Talecris Gains FDA approval for Gamunex-C

Image via Talecris

Being a former employee of Talecris I am familiar with the IGIV Gammunex program.  This is good news for Talecris (TLCR) as it gains Patent Protection approval for providing viral free blood products to those with ImmunoDeficiency.  Those with Immuno Deficiency desperately need Talecris' Life Saving BioPharmaceuticals to its patients.  It is a very rewarding job to know that the product you are making is actually saving lives. 

Would You Actually Take This Medication If You Had To?  That is an important question for a company to ask it's employees.  Some places you might not actually do so.  That is how bad some companies can get.  Talecris is not one of them.  They have sophisticated GMP sterile fill lines that have extensive quality controls of their product.  I should know, I tested the samples day in and day out.  It was a clean, sterile facility designed with Sterilty in mind.

Gamunex is a production is a Bayer Biological Designed facility and Talecris is venture capitalized  after being acquired from Bayer. 

Talecris---Wikinvest

Talecris does have some of long term debt but that will be reduced after this announcement.
They are a takeover target with this approval in my mind.  They did not merge with their Australian counterpart a year ago due to fears of monopolizing the drug market

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Talecris Biotherapeutics Receives FDA Approval for Gamunex®-C

New Subcutaneous Administration Provides another Mode of Delivery For Patients with Primary Immunodeficiency

RESEARCH TRIANGLE PARK , N.C., Oct. 14 /PRNewswire

Talecris Biotherapeutics (Nasdaq: TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex®-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

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

Red Hot Somaxon gets even hotter with Proctor & Gamble deal

Image via Wikipedia Red Hot Somaxon Pharmaceuticals is up heavily in trading today. The stock has done extremely well this year and will probably do even better after this deal was made today. Somaxon Pharmaceuticals (SOMX) is trading at 4.34 up 0.97 a 28.78% gain. Earlier today it reached a high of 5.43 before a strong selloff. The stock has been in a heavy downslide trend following it's March FDA approval. Look for things to get a little better after today with increased sales for insomnia medication Silenor

Vivus Inc.'s FDA Review Of Weight Loss Drug Qnexa could Hint At Future Approval For Arena And Orexigen

Tomorrow is a big day for Vivus, Inc. and stock VVUS. Vivus is preparing tomorrow for the FDA's Endocrinologic and Metabolic Drugs Advisory Committee review panel on the weight loss drug Qnexa. I wrote an article on this subject last year based on their Phase III clinical trial results titled Vivus's Qnexa Drug Approval Makes It a Nice Trade, and was impressed with the long-term growth potential in the $40B weight loss industry.

FDA approve's Dendreon's Provenge

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Here's Dendreon's newswire on it's approval of Provenge. Stock hit an all time high of 57.55 and has tapered off a bit around the 53 point range. This is a quality stock and it's profits should help the bottom line with this big news on April 29th, 2010.

SEATTLE, April 29, 2010 /PRNewswire via COMTEX/ --Dendreon Corporation (Nasdaq: DNDN ) today announced that the U.S. Food and Drug Administration (FDA) has approved PROVENGE(R)
(sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class known as autologous cellular immunotherapies.