News
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
FEATURED STORIES
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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
In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis discusses mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines, and Pad Chivukula of Arcturus Therapeutics.
The deal, which involves a $700 million upfront payment, gives AbbVie access to ISB 2001, a clinical-stage first-in-class trispecific antibody currently being tested for certain kinds of multiple myeloma as well as autoimmune indications.
Partners Ultragenyx and Mereo BioPharma saw their stocks drop by 21% and 30%, respectively, after announcing that the Phase II/III study of their osteogenesis imperfecta candidate will proceed to final analysis, implying it did not show sufficiently strong results at an interim analysis.
The move has sparked concern that the U.S. Preventive Services Task Force could soon be dismissed after a decision by the high court affirmed Health Secretary Robert F. Kennedy Jr.'s power to remove its members at will.
The Global Fund to Fight AIDS, Tuberculosis and Malaria will work with Gilead and other private backers to ensure the HIV preventive Yeztugo, approved last month by the FDA, is available in low- and middle-income countries, concurrent with high-income nations.
The number of employees laid off and companies letting people go increased year over year during the first half of 2025. BioSpace recaps the five largest layoff rounds, including cuts at Bayer, BMS and Teva.
Nuclidium’s radiopharmaceutical platform is unique in its use of copper-based payloads, which the biotech claims can deliver higher doses while also being safer.
The deal gives AstraZeneca’s rare disease unit Alexion access to specialized capsids developed by the Japanese biotech JCR Pharmaceuticals for use in up to five of Alexion’s gene therapies.
In the second biggest acquisition of the year, Merck gains the commercial COPD drug Ohtuvayre, which could help offset the loss of revenue when Keytruda’s patent expires later this decade.
The high court’s order blocks a May decision by a California court that temporarily blocked the efforts of Health Secretary Robert F. Kennedy Jr. to drastically reduce the size of his agency’s workforce.