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Europe

‘Our Commitment Is Serious’: Fresenius Kabi’s CEO Pierluigi Antonelli On Biosimilars And Beyond

Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company’s CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company’s results so far and how it’s investments in biosimilars, acquisitions and manufacturing is paying off.

Therapeutic Or Cosmetic? Patent Strategies For Dual-Use Innovations

In the pharma and cosmetic sectors, innovation often arises from new uses for known compounds. While the compounds may not be patentable, their new applications can be. European law allows patents on substances used in medical methods, but not on the methods themselves.

EU Countries Unite On Confidentiality For National Consultations On Joint Clinical Assessments

The Member State Coordination Group on HTA has also resolved to improve information sharing with drug developers to improve resource planning for EU-level joint clinical assessments.

Stada Breaks The €4bn Barrier Ahead Of Potential IPO – Sooner Or Later?

Stada has set out annual results that it says demonstrate that the German firm is outperforming the market in all of its business segments, with the company breaking the €4bn sales barrier for the first time. The results come ahead of a long-awaited potential IPO that conflicting rumors suggest could either come very soon indeed, or may be delayed until later this year.

Big Pharma Backing For Sofinnova Biotech Acceleration Plans In Europe

The Biovelocita II fund is supported by the likes of Amgen, Bristol Myers Squibb and Pfizer

Industry Welcomes Critical Medicines Act But With Mixed Responses

The EU’s Critical Medicines Act is finally here. But did the European Commission’s decision to fast-track the legislation result in it falling short?

Richter Welcomes Generic Xarelto And Pradaxa Impact As Revenues Climb In 2024

Gedeon Richter enjoyed a solid 2024 as it capitalized on key generic launches and progressed significantly with proposed biosimilars to both Prolia/Xgeva and Actemra/RoActemra. The Hungarian firm also shed light on its strategy over the next decade in a newly-launched ten-year strategic plan.

Germany: Standardized Clauses In Clinical Trial Agreements Bring Opportunities But Also Tougher Negotiations

Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.

New EU Project Could Make Comparative Rare Diseases Trials More Feasible For Companies

A new Innovative Health Initiative project will see the German health technology appraisal (HTA) body, IQWiG, work towards ensuring evidence generated in clinical studies meets the needs of HTA bodies and regulators.

Spain Boosts Transparency On Reimbursement Decisions And Sheds Light On Agreements With Companies

The first reimbursement reports published by the Spanish health ministry to improve transparency focus on CSL’s Hemgenix, BMS’ Camzyos and Pfizer’s Velsipity.