Market Access

The US pharmaceutical market is critical for European pharma companies, but new policies introduced by the Trump administration are creating an increasingly complex and uncertain environment for them.

With the separation from its parent company now behind it, Samsung Bioepis celebrated its highest-ever annual revenues and outlined its vision of further growth.

Conclusion of India-EU talks sets ground for a free trade agreement to cut pharma tariffs, in turn lowering the cost for novel drugs like Novo’s obesity treatment Wegovy, though an investment protection agreement – likely influencing data exclusivity – will be concluded later.

An India-EU trade deal sets ground for a free trade agreement to lower tariffs on pharma, though an investment protection agreement – likely influencing data exclusivity – will be concluded later. Will the US now reconsider its India tariffs?

ACC/AHA guidelines are reshaping US payer policies, expanding coverage and access to breakthrough cardiovascular therapies like SGLT2 and PCSK9 inhibitors. But costs, red tape, and uneven access still stand in the way.

The medtech industry has been disrupted by tariffs and China’s volume-based procurement policies. While India is expected to emerge as a key long-term growth market, near-term upside may come from a potential rebound in EU attractiveness following the MDR reform proposals in December 2025.

In line with previously disclosed launch and partnering plans for GLP-1 products, Lupin shook hands with Galenicum, securing commercial rights to injectable semaglutide.

Generics Bulletin reviews global regulatory developments across the world.

Two major EU trade agreements are on hold, with ramifications for the pharmaceutical market.

Hyloris and Orion continue to build on their partnership with another value-added medicine collaboration in Europe.

BMS tells Scrip it will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company

Zydus is to gain from a world-first nod for a Menkes disease drug in the US amid speculation on a deal to acquire Ardelyx. Scrip examines how Zycubo approval, Agenus’s oncology BOT/BAL combination progress and a Formycon partnership help the Indian major