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dDT

05/06/12 10:29 AM

#8585 RE: dDT #8584

ARNA FDA play this week

5/10/2012 ARNA Arena Pharmaceutical Inc.
Lorcaserin (NDA resubmission) FDA panel to review Lorcaserin for obesity

Tuff-Stuff

05/06/12 9:17 PM

#8587 RE: dDT #8584

(GILD) wsj<>FDA Panel Considers HIV Drug For New Use
Advisers to Weigh Pros, Cons of a $14,000-a-Year Drug for Use in People at High Risk of Getting Virus That Causes AIDS

BY JENNIFER CORBETT DOOREN

A Food and Drug Administration advisory panel this week will decide whether to recommend for the first time that certain healthy but at-risk people take a drug to help prevent them from contracting the virus that causes AIDS.

Approval by the agency would mark another milestone in the three-decade effort to combat HIV and AIDS. Huge advances in drugs to treat infection and its symptoms have allowed patients to live significantly longer and healthier lives for a disease that in the 1980s was a death sentence.

On Thursday, an FDA panel will weigh whether Gilead Sciences Inc., which makes the

http://online.wsj.com/article/SB10001424052702304020104577384502756088234.html?mod=rss_whats_news_us_business

Tuff-Stuff

05/09/12 10:26 AM

#8817 RE: dDT #8584

Risk of Unprotected Sex Debated in Gilead HIV Pill Review
By Ryan Flinn and Shannon Pettypiece - May 9, 2012 9:56 AM ET


Healthy people can protect themselves from the deadly HIV virus if they take Gilead Sciences Inc. (GILD)’s Truvada every day. Whether patients will is an issue dividing AIDS advocates as U.S. regulators weigh approving the pill as the first preventative measure against the disease.

Truvada is safe and effective enough as a preventative medicine, Food and Drug Administration staff concluded in a report yesterday. An advisory panel recommendation for approval, set for debate tomorrow, hinges on who would get the pill and whether patients can be educated on the importance of following through with a prescription.

Doctors say the idea is to get healthy individuals in certain high-risk groups to take a $14,000-a-year pill every day to reduce the estimated 48,000 new U.S. cases of HIV each year. Some advocates say such a medicine to prevent the virus that can be avoided with condoms may encourage unprotected sex and increase infections.

cont http://www.bloomberg.com/news/2012-05-09/risk-of-unprotected-sex-debated-in-gilead-hiv-pill-review.html?cmpid=yhoo

dDT

05/09/12 11:28 AM

#8827 RE: dDT #8584

GILD re-posted ... link back

PoemStone

05/09/12 12:00 PM

#8831 RE: dDT #8584

Hi dDT. reposted.