GLG News by Psychiatrists (US)

The focus of Memory Pharmaceuticals & Roche Expansion of their Development Program for MEM 3454 in schizophrenia is symptomatic of a trend in schizophrenia research that has identified cognitive deficits as the fundamental abnormality in brain functioning.  It is an eminently reasonable...

Lundbeck’s pipeline has been gathering some real momentum in recent months, having advanced a number of investigational CNS drugs.  The initiation of this 600 person Phase II study of Lu AA34893 in bipolar depression, yet another Lundbeck drug candidate shrouded in some mystery (ie, we know that...

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.      ...

Quality is critical in human pharmaceutical processes from research and development through to manufacturing and commercialization of pharmaceuticals for human consumption. Slippage in quality norms may reflect an underlying shift in culture within an organization.  FDA compliance and inspectional...

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 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