Advanced Technologies

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Pink Sheet reporter and editors discuss the potential impact George Tidmarsh could have as director of the US FDA Center for Drug Evaluation and Research and the issues threatening the future of Sarepta’s gene therapy Elevidys.

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.

The FDA is pushing the use of novel alternatives to animal models, but the Government Accountability Office said sponsors need more clarity and hopes an upcoming guidance will help.

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA