All GLG News Analyses Filed Under: Business of Medicine
Posted May 1, 2008
Expect speeder FDA reviews in a year maybe.
Analysis of: FDA Embarks on Major Hiring Initiative for its Public Health Mission | pharmalive.com
Author: GLG Member Program Contributor
Analysis of: FDA Embarks on Major Hiring Initiative for its Public Health Mission | pharmalive.com
Author: GLG Member Program Contributor
In this publications there is am implication that the FDA will approve things faster as the FDA will after hiring so many people with fancy science backgrounds. This might be true but it probably won't be the case.
Posted May 1, 2008Risks when Politicians Tackle Supply Chain Security
Analysis of: Lawmakers Fault FDA on Heparin | online.wsj.com
Author: Adam Fein, Founder & President Pembroke Consulting Inc
The Heparin contamination has pushed the security of America’s pharmaceutical supply chain to the forefront of the news. I’m not yet sure how politician’s newfound involvement in the topic will play out. America needs to harmonize its own internal standards for the pharmaceutical supply chain, but politicians’...
Posted May 1, 2008The AMP Pharmacy Reimbursement Saga Drags On
Analysis of: NACDS, NCPA Seek to Amend AMP Lawsuit Challenging CMS' Interim Final Rule Redefining “Multiple Source Drug” | www.nacds.org
Author: Adam Fein, Founder & President Pembroke Consulting Inc
There are some new developments for Average Manufacturer Price (AMP), although the situation has now devolved into a somewhat arcane legal battle. Unless there is a legislative fix (unlikely), then I expect that Center for Medicare and Medicaid Services (CMS) will punt this issue to the next administration...
Posted May 1, 2008
Mipomersen will make it to market but with limited market share
Analysis of: FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen | www.pipelinereview.com
Author: GLG Member Program Contributor
Analysis of: FDA Provides Clarity to Isis Regarding the Development Path for Mipomersen | www.pipelinereview.com
Author: GLG Member Program Contributor
Mipomersen (formerly known as ISIS 301012) is a in class of novel therapeutic agents that reduce the production of a protein in the liver that is responsible for cholesterol production. It is though that inhibiting that production on a molecular level would decrease the levels of cholesterol. Mipomersen...
Posted April 30, 2008
FDA: Chinese Manufacturer of Tainted Heparin Involved in Fraud.
Analysis of: UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com
Author: Joe Atkins, Chief Executive Officer Medical Concepts & Innovations
FDA: Chinese Manufacturer of Tainted Heparin Involved in Fraud.
Analysis of: UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com
Author: Joe Atkins, Chief Executive Officer Medical Concepts & Innovations
First, and foremost, the only working link for this article can be found at: http://www.reuters.com/article/domesticNews/idUSWAT00934620080415?feedType=RSS&feedName=domesticNews Although there is no proof offered in the article to substantiate the suggestion of fraud, there is enough circumstantial...
Posted April 30, 2008Generic Biologics Won't Get A Free Ride
Analysis of: Don't compromise the safety of biotech drugs | www.latimes.com
Author: Jeff Stier, Associate Director American Council on Science and Health
Allowing "generic" versions of biotech drugs to market without full safety testing would endanger consumers
Posted April 30, 2008
FDA Fees Must Be Increased to Fund Inspection of Chinese Products.
Analysis of: FDA fees eyed to boost food, drug safety | www.usatoday.com
Author: Joe Atkins, Chief Executive Officer Medical Concepts & Innovations
FDA Fees Must Be Increased to Fund Inspection of Chinese Products.
Analysis of: FDA fees eyed to boost food, drug safety | www.usatoday.com
Author: Joe Atkins, Chief Executive Officer Medical Concepts & Innovations
One only has to read about the Heparin debacle, which has killed, at least, 81 Americans, to realize that there is a serious issue with the quality of medicines produced in China. Manufacturing of medical food and consumer goods in China is growing at such a rate, the Chinese government has neither...
Posted April 30, 2008
Who to Blame for Waste in the Medical Industry? Who's on First?
Analysis of: The Price of Excess: Identifying Waste in Healthcare Spending | blogs.wsj.com
Author: Joe Atkins, Chief Executive Officer Medical Concepts & Innovations
Who to Blame for Waste in the Medical Industry? Who's on First?
Analysis of: The Price of Excess: Identifying Waste in Healthcare Spending | blogs.wsj.com
Author: Joe Atkins, Chief Executive Officer Medical Concepts & Innovations
It's easy to point fingers of blame and this article does that, very well. According to the "annalysis" everybody is to blame. And, they're right, everyone is to blame, but where the article fails is the authoris inability to point out a real solution to the problem of wasted dollars spent...
Posted April 28, 2008
Hefty price but promising potential
Analysis of: GlaxoSmithKline to acquire Sirtris Pharmaceuticals, a world leader in 'Sirtuin' research and development | www.pipelinereview.com
Author: GLG Member Program Contributor
Analysis of: GlaxoSmithKline to acquire Sirtris Pharmaceuticals, a world leader in 'Sirtuin' research and development | www.pipelinereview.com
Author: GLG Member Program Contributor
Situins are enzymes that regulate predetermined cell death, activity in muscle and fat cells as well as energy expenditure. There are several classes of these enzymes (SIRT 1 through 7). The technology is promising in that it promises to regulate some of the causes of diabetes and obesity rather than...
Posted April 28, 2008
Waste not Want not: Will this Ever Apply to U.S. Healthcare?
Analysis of: The Price of Excess--Identifying Waste in Healthcare Spending | www.pwc.com
Author: GLG Member Program Contributor
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of 648Analysis of: The Price of Excess--Identifying Waste in Healthcare Spending | www.pwc.com
Author: GLG Member Program Contributor
For the first time a major comprehensive authoritative national study (by PricewaterhouseCoopers, LLP) has concluded that over one half of the nation's $2.2 trillion in annual health spending (fully $1.2 trillion) is wasted. Other studies have put this percentage in the 25 to 40% range. ...
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