Advanced Technologies

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

With the roll out of agentic AI, the US FDA continues to expand its capabilities, following the launch of Elsa, its generative AI tool in May.

New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

However, the agency updated warnings on myocarditis risk and mitigation for the gene therapy, including more specific information about its severity and timeframe for occurrence in Duchenne muscular dystrophy patients.

Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.

While there is a general shift towards alignment and collaboration in health technology assessments in the EU under the new HTA Regulation, member states still have “their own recipe” when it comes to making reimbursement decisions.

While the volume of questions that companies have received from the EU member states under the Health Technology Assessment Regulation has been lower than expected, some firms are struggling with the comparator analysis required to answer some questions, an expert says.

The FDA proposed conditions for eliminating six-month animal studies in mAb development and gave examples when shorter-duration studies could be eliminated.

The UK MHRA is looking to support drug sponsors in using in silico data during the drug development process – a move that will reduce the use of animal models.

Companies have until early November to respond to a public consultation from the European Commission on its planned Biotech Act, which it hopes will help unleash the potential of small and midsize enterprises in the bloc.

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.

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