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The Motley Fool May 15, 2008 Brian Orelli |
Wanted: FDA Approval -- Pronto Teva and Amphastar have the courts on their side, but the FDA still stands in the way of a generic-drug launch.  |
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 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 November 2, 2010 Travis Hoium |
Momenta Pharmaceuticals Shares Plunged: What You Need to Know Momenta Pharmaceuticals shares fell 10% in trading early Tuesday after Teva Pharmaceutical Industries said it expects FDA approval this year on a drug to compete with Momenta's enoxaparin.  |
The Motley Fool June 2, 2008 Brian Orelli |
The Anticoagulation Competition Bloodbath Bayer and Johnson & Johnson give Sanofi's Lovenox another beating.  |
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 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 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 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 March 23, 2010 Brian Orelli |
No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.  |
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 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 June 8, 2010 Brian Orelli |
Injecting Uncertainty Into the Multiple Sclerosis Market Novartis' oral MS drug could be a blockbuster -- if it can get past the FDA.  |
The Motley Fool July 14, 2008 Brian Orelli |
Teva Gets a Taste of Its Own Medicine Momenta Pharmaceuticals and Novartis are challenging the patents on Teva Pharmaceutical's blockbuster multiple sclerosis drug Copaxone.  |
The Motley Fool December 31, 2008 Brian Orelli |
An Imminent Drug Approval? Really? Lilly may finally hear about prasugrel.  |
The Motley Fool September 11, 2007 Brian Lawler |
Where Momenta Stands Momenta Pharmaceuticals updates investors as to the status of drugs in its pipeline. Until the FDA makes up its mind on its lead drug, an anticoagulant, it's anyone's guess as to what the value of the pipeline is. Investors should take note.  |
The Motley Fool November 26, 2010 Brian Orelli |
Black Friday Biotech Bargains Drugmakers on sale.  |
The Motley Fool July 28, 2010 Brian Orelli |
Fighting Hard to Keep a Blockbuster Sanofi is suing the FDA to take back approval of a competing generic drug. Did you expect something different?  |
The Motley Fool February 11, 2010 Brian Orelli |
A Turnaround Year, But Not in a Good Way 2009 was a solid year for sanofi-aventis thanks to a boost from sales of swine flu vaccine and some help from the exchange rate. But 2010? Not so solid.  |
The Motley Fool November 7, 2007 Brian Orelli |
Momenta Stopped Momenta and Novartis receive a not-approvable letter for their new drug application on their generic version of Lovenox, due to worries that it might cause an immune reaction. Investors, take note.  |
The Motley Fool May 9, 2007 Brian Lawler |
Where Is Momenta's Momentum? Momenta awaits an FDA regulatory decision and announces quarterly financial results. Investors, take note.  |
The Motley Fool July 1, 2008 Brian Orelli |
As the FDA Generics Office Turns The FDA reluctantly gives Teva a 180-day exclusive period to sell generic Risperdal.  |
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 February 27, 2009 Brian Orelli |
Get a Life, Congress! A Congressional investigation into whether the FDA was right to pull a doctor off of the advisory panel for Eli Lilly's blood thinner prasugrel illustrates why Congress needs to keep its nose out of scientific discussions.  |
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 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 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 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 July 27, 2010 Brian Orelli |
Brilinta? I Think Not. AstraZeneca's new blood thinner is far from brilliant.  |
The Motley Fool December 8, 2010 Brian Orelli |
Up 100% With Room to Fly Orexigen gets a positive FDA panel nod.  |
The Motley Fool August 20, 2010 Brian Orelli |
Depression Is Painful. Advisory Panels More So. Eli Lilly's Cymbalta has a rough time in from of the panel of experts.  |
The Motley Fool July 23, 2010 Luke Timmerman |
Momenta Gets FDA Green Light for Generic Anti-Clotting Drug The FDA says "yes" to Momenta Pharmaceuticals.  |
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 July 16, 2010 Brian Orelli |
A Positive Sign for Pharma Earnings Season Strong first-half results drove Novartis to increase its sales guidance for the year.  |
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 August 18, 2010 Brian Orelli |
More Pain Ahead for Eli Lilly? An advisory panel meeting tomorrow could further the company's slide.  |
The Motley Fool September 15, 2008 Brian Orelli |
Teva and FDA's Never-Ending Court Battle The Food and Drug Administration has won the latest installment of its grudge match with Teva Pharmaceuticals over the 180-day exclusivity period for generic versions of Johnson & Johnson's Risperdal.  |
The Motley Fool April 1, 2011 Travis Hoium |
Optimer Pharmaceuticals Shares Popped: What You Need to Know Shares of Optimer Pharmaceuticals jumped 12% today after positive news from the FDA was released.  |
The Motley Fool July 21, 2011 Brian Orelli |
Keep an Eye on Biotech Partners' Earnings Novartis' earnings are important for small biotechs Momenta and Vanda.  |
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 August 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals  |
The Motley Fool November 30, 2011 Brian Orelli |
Drugmakers Bleeding Out That's not what blood thinners are supposed to do.  |
The Motley Fool January 13, 2011 Brian Orelli |
FDA Panel Gives Eli Lilly Indigestion Eli Lilly's new acquisition causes a tummy ache.  |
The Motley Fool January 5, 2010 Brian Orelli |
Lilly's Effient: Cheap Enough, for Now In order to justify the use of Effient, Eli Lilly is touting a study published in today's Circulation demonstrating the cost effectiveness of Effient over Plavix.  |
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 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 March 18, 2011 Brian Orelli |
Forget Getting Approved, for Now The FDA wants more information on Eli Lilly's Amyvid.  |
The Motley Fool May 29, 2009 Brian Orelli |
The Clouds Are Parting The Food and Drug Administration has scheduled an advisory committee meeting for Aug. 4 to get input on whether the agency should approve generic versions of ViroPharma's antibiotic, Vancocin.  |
The Motley Fool August 13, 2010 Brian Orelli |
Already a Slippery Slope for Eli Lilly The company gets a whiff of what its patent cliff might be like.  |
The Motley Fool October 30, 2009 Brian Orelli |
Shrugging Off the Side Effects Sanofi-aventis is looking good, but still faces the patent protection loss of Lovenox.  |