Healthcare News by GLG Council Members

Ken PowellPresidentGenesis Business Development, LLC

SACGHS Genetic Testing Report Slammed

October 17, 2009

Analysis of:SACGHS Gene Patent Report Stirs Pushback | www.genomeweb.com

The recent draft report and recommendations from the Secretary's Advisory Committee on Genetics Health and Society (SACGHS) was severely criticized from the inside by task force advisor Brad Stanton.  The draft report recommended that patents for genetic testing be exempt from exempt from patent infringement.

Kelly ClosePresidentClose Concerns

LEAD-6 Extension Trial Results Announced-- Look Positive for Novo Nordisk

October 17, 2009

Analysis of:Switching From Exenatide to Liraglutide for Type 2 Diabetes Demonstrates Benefits: Presented at EASD | www.docguide.com

LEAD-6 was a randomized open label parallel group study conducted at 132 sites in the US and EU, comparing the use of liraglutide and exenatide in type 2 diabetes patients 18-80 years of age. In the extension arm of the study, patients on 1.8 mg of liraglutide continued on the drug for another 14 weeks while patients originally randomized to the exenatide treatment group were switched to 1.8 mg liraglutide therapy for 14 weeks. After 40 weeks,  both groups had identical A1c levels. 

Health Insurers may have Sealed their own Fate

October 16, 2009

Analysis by: GLG Expert Contributor

Analysis of:A Hatchet Job so Bad It's Good | www.nytimes.com

By relentlessly attacking the major provisions of the Senate Finance Bill which would appear to be serving as the template for compromise reform legislation at least capable of overcoming a Republican fillibuster, the health insurance industry may have done itself no favors. While at least giving the impression of playing nice up until unveiling a very critical report of the Senate Finance bill on the eve of its passage, the industry at least had a seat at the reform table. No more.

Ken PowellPresidentGenesis Business Development, LLC

Myriad Genetic Receives Pancreatic Gene License

October 16, 2009

Analysis of:Myriad Licenses Rights to Pancreatic Cancer Gene Patents | councils.glgroup.com

Myriad Genetics , a leading molecular diagnostics company received an exclusive license from Johns Hopkins University for a gene linked to pancreatic cancer.  About 42,470 new cases of pancreatic cancer will be diagnosed in 2009  and 35,240 will die from the disease.  Seventy-five percent of pancreatic cancer patients die within the first 12 months of the diagnosis. The 5-year survival rate is 5 percent.

Fresh Hope for Diabetes Patients

October 15, 2009

Analysis by: GLG Expert Contributor

Analysis of:ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes | www.pipelinereview.com

The success of ONGLYZA (saxagliptin) will largely depend on its long-term safety. Saxagliptin is the second drug from this class to be approved in Europe and the US - Merck's Januvia (sitagliptin) was the first. Saxagliptin has had to overcome several new regulatory hurdles as a result of major recent safety issues with other diabetes drugs including sitagliptin. Sceptical prescribers and heavy postmarketing scrutiny will likely mitigate a rapid uptake.    

Fampridine Clears Major Hurdle at FDA Review Panel

October 14, 2009

Analysis by: GLG Expert Contributor

Analysis of:FDA Panel Backs Proposed Acorda Multiple Sclerosis Drug (fampridine) To Improve Walking | online.wsj.com

Fampridine has been recommended for approval on 10/14. There are several more steps needed at the regulatory level, but the medicine is back on the approval track after a critical pre-meeting FDA report raised serious criticisms.

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.

John AnsellDirectorJohn Ansell Consultancy

GSK's new venture into Duchenne's makes sense

October 14, 2009

Analysis of:GlaxoSmithKline and Prosensa form alliance to fight Duchenne Muscular Dystrophy | www.pipelinereview.com

GSK's latest deal on Duchenne's muscular dystrophy with the Dutch company Prosena is a further indication of the former's interest in diversifying out of the more obvious, major areas of medicine.This can make sense: such "esoteric" indications areas are less well understood, there is less competition and commercial rewards can turn out to be greater than superficially apparent.

Eric WhitmanMedical Director, Office of Grants and ResearchATLANTIC HEALTH SYSTEM INC

Plexxikon Drug for Melanoma Continues to Show Great Promise

October 14, 2009

Analysis of:Researchers herald 'breakthrough' skin cancer therapy | www.fiercebiotech.com

The new drug PLX-4032, being developed by Plexxikon and Roche, continues to show impressive short term results in melanoma patients with specific BRAF mutations, with a reported 70% tumor response rate.

Donald FlemingDivision Head of Hematology and OncologyDAVIS HEALTH SYSTEM INC

Triple negative Breast Cancer Strategies

October 14, 2009

Analysis of:MediGene completes patient recruitment into EndoTAGTM-1 phase II breast cancer trial | www.pharmabiz.com

Triple negative Breast cancer has been a phenotype with little hope up until recentlyWhile advances in hormonal therapy and Her2 blocking agents has revolutionized ER/PR + and Her 2 positive breast cancer therapy, triple negative breast cancer pulls down the outcomes, with similar responses as for non small cell lung cancer

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