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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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Biopharma and life sciences organizations strengthen their leadership teams and boards with these Movers & Shakers.
While the president temporarily shores up leadership at the OSTP, the NIH is losing another long-time career researcher, John R. Mascola.
By the end of the CREDIT-1 study, patients experienced a significant reduction in low-density lipoprotein cholesterol compared to the placebo group.
It’s not clear if the recent deaths reported in FAERS resulted from the patients taking Aduhelm. This article takes a deep dive into this controversy.
95% of those surveyed agreed that the pandemic showed the vulnerabilities of the medicine supply chain.
Researchers found that augmenting estrogen levels in postmenopausal women who had tested positive for SARS-CoV-2 might help reduce one’s risk of death from COVID-19.
Research Roundup for February 18
In April 2021, the U.S. Food and Drug Administration issued Acadia a Complete Response Letter (CRL) related to its previous attempt to expand the approved indication for Nuplazid.
At this time, 73% of Americans are immune to Omicron, and it could rise to 80% by mid-March. For that and more COVID-19 news, continue reading.
The FDA will evaluate AMX0035, an investigational oral fixed-dose drug intended for people diagnosed with ALS.