US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.
Multiple, wide-ranging revisions to Japan's PMD Act, including provisions on pediatric R&D, use of real-world data and cell therapies, look set to receive formal political approval within the next few months. There is also more clarity on a controversial scheme to support venture companies.
In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.
The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.
Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.
Japan ships the first batch of 50,000 mpox vaccine doses to DRC after training local healthcare providers dealing with the persistent outbreak.
Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.
While Japan looks set to further improve policies to support ventures and ease market entry this year, these will contrast with ongoing reimbursement price controls.
The Japanese pharma firm sued a politician, claiming defamatory actions on social media related to its novel COVID-19 vaccine.
Faster approvals and regulatory flexibility are among moves India has made to draw clinical trial investments. As MNCs seek to replace products close to patent expiry with new blockbusters and domestic companies tap unmet needs, how will the R&D landscape shape up in 2025?
China’s State Council has released a wide-ranging set of policy incentives intended to eliminate regulatory barriers and improve market access for innovative drugs.
2024 saw important regulatory changes in India including in areas such as GMP, clinical trials and efforts to rein in unethical marketing practices. Further action is expected to play out in the new year as well.
Major foreign pharma industry groups in Japan are threatening to pull out of a planned public-private council initiative over a proposed sales tax on certain drugs to fund drug discovery.
The policies for China’s biopharma industry in 2024 centered around innovative small molecules, biologics and cell and gene therapies. Regulation changes for the industry in 2025 could be a continuation of that.
Multiple industry groups in Japan warn that a decision to implement an "off-year" drug price revision in April will reverse other recent policy moves to support innovation.
The Pink Sheet looks at what major policies and regulations South Korean authorities prioritized in 2024 and what may be in store for this year.
China has granted its first approval for a stem cell therapy, to domestic firm Platinum Life Biotech’s umbilical cord-derived mesenchymal stem cell product for corticosteroid-failed acute graft-versus-host disease with gut involvement.
Speedier approval of clinical trials, flexibility towards new technologies, faster access to new drugs and lingering regulatory barriers to decentralized trials are among the challenges South Korea is facing in becoming a global trial hot spot.
China is advocating reforms to health insurance, particularly the wider use of commercial schemes, for reasons to support innovative drug development.
A shifting political power balance in Japan is leading to renewed debate on the pace of regular drug reimbursement price cuts.