In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
Korro Bio Inc.’s latest update on RNA editing prospect KRRO-110 may mean one less competitor in alpha-1 antitrypsin deficiency (AATD), and shares of the firm (NASDAQ:KRRO) closed Nov. 13 at $6.50, down $24.92, or 79%. As part of the third-quarter earnings report, Korro said KRRO-110 produced functional protein in AATD patients but fell short of projected levels of functional protein after a single administration.
Phase III data from Novartis AG for the malaria treatment Ganlum (KLU-156) show it met the primary endpoint of noninferiority to the current standard of care, Coartem, a combination of artemether and lumefantrine. The results are a step to curbing a problem that has seen rising numbers in recent years.
Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.
A year ago, BioWorld published a special series on the women’s health drug development ecosystem, showing that while women make up half of the population, venture capital investment and life sciences partnerships in the space – specifically those deals supporting innovations for conditions primarily affecting women – pale in comparison to efforts addressing diseases more men experience. That appears to be changing, according to an updated look of BioWorld data, supported by findings in the Silicon Valley Bank 2025 Innovation in Women’s Health Report published in April, and Clarivate’s Nov. 13 release of its latest Companies to Watch 2025 report, Rediscovering women’s health.
ABL Bio Inc. inked a license and research agreement with Eli Lilly and Co. worth up to $2.6 billion to develop multiple therapeutics using the Grabody-B platform. Under the terms announced Nov. 12, ABL will receive a $40 million up-front payment and up to $2.56 billion in development, regulatory and commercialization milestones, plus tiered royalties on net sales.
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