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The Motley Fool
August 17, 2007
Brian Orelli
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully. mark for My Articles similar articles
The Motley Fool
September 5, 2006
Brian Lawler
Neurocrine Wakes Up Indiplon The biotech company announces new drug delays. Investors, take note. mark for My Articles similar articles
The Motley Fool
February 16, 2010
Brian Orelli
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. mark for My Articles similar articles
The Motley Fool
July 18, 2006
Brian Lawler
Neurocrine's Tale of Woe After a couple of tough months, Neurocrine released its second-quarter results. This may be a great stock to own -- if you have the stomach to tolerate the risk. mark for My Articles similar articles
The Motley Fool
December 14, 2007
Brian Lawler
FDA Knocks Neurocrine a Knuckle Sandwich The FDA clobbers drugmaker Neurocrine with another delay. mark for My Articles similar articles
The Motley Fool
June 15, 2007
Brian Lawler
Neurocrine Moves Ahead Neurocrine resubmits a marketing application for its lead drug. Investors, take note. mark for My Articles similar articles
The Motley Fool
September 24, 2007
Brian Lawler
Encysive Hears the Voice of Reason To please the FDA, Encysive Pharmaceuticals announces it is planning an additional phase 3 trial to try and bring its lead drug, Thelin, to market in the United States. mark for My Articles similar articles
The Motley Fool
June 15, 2007
Brian Lawler
Encysive's Date With Destiny Approaches A decision on the specialty drugmaker's lead drug is imminent. Betting against the FDA is generally not a good idea for investors. Here are statements from Encysive's past press releases about Thelin mark for My Articles similar articles
The Motley Fool
January 24, 2007
Brian Lawler
Neurocrine in the Green 2006 wasn't kind to the drug developer, but whatever happens with indiplon, Neurocrine's management deserves kudos for keeping investors well informed on the status of the drug and where the company stands as far as timelines go. mark for My Articles similar articles
The Motley Fool
August 12, 2008
Brian Lawler
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? mark for My Articles similar articles
The Motley Fool
June 18, 2007
Brian Lawler
The Third Time Isn't the Charm for Encysive The approvable letter for the pulmonary arterial hypertension treatment marks the third time Thelin has failed to get full approval from the FDA. Investors, take note. mark for My Articles similar articles
The Motley Fool
November 6, 2006
Brian Lawler
Neurocrine's Big Headache Another clinical trial means a steep drop in share price, but the biopharmaceutical's not dead yet. Investors, take note. mark for My Articles similar articles
The Motley Fool
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
The Motley Fool
February 6, 2008
Brian Lawler
Neurocrine on the Upswing? Neurocrine Bioscience releases year-end numbers, and updates investors on the status of its top drugs. mark for My Articles similar articles
The Motley Fool
June 21, 2007
Brian Lawler
Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note. mark for My Articles similar articles
The Motley Fool
April 17, 2007
Brian Lawler
Neurochem Must Wait The FDA delays a regulatory decision on Neurochem's lead compound. Investors, take note. mark for My Articles similar articles
The Motley Fool
July 18, 2007
Brian Lawler
More Misery for Neurochem It's hard to find another drug developer that has mishandled its correspondence with investors about its drug candidates as badly as Neurochem has over the past year. mark for My Articles similar articles
The Motley Fool
December 11, 2006
Brian Lawler
Another Go for Encysive Drug Trials Sometimes shares of small specialty-pharma stocks rise and fall much more than warranted on every piece of news, and this appears to have happened to Encysive Pharmaceuticals. mark for My Articles similar articles
The Motley Fool
November 14, 2007
Brian Lawler
Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years. mark for My Articles similar articles
The Motley Fool
September 6, 2007
Brian Lawler
Encysive, Please Stop Its failure to acquiesce to the FDA's request means the competition is going forward as this drugmaker's product stays stagnant. Investors, take note. mark for My Articles similar articles
The Motley Fool
September 26, 2007
Brian Lawler
Following the Fallen Biotech Class of 2006 Let's take a look a list of the biggest development stage drugmaker disasters from 2006 and how the tiny drug developers have fared since they announced their clinical trial or regulatory failures. mark for My Articles similar articles
The Motley Fool
December 22, 2003
Alyce Lomax
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. mark for My Articles similar articles
The Motley Fool
October 3, 2007
Brian Lawler
FDA Says Nay to Endo Endo Pharmaceuticals announces that the FDA issued a "not approvable" letter in response to the company's attempt to expand the label for migraine treatment Frova. mark for My Articles similar articles
The Motley Fool
December 10, 2007
Brian Lawler
Neurochem's Sure Bet at Failure Investors should add another regulatory date to their biotech calendars, this one regarding Neurochem's lead drug, KIACTA. mark for My Articles similar articles
The Motley Fool
January 31, 2011
Brian Orelli
5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list. mark for My Articles similar articles
The Motley Fool
December 15, 2006
Brian Lawler
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. mark for My Articles similar articles
The Motley Fool
December 29, 2006
Brian Lawler
Third Time's the Charm for Encysive? It seems like every other week we hear about a new delay for Encysive's lead drug Thelin. With shares of Encysive down more than 20% yesterday, investors can only hope that the third time is the charm for Thelin's approval from the FDA. mark for My Articles similar articles
The Motley Fool
March 3, 2009
Brian Orelli
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals. mark for My Articles similar articles
The Motley Fool
May 30, 2008
Brian Orelli
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil. mark for My Articles similar articles
The Motley Fool
March 8, 2010
Brian Orelli
Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting. mark for My Articles similar articles
The Motley Fool
October 8, 2007
Brian Orelli
Pozen Submits Safety Data Will Pozen's response to its second approvable letter be enough? Investors may want to take this with a grain of salt. mark for My Articles similar articles
The Motley Fool
April 2, 2007
Brian Lawler
FDA Keeps Cephalon Waiting The FDA issues Cephalon an approvable letter for one of its drugs. Investors, take note. mark for My Articles similar articles
The Motley Fool
September 9, 2010
Brian Orelli
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. mark for My Articles similar articles
The Motley Fool
August 27, 2010
Brian Orelli
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. mark for My Articles similar articles
The Motley Fool
May 9, 2007
Brian Lawler
Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note. mark for My Articles similar articles
The Motley Fool
July 25, 2006
Brian Lawler
Strike Two for Encysive The FDA still won't quite give Thelin a thumbs-up. For now, Encysive investors can only sit and wait. mark for My Articles similar articles
The Motley Fool
April 29, 2008
Brian Orelli
Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month. mark for My Articles similar articles
The Motley Fool
January 28, 2011
Brian Orelli
Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result. mark for My Articles similar articles
The Motley Fool
November 8, 2006
Brian Lawler
Stumbling Block for Adolor Another approvable letter from the FDA means investors may have to be patient. mark for My Articles similar articles
The Motley Fool
April 2, 2008
Brian Lawler
Following the Drugmaker Formerly Known as Neurochem Neurochem would have been set to hear FDA news on its lead drug candidate Kiacta today, if they had not pulled their marketing application earlier this month. mark for My Articles similar articles
The Motley Fool
January 21, 2009
Brian Orelli
Pharma Foe Speaks Up for Investors Some good ideas for President Obama's new Food and Drug Administration chief that would benefit investors in drug companies. mark for My Articles similar articles
The Motley Fool
August 1, 2007
Brian Lawler
Neurocrine Awaits Its Destiny Neurocrine Biosciences updates investors on its plans for the rest of the year. A new marketing application was submitted for lead drug indiplon, following a negative FDA decision last year. Good news could come as soon as December 2007. mark for My Articles similar articles
The Motley Fool
January 14, 2008
Brian Lawler
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure. mark for My Articles similar articles
The Motley Fool
July 28, 2010
Jordan DiPietro
3 Biotechs on Your Radar Screen It's not easy keeping track of all the drugs coming in and out of the development pipeline, but if you can stay up to date, you often have an advantage mark for My Articles similar articles
The Motley Fool
December 3, 2007
Brian Orelli
Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol. mark for My Articles similar articles
The Motley Fool
October 5, 2011
Brian Orelli
1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response. mark for My Articles similar articles
The Motley Fool
September 17, 2010
Luke Timmerman
Cell Therapeutics OK'd to Sell Shares to Stay Alive Is the company being straight with shareholders? mark for My Articles similar articles
The Motley Fool
January 31, 2008
Brian Lawler
Prioritizing Millennium The FDA grants a speedy review for Millennium Pharmaceuticals's lead multiple myeloma drug. mark for My Articles similar articles
The Motley Fool
June 3, 2011
Brian Orelli
FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully. mark for My Articles similar articles
The Motley Fool
July 19, 2007
Brian Lawler
Will Encysive's FDA Challenge Fail? The pharmaceutical gets set for a showdown with the FDA. Investors should think long and hard about whether shares of Encysive are worth holding, considering that the likely result of this dispute resolution process won't be positive. mark for My Articles similar articles