The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned effective immediately Nov. 2 after being placed on administrative leave two days earlier amid a Department of Health and Human Services probe.

John Crowley doesn’t worry about where his kids’ toys are made, but he told the Senate Health, Education, Labor and Pensions Committee that he does care where their medicines are made. His concerns, as a father and as president/CEO of the Biotechnology Innovation Organization, are becoming more urgent, he testified at an Oct. 29 HELP hearing on the future of biotech in the U.S.

The U.S. FDA has granted orphan drug designation to Dewpoint Therapeutics Inc.’s DPTX-3186, its first-in-class condensate modulator for the treatment of gastric cancer. The designation follows the recent opening of Dewpoint’s IND application for DPTX-3186 earlier in October, and is the first orphan designation ever granted to a condensate-modulating therapeutic.

The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.

Roche Holdings AG received CE mark approval for its Elecsys Dengue Ag test, a fully automated, high-throughput immunoassay to help diagnose acute dengue virus infections. With cases of dengue on the rise worldwide, the test, which delivers results in 18 minutes, offers high sensitivity and specificity across all four dengue virus serotypes, and will help clinicians confidently distinguish dengue from other illnesses causing acute fever.

Exousia Pro Inc.’s subsidiary, Exousia AI, has received orphan drug designation from the FDA for its exosome-based treatment for malignant glioma.

Based on positive phase III study results, Metis Techbio is planning to file an NDA for its AI-derived orally disintegrating tablet drug candidate for pseudobulbar affect, MTS-004, in China next year.

Microbiotix Co. Ltd. has obtained IND approval from the Korean Ministry of Food and Drug Safety (MFDS) for MP-101, a bacteriophage therapy for patients with acute pneumonia. A phase I study in adult patients with Pseudomonas aeruginosa-induced pneumonia is expected to enroll its first patient within the year.