This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

FDA Delays Cadence Drug Review: BioBuzz

SAN DIEGO, Calif. ( TheStreet) -- Another U.S. Food and Drug Administration drug review -- delayed.

This time, it's Cadence Pharmaceuticals (CADX), which said Friday that FDA is pushing back review of its intravenous acetaminophen by three months. The new approval decision date is now Feb. 12, 2010.

Last week, the FDA also delayed by three months a review of a restless leg syndrome drug by GlaxoSmithKline (GSK) and Xenoport (XNPT). The FDA has had difficulty meeting drug approval review deadline this year, in part because of staffing shortages but also because of the agency's renewed focus on drug safety.

Cadence is developing its intravenous acetaminophen for use in hospitalized patients. The drug's U.S. and Canadian marketing rights was licensed from Bristol-Myers Squibb (BMY), which already sells the drug in Europe.

Gilead Benefits From New HIV Treatment Rules

Earlier this week, the European AIDS Clinical Society revised its HIV treatment guidelines, calling on doctors to start treating newly diagnosed HIV patients earlier.

The new European recommendation calls for doctors to begin treating HIV patients when their CD4 counts (a key measure of immune system health) fall to 500. In the past, doctors waited until CD4 counts fell to 350 before beginning treatment. The change comes on the heels of mounting clinical evidence from large studies showing that earlier treatment benefits HIV patients.

The new guidelines are a boon to drug companies that sell HIV medicines, and none will benefit more than Gilead Sciences (GILD), given its market-leading HIV drug franchise. Earlier treatment starts for newly diagnosed HIV patients will translate into more HIV patients starting therapy with Gilead's Atripla or Truvada, and for longer durations.

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,987.51 -61.49 -0.36%
S&P 500 1,985.54 -11.91 -0.60%
NASDAQ 4,567.5980 -24.2080 -0.53%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs