Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
To strengthen its cancer pipeline, South Korea’s Dong-A ST Co. Ltd. made a strategic investment of ₩25 billion (US$18.45 million) in Seocho-gu, Seoul-based Idience Co. Ltd., a cancer-focused subsidiary of Ildong Pharmaceutical Co. Ltd. on May 20.
Osaka, Japan-based Shionogi & Co. Ltd. said May 13 that ensitrelvir fumaric acid (Xocova), its oral antiviral for COVID-19, showed no statistical difference against placebo in completely resolving 15 common COVID-19-related symptoms in a global phase III Scorpio-HR trial.
As the average cost of new drug R&D continues to skyrocket, the perception around using artificial intelligence (AI) as a tool to boost drug discovery is changing. “Developing new AI-based drugs is a difficult task, not only for Korea but also for countries with leading AI technology,” Hyeyun Jung, principal researcher of Korea Health Industry Development Institute’s Center for Health Industry Policy, told the audience at the Bio Korea meeting on May 9. “But there is a change in perception; [namely that] applying AI to new drug development is not an option but a necessity.”
SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer.
AC Immune SA has landed a potential $2.2 billion deal for its anti-amyloid beta Alzheimer’s disease vaccine, ACI-24.060, with Takeda Pharmaceutical Co. Ltd., under which it will get $100 million up front and is eligible to receive an option exercise fee, plus potential development, commercial and sales-based milestones of up to $2.1 billion.
As Poseida Therapeutics Inc. anticipates reporting further data this year from allogeneic CAR T-cell therapy P-MUC1C-ALLO1, for which Astellas Pharma Inc. has nabbed first negotiation rights, the two companies inked a second deal aimed at combining their respective cell therapy platforms in an early stage collaboration targeting solid tumors.
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
The latest World Health Organization’s (WHO) Pandemic Agreement falls short of protecting all countries in future pandemics, said international patient groups and public health organizations.
The industry in the U.K. is starting to get concerned about the U.S. Biosecure Act and the possible impact on its ability to use Chinese service providers, and the implications for future dealmaking with U.S.-based companies.
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