With the recent FDA delay, what's the deal with Sarepta Therapeutics. Seems like a sure thing but then why would the FDA delay their decision and request more data.
A good look at their clinical trail is in the WSJ this week. Where's the drug FDA?
The Food and Drug Administration is sitting on a therapy for Duchenne muscular dystrophy, and the agency may have days to waste but the boys don’t. Bureaucratic malpractice on a safe and effective treatment is corroding the agency’s scientific credibility and the public’s trust.
FDA in May delayed a decision on eteplirsen by Boston-based Sarepta Therapeutics. There is no treatment for Duchenne, a fatal disease that claims a boy’s ability to walk before organ failure in his 20s. Eteplirsen jumps over genetic code to produce a missing protein known as dystrophin.
Read more at WSJ(FYI, if you google the link title you can get around their purchase options sometimes)
A look at their stock profile: $SRPT
I have enjoyed CNBC Meg Terrill's Look at Biopharma lately as well with the upcoming elections and terrible year that Biotech has been having.
Check out more videos of Meg here. http://www.cnbc.com/meg-tirrell/
Showing posts with label Biotech. Show all posts
Showing posts with label Biotech. Show all posts
8/27/15
Biopharma Investor Further Development - Stock Trading
So it's been a minute. The principles of the Bio Pharmaceuticals of Stock investments still runs true today. I plan on continuing with the Biopharma process and provide more Data Analytical approach with Financial Data in Biotech and Pharmaceuticals. I went back to school for computer programming and data analysis and now work for a healthcare company in finance. Can't wait to provide better data analysis and web development on this website. And thankfully have enough time to work on it now.
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| Singapore Investing |
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| Protein and DNA technologies |
7/26/13
4 Best Biopharma Stock Trades 2013
Below are some of the best trades in the Biopharma Stock Sector since January 2013. I have gathered my research from a pretty good stock investment forum, 4-Trader. It's all free. I would never ask you to pay for anything on my site. No catches, no gimmicks.
If you want to search for other Sectors or other Countries, you can check them out here:
If you want to search for other Sectors or other Countries, you can check them out here:
4-Trader.com Stock Sector Research
4-Trader.com Healthcare Sector: Biotech and Pharmaceutical
These are highly potential breakout stocks that I have researched and just posting their results and how to learn more about these Top Stocks in the Healthcare Sector. More Specifically Biotech and Pharmaceutical Stocks that I predict will be doing very well in the next year with the stock market doing well and the Obamacare being implemented in 2014. There were a lot to choose from so I pick the best ones that I thought had potential for further gains.Make Money Off Obamacare
As bad as Obamacare is for business, I think it will improve the Healthcare Sector in the upcoming year and these are all good stocks that I would recommend. But you can perform your own due diligence yourself, this are the ones that stuck out to me.Top 4 Biopharma Trades
These are the all the best trades since January, most are above 50% in stock share growth. Most have higher potentials for further earnings. These are my own personal 4 picks that I thought were the best of the bunch.Santarus Inc. (SNTS)
10/14/10
Blockbuster FDA Decisions In The Next Few Months--FDA Calendar Predictions
FDA's Upcoming Blockbuster Drug Decisions for Q4 2010
October 11, 2010
Again I am predicting the upcoming FDA Calendar for the next upcoming months for the Fourth Quarter. This is just an initial walkthrough of all the upcoming decisions. Lets see how well I do. I am doing pretty well from October's FDA calendar.
The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.
In every case, BioPharma Investor has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.
The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.
I have to do some more research on my Approval Decisions---Here is an preliminary list of FDA Approvals coming in the 4th Quarter of 2010. This is just an estimated guess off the top of my head. Some are toss-ups. The FDA is leaning more on the Complete Response Letter side which isn't necesarily a death sentence as why the drug was not approved and how it might be possible to get approval. Usually, it requires more Clinical Trials when a company receives a CRL from the FDA.
If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions. Biopharma Investor
FDA Calendar Predictions
October 11, 2010
Again I am predicting the upcoming FDA Calendar for the next upcoming months for the Fourth Quarter. This is just an initial walkthrough of all the upcoming decisions. Lets see how well I do. I am doing pretty well from October's FDA calendar.
The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.
In every case, BioPharma Investor has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.
The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.
I have to do some more research on my Approval Decisions---Here is an preliminary list of FDA Approvals coming in the 4th Quarter of 2010. This is just an estimated guess off the top of my head. Some are toss-ups. The FDA is leaning more on the Complete Response Letter side which isn't necesarily a death sentence as why the drug was not approved and how it might be possible to get approval. Usually, it requires more Clinical Trials when a company receives a CRL from the FDA.
If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions. Biopharma Investor
FDA Calendar Predictions
Talecris Gains FDA approval for Gamunex-C
Image via TalecrisBeing 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
If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions. Biopharma Investor
See more news releases in: Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, New Products & Services, FDA Approval
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).
9/7/10
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Help keep this site bring everyone up to date BioPharma News for Free. Any donations made help keep this site free. It only takes a second. Thanks For Your Continued Support. Again thank you as I am entering my Second Year of providing BioPharma Stock updates and advice.
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