In this issue: Knock on effects of the Valsartan recall, the future of...
- Find out how pharma is fighting respiratory illnesses in the latest Pharma Technology Focus
- FDA accelerated review denial is a blow to Spectrum’s poziotinib
- Poxel closes enrolment in TIMES 2 trial of Imeglimin in Japan
- Cocrystal Pharma to study hepatitis C drug in Hong Kong
- Allergan assesses brazikumab in two clinical programmes for IBD
ARCA biopharma to study Gencaro in Phase III trial
ARCA biopharma has announced plans to investigate Gencaro (bucindolol hydrochloride) as a genetically-targeted therapy in a pivotal Phase III clinical trial for atrial fibrillation (AF) in patients with a certain type of heart failure (HF).
FDA halts Xencor’s leukaemia drug trial following patient deaths
The US Food and Drug Administration (FDA) has placed a partial clinical hold on biopharmaceutical firm Xencor’s Phase I trial of XmAb14045.
BeiGene doses first patient in Phase II trial of zanubrutinib
BeiGene has dosed the first patient in a global Phase II trial to evaluate the efficacy of zanubrutinib for the treatment of relapsed or refractory (R/R) marginal zone lymphoma (MZL).
Intercept reports fibrosis improvement in NASH trial
Intercept Pharmaceuticals has reported positive top-line results from the pivotal Phase III REGENERATE clinical trial of obeticholic acid (OCA) in patients with liver fibrosis caused due to non-alcoholic steatohepatitis (NASH).
Sosei Heptares initiates clinical programme for endocrine disorders
Japan-based biopharmaceutical group Sosei Heptares has initiated clinical development programme of HTL0030310 for the treatment of endocrine disorders, including Cushing's disease.
Novus Therapeutics begins dosing in otitis media drug trial
Novus Therapeutics has commenced dosing in a Phase IIa clinical trial of OP0201 for the treatment of otitis media, an inflammatory disease affecting the middle ear.
Pfizer-Lilly’s tanezumab reduces chronic low back pain in trial
Pfizer and Eli Lilly have reported positive top-line results from a Phase III clinical trial of tanezumab in patients suffering from moderate-to-severe chronic low back pain (CLBP).
Inventiva’s lanifibranor fails to meet endpoint in FASST trial
French biopharmaceutical company Inventiva has reported findings from the Phase IIb FASST clinical trial of lanifibranor in patients with diffuse cutaneous systemic sclerosis (dcSSc), a rare autoimmune, rheumatic disease.
Bionomics reports additional data from RESTORE trial
Australia-based Bionomics has reported positive data from additional analysis of the Phase II RESTORE trial that evaluated its BNC210 in post-traumatic stress disorder (PTSD).
CStone to study avapritinib in trial for GI stromal tumours
CStone Pharmaceuticals is set to initiate a Phase III clinical trial to study its avapritinib drug candidate as a third-line treatment for KIT-driven gastrointestinal stromal tumours (GIST).
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