What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in 2023, gave the FDA the authority to require that a confirmatory trial be underway at the time accelerated approval is granted.
Stressing the importance of integrity in taxpayer-funded biomedical research, the U.S. Department of Justice reported that Athira Pharma Inc. has agreed to pay more than $4 million to resolve False Claims Act allegations that it failed to report potential research misconduct to the NIH and the Department of Health and Human Services’ Office of Research Integrity in grant applications and progress reports.
China’s health regulator gave conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001, Ruibosheng) as the nation’s first human umbilical cord-derived mesenchymal stem cell therapy to treat steroid-refractory acute graft-vs.-host disease on Jan. 2, 2025.
Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s Herceptin (trastuzumab). The CRL cites unnamed issues that need to be addressed by the downstream manufacturer of TX-05, which is a third-party service provider of Tanvex U.S. for its drug product.
South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% hike for the Ministry of Health and Welfare’s budget and a near 15% increase in funding to research and develop innovative biotechnologies.
With artificial intelligence (AI) becoming more and more common in drug development since 2016, the U.S. FDA is now issuing its first draft guidance on that use. The “FDA recognizes the increased use of AI throughout the drug product life cycle and across a range of therapeutic areas. In fact, CDER has seen a significant increase in the number of drug application submissions using AI components over the past few years,” a CDER spokesperson told BioWorld. “These submissions traverse the drug product life cycle, which includes nonclinical, clinical, postmarketing and manufacturing phases.”
Makers of digital health apps are not often subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), but any such liabilities may soon become more onerous. The Department of Health and Human Services released a draft update for HIPAA cybersecurity mandates – the final version of which is sure to be accompanied by much more vigorous enforcement.
The U.K. is embarking on the biggest overhaul of clinical trials regulations in 20 years in a bid to retake ground that was lost following Brexit, when the Medicines and Healthcare products Agency was excised from the EMA’s regulatory system.
It was in with the new and out with the old Jan. 3 as the gavel came down on the first session of the 119th U.S. Congress. Although Republicans will control both the House and Senate for the next two years, their narrow majority could prove a challenge to passing some of President-elect Donald Trump’s agenda, including his proposal to cut the corporate tax rate to 15% for companies that manufacture their products in the U.S.
Rounding out a year of insider trading charges involving biopharma companies, the U.S. SEC reported Dec. 30 that it had filed a complaint against two top Humanigen Inc. executives, Cameron Durrant, CEO, and Dale Chappell, chief science officer,
for trades based on insider knowledge of FDA actions.
RSS
