Citeline, a Norstella company

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Axcelead/Lotte Biologics/Kanaph and NextCure/Simcere also unveil ADC-focused pacts, plus deals involving Avata/Oceanus, GSK/Bharat Biotech, Cullinan/Genrix and more.

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.

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

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.

Henlius is investigating the optimum dose for its PD-L1-targeting antibody-drug conjugate HLX43 to support potential first-line use, its CEO explains to Scrip.