Janssen Vaccines & Prevention, a Johnson & Johnson unit, along with a consortium...
Takeda’s dengue vaccine shows promise in Phase III trial
Takeda Pharmaceutical has reported positive results from the ongoing Phase III TIDES clinical trial of its dengue vaccine candidate, TAK-003.
Catalyst’s Phase III trial of Firdapse in CMS fails to meet goals
Catalyst Pharmaceuticals has reported top-line data from the Phase III CMS-001 clinical trial of Firdapse (amifampridine phosphate) as a symptomatic treatment of congenital myasthenic syndromes (CMS).
Zogenix’s Fintepla reduces seizures in study participants
Zogenix has reported that its Fintepla drug led to a long-term, clinically meaningful decrease in seizures of study participants with Dravet syndrome.
AtreMorine for Parkinson’s Disease and Dopamine-Related Disorders
AtreMorine is a novel biopharmaceutical compound obtained through non-denaturing biotechnological procedures from the structural components of the Vicia faba L plant, for the prevention and treatment of Parkinson´s disease (PD) and related disorders.
Supporting the Pharmaceutical Industry, 21 CFR Part 11 Compliance Readiness
The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA.
Tecentriq and Avastin improves survival in Phase III cancer trial
Roche has reported that the Phase III IMbrave150 clinical trial of Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) met the co-primary endpoints in hepatocellular carcinoma (HCC) patients.
FDA accepts BLA from AstraZeneca and Daiichi for targeted chemotherapy
AstraZeneca and Daiichi Sankyo have announced that the US Food and Drug Administration (FDA) has accepted their biologics license application (BLA) for targeted cytotoxic chemotherapy trastuzumab deruxtecan.
Lilly’s pegilodecakin fails in Phase III pancreatic cancer trial
Eli Lilly has reported that the Phase III SEQUOIA clinical trial of pegilodecakin failed to meet the primary endpoint of overall survival in patients with metastatic pancreatic cancer.
Novartis-Incyte’s Jakavi yields positive data in GvHD trial
Novartis and Incyte have reported positive results from the Phase III REACH2 clinical trial of Jakavi (ruxolitinib) conducted in steroid-refractory acute graft-versus-host disease (GvHD) patients.