Zyprexa

In a Para IV application, the applicant who intends to make the generic version of a drug believes that the patent (of the innovator) is not infringed or it is invalid.

The truth is that generic drug manufacturing companies have had a poor run since 2004 in major litigation challenging patents in international courts.

Nevertheless, Indian pharmaceutical makers are still looking for other ways to make their presence felt on the world markets.

Analysts tracking the developments in the industry said that out-of-court settlements and market exclusivity agreements — similar to the one inked by Ranbaxy and Cephalon Inc on narcolepsy drug Provigil — could well turn out to be the favoured road as generic drug manufacturers seek to get a foothold in global markets.

Pharma makers have also been buying boutique drug outfits in the US and other countries.

Nicholas Piramal for instance acquired British pharma major Avecia for £9.5 billion.

Ranbaxy Laboratories has sought to establish firm foothold in Asia, particularly in Japan.

Around the same time, Dr Reddy's Laboratories Ltd inked a deal to acquire Swiss pharma company Roche's facility manufacturing active pharmaceutical ingredien...

Michael J.

Sernyak, monitored the frequency of undiagnosed high blood sugar in 647 patients taking various atypical antipsychotics, including: Clozaril (clozapine), Risperdal (risperidone), Over the course of two years, 153 of the participants had a fasting blood sugar result.

The study’s findings, published in the Journal of Clinical Psychiatry for December 2005, show that blood sugar levels...

But such drugs have serious limitations.

Their side effects, including weight gain and sexual dysfunction, can be more debilitating than the original disorder.

And their effect on stuttering has not been extensively tested.Pagoclone, the experimental pill from Indevus, started its life in the 1990s as a potential psychiatric drug.

It was licensed to the pharmaceutical giant Pfizer Inc., which tested its effects on both panic and anxiety with mixed results.

It had few side effects, but tests didn't show clear improvements either.

Pfizer killed the program in 2002, sending Indevus stock into a tailspin.Indevus officials, however, were intrigued by a striking and unanticipated effect on test patients: Two of them suddenly stopped stuttering.''It really made us believe that it's worth investing the money to do a proper trial," said Jim Shipley, the company's vice president for medical affairs.Indevus re-acquired the rights to pagoclone, took out a fresh patent based on its possible use as a treatment for stuttering, and launched a new clinical trial designed to show whether it can help a broader population.

They have enrolled about half of the 120 patients they hope to test, and expect to have results by the middle of 2006.Indevus warns that even if the trial succeeds, a larger trial will need to follow, and approval wouldn't come for at least three years.But even if the drug ultimately ...