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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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After beginning July with a splash in the Alzheimer’s space, the FDA is expected to make three decisions during the next two weeks; two for cancer and one for a viral skin disease.
For over three years, no interest has accrued on federal student loans and no payments were required. Soon, mandatory payments will resume, leaving workers with less money in the bank.
Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer’s drug development.
The regulator on Thursday approved Opill, the first oral contraceptive available in the U.S. without a prescription. Perrigo shares rose 6% in response to the news.
Data from the OCARINA II trial shows that a 10-minute subcutaneous injection of Ocrevus achieves similar pharmacokinetics as the typical hours-long intravenous infusion in multiple sclerosis patients.
Following its initial lawsuit last month, Merck has now requested that a federal judge rule on its Inflation Reduction Act case against the Biden administration without a trial.
As the market recovers from the effects of the COVID-19 pandemic, employers are beginning to regain some of the power they lost in recruiting, forcing candidates to adjust their asks.
The tech giant is investing $50 million in the Utah-based biotech to accelerate development of its AI foundation models for drug discovery.
The FDA recently approved the first cellular therapy for Type 1 diabetes and others may not be far behind. But experts say challenges still exist to the widespread application of these treatments.
For closing its $8 billion acquisition of Grail without regulatory approval, the European Union has slapped Illumina with a record $476 million fine—the maximum sanction allowed under the EU’s rules.