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AstraZeneca’s Camizestrant Misses Key First-Line Breast-Cancer Trial Goal

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AstraZeneca said its oral next-generation selective estrogen receptor degrader (SERD), camizestrant (Etcamah), missed the primary endpoint in the Phase III SERENA-4 study. In 1,371 people with previously untreated ER-positive/HER2-negative advanced breast cancer, camizestrant plus Pfizer’s palbociclib (Ibrance) showed only a numerical—not statistically significant—improvement in progression-free survival versus anastrozole plus palbociclib. The outcome is a setback for using camizestrant broadly as an upfront, first-line treatment in this population. AstraZeneca has not yet released the detailed efficacy data and plans a future scientific presentation. The disappointment contrasts with the earlier SERENA-6 trial, where switching to camizestrant after an ESR1 mutation emerged during first-line endocrine therapy significantly improved progression-free survival. That suggests its potential may be more targeted than universal first-line use. Reuters reported the result on September...

Definium reports another Phase 3 win for LSD-based anxiety drug DT120

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Scholar Rock wins FDA approval for ISEMBYLD, a muscle-targeted SMA treatment

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Novo Nordisk seeks a reset after major setbacks

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FDA Reassesses Rare-Disease Trial Standards and Endpoint Selection

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GSK to wind down Dresden vaccine factory amid weak flu-vaccine demand

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Ivonescimab Shows Survival Advantage Over Keytruda in Lung Cancer Trial

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Cyclic peptides advance toward new drug targets, but manufacturing capacity may determine how fast

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Allarity Therapeutics Files Registration Statement for Proposed $100 Million SPAC IPO

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GSK’s Ris-Rez cuts death risk by 54% in relapsed small-cell lung cancer trial

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Novartis board faces investor scrutiny after M&A misfires and R&D setbacks

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Major Novartis shareholder calls for board shake-up after trial setbacks

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Major Novartis shareholder calls for board shake-up after trial setbacks

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