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The Motley Fool April 3, 2007 Brian Lawler |
Merck Gets the Combo Merck gets marketing approval for a diabetes combination drug. Investors, take note. |
The Motley Fool December 19, 2007 Brian Lawler |
Novartis' Diabetes Battle Can Begin Novartis gets set to market a novel diabetes treatment, with EU approval that is not all it had hoped for. |
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 |
Merck Raises the Earnings Roof Shares of Merck soar after it raises 2007 earnings guidance. |
The Motley Fool April 4, 2007 Brian Lawler |
Novartis Gets Nicked Novartis pulls one of its top-selling drugs from the market. Investors should come to expect drug delays or similar issues popping up from time to time when doing their analysis of large pharmas. |
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 December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
The Motley Fool November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. |
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 February 28, 2007 Brian Lawler |
Merck's Mighty Future Merck ups its 2007 financial forecast, while positive developments occur for two of its most promising new therapies. |
The Motley Fool June 22, 2007 Brian Lawler |
Novartis' Good Week The pharma receives a pair of positive regulatory decisions. Investors, take note. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool January 22, 2007 Brian Lawler |
Another Busy Year in Store for Novartis Trying to place a value on Novartis is a tough thing to do now with so many important drugs awaiting regulatory review and its addiction to acquisitions and divestitures making financial comparisons between the years tough. |
The Motley Fool June 12, 2007 Brian Lawler |
Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg. |
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 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. |
Pharmaceutical Executive December 1, 2006 |
Thoughtleader: Thomas Ebeling, Novartis The Next Big Thing: An interview with the pharma's CEO, who has witnessed tremendous financial and scientific growth at the company and is on the brink of his next major milestone. |
The Motley Fool October 5, 2010 Brian Orelli |
You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure. |
The Motley Fool December 28, 2010 Brian Orelli |
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. |
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 March 3, 2011 Brian Orelli |
3 Cheers for an FDA Rejection German drugmaker Merck said that the Food and Drug Administration had turned down its multiple sclerosis drug cladribine. The pill would have competed with Novartis' Gilenya, which gained FDA approval last year. |
The Motley Fool February 28, 2007 Brian Lawler |
Discovery Prepares for Its Fate Discovery Labs announces its quarterly financial results as it prepares for another meeting with the FDA. Investors, take note. |
The Motley Fool July 7, 2010 Dave Mock |
A Big Upgrade for Novartis This bullish call comes from more than just one analyst. |
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 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 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 December 24, 2009 Brian Orelli |
Another Reason to Worry About Pfizer The FDA fails to approve Lyrica for treating anxiety. |
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 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 November 3, 2009 Brian Orelli |
A Little Distracted, Are You, Merck? The FDA rejects its latest application. |
The Motley Fool June 18, 2010 Brian Orelli |
Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday. |
The Motley Fool November 8, 2007 Charly Travers |
BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent. |
The Motley Fool September 19, 2008 Brian Lawler |
FDA Tells Gilead to Take 1 More Step There's a small consolation prize for Gilead Sciences in this rejection from the FDA. |
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 April 13, 2011 Brian Orelli |
Drug Duo Escapes Advisory Panel Unharmed Pfizer and Novartis are on their way to expanding their cancer drug indications. |
The Motley Fool December 18, 2007 Brian Lawler |
Cervarix Won't Save Glaxo Yet The FDA has another delay for this HPV vaccine. The agency has completed its review, but still has questions. |
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 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 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 May 4, 2006 Stephen D. Simpson |
AstraZeneca Snuffs Out Galida Will any of the new dual-PPAR drugs make it to the market? Here's another good reminder for pharmaceutical and biotech investors that you shouldn't count your chickens until the FDA has let them hatch. |
The Motley Fool February 3, 2010 Brian Orelli |
Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease. |
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 August 27, 2010 Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. |
The Motley Fool April 3, 2007 Brian Lawler |
Dendreon's Positive Panel Surprise Shares of the drugmaker jump after a FDA advisory panel finds in favor of its lead cancer compound. |
The Motley Fool October 30, 2007 Billy Fisher |
Is Forest Labs' Nebivolol Ready for Prime Time? Shareholders of the pharmaceutical company have been looking for a way to boost their floundering stock. The FDA's likely approval of hypertension drug Nebivolol may be the answer. |
The Motley Fool July 8, 2008 Brian Lawler |
Blockbuster Drugs Bound for Extinction? One of the biggest classes of prescription drugs, those for diabetes treatments, faces tougher FDA standards. |
The Motley Fool February 22, 2011 Brian Orelli |
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. |
Pharmaceutical Executive March 1, 2013 Ben Comer |
Brand of the Year: Januvia When Merck's Januvia received its first regulatory approval, in Mexico in 2006, no one predicted its long-term success. In 2012, the company's diabetes franchise became the highest-selling product family in Merck's 122-year history. |
The Motley Fool June 11, 2010 Brian Orelli |
25 to 0! Now That's a Ringing Endorsement Novartis flies through its advisory panel meeting nearly unscathed. |