Yazılar

Drugmakers Turn to AI to Speed Trials and Submissions

/in /tarafından

Pharmaceutical companies are increasingly using artificial intelligence to accelerate clinical trials and regulatory submissions, even as AI has yet to deliver major breakthroughs in discovering new drugs. Industry executives say the technology is already saving weeks by automating participant recruitment, site selection, and the preparation of vast regulatory documentation.

Executives from major drugmakers including Eli Lilly, AstraZeneca, Roche, and Pfizer said at the JP Morgan Healthcare Conference that AI tools are helping manage thousands of pages of clinical, safety, and manufacturing records required by regulators worldwide.

Drug development can take more than a decade and cost around $2 billion. Companies are betting that AI can improve efficiency and success rates by handling what executives call the “messy middle” of development. Consultancy McKinsey estimates that autonomous, or agentic, AI could lift clinical development productivity by up to 45% over the next five years.

Israeli drugmaker Teva Pharmaceutical Industries said it is using AI to streamline processes so researchers can focus on bringing new medicines to market. Meanwhile, Novartis used AI to cut site selection for a large cardiovascular trial from weeks to hours, helping it hit enrollment targets with minimal overshoot.

Other companies are also reporting tangible savings. GSK said digital and AI tools helped reduce late-stage trial costs by millions of pounds, while Denmark’s Genmab plans to deploy AI agents to automate post-trial analysis and reporting.

While investors are still waiting for the first fully AI-designed blockbuster drug, executives say the technology is already reshaping how trials are run and how data is submitted. Amgen’s research chief said many AI-designed molecules are already moving through pipelines, suggesting the biggest impact may still lie ahead.

Roche’s Genentech Doubles North Carolina Facility Investment to About $2 Billion

/in /tarafından

Genentech, a unit of Roche, said it will more than double its planned investment in a biomanufacturing facility in North Carolina to about $2 billion, reinforcing its commitment to expanding production in the United States.

The facility, located in Holly Springs, North Carolina, is expected to become operational by 2029 and will focus on manufacturing next-generation treatments for metabolic conditions, including obesity. Genentech said the expanded investment will significantly increase production volumes and manufacturing capacity at the site.

The project is expected to support more than 2,000 jobs, including around 500 high-wage manufacturing roles and approximately 1,500 construction jobs. The expansion builds on an initial investment of more than $700 million announced in May last year, as the company sought to strengthen its U.S. footprint.

The move aligns with broader efforts by major pharmaceutical companies to boost domestic manufacturing, amid calls from U.S. President Donald Trump for drugmakers to onshore more production. Roche and Genentech have said the investment forms part of a wider $50 billion commitment to the U.S. market.

MercadoLibre enters Brazil’s online pharmacy market with first drugstore acquisition

/in /tarafından

MercadoLibre, Latin America’s largest e-commerce company, will begin selling medicines online in Brazil for the first time after acquiring a local drugstore, executives said on Thursday. The move marks the firm’s entry into one of the region’s largest and most tightly regulated pharmaceutical markets.

While MercadoLibre already operates online drug sales in Mexico, Argentina, Chile, and Colombia, Brazil’s laws require a company to own at least one licensed physical pharmacy to sell medications online. Local head Fernando Yunes confirmed the acquisition and said the company’s aim is to act as a marketplace platform rather than build a nationwide pharmacy chain.

“The pharmaceutical sector is the only one in Brazil we haven’t entered yet, and we see a big opportunity to improve access,” Yunes said. “We want small and medium-sized pharmacies selling through MercadoLibre, not to compete directly with them.”

Executives said the company will evaluate next steps based on the performance of its first pharmacy. MercadoLibre is also in discussions with Brazilian regulators to modernize existing laws that restrict online pharmaceutical trade, calling for reforms to make it easier for pharmacies to reach customers digitally.

The move signals MercadoLibre’s growing ambitions to expand its healthcare footprint in Brazil, its largest market by revenue, and tap into the country’s rapidly growing digital health sector.