News Wire

The FDA has given the green light to reslizumab (Cinqair, Teva Pharmaceuticals) for use with other asthma medications for the maintenance treatment of severe asthma in patients 18 years of age and older. Reslizumab is approved for patients who have a history of severe asthma attacks (exacerbations)…
Positive results have been reported from a phase 3 trial evaluating alirocumab (Praluent, Sanofi) injection in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), whose cholesterol levels required chronic weekly or biweekly apheresis therapy.…
The FDA has announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. The agency is also requiring several additional…
The FDA has approved ixekizumab (Taltz, Eli Lilly) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Ixekizumab is designed to specifically target interleukin-17A, a protein that plays a role in driving…
A new guideline from the American Cancer Society (ACS) provides clinicians with recommendations on key areas of clinical follow-up care for survivors of head-and-neck cancer—a growing population numbering approximately 436,060 individuals and accounting for 3% of all cancer survivors in the United…
Despite being costly and of little proven benefit, a procedure for treating pulmonary embolism with blood clot filters is routinely used in older adults, Yale School of Medicine researchers have found. Published in the Journal of the American College of Cardiology, the study also showed that the utilization…
AstraZeneca has announced the results from the pivotal SOCRATES trial, which assessed the efficacy of ticagrelor (Brilinta) 90 mg twice daily compared with aspirin 100 mg once daily in patients with acute ischemic stroke (AIS) or transient ischemic attack (TIA). The primary efficacy endpoint of the…
Thirty-six experts in the field of Duchenne muscular dystrophy have signed a letter to the FDA saying that, based on existing scientific data, the agency should approve eteplirsen (Sarepta Therapeutics), which is awaiting a final verdict. The letter was delivered to the FDA’s Division of Neurology…
Mount Sinai Hospital is the first center in the U.S. to use a new cancer treatment consisting of luminescent chemotherapy-filled beads injected into tumors through the wrist. The minimally invasive treatment, using M1 LUMI beads (BTG plc) filled with doxorubicin, is available for patients with inoperable…
Patients undergoing a coronary artery bypass graft (CABG) procedure could pay vastly different sums for the operation depending on where they have it performed, according to a new study published in the American Journal of Cardiology. Researchers at the University of Iowa found that prices for CABG…
Scientists at the University of Leeds in the United Kingdom have answered a 25-year-old question about how a family of proteins allows bacteria to resist the effects of certain antibiotics. Proteins of the ABC-F family are a major source of antibiotic resistance in “superbugs,” such as Staphylococcus…
Promising data have been reported from an ongoing phase 2 trial of Reolysin (Oncolytics Biotech), a proprietary formulation of the human reovirus, in combination with paclitaxel in women with ovarian cancer. The randomized study is comparing paclitaxel monotherapy with paclitaxel plus Reolysin in patients…
The FDA has announced a proposal to ban most powdered gloves in the United States. While the use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients, and other individuals who are exposed to them, which cannot be corrected…
Positive findings have been announced from a pivotal phase 3 trial of romosozumab (Amgen/UCB) in men with osteoporosis. The study met its primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual-energy x-ray absorptiometry)…
Eagle Pharmaceuticals has received a complete response letter from the FDA for its ready-to-use, stable liquid intravenous formulation of bivalirudin (5 mg/mL in a 50-mL vial). The treatment is intended for use as an anticoagulant in patients 1) undergoing percutaneous coronary intervention (PCI) with…

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