FDA Approves Avanir and Forest Labs Treatments for PBA and Bacterial Infections

FDA Ends October With Drug Approvals

BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).

Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.

October was a busy but tough month for new drug approvals at the FDA. Regulators rejected seven new drugs, including a diabetes drug from Amylin Pharmaceuticals (AMLN) and weight-loss drugs from Arena Pharmaceuticals (ARNA) and Vivus (VVUS), respectively.

The FDA approved four drugs: the two mentioned above plus drugs from Questcor Pharmaceuticals(QCOR) and Alkermes (ALKS).

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The Forest Labs (FRX) injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.

Jim Cramer Makes Mistakes Too

Image by Michael McDonough via FlickrJim Cramer apologizes for his mistakes.  Jim Cramer isn't always right on his calls so just take that in mind when you watch Mad Money.  But the guy is entertaining And sometimes he is right and sometimes he is wrong.  I too didn't see this decision by the FDA happening and apologize myself but I only liked Alkermes as a trade and still think it is a buy right now.  Alkermes symbol ALKS.  Eli Lilly (LLY) also posted strong 3Q earnings and was up Friday. 

4 Rules for Trading Biotech Spec Stocks

Two stocks that Cramer recommended last Thursday, Oct. 14 got crushed this week after an expected Food & Drug Administration approval never happened.

Everyone, including the “Mad Money” host, assumed regulators would bless a new diabetes medication being made by Amylin [AMLN 11.30 -0.18 (-1.57%) ] and Alkermes [ALKS 11.07 -0.03 (-0.27%) ]. But when the FDA on Tuesday requested more data rather than approving the drug, their share prices plummeted 50 percent and 30 percent, respectively.

So where did Cramer, and even the most negative of analysts, go wrong? What lessons has he learned from this week? He broke them down into four takeaways for any investors considering a little biotech speculation going forward. Watch the video 4 Rules For Trading Biotech for his full report.

Related articles

• 4 Rules for Trading Biotech Spec Stocks - CNBC (news.google.com)
• F.D.A. Rejects New Diabetes Drug (prescriptions.blogs.nytimes.com)
• Amylin, Alkermes Once-Weekly Diabetes Drug Fails to Win FDA Approval (xconomy.com)

Down Biotechs, Equates to Foreign Investments

Between Alkermes (ALKS), Exact Sciencees (EXAS), and Human Genome Sciences (HGSI), I'm actually down a few points than I would like to admit.  But these things are typical with the times and I have investments in other foreign markets that actually balance out some of the loses. Don't panic.  Work it out, Breath. It's Ok. 

My 401K is where I keep the "safe" investments of Emerging Markets, Precious Metals, ETFs, and Funds in Southeast Asia and Latin America.  Those have handily gained close to 30% this year alone.  But my stock account does have ups and downs.  I am not too worried about it though.  Just relax and watch them return double digit gains in a few weeks. The market just fluctuates in this recession. I know that's not what you want to hear but its the truth.  It creates further opportunities to Buy and Sell.  You have to have some iron will and believe that it will be for the longer term.

The Short-Seller Who Got Amylin Right

Image via WikipediaNEW YORK (TheStreet) -- Not all investors are shocked and upset about the decision by U.S. regulators to reject Amylin Pharmaceuticals' (AMLN) diabetes drug Bydureon. Short-sellers -- investors who bet that Amylin shares would fall -- are positively giddy and making money.

Amylin shares are down $10.35, or 50%, to $10.14 in Wednesday trading.

How did the shorts get Amylin right when a majority of investors believed Bydureon was going to be approved? I spoke with one Amylin short early Wednesday about his bear thesis. This hedge fund manager asked to remain anonymous because the rules of his fund forbid him to speak publicly about his investments.

"I always believed that Amylin and Eli Lilly (LLY) were taking shortcuts to get Bydureon through the FDA" and the agency was going to have problems with this approach, said this short seller.

Alkermes Gains FDA Approval For Vivitrol, Anticipating Oct 22 Approval with Amylin Pharmaceuticals

Image via CrunchBase

Again another winning prediction from my FDA calendar for October.  Expect large gains for Alkermes tomorrow.  I wouldn't sell the stock as they have another approval up on Oct. 22nd in conjunction with Amylin and Eli Lilly for Bydureon, a weekly injectible diabetes medication.  I expect a FDA approval for that one too.  But you never know with the FDA.  Amylin already has approvals for daily injections but has modified the technology for weekly injections, so again I anticipate its approval as well.  Good news for Alkermes.

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Wikinvest---Alkermes (ALKS)
Wikinvest--Amylin Pharmaceuticals (AMLN)

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 Alkermes addiction drug wins wider U.S. approval

Tue Oct 12, 2010 7:26pm EDT

* Vivitrol already used in U.S. for alcoholics
* Approval may help turn around money-losing drug
* Shares up nearly 69 percent in 2010
* Shares up another 4.2 percent after hours

The Street's FDA Drug Approval Contest: October's FDA Calendar

Image via CrunchBase Here is Ocotber's FDA Calendar. Along with the Calendar I have put my recommendation for each stock. Some you should really be buying, like Alkermes, others you should be shorting, like Arena, Vivus, and Jazz Pharma.

The poll has 3 results:
1. Full Approval
2. Complete Response Letter (aka delayed approval or no approval)
3. No Decision (more time, the FDA has a lot of approvals in such a given short period)

Oct. 1: Hospira's(HSP) Dyloject for acute moderate to severe pain in adults. (CRL)---Big Company so no big deal, still a buy

Oct. 4: Human Genome Sciences'(HGSI) Zalbin for hepatitis C. (CRL--Lupus drug approval set for December so still a buy)

Oct. 11: Alexza Pharmaceuticals'(ALXA) AZ-004 for agitation in patients with schizophrenia or bipolar disorder. (I'm going with No Decision, short this stock, as this is their first FDA decision for the Staccato technology) Slightly leaning toward CRL but I will say No Decision as my final answer.

Oct. 11: Jazz Pharmaceuticals'(JAZZ) JZP-6 for fibromyalgia. (CRL--FDA panel killed this drug, it works but the FDA isn't approving a GHB type drug right now. Short this stock)

Oct. 12: Alkermes'(ALKS) Vivitrol for opioid addiction. (Full Approval--Jim Cramer would say Buy, Buy Buy)

Oct. 16: ISTA Pharmaceutical (ISTA) XiDay is simply aonce daily version of twice daily solution, and avoid generic competition (FDA Approval)

Oct 22: Arena Pharmaceuticals'(ARNA) lorcaserin for obesity. (No way in he##, CRL) I would recommend shorting this stock.

Oct 22: Amylin Pharmaceuticals(AMLN) (Partnered with Alkermes and Eli Lilly) Once weekly Diabetes Shot exenatide or Bydureon---This is a delay from CRL in March so I expect Full Approval this time around.

Oct 28: Vivus'(VVUS) Qnexa for obesity. (Give me a break, CRL) I don't care what data they have come up with, I would recommend Shorting this stock.

Oct 29: Avanir Pharmaceuticals'(AVNR) Zenvia for pseudobulbar affect. (I'm going to go with Full Approval although it's a toss-up)

Forest Labs(FRX) ceftaroline for Community Acquired Pneumonia. I can't find this on the FDA calendar---But I will say Full Approval even though I can't find it.

Oct 30: Biodel's(BIOD) Linjeta for diabetes. (No Decision, short this stock) Again on the fence, possible CRL.

Alkermes Gains FDA Recommendation For Vititrol

Cover of The Treatment of Opioid Dependence I expect a huge day tomorrow for Alkermes with the FDA recommendation of Vivitrol. PFUDA is Oct. 12, 2010. I expect approval with Vivotrol but you can never be sure with the FDA. Again big day tomorrow for Alkermes.

Wikinvest---Alkermes (ALKS)

Alkermes Announces FDA Advisory Committee Recommends Approval Of VIVITROL® For Opioid Dependence

Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL ^® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence. Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL ^® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

The Essential Biotech Sector Fall Preview

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Stock quotes in this article: DNDN, HGSI, GENZ, ARNA, AMLN, IDIX, PCYC

The Essential Biotech Sector Fall Preview

BOSTON (TheStreet) -- Labor Day is over and Hurricane Earl is out to sea, which means Wall Street is returning to work in earnest for the last three months of the year. To put everyone in the right mindset, I've compiled a "Back to School" guide covering the essential information biotech investors need to profit from what should be a very busy fall season.