For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.
Illumina Inc. presented at the J.P. Morgan 2026 Healthcare Conference on Jan. 13 and introduced what it said is the world's largest genome-wide genetic perturbation dataset, being built to accelerate drug discovery through AI across the pharmaceutical ecosystem. This is a move away from its core focus on DNA sequencing technology.
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
Insilico Medicine founder and CEO Alex Zhavoronkov told BioWorld that he tries to spend as much time as possible in China, because that's where the artificial intelligence (AI) drug development company conducts synthesis and tests for early stage discovery. “And nowadays, not a day goes by without somebody launching an AI drug discovery company,” he said, noting that Chinese AI company Deepseek could be a huge disrupter.
Insilico Medicine founder and CEO Alex Zhavoronkov told BioWorld that he tries to spend as much time as possible in China, because that's where the artificial intelligence (AI) drug development company conducts synthesis and tests for early stage discovery. “And nowadays, not a day goes by without somebody launching an AI drug discovery company,” he said, noting that Chinese AI company Deepseek could be a huge disrupter.
It’s one thing for the scientific community to propose a fundamental change to the way obesity is defined and diagnosed. But it’s another for that proposal to be adopted by regulators, especially when the current definition that relies primarily on the body mass index is entrenched in guidance and obesity drug development and approval.
It’s one thing for the scientific community to propose a fundamental change to the way obesity is defined and diagnosed. But it’s another for that proposal to be adopted by regulators, especially when the current definition that relies primarily on the body mass index is entrenched in guidance and obesity drug development and approval.
With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight.
What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in 2023, gave the FDA the authority to require that a confirmatory trial be underway at the time accelerated approval is granted.
