Data

A new face seconded to the European Commission's medtech unit and changes to several EU rules impacting medtech

Beyond the fierce Lilly and Novo Nordisk competition in the weight-management market, other deep-pocketed firms are advancing their novel candidates and seeking a way in through dealmaking.

The pharmaceutical industry continues to experience significant shifts in sales performance, with some companies achieving remarkable growth while others face stagnation or decline.

The verdict from the front lines of drug development is unmistakable: RWD and AI won’t transform trials through hype alone – they deliver only when welded to airtight data practices, transparent models and accountable operations.

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?

By offering free sequencing and embracing radical openness with global partners, Regeneron Genetics Center has gathered over 3 million samples, leading to the identification of over 30 drug targets now in Regeneron’s pipeline.

Eleven $1bn+ alliances were penned in October, and four exceeded $2bn. In the top alliance by deal value, Innovent Biologics entered into a potential $11.4bn collaboration with Takeda to co-develop and commercialize next-generation immuno-oncology and antibody-drug conjugate cancer therapies.

In 2024, trial initiations shifted following the post-pandemic decline in COVID-19 studies. Cardiovascular trials showed the greatest growth by therapeutic area but trailed the previous year’s initiation levels.

How will medtech be buffeted by what is seen as the EU’s capitulation to US demands to water down its AI and data regulations?

With another regulator now considering the removal of clinical efficacy trials for biosimilars, BioPharmaSpec’s technical director Richard Easton paints the picture of data-powered biosimilarity assessment.

C-suite executives from Stryker, Intuitive Surgical and Fresenius passed a mainly upbeat verdict on the Indian medtech market and industry.

An extensive list of blockbuster drugs face patent expiry over the next six years, putting significant revenues at risk for major companies. While Eli Lilly and Novo Nordisk are reaping the rewards of GLP-1 successes, other large pharmas face steep challenges in closing their growth gaps.