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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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Following the regulator’s request for more data beyond the scope of its Phase III TIDES trial, Takeda decided to voluntarily withdraw the Biologics License Application for its TAK-003 dengue vaccine.
The company’s ruxolitinib cream Opzelura led to higher rates of treatment success in children with atopic dermatitis than with a control cream.
Severe respiratory problems killed seven patients and affected five others, though the company said that most of these were likely unrelated to the drug.
After paying $300 million upfront to BeiGene for option rights to ociperlimab in December 2021, Novartis has dropped the agreement and given the rights back to the Chinese biotech.
A handful of biotechs and pharma companies have posted sizable IPOs in 2023, despite a tight economy. Still, the numbers are way down from last year.
Burjeel Holdings and BridgeBio Pharma ink partnership deal in rare genetic diseases with a plan to set up headquarters in Abu Dhabi.
Bristol Myers Squibb is paying a total of $95 million to the two companies for exclusive global rights to programs developed within long-term partnerships designed to further BMS’ neuro pipeline.
Following its $5.9 billion Iveric Bio buy, Astellas is leaning into the eye disease space with a licensing agreement for 4D Molecular Therapeutics’ proprietary intravitreal AAV delivery system.
Despite a government report showing that hiring slowed over the month of June, job postings on BioSpace’s life sciences-focused job board saw a marked increase.
Early-stage data shows that Viridian’s thyroid eye disease candidate induces clinically meaningful improvements in eye protrusion after six weeks of treatment.