Robert Kim

EU Pharma Package exclusivity timelines: what innovators can do now

The EU Pharma Package revision is designed to improve timely, equitable access to medicines and strengthen supply security across the bloc. This plan focuses on the current exclusivity framework, the proposed revision, and the specific questions innovators are asking.

EMA board backs Ebola response, flags 2025 annual report at June meeting

EMA’s Management Board met in June 2026 and highlighted the Agency’s support for the Ebola outbreak response in Africa. The board also gave a positive assessment of EMA’s 2025 annual activity report.

EMA Tightens Liver Safety Checks for Tavneos After Fatal Cases

EMA's PRAC has tightened monitoring and stopping rules for Tavneos (avacopan) after reviewing serious liver injury cases, including fatal outcomes. The update adds liver injury as a rare side effect and creates a new regulatory watchpoint for Amgen and ANCA-associated vasculitis teams.

China Becomes Big Pharma's Essential R&D Partner

Pharmaceutical Executive journal coverage shows China’s role in drug development has expanded from a source of molecules to a core R&D partner. Official and market data confirm China is now the world’s second-largest pharmaceutical industry and holds about 30% of innovative drugs in development.

Novo wins UK approval as race to launch weight-loss pill intensifies

Novo Nordisk won UK approval for its oral Wegovy weight-loss pill, making the UK the first European market to allow access. The decision strengthens Novo’s lead in the oral GLP-1 race as Eli Lilly advances orforglipron.

MHRA targets medicine safety with new AI sandbox

MHRA targets medicine safety with a new AI sandbox designed to let innovators test AI systems under regulatory supervision. The programme is intended to improve safety, speed development, and reduce reliance on animal testing.

EMA researchers map AI research priorities across the medicines lifecycle

EMA researchers and collaborators ran a survey to identify priority research areas for AI across the medicines lifecycle, from development to post-authorization monitoring. The top priority across all groups was accuracy and reliability of AI tools.

AI in Drug Discovery Examples: What’s Changed Beyond Early Use Cases

AI in drug discovery examples now extend beyond target finding into trial design, patient stratification, and regulated evidence generation. For BD teams and investors, the key shift is from standalone tools to systems that can influence the full development chain.

EMA Post Authorisation Guidance Faces Evidence Gaps After 10 Years

EMA post authorisation guidance is central to how the EU tracks safety and lifecycle changes after approval. For BD teams, investors, and analysts, the key issue is what the framework can prove today—and where incomplete evidence still limits decision-making.

EMA approves TX01 PIP, unlocking the PUMA pathway for Theranexus and Exeltis

THX Pharma (Theranexus) and Exeltis have secured EMA approval of the paediatric investigation plan (PIP) for TX01. The decision unlocks the PUMA registration pathway and is tied to 10 years of European market protection in Niemann-Pick type C disease.

Europe Drug Prices Face Pressure as U.S. Benchmarking Tightens

Europe drug prices are under fresh pressure as companies weigh how lower pricing in Europe could affect U.S. pricing power. The result may reshape launch sequencing, access strategy, and competitive positioning across major EU markets.

KRX IR Reference : Executive Summary Plan for SCD NDR (ENG, Jun 2026)

This page should frame the KRX English IR reference as a company disclosure/investor-relations document and give readers a concise way to navigate its purpose and likely themes. Keep the summary factual and avoid adding performance or product claims not present in the source.

EU secures emergency Favipiravir deliveries for hantavirus response

The European Commission said the EU has secured emergency deliveries of experimental Favipiravir for hantavirus, with first doses going to France, Spain and the Netherlands. The move appears aimed at strengthening preparedness and faster access if cases rise further.

World Lightproof Bottle Opaque Liners Market: Pharma Growth to 2035

The global lightproof bottle opaque liners market is projected to grow at a 6.0% CAGR from 2026 to 2035, driven by increasing demand for UV-sensitive biologic drug packaging. This analysis provides key insights for pharmaceutical business development and strategy teams.

EC nod for Chiesi Lojuxta for pediatric HoFH: what it means for pharma

The European Commission has expanded Lojuxta's indication to include children aged 5 years and older with homozygous familial hypercholesterolemia. This analysis covers the regulatory shift, implications for Chiesi's rare disease franchise, and what investors and BD teams should monitor next.

New EU Template for Clinical Trial Recruitment and Informed Consent: What Pharma Teams Need to Know

The European Medicines Agency (EMA) has introduced a new harmonised template for participant recruitment and informed consent procedures in clinical trials. This article explains the key changes, their impact on pharmaceutical companies, and answers frequently asked questions.

Maersk Europe Market Update June 2026: Key Changes for Pharma Supply Chains

Maersk's June 2026 Europe market update details emergency bunker surcharges, war risk premiums, and ongoing port congestion. This analysis explains the implications for pharmaceutical supply chains, freight costs, and strategic planning.

FDA Voucher Program Pause Urged: Rare Disease Policy Analysis

Drug companies and patient groups are urging the FDA to pause its commissioner's voucher program, citing concerns over political meddling in rare disease drug reviews. This analysis tracks the policy shift and its implications for pharma business development and investment teams.

The Baker Company Benelux BV joins EuropaBio: Advancing cell culture and lab safety technologies

The Baker Company Benelux BV has joined EuropaBio, the European Association for Bioindustries, to advance cell culture and lab safety technologies. This membership signals a strategic push to align biosafety cabinet innovation with European biotech regulatory frameworks.

Staff Stick: A B2B Guide to the Dual Meaning and Pharma Context

This article clarifies the dual meaning of 'staff'—as a stick and as employees—and applies it to a competitive benchmarking analysis of EuropaBio's team structure for pharma analysts and BD teams.

MFN Drug Pricing Reshapes International Life Sciences Licensing Deals

The Most Favored Nation (MFN) drug pricing policy is fundamentally altering the landscape for international life sciences licensing deals. This analysis explores how MFN pricing introduces sustained downward pressure on U.S. list prices, reshapes valuation and diligence, and creates new strategic considerations for BD teams and investors.

Japan Grants Orphan Status to QRX003 for Netherton Syndrome: Implications for Pharma Teams

Japan's MHLW has granted orphan drug designation to Quoin Pharmaceuticals' QRX003 for Netherton syndrome, a rare skin disorder with no approved treatment. This designation provides up to 10 years of market exclusivity and priority review, signaling a significant regulatory milestone for the candidate.

데일리팜 리크루트: Vyloy (zolbetuximab) Reimbursement Progress and Market Implications for Gastric Cancer

Vyloy (zolbetuximab) has passed the HIRA Pharmacoeconomic Evaluation Subcommittee and is set for Drug Reimbursement Evaluation Committee review. This analysis covers the clinical evidence, regulatory milestones, and strategic implications for pharma stakeholders.

From Approval to Access: Europe’s Next Health Imperative for Pharma

Despite EMA approvals, patients across Europe face delayed or no access to new medicines. This analysis examines the systemic barriers, the EU Pharma Package response, and the strategic implications for European pharma companies and investors.