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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 companies will design and develop targeted gene therapies for a liver-directed rare disease program and conduct additional studies for central nervous system-directed rare disease programs.
GlaxoSmithKline unveiled plans for its new spinout in the consumer health division, Haleon. It is expected to be in place by mid-2022.
Weeks after announcing that its lead monoclonal antibody was demonstrating efficacy against the Omicron variant, Adagio Therapeutics CEO Tillman Gerngross steps down.
Proceeds will be used to assemble and develop a diversified pipeline of therapies to address sight-threatening illnesses.
Health authorities in Malawi discovered an outbreak of wild poliovirus type 1 on Thursday. The announcement comes after a case was detected in a young child in Lilongwe.
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
Synairgen watched its stock plummet 85% after reporting disappointing Phase III results for its inhaled COVID-19 treatment on Feb. 21.
The COVID-19 pandemic and the virus that causes it, SARS-CoV-2, has been resilient, unpredictable and confounding from the very beginning.