GLG News by Dermatologists (US)

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Peplin merger with Leo pharma

November 19, 2009

Analysis of:Leo Pharma completes merger pact with Peplin | www.pharmabiz.com

The recent merger of Peplin with Leo pharma is of some significance and will benefit both companies. It would have been difficult for Peplin to fully develop and market their flagship product alone.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Presta Trial shows good results for Enbrel

October 14, 2009

Analysis of:New data from PRESTA trial demonstrate the benefit of Enbrel in patients with psoriasis & psoriatic arthritis | www.pharmabiz.com

This trial showed predicatably good results for Enbrel in patients with psoriasis and psoriatic arthritis. This included improvement in signs and symptoms and quality of life. This will increase sales of Enbrel in the short term. However the two newer agents, Humira and Stelara have better efficacy, and more convenient dosing regimens. Both will be doing similar studies.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Starpharma gets US patent for use of VivaGel for protection against STIs

September 29, 2009

Analysis of:Starpharma gets US patent for use of VivaGel for protection against STIs | www.pharmabiz.com

Starpharma's lead product, is a vaginal microbicide gel under development for the prevention of sexually transmitted infections (STIs), including genital herpes and HIV infection. The VivaGel® product concept is designed to offer a safe, convenient and affordable means for women to protect themselves from infection with genital herpes and HIV during sex. Surveys show that there is substantial demand in North America and Europe for such a product with an estimated billion dollar market for STI prevention products in the developed world.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Stelara new Option for Psoriasis

September 26, 2009

Analysis of:Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults | www.webmd.com

The FDA approved Stelara based on three studies of 2,266 patients who either got shots of Stelara or a placebo. Patients who got Stelara were more likely to achieve the studies' benchmark for reduction in psoriasis.In a news release, the FDA notes that because Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. "Serious infections have been reported in patients receiving the product and some of them have led to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer," the FDA states.

Alan FleischerProfessor and Chair of DermatologyWake Forest University School of Medicine - CC

Probiotics and Atopic Dermatitis

April 27, 2009

Analysis of:Probiotics for the treatment or prevention of atopic dermatitis: a review of the evidence from randomized controlled trials. | www.ncbi.nlm.nih.gov

Large, well-conducted meta-analysis shows as a preventative strategy, probiotics may have a modest effect on decreasing the incidence of atopic eczema. However, in terms of treating active disease or preventing recurrence of disease, no convincing evidence supports the use of the probiotics examined thus far.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Will the withdrawl of Efalizumab effect the biologic market?

April 15, 2009

Analysis of:Efalizumab withdrawn from US Market | www.medscape.com

This article is important in that the withdrawal of efalizumab by Genentech was appropriate in view of its serious side effect of progressive multifocal leukoencephalopathy (PML). This biologic agent was already declining in usage because of its other side effects, and the presence of other strong competitors with equal or higher efficacy and less side effects. This was to be compounded by the impending release of ustekinumab

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Aurobindo terbinafine approval- what effect will this have?

January 21, 2009

Analysis of:Aurobindo Pharma gets approval for Terbinafine Tablets | myiris.com

This article is important in that it confirms another terbinafine competitor to the Novartis Lamisil brand is being released. The majority of terbinafine prescriptions in North America are generic. The market for this product will be good at least until more effective oral or topical agents are released. The majority of the prescriptions are for onychomycosis (toenail fungus). The newer products will be released in 3-4 years, at which time the market for terbinafine will shrink significantly.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Filler Warnings- Are They Necessary?

November 24, 2008

Analysis of:FDA Faults Wrinkle Fillers Over Warnings | online.wsj.com

This article is important in that it discusses a rare but known side effect of filler injections- reactions to these agents. These reactions include allergies, infections, etc. The incidence is low- approximately 1000 cases out of 1.5 million injections. The majority of these reactions were not serious. The various fillers were not differentiated, but it is likely that the hyaluronic acid fillers like Restylane/Perlane/Juvaderm will have the lowest incidence as they are the closest to human hyaluronic acid that is present in the skin. This article and the FDA warning is unlikely to effect the use or sales of these fillers.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Will access to dermatology care suffer with increased cosmetic procedures ?

August 1, 2008

Analysis of:As Doctors Cater to Looks, Skin Patients Wait | www.nytimes.com

 This article is important in that it describes a growing trend among dermatologists to offer a higher level of "customer service" for their cash paying cosmetic patients. This has contributed in a small way to the long waits for non cosmetic dermatology patients to be able to see a dermatologist. A larger cause of the long waits is the small number of dermatologists being trained, and many of them working less than a full schedule. As the waits become longer and access more difficult, many dermatologists will opt out of managed care plans and move toward a cash/fee for service practice. This trend is already beginning. Also many primary care physicians are also offering ancillary procedures, and access for their patients may also become limited, which has more serious implications.

Sunil DhawanClinical Assistant Professor of DermatologySTANFORD UNIVERSITY

Will prescription drug spending decreases affect dermatology?

July 18, 2008

Analysis of:Patients Curb Prescription Spending | online.wsj.com

This article is important in that it describes a worrying trend for branded  pharmaceutical companies. As copays for branded products go up and the patients economic status worsens, the use of these drugs will fall. This may be especially true for medications in dermatology, where the perceived need may be less than that for a cardiac drug. The pipelines in dermatology are smaller due to high drug development costs, and limited means to recover them, because the market is smaller than that for other conditions. Many of our patients are complaining about difficulty in getting insurers to cover their branded products, and copays and requests for prior authorizations have increased exponentially. A positive factor is that many of the products in dermatology still enjoy several years of patent protection.

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