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
Late-stage study suggests Merck’s Keytruda is a promising treatment candidate in newly diagnosed patients with locally advanced cervical cancer, inducing better progression-free survival.
J&J, Merck and Pfizer are the subjects of a House Judiciary Committee investigation for their alleged participation in a government-sanctioned censorship campaign during the COVID-19 pandemic.
Industry advocates argue price negotiation via the IRA may jeopardize the prices relied upon by biosimilar manufacturers to recoup their investments.
The company also terminated a Phase III trial of its TGFB inhibitor as a treatment for metastatic pancreatic ductal adenocarcinoma, though that drug will continue to be tested as a treatment for colorectal cancer.
Tuesday’s partnership will dig into Flagship’s deep ecosystem of companies and technologies to discover medicines in line with Pfizer’s core strategic areas.
Less than two years after launch, the startup posts positive Phase II results and heads into Phase III trials for major depressive disorder with a new CEO.
Following the full approval of Leqembi, the CMS suggests expanding its coverage of beta-amyloid PET scans, which could improve the uptake of novel Alzheimer’s disease treatments.
The Netherlands-based immunology company said Wednesday it brought in $1.1 billion by selling more than two million shares in the U.S. and Europe.
The U.S. regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.
Part B of the study, cleared to proceed in Canada, remains on hold in the U.S. due to findings from non-clinical chronic toxicology studies.