Bringing a new drug to market can cost billions. Here’s the tally for each phase of a clinical trial—and how those costs dictate what you pay at the pharmacy.

Clinical trials are the scientific engine behind nearly every new innovative therapy for chronic conditions including autoimmune, genetic, and neurological disorders. Rigorous studies are especially important for developing treatments for rare conditions that have historically received less research attention. Without them, life-saving discoveries made in laboratories would never reach those who are diagnosed with these diseases.

Even so, conducting a clinical trial is an enormous undertaking, often requiring more than a decade to organize and running up serious sums to launch and see through, according to recent research that details how drug development can take 10 to 15 years from discovery to approval for clinical use, costing anywhere between $1 billion to $2 billion.

Read more at: Health Central

 What does our CEO Carsten Faltum think about the FDA’s new stance that a single pivotal trial is now the default for full drug approval?

Click below to see what Carsten discussed with BioSpace - what this means for drug development, why trial design quality matters more than ever and how Celex Oncology Innovations Ltd’s pancreatic cancer programme was built around this approach from the outset.

Read his perspective in full in BIOSPACE

We’re pleased to see our Director and General Counsel, Larry Cohen, published today in Life Science Daily News.

In this article, Larry explores a critical issue facing biotech companies as innovation accelerates: how to communicate emerging science responsibly without creating unintended regulatory or commercial risk. The piece examines the interplay between real-world evidence, intellectual property strategy and off-label use, and why disciplined communication has become a strategic capability rather than a compliance exercise.

At Celex Oncology Innovations Ltd Oncology, we believe that strong governance and responsible innovation go hand in hand. Clear thinking at the intersection of law, regulation and science is essential to translating promising biology into durable clinical and commercial outcomes.

Congratulations to Larry on a thoughtful contribution to an important industry conversation.

The Full story can be read on: Life Science Daily

This November, during Pancreatic Cancer Awareness Month, we’re reflecting on where new hope is emerging in one of the hardest cancers to treat.

About 90% of pancreatic cancers carry a mutation called KRAS -  a change that helps tumours grow and spread without any restrictions.

At Celex Oncology Innovations Ltd, our research focuses on voltage-gated sodium channels (VGSCs) - molecules that sit upstream of KRAS and influence how aggressive cancer cells become.

Let’s take a look at what our CEO Carsten Faltum says about why new treatment methods are needed.

By understanding and targeting these early drivers of tumour behaviour, we aim to help pave the way for future approaches that may one day slow or better manage the spread of pancreatic cancer.

Because when you decode how cancer is progressing, you can start to control it.

Celex Oncology Innovations Ltd was recently highlighted in Pink Sheet’s article, “EU Pharma Reform: Lawyers Unpack Diverging Visions for Innovation,” where we shared our insights on harmonising HTA, incentive models and launch strategies across Europe.

This spotlight aligns perfectly with our core mission at Celex Oncology:
⚕️Bioelectric‑driven oncology: We’re pioneering inhibitors of voltage-gated sodium channels (VGSCs), such as Nav 1.5, which uniquely target tumour cell aggression, a mechanism backed by strong preclinical and real-world data
⚕️Transforming metastatic care: Our proprietary pipeline targeting tumour metastasis is advancing through preclinical stages toward clinical development.
⚕️European expansion and equity: As EU regulations evolve, our work underscores why coherent HTA frameworks and pan-EU launch incentives are vital to ensure innovative, life-extending therapies like ours reach every patient in Europe without delay

With the EU refining its pharma package and global market access trends intensifying, Celex Oncology stands ready to deliver on its promise: turning invasive tumours benign, extending life and preserving quality through groundbreaking science and strategic launch excellence.

➡️Read the full Pink Sheet feature to discover how we’re shaping the future of oncology innovation and access in Europe. Connect with us to explore opportunities for collaboration, investment or partnership.

Full Article here on Pink Sheet

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By Katia Schlienger, MD, Ph.D., chief medical officer, Celex Oncology Innovations, Ltd.

Small biotech companies face significant challenges when advancing new drugs from early development into clinical trials, especially in oncology. While they often partner with CROs for Phase 1/2, first-in-human, Phase 2b/3, or RWE studies, this approach is not ideal as biotechs, which must ensure patient safety first, have to establish a parallel internal framework to oversee the CRO (biotechs retain full regulatory responsibility when working with CROs).

This oversight demands substantial internal expertise and a significant expansion of their organization to address additional governance structures. Specifically, small biotechs lack the infrastructure to oversee CRO-run trials, requiring the hiring of new teams for project management, operations, quality control, regulatory compliance, safety monitoring, biomarker strategy, analytics, and clinical site management - functions larger pharmaceutical companies typically manage in-house. Furthermore, managing multiple vendors, ensuring data integrity across different systems, navigating fragmented trials, and coordinating with external oversight bodies, such as data and safety monitoring boards (DSMBs), all add considerable complexity and inefficiency.

Adaptive trial designs, which permit planned modifications in response to ongoing trial data, together with real-world evidence (RWE) approaches, promise to soften some of these burdens – for example, by improving trial flexibility, better aligning the trial protocol with patients’ actual care settings, and boosting evidentiary support for regulatory and commercial decision-making. Yet, adopting adaptive trials and integrating RWE still require robust oversight, regulatory clarity, and organizational capacity — issues small biotechs must address to benefit from these evolving methods.

Read the full story at Clinical Leader

Surgery, chemotherapy, radiotherapy, and immunotherapy are designed to kill cancer, but what if we could control cancer?

Cancer care has seen remarkable progress with targeted therapies, AI-enabled diagnostics and early detection tools. However, treatment approach has remained static for decades, focusing on eliminating primary tumours and killing cancer. The reality is that patients are at the mercy of metastasis, which is responsible for 90% of cancer deaths. Are we stuck in a paradigm that we are struggling to escape?

Foundational assumptions need challenging, including the idea that cancer cells must be eliminated at all costs. What if we approached cancer differently? What if cancer is something to be managed and controlled over time, like diabetes, which over 100 years ago saw a shift in the approach from cure to management?

Here, we explore gaps in oncology and cancer care, proposing a collective call for intelligent innovation and radical collaboration. Together we can work towards the fourth revolution in cancer care, prioritising control, quality of life, and long-term management.Read more at PharmaPhorum