News Wire

Martin Shkreli, the former drug company CEO charged with securities fraud, has been subpoenaed by a U.S. congressional committee investigating the price of drugs, according to a report from BloombergBusiness. The House Committee on Oversight and Government Reform will hold a hearing on January 26 to…
Days after a phase 1 clinical trial studying an experimental fatty acid amide hydrolase (FAAH) inhibitor being developed by the Portuguese company Bial-Portela left one patient dead and five others hospitalized in France, numerous questions remain unanswered, according to an article on the BioSpace…
Drug manufacturers have unconscionably high profit margins, and the industry must rein in some of its more excessive practices, Catherine DeAngelis, MD, the retired editor-in-chief of JAMA, argues in an editorial published in the Milbank Quarterly. “Big Pharma has crossed the line from reasonable…
David Ross is a violence intervention specialist at the University of Maryland Medical Center. His team works with patients who are victims of violent injuries — stabbings, gunshots, or physical assaults — and who physicians flag as candidates for the program’s assistance. His challenge is to…
When quality improvement organizations (QIOs) took over the role of education and enforcement for the two-midnight rule on October 1, 2015, many anticipated that the reviews would only look at records from that date forward. But some hospitals have reported QIO records requests zeroing in on cases as…
The FDA has approved a supplemental biologics license application for the use of ofatumumab (Arzerra, Genmab/Novartis) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). The approval…
Positive efficacy findings have been reported from the bestPWS ZAF-311 study, a pivotal phase 3, double-blind, placebo-controlled trial evaluating the safety and efficacy of beloranib (Zafgen, Inc.), a MetAP2 inhibitor, in patients with Prader–Willi syndrome (PWS) during a six-month randomized treatment…
Reducing excessive medical costs associated with high hospital readmission rates is a pillar of health care reform. From 2007 to 2011, as many as 19% of patients in the U.S. returned to hospitals less than a month after discharge, accounting for an estimated $15 million in preventable hospitalization…
Better coordination between hospitals and post-acute care facilities could reduce patient readmission to hospitals and mortality rates, according to a new study of risk factors conducted by researchers at the University of Colorado’s Anschutz School of Medicine. In a review of more than 3,200 hospitalizations…
It can be difficult to quantify the exact economic burden of Clostridium difficile infections on hospitals and the health system as a whole, but a recent study has put a dollar amount on the cost of C. difficile-associated diarrhea that is not only big but also likely to be underestimated, according…
The FDA has approved secukinumab (Cosentyx, Novartis) for the treatment of adults with two new indications: active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are life-long painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated…
A new drug application (NDA) has been submitted to the FDA for the approval of oral once-daily baricitinib (Eli Lilly/Incite Corporation) for the treatment of moderately to severely active rheumatoid arthritis (RA). Baricitinib is the only once-daily oral selective Janus kinase-1 (JAK1) and JAK2 inhibitor…
Glioblastoma multiforme (GBM) is a disease with some of the highest unmet needs in oncology, with patients having a median overall survival (OS) of between one and two years. The lack of effective therapies is primarily due to the inability of drugs to penetrate the blood–brain barrier. The GBM market…
The FDA has informed Heron Therapeutics, Inc., that it has not yet completed its review of the new drug application for granisetron injection, extended release (Sustol), and would not be taking action by the Prescription Drug User Fee Act goal date of January 17, 2016. The agency now anticipates taking…
The largest analysis of breast cancer cell function to date has suggested dozens of new uses for existing drugs, new targets for drug discovery, and new drug combinations. The results of the study, which was conducted by researchers in New York City and Toronto, were published online in Cell. “This…

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