News Wire

The FDA’s Arthritis Advisory Committee has recommended approval of all eligible indications for CT-P13 (Celltrion/Pfizer), a proposed biosimilar to Janssen Biotech’s Remicade (infliximab), by a vote of 21 to 3. CT-P13 is the first biosimilar monoclonal antibody medication to be considered by the…
Positive results have been reported from the second of two replicate pivotal phase III trials evaluating the efficacy and safety of elagolix (AbbVie/Neurocrine Biosciences) in premenopausal women with pain from endometriosis. After six months of continuous treatment, both doses of elagolix (150 mg once…
Cigna Corp and Aetna have made deals with Novartis for a performance-based price for the new heart drug Entresto, according to a Reuters report. Cigna said its payments to Novartis will be linked to how well the drug improves the relative health of Cigna customers. Specifically, Cigna said payments…
New evidence indicates that problems with contaminated duodenoscopes were apparent nearly four years ago but the FDA dropped the ball, allowing the scopes to be used for three more years, according to the Los Angeles Times. An outbreak at a Pennsylvania hospital in late 2012 should have been an early…
The FDA has informed Sarepta Therapeutics that it will require additional time to complete its review of the new drug application (NDA) for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The Prescription Drug User Fee Act (PDUFA) date for eteplirsen has…
The U.S. Preventive Services Task Force (USPSTF) has released a final recommendation statement on screening for depression in children and adolescents. The task force recommended screening for major depressive disorder (MDD) in adolescents 12 to 18 years of age and found that there was not enough evidence…
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…
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…
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…
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.…

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