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The Motley Fool
September 7, 2011
Brian Orelli |
J&J and Bayer Head in Front of the Firing Squad An expanded indication for Xarelto seems unlikely.   |
The Motley Fool
May 29, 2009
Brian Orelli |
Delayed, Reason Unknown As long as Bayer and Johnson & Johnson can answer the FDA's questions relatively quickly, it shouldn't affect the companies too much. |
The Motley Fool
July 5, 2011
Brian Orelli |
Drug Approved, But No Fireworks Yet The second FDA approval for Bayer and Johnson & Johnson's Xarelto is more important. |
The Motley Fool
November 7, 2011
David Williamson |
Health-Care News You Can't Afford to Miss Highlighting the day's health-care stories: FDA approval for Johnson & Johnson... Inhibitex kept its streak of double-digit gains alive with another 14% surge today... 13% plunge for Optimer Pharmaceuticals... |
The Motley Fool
August 1, 2007
Brian Lawler |
Elan Gets a Vote of Confidence Elan receives some good news from an FDA advisory panel in the form of a recommendation to expand the use of Tysabri to treat Crohn's disease. |
The Motley Fool
April 6, 2011
Brian Orelli |
$1 Billion in Drug Sales Bleeds Out Don't feel too bad for Bayer and J&J though. |
The Motley Fool
August 30, 2011
Brian Orelli |
Pfizer and Bristol-Myers Glide Through For Pfizer and Bristol-Myers Squibb's new atrial fibrillation treatment, Eliquis, the devil seems to have left the building. |
The Motley Fool
June 23, 2011
Brian Orelli |
In Addition, Our Drug Actually Rocks Pfizer and Bristol get good data on Eliquis. |
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
March 19, 2009
Brian Orelli |
One Down, One to Go Sanofi-aventis slides past an FDA panel and hopes for more good news today |
The Motley Fool
September 8, 2011
Arlene Weintraub |
Bristol-Pfizer Team on Alert as FDA Reviews Stroke-Prevention Drug From Rivals J&J and Bayer Who will come out ahead? |
The Motley Fool
November 15, 2010
Brian Orelli |
A Mega-Blockbuster Showdown Boehringer Ingelheim's Pradaxa was recently approved to treat patients with an erratic heartbeat, and Bayer and Johnson & Johnson have a second compound, Xarelto, that isn't far behind. |
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
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
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
November 30, 2011
Brian Orelli |
Drugmakers Bleeding Out That's not what blood thinners are supposed to do. |
The Motley Fool
December 12, 2007
Brian Lawler |
No Shock for Cardiome An FDA advisory panel gives the nod to Cardiome's heart drug. Investors, take note. |
The Motley Fool
November 19, 2010
Brian Orelli |
Up 95%, but Still Risky as Heck That's an understatement for MELA Sciences. |
The Motley Fool
December 10, 2007
Brian Lawler |
Will the FDA Clear Cardiome? The agency prepares to debate Cardiome's lead drug candidate, Vernakalant, a treatment for abnormal heart rhythms. Investors, take note. |
The Motley Fool
March 17, 2008
Brian Lawler |
The Panelling on Amgen's Walls One FDA panel ruling is a win, another is much less upsetting than investors feared. |
The Motley Fool
June 16, 2011
Brian Orelli |
No Poke in the Eye Here What's the biggest sign that the Food and Drug Administration is all set to approve Regeneron Pharmaceuticals' Eylea? The briefing documents for the advisory committee contained a proposed version of the label. |
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 14, 2007
Brian Lawler |
Ignore the Dendreon Hoopla A Congressional probe request will have no effect on Dendreon or Provenge's odds at making it through the FDA, since it was not the FDA reviewers of the Provenge marketing application that were accused of anything bad. |
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
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
November 29, 2007
Brian Lawler |
Another Chapter in Glaxo's Relenza Saga An FDA advisory panel suggested that the Relenza label should be strengthened to include the possibility of abnormal behavior and hallucinations in those who take it. |
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
June 11, 2010
Brian Orelli |
Pfizer and Bristol Coagulate Against Clots Let's see how apixaban does against warfarin before we break out the "blockbuster" stamp. |
The Motley Fool
November 16, 2010
Brian Orelli |
Well, That Just Stinks Glaxo's Lovaza doesn't fix heart rhythm problems. |
The Motley Fool
July 12, 2011
Luke Timmerman |
Seattle Genetics' New "Empowered Antibody" Looks Clean in FDA Staff Documents FDA reviews Seattle Genetics' Hodgkin's lymphoma drug. |
Pharmaceutical Executive
December 1, 2010
Walter Armstrong |
Acute Coronary Syndrome A new class of anticoagulants is competing to dethrone difficult-to-manage warfarin, long the sole option in the prevention of stroke and other bleeding complications in the 2.5 million US patients with atrial fibrillation. |
The Motley Fool
April 26, 2011
Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
The Motley Fool
August 24, 2009
Brian Orelli |
J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell. |
The Motley Fool
July 14, 2011
Luke Timmerman |
Seattle Genetics Wins Unanimous OK for Lymphoma Drug from FDA Panel An FDA panel of cancer drug experts recommended in a 10-0 vote that the company's drug for Hodgkin's lymphoma should be cleared for sale in the U.S. |
The Motley Fool
March 18, 2009
Brian Orelli |
Johnson & Johnson and Shakespeare The stage is set for a dramatic decision. |
The Motley Fool
October 26, 2010
Brian Orelli |
Where's the Growth in Big Pharma? The theme for the pharmaceutical industry's 2010 third-quarter earnings reports has been officially set: If you can't get it done through sales, just cut costs. |
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
May 26, 2009
Brian Orelli |
Will the FDA Approve These Drugs? Plenty of Prescription Drug User Fee Act dates are right around the corner. Read on to see which pharma companies may be affected. |
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
November 22, 2010
Brian Orelli |
Pfizer's Mixed Bag Pfizer had a mixed bag of clinical trial results at the end of last week. And probably the company would have rather seen the results flip-flopped. |
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
August 24, 2011
Alexander Crawford |
Pfizer & Bristol-Myers to Release Highly Anticipated Data on Bloodthinner Hopeful How big could this market be? |
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 4, 2012
Brian Orelli |
Mark Your Calendars, Biotech Investors Cell Therapeutics' advisory panel meet ought to be entertaining. |
The Motley Fool
September 14, 2010
Luke Timmerman |
Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug. |
The Motley Fool
November 27, 2007
Brian Lawler |
Cardiome Makes Them Wait Cardiome Pharma announces a delay in the release of data on an oral version of its lead heart drug. Investors, take note. |
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 29, 2011
Brian Orelli |
Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA. |
The Motley Fool
November 30, 2011
Brian Orelli |
3 Things More Important to Pfizer Than Losing Lipitor It's not like we didn't see it coming. |
