Articles
European pharma is undergoing regulatory reform aimed at speeding access and balancing innovation with affordability. While new rules and incentives are emerging, major companies often view investment prospects outside Europe as more attractive, even as regional policy shifts seek to strengthen competitiveness.
Major regulatory overhaul in the EUThe European Union’s lawmakers have agreed a provisional pharma package to modernise medicine rules, speed up patient access, and boost competitiveness across the bloc. New provisions include defined periods of data and market protection for novel drugs and tools to improve supply security and antibiotic development. Some industry groups argue the measures still lag behind US incentives, potentially limiting Europe’s investment attractiveness. Reute…
Major regulatory overhaul in the EUThe European Union’s lawmakers have agreed a provisional pharma package to modernise medicine rules, speed up patient access, and boost competitiveness across the bloc. New provisions include defined periods of data and market protection for novel drugs and tools to improve supply security and antibiotic development. Some industry groups argue the measures still lag behind US incentives, potentially limiting Europe’s investment attractiveness. Reute…
11-Dec-2025
2026 looks set to be a landmark year for therapeutics as late‑stage programs convert into global regulatory filings and commercial launches. Advances span neurology, immunology, cardiology, oncology, metabolic disease and rare genetic disorders, driven by targeted biologics, next‑generation cell and gene therapies, and improved small‑molecule and peptide agents. Expect broader access via biosimilars and formulation innovations (e.g., subcutaneous and oral versions), faster patient impact from accelerated pathways, and shifting treatment paradigms as pivotal trial successes translate into regionally staggered approvals and rapid market rollout.
Drug / Asset Developer Indication Expected region(s) Concise regulatory status Pivotal trial Oveporexton Takeda Narcolepsy (orexin‑2 agonist)…
Drug / Asset Developer Indication Expected region(s) Concise regulatory status Pivotal trial Oveporexton Takeda Narcolepsy (orexin‑2 agonist)…
2025 marked a historic breakout for Chinese innovative drugs: total out-licensing deals exceeded $100 billion, with three record-shattering transactions—Sanofi-Pfizer ($1.25B upfront), Hengrui-GSK ($12.5B), and Innovent-Takeda ($11.4B). 66 novel drugs were approved as R&D spending and clinical trials surged. Lower costs (30-40% of US levels) and strength in ADC, GLP-1, and oncology assets drove global giants to aggressively partner with Chinese biotechs. The Hang Seng Innovative Drug Index rose 60% from June, reflecting renewed confidence. DengYueMed views 2025 as China’s true “going-global” inflection point.
As we wrap up 2025, the pharmaceutical landscape in China has undergone a seismic shift, one that positions the country not just as a manufacturing powerhouse but as a global innovator…
As we wrap up 2025, the pharmaceutical landscape in China has undergone a seismic shift, one that positions the country not just as a manufacturing powerhouse but as a global innovator…
A drug launch is the coordinated process of making a new therapy available after regulatory approval. It includes market access, medical education, commercial strategy, sales engagement, marketing, supply chain, safety monitoring, analytics, and patient support. Successful launches drive adoption and long term product impact.
A drug launch is one of the most defining events in the pharma and biotech lifecycle. It marks the moment a therapy moves from years of research and clinical testing into real world availability for patients. Launch success can determine whether a company grows, stalls, or even survives. Below is a clear,…
A drug launch is one of the most defining events in the pharma and biotech lifecycle. It marks the moment a therapy moves from years of research and clinical testing into real world availability for patients. Launch success can determine whether a company grows, stalls, or even survives. Below is a clear,…
In 2026, NHS CIOs will shift focus from flashy AI tools to strategic, outcome-driven platforms that improve clinical care, streamline operations, and deliver measurable value.
AI continued to dominate the conversation in 2025, but in 2026, healthcare CIOs are shifting gears. After a year of rapid adoption and high expectations surrounding artificial intelligence, 2026 is shaping up to be the year CIOs apply a more strategic lens. Not to slow progress, but to steer it in a smarter direction. One that aligns with the NHS 10-Year Plan and delivers on integrated care ambitions. In 2025, we saw the rise of AI copilots across almost every platform imaginable as the world raced to embrace assistance-on-demand. But whil…
AI continued to dominate the conversation in 2025, but in 2026, healthcare CIOs are shifting gears. After a year of rapid adoption and high expectations surrounding artificial intelligence, 2026 is shaping up to be the year CIOs apply a more strategic lens. Not to slow progress, but to steer it in a smarter direction. One that aligns with the NHS 10-Year Plan and delivers on integrated care ambitions. In 2025, we saw the rise of AI copilots across almost every platform imaginable as the world raced to embrace assistance-on-demand. But whil…
Independent survey exposes significant gaps in quality systems, supply chain oversight and data integration as EU GMP regulations tighten
OXFORD, UK, December 9, 2025 — Nearly one in four European pharmaceutical companies remains vulnerable to regulatory risks due to inadequate quality systems, according to new research from NSF, a leading global public health and safety organization.The independent study conducted by Opinium surveyed 100 senior regulatory and quality leaders across Europe and the UK. It found that 23% of companies operate with only basic compliance-level quality systems, exposing them to significant regulatory and operational risks as regulatory authority expectations increase.“European life sciences organizations are facing profound structural changes, from stricter regul…
OXFORD, UK, December 9, 2025 — Nearly one in four European pharmaceutical companies remains vulnerable to regulatory risks due to inadequate quality systems, according to new research from NSF, a leading global public health and safety organization.The independent study conducted by Opinium surveyed 100 senior regulatory and quality leaders across Europe and the UK. It found that 23% of companies operate with only basic compliance-level quality systems, exposing them to significant regulatory and operational risks as regulatory authority expectations increase.“European life sciences organizations are facing profound structural changes, from stricter regul…
The field of oncology is advancing rapidly with innovative anti-tumor therapeutics that enhance efficacy and reduce side effects through technologies like liposomes and albumin-bound formulations.
In the rapidly evolving field of oncology, the development of advanced anti-tumor therapeutics continues to offer new hope for patients battling various forms of cancer. As global healthcare systems grapple with rising cancer incidences, pharmaceutical innovations—particularly in targeted drug delivery systems like liposomes and albumin-bound formulations—are playing a pivotal role in improving treatment efficacy while minimizing side effects. This article explores key advancements in anti-tumor products, highlighting how these formulations are transforming cancer care and the importance of effici…
In the rapidly evolving field of oncology, the development of advanced anti-tumor therapeutics continues to offer new hope for patients battling various forms of cancer. As global healthcare systems grapple with rising cancer incidences, pharmaceutical innovations—particularly in targeted drug delivery systems like liposomes and albumin-bound formulations—are playing a pivotal role in improving treatment efficacy while minimizing side effects. This article explores key advancements in anti-tumor products, highlighting how these formulations are transforming cancer care and the importance of effici…
Digital first healthcare is transforming clinical trial engagement with AI, analytics, and personalised digital tools. Real time insights, adaptive education, and proactive communication strengthen retention, improve data quality, and build trust, helping sponsors deliver more efficient and patient centered trials.
The rise of digital-first healthcare is reshaping how clinical trial sponsors view patient engagement. Once focused primarily on regulatory compliance and data collection, patient engagement is now expanding to include features that improve the patient experience via communication and continuous support throughout the clinical journey. According to McKinsey, most healthcare consumers expect their interactions to be personalized and digitally enabled, implying that trial participa…
The rise of digital-first healthcare is reshaping how clinical trial sponsors view patient engagement. Once focused primarily on regulatory compliance and data collection, patient engagement is now expanding to include features that improve the patient experience via communication and continuous support throughout the clinical journey. According to McKinsey, most healthcare consumers expect their interactions to be personalized and digitally enabled, implying that trial participa…
A guide to the most important roles in clinical research, from CRAs and CTAs to medical monitors, biostatisticians, data managers, and regulatory affairs professionals. Ideal for life sciences professionals exploring career paths in pharma and biotech.
Clinical research is one of the most dynamic and rapidly growing areas within the pharma and biotech industry. As new therapies, technologies, and regulatory expectations evolve, so do the roles that drive clinical development. Whether you are entering the industry for the first time or progressing into a more senior position, understanding the core job functions within clinical research can help you navigate your career path with confidence. 1. Clinical Research Associate (CRA)Often considered the backbone of clinical trials, CRAs mana…
Clinical research is one of the most dynamic and rapidly growing areas within the pharma and biotech industry. As new therapies, technologies, and regulatory expectations evolve, so do the roles that drive clinical development. Whether you are entering the industry for the first time or progressing into a more senior position, understanding the core job functions within clinical research can help you navigate your career path with confidence. 1. Clinical Research Associate (CRA)Often considered the backbone of clinical trials, CRAs mana…
A collection of comments from life science and healthcare leaders regarding the UK's Autumn Budget.
The UK BioIndustry Association (BIA) welcomes key measures in today’s Autumn Budget that support the growth of life science and biotech scale-ups, while flagging concerns over rising costs for laboratory space. Commenting on the Chancellor's Autumn Budget 2025, Jane Wall, Managing Director of the UK BioIndustry Association (BIA), said: "BIA has long argued that outdated limits on venture investment tax incentives and employee share options are holding back the scale-up of life science companies, so we are delighted that the Chancellor has chosen to extend these today. Ahead of the Budget, the CEOs of 200 of our member companies wrote to the Chancellor calling for these changes, so we are pl…
The UK BioIndustry Association (BIA) welcomes key measures in today’s Autumn Budget that support the growth of life science and biotech scale-ups, while flagging concerns over rising costs for laboratory space. Commenting on the Chancellor's Autumn Budget 2025, Jane Wall, Managing Director of the UK BioIndustry Association (BIA), said: "BIA has long argued that outdated limits on venture investment tax incentives and employee share options are holding back the scale-up of life science companies, so we are delighted that the Chancellor has chosen to extend these today. Ahead of the Budget, the CEOs of 200 of our member companies wrote to the Chancellor calling for these changes, so we are pl…
As the biologics landscape accelerates toward increasingly complex, hybrid modalities, Syngene is positioning itself at the nexus of chemistry and biology. We sat down with Peter Bains, MD & CEO of Syngene International at CPHI Frankfurt, to discuss how the company is responding to this shift — from recent investments in peptide synthesis and ADC bioconjugation to the expanding expectations of CDMO partners, the growing role of automation, and India’s emergence as a global scientific force. In our conversation, Bains offers a clear view of how integrated capabilities, digital maturity, and cross-functional collaboration are shaping the next era of drug development.
1) Syngene has made two significant investments recently — in peptide synthesis and ADC bioconjugation. What do these mov…
1) Syngene has made two significant investments recently — in peptide synthesis and ADC bioconjugation. What do these mov…
Vendor neutral MSP models give life sciences organisations a scalable and transparent way to manage post market surveillance. By combining real world data expertise, merit based staffing and continuous quality oversight, they deliver faster insights, stronger compliance and a more agile response to global regulatory demands.
In a complex regulatory environment, post-market surveillance is a continuous process that demands precision, adaptability and scale. As life sciences organizations increasingly rely on real-world data to understand the long-term safety and performance of medical products, the workforce behind these efforts must be equally dynamic. This is where the vendor-neutral MSP post-market surveillance model comes into play. Challenges in Traditional Device Monitoring Traditiona…
In a complex regulatory environment, post-market surveillance is a continuous process that demands precision, adaptability and scale. As life sciences organizations increasingly rely on real-world data to understand the long-term safety and performance of medical products, the workforce behind these efforts must be equally dynamic. This is where the vendor-neutral MSP post-market surveillance model comes into play. Challenges in Traditional Device Monitoring Traditiona…
UK Biobank is a world leading health data resource that supports breakthroughs across genomics, AI and drug development. Its scale, depth and open research model make it central to the future of UK life sciences and a critical driver of innovation, investment and talent demand.
UK Biobank is one of the most ambitious population health research resources in the world. Launched in 2006, it holds in depth health, lifestyle and genomic data from half a million UK participants. Its scale, diversity and long term follow up make it a cornerstone of modern biomedical research. For the UK life sciences sector, it is becoming even more influential as new technologies transform the way data can be analysed and applied. At its core, UK Biobank provides a uniquely comprehensive view of human health. Par…
UK Biobank is one of the most ambitious population health research resources in the world. Launched in 2006, it holds in depth health, lifestyle and genomic data from half a million UK participants. Its scale, diversity and long term follow up make it a cornerstone of modern biomedical research. For the UK life sciences sector, it is becoming even more influential as new technologies transform the way data can be analysed and applied. At its core, UK Biobank provides a uniquely comprehensive view of human health. Par…
Pharmacovigilance (PV) is an essential component in the patient safety system to find, evaluate and prevent adverse effects for medicinal products. As the life sciences sector continues to mature beyond national boundaries, pharmaceutical and biotech companies are given a strategic option — to choose global pharmacovigilance consulting services, or local PV partners.
Global vs Local Pharmacovigilance Consulting Partner Pharmacovigilance (PV) is an essential component in the patient safety system to find, evaluate and prevent adverse effects for medicinal products. As the life sciences sector continues to mature beyond national boundaries, pharmaceutical and biotech companies are given a strategic option — to choose global pharmacovigilance consulting services, or local PV partners. Each ap…
Global vs Local Pharmacovigilance Consulting Partner Pharmacovigilance (PV) is an essential component in the patient safety system to find, evaluate and prevent adverse effects for medicinal products. As the life sciences sector continues to mature beyond national boundaries, pharmaceutical and biotech companies are given a strategic option — to choose global pharmacovigilance consulting services, or local PV partners. Each ap…
Recombinant Human Albumin Injection (Oryza Sativa), or OsrHSA, is a plant-based therapy for hypoalbuminemia (≤30 g/L) in cirrhosis patients, developed by Wuhan Healthgen Biotechnology. Produced from rice grains, it provides a safe alternative to plasma-derived albumin, free from pathogen risks and supply issues. Approved by China's NMPA on July 18, 2025, phase III trials showed non-inferior efficacy in increasing albumin levels and managing ascites. The NCT06355479 study confirmed its safety in decompensated cirrhosis. Hong Kong wholesalers like DengYuePharma specialize in exporting such rare drugs globally, boosting access. This advances sustainable biotech in liver care.
Hypoalbuminemia, characterized by serum albumin levels ≤30 g/L, is a common complication in patients with cirrhosis, of…
Hypoalbuminemia, characterized by serum albumin levels ≤30 g/L, is a common complication in patients with cirrhosis, of…
Life‑science senior professionals succeed through strategic networking: set clear goals, engage both online and offline, nurture genuine relationships, add value, and stay consistent to turn contacts into career‑fuelled opportunities.
Senior professionals in the life sciences must approach networking with strategic intention; not simply exchanging business cards. First, clarify your goals: Are you looking for new collaborations, mentorship, or insights into emerging sectors? Effective networking starts with preparation. Research events, identify key attendees, and craft a concise elevator pitch that clearly reflects your expertise and objectives. Leverage both in‑person and online channels. Attend conferences and workshops to connect face‑to‑face; engage on platforms like LinkedIn by…
Senior professionals in the life sciences must approach networking with strategic intention; not simply exchanging business cards. First, clarify your goals: Are you looking for new collaborations, mentorship, or insights into emerging sectors? Effective networking starts with preparation. Research events, identify key attendees, and craft a concise elevator pitch that clearly reflects your expertise and objectives. Leverage both in‑person and online channels. Attend conferences and workshops to connect face‑to‑face; engage on platforms like LinkedIn by…
A just-published report from a House of Lord Select Committee has highlighted several critical issues facing the UK’s vital life sciences sector. Leading academic Ivan Wall, Professor of Regenerative Medicine at the University of Birmingham, says the report makes a vital contribution to the debate around the UK’s viability to realise its full potential in this key area, but notes its failure to address a critical underpinning element – the need to train a new generation for working in the sector.
A just-published report from a House of Lord Select Committee has highlighted several critical issues facing the UK’s vital life sciences sector. The report follows the news in recent weeks that Merck has scrapped a £1 billion investment in the UK, AstraZeneca has paused projects, and Eli Lilly ha…
A just-published report from a House of Lord Select Committee has highlighted several critical issues facing the UK’s vital life sciences sector. The report follows the news in recent weeks that Merck has scrapped a £1 billion investment in the UK, AstraZeneca has paused projects, and Eli Lilly ha…
Innovation in drug development has never moved faster! New modalities, real-world evidence, complex patient stratification, and AI are reshaping what’s possible. Yet one of the biggest bottlenecks remains stubbornly constant: the fragmented, slow, and opaque way that benefits–risk assessments are built and communicated between pharma innovators and regulatory bodies.
In all honesty, the risk-benefit process for drug approvals has barely evolved in the last twenty years. The emergence of AI has created a huge opportunity for players to disrupt this market and look at ways to transform how new drugs are evaluated and approved. This new type of technology is finally equipping regulators and companies with tools to assess, in real time and from large, diverse data, how likely a drug is t…
In all honesty, the risk-benefit process for drug approvals has barely evolved in the last twenty years. The emergence of AI has created a huge opportunity for players to disrupt this market and look at ways to transform how new drugs are evaluated and approved. This new type of technology is finally equipping regulators and companies with tools to assess, in real time and from large, diverse data, how likely a drug is t…
30-Oct-2025
Precision-fermented proteins offer the tantalising prospect of radically uncoupling our nutrition from arable land. However, the journey from laboratory titre to multi-kiloton commodity supply chains has many non-trivial hurdles in between.
Protein fermentation describes the microbial population's controlled breakdown and build-up of nitrogenous compounds under specific redox potential, pH balance and substrate limitation constraints. The process generally begins with the extracellular degradation of high molecular weight proteins. Protein hydrolysis by microbial aspartic proteases (fungi) or metalloproteases (bacteria) yields oligopeptides (2–20 residues) that are taken up into the cell via specific oligopeptide permeases. Intracellular di- and tri-peptidases further hydrolyze peptide…
Protein fermentation describes the microbial population's controlled breakdown and build-up of nitrogenous compounds under specific redox potential, pH balance and substrate limitation constraints. The process generally begins with the extracellular degradation of high molecular weight proteins. Protein hydrolysis by microbial aspartic proteases (fungi) or metalloproteases (bacteria) yields oligopeptides (2–20 residues) that are taken up into the cell via specific oligopeptide permeases. Intracellular di- and tri-peptidases further hydrolyze peptide…
30-Oct-2025
In chemistry, materials science and many industries, polyethylene glycol (PEG) and ethylene glycol (EG) are two very crucial chemicals. Both are structurally similar but very different in terms of physical characteristics, chemical characteristics and functional fields.
Chemical Structure and Molecular Weight Polyethylene Glycol is the polymer form of EG, with its molecular weight varying depending on the degree of polymerization. The molecular weight of PEG generally ranges from hundreds to tens of thousands, while EG has a molecular weight of only 62. This difference in molecular weight leads to significant differences in their physical properties and applications. The polymer structure of PEG gives it higher viscosity and better biocompatibility, whereas EG's low molecular weight r…
Chemical Structure and Molecular Weight Polyethylene Glycol is the polymer form of EG, with its molecular weight varying depending on the degree of polymerization. The molecular weight of PEG generally ranges from hundreds to tens of thousands, while EG has a molecular weight of only 62. This difference in molecular weight leads to significant differences in their physical properties and applications. The polymer structure of PEG gives it higher viscosity and better biocompatibility, whereas EG's low molecular weight r…
