GLG News by Physicians who Treat Atopic Eczema (US)

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Will Merck's New Asthma Drug Make the Big Time?

July 6, 2010

Analysis of:FDA Approves Merck's DULERA® Inhalation Aerosol | www.reuters.com

The FDA recently approved Merck's Dulera, inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination, for moderate to severe asthma control. This agent is the third combo inhaler, after Advair and Symbicort; thus it starts with an immediate disadvantage in the market. Furthermore, timing seems most inauspicious in light of the FDA's current phobia with the entire class of LABA agents. Any potential profits may be negated by the expense of conducting mandatory long-term safety trials.

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.

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

Qforma's Online Database: Exposing Pharma's Physician Marketers?

May 15, 2009

Analysis of:In patients' hunt for care, doctor database 'a place to start' | www.usatoday.com

undefinedundefined undefined If the Qfarma database makes public those physicians with significant financial conflicts of interest, will this lead to more intense regulatory  scrutiny of these physicians?  Does this online database place at risk the industry practices?

Edward LisbergDirectorAsthma and Allergy Center of Chicago, S.C.

LABA daba done?

December 11, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

Some information of note, the current FDA briefing document (http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4398b1-00-index.htm) is a publication entirely created by GSK,  Novartis, and AstraZeneca and not an independently created FDA review.  It merely is a summary of trials data already published; in as much, there may be other unpublished data by these pharma co's that may be relevant but will not be part of the debate.  Absent from the FDA document are the FDA reviewer's comments..?redacted.  Furthermore, none of the individual SAE reports are included for review and analysis; we are again left only with pharma's version and clinical trials interpretation. 

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

FDA Poised to Damage Asthma Pharmacotherapy Advances

December 10, 2008

Analysis of:FDA: Long-Acting Asthma Drugs Increase Asthma Risks | online.wsj.com

The use of long-acting beta-agonists (LABAs) in the treatment of persistent asthma has become one of the most controversial issues of respiratory disease management during this decade. Both salmeterol and formoterol have been shown in numerous clinical trials of asthma to dramatically improve pulmonary function, symptoms scores, and need for rescue medication. However, some long-term safety studies have demonstrated increased risk of severe asthma exacerbations when these LABAs are used as monotherapy without concomitant inhaled steroid therapy. Based on this data, the FDA is considering the withdrawal of LABAs from the US market. I anticipate the FDA will come to their senses and appreciate the significant benefit that combination LABA/ICS therapy has in the vast majority of moderate and severe asthmatics for whom they are appropriately prescribed. In my opinion, cessation of LABA therapy for asthma would return us to asthma mortality rates not seen since the 1990s.     

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

Issues with Ustekinumab

June 23, 2008

Analysis of:Positive news on J&J's ustekinumab diminished by safety concerns - analysts | www.tradingmarkets.com

On Tuesday, the FDA's Dermatologic and Ophthalmic Drug Advisory Panel voted unanimously to approve the use of the injectable drug for the treatment of plaque psoriasis, a severe skin disease. As the FDA usually follows the recommendations of its advisory panels when reviewing new drugs for approval, it is anticipated that the regulatory body will approve the drug in the fourth quarter, analysts said. But concerns over the drug's carcinogenic potential and the panel's recommendation that the drug be administered only by a physician and not directly by the patient could diminish enthusiasm over ustekinumab and lessen the drug's potential market share.

Mark VandewalkerAllergy Specialist and PartnerAllergy & Asthma Consultants Of The Ozarks Ltd

Will Xolair Become Obsolete in the Treatment of Allergies?

June 10, 2008

Analysis of:Investigational Anti-IgE Antibody Promising as Extracorporeal Allergy Therapy | www.medscape.com

This recent report characterizes a newly discovered anti-IgE monoclonal antibody (mAb12) which appears dramatically more potent than omalizumab (Xolair) in its ability to reduce systemic IgE levels. If further studies confirm this enhanced reduction of IgE and IgE-bearing cells, mAb12 has significant potential to replace omalizumab as effective anti-IgE therapy with just one dose, even in patients with very high initial levels of total IgE. The potential market share for such a treatment is enormous since at least 25% of the population suffers from Ige-mediated diseases such as allergic rhinitis, asthma, atopic eczema, and food allergy.

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

Ustekinumab

December 19, 2007

Analysis of:Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis | www.jnj.com

This drug is four times yearly This will be attractive to MDs and patients It is highly efficaciuous

Kenneth EdelsonAssociate Clinical Professor of DermatologyMOUNT SINAI SCHOOL OF MEDICINE

Cost is key, but not enough!

December 17, 2007

Analysis of:Ipsen and Medicis announce submission of Reloxin(R) in aesthetics to the FDA | www.pipelinereview.com

Lowering cost of Botox is key, but not enough to induce patients to undergo Botox treatments.

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