FDA Delays AstraZeneca Drug; Brazil OKs Generic Ozivy
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- STAT+ reports FDA extends decision deadline for AstraZeneca’s camizestrant breast‑cancer pill to review additional data after advisory panel voted against the drug in combination with a CDK4/6 inhibitor.
- STAT+ reports Brazil’s health regulator approves EMS’s generic Ozempic (Ozivy) for type 2 diabetes at 30% lower price, with 350,000 pens initially and 1.2 million units projected in the first year.
Why it matters: AstraZeneca’s camizestrant faces a longer review, delaying potential revenue, while Brazilian patients and EMS gain faster, cheaper access to a GLP‑1 diabetes drug, likely expanding EMS’s market share by millions of units.
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