Dr. Elena Rossi PhD Pharmaceutical Sciences

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.

FDA approves capivasertib plus abiraterone and prednisone in PTEN-deficient mHSPC

The FDA approved capivasertib plus abiraterone and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer. The move creates a new catalyst for AstraZeneca’s Truqap and adds a biomarker-defined prostate cancer use to track.

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.

BioCryst’s New ORLADEYO Data Adds Real-World HAE Evidence

BioCryst Pharmaceuticals is presenting new clinical data and real-world evidence for ORLADEYO (berotralstat) in hereditary angioedema. The update matters because it expands the evidence base around an FDA-approved oral prophylactic option for adults and pediatric patients 2 years and older.

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.

Truqap gains US approval in PTEN-deficient metastatic prostate cancer

AstraZeneca’s Truqap (capivasertib) has been approved in the US with abiraterone and prednisone for PTEN-deficient metastatic prostate cancer. The move creates a first-in-class targeted option and a new catalyst to watch for BD teams, investors, and analysts.

Duty of care at oncology conferences spotlights planetary health research

Nature’s June 11, 2026 editorial argues for better amplification of planetary health research at oncology conferences. The piece links climate and environmental disruption to cancer risk and frames the issue for cancer-care stakeholders.

Synthetic real-world data reshapes oncology trial decision-making

Synthetic real-world data is being positioned to support oncology clinical trials by helping construct external control groups. Evidence also points to frameworks for evaluating how generalizable oncology randomized trial results are to real-world practice.

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 approved 104 human medicines in 2025: what changed

EMA recommended 104 medicines for marketing authorisation in 2025, with 38 new active substances and a record biosimilar share. The update matters for BD teams, investors, and analysts tracking EU regulatory catalysts and near-term competitive readouts.

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.

CHMP backs nerandomilast for IPF and PPF in EU

The EMA’s CHMP has issued a positive opinion recommending marketing authorization for Jascayd (nerandomilast) in the EU for adults with IPF and PPF. For BD teams and investors, the key catalyst is the next European Commission decision and how the asset fits into the fibrosis treatment landscape.

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.

Eye drugs list: Sodium hyaluronate, tafluprost, tobramycin uses

This plan organizes a tightly sourced Eye drugs list around dry eyes, glaucoma, and eye infections. It keeps the focus on what the evidence confirms and avoids unsupported market or investment claims.

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.

EMEA 2026 Life Sciences Report: Key Market Shifts for Pharma BD and Investors

JLL's EMEA 2026 Life Sciences Industry & Cluster Report highlights strong public market performance, rising venture capital flows, and the transformative impact of AI on European life sciences clusters. The analysis provides actionable intelligence for pharma business development teams and investors navigating the evolving landscape.

Federal Court Litigation on Reproductive Health: Rare Disease Implications

This analysis examines recent federal court litigation involving reproductive health and rights, with a specific focus on implications for rare disease drug development and regulatory pathways. It provides decision-useful insights for pharma business development teams, investors, and analysts tracking FDA policy changes.