Phase I
In May the FDA placed a hold on the trial and IND for CTX001, an investigational gene editing treatment, citing concerns over questions that had not been addressed in the IND.
Affimed, based in Heidelberg, Germany, placed a clinical hold on its two AFM11 Phase I clinical trials. AFM11 is being evaluated in the trials for relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma and acute lymphoblastic leukemia.
Data Supports Akari’s Ongoing Clinical Expansion into a Range of Orphan Autoinflammatory Diseases That Are Either Mediated by Complement C5 or Have Synchronous C5 and Leukotriene B4 (LTB4) Activity
Shares of Cambridge, Mass.-based Avrobio plunged more than 50 percent on Monday after the company provided an updated look at its gene therapy for Fabry disease that showed promise for the treatment, but also raised some concern for investors.
Janssen Biotech, a Johnson & Johnson company, informed Aduro Biotech that it was terminating its research and license deals related to Aduro’s Listeria treatment for cancers.
Botanix has received Human Research Ethics Committee approval to commence the planned BTX 1308 psoriasis Phase 1b patient study
Oral alicaforsen appears safe and well-tolerated
A study aimed at demonstrating the clinical superiority of THN201 over a standard of care treatment for this severely debilitating symptom
Eli Lilly just signed a license deal with Tokyo’s Chugai Pharmaceutical Co. for OWL833, Chugai’s oral non-peptidic GLP-1 receptor agonist. It is Phase 1-ready being evaluated for type 2 diabetes.
A three-year-old cancer research alliance between U.S. and Cuban scientists is bearing fruit. A Cuban-developed lung cancer treatment combined with Opdivo shows promise in treating patients.
PRESS RELEASES