After a decade-long wait, China has finally approved its first HPV vaccine, GSK's Cervarix, handing a lead to the UK-based firm over its US competitor Merck in the world’s second largest pharma market. But with Chinese companies also vying for a slice of the pie, the battle is just beginning, and pricing will be a key element.
BEIJING – The wait is over. Each year, thousands of young Chinese females had to make their way to Hong Kong if they wanted to get a shot against human papillomavirus (HPV), but those in future now have the lower hassle option of receiving this at home on the mainland.
The China FDA has approved the first HPV vaccine in the country, GlaxoSmithKline PLC's Cervarix - which protects against...
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.
