Dr. Eric Gruff PhD MBA

GLG News by Dr. Eric Gruff PhD MBA, Principal

GLG News is now G+ Insights

G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.

The Benefits of R&D Outsourcing in Pharma and Biotech

October 1, 2010

Outsourcing of R&D activities can be a major competitive advantage for medium to large pharma/biotech companies if done correctly. While the general assumption is that outsourcing is cheaper than insourcing (also known as "do it yourself"), the total cost of outsourcing is much greater than the amount paid to the CRO for the work. There are many benefits to outsourcing, however, and when conducted in a strategic context, can provide a significant competitive advantage.

Link to Pancreatitis is Bound to Negatively Impact Byetta Sales

August 21, 2008

Analysis of:FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov

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 for many patients given the new information. The long-acting form of Byetta (LAR) may suffer the most since its long half-life will make reversal of pancreatitis that much more difficult and may lead to additional damage.

Tainted Heparin Will Mean More Scrutiny of Drug Manufacturers

April 21, 2008

Analysis of:UPDATE: FDA Head Sees Economic Fraud Behind Tainted Heparin | www.reuters.com

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 intend to step up the scrutiny is still open to debate, but the ultimate responsibility lies with the license holder.

AtheroGenics' AGI-1067 Shows Some Promise, But There Are Still Questions

April 16, 2008

Analysis of:AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes | www.fiercebiotech.com

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.

Cubist's Antibiotic Cubicin is Tainted: A Mess Not of Their Doing? Maybe, Maybe Not.

April 14, 2008

Analysis of:Cubist Finds Its Antibiotic Cubicin Is Tainted | online.wsj.com

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, Cardinal, the FDA, doctors, and patients) have good reason to worry.

Insurers Should be the First Line of Defense Against Vytorin

April 8, 2008

Analysis of:Will Insurers Reduce Coverage For Vytorin? | www.pharmalot.com

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 make money.

Pfizer's Melanoma Treatment Setback Has Bigger Implications

April 8, 2008

Analysis of:Pfizer Ends Clinical Trial Of Melanoma Treatment | online.wsj.com

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 to the need for even more investment in better biomarkers.

Are Generic Drugs Truly Bioequivalent to Their Brand Name Counterparts?

October 18, 2007

Analysis of:Generic Drugs: Dangerous Differences? | abcnews.go.com

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 dissolution. Patients who report a difference could suffer from the Placebo Effect, or there could be a real and possibly harmful difference.

Wyeth's Acquisition of Haptogen Will Enhance Their Pipeline, But The Real Test is Whether This Will Lead to More Approved Therapies

October 11, 2007

Analysis of:Wyeth Pharmaceuticals Acquires Haptogen Ltd. to Boost Biotechnology Drug Discovery | www.pipelinereview.com

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 market, something the entire pharmaceutical industry has struggled with over the past several years.

Microsoft's HealthVault: Putting Medical Information on the Web Offers Great Promise and Great Risk

October 8, 2007

Analysis of:Microsoft launches Web site to hold medical records | uk.reuters.com

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 those that will take advantage of it.

Diabetes Patients Still Seek More Convenient Therapies. Pharma Isn't There Yet.

October 5, 2007

Analysis of:Burden of diabetes care rivals disease complications | www.reuters.com

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 day. While patients greatly fear the most severe end-stage complications like blindness, kidney failure, and stroke, many indicated a willingness to give up years of life (or quality of life) to avoid daily treatments.

"The Big GLP" - Should We Be Excited About Novo's Liraglutide?

August 23, 2007

Analysis of:Liraglutide improves glucose control and lowers body weight in two phase 3 studies comprising more than 2,000 patients | www.pipelinereview.com

The results of two Phase III trials conducted by Novo Nordisk on liraglutide, a once-daily dosed GLP-1 analog, indicate significant glucose lowering efficacy and weight loss. On a positive note, Novo has to be relieved that they are seeing the same magnitude of HbA1c reduction and weight loss as exenatide (Byetta) with less-frequent dosing. However, given the ADA's refusal to include exenatide (and by inference, other GLP-1 analogs) in first-line therapy, it's hard to get too enthusiastic over this incremental improvement to Byetta, especially since the once-weekly form of Amylin's therapy (Byetta LAR) is roughly a year away from the market.

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