FDA Delays Cadence Painkiller Review
Delaying yet another drug review, the U.S. Food and Drug Administration (FDA) has pushed back the review of Cadence Pharmaceuticals intravenous acetaminophen by three months, with the expected approval date now said to be 12th February 2010.
In the same manner, GlaxoSmithKline's restless leg syndrome drug has also been delayed by three months by FDA, last week.
Cadence, who has acquired U.S. and Canadian marketing rights from Bristol-Myers Squibb, already selling the drug in Europe, is developing its own intravenous acetaminophen for use in hospitalized patients.
Revising its HIV treatment guidelines earlier this week, the European AIDS Clinical Society called on doctors to begin early treatment for those patients who have been newly diagnosed with HIV.
According to the new European recommendations, doctors are asked to begin treating HIV patients when their CD4 counts i.e. the key measure of immune system health falls to 500. In the past, doctors only began treatment after the CD4 counts fell to 350. There is mounting clinical evidence that early treatment benefits HIV patients, and the new guidelines will only serve as a boon to drug companies selling HIV medicines, none more so than Gilead Sciences, given it has the market-leading HIV drug franchise for Atripla or Truvada.
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