An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.
Results showed that the placebo group actually had a greater reduction in itch score, with 76% of this group having an itch score of 0 compared to 62% of patients in the prednisone group.
Protection against skin cancer is important but "moderate levels of unprotected sun exposure can be very helpful in boosting vitamin D."
"As an aesthetics company, we understand that beauty starts from the inside out. With Mederma Spezial, consumers now have the opportunity to impact the health not only of their skin, but of their hair and nails," said Jim Hartman, VP and U.S. Head of Merz Aesthetics Marketing and OTC.
A biosimilar product must demonstrate no clinically meaningful differences in safety or efficacy from the reference product.
Rhofade applied once-daily demonstrated a reduction in persistent facial erythema associated with rosacea through 12 hours in both clinical trials.
The safety and efficacy of Humira in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis was evaluated in a Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study.
Dupixent, a human monoclonal antibody, works by inhibiting the overactive signaling of IL-4 and IL-13 proteins, which are believed to play a major role in the persistent inflammation in atopic dermatitis.
Allergan and Paratek announced positive results from two Phase 3 studies of sarecycline for the treatment of moderate to severe acne.
The new OXY On-The-Go Acne Stick allows teens to spot-treat at any time; it can be used for different skin types.
Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
The injectable gel is balanced with firmness and low cohesivity delivering results that last up to 18 months from the initial or touch-up injection.
Among those who developed PED, the condition continued for months or years, despite patients stopping treatment.
A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.
The new findings come from an uncontrolled extension of two previous secukinumab trials in which patients were re-randomized to placebo following PASI achievement.
Patients confirmed as having NIUA develop tolerance to NSAIDs over time
Cutanea Life Sciences has announced the availability of Aktipak (erythromycin and benzoyl peroxide) Gel, 3%/5% for the topical treatment of acne vulgaris.
Janssen announced new findings from VOYAGE 2 and NAVIGATE, two pivotal Phase 3 studies evaluating guselkumab for the treatment of moderate to severe plaque psoriasis.
The study achieved its primary endpoint, demonstrating that treatment with oral fusidic acid is non-inferior to oral linezolid.
Among randomized patients who entered the long-term extension trial period , 79.2% of patients receiving ustekinumab every 12 weeks and 87.1% of patients receiving ustekinumab every 8 weeks were in remission,
The drug carries a Black Box Warning and is available only through a restricted program.
Psoriasis patients who interrupted therapy with ixekizumab displayed a reduced level of response.
Most cases of rhytidectomy malpractice litigation are resolved in the defendant's favor, according to research published online February 9 in JAMA Facial Plastic Surgery.
Perrigo announced a recall of 10 lots of Clindamycin Phosphate and Benzoyl Peroxide Gel (1.2%/5%) due to the presence of a small amount of mold on the caps of the tubes.
Patients with alopecia areata (AA) have significantly lower serum levels of zinc and selenium, according to a meta-analysis published online February 2 in The Journal of Dermatology.
Among patients with eczema, most moisturizers showed some benefit but better results were seen when used with topical active treatment, according to a Cochrane Review.
Prescribing practices vary among U.S. and Canadian physicians treating severe childhood atopic dermatitis (AD), according to a study published in the Journal of the American Academy of Dermatology.
Intralesional immunotherapy is more effective than cryotherapy for treatment of wart lesions, according to a study published online in the International Journal of Dermatology.
Reactions can occur within minutes of exposure.
3M announced the launch of Cavilon Advanced Skin Protectant for the prevention of moderate to severe incontinence-associated dermatitis (IAD).
For elective surgery scars, application of super-pulsed fractional CO2 laser application improves the aesthetic quality of scars more than silicone gel, according to a study published online in Lasers in Surgery and Medicine.
Novan has announced results from its two Phase 3 trials of SB204 gel 4%, its investigational candidate for the treatment of acne vulgaris.
Climbazole enhances retinoid-associated biological activities in vivo and in vitro, according to a study published online January 19 in the International Journal of Cosmetic Science.
Atopic dermatitis (AD) is associated with increased risk of alopecia areata (AA) and vitiligo, according to research published online Januanry 18 in Allergy.
Childhood psoriasis impacts parents' quality of life in multiple domains, especially their emotional well-being, according to a study published in the February issue of the Journal of the American Academy of Dermatology.
Allergan announced that the Food and Drug Adminisration (FDA) has approved Rhofade (oxymetazoline HCl) cream for the topical treatment of persistent facial erythema associated with rosacea in adults.
Clinicians and pharmacists who prescribe and fill medications containing the drug are advised to inform patients to avoid exposure to pets.
Tridesilon (desonide) Cream, 0.05%, has been made available by Encore Dermatology. This low-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Tetracycline combined with colchicine is effective for treatment of hidradenitis suppurativa (HS), according to a study published online in the International Journal of Dermatology.
Ivermectin (IVM) has anti-inflammatory properties that could be beneficial in treatment of T-cell mediated skin inflammatory diseases, according to an experimental study published online in Allergy.
Fibrocell Science announced that the Food and Drug Administration (FDA) has granted Fast Track designation to FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).
Galderma announced that the Food and Drug Administration (FDA) approved 2 new dermal fillers for the treatment of nasolabial folds (NLF), also known as "laugh lines," in patients aged >21 years old.
The highest amounts of spending were seen with these 10 conditions.
Janssen Biotech announced the submission of a supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) for Stelara (ustekinumab) to treat adolescents (12-17 years old) with moderate to severe plaque psoriasis.
BD announced the launch of BD Neopak 2.25mL prefillable glass syringes intended for biopharmaceutical manufacturers that handle high-value and sensitive biologic agents that require higher quality levels and performance to treat rheumatoid arthritis, psoriasis, lupus, severe asthma, and other chronic conditions.
The Food and Drug Administration (FDA) has approved Eucrisa (crisaborole ointment; Pfizer) for the treatment of mild to moderate atopic dermatitis in patients aged ≥2 years.
A new review published in the Journal of Asthma and Allergy assessed the diagnostic and treatment approaches to aquagenic urticaria (AU), a difficult to treat, rare form of urticaria triggered when skin is exposed to water, including sweat and tears.
UCB and Dermira have announced topline results from their Phase 3 trial (CIMPASI-1) evaluating the safety and efficacy of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis.
Valeant announced positive results from a Phase 3 study of IDP-118 (halobetasol propionate and tazarotene lotion) in the treatment of plaque psoriasis.
Daily application of petroleum jelly for the first 6 months of an infant's life can provide effective protection against atopic dermatitis, equating to a cost benefit of $353 per quality-adjusted life year (QALY).
To address the lack of standardized management guidelines in the treatment of psoriasis, the National Psoriasis Foundation conducted a study among psoriasis experts in an effort to define consensus based treatment targets.
Momenta has announced their adalimumab biosimilar candidate, M923, has met its Phase 3 primary endpoint of at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment.
Janssen has announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA), seeking approval of guselkumab for the treatment of adults with moderate to severe plaque psoriasis.
Aclaris has announced positive results from its two pivotal Phase 3 trials of A-101 40% Topical Solution (A-101), a novel treatment for seborrheic keratosis (SK).
Adalimumab was associated with significantly greater improvement in psoriasis severity, regardless of body region impacted, when compared with placebo.
Having greater gut bacteria diversity may indicate a greater response to immunotherapy treatment in patients with malignant melanoma, according to new research conducted by scientists at the University of Texas MD Anderson Cancer Center.
Amgen announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded indication of Enbrel (etanercept) injection to include pediatric patients aged 4-17 years with chronic moderate-to-severe plaque psoriasis.
Electronic prescriptions are associated with a lower rate of primary nonadherence to medications compared to paper prescriptions, according to a new three-year study published in JAMA Dermatology.
Allergan has announced the availability of Juvèderm Volbella XC for lip augmentation and for correction of perioral rhytids in adults over the age of 21.
Pfizer announced that Inflectra (infliximab-dyyb) for injection will be shipped to wholesalers in late November 2016.
This prescription-only lotion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis.
The reSURFACE 1 and 2 trials were randomized, placebo-controlled, multicenter studies designed to demonstrate the efficacy of tildrakizumab in moderate-to-severe plaque psoriasis vs. placebo and comparative drug, and to assess safety and tolerability.
Patients in the SCULPTURE extension received the same blinded maintenance treatment regimen and dose up to the end of Year 3; the study became open label in Year 4.
The trial included an active comparator arm evaluating guselkumab vs. adalimumab, which demonstrated the superiority of guselkumab for major study endpoints and through Week 48 of treatment.
Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD).
Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adult patients.
The Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto; Amgen) as a biosimilar to Humira (adalimumab; AbbVie) for various inflammatory diseases.
Injection of platelet-rich plasma (PRP) and hyaluronic acid (HA) is associated with a clinically visible and statistically significant improvement in aging facial skin, according to a study published online in the Journal of Cosmetic Dermatology.
A literature review of head lice treatments in the U.S. found a significant decline in the effectiveness of over-the-counter (OTC) permethrin and synergized pyrethrins (collectively pyrethroids) treatments, indicating a need for judicious use of effective treatments by clinicians.
The Food and Drug Administration has granted Orphan Drug designation to TXA127 (Tarix Orphan) for the potential treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder.
The Food and Drug Administration (FDA) issued a final rule regarding over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ozenoxacin 1% cream (Medimetriks) for the treatment of impetigo.
The Food and Drug Administration (FDA) has approved Erelzi (etanercept-szzs; Sandoz) injection, a biosimilar to Enbrel (etanercept; Amgen).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Regenicin's cultured skin substitute, NovaDerm, for the treatment of burns requiring skin grafting.
Increased coronary artery calcium, indicative of asymptomatic coronary atherosclerosis, is apparent in patients with psoriasis, and similar to that seen in patients with type 2 diabetes, according to a study published online in JAMA Dermatology.
A marine complex supplement is beneficial for men with thinning hair, according to a study published online August 9 in the Journal of Cosmetic Dermatology.
Alitretinoin treatment aids in normalizing expression of barrier genes and proteins in patients with chronic hand eczema (CHE), according to a study published online in the British Journal of Dermatology.
Coherus BioSciences announced topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira) biosimilar candidate, for the treatment of patients with psoriasis.
Topical cowhage provocation and skin prick testing with histamine can diagnose atopic dermatitis (AD), according to a study published online July 29 in Allergy.
For patients with hidradenitis suppurativa, adalimumab is associated with higher clinical response rates, according to a study published in the New England Journal of Medicine.
Significant improvements in patient-reported outcomes (PROs) were seen with ustekinumab vs. placebo in 3 antecedent-exposure populations of patients with psoriatic arthritis, including those with prior methotrexate and anti-tumor-necrosis factor (TNF) use, according to findings from a study published in Arthritis Care & Research.
Sage Products announced a voluntary recall of one lot of Comfort Shield Barrier Cream Cloths due to contamination with the bacteria Burkholderia cepacia.
Eczema have a serious impact on patients' quality of life and overall health, both physically and mentally, according to a report from the annual American Academy of Dermatology Summer Meeting, held from July 28 to 31 in Boston.
GlaxoSmithKline announced a recall of 13 lots of Bactroban (mupirocin) Nasal Ointment, Bactroban Ointment, and Bactroban Cream. This recall is a precautionary measure due to potential contamination during manufacturing.
Valeant announced that the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee has voted 18-0 for the approval of brodalumab injection to treat adults with moderate-to-severe plaque psoriasis with conditions related to product labeling and post-marketing/risk management obligations.
The Food and Drug Administration (FDA) is investigating cases of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products.
The Food and Drug Administration (FDA) has approved Differin Gel (adapalene; Galderma) 0.1% for over-the-counter (OTC) treatment for acne in patients aged ≥12 years.
AbbVie will present positive data from a Phase 3 study evaluating Humira (adalimumab) in patients with moderate to severe fingernail psoriasis at the Psoriasis 2016 - 5th Congress of the Psoriasis International Network in Paris, France.
For patients with psoriasis, long-term weight loss had lasting beneficial effects on the severity of psoriasis, according to a study published in the American Society of Nutrition.
In a study published in Clinical Reviews in Allergy & Immunology, researchers found that tumor necrosis factor (TNF inhibitors appeared to have clinical benefits with regard to adverse cardiovascular events in psoriasis and/or psoriatic arthritis.
Ozenoxacin belongs to a novel generation of non-fluorinated quinolones
A patient-reported study of hormonal contraceptives has found a significantly varied effect on acne among commonly prescribed agents.
The safety and efficacy of topical minoxidil for the treatment of female pattern hair loss was supported by moderate to low quality evidence in a recent Cochrane systematic review.
Regeneron and Sanofi announced that the Phase 3 study, LIBERTY AD CHRONOS, met its primary and key secondary endpoints for dupilumab in the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients.
Allergan announced that the Food and Drug Administration (FDA) has approved Juvederm Volbella XC for use in lip augmentation and for correction of perioral rhytids (referred to as perioral lines) in adults aged >21 years old.
Wockhardt/Morton Grove Pharmaceuticals announced the discontinuation of Lindane Lotion 1%. The Companies have decided to stop manufacturing this product as of June 2, 2016.
The FDA has accepted for review the Biologics License Application (BLA) for SB2 (Samsung Bioepis), a biosimilar candidate to Remicade (infliximab; Janssen), for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for oxymetazoline HCl cream 1% (Allergan) for the treatment of persistent facial erythema associated with rosacea in adults.
Mirvaso (brimonidine; Galderma) Topical Gel 0.33% is now available in a pump dispenser.
The Food and Drug Administration (FDA) has approved Ameluz (aminolevulinic acid HCl; Biofrontera) gel, in combination with photodynamic therapy using BF-RhodoLED lamp, for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.