News Wire

The FDA has granted breakthrough therapy status to intravenous (IV) oliceridine (TRV130) for the management of moderate-to-severe acute pain. After two successful phase 2 studies, oliceridine is now in phase 3 development. The ATHENA-1 safety and tolerability study is ongoing in approximately 900 patients,…
U.S. and Brazilian medical experts have launched a research partnership to find a vaccine against the Zika virus, according to a Reuters report. Researchers from the National Institutes of Health and the Centers for Disease Control and Prevention, along with experts from the FDA and the Department of…
Anti-anxiety medications play a large but overlooked part in the opioid-related deaths that are currently grabbing headlines, according to an article posted on the STAT website. In 2013, benzodiazepines, such as alprazolam (Xanax, Pfizer) and diazepam (Valium, Roche), were involved in more than 30%…
The FDA has given the nod to brivaracetam (Briviact, UCB, Inc.), a high-affinity synaptic vesicle protein 2A (SV2A) ligand, as an add-on treatment to other medications to treat partial-onset seizures in patients 16 years of age and older with epilepsy. Epilepsy has many possible causes, including stroke,…
The FDA has granted a breakthrough therapy designation to midostaurin (PKC412, Novartis) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FMS-like tyrosine kinase-3 (FLT3) mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard…
Pioglitazone, a drug used to treat type-2 diabetes, may prevent recurrent stroke and heart attacks in people with insulin resistance but without diabetes. The results of the Insulin Resistance Intervention After Stroke (IRIS) trial, published in the New England Journal of Medicine (NEJM), suggest a…
Researchers in Rio de Janeiro, Brazil, have detected Zika virus in the amniotic fluid of two pregnant women whose fetuses have been diagnosed with microcephaly, according to a study published online in Lancet Infectious Diseases. Although the report suggests that Zika can cross the placental barrier,…
Hollywood Presbyterian Medical Center paid a $17,000 ransom in bitcoins to a hacker who seized control of the hospital’s computer systems and wouldn’t give back access until he was paid, the hospital has reported. The cyber-assault occurred on February 5, when a hacker using malware infected the…
The FDA may have greatly underestimated the number of fetal deaths among women who became pregnant after using the contraceptive device Essure (Bayer), according to a Reuters report. The device consists of two metal coils inserted into the fallopian tubes. Approved in 2002, Essure was marketed as an…
Positive efficacy results have been reported from a phase 2b trial (ZAF-203) evaluating beloranib (Zafgen), a MetAP2 inhibitor, in the treatment of severe obesity complicated by type-2 diabetes. The study achieved its primary efficacy endpoint, as treatment with 1.8-mg and 1.2-mg doses of beloranib…
Positive results have been reported from an analysis of long-term follow-up data from a phase 2 study of MultiStem stem-cell therapy (Athersys, Inc.) in patients with ischemic stroke. The data demonstrated that MultiStem-treated subjects continued to improve through one year and had a significantly…
As a safety measure against the emerging Zika virus outbreak, the FDA has issued new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.…
The FDA is alerting health care professionals of a voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride, 1 mL syringe, CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals in Noblesville, Indiana, because the product is super-potent. Pharmakon…
The FDA has granted breakthrough therapy status to durvalumab (MEDI4736, AstraZeneca) for the treatment of patients with programmed death ligand-1 (PD-L1)–positive inoperable or metastatic urothelial bladder cancer whose tumor has progressed during or after one standard platinum-based regimen. Durvalumab…
Experts at the National Institutes of Health conducted systematic reviews of the literature to address 57 clinical questions related to the treatment of patients with ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (SpA). For patients with active AS, the authors strongly recommend…

Pages