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news.BioInvent wins FDA approval to study TB-403 for treatment of pediatric brain tumors
The FDA has accepted the company’s investigational new drug (IND) application for the phase I/IIa study of TB-403, which is expected to start in the first quarter of
The FDA has accepted the company’s investigational new drug (IND) application for the phase I/IIa study of TB-403, which is expected to start in the first quarter of
The company said all five patients in the low-dose cohort had Factor IX (FIX) phenotypic features of severe or moderately-severe hemophilia including documented FIX levels less than 1%
The collaborative research agreement with Janssen Biotech and the French National Institute for Agriculture Research (INRA) will focus on the discovery of novel targets and therapeutics for Crohn’s
The selected candidate, ImmTAC, will address a target relevant in several cancer indications such as synovial sarcoma, bladder and non-small cell lung (NSCL) cancers. Immunocore will carry out
The drug had no serious adverse events, bleeding or injection site reactions, the company said. The 59-patient trail has revealed that patients who were given 30 mg and
EMB-001 is a patented combination product comprising metyrapone and oxazepam drugs, which have been approved by the US Food and Drug Administration. It targets the stress response system
MannKind is reviewing its strategic options for Afrezza as a result of the termination of its license and collaboration agreement. The termination will take effect no later than
The study’s data monitoring committee (DMC) recommended for termination of the trial early because of lack of efficacy. Gilead is however continuing the phase 2 trials of the
HD affects muscle coordination and leads to deterioration of mental abilities and physical control. IONIS-HTT Rx, which is currently in phase 1/2a study, is an antisense drug designed
Gilead filed a new drug application for the treatment, a combination of the company’s Sovaldi with velpatasvir, in October last year. A final decision from the FDA is