Daiichi Sankyo’s Late Stage Trial of leukemia candidate in progress-The enrollment process begun for Phase 3 clinical study, QuANTUM-First, evaluating Daiichi Sankyo’s $DSKYF, $DSNKY, orally available quizartinib for the treatment of patients with newly dignosed acure myeloid leukemia (AML), having a genetic mutation called FLT3-ITD, which occurs in about 30% of AML classes. The mutation is associated with quickly worsening cancer, which characterizes higher relapse rate and lower survival rate (OS). The anticipated final data collection for the primary endpoint is January 2020, according to ClinicalTrial.gov.
Quizartinib, came under its development program following the September 2014 acquisition of Ambit Biosciences. It is a small molecule inhibitor of FLT3-ITD (FMS-like tyrosine kinase-3-internal tandem duplication), a growth driver of abnormal cells that contributes to the development of AML. It has Orphan Drug status in the U.S. and Europe.
Biostar Pharma to launch new treatment in China-Nano cap Biostar Pharmaceuticals $BSPM skyrocketed in response to its announcement that it will launch a new topical product in China next month called “Easy Breathing” for the treatment of rhinitis and sinusitis. The treatment, based on the principles of traditional Chinese medicine, was developed internally over the past three years by the company's R&D unit. The company expects to sell about 4000 units in the next two years, which should generate approx. $7.5mn.
Nymox’s BPH Phase-3 candidate shows positive-long term results-Nymox Pharmaceutical $NYMX soared amid heavy trading volume on Tuesday in response to its announcement of encouraging long-term results in 344 men with benign prostatic hyperplasia (BPH), or enlarged prostrate, who received a single repeat injection of lead product candidate fexapotide after the intial blinded treatment with the drug placebo in Phase 3 clinical trial. The company has concluded seven phase 3 trials on BPH studies in the U.S. and it now plans to file regulatory application in the next one to two quarters.
Neurocrine Biosciences’ Ingrezza under NDA Review-The FDA accepted under Priority Review Neurocrine Biosciences' $NBIX New Drug Application (NDA) seeking approval of INGREZZA (valbenazine) for the treatment of tardive dyskinesia, an involuntary movement disorder characterized by repetitive movements of the face, trunk or extremities. The agency's action date (PDUFA) is April 11, 2017. Priority Review status reduces the review clock to six months from the standard 10 month-period.
FDA rejects Novo’s NDA for aspart insulin- In an announcement published today, Novo Nordisk $NVO reported that it received a Complete Response Letter (CRL) from the regulator on October 7 concerning its New Drug Application (NDA) seeking approval for faster-acting insulin aspart. The submission was filed in December 2015. The drug-maker did not reveal the specific reasons for the rejection but says it will work closely with the agency to resolve the outstanding issues.
Roche’s Lucentis Gets Priority Review Status-The FDA granted Priority Review status to Roche's $RHHBY supplemental Biologics License Application (sBLA) seeking approval of Lucentis (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of new sightedness that can result in to blindness. If approved, it will be the first anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV. Priority Review status reduces the review clock to six months from the usual 10- month period.