Of the 30 U.S. children who have died from the flu so far this season, some 85% had not been vaccinated, said Centers for Disease Control and Prevention Director Brenda Fitzgerald, MD, who urged Americans to get flu shots amid one of the most severe flu seasons in years. “My message is, if you haven’t…
The FDA has permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized the Banyan Brain Trauma Indicator (Banyan Biomarkers, Inc.) in less than six months as part of its Breakthrough Devices…
The FDA has granted a breakthrough therapy designation for erdafitinib (Janssen Pharmaceuticals) in the treatment of urothelial cancer, an often-aggressive disease with a grim prognosis that is seen most frequently in the bladder. It’s the sixth most common type of cancer in the U.S. The breakthrough…
A large study of cardiovascular events in gout patients taking one of two medications to prevent excess build-up of uric acid has found that one of the drugs, febuxostat (Uloric, Takeda), increased the risk of death for those with heart disease compared with the other drug, allopurinol. Yet the two…
The FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) in combination with chemotherapy in adult patients with previously untreated stage III or IV classical Hodgkin’s lymphoma. The approval is based on the successful outcome of the phase 3 ECHELON-1 clinical trial that compared…
Influenza activity decreased in the United States during the week ending February 24, according to the Centers for Disease Control and Prevention (CDC). In week 8 of this trying flu season, the proportion of outpatient visits to doctors blamed on influenza-like illness (ILI) fell for the third straight…
Dulaglutide (Trulicity, Eli Lilly and Company) significantly improved HbA1C when added to ongoing type-2 diabetes treatment with a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, according to results from the phase 3b AWARD-10 trial. The data were published online in The Lancet Diabetes & Endocrinology…
Smoking is associated with increased risk of hearing loss, according to a study of more than 50,000 participants over eight years. Researchers analyzed data from annual health checkups, which included audio testing performed by a technician and a health-related lifestyle questionnaire completed by each…
Allergan’s attempt to protect six Restasis patents by assigning them to the St. Regis Mohawk Tribe has hit a snag: The U.S. Patent Trial and Appeal Board (PTAB) has denied the tribe’s motion to terminate Mylan's patent challenge. "The PTAB's ruling reinforces our belief that Allergan's maneuvers…
A pregnant woman who becomes ill from the Zika virus faces a 7% chance that her child will be born with birth defects, and that risk jumps to nearly 13% if she becomes ill during the first trimester, a study conducted in French territories in the Americas has concluded. The finding “emphasizes the…
The FDA has approved the world’s smallest mechanical heart valve to aid in the treatment of congenital defects in newborns. The 15-mm valve size was added to the existing Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff (St. Jude Medical). “While larger replacement heart valves…
For the second consecutive year, total payments to care for individuals living with Alzheimer’s or other dementias are projected to surpass a quarter of a trillion dollars ($277 billion), which includes an increase of nearly $20 billion over last year, according to data reported in the Alzheimer’s…
The FDA has approved a supplemental new drug application (sNDA) for afatinib (Gilotrif, Boehringer Ingelheim) for the first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR) mutations as detected by…
Outpatient visits for flu-like illness dropped for a second week in a row but remained above the peak seen during many flu seasons, federal officials say. They predict that flu activity is likely to remain elevated for several weeks. During the week ending February 17—week 7 of this flu season—the…
Aimmune Therapeutics, Inc., has announced that its peanut allergy drug met the main goal of an eagerly awaited late-stage study, sending its shares up 18% pre-market, Reuters reports. The positive trial data comes nearly four months after French drug developer DBV Technologies SA’s stick-on patch…
