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Galvus, Another DPP-4 Inhibitor on the Horizon (Healthcare, Novartis)

October 3, 2007

Analysis of:Galvus(R) receives European approval as new treatment for type 2 diabetes with broad range of indications | www.pipelinereview.com

Galvus sounds very similar to Januvia, which is already approved and being used here in the United States with good results so far.  Because it targets the beta cell dysfunction and the glucagon pathway, it is very useful in the fight against diabetes, especially in combination therapy.  Januvia has shown a low risk for hypoglycemia as opposed to the sulfonylureas, therefore there is increased compliance with it.  Galvus, because it's in the same class, should have similar effects and should be effective in those patients that are not at goal on their current medication regimen.

Esophyx Receives FDA Approval after Three Surgeries (Healthcare)

October 1, 2007

Analysis of:EsophyX(TM) Receives FDA Clearance For Performing Transoral Incisionless Fundoplication Surgery | www.medicalnewstoday.com

The results of the three surgeries done in the United States with Esophyx must have been very convincing in order for it to have received FDA approval that quickly.  Using natural orifices to do surgeries makes much sense, especially because it decreases the risk of adhesions and further complications down the line.  Since the surgery has also been done in Europe, the FDA must have used that data along with the data from the surgeries done here in the approval process.  All in all, it's a win win situation because the procedure becomes less complicated for the surgeon, and the patient suffers less possible complications from general anesthesia and open/laparascopic surgery.

Eczema - not innovative, but common (Healthcare)

September 27, 2007

Analysis of:Relieva Exceeds Expectations In Recent Clinical Trial For Eczema (Atopic Dermatitis) | www.medicalnewstoday.com

Although eczema is not an innovative topic to study, it is a very common condition and affects many people.  Atopic dermatitis, along with asthma and many other atopic conditions, has become more and more prevalent these days.  There are many theories as to why this is so, but the important thing is that more and more people are being affected and more medications may be needed for the harder to treat cases.  Therefore, having another alternative therapy, and a more "natural one" as this drug is dubbed, is sure to strike big with the consumers.

Peramavir looks to have a promising future (Healthcare, BioCryst)

September 24, 2007

Analysis of:Biocryst Reports Preliminary Results from A Phase II Clinical Trial of Peramivir in Subjects with Acute Influenza | www.pipelinereview.com

Peramavir's future still looks promising despite the failure of phase II trials to show statistical significance.  As described in the article, this may be mainly due to the fact that the injections may not have been administered properly because of the shorter needles.  Since, the post hoc trials showed more statistical significance, it is important to wait and see what the phase III trials will show, but it definitely looks promising.  The success of the phase III trials will be very important because having a parenteral formulation of an anti-influenza agent has the potential to greatly decrease the morbidity and mortality associated with influenza, especially in hospitilized patients.

Lipodissolve - Hight Potential for Success but Needs More Research (Healthcare)

September 21, 2007

Analysis of:Feel Pudgy? There’s a Shot for That | www.nytimes.com

It's not surprising that the marketplace for "lipodissolve" therapy is exploding even though it is not regulated by the FDA or any other agency.  One just needs to look at the amount of junk mail one receives for weight loss drugs, backed by a "100% money back guarantee," and millions of people buy into it.  Although the pills are also usually backed by one doctor or another stating the science behind it and how it works, it's alarming that these shots are administered by physicians even though they are not backed by the FDA.  It's true that we do many things "off label," but at least the drugs themselves are approved by the FDA and their safety has been studied.  In this case, however, neither the safety or the efficacy has been studied, nor has the drug been approved by the FDA.  Hopefully the physicians that are using this drug know what they are getting into.  It will be interesting to see what the small scale study to be done will show.

Glucagon Receptor Antagonist - another weapon in our fight against Diabetes (Healthcare)

September 21, 2007

Analysis of:Metabasis Therapeutics Presents Promising Preclinical Results with Its Novel Glucagon Antagonist for the Treatment of Type 2 Diabetes | www.pipelinereview.com

Glucagon receptor antagonists sound like they will be a welcome addition to the current medications used to treat diabetes.  Although, they will probably only be helpful in type 2 diabetes because that is where the pancreas is still functioning, they are targetting a pathway that has not yet been used with the current medications available.  In patients who are already on the full cocktail of drugs used to treat diabetes, yet are still poorly controlled based on home fingersticks and HgbA1c's, this medications looks like a promising addition to the current available drugs.

Reclast sounds promising (Novartis, Healthcare)

September 21, 2007

Analysis of:First osteoporosis study in patients with hip fracture finds once-yearly Aclasta(R)-Reclast(R) prevents additional fractures and improves survival | www.pipelinereview.com

Reclast sounds like a promising new drug.  Although many osteoporosis drugs are currently on the market, this is the only one that has shown such a dramatic decrease in the recurrence of fractures, which is definitely a plus.  In terms of compliance, it is also very innovative, because instead of once weekly or once monthly, the patients only have to take it once a year.  Although, the fact that it is an infusion may not be as acceptable by some patients, in very high risk patients, it will be a very welcome addition to our current armamentarium of therapeutics. 

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