Citeline, a Norstella company

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

Chinese API exports to US fell 24% year-on-year to $255m in May, when US and China called a truce in a previously escalating trade war.

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Biopharma executives and investors at the BIO convention noted the competition emerging from China with high-quality assets that could make strong additions to their portfolios.

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

Financial markets were expected to loosen up in 2025, but BIO convention attendees indicated that conditions have worsened this year, so public and private firms are making tough choices.

Deal Snapshot: The French drugmaker has been shifting its investments away from cancer to focus on immunology and inflammation but it continues to seek out interesting early-stage oncology assets.

The drugmaker presented data from its Phase I study of JNJ-79635322 at ASCO and EHA showing a 100% response rate in BCMA- and GPRC5D-naïve patients.

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.

Innovent presented data on multiple pipeline assets at ASCO, including promising OS results for its first-in-class anti-PD-1/IL-2α-bias bispecific. The Chinese firm is also continuing to build out its metabolic disease portfolio and consider its partnering strategies, its CEO tells Scrip.