Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is to establish in April a new Asian Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, in a move that will further formalize the regulator's various ongoing initiatives in this area.
Japan PMDA To Kick Off New Asia Training Center
Japan's regulatory body will set up a new center next month to help in the training of other drug and device authorities across Asia, as part of its growing international activities.
More from Focus On Asia
As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.
DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.
CSPC’s SYS6010, the first monospecific EGFR-targeting antibody-drug conjugate in the clinic for advanced NSCLC, has shown Phase I promise, but could face close competition with another China-originated bispecific.
More from Scrip
On its Q1 earnings call, Moderna avoided criticizing policy changes affecting vaccines but de-emphasized its flu/COVID-19 vaccine for under-50 and prioritized cancer programs.
Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.
Attorneys Andrew Goodman and Alan Minsk, as well as Naya CEO Daniel Teper, discussed the ramifications of US FDA staff cuts on M&A activity with Scrip senior writer Joseph Haas.