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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.
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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Clinical Catch-Up for February 21
Patient enrollment for the clinical trial, which was testing Atara’s autologous chimeric antigen receptor (CAR) T-cell immunology therapy called ATA2271, has been paused.
After roaring into February with positive data in five different indications, Regeneron and Sanofi announced today a late-stage Dupixent trial has been halted due to futility.
Biomarin indicated that the FDA had requested more data from non-clinical studies to evaluate the theoretical cancer risk to human trial participants. This is likely to take several quarters.
Bayer is heading back to the FDA to seek approval for a new indication of its prostate cancer drug Nubeqa, following positive Phase III results.
GlaxoSmithKline has voluntarily paused activities in its Phase III GRACE trial on a candidate maternal vaccine for respiratory syncytial virus.
The FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.
In addition to massive layoffs – around 60% of its workforce – Yumanity also said it is considering “strategic alternatives” to its financial woes, including the possibility of selling or merging.
BioSpace spoke with four veterans in the field about the less obvious reasons why companies with good science may still fail.