rNPV in Drug Development

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 …
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October 6, 2023
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A Freedom-To-Operate analysis – do you need to bother?

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 …
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August 11, 2023
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The 4 largest hospitals in CEE

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, …
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June 30, 2023
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Top 3 news from ASCO 2023

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 …
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June 13, 2023
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ambiom presented current issues in companion diagnostics (CDx) at Central & East European Health Policy Network Oncology Workshop in Bratislava

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 …
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June 6, 2023
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HTA and MEA legislation in Ukraine: New rules in access to medical technology

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. …
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May 12, 2023
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Life science incentives; UAE vs Central Europe

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 …
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March 16, 2023
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CDx expert: “Genomics might only be the tip of the iceberg.”

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 …
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January 19, 2023
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The 4 most expensive single-dose drugs in 2022

In 2019, Novartis’s gene therapy Zolgensma has 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 …
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November 13, 2022
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NGS in clinical routine – where are we in 2022?

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 …
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October 10, 2022
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Life science dealmaking in 2022

The first year with eased-up COVID-19 restrictions, but with significant economic crisis. How did the life science dealmaking fare in the first half of 2022, following the banner year of 2021?  Decrease in IPOs, …
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August 20, 2022
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A year with MDR, does it stifle innovation?

The MD Regulation (MDR) 2017/745 is a recent EU directive on medical devices which entered into full force on 26th May 2021 after a transition period of three years, extended in early 2020 for …
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July 24, 2022
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Companion diagnostics – status in 2022 and future outlook

Companion diagnostics (CDx) is used as a companion to a therapeutic agent to determine its applicability (e.g. predict response to therapy, toxicity...) to a specific person. Commonly, companion diagnostics is named as one of …
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July 5, 2022
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7.9% of drugs entering clinical development were approved by FDA over the past decade.

Clinical research success rates of different disease areas have far-reaching implications in the structure of corporate R&D budgets, pharmaceutical asset valuation and, eventually, M&A activity. The report published in February 2021 considers success rates of clinical …
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July 5, 2022
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Top 3 news from ASCO 2022

The 2022 annual conference of the American Society of Clinical Oncology (ASCO) was held in Chicago between June 3rd-7th, widely recognised as one of the most important oncology gatherings worldwide and perhaps the most …
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June 23, 2022
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IVDR is here – 5 major changes to look out for

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices (shortened to IVDs here for simplicity). IVDR officially entered into force on 25th May 2017 …
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May 31, 2022

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ambiom s.r.o.
Karpatské námestie 7770/10A
831 06 Bratislava
IČO: 54219035

Contact

info@ambiom.com
+421 948 652 276

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