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Another fast-track drug is under FDA scrutiny. The Shire blood-pressure drug ProAmantine won agency approval in 1996 under its accelerated approval process. But follow-up studies required by that program--to confirm that it was really as effective as b...

A federal judge has recommended that Watson Pharmaceuticals CEO Paul Bisaro be forced to testify in a Federal Trade Commission probe of a patent settlement between the generic drugmaker and Cephalon over the narcolepsy drug Provigil, Dow Jones reports...

Shire says it is removing its low-blood pressure drug ProAmatine from the market, as it isn't profitable enough to justify the additional clinical tests that the FDA is requiring to stay on the market.

Drug counterfeiting has become a $200-billion business annually, according to the World Customs Organization. By some calculations, the counterfeiting trade has become more lucrative than the narcotics business. It's a global problem. And experts say t...

The cost of a pharmaceutical ingredient is determined by far more than its monetary value. Hilary Ayshford talked to Tom Beil, vice president of quality at SAFC, about the ways in which the industry is seeking to protect itself.

Reaxa ceo, Dr Pete Jackson, illustrates how EnCat technology is proving to be cost-effective in simplifying process work-up for pharma production at scale.