Asia

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.

The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

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.

Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.

Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.

MSN Laboratories will be unable to move forward with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US for now after the originator won a stay of the firm’s ANDA approval pending appeal from the US Court of Appeals for the District of Columbia Circuit.

After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting reimbursement prices. How has the sector panned out over the last decade?

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.

A Japanese approval for Lilly's Alzheimer's drug donanemab is expected soon following a positive recommendation from the MHLW. The ministry has also announced reimbursement prices for 12 new products including Fabhalta, along with price cuts for Tezspire, Dupixent and competitors following a review.

Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.

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.

HPV vaccine shipments to China are expected to fall after a government crackdown on bribery and corruption caused scientific communication with health care providers to decline. Gardasil also may be hurt by budgetary pressures on distribution of the government-reimbursed vaccine.