Tag: clinical trials
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FDA Pauses Opakalim Enrollment Days After SK Biopharmaceuticals Deal
The FDA paused new enrollment in Biohaven’s opakalim program, adding regulatory uncertainty to SK Biopharmaceuticals’ $795 million epilepsy licensing deal.
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Novartis’ Pelacarsen Fails Phase 3 Lp(a)HORIZON Despite Lowering Lp(a)
Novartis and Ionis reported that pelacarsen lowered Lp(a) but failed to significantly reduce 4-point MACE in the Phase 3 Lp(a)HORIZON trial, raising new questions about the clinical validity of Lp(a) lowering.
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Why Lowering Lp(a) Wasn’t Enough: What Pelacarsen’s Phase 3 Failure Means
Pelacarsen targets LPA mRNA to reduce apo(a) production and circulating Lp(a), but the Phase 3 Lp(a)HORIZON result showed that molecular target engagement did not translate into fewer major cardiovascular events.
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AstraZeneca Keeps Its $80 Billion Goal Despite a Major Trial Setback
AstraZeneca reaffirmed its $80 billion revenue ambition after reporting solid second-quarter results. Strong oncology and rare disease sales helped restore confidence following the failure of a major Wainua trial.
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Why AstraZeneca Says Drug Development Must Move at “Chinese Speed”
AstraZeneca believes the next pharmaceutical race will be defined not only by scientific innovation, but also by development speed. As competition from Chinese biotech grows, AI could help accelerate drug development and improve efficiency.
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Eli Lilly Advances Obesity Drug Pipeline After Positive Phase 2 Results
Eli Lilly has advanced its novel non-incretin obesity drug into Phase 3 clinical trials after promising Phase 2 results. This move marks a significant milestone in the evolving obesity-treatment landscape, as the company explores mechanisms beyond the incretin pathway. The announcement highlights the growing diversification of obesity therapies and intensifying competition among global pharma leaders.