GLG News in Healthcare

Drugs are released to the market without adequate study, then, after around 70 to 100 patient deaths due to the drug are reported, the drug is pulled from the market.  Getting in front of this "problem" would improve the safety of our drug supply.

A few months ago, a small company tried to import Lumigan (bimatoprost), licensed by Allergan, in an eyelash applicator. It was held by the FDA as an unapproved use of a prescription medication. Now the owner of the patent is trying to import the same drug legally.

makes no sense to introduce a product that does not last as long as others on the market unless you are going t sell it to the patient at a substantial prce savings. Even in that scenario, needle fatigue wil eventually make the patient seek a different filler.

We may be able to analyze EGFR mutations from periperal blood of lung cancer patients. Very frequently enough tissue fromm needle biopsies are not available for analysis. This may replace the need for new biopsies.

‘One drug, many uses’ can make lots of sense clinically and commercially.   Seeking additional FDA indications for a specific drug has obvious business benefits:  greater revenue stream, improved branding, potentially longer market exclusivity, greater franchising potential of the drug into ‘improved’ formulations/uses (ie, Astra Zeneca’s Seroquel and then Seroquel XR; or GSK’s Wellbutrin...

This oral Vascular Endothelial Growth Factor (VEGF) inhibitor appears to have activity in radioresistant differentiated thyroid carcinoma.

When drug studies are done some unexpected findings emerge. If these results can show promise and expand drug use they should be persued as the cost will likely be less than developing a whole new drug.

It is likely that with all the bad press the FDA will require many more safety studies prior to allowing a drug on the market. Many nmay not make it because it will be too prohibitive to do. There is NO magic safe pill however.

United Therapeutics, a profitable US biotech company is about 12 months away from FDA approval of Inhaled Treprostinil for Pulmonary Arterial Hypertension.  This drug will significantly add to the Company’s current 60% prostacyclin market share and help ensure the continued 30% revenue growth rate for the next 3-5 years. 

If this isn't fixed, it won't be long before cognitive specialties, like internal medicine and neurology, start capping their practices and not allowing new Medicare patients.