The Expertise Imperative and Compliance Technology
Access to a diverse array of specialized expert inputs drives superior decisions in every organizational context: within corporations, by investors and consultancies, and within nonprofits. When decision makers are confident of their decision inputs, they can respond more quickly and creatively to challenges and opportunities.Learn more about GLG's Compliance Framework
This page may include content provided by Council Members, your access to which is subject to the Terms of Use.
New clinical indications add to a drug’s period of FDA market exclusivity (different than patent exclusivity) and is a common strategy used by pharmaceutical companies to generate additional revenue from a drug, in pharmaspeak referred to as creating a “successful lifecycle management” strategy. ...
Long-acting neuroleptics are extremely beneficial in treatment of non-compliant chronically mentally ill because it allows more medical oversight and assurance of compliance with pharmacotherapy. Olanzapine is a particularly bad atypical (new generation) neuroleptic when it comes to weight gain...
Lilly's new Long-Acting Zyprexa will face FDA panel scrutiny and a likely focus of concern will be the sedation problem occurring in some patients soon after injection. However, this should not be a deal-breaker..given the high degree of efficacy of this medication in schizoprenic (and bipolar...
Doxepin HCL has a long history of use both as an antidepressant and for its hypnotic effect. What does this reincarnation of an old (but good) drug add to the marketplace...and why would it be successful?
The long term efficacy of botulinum toxin Type A for the treatment of glabellar frown lines was recently discussed in San Antonio, Texas at the 66th annual meeting of the American Association of Dermatology. Kawashima and other fellow Japanese investigators presented long-term (64 weeks)...
The NDA submission of Somaxon’s Silenor, a reformulation of the tricyclic antidepressant doxepin at very low doses, for the treatment of insomnia is not particularly compelling news clinically. Low doses of doxepin provide an anti-histamine effect with less norepinephrine or serotonin reuptake...
When varenicline (Chantix) first became available for use in patients, I was incredibly impressed by how effective it was. I had one patient who was so addicted to cigarette smoking that he could not sleep through the night without a smoke--he would awake every hour or two and then go back to...
No good data that Chantix is associated with suicide
Need more controlled research to answer questions
Scary adverse events are not the same as side effects directly linked to medication
Doxepin was developed as an antidepressant nearly 40 years ago. It has been used by generations of psychiatrists for its sedating and sleep promoting actions, much as many other of the sedating antidepressants of yore. Now it is being developed as a treatment of insomnia--the one twist is...
Somaxon Pharmaceuticals has submitted a NDA for Silenor for the treatment of insomnia. The active ingredient is doxepin, which has been available for years.The effect of the drug can be expected to be very modest, side effects unfavorable when compared to Ambien or Lunesta, and with both significant...