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The biopharma’s acute myeloid leukemia hopeful is on partial clinical hold, affecting two Phase III AML studies, Gilead announced Monday. The CD47 candidate also spent four months on hold in 2022.
The companies will evaluate Moderna’s investigational Claudin18.2 mRNA cancer vaccine in combination with CARsgen’s Claudin18.2 CAR T cell candidate.
While grappling with financial challenges, the biotech industry is forced to pivot to flexible business models.
Many products are facing the loss of their patents or exclusivity clauses. Here’s what to expect in the coming months.
After sustaining two Phase III fails, Roche and Exelixis finally reported a late-stage win for their combination regimen of Tecentriq and Cabometyx in metastatic castration-resistant prostate cancer.
Following a prior rejection due to manufacturing problems, Regeneron’s higher-dose Eylea won the FDA’s approval Friday, allowing for more infrequent dosing for the treatment of various eye diseases.
The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab) makes it the first and only treatment indicated for children and adults with CHAPLE disease.
Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.
The company is continuing its renal cell carcinoma push for its oral HIF-2α inhibitor Welireg with promising Phase III data showing significant progression-free survival improvements in patients.
In a European Phase I/II clinical trial, the experimental drug for treating Crigler-Najjar syndrome reduced bilirubin below toxic threshold in the liver with a single intravenous injection.
After the company’s investigational eye therapy recently failed two late-stage studies, Kodiak Sciences’ Chief Medical Officer and Chief Development Officer Jason Ehrlich has resigned from his roles.
The companies contend that their updated COVID-19 vaccines for the fall vaccination season can elicit strong immune responses against the virus’ currently dominant and emerging subvariants.