Cimzia Effectiveness Assessed for Chronic Plaque Psoriasis

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.

Efficacy Results Announced for Combo Psoriasis Therapy

Valeant announced positive results from a Phase 3 study of IDP-118 (halobetasol propionate and tazarotene lotion) in the treatment of plaque psoriasis.

Prophylactic Moisturizing May Help Protect Infants from Atopic Dermatitis

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).

NPF: New Psoriasis Guidelines Outline Treatment Goals

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.

Biosimilar Candidate Effective in Phase 3 Psoriasis Trial

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.

FDA to Review Investigational Plaque Psoriasis 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.

Positive Results Announced for Seborrheic Keratosis Treatment

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).

Psoriasis Tx Efficacy Assessed by Body Region

Adalimumab was associated with significantly greater improvement in psoriasis severity, regardless of body region impacted, when compared with placebo.

Immunotherapy for Melanoma: Why Gut Bacteria May Be Key

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.

First Systemic Tx to Treat Peds With Plaque Psoriasis

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 vs. Paper Prescribing: Does It Impact Adherence to Dermatologic Meds?

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.

FDA-Approved Filler Juvèderm Volbella XC Now Available

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.

Biosimilar Inflectra Now Available

Pfizer announced that Inflectra (infliximab-dyyb) for injection will be shipped to wholesalers in late November 2016.

New Treatment Option for Patients with Atopic Dermatitis

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.

Positive Results for Investigational IL-23p19 Inhibitor in Psoriasis Studies

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.

Long-Term Efficacy Data for Cosentyx Shows Consistent Skin Clearance in Psoriasis

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.

Guselkumab Goes Head-to-Head with TNF Blocker in Plaque Psoriasis Study

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.

Dupilumab Granted Priority Review for Atopic Dermatitis

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).

Stelara Approved to Treat Crohn's Disease

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.

FDA Approves Fourth Biosimilar Drug Amjevita

The Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto; Amgen) as a biosimilar to Humira (adalimumab; AbbVie) for various inflammatory diseases.

Efficacy of Platelet-Rich Plasma Injections Tested in Facial Aging

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.

Growing Resistance May Make OTC Head Lice Treatments Obsolete

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.

FDA Grants TXA127 Orphan Drug Status for Rare Genetic Skin Disorder

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.

FDA: Final Ruling on OTC Antibacterial Soaps

The Food and Drug Administration (FDA) issued a final rule regarding over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients.

FDA to Review New Generation Topical Quinolone for Impetigo

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.

FDA Approves First Biosimilar to Enbrel

The Food and Drug Administration (FDA) has approved Erelzi (etanercept-szzs; Sandoz) injection, a biosimilar to Enbrel (etanercept; Amgen).

Skin Substitute Granted Orphan Drug Status for Burn Patients

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.

Coronary Artery Calcium Scores in Psoriasis Patients Similar to T2DM Patients

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.

Dietary Supplement May Promote Hair Growth in Men

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 Evaluated in Chronic Hand Eczema

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.

Positive Results Announced for Adalimumab Biosimilar in Psoriasis Study

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.

Atopic Dermatitis May be Diagnosed Via Plant Provocation, Study Finds

Topical cowhage provocation and skin prick testing with histamine can diagnose atopic dermatitis (AD), according to a study published online July 29 in Allergy.

Adalimumab Efficacy Evaluated in Hidradenitis Suppurativa Study

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.

Ustekinumab Significantly Improves Patient-Reported Outcomes in PsA

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.

Contaminated Skin Protectant Cloths Recalled

Sage Products announced a voluntary recall of one lot of Comfort Shield Barrier Cream Cloths due to contamination with the bacteria Burkholderia cepacia.

QoL Acutely Impacted by Eczema, Stressing Need for Long-Term Solution

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.

Recall Initiated for Antibacterial Cream, Ointments

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.

FDA Panel Recommends Approval of New Psoriasis Drug but with Some Concerns

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.

FDA: Balding, Rash Associated with Hair Cleanser

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.

FDA Approves First OTC Retinoid Acne Treatment

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.

Humira Evaluated for Fingernail Psoriasis in Phase 3 Study

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.

Weight Loss May Lessen Severity of Psoriasis, Study Finds

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.

Do TNF Inhibitors Offer CV Benefits in Psoriasis, Psoriatic Arthritis?

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.

FDA to Review Novel Topical Antibiotic for Impetigo

Ozenoxacin belongs to a novel generation of non-fluorinated quinolones

Acne Outcomes Vary Based on Hormonal Contraceptive Used

A patient-reported study of hormonal contraceptives has found a significantly varied effect on acne among commonly prescribed agents.

Efficacy of Treatments Compared for Female Pattern Hair Loss

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.

Dupilumab + Topical Corticosteroids Beats TCS Alone in Atopic Dermatitis Study

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.

Juvederm Volbella XC Approved for Perioral Rhytids

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.

Scabies Treatment No Longer Available

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.

Biosimilar Candidate to Remicade Under FDA Review

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.

FDA to Review Topical Rosacea Treatment

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 Gel Available in New Pump Delivery System

Mirvaso (brimonidine; Galderma) Topical Gel 0.33% is now available in a pump dispenser.

Ameluz Gel Approved for Treating Actinic Keratoses

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.

Certain Lots of Tazorac Gel Recalled

Allergan issued a voluntary recall of two lots of Tazorac (tazarotene) Gel 0.05% due to routine stability results for one lot that were slightly below regulatory specifications for Product Concentration and Content Uniformity.

Black Salve Users Often Unaware of Potential Harm

Some patients use these products on suspected skin cancers because they believe it is a convenient way to remove them.

Lycelle Head Lice Removal Kit Now Available without Rx

Mission Pharmacal announced that Lycelle Head Lice Removal Kit (sodium laureth sulfate, isopropanol, citronellyl acetate, hypromellose, methyl salicylate, methylparaben, citric acid) is now available without a prescription.

Taltz Now Available for Moderate-to-Severe Plaque Psoriasis

Eli Lilly announced that Taltz (ixekizumab) injection is now available for the treatment of moderate-to-severe plaque psoriasis through a network of specialty pharmacies.

Which Drugs Are Most Associated With Stevens-Johnson Syndrome?

New findings from a study published in the American Journal of Medicine may help clinicians identify high-risk drugs and high-risk patients linked to the development of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) in order to reduce its incidence.

Positive Results Announced for Dupilumab in Atopic Dermatitis Studies

Regeneron and Sanofi announced that the two Phase 3 studies, LIBERTY AD SOLO 1 and SOLO 2, evaluating dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), met their primary endpoints.

Aczone 5% Gel 30g Tubes Now Discontinued

Allergan announced the discontinuation of Aczone (dapsone) 5% 30g tubes.

New Biosimilar Inflectra Gets FDA Approval

The Food and Drug Administration (FDA) has approved Inflectra (infliximab-dyyb; Celltrion) for injection, a biosimilar to Remicade (infliximab; Janssen).

Skin Infection Patients Adhere to Just Over Half of Their Antibiotic Regimen, Study Finds

Patients with Staphylococcus aureus skin and soft tissue infections took an average of 57% of their antibiotic doses after being discharged from the hospital, a new study published in Antimicrobial Agents and Chemotherapy reported.

Taltz Approved for Moderate-to-Severe Plaque Psoriasis

Eli Lilly announced that the Food and Drug Administration (FDA) has approved Taltz (ixekizumab) injection for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

New Homeopathic Wipes for Insect Bites and Stings Available

Tec Labs announced the launch of Tecnu Bites & Stings Medicated Itch and Pain Relief Wipes for treating insect bites and bee stings.

FDA to Review Novel Non-Steroidal Tx for Atopic Dermatitis

Anacor Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) of crisaborole 2% topical ointment for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

Corticosteroid Injection Currently in Shortage

The FDA is reporting a shortage in certain presentations of Solu-Medrol Powder for Injection (Pfizer) and the generic Methylprednisolone sodium succinate for injection (Fresenius Kabi).

FDA to Review Enbrel for Pediatric Plaque Psoriasis

Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for review their supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept).

Nonsurgical Treatment Improves Appearance of Double Chin

At the American Academy of Dermatology's annual meeting, researchers presented study findings supporting the safety and efficacy of ATX-101 in reducing the appearance of a double chin.

Results for Cosentyx vs. Stelara Announced in PASI 90 Endpoint

Novartis announced late-breaking data from the CLEAR study that demonstrated Cosentyx (secukinumab) was superior to Stelara (ustekinumab) in reaching near clear skin on the PASI 90 in significantly more moderate to severe psoriasis patients at Week 52.

Long-Term Safety Data for Otezla Announced

Celgene announced long-term safety data for Otezla (apremilast) from ongoing clinical trials at the American Academy of Dermatology's Annual Meeting.

Ixekizumab Demonstrates Efficacy in Two Phase 3 Psoriasis Studies

Lilly announced positive results from two Phase 3 studies, UNCOVER-2 and UNCOVER-3, of ixekizumab for the treatment of moderate-to-severe plaque psoriasis compared to etanercept or placebo. Study findings were recently presented at the American Academy of Dermatology (AAD) Annual Meeting in Washington, D.C.

Treatment Options for Dermatoses in Pregnancy Explored

Dermatoses in pregnancy provides a challenge to dermatologists when it comes to recommending treatments that are effective yet safe to the fetus.

New OTC Dual Action System Launched for Hair Loss

Galderma announced the launch of qilib Hair Regrowth + Revitalization System and qilib Hair Health Reinforcement Biotin + Multivitamin Supplement indicated for hair thinning and hair loss

New Topical Gel Approved for Acne Vulgaris

Allergan announced that the Food and Drug Administration (FDA) has approved Aczone Gel 7.5%, a new topical treatment for acne vulgaris in patients aged ≥12 years.

New Acne Treatment Guidelines Released

The American Academy of Dermatology has released its new "Guidelines of care for the management of acne vulgaris" that includes acne treatment recommendations for adults and adolescents.

Advisory Panel Recommends Approving Biosimilar of Remicade

Celltrion announced that the Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all indications for CT-P13, a biosimilar candidate of Remicade (infliximab; Janssen Biotech).

New Topical Steroid Approved for Plaque Psoriasis

Dr. Reddy's announced that Promius Pharma has received approval for Sernivo (betamethasone dipropionate) Spray 0.05% for the treatment of mild to moderate plaque psoriasis in patients aged ≥18 years.

New Oral Rosacea Drug Gains Tentative FDA Approval

Dr. Reddy's Laboratories announced that the Food and Drug Administration (FDA) has granted tentative approval for Zenavod (doxycycline) capsules for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adults.

BLA for Adalimumab Biosimilar Accepted for Review

Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

BLA for New Plaque Psoriasis Tx Under FDA Review

Valeant, in partnership with AstraZeneca, announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for brodalumab injection for patients with moderate-to-severe plaque psoriasis.

Cosentyx Gains Two New Arthritis Indications

Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

Granulex Aerosol Spray Discontinued

The Food and Drug Administration (FDA) informed that Granulex Aerosol Spray (trypsin, balsam peru, castor oil; Mylan) has been discontinued due to market conditions.

FDA: Watch for Eye, Skin Injuries with Laser Pointers

The Food and Drug Administration (FDA) is alerting healthcare professionals about possible eye and skin injuries from exposure to laser-containing products.

FDA Proposes Tanning Bed Restrictions, Including Age Limits

The Food and Drug Administration (FDA) has proposed steps to prevent the use of sunlamp products by minors and to reduce the risk of these devices for adults.

New Treatment for Rosacea Launched

Bayer HealthCare announced the launch of Finacea Foam (azelaic acid) 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

Topical Combo Treatment Approved for Plaque Psoriasis

Leo Pharma announced that Enstilar (calcipotriene and betamethasone dipropionate) foam has been approved for the topical treatment of plaque psoriasis in adults aged ≥18 years.

Complete Response Letter Issued for Xeljanz on New Indication

The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate; Pfizer) for the treatment of adults with moderate to severe chronic plaque psoriasis.

New Findings for Plaque Psoriasis Tx Otezla Presented

Celgene announced that new findings from its ongoing Phase 3 LIBERATE trial evaluating Otezla (apremilast) in patients with moderate to severe plaque psoriasis were presented at the 24th European Academy of Dermatology and Venereology (EADV) Congress.

FDA Grants Avelumab Fast Track Status for Aggressive Skin Cancer

The Food and Drug Administration has granted avelumab (Pfizer/Merck) Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.

Rash and Fever in Adults Could Indicate Rare But Deadly Disease

Skin rashes accompanied by a fever could be indicative of serious or life-threatening illness in adults and warrant immediate medical attention, according to a lecture to be presented at the American Osteopathic Association's Annual Osteopathic Medical Conference and Exposition (OMED).

Novel Combination Treatment Approved for Unresectable or Metastatic Melanoma

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Depression Screening Recommended for Psoriasis Patients

Psoriasis patients, regardless of disease severity, may be at an increased risk of depression, according to a study recently published in JAMA Dermatology.

FDA Designates Avelumab Orphan Drug for Skin Cancer

The FDA has granted Orphan Drug designation to the investigational cancer immunotherapy avelumab (Pfizer/Merck) for the treatment of Merkel cell carcinoma (MCC).

Vinegar May Be an Effective Alternative Against Bacteria in Burn Wounds

The active ingredient in household vinegar was effective in preventing infections and killing bacteria present in burn wounds, a new study has found.

Nalbuphine ER: Promising Study Results for Uremic Pruritus

Trevi Therapeutics announced statistically significant results from its Phase 2/3 trial of Nalbuphine ER for the treatment of moderate to severe uremic pruritus.

OTC Laser Tx for Male Baldness to Be Evaluated in Study

Theradome announced that it has initiated one of the most comprehensive studies to date to evaluate its Theradome LH80 PRO Laser Helmet on men with thinning hair or who are showing signs of balding.

FDA Accepts Keytruda sBLA for First-Line Melanoma Indication

The Food and Drug Administration (FDA) has accepted for review the sBLA for Keytruda (pembrolizumab, Merck) for the first-line treatment of unresectable or metastatic melanoma patients.

FDA: Reports of Severe Allergic Reactions with Picato

The Food and Drug Administration (FDA) is warning about reports of severe allergic reactions and herpes zoster associated with the use of Picato (ingenol mebutate topical gel).

What Tests, Txs May Be Unnecessary in Dermatology?

The American Academy of Dermatology has issued new recommendations regarding potentially unnecessary dermatologic tests and treatments as part of the Choosing Wisely campaign.