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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 strategic collaboration centers on Remix’s REMaster platform for the discovery and development of small molecule therapies that modulate RNA processing.
BioNTech is opening one of the largest mRNA vaccines manufacturing facilities in the world to expand the availability of the COVID-19 vaccine.
Biopharma and life sciences companies from across the globe provide updates to their pipelines and businesses.
On Wednesday, Third Harmonic Bio closed on Series B financing, bringing the total capital raised to $155 million.
Sage and Biogen announced positive topline results from the Phase III study of zuranolone that showed a rapid reduction in depressive symptoms after three days.
The FDA sent an email holding the planned Phase I trial for LB1901 after the first and only patient dosed was found to have low CD4+ T-cell counts in the peripheral blood.
With the Omicron surge waning, at least in the U.S., there is speculation that the COVID-19 pandemic may be in its end stages. Some experts, however, warn that this could be premature.
The FDA committee voted 8 yes and 14 no. The decision now goes back to the OND to decide the FDDR on Avenue Therapeutics’ IV Tramadol.
Star Therapeutics has exited stealth mode and announced a spin-off company, Electra Therapeutics.
Moderna announced plans to expand in Asia with the opening of four new subsidiaries in Malaysia, Taiwan, Singapore and Hong Kong.