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783,738 Results for "kai pharmaceuticals inc acquired by amgen".
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Regulatory
Amgen continues to defend Tavneos as global regulatory pressure mounts
Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
July 10, 2026
·
4 min read
·
Nick Paul Taylor
Regulatory
Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing
CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA.
September 2, 2026
·
2 min read
·
Tristan Manalac
Immunology and inflammation
AstraZeneca, Amgen poised to challenge Dupixent’s reign with esophagitis win
Even without specific Phase 3 data yet revealed, analysts see AstraZeneca and Amgen’s Tezspire as a potential threat for Dupixent in eosinophilic esophagitis.
August 28, 2026
·
2 min read
·
Tristan Manalac
Business
Amgen hit with cybersecurity breach, patient data affected
The hack is unlikely to affect Amgen’s financial reporting and other operations, nor does the pharma expect its ability to meet patient needs will be compromised.
August 3, 2026
·
2 min read
·
Tristan Manalac
Regulatory
Pressure piles on Amgen after EU pulls Tavneos, flags ‘serious breaches’ in pivotal study
Sponsors of the pivotal study behind Amgen’s rare disease drug Tavneos saw unblinded findings for the drug and re-adjudicated data from nine patients to make the drug seem effective, according to European regulators.
August 14, 2026
·
2 min read
·
Tristan Manalac
Obesity
Amgen’s MariTide stands alone after obesity cull while analysts seek more M&A
Amgen has discontinued Phase 1 obesity candidate AMG 513, leaving MariTide as its sole weight loss asset. Meanwhile, executives said the company’s late-stage pipeline is largely full and future business development will focus on earlier-stage opportunities.
August 5, 2026
·
2 min read
·
Tristan Manalac
Podcast
Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water
The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
July 1, 2026
·
2 min read
·
Jef Akst
Regulatory
Amgen’s Tavneos troubles continue as
NEJM
retracts pivotal publication
Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.
June 30, 2026
·
2 min read
·
Tristan Manalac
Press Releases
KAI Conversations Announces Strategic Partnership with Syneos Health to Advance U.S. Pharmaceutical Commercialization
April 30, 2026
·
2 min read
Regulatory
Amgen deploys patients to defend troubled Tavneos in FDA hearing request
Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
July 24, 2026
·
4 min read
·
Annalee Armstrong
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