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Personally the biomed niche market has more than handsomely rewarded me in the past and it continues to be a hot sector.From Penny Plays to Large Caps there are tremendous opportunities within the biomed arena.

Among the highlights from the 2012 FDA drug-approval calendar that should be of most interest to bio-pharma investors: A first-quarter FDA advisory panel that will once again tackle the thorny issue of obesity-drug safety, including Vivus'(VVUS_) Qnexa; approval decisions for novel inhaled medicines from Alexza Pharmaceuticals(ALXA_) and MAP Pharmaceuticals(MAPP_); and the fifth (!!) attempt at approval for Discovery Labs'(DSCO_) lung therapy for premature infants.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst.

Biogen Idec(BIIB_) and Elan (ELN_)
Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.

Columbia Laboratories(CBRX_)
Drug/indication: Prochieve for reduction of risk of premature birth.
FDA advisory panel: Jan 20, 2012
Approval decision date: Feb. 26, 2012

Amylin Pharmaceuticals(AMLN_)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly(LLY_). Alkermes(ALKS_) retains its royalty split on Bydureon sales.

Bristol-Myers Squibb(BMY_)
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012


Pfizer(PFE_)
Drug/indication:Inlyta (axitinib) for kidney cancer
Approval decision date: Feb-April 2012
On Dec. 7, an FDA advisory panel voted 13-0 to recommend Inlyta's approval.

Alexza Pharmaceuticals(ALXA)
Drug/indication:Adasuve for agitation related to schizophrenia
Approval decision date: Feb. 4, 2012
Adasuve uses Alexza's proprietary Staccato inhaler system to deliver the anti-agitation medicine loxapine directly into the lungs where it gets into the bloodstream and begins to work quickly. The FDA advisory panel is expected to focus much of its attention on the potential side effects and safety issues related to delivering Adasuve into patients' lungs.

FDA initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August. On Dec. 12, an FDA advisory panel voted 9-8 with one abstention to recommend approval of a single dose of Adasuve. The panel also recommended the drug only be distriuted with a restrictive risk-management plan.

NeurogesX(NGSX_)
Drug/indication: Qutenza for HIV-associated peripheral neuropathy
FDA advisory panel: Feb. 9, 2012
Approval decision date: March 7, 2012

Teva(TEVA_) and BioSante Pharmaceuticals(BPAX_)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men.

Corcept Pharmaceuticals(CORT_)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux.

Chelsea Therapeutics(CHTP_)
Drug/indication: Northera for orthostatic hypotension
FDA advisory panel: Feb. 23, 2012 (tentative) Approval decision date: March 28, 2012


Vivus(VVUS_), Arena Pharmaceuticals(ARNA_) and Orexigen Therapeutics(VVUS)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: The Endocrinologic and Metabolic Drugs Advisory Committee has tentative meetings scheduled for Feb. 22 and March 28-29, 2012.
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.

Discovery Labs(DSCO_)
Drug/indication: Surfaxin for respiratory distress syndrome in premature infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin.

Roche(RHHBY) and Curis(CRIS_)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012.


MAP Pharmaceuticals(MAPP_)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex.

Affymax(AFFY_)
Drug/indicationeginesatide for anemia in kidney dialysis patients.
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's(AMGN_) Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. On Dec. 7, an FDA advisory panel voted 15-1 to recommend peginesatide's approval.

Vivus(VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns.

Currently I am in AEN,ANX,CXM,MMED,SGLB,MMRF and have a huge watch on TEVA.If you have been keeping up with market pulse you are aware TEVA is in a struggle with FDA,the court system and PFE for their right to market/sell a generic brand of Viagara.The courts suddenly extended the rights of exclusivity to PFE last week until 2019.TEVA has appealed the decision and I wait in anticipation.

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FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice.
Please do your own DD as I can only be held responsible if/when you make $$$$$$!

Just a reminder of upcoming FDA approvals and reviews for your pharma green opportunities.It`s all here for your info.

__________________
FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice.
Please do your own DD as I can only be held responsible if/when you make $$$$$$!

Februray is upon us,,,just a 2nd reminder of the upcoming FDA approvals in the pipeline from the origional article posted here.
Add BPAX to the list for the 14th,,,and TEVA is already on .

__________________
FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice.
Please do your own DD as I can only be held responsible if/when you make $$$$$$!

Teva, BioSante Win FDA Approval to Sell Men’s Testosterone-Replacement Gel
By Molly Peterson - Feb 14, 2012 4:55 PM ET

Teva Pharmaceutical Industries Ltd. (TEVA) and BioSante Pharmaceuticals Inc. (BPAX) won U.S. clearance to sell Bio-T-Gel, a testosterone replacement therapy for men.

The Food and Drug Administration approved the transdermal gel, the agency said today in an e-mail. Teva, of Petach Tikva, Israel, will market Bio-T-Gel for men with low testosterone. The condition, known as hypogonadism, can cause erectile dysfunction, infertility, osteoporosis and muscle loss, according to the Mayo Clinic in Rochester, Minnesota.

BioSante, the original developer of Bio-T-Gel, estimates the market for male testosterone products is more than $1.2 billion in the U.S., where hypogonadism affects as many as 5 million men. BioSante, of Lincolnshire, Illinois, licensed the gel to Teva, the world’s largest generic-drug maker, and will receive milestone payments and royalties when the drug is commercialized.

Abbott Laboratories (ABT) won FDA approval in April for a testosterone product known as AndroGel and later sued Teva, alleging that Bio-T-Gel infringed the product’s patent. Abbott, of Abbott Park, Illinois, and Teva settled the litigation in December without disclosing the terms, BioSante said Jan. 31 in a statement.

BioSante’s other experimental testosterone product, LibiGel, is a topical treatment applied to the arm for female sexual dysfunction. The company fell 77 percent, the most in 12 years, on Dec. 15 after the drug failed to work better than a placebo in two trials. BioSante said Jan. 31 that it would decide within 90 days whether to continue studying LibiGel.

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloombe

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FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice.
Please do your own DD as I can only be held responsible if/when you make $$$$$$!

WOW,,,if you missed BPAX and now VVUS maybe the calendar is important.


NEW YORK (TheStreet) -- Shares of VIVUS(VVUS) soared late Wednesday after the company confirmed a Food and Drug Administration advisory committee has recommended Qnexa, its proposed treatment for obesity in adults, receive marketing approval.

More on VVUS

Orexigen Therapeutics Inc.| OREX Vivus| VVUS Arena Pharmaceuticals Inc.| ARNA The stock was last quoted at $21.02, up 99.2%, on volume of 1.9 million, according to Nasdaq.com.

"We are pleased with the panel's approval recommendation in support of the safety and efficacy of Qnexa," said Peter Tam, the company's president, in a statement. "We look forward to working with the FDA as they complete their evaluation. Obesity is a serious medical condition, and we are committed to making Qnexa available and providing physicians with a new medical treatment option in their battle with this public health epidemic."

VIVUS said the committee voted 20-to-2 in favor of making the recommendation for approval based on a "favorable benefit-risk profile."
The company noted that the recommendation doesn't guarantee the drug will receive approval from the FDA. Rather the guidance will be considered when the FDA reviews the company's new drug application for Qnexa, which was submitted in October 2011. A previous bid for approval of Qnexa failed because of health safety concerns.

VIVUS added that the scheduled Prescription Drug User Fee Act date for an FDA decision on Qnexa is April 17.

The news sent shares of both Orexigen Therapeutics(OREX) and Arena Pharmaceuticals(ARNA) higher in the extended session as well.
Orexigen's stock jumped nearly 18% to $3.78 on volume of more than 700,000, while shares of Arena Pharmaceuticals rose 17% to $2.12 on volume of more than 4 million, according to Nasdaq.com.

Orexigen and Arena both have anti-obesity drugs in development, so the favorable news of Qnexa is being seen as a positive indicator for their efforts.
Check out TheStreet's quote page for VIVUS for year-to-date share performance, analyst ratings, earnings estimates and much more.
--Written by Michael Baron in New York.

__________________
FYI when I post I do not link charts as you and I have diff settings and we both know charts can turn on a moments notice.
Please do your own DD as I can only be held responsible if/when you make $$$$$$!