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Well, this wraps up one of the most eventful weeks of the biotech year — ASCO, followed by BIO. Anyone else as zonked as I am? Today, we discuss the impact that the BIOSECURE Act is already having on the industry, preview what FDA reviewers want to know about donanemab, and more.
The need-to-know this morning
- The FDA approved Geron‘s drug imetelstat for certain patients with myelodysplastic syndromes, a type of slow-moving blood cancer. Marketed as Rytelo, it’s the first drug to emerge from the once-ballyhooed company since its founding in 1990.
BIOSECURE shaking up partnerships at BIO
Although it isn’t yet a law, the BIOSECURE Act is already making waves in the biotech industry — as evidenced by some notable shifts at this week’s BIO International Convention in San Diego. STAT’s Jonathan Wosen and I were on site, and found that, with the possible blacklisting of certain Chinese suppliers looming, biotechs are scrambling to find alternatives to manufacturers like WuXi. Meantime, an executive at one U.S.-based CDMO said “month to month, new business has gone through the roof.”
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