Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The primary HTA authority is the Saudi Food and Drug Authority (SFDA), which hosts a dedicated HTA/Economic Evaluation Unit established in 2023. Its main responsibility is to evaluate clinical and economic evidence (EES) for: New…
Pharma Legal Handbook 1.Price Control How does price control at ex-factory prices work in your country? Ex-factory prices are strictly regulated by the Saudi Food and Drug Authority (SFDA) using External Reference Pricing (ERP). SFDA sets a Ceiling CIP price based on the lowest value from a basket of 34 reference countries. Manufacturers…
Denmark Despite its diminutive size, Denmark boasts a world-renowned healthcare and life science industry containing both household pharma giants as well as a robust network of academia, a host of niche service providers, and a growing throng of biotech start-ups. And with life science exports surpassing EUR 23 billion last year…
Denmark When it comes to Denmark’s flourishing local biotech scene, the country is again clearly punching far above its weight. The EU member state has already managed to muster world-class expertise in areas like peptide chemistry and metabolic disorders, anchored by the success stories of homegrown entities that made it big…
Switzerland Marc Gitzinger, CEO and Founder of BioVersys, launched the company from his doctoral research at ETH Zurich on antibiotic resistance. Bioversys began with a tuberculosis programme; today, it owns two proprietary platforms to develop new antibiotics and leads with BV-100, advancing to Phase III for severe hospital infections. Gitzinger also…
Switzerland Kasha Witkos, Senior Vice President and Head of International Business at Alnylam Pharmaceuticals, shares her journey from academic researcher to global biotech leader, driven by personal family experience of chronic disease. Witkos highlights Alnylam’s pioneering role in delivering RNA interference (RNAi) technology to patients around the world, the company’s global…
China 3D Medicines has charted a deliberate path from domestic clinical execution to global oncology innovation. Since its IPO, the company has sharpened its focus on differentiated assets like Envafolimab, while expanding into radioligand and mRNA-based platforms with broad therapeutic potential. Chairman and CEO Dr John Gong outlines how strategic discipline,…
Switzerland Eight years after establishing its Swiss affiliate as a one-man operation, Accord Healthcare has built a strong position in one of Europe’s most competitive markets, with a focused strategy in oncology, rheumatology, and neurology. In this interview, Country Director and General Manager Richard Hummel reflects on the affiliate’s rapid growth,…
USA Neurvati Neurosciences is carving a distinctive path in one of medicine’s most high-risk arenas: neuroscience. In this interview, President and CEO Dr Bruce Leuchter explains how a private equity-inspired model, backed by Blackstone Life Sciences, is enabling the company to advance late-stage assets, forge global partnerships, and build a values-driven…
MEA The Middle East and Africa (MEA) pharmaceutical market is booming. According to IQVIA, the market reached USD 32.6 billion in value last year with value sales growth at 10.5 percent versus the previous year. Saudi Arabia, the largest market in MEA at USD 11.6 billion in value, expanded at 9.1…
USA The latest stories from healthcare and the life sciences in the US. RFK Jr shares his 128 recommendations for addressing childhood chronic disease; Suspension of Capsida’s gene therapy clinical trial after patient death; Courts half another attempt to challenge the IRA’s negation program; Takeda scoops up former Lilly exec to…
USA Jake Becraft, Co-founder and CEO of Strand Therapeutics, explains their innovative autonomous medicine platform that targets gene expression for precise cell-specific genetic therapies. Focusing initially on cancers like melanoma and breast cancer, the company aims to overcome current therapy limitations and build a fully integrated biotech, while tackling industry challenges…
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