News Wire

The FDA has accepted a supplemental new drug application for empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) based on cardiovascular (CV) risk-reduction data from the landmark EMPA-REG OUTCOME trial. A decision from the FDA is expected within the standard review time frame. Cardiovascular…
OncoMed Pharmaceuticals has announced an update on its phase 2 ALPINE trial of the pancreatic cancer drug tarextumab after a preplanned interim efficacy assessment by an independent data safety monitoring board (DSMB). The DSMB evaluated data from 172 patients treated as of a data cutoff date of January…
Johnson & Johnson (J&J) has suspended international trials of a drug in the same class as an investigational compound made by Portuguese pharma company Bial, whose tests in France left one person brain-dead and five others hospitalized, according to a report from Reuters. A J&J spokesman…
After years of stagnation, organ donations are up, and organizations that collect organs for transplantation and the hospitals they work with say their partnerships have been the key to getting the numbers to grow, according to an article posted on the HealthLeaders Media website. The number of organs…
The FDA has approved the supplemental new drug application for carfilzomib (Kyprolis, Amgen) for injection in combination with dexamethasone or with lenalidomide (Revlimid, Celgene) plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to…
The FDA has approved Botox (onabotulinumtoxinA, Allergan) for the treatment of lower limb spasticity in adults to reduce the severity of increased stiffness in ankle and toe muscles. Botox is the only botulinum toxin product to be cleared by the FDA for the treatment of multiple muscle groups of the…
A new study has raised concerns that ambulatory care nurses fail to comply with standard precautions intended to protect them from blood-borne pathogens, according to an article on the FierceHealthcare website. Standard precautions are the minimum infection control practices that nurses must follow…
Once the realm of science fiction, telemedicine has become a reality of health care –– and an option for patients who might once have been difficult to reach, according to an article posted on the HealthLeaders Media website. San Francisco-based Dignity Health, for example, performed 12,000 telemedicine…
The FDA has approved a supplemental new drug application (sNDA) to update the label for dalbavancin (Dalvance, Allergan) for injection. The expanded label will include a single dose administered as a 30-minute intravenous infusion of dalbavancin for the treatment of acute bacterial skin and skin-structure…
It is well recognized that stress can lead to episodes of depressive illness and that some depressed patients have elevated levels of the stress hormone cortisol as an indication of their mental health. A study conducted at Newcastle University in the United Kingdom has shown that a drug that blocks…
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…
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…
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…
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…

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