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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 reporting a failed clinical trial of ELX-02 for cystic fibrosis (CF), Eloxx Pharmaceuticals plans to shift its focus and use the drug to treat Alport syndrome, a rare kidney disease.
Novartis confirmed it is the subject of an investigation by the Swiss Competition Commission over possible unlawful patent use.
Pfizer is leveraging its funding and experience with vaccines, developing its meningococcal, flu, and RSV vaccines. It also announced its venture investment in Nimbus Therapeutics.
Gala Therapeutics and Galaxy Medical will be folded into Galvanize Therapeutics to continue to develop their electric pulse therapies for bronchitis, cardiac arrhythmias and solid tumors.
NSCLC At ESMO: Pollution does indeed cause lung cancer; Tecentriq shows promise in poor prognosis patients, Amgen makes progress in KRAS G12-mutated disease and an update on a Daiichi Sankyo ADC.
Biden issued an executive order to keep U.S.-based innovation ahead of advances made by counterparts in China biotechnology and biomanufacturing Monday.
This week was rife with Series financings, which channeled money into innovative treatments for immune diseases and cancers, genomic treatments and precision healthcare.
Bayer CEO Werner Baumann may be on the way out. For the past several years, Baumann has been in the sites of angry shareholders but has evaded an ouster. That soon may be over.
With $165 million in the bank, Capstan launched Wednesday to combine the potency of cell therapy with the precision of genetic medicines against various difficult-to-treat diseases.
A Manhattan court dismissed a whistleblower lawsuit against Novartis, which had alleged the company paid doctors to promote its multiple sclerosis drug Gilenya.