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780,045 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
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
FDA alleges ‘manipulated’ data supported approval of Amgen’s autoimmune drug
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.
April 28, 2026
·
2 min read
·
Tristan Manalac
Manufacturing
Amgen recalls almost 1 million bottles of heart failure drug over quality issue
The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy.
July 8, 2026
·
1 min read
·
Nick Paul Taylor
Postmarket research
Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
May 21, 2026
·
3 min read
·
Tristan Manalac
Rare diseases
Amgen shores up Tavneos’ FDA defense with Duke data analysis
After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.
June 12, 2026
·
2 min read
·
Tristan Manalac
Press Releases
Septa Pharmaceuticals Inc. Acquires CeeNU® (Lomustine) from Bristol Myers Squibb, Canada
July 15, 2026
·
2 min read
Press Releases
Dark Blue Therapeutics acquired by Amgen for up to $840 million
January 7, 2026
·
4 min read
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