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
Blue Cross and Blue Shield of Louisiana has filed a case against Bristol Myers Squibb alleging the company conducted patent fraud to extend protections for its multiple myeloma drug Pomalyst.
The company has withdrawn a suit against the Department of Health and Human Services after its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list.
Interim data from the company’s late-stage clinical trial suggests its cell therapy treatment for heart failure likely won’t meet the primary efficacy endpoint, BioCardia announced on Tuesday.
The vaccine maker reported new trial data confirming an 8.7 to 11-fold increase in neutralizing antibodies against circulating strains, including the highly watched BA.2.86, EG.5 and FL.1.5.1 variants.
Citing the need to improve its Risk Evaluation and Mitigation Strategy, the regulator has declined AstraZeneca’s bid to get its C5 complement inhibitor approved in neuromyelitis optica spectrum disorder.
Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.
Biotech Beam Therapeutics has dosed the first patient in a Phase I/II study of its base-edited CAR-T therapy in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma.
With several of the first 10 selected drugs facing patent expirations and generic competition, the drug price negotiations dictated by the IRA may not greatly affect revenues. But that could change quickly.
Former Agilent Technologies executive Jacob Thaysen will take the reins later this month replacing CEO Francis deSouza, who stepped down in June following a proxy fight with activist investor Carl Icahn.
The company Tuesday posted Sandoz’s financial performance for the first half of 2023, as it looks to secure the approval of shareholders this month for the generics and biosimilars spin-off.