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The Ultimate Pharmaceutical Watchlist (FDA Approvals, news and Alerts)

post #1 of 788
Thread Starter 
Hello Everyone,

Recently, we've seen many pharmaceutical companies see huge gains on rumors and news of FDA approvals, clinical trials and successful phases. Many times, these are small never heard of companies where the PR is released usually after the rumor or the FDA approval and we end up missing the ride to the top.

This thread will bring an end to this madness. With your contribution, I will keep a list on this thread with the pharmaceutical companies that are due to hear back from the FDA on a certain date regarding a certain drug. Please post your findings and let’s keep this thread for that purpose only. We'll discuss the actual companies in their given threads.

Submission Rules: Please post below the company name, symbol, date due, information about the drug and what sort of news are we to expect. I will then update this list below and credit you with the finding. Also, it would be helpful to provide a link to the drug information and a link to the PR where they announce an FDA target date.

List as of Feb. 6, 2009 - List will be updated daily with the companies with the earliest target date listed first.

-- List removed to be updated --

Quote:
FDA process and timeline:


Detailed process: More here

How is a medicine approved by FDA?
Drug companies seeking approval to sell a drug in the United States must test it. First, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in humans is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. The company then sends FDA's Center for Drug Evaluation and Research (CDER) the data from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

Over-the-counter (OTC) drugs are regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System."

More on the process..
FDA estimates that it takes approximately eight-and-a-half years to study and test a new drug before it can be approved for the general public. This estimate includes early laboratory and animal testing, as well as later clinical trials using human subjects.

There is no standard route through which drugs are developed. A pharmaceutical company may decide to develop a new drug aimed at a specific disease or medical condition. Sometimes, scientists choose to pursue an interesting or promising line of research. In other cases, new findings from university, government, or other laboratories may point the way for drug companies to follow with their own research.

New drug research starts with an understanding of how the body functions, both normally and abnormally, at its most basic levels. The questions raised by this research help determine a concept of how a drug might be used to prevent, cure, or treat a disease or medical condition. This provides the researcher with a target. Sometimes, scientists find the right compound quickly, but usually hundreds or thousands must be screened. In a series of test tube experiments called assays, compounds are added one at a time to enzymes, cell cultures, or cellular substances grown in a laboratory. The goal is to find which additions show some effect. This process may require testing hundreds of compounds since some may not work, but will indicate ways of changing the compound's chemical structure to improve its performance.

More information: FDA Website
Important Disclaimer: Although many of these companies see a huge spike in their stock price days to weeks in advance of any FDA news, do keep in mind one of the most important rules in investing: Buy on the rumor, sell on the news. The list above is only an FYI of which companies are receiving approvals of their drugs from the FDA. This is by no means a recommendation to BUY or SELL, this is only a small step to help you, the investor, in better decision making. Always do your on Due Diligence when investing. Also take into consideration that the FDA sometimes occasionally DOES give an approval or dissaproval before the said date.
post #2 of 788

The Pharmaceutical Stock List

The Pharmaceutical Stock List

ACUR ADLR ALO ALTH ANPI ARIA BCRX BMY BVF CBST CEPH CHTT CLGY.PK CLPA CNDO CNTBY COB CTAL DRAX DRMD DSCO DURA ELI ELN EMIS ETOP.PK FLML FRX GSK HEPH HITK IFLI.OB IG ISPH ISV ISTA IVX JNJ KG KVA KVB LJPC LLY MACM.OB MDCO MRK MRNA MRX MYL NEOL NEXM NKTR NOVN NPSP NTEC NTMD NVGN NVO NVS NXXI PARS PFE POLXF.OB PPCO PRGO PRX PTIE QGLY QLTI SCLN SEPR SGP SHPGY SKYPY.PK SPPI SUPG TAROF.PK TEVA UG VRX WPI WYE ZILA

ACUR through ZILA

The Pharmaceutical Index Stock List

^DRG ABT AMGN AZN BMY FRX GSK JNJ KG LLY MRK PFE SGP WYE

IBD Medical - Drugs/Diversified

ABT BMY JNJ KG WYE

Medical - Ethical Drugs


ALTH AMRN ANPI ARRY AZN BVF CBRX CLPA CTIC CVTX DUSA ELN ENDP FRX GSK ICN IMGN ISPH LJPC LLY MATK MACM.OB MRK MRX NKTR NOVN NTEC NVS PCYC PFE POZN PPCO QLTI RIGL SGP SHPGY SKYPY.PK SLXP SPPI TGX UTHR VPHM VRX

Medical - Generic Drugs

ALO MYL PRX PTIE TARO.PK TEVA WPI

Medical - Wholesale Drugs

ABC CAH ESRX MCK OMI

Let me search for more news
SEARCH YAHOO NEWS
post #3 of 788
post #4 of 788
Thread Starter 
I understand there are many charts and excel sheets out there with this information, however, this thread will be the HSM list, something by HSM members for HSM members. The list you posted will only have some 5-10 winners maybe.. this list we're working on is after DD.
post #5 of 788
u should take into consideration that the FDA sometimes occasionally DOES give an approval or dissaproval before the said date.
post #6 of 788
Quote:
Originally Posted by Stawkryda88 View Post
u should take into consideration that the FDA sometimes occasionally DOES give an approval or dissaproval before the said date.
Yes see EPIX about 8 days early.
post #7 of 788
Quote:
Originally Posted by Stawkryda88 View Post
u should take into consideration that the FDA sometimes occasionally DOES give an approval or dissaproval before the said date.
x 2

word indeed
post #8 of 788
Quote:
Originally Posted by jbreaux View Post
Yes see EPIX about 8 days early.
a week earlier than expected, it was ridiculously crazy for daytrading
post #9 of 788
On that link above, SVNT released news today about being accepted. SVNT shot up 8% in afterhours today. This is not the news you want just yet. SVNT needs to be added to that list for Apr 30, 2009
post #10 of 788
Quote:
Originally Posted by Norlan View Post
a week earlier than expected, it was ridiculously crazy for daytrading
and I totally missed out by waiting. I am getting in 2 weeks or so earlier so as not to miss the pops.
post #11 of 788
Quote:
Originally Posted by DayTrader View Post

This should make my thread obselite, lol.
Nope...should just make your spelling obsolete...
post #12 of 788
Great idea for a thread
I've been watching mainly pharmaceuticals as of late and 2009 looks to be a promising year for this industry
post #13 of 788
BTW, are you going to keep updating the first post with new material/picks? Or just post new findings in the most recent post?

Just so that we're all on the same page ...so to speak...LOL
post #14 of 788
Thread Starter 
lol, shut it..

I never knew that list existed.. How can we make better use of this thread? should we make it just a nonofficial watch list for all pharmas?
post #15 of 788
Quote:
Originally Posted by DayTrader View Post
lol, shut it..

I never knew that list existed.. How can we make better use of this thread? should we make it just a nonofficial watch list for all pharmas?
That blog is for it's followers, this thread will be for HSM followers. Many, including myself, would prefer not to leave this forum unless necessary. If you keep updating in tandem with that "other" blog, then I'll have no reason to look any further
post #16 of 788
Thread Starter 
alright, lets make it "our thread".

Lets start posting..
post #17 of 788
Thread Starter 
This thread will be the HSM list, something by HSM members for HSM members. The list previously posted will only have some 5-10 winners maybe.. this list we're working on is after member's DD and findings..
post #18 of 788
APPY, 1-3 weeks

CASTLE ROCK, CO -- (MARKET WIRE) -- 12/10/2008 -- AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported its FDA 510(k) clinical trial for AppyScore™, the world's first blood-based diagnostic test for human appendicitis, has reached the 800 patient (study "subjects") target and thereby has officially concluded enrollment in the study.


http://www.easyir.com/easyir/prssrel...ve&prid=459395
post #19 of 788
Thread Starter 
Quote:
Originally Posted by Stawkryda88 View Post
u should take into consideration that the FDA sometimes occasionally DOES give an approval or dissaproval before the said date.
added to the disclaimer
post #20 of 788
Thread Starter 
Quote:
Originally Posted by Malicious View Post
APPY, 1-3 weeks

CASTLE ROCK, CO -- (MARKET WIRE) -- 12/10/2008 -- AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, reported its FDA 510(k) clinical trial for AppyScore™, the world's first blood-based diagnostic test for human appendicitis, has reached the 800 patient (study "subjects") target and thereby has officially concluded enrollment in the study.


http://www.easyir.com/easyir/prssrel...ve&prid=459395

This company will be releasing results of a clinical study, not fda approval.. Do you have any FDA dates?
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