Mixed results have been reported from two pivotal, phase 3 studies of the opioid painkiller oliceridine (Olinvo, Trevena, Inc.) in subjects with moderate-to-severe acute pain after bunionectomy or abdominoplasty.
A biologics license application for inotuzumab ozogamicin (Pfizer) has been accepted for filing and granted a priority review by the FDA. The compound is being evaluated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The goal date for an approval decision is in August.
The FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for naloxone hydrochloride 2.0 mg/0.5 mL nasal spray. Amphastar Pharmaceuticals is seeking approval of the product for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
As the health care industry continues its metamorphosis from a fee-for-service to a value-based model, industry leaders will rely on several key areas to fuel financial growth, according to a new HealthLeaders Media survey.
Hard-right and more-centrist Republicans are divided over both policy and strategy for repealing and replacing the Patient Protection and Affordable Care Act (PPACA), according to an article posted on the Modern Healthcare website. One of their biggest disagreements is over the future of the PPACA’s expansion of Medicaid coverage.
The ACA mandates that health care benefit packages sold to individuals and small groups look like plans offered in a typical employer-sponsored package and “those are still pretty generous.” That’s Timothy Jost, an emeritus professor at Washington and Lee University Law School, explaining to Kaiser Health News why GOP officials are considering watering down the 10 essential benefits that the ACA says must be covered. Republicans do not have the 60 votes needed to repeal and replace, as of this writing, but they do have the necessary majority needed to change existing law.
A 54-week, phase 3 trial has met its primary endpoint, demonstrating that, at six weeks, the efficacy and safety of treatment with Inflectra (infliximab-dyyb, Pfizer/Celltrion Healthcare) was similar to that of treatment with Remicade (infliximab, Janssen) in patients with moderate-to-severe Crohn’s disease (CD), thereby meeting the criterion for noninfer
Nine years ago, researchers with SWOG (formerly the Southwest Oncology Group) confirmed a new standard of care for patients with incurable gastrointestinal stromal tumors (GISTs), who could survive by being treated with imatinib mesylate (Gleevec, Novartis).
Dr. Katherine Baker of Pennsylvania State University and other microbiologists have been warning for years that antibacterial soaps containing triclosan contribute to the spread of drug-resistant “superbugs.” Triclosan also affects hormones and can disrupt the endocrine cycle.
In a new study, state programs that require physicians to check drug registries before writing prescriptions appeared to reduce the odds of doctor-shopping for opioid pain relievers, according to a Reuters report.
The cost of caring for people with chronic, serious health conditions is immense, and how to pay for it has plagued both political parties for years. Republicans are now touting high-risk pools as a way to do it, but past attempts have not been successful, according to a report from the Pew Charitable Trusts.
Merck has announced that it will stop its phase 2/3 EPOCH trial of verubecestat, an investigational small-molecule inhibitor of the beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1), in subjects with mild-to-moderate Alzheimer’s disease (AD).
Emergency patients treated with naproxen and placebo had outcomes as good as or better than patients treated with naproxen and diazepam (Valium, Roche) for acute lower back pain, according to the results of a double-blind, randomized clinical study published in the Annals of Emergency Medicine.
The phase 3 SUNBEAM trial, which evaluated the efficacy and safety of ozanimod (Celgene), an investigational oral, selective sphingosine phosphate receptor 1 (S1P1) and S1P5 modulator, in patients with relapsing multiple sclerosis (RMS), met its primary endpoint in reducing the annualized relapse rate (ARR) compared with weekly inter