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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 April 2, 2009 Brian Orelli |
A Diabetic Compromise Bristol-Myers and AstraZeneca will have to test their drug after it goes on the market. |
The Motley Fool July 9, 2010 Brian Orelli |
2 Days, 1 Blockbuster, Fate Unknown GlaxoSmithKline heads before a marathon two-day Food and Drug Administration advisory panel review of its diabetes drug Avandia. |
The Motley Fool June 29, 2010 Brian Orelli |
Diabetes Drug Development Pops and Drops When companies present at a major meeting, there's bound to be both. |
The Motley Fool July 30, 2007 Brian Lawler |
Is Glaxo's Avandia Down for the Count? An FDA advisory committee is set to debate one of Glaxo's top compounds. What will it mean to investors? |
Chemistry World September 24, 2010 Andrew Turley |
End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use. |
Chemistry World July 16, 2010 Matt Wilkinson |
Bittersweet victory for GSK's Avandia GlaxoSmithKline has received a muted 'thumbs up' from a US regulatory advisory panel for its much-maligned Type 2 diabetes drug Avandia (rosiglitazone), making it likely the US Food and Drug Administration will allow the UK-based pharma giant to continue selling the drug in the US. |
The Motley Fool September 30, 2008 Brian Lawler |
Novo Nordisk Takes On All Comers Its diabetes franchise is about to get bigger. |
The Motley Fool February 20, 2009 Brian Orelli |
The Skinny on Diabetes Drugs The goal of diabetes drugs is to get the patient's blood glucose levels under control, but one class of drugs, called GLP1 agonists, have a nice side effect: weight loss. Which pharma companies can benefit? |
The Motley Fool June 26, 2009 Brian Orelli |
Looking for a Sliver of the Me-Too Pie Another diabetes drug is close to hitting the market. |
The Motley Fool April 13, 2009 Brian Orelli |
Will These Drugs Get Past the FDA? Hopefully April won't bring showers of tears to these drugmakers: Eli Lilly... AstraZeneca... Bristol-Myers Squibb... Novo Nordisk... Johnson & Johnson... |
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 15, 2006 Brian Lawler |
Glaxo's Burgeoning Blockbuster With a deep drug pipeline filled with potential blockbusters for nearly every major disease, and an attractive 3% dividend yield, Glaxo makes a fine investment opportunity for investors willing to brave the pharmaceutical sector. |
The Motley Fool November 24, 2010 Brian Orelli |
Profit From the United States of Diabetes Half the country could have an early form by 2020. |
The Motley Fool February 22, 2010 Brian Orelli |
Warning: Avandia Could Cause Drool Among Trial Lawyers An unintended side effect of Glaxo's Avandia might be excessive salivation among trial lawyers. A 342-page report by the Senate Finance Committee is painting the diabetes drug in a not-so-great light. |
The Motley Fool July 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
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 29, 2010 Brian Orelli |
This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either. |
The Motley Fool April 16, 2010 Brian Orelli |
It'll Be a Blockbuster! High Fives All Around, Right? Sanofi-aventis releases top-line data for its phase 3 diabetes drug candidate, lixisenatide. The trial was a success, but don't pencil it in as a blockbuster just yet. |
The Motley Fool June 30, 2011 David Williamson |
Biotech Takes On the Next Big Problem The news coming out of this week's annual conference of the American Diabetes Association wasn't good. |
The Motley Fool June 9, 2008 Brian Lawler |
Novo Nordisk's Daring Success Novo Nordisk's potential blockbuster compound excels in late-stage head-to-head testing. Investors, take note. |
The Motley Fool February 12, 2010 Brian Orelli |
Don't Ignore This Potential Blockbuster Five trials later, Roche's diabetes drug taspoglutide seems like a winner. |
The Motley Fool January 28, 2011 Brian Orelli |
Looking Ahead at Bristol-Myers Product approvals now will help with the upcoming patent cliff. |
The Motley Fool June 27, 2008 Brian Lawler |
This Drug Market Is Booming One therapeutic category seems to be expanding significantly faster than most of its peers, the one that helps the unfortunately burgeoning number of diabetics in the U.S. and worldwide. |
The Motley Fool October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
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 March 5, 2008 Brian Orelli |
FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs. |
The Motley Fool June 23, 2010 Brian Orelli |
Duo of Diabetes Drug Deals Make J&J Better Licensing deals add to Johnson & Johnson's diabetes franchise. |
The Motley Fool January 7, 2010 Brian Orelli |
Warning: Potential Anemic Growth Ahead Anemia-drug makers get more scrutiny from the FDA. |
The Motley Fool June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
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 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 July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
The Motley Fool July 31, 2007 Brian Lawler |
Avandia Can Stay An FDA advisory panel votes to allow GlaxoSmithKline's top diabetes compound, Avandia, to remain on the market. |
The Motley Fool March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool April 11, 2011 Brian Orelli |
A Double Dose of Trouble for Big Pharma? Pfizer's Sutent and Novartis's Afinitor head in front of an FDA advisory panel. |
The Motley Fool December 31, 2007 Brian Lawler |
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency. |
The Motley Fool March 16, 2010 Brian Orelli |
How to Lose $114 Million in One Day You've got to be a very trusting investor to buy shares in pharmaceutical company, MannKind. |
The Motley Fool November 29, 2011 Brian Orelli |
Winners and Losers of Roche's Avastin Woes What the FDA giveth, the FDA can taketh away. |
The Motley Fool September 30, 2011 Brian Orelli |
A Drug Market That's 366 Million Strong Diabetes drugs have potential. |
The Motley Fool June 18, 2010 Brian Orelli |
Hot Dog! No Competition for Now Roche's diabetes pipeline drug is delayed. |
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 November 16, 2007 Brian Lawler |
Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx. |
The Motley Fool June 25, 2010 Brian Orelli |
Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review. |
The Motley Fool September 20, 2010 Brian Orelli |
Potential Blockbuster, No Me-Too About It A diabetes-fighting duo do it right this time. |
The Motley Fool September 2, 2010 Luke Timmerman |
Orexigen Nabs $1B Deal With Takeda to Market Obesity Drug, Shares Climb San Diego-based Orexigen Therapeutics has found a partner to help it compete in the growing market for drugs to combat obesity, Japan-based Takeda Pharmaceutical. |
The Motley Fool January 28, 2010 Brian Orelli |
How to Make a Billion Bucks in Biotech Drug companies and investors alike have to balance the risk and reward. |
The Motley Fool April 25, 2011 Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it? |
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 September 9, 2008 Brian Orelli |
Drug Duo Combines Its Way Toward an Approval Bristol-Myers and AstraZeneca are trying to get their diabetes drug approved as a combination treatment. |