China recently made strategic moves to allow direct foreign investments into cell and gene therapy development, as well as into hospitals in certain cities and regions across the country. Foreign firms are generally optimistic despite some challenges.
With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
Contract research organizations in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
Japan has started to charge patients a portion of the difference between the reimbursement price of the generic and non-generic product if they insist on the latter without a supporting recommendation from the prescribing physician, in a policy designed to further drive generic use.
The US FDA Commissioner pushed for rebalancing the US’s pharmaceutical supply chains while also stressing that US-China commerce has a role that would be risky to compromise.
Japan plans to offer wider support to foreign firms and ventures with innovative candidates to start clinical trials in the country, as part of key measures from current prime minister Fumio Kishida.
With BIOSECURE's legislative progress on pause until after the election, a Pink Sheet infographic looks back on the Capitol Hill progress to date and looks ahead to the potential impact if it is enacted, using Evaluate Pharma data to highlight the likely holes in pharma’s supply chain.
The five-year roadmap aims to expand support for AI research and development in essential health care and new drug development, as well as advance medical data usage systems and enable its safe use.
A senior McKinsey executive discusses trends in the CDMO sector amid geopolitical tensions, the spurt in customer queries at Indian firms and also facets of the deals scenario.
With the BIOSECURE Act halfway to congressional approval, stakeholders are pushing for a financial boost to ensure the US gains the business Chinese companies will lose, but that may be a big lift.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
Under the new drug approval innovation measures, Korea will cut the review and approval period of new drugs to 295 days from 420 days and increase the number of expert reviewers to enhance review capabilities.
If the US Congress continues to target trials at Chinese military hospitals, the impact could be relatively small, while a broader focus could upend multinational development programs.
South Korea has yet to come up with detailed plans for a major national biopharma cluster, but is considering a virtual approach to connect existing industry hubs nationwide. At a recent policy forum, experts discussed related issues including governance and insufficient investment, as well as the need to attract foreign firms and capital to compete with rival clusters in Asia.
Japan has issued positive approval recommendations for 10 new drugs, including Catalyst’s Firdapse and Idorsia/Nxera’s Quviviq, as well as a global-first nod for mecobalamin in ALS.
The deadline is nearing for pharmacopoeias to express their interest in joining the decades-old discussion group that works to harmonize excipient monographs and general chapters and reduce the burden on manufacturers to perform analytical procedures in different ways depending on the jurisdiction.
The country is aiming to tighten collaboration with Asian authorities and share globally its knowledge and experience of universal health coverage systems globally and will open a joint office in Tokyo with the WHO and World Bank in 2026.
South Korea is set to provide an additional $18m in support to CEPI amid heighted global worries over mpox. The coalition's CEO and Korea's foreign minister met to discuss strengthened collaboration to prevent and respond to any future pandemics.