Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Drugmakers must meet U.S. onshoring requirements for reduced tariffs
- Drugmakers must complete a detailed, government‑monitored application process to qualify for a 20% tariff reduction, including disclosing manufacturing locations, investment plans and timelines for shifting production to the U.S.
- To maintain the lower tariff rate, companies must onshore pharmaceutical and active pharmaceutical ingredients production by 2029 as much as possible, justify any products that cannot move and meet ongoing compliance requirements or face tariffs rising to 100%, reports Endpoints News.
U.S. and China drug development partnership announced
- Two pharmaceutical companies in the U.S. and China formed a broad drug development partnership covering up to 13 early-stage programs, with a potential total worth of $15.2 billion, including upfront payments and milestone-based payouts.
- According to Biopharma Dive, the deal reflects a growing trend of U.S. pharma companies partnering with Chinese firms to access faster, lower-cost, early-stage drug innovation, as cross-border collaborations continue to expand and reshape global pipelines.
FDA explores new pathway to repurpose approved drugs using existing data
- The U.S. Food and Drug Administration is exploring a new initiative to repurpose existing approved drugs for new indications or patient populations, using existing safety and scientific data to speed access to treatments and address unmet medical needs.
- The agency is requesting public input on potential drugs and disease areas—particularly where there is little commercial incentive to pursue new uses—as part of a broader effort to update drug labeling using real‑world evidence instead of relying solely on new clinical trials.
Biopharmas partner to commercialize hepatitis B treatment across China
- In an effort to leverage local, commercial distribution partners, two biopharma companies have entered an exclusive agreement to sell hepatitis B therapy across mainland China, reports the European Medical Journal, providing access to more than 5,000 medical centers in China.
- The agreement highlights continued pharmaceutical expansion into China’s hepatitis B market and reflects the growing use of regional commercial partnerships to accelerate market access and distribution for late-stage therapies.
FDA approves AI-based breast cancer risk prediction tool
- The FDA cleared an artificial intelligence-based tool that analyzes pathology images and clinical data to predict the risk of distant metastasis in certain early-stage breast cancer patients, helping to classify them into low- and high-risk groups.
- The technology could support more personalized treatment decisions, potentially guiding chemotherapy use and offering faster, more cost-effective insights than traditional genomic testing methods, reports Medtech Dive.
For more insights in life sciences, check out RSM’s industry outlook.
