The threat of Chinese dominance in the prescription drug sector appears to be a strong, unifying theme for legislators heading into the US Food and Drug Administration user fee reauthorization cycle, but two very different sets of policy issues must be addressed.
The acceleration of commercial health insurance was included in national development plans for 2026 released by the Chinese government in the recent “Two Sessions” policy meetings, and appears key for the next generation of innovative drugs to achieve domestic success.
China's government formally designated the biopharma sector as a newly emerging "pillar industry" in the recent “Two Sessions” meeting in Beijing, the repositioning implying it will be a high-priority industry for the next decade.
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
Japan's regulatory authorities recommend approval of products including a cell therapy, while setting reimbursement prices of newly approved drugs and cutting some others following cost-effectiveness assessment.
Daiichi Sankyo’s MMR Vaccine, Ultragenux’s triheptanoin also won approval recommendations.
Clinigen's CEO and senior executives outline how the services company navigated Japan’s rigorous regulatory framework to secure approval for Prolacta’s human milk–based fortifier as a prescription biological product.
South Korea starts development of AI-supported system to dramatically shorten drug approval reviews and announces new national strategy for AI in biopharma targeting 10x expansion in the country’s new drug pipeline.
Parexel’s CEO Peyton Howell and India chief Sanjay Vyas talk to the Pink Sheet about clinical trials amid global turmoil, the slowdown in big pharma decision-making and pivot in some cases to the FSP outsourcing model, evolving DCT definitions and India opportunities.
Idvynso, Merck & Co.'s oral once-daily combination of doravirine and Japan-originated molecule islatravir, has been granted its global-first approval in Japan, ahead of the US.
Japan's regulatory authorities are implementing a number of updates and revisions to the national drug law in measures designed to address shortages of high-demand products and clarify guidance in areas including conditional approvals.
India’s proposal to speed up multicenter research through a single ethics review system is drawing strong interest from the research community.
A regulatory sandbox and greater global harmonization will not only improve pathways for Indian cell and gene and other advanced therapies to reach the UK’s National Health Service but also speed up approvals in India
Designation of more regulatory resources by China’s top drug regulator to the cell therapy sector appears key to the recent consecutive release of guidelines related to CAR-T products in the country.
Japan's drug regulatory agency is rolling out a new system of priority consultations for smaller companies with no presence in the country to support the more timely commercialization of high-need new drugs.
From enforcing new GMP norms to risk-based inspections and 850 CAPA notices, India’s drugs regulator is moving to tighten compliance across domestic pharma units. A striking step up in the regulator’s internal scientific cadre and more regulatory rationalization are also on the cards.
NextGate Partner’s Jay Byun gives a mixed review of South Korea’s recent biopharma policy measures, saying providing government support to all cycles of R&D may lower efficiency.
Japan has granted the first positive approval recommendations worldwide for two allogenic cell therapies derived from induced pluripotent stem cells, Sumitomo’s raguneprocel for Parkinson’s and Cuorips’ cardiomyocyte patches for heart failure.
Elevidys granted reimbursement in Japan following its conditional approval at almost $2m per patient, a price local regulators note is still lower than levels in the US.
The US-India dance around pharma goes on as they announce a trade deal framework that continues to exempt generics from the reduced 18% tariffs till a “negotiated outcome” is reached post a Sec. 232 investigation. However, oil imports from US could increase costs for Indian pharma makers