News Wire

Encouraging interim efficacy and safety results have been reported from an ongoing phase 3, open-label study of ARX-04 (AcelRx Pharmaceuticals) for the treatment of adult patients who present to the emergency room with moderate-to-severe acute pain associated with trauma or injury. ARX-04 is an investigational…
The Centers for Disease Control and Prevention (CDC) and state public health departments are investigating 14 new reports of possible sexual transmission of Zika virus, including several involving pregnant women. On February 5, the CDC published interim recommendations for protecting people against…
Collaboration between two Texas Medical Center institutions has resulted in the release of the country’s first hospital-based rapid tests for the Zika virus. Pathologists and clinical laboratory scientists at Texas Children’s Hospital and Houston Methodist Hospital developed the Zika direct test…
A survey of 54 hospitals in six metropolitan areas across the U.S. has revealed that consumers seeking a price estimate for a routine medical procedure can face a frustrating task despite price-transparency provisions in the Patient Protection and Affordable Care Act, according to a new policy brief…
Physicians at the University of Pittsburgh Medical Center and the University of Pittsburgh School of Medicine (UPSM) are helping to rewrite the clinical rule book on sepsis, a major patient killer in hospitals. An international task force has published articles in the Journal of the American Medical…
Positive results from the LATTE-2 study have been reported at the Conference on Retroviruses and Opportunistic Infections in Boston. Interim results were announced in November 2015. LATTE-2 is an ongoing phase 2b, parallel-group, open-label study investigating long-acting, injectable formulations of…
PTC Therapeutics, Inc., has announced that it received a “refuse to file” letter from the FDA regarding the company’s new drug application for ataluren (Translarna), an oral, first-in-class protein-restoration therapy for the treatment of patients with nonsense mutation Duchenne muscular dystrophy…
Positive interim results have been reported from the pivotal phase 3 ONCEMRK trial, which is evaluating an investigational formulation of raltegravir (Isentress, Merck), given as two times 600 mg (1,200 mg) once-daily, for previously untreated adults with human immunodeficiency virus-1 (HIV-1) infection.…
The FDA has accepted for review a supplemental new drug application for enzalutamide (Xtandi, Astellas Pharma/Medivation, Inc.) in men with metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections…
The American Council on Science and Health (ACSH) has called Zika “possibly the scariest virus since HIV” for various reasons, including that it is “all but proven” to cause birth defects. Other viruses are known to harm neonates. For example, genital herpes can be fatal to a newborn, but this…
The cost of an effective, widely used clot-busting treatment has more than doubled during the past decade, but Medicare/Medicaid reimbursement lags far behind, according to new research presented at the American Stroke Association’s International Stroke Conference 2016. “Stroke health care professionals…
Reducing excessive emergency room (ER) use was one of the key objectives of the Patient Protection and Affordable Care Act (PPACA), but the law has barely made a dent in the problem, according to a new report from the Centers for Disease Control and Prevention (CDC). Using the 2013 and 2014 National…
As “superbug” outbreaks caused alarm across the country last year, Dr. Jeffrey Tokar, director of gastrointestinal endoscopy at Fox Chase Cancer Center in Philadelphia, pointed to recent outbreaks from contaminated medical scopes and discussed steps doctors and hospitals should take to ensure patient…
The FDA has approved a new indication expanding the use of palbociclib (Ibrance, Pfizer) 125-mg capsules, a therapy for metastatic breast cancer. Palbociclib is now approved for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced or…
The primary endpoint of improved overall survival has been met in a phase 3, randomized, open-label study comparing blinatumomab (Blincyto, Amgen) with standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).…

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