Pharma News

Lipocine Inc., a specialty pharmaceutical company, announced that it has received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.

 A single dose of either of two experimental Zika vaccines fully protected mice challenged with Zika virus four or eight weeks after receiving the inoculations. The research, conducted by investigators supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, suggests that similar vaccines for people could be similarly protective.

High triglycerides a type of fat, or lipid, in the blood  increase the risk of heart disease and perhaps type 2 diabetes. For the first time, it has been shown that profoundly lowering triglycerides in diabetics improves their insulin sensitivity over time, which helps them maintain healthy glucose - blood sugar levels. Volanesorsen, an experimental lipid-lowering medication, improved insulin sensitivity and glucose control by significantly decreasing patients' overall hemoglobin A1c the standard clinical measurement of blood glucose levels for diabetics in a new study reported by researchers from the Perelman School of Medicine at the University of Pennsylvania. The results are published online this month in Diabetes Care.

A meta-analysis of studies in people with diabetes and pre-diabetes has shown that oral aloe vera use was associated with significant decreases in both fasting blood glucose (FBG) and hemoglobin A1c (HbA1c).

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AstraZeneca announced that the European Commission (EC) has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation.

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Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).

Kyowa Hakko Kirin Co., Ltd. announced KRN23, an investigational recombinant fully human monoclonal IgG1 antibody against the phosphaturic hormone fibroblast growth factor 23(FGF23), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of X-linked hypophosphatemia (XLH) in pediatric patients one year of age and older. Kyowa Hakko Kirin and Ultragenyx entered into a collaboration and license agreement in August 2013 to develop and commercialize KRN23.

Accuray Incorporated announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radixact™ Treatment Delivery Platform. Accuray also received 510(k) clearance for its new treatment planning and data management systems, Accuray Precision™ Treatment Planning System and iDMS™ Data Management System. These next generation hardware and software solutions which, together, make up the new Radixact system, enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing retreatment.  The new Radixact system represents a major step forward in the evolution of the TomoTherapy® System in treatment speed and ease of use.

QT Vascular Ltd., together with its subsidiaries, a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced it has received 510(k) clearance from the US Food and Drug Administration (“FDA”) for the sale and distribution of the Chocolate XD™ PTCA catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.