Tuesday's FDA Panel Review for Human Genome Science's Benlysta

Purple Walk for Lupus Awareness

Everything you need to know about Tuesday's FDA panel recommendation for Human Genome Sciences therapy for Lupus, Benlysta.  If approved Benlysta would be the first approved therapy in 50 years for Lupus.  Friday the FDA released the notes for the upcoming panel review Tuesday, November 16th.  Concerns for the panel Tuesday were an increased risk of suicide, risk of infection, and decreased efficacy in African-American patients, who are more prone to Lupus.  Forbes' The Medicine Show Blog with Matthew Herper highlighted some of these concerns.  Benlysta is teamed up with Glaxo SmithKline and if approved Human Genome Sciences will share marketing costs and profits.  The expected market is anywhere between 1-3 Billion.

I think the benefits for the drug outweigh any concerns and it could be approved December 9th by the FDA.  With that being said though, the FDA has rejected a lot of drugs this year and is very conservative.  There are some concerns and more clinical trials could be advised before approval.  We will have to see.  Today's FDA review notes had concerns with the drug's suicide rate and it's efficacy for African-Americans, who are more likely to have Lupus.  The concerns dropped the stock and has investors spooked, but I still think that it will be recommended.  I hope I am not wrong on this one. 

For more information about Human Genome Sciences visit their website HGSI.com. 

Learn more about Lupus (SLE), please visit their website at Lupus.org.

Wikinvest--Human Genome Sciences (HGSI)

Wikinvest--Glaxo (GSK)

Yahoo Finance--HGSI

Yahoo Finance--GSK

For more on Tuesday's Decision

Forest Labs FDA Panel Review and Phase II Clinical Trial Results

Chemical Structure of Ceftaroline This just in to marketwatch today.

Forest-Gedeon Richter drug misses overall goal

TEL AVIV (MarketWatch) -- Forest Laboratories Inc. FRX 29.56, +0.37, +1.27%) and Gedeon Richter PLC said Monday that in a Phase II study of cariprazine, a potential treatment for bipolar depression, the overall result for patients taking the drug was not statistically different from that of the patients taking placebo. In higher doses, however, the antipsychotic drug did show "evidence of a clinically relevant treatment effect," the drugmakers, based respectively in New York and Budapest, said. The primary endpoint was the scores on the Montgomery Asberg Depression Rating Scale, they said. The companies are mulling whether to do another Phase II study of the drug to examine a wider range of doses. Meantime, the drug is in Phase III trials for, separately, schizophrenia and bipolar mania

News concerning Tomorrow's FDA decision. This is an antibiotic up for approval up for review tomorrow Sept. 7th, 2010.

FDA Panel Alert: Forest Labs

Forest Labs Antibiotic Seems Effective FDA Notes Revealed

Image via Wikipedia FDA staff back safety, efficacy of ceftaroline

* Advisory panel to review drug on Tuesday
* Forest shares up 5.4 pct in afternoon
* Nearly $361 million in ceftaroline sales seen in 2014 (Revises first sentence, adds analyst comment, updates shares)
By Lisa Richwine

WASHINGTON, Sept 2 (Reuters) - A Forest Laboratories Inc (FRX.N) antibiotic appears effective with risks similar to current options, U.S. drug reviewers said in an analysis that raised hopes for the medicine's approval.

Shares of Forest, which needs new medicines to offset looming patent expirations on its major drugs, were up $1.49 or 5.4 percent at $29.14 on the New York Stock Exchange after the Food and Drug Administration released its preliminary review on Thursday.

Analysts expect nearly $361 million in sales in 2014 for the potential new antibiotic called ceftaroline, according to Thomson Reuters forecasts.

FDA Advisory Panels Recommends Fewer Drugs This Year

Image via Wikipedia It has been a rough year for Drug Candidates this year. Time after time FDA panels are rejecting more qualified drug approvals. So what really is going on here. Are drug up for FDA approval less safe, less effective, or are the panels more cautious on approvals. These panels have had a devastating effect on the company's stock after these No recommendations. Let's take a closer look into what's really going on.

FDA Advisory Panels: A Coin Flip