South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.

Kura Oncology Inc. and Kyowa Kirin Co. Ltd. have joined hands in a global strategic collaboration worth $1.49 billion to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor for treating patients with acute myeloid leukemia (AML) and other hematologic malignancies.

The U.S. FDA approved 15 drugs in October, marking a decline from 24 in September and 22 in August. Despite the drop, the 2024 monthly average stands at about 19 approvals, exceeding last year’s average of 16, 2022’s 12.5, and the 17-per-month averages recorded in both 2021 and 2020.

Biopharma deal activity in October totaled $22.31 billion, marking a 72% jump from $13.01 billion in September. Year-to-date deal values have decreased by 2%, from $175.29 billion during the first 10 months of 2023 to $171.77 billion in the same period this year, positioning 2024 as the second-highest year on record, according to BioWorld.

Biopharma financing continued to excel through the first 10 months of 2024, reaching $93.64 billion, a 53% increase from $61.04 billion during the same period in 2023.

Positive findings from a phase III trial of semaglutide in metabolic dysfunction-associated steatohepatitis (MASH) is moving Novo Nordisk A/S to expand the glucagon-like peptide-1 (GLP-1) agonist’s indications in the U.S. and Europe, the Danish pharma said, as the MASH field sights more novel therapies.

In September 2024, BioWorld recorded 252 clinical trial updates, up from 92 in August, due in part to news from the European Society for Cardiology Congress, the IASCLC World Conference on Lung Cancer and the European Association for the Study of Diabetes, among others. The month included 35 successful phase III trial updates and four failures.

The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.

U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.

Virus is associated with sickness, but oncolytic virus therapies, which harness viruses to attack and kill cancer cells, may soon change the standard of treatment for cancer, including those long deemed uncurable like malignant glioma.