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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. |
The Motley Fool September 5, 2006 Brian Lawler |
Neurocrine Wakes Up Indiplon The biotech company announces new drug delays. Investors, take note. |
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. |
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. |
The Motley Fool December 14, 2007 Brian Lawler |
FDA Knocks Neurocrine a Knuckle Sandwich The FDA clobbers drugmaker Neurocrine with another delay. |
The Motley Fool June 15, 2007 Brian Lawler |
Neurocrine Moves Ahead Neurocrine resubmits a marketing application for its lead drug. Investors, take note. |
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. |
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 |
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. |
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? |
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. |
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. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
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. |
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. |
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. |
The Motley Fool December 15, 2006 Brian Lawler |
Reformatting Encysive Yet another delay from the FDA leaves investors hanging. |
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. |
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. |
The Motley Fool May 30, 2008 Brian Orelli |
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil. |
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. |
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. |
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. |
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. |
The Motley Fool August 27, 2010 Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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 |
The Motley Fool December 3, 2007 Brian Orelli |
Nebivolol's Almost Approvable Letter Forest and Mylan get an approvable letter for Nebivolol. |
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. |
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? |
The Motley Fool January 31, 2008 Brian Lawler |
Prioritizing Millennium The FDA grants a speedy review for Millennium Pharmaceuticals's lead multiple myeloma drug. |
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. |
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. |