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GLG News by Cubicin Prescribers (US)

Peter Bornstein, Partner and Consultant in Infectious Diseases

Peter BornsteinPartner and Consultant in Infectious DiseasesSt. Paul Infectious Disease Associates, Ltd What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

The good news is that these drugs are already approved

October 28, 2009

Triple-combo Drug Shows Promise Against Antiviral Resistant H1N1 | www.medicalnewstoday.com

Adamas has a proprietary mixture of three drugs: amantadine, oseltamivir and ribavirin to treat antiviral resistant strains of novel H1N1 Influenza A.

Jeffrey Weinberg, Director of Clinical Research - Dermatology

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

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

September 29, 2009

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 Weinberg, Director of Clinical Research - Dermatology

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Stelara new Option for Psoriasis

September 26, 2009

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.

Peter Bornstein, Partner and Consultant in Infectious Diseases

Peter BornsteinPartner and Consultant in Infectious DiseasesSt. Paul Infectious Disease Associates, Ltd What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Potential game changer for patients and hospitals regarding C. difficile colitis

July 18, 2009

Rapid DNA Test to Detect Clostridium difficile Infection Approved by FDA Today | www.medscape.com

Clostridium difficile-associated colitis is a disabling, and potentially life-threatening infection.  Moreover, hospitals spend great resources in isolating patients with this disease to prevent infection within the hospital. This new technology from Cepheid offers faster, and more accurate diagnosis, leading to potentially quicker treatment for patients, but potentially huge savings for hospitals, that can shorten isolation periods for these patients. 

Peter Bornstein, Partner and Consultant in Infectious Diseases

Peter BornsteinPartner and Consultant in Infectious DiseasesSt. Paul Infectious Disease Associates, Ltd What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

18 months too late for this outbreak, but may be the way toward the future.

July 8, 2009

Cadila Pharma-Novavax JV to produce swine flu vaccine | www.business-standard.com

The referenced article states that the joint venture would begin producing swine flu vaccine in two years, possibly based on viral-like particle (VLP) technology.  While this is too late to have significant impact in the current pandemic, it points to possible future technologies for vaccine development.

Alan PattersonObstetrician and GynecologistALAN B PATTERSON MD, PA What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Sequenom's delay

May 4, 2009

UPDATE 2-Sequenom delays Down Syndrome test; shares plunge | uk.reuters.com

This delay is not good for the company, especially since there are already tests in place that are effective to screen for Down's syndrome.  These tests now are the standard of care, so the longer it takes for Sequenon to launch it's test the worse, for the company.

Peter Bornstein, Partner and Consultant in Infectious Diseases

Peter BornsteinPartner and Consultant in Infectious DiseasesSt. Paul Infectious Disease Associates, Ltd What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Better Tuberculosis vaccine is desperately needed, but will a vaccinia-based vaccine be safe and embraced?

April 23, 2009

TB vaccine enters advanced clinical trials at Oxford | timesofindia.indiatimes.com

The decades old BCG vaccine needs to be replaced.  It offers at best 50% efficacy, can at times cause severe reaction, and renders subsequent tracking of active TB difficult to impossible. This article describes a trial in South Africa to assess the effectiveness of a new candidate vaccine in infants already immunized with BCG. There is a significant reason why there are so few specifics in the press release.

Peter Bornstein, Partner and Consultant in Infectious Diseases

Peter BornsteinPartner and Consultant in Infectious DiseasesSt. Paul Infectious Disease Associates, Ltd What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Safety profile similar to placebo! Can't do better than that.

April 6, 2009

Intercell announces European approval of new vaccine, IXIARO®, to prevent Japanese Encephalitis | www.pipelinereview.com

Intercell vaccine is as effective as current JE-VAX, with side-effects similar to placebo. The current JE-VAX is used parsimoniously because of the risk of hypersensitivity reactions. This new vaccine will likely supplant and replace the current vaccine. However, until it has US approval, there may not be recommendations from CDC regarding its use.

Peter Bornstein, Partner and Consultant in Infectious Diseases

Peter BornsteinPartner and Consultant in Infectious DiseasesSt. Paul Infectious Disease Associates, Ltd What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Trial set to fail?

March 5, 2009

Novexel's NXL104/ceftazidime Combination Commences Second Phase II Clinical Trial in Hospital Patients With Complicated Intra-Abdominal Infections (cIAIs) | www.pipelinereview.com

Novexel's trial of their novel beta-lactamase NXL104 combined with ceftazidime and metronidazole vs meropenem is an interesting choice.  While the Novexel arm looks to have very good activity against gram negative organisms and anaerobes, it almost completely lacks coverage against gram positive agents.  This appears to be a trial set to fail.

Jeffrey Weinberg, Director of Clinical Research - Dermatology

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Issues with Ustekinumab

June 23, 2008

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.

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