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The FDA has accepted for review a supplemental new drug application (sNDA) for a proposed labeling update of brexpiprazole (Rexulta, Otsuka/Lundbeck) for the maintenance treatment of adults with schizophrenia. The Prescription Drug User Fee Act (PDUFA) date is September 23, 2016. The sNDA was supported…
Positive preliminary findings have been reported from the AURION (Aurinia Early Urinary Protein ReductION Predicts Response) study of voclosporin (Aurinia Pharmaceuticals) in patients with lupus nephritis. All of the first seven patients who had reached at least eight weeks of therapy achieved at least…
The Obama administration is asking Congress for more than $1.8 billion in emergency funding to fight the Zika virus in the U.S. and other countries, according to a Reuters report. The money would be divided among the Department of Health and Human Services, the Agency for International Development,…
The Centers for Disease Control and Prevention (CDC) has issued new interim guidance on preventing the sexual transmission of Zika virus after confirming through laboratory testing, in collaboration with Dallas County Health and Human Services in Texas, the first case of Zika virus infection in a nontraveler…
In response to the current opioid-abuse epidemic, Dr. Robert Califf, the FDA’s Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, has called for an action plan to reassess the agency’s approach to opioid medications. The FDA intends to: Re-examine the risk–benefit…
Exposure to specific antibiotics is linked to the development of certain strains of antibiotic-resistant Clostridium difficile, one of the fastest-growing “superbugs,” according to a new study led by Stuart Johnson, MD, of Loyola University. C. difficile now rivals methicillin-resistant Staphylococcus…
Public health agencies, as well as individual health care providers, have their work cut out for them in the looming battle against the Zika virus, according to an article posted on the FierceHealthcare website. In an interview on National Public Radio, Tom Frieden, MD, director of the Centers for Disease…
In a report issued ahead of a meeting scheduled for February 9, FDA staff members have supported a biosimilar version of Janssen Biotech’s best-selling arthritis drug Remicade (infliximab). The product, called CT-P13, was developed by a Korean company, Celltrion, in partnership with Pfizer. If approved…
Vertex Pharmaceuticals has received a complete response letter from the FDA in answer to the company’s supplemental new drug application (sNDA) for the use of ivacaftor (Kalydeco) in patients 2 years of age and older with cystic fibrosis (CF) who have one of 23 residual function mutations in the cystic…
A prespecified interim analysis has shown that the primary endpoint of improved overall survival was met in the phase 3 TOWER trial. This randomized, open-label study evaluated the efficacy of the antibody construct blinatumomab (Blincyto, Amgen) compared with standard-of- care chemotherapy in adult…
A new method for detecting infection in wounds could take physicians less than one minute to complete rather than the current 24 hours it takes to “plate” bacteria and leave them to incubate overnight, according to research from George Washington University’s School of Medicine & Health Sciences.…
The World Health Organization (WHO) has expressed concern over the recent sexual transmission of the Zika virus in Texas amid worries that such infections could make efforts to combat the virus even more difficult, according to a report from Reuters. Earlier, WHO had declared a global health emergency,…
How concerned should people be about the Zika virus? What research is being conducted on the virus? Is a vaccine the best or only approach to containing the virus? Scientists at Colorado State University’s Arthropod-Borne and Infectious Diseases Laboratory are among the nation’s experts on these…
The FDA has approved a supplemental new drug application (sNDA) for intravenous (IV), single-dose fosaprepitant dimeglumine (Emend, Merck), a substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medications, for the prevention of delayed nausea and vomiting in adults…
The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that substantial evidence had been presented to support the efficacy of vortioxetine (Brintellix, Takeda/Lundbeck) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The committee…

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