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Genelabs Technologies, Inc. announced today that, after its receipt of $12.5 million in up-front payments under its recently announced agreement with Novartis, Genelabs expects its June 30, 2006 cash and cash equivalents to be approximately $15 million.
Synovics Pharmaceuticals, Inc., a specialty pharmaceutical company with proprietary technologies for the development of controlled-release generic and branded oral drugs, today announced that its wholly owned subsidiary, Synovics Laboratories, Inc., has initiated the process for U.S. chemical, manufacturing and control (CMC) development of its third controlled-release generic drug candidate, SNG1003.
Questcor Pharmaceuticals, Inc. announced today that it began to ship its new CNS product, Doral (quazepam), a non-narcotic, selective benzodiazepine receptor agonist that is indicated for the treatment of insomnia, characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.
The FDA has granted orphan drug designation to Isis Pharmaceuticals' ISIS 301012, intended for the treatment of homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder that results in extremely high cholesterol.
The FDA's efforts to eliminate unapproved drugs from the market is more show than substance and seems to be part of an agency trend to tread lightly where industry is involved, an activist group says.
Fine chemicals company Hovione has passed an inspection by the US Food and Drug Administration (FDA) at its active pharmaceutical ingredient (API) manufacturing site in Loures, Portugal, as it tries to conform with ever-stricter standards.