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The Motley Fool December 17, 2010 Brian Orelli |
An Overnight Double: Santa Visits InterMune in Europe The Committee for Medicinal Products for Human Use issued a positive recommendation for the approval of InterMune's idiopathic pulmonary fibrosis treatment, Esbriet, sending shares up 140%. |
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 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 December 19, 2008 Brian Orelli |
Eli Lilly's Good News Misses the Mark EU approval of its blood thinner is nice, but U.S. approval is what will really matter. |
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 July 16, 2009 Brian Orelli |
Keep Your Chin Up, J&J An FDA advisory committee smacked down its drug candidate. |
The Motley Fool December 10, 2008 Brian Orelli |
A Painless Advisory Panel Meeting Genzyme might be getting a Christmas present from the Food and Drug Administration. An FDA advisory panel unanimously recommended approval for Genzyme's osteoarthritis pain drug Synvisc-One. |
The Motley Fool August 21, 2008 Brian Orelli |
Johnson & Johnson Gets Rejected The FDA rejects Johnson & Johnson's bid to expand the label of its antibiotic. |
The Motley Fool February 4, 2009 Brian Orelli |
Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval. |
The Motley Fool December 11, 2009 Brian Orelli |
Gilead Gets the Experts on Its Side An advisory committee says yes after the FDA said no. |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod. |
The Motley Fool October 7, 2010 Brian Orelli |
Asset Sold, Questions Begin Why did InterMune sells its stake in danoprevir? |
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 June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
The Motley Fool December 6, 2010 Brian Orelli |
3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise. |
The Motley Fool May 13, 2011 Brian Orelli |
FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved. |
The Motley Fool September 16, 2010 Brian Orelli |
Abbott's Product Line May Get Thinner Not that it needs the obesity drug. |
The Motley Fool September 25, 2007 Brian Orelli |
Onyx Moves Ahead Bayer and Onyx score a positive recommendation from an EU committee, moving one step closer to being able to market their cancer-fighting drug Nexavar in Europe. |
The Motley Fool November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
The Motley Fool February 1, 2011 Brian Orelli |
Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon. |
The Motley Fool April 25, 2008 Brian Orelli |
Progenics' Double Dose of Good News Its lead drug gets FDA approval and a positive EU recommendation. |
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 June 11, 2010 Brian Orelli |
25 to 0! Now That's a Ringing Endorsement Novartis flies through its advisory panel meeting nearly unscathed. |
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. |
Chemistry World August 2, 2007 Victoria Gill |
Europe Poised for a Surge in Generic Drugs The European Medicines Agency's Committee for Medicinal Products for Human use has recommended the approval of a schizophrenia treatment which is the first generic drug to be assessed under Europe's centralized procedure. |
The Motley Fool July 16, 2010 Brian Orelli |
Why VIVUS Is 57% Thinner In a move that slashed the pharmaceutical's shares, Food and Drug Administration advisory committee recommended that the agency not approve their obesity drug Qnexa. |
The Motley Fool October 19, 2010 Brian Orelli |
When the Status Quo Is a Big Win The lack of an FDA rejection will do just fine. Amgen and Johnson & Johnson seemed to get through the FDA advisory panel process without much problem yesterday. |
The Motley Fool August 14, 2009 Brian Orelli |
Amgen Close to Scoring Big Amgen gets good-enough results from a FDA panel. |
The Motley Fool February 22, 2010 Brian Orelli |
So Long, See You in Arbitration After another rejection, Johnson & Johnson and Basilea call it quits. |
The Motley Fool March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note. |
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 September 14, 2010 Brian Orelli |
42% Drop? Really? Tell Us Something We Didn't Know. Arena Pharmaceuticals gets knocked down for no good reason. |
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 July 13, 2010 Brian Orelli |
A Triple Delight: 3 Stocks All Up More Than 10% What's good for the obese goose is good for the gander when it comes to new drug treatments for losing weight. |
The Motley Fool October 11, 2010 Brian Orelli |
What Meridia's Demise Means for Arena, VIVUS, and Orexigen Safety first ... and second ... and third... |
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 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 February 3, 2009 Brian Orelli |
InterMune Batting .500 The results weren't exactly what Rule Breakers pick InterMune was looking for, but things could have been worse -- and the stock is up 38% today on the news. |
The Motley Fool January 31, 2007 Brian Lawler |
Mylan on the Generic Attack Two new drug approvals for the generic drugmaker come in the midst of a changing regulatory environment. Investors, take note. |
The Motley Fool May 3, 2010 Brian Orelli |
While You Were Reveling in Dendreon's Win The FDA has approved Vimovo, an arthritis drug from Pozen and AstraZeneca, and Bristol-Myers Squibb also got a decision from the FDA, but it wasn't the positive kind. |
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 December 3, 2010 Brian Orelli |
Obesity Drug Companies Are (Still) Risky Orexigen heads before an FDA panel. |
The Motley Fool November 12, 2010 Brian Orelli |
Benlysta: Not Perfect, but Good Enough Human Genome should get past the FDA advisory panel next week. |
The Motley Fool December 31, 2007 Brian Lawler |
Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price. |
The Motley Fool December 22, 2010 Matt Koppenheffer |
Arena Pharmaceuticals Shares Plunged: What You Need to Know Shares of biopharma company Arena Pharmaceuticals dipped as much as 13% in intraday trading on massive volume. |
The Motley Fool November 27, 2009 Brian Orelli |
A Mostly Meaningless FDA Approval After an accelerated approval, the positive effects of a full approval are minimal for Johnson & Johnson's drug, Intelence. |
The Motley Fool March 28, 2011 Brian Orelli |
Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news. |
The Motley Fool March 20, 2009 Brian Orelli |
EU to Gilead: More Trials for You The U.S. isn't ready for Gilead Sciences' new cystic fibrosis drug, and neither is Europe. |
The Motley Fool June 29, 2009 Brian Orelli |
Gilead Says "Pleeeease." EU Says "Well, OK." This appeal actually resulted in an approved drug. |
The Motley Fool March 18, 2009 Brian Orelli |
Johnson & Johnson and Shakespeare The stage is set for a dramatic decision. |