China's Center for Drug Evaluation has issued fresh warnings that it will tighten reviews of anti-tumor drugs on the grounds that “redundant” development activities waste clinical resources.
The patience of China’s regulatory authorities seems to be wearing ever thinner in the face of a never-waning influx of investigational new drug (IND) applications from domestic developers of anti-PD-1 antibodies, as agency officials vow to continuously raise approval review requirements to prevent a drain on clinical resources.
If clinical trials lacking superior early-stage results were allowed to progress unchecked, “it would undercut the sustainable development of clinical...
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."
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
China’s top drug regulator is implementing a pilot program offering shorter review times for IND applications to improve the quality and efficiency of clinical studies and stimulate the country’s innovative drug sector.
Shanghai issues a new set of policies and financial incentives designed to support and speed up regulatory and commercial activities in the biopharma sector, in a comprehensive stimulus package for companies based in the major Chinese city.
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.
