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GLG News by Drug Development Software Experts

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Eric GruffAugust 21, 2008
Link to Pancreatitis is Bound to Negatively Impact Byetta Sales
Analysis of: FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov
Author: Eric Gruff, Principal, E4 Consulting
The recent publication of new cases of pancreatitis that are occurring in patients taking Byetta (exenatide) can't be good for Amylin/Lilly. While Byetta and investigational GLP-1 analogs are still very viable therapeutics for Type 2 Diabetes, prescribers will have to reassess the risk-benefit ratio...
Eric GruffApril 21, 2008
Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers
Analysis of: UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com
Author: Eric Gruff, Principal, E4 Consulting
Regardless of the reason (greed, carelessness, incompetence, etc.) that Chinese heparin became tainted, the end result will be increased scrutiny on imported raw materials and other ingredients, not only from China, but from all 3rd World suppliers. How the FDA and other regulatory agencies actually...
Eric GruffApril 16, 2008
AtheroGenics' AGI-1067 Shows Some Promise, But There Are Still Questions
Analysis of: AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes | www.fiercebiotech.com
Author: Eric Gruff, Principal, E4 Consulting
The 3-month reduction in HbA1c demonstrated by AGI-1067 is promising, but I still have many questions regarding the design and outcomes. There are many existing therapies that lower A1c - many have undesireable side effects like weight gain or hepatotoxicity.
Eric GruffApril 14, 2008
Cubist's Antibiotic Cubicin is Tainted: A Mess Not of Their Doing? Maybe, Maybe Not.
Analysis of: Cubist Finds Its Antibiotic Cubicin Is Tainted | online.wsj.com
Author: Eric Gruff, Principal, E4 Consulting
The news that Cubist's Cubicin has been contaminated with 2-mercaptobenzothiazole (MBT) has caused great concern for patients. It appears that the MBT has leeched out of the Cardinal Health ReadyMED drug pumps that are used for delivering Cubicin. Regardless of who is at fault, everyone involved (Cubist,...
Eric GruffApril 8, 2008
Insurers Should be the First Line of Defense Against Vytorin
Analysis of: Will Insurers Reduce Coverage For Vytorin? | www.pharmalot.com
Author: Eric Gruff, Principal, E4 Consulting
The pharmaceutical industry continues to lay its collective head on the chopping block by pushing drugs like Vytorin that demonstrate at best marginal activity. Insurers have a fiduciary duty to push back against the poor judgement of drugmakers who take advantage of confusion and DTC advertising to...
Eric GruffApril 8, 2008
Pfizer's Melanoma Treatment Setback Has Bigger Implications
Analysis of: Pfizer Ends Clinical Trial Of Melanoma Treatment | online.wsj.com
Author: Eric Gruff, Principal, E4 Consulting
While disappointing for patients and caregivers, Pfizer's loss of a late-stage treatment for melanoma casts an even darker shadow on the ability of pharmaceutical and biotech companies to successfully bring new treatments to market. Coupled with other recent Phase 3 failures, this latest outcome points...
Eric GruffOctober 18, 2007
Are Generic Drugs Truly Bioequivalent to Their Brand Name Counterparts?
Analysis of: Generic Drugs: Dangerous Differences? | abcnews.go.com
Author: Eric Gruff, Principal, E4 Consulting
A recent study by ConsumerLab.com suggests that some generic versions of pharmaceutical products may not be bioequivalent to their brand name counterparts. The difference seems to be in the release rates for extended-release (ER) dosage forms as determined by in vitro ("test tube") analysis of...
Eric GruffOctober 11, 2007
Wyeth's Acquisition of Haptogen Will Enhance Their Pipeline, But The Real Test is Whether This Will Lead to More Approved Therapies
Analysis of: Wyeth Pharmaceuticals Acquires Haptogen Ltd. to Boost Biotechnology Drug Discovery | www.pipelinereview.com
Author: Eric Gruff, Principal, E4 Consulting
Wyeth's acquisition of Haptogen, a Scottish biotechnology company specializing in novel protein-based therapeutics, is a promising development for Wyeth's biotechnology pipeline. This is a welcome addition for Wyeth, but the key will be translating the increased pipeline into additional drugs on the...
Eric GruffOctober 8, 2007
Microsoft's HealthVault: Putting Medical Information on the Web Offers Great Promise and Great Risk
Analysis of: Microsoft launches Web site to hold medical records | uk.reuters.com
Author: Eric Gruff, Principal, E4 Consulting
Microsoft's HealthVault will store medical information in an encrypted database available via the Web. In addition, there will be access to health information available to the public. Putting secured health data online seems like a great idea provided that personal information remains out of reach of...
Eric GruffOctober 5, 2007
Diabetes Patients Still Seek More Convenient Therapies. Pharma Isn't There Yet.
Analysis of: Burden of diabetes care rivals disease complications | www.reuters.com
Author: Eric Gruff, Principal, E4 Consulting
A recent Chicago-area study has made it clear that diabetics view the daily-injection routine as being equally as onerous as many of the long-term complications from the uncontrolled disease. In addition to multiple daily injections, diabetic patients usually take several concommitant medications every...

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