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

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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

Gleevec Provides Long-Term Survival in GIST Patients

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).

Antimicrobial Soaps Do More Harm Than Good in Fight Against “Superbugs,” Scientist Says

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.

Study: Prescription-Drug Monitoring Cuts Doctor-Shopping for Painkillers

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.

GOP to Revive High-Risk Pools in Obamacare Repeal

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.

Another Alzheimer’s Drug Bites the Dust

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).

Study: Valium No Better Than Placebo for Lower Back Pain in the ED

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.

Oral Ozanimod Shows Efficacy, Safety in Phase 3 Relapsing MS Trial

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

New Method Could Fast-Track Existing Drugs as Novel Treatments for Depression

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.

China Bans Carfentanil, Possible “Game-Changer” in U.S. Opioid Epidemic

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.

GOP’s Obamacare Replacement Plan Begins To Emerge

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.

Prime Therapeutics’ Clients See Only 2.5% Drug Spend Increase in 2016

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

Long-Term Data Support Safety and Efficacy of Genvoya for HIV Infection

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.

FDA Expands Spiriva Respimat Label

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.

FDA Approves New Psoriasis Drug

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.

Paul Lendner

Paul Lendner ist ein praktizierender Experte im Bereich Gesundheit, Medizin und Fitness. Er schreibt bereits seit über 5 Jahren für das Managed Care Mag. Mit seinen Artikeln, die einen einzigartigen Expertenstatus nachweisen, liefert er unseren Lesern nicht nur Mehrwert, sondern auch Hilfestellung bei ihren Problemen.

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