Xellia announced that the Food and Drug Administration (FDA) has approved its Premixed Vancomycin Injection in a Ready-to-Use bag.
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The NDA included data from the Phase 3 REVIVE-1 and REVIVE-2 trials.
Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
The approval was based on data from 2 large, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials involving patients with moderate to severe acne vulgaris.
Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
In the ECLIPSE study (N=1048), patients were randomized to receive guselkumab 100mg at weeks 0, 4, and 12 followed by every 8-week dosing or secukinumab 300mg at weeks 0, 1, 2 3, 4 followed by every 4-week dosing.
The approval was supported by data from 2 prospective, multicenter, randomized, double-blind clinical trials.
Dupixent is also being assessed in other allergic/inflammatory conditions, including pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, and peanut allergy.
The 23andMe Personal Genome Service Pharmacogenetic Reports test can detect 33 variants for multiple genes, corresponding to more than 50 commonly prescribed medications and over-the-counter products.
Altreno Lotion should be used with caution in patients with known sensitivity or allergy to fish.
Tremfya, a human anti-interleukin (IL)-23 monoclonal antibody, is a subcutaneous injection currently approved to treat adults with moderate to severe plaque psoriasis,
Currently, oral minocycline and doxycycline are first-line therapies for this condition but are associated with potentially serious systemic adverse effects.
The Phase 3 study (N=318) enrolled patients aged 18 to 78 years with moderate-to-severe chronic plaque psoriasis who had not previously received treatment with ≥1 biologic.
PF-06651600 is an investigational oral Janus kinase 3 (JAK3) inhibitor that is being evaluated in a Phase 2 study which will assess the treatment based on changes from baseline in Severity of Alopecia Tool (SALT) score.
Clinical enrollment for an open-label, single-arm Phase 1/2 trial of FCX-013 was initiated in August 2018.
The infection developed within several months of the patients starting SGLT2 therapy and the drug was discontinued in most cases. All patients required surgery and there was 1 reported death.
Its long-term safety was evaluated in a phase 3, multicenter, open-label study of 555 adults with moderate to severe plaque psoriasis.
Clinical data has indicated that the drug exhibits a low propensity for resistance development as well as a favorable tolerability profile.
Patients with TGM-1 deficiency may have chronic pronounced scaling of the skin with increased transepidermal water loss, as the TGM-1 enzyme is essential for facilitating the formation of the epidermal barrier, which prevents dehydration.
The Committee’s recommendation was based on data from the omadacycline global development program that included nearly 2000 adults in three Phase 3 studies.
The primary endpoint was the proportion of patients with an IGA score of 0 (clear) or 1 (almost clear) at Week 16.
The multicenter retrospective study (N=377) was conducted to investigate the causes, treatment protocols, and mortality rates of US adults with SJS/TEN.
Researchers found that a non-immunosuppressant drug originally designed to treat osteoporosis (WAY-316606) targeted the same mechanism by antagonizing SFRP1, and after treating hair follicles with WAY-316606 for 6 days, the authors found enhanced human hair growth.
Treatment with the combination gel + oral doxycycline was associated with a 66.2% reduction in inflammatory lesions, a 58.7% reduction in non-inflammatory lesions, and a 62.6% reduction in total lesions at Week 12 vs baseline (P <.0001).
Encore Dermatology announced the launch of Impoyz Cream 0.025% for the treatment of moderate to severe plaque psoriasis.
The BLA is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients.