Samsung Bioepis has gained approval for their etanercept biosimilar in 38 countries in addition to the US.
All articles by Diana Ernst
The FDA has approved Tremfya (guselkumab; Janssen) One-Press, a single-dose patient-controlled injector for the treatment of moderate-to-severe plaque psoriasis in adults.
Baricitinib, a Janus kinase inhibitor, is currently approved under the brand name Olumiant for the treatment of moderately-to-severely active rheumatoid arthritis.
Jeuveau, an aesthetic-only neurotoxin, was evaluated in 2 US Phase 3 placebo-controlled trials and a European and Canadian Phase 3 head-to-head trial vs onabotulinumtoxinA (Botox Cosmetic; Allergan).
In the ERASURE, FIXTURE, FEATURE, and JUNCTURE trials, psoriasis patients who reported problems in these quality of life measures (through the EQ-5D-3L questionnaire) were randomized to receive secukinumab 300mg or placebo and were assessed at weeks 4, 8, and 12.
An expert panel assessed 41 diets to come up with their final results, examining the evidence behind each diet’s claims, the short-term and long-term weight loss associated with the diet, how easy the diet is to follow, how well each diet conforms to current nutrition standards, and its effect on diabetes and cardiovascular disease prevention.
Using data from the 2011 to 2016 National Vital Statistics System-Mortality files, the authors conducted a literal text analysis of death certificates to identify drugs mentioned as contributing to the cause of overdose death.
To investigate the link between organic food consumption and cancer risk, study authors conducted a population-based prospective cohort study among French adults.
Ilumya has been made available by Sun Pharma for the treatment of adults with moderate-to-severe plaque psoriasis.
The approval of Bryhali was based on data from 2 randomized, double-blind studies conducted in 430 patients with moderate to severe plaque psoriasis.
Participants who responded to a question related to rosacea diagnosis in 2005 were included in the final analysis (N=82,737).
The approval was based on Phase 3 data from 2 studies in ABSSSI, where treatment with Nuzyra was compared with linezolid, and 1 study in CABP comparing Nuzyra with moxifloxacin. Across all 3 trials, Nuzyra was found to be effective and generally safe and well-tolerated.
The approval was based on data from 2 large, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials involving patients with moderate to severe facial acne vulgaris.
A single cloth should be used to apply Qbrexza to both underarms.
The approval was based on data from 2 open-label studies where patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation received Libtayo 3mg/kg intravenously every 2 weeks for up to 48 weeks or up to 96 weeks until disease progression, unacceptable toxicity, or completion of planned treatment.
The patient, a 42-year-old female with systemic lupus erythematosus treated with mycophenolate mofetil and prednisone, reported swelling and pain in the fifth finger of her left hand for about 1-week.
The approval was based on 2 double-blind clinical trials involving 1640 patients 9 years of age and older with moderate to severe acne vulgaris.
The case involved a 68-year-old female patient with rheumatoid arthritis on methotrexate 10mg weekly who presented to the emergency department with complaints of lethargy and weakness after being prescribed a 2-week course of TS for a bacterial skin infection.
In a press release Dr. David Young, CEO of Processa said “We plan to begin our clinical studies in 2018 and to accelerate the development of PCS499 in order to provide clinical benefit to [necrobiosis lipoidica] patients as soon as possible.”
The approval was based on data from a randomized, single-blind, multicenter, dose-ranging, crossover study which evaluated the safety and efficacy of Cinryze in 12 pediatric patients (7 to 11 years old).
The NDA includes safety and efficacy data from two Phase 3 trials (REVIVE-1 and REVIVE-2; N=1190) which compared intravenous iclaprim to standard-of-care vancomycin in patients with ABSSSI.
The approval was based on data from the Ritux 3 trial (N=90) which compared rituximab + short-term oral prednisone (Ritux 3 regimen) to oral prednisone alone as a first-line treatment for patients with newly diagnosed moderate to severe PV.
Eskata is a high-concentration hydrogen peroxide-based topical solution intended for in-office application.
Approval was based on COMBI-AD, an international, multi-center, randomized, double-blind, placebo-controlled trial in 870 patients with Stage III melanoma with BRAF V600E or V600K mutations, and pathologic involvement of regional lymph node(s).
The Food and Drug Administration has accepted for review the New Drug Application for a once-daily medication for the treatment of moderate to severe acne vulgaris in patients ≥9 years of age.
The FDA has approved an adjuvant treatment for patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection.
A new case report links proton pump inhibitor use to 2 distinct dermatological reactions.
This case reports on a patient who developed PsA after being stung by wasps 6-8 times.