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…
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…
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…
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…
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…
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…
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…
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…
An analysis commissioned by a pharmaceutical industry trade group found that hospitals participating in the 340B Drug Discount Program have higher per-patient outpatient pharmacy costs than their non-340B counterparts––indicating patients at 340B hospitals are prescribed more medicines, more expensive…
The FDA’s Center for Biologics Evaluation and Research has expanded the indication for Fluarix Quadrivalent (influenza vaccine, GlaxoSmithKline) to include use in people 6 months of age and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses…
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…
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…
