Pharma News

Nicox SA an international ophthalmology company, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.  The IND was submitted to the U.S. FDA in December 2018 ahead of the target of the first quarter of 2019.

The NPPA has fixed the retail price of 29 formulations under Drugs Price Control Order (DPCO), 2013 through a notification dated 25 January 2019.

Committee for Medicinal Products for Veterinary Use (CVMP) adopted by consensus a positive opinion for a type II variation application (subject to a worksharing procedure) for Purevax RC, Purevax RCP, Purevax RCP FeLV, Purevax RCPCh FeLV and Purevax RCPCh concerning quality changes.

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The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of NIH, developed the investigational treatment and conducted and sponsored the clinical trial.

Preliminary results from the ANNOUNCE study show that Lartruvo (olaratumab) in combination with doxorubicin is not more effective at prolonging the lives of patients with soft tissue cancer than doxorubicin alone.

African-Americans who smoke appear to be at greater risk for peripheral artery disease, or PAD, new research has found. Additionally, the findings suggest that smoking intensity – how many cigarettes a day and for how many years – also affects the likelihood of getting the disease.

Researchers have developed a simple blood test that can detect when a newly transplanted lung is being rejected by a patient, even when no outward signs of the rejection are evident. The test could make it possible for doctors to intervene faster to prevent or slow down so-called chronic rejection—which is severe, irreversible, and often deadly—in those first critical months after lung transplantation. Researchers believe this same test might also be useful for monitoring rejection in other types of organ transplants. The work was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.

The U.S. Food and Drug Administration permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.

Children with a history of prior dengue virus infection had a significantly lower risk of being symptomatic when infected by Zika virus, according to a study in Nicaragua of more than 3,000 children aged 2 to 14 years. Experts have worried that prior dengue virus infection could exacerbate severe Zika disease. However, the new findings, published in PLOS Medicine, indicate that prior dengue immunity in children may in fact be protective against symptomatic Zika disease.

The ILO Global Commission on the Future of Work calls for fundamental changes in the way we work in the new wave of globalization, rapid technological development, demographic transition and climate change, according to its report Work for a Brighter Future published today. The report examines how to achieve a better future of work for all at a time of unprecedented change and exceptional challenges in the world of work.