Infliximab Biosimilar Is Noninferior to Remicade in Phase 3 Crohn’s Disease Study

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

Research from King’s College London reveals a new method of repurposing existing drugs as novel treatments for depression using laboratory studies of brain cells.

So deadly it’s considered a terrorist threat, carfentanil has been legal in China—until now. Beijing is banning carfentanil and three similar drugs as of March 1, China’s Ministry of Public Security said Thursday, closing a major regulatory loophole in the fight to end America’s opioid epidemic.

It perhaps raises more questions than it answers, but isn’t that the way any process to overhaul the health care system starts? Republican legislators yesterday unveiled aspects of what will come after Obamacare. President Trump in a contentious news conference yesterday took a shot at the ACA.

Pharmacy benefits managers (PBMs) served notice last week that they refuse to be labeled as bad guys because of soaring drug costs.

Positive 144-week data have been reported from two phase 3 studies of Genvoya (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg, Gilead Sciences) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in treatment-naïve adults.

The FDA has approved Spiriva Respimat (tiotropium bromide, Boehringer Ingelheim), a steroid-free inhalation spray, for the long-term, once-daily maintenance treatment of asthma in patients 6 years of age and older. The agency approved the supplemental new drug application under a priority review designation.

The FDA has given the green light to brodalumab (Siliq, Valeant Pharmaceuticals) for the treatment of adults with moderate-to-severe plaque psoriasis. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond or have stopped responding to other systemic therapies.