News
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.
FEATURED STORIES
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
Eikon’s lead candidate, EIK1001, is being tested for advanced melanoma. The candidate is currently in late-stage development, which the biotech will fund using Wednesday’s series D raise.
SpringWorks Therapeutics sprung out of Pfizer’s storeroom, when a rare disease advocacy group pushed to keep a program for neurofibromatosis alive. This method could work for “every rare disease under the sun,” advocates say.
SpringWorks Therapeutics is the perfect case study for rescuing a discontinued assets. It’s time to repeat the process for every rare disease, experts say.
As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
While many industry players and observers have high hopes for the EPIC Act, some say budgetary headwinds could make it difficult for the current administration to make meaningful repeals or amendments to the IRA.
Kiniksa will now focus its development efforts on the IL-1 blocker KPL-387, which it is testing for recurrent pericarditis with Phase II/III trials planned for mid-2025.
Emalex is gearing up for a New Drug Application for ecopipam in Tourette syndrome later this year.
The latest Repare Therapeutics layoffs will include its chief medical officer and could leave the biotech with fewer than 35 employees as it works to advance two Phase I clinical programs.
BridGene strikes another partnership with Takeda as the latter company continues its dealmaking streak, following high-ticket agreements with Keros Therapeutics, AC Immune and Degron Therapeutics in the past nine months.
At the 2025 National Biotechnology Conference, gene therapies, bispecific antibodies and other novel modalities—relative newcomers to medicine—will be much discussed. In this curtain raiser, BioSpace speaks with conference chair Prathap Nagaraja Shastri of J&J about these highly anticipated topics.