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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 31, 2007 Victoria Gill |
FDA Advised: Avandia Should Stay on the Market The US Food and Drug Administration's (FDA's) Advisory Committee came to an almost unanimous decision yesterday for Avandia, GlaxoSmithKline's much-maligned diabetes treatment, to remain on the US market. |
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 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 July 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
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 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. |
Chemistry World May 22, 2007 Victoria Gill |
GSK Drug's Safety Questioned A prominent US clinician has concluded that a diabetes drug produced by UK pharmaceutical company GlaxoSmithKline increases the risks of heart attack and death. |
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 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? |
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 March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note. |
Chemistry World February 26, 2010 Sarah Houlton |
Report hits out at GSK's Avandia GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) has been dealt another blow, with the publication of a report by two US senators claiming the company knew about safety problems long before they reached the public domain. |
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 October 25, 2007 Brian Lawler |
Rope-a-Dope at GSK? Following the negative FDA panel hearings and safety review of diabetes drug Avandia and exchange rate movements against it, revenue fell 3% in the third quarter for GlaxoSmithKline. Operating income and profit were also slightly down. |
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 July 26, 2007 Brian Lawler |
Glaxo Getting Through Avandia Loss Glaxo's earnings aren't hurt by the decline in Avandia sales. When excessive fears start to bring down shares of a drugmaker with good sales-growth potential over the long run, smart investors should see a buying opportunity. |
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 June 8, 2009 Brian Orelli |
For the RECORD... Avandia's not going to make a comeback for GlaxoSmithKline. |
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 April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate. |
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 June 14, 2007 Brian Lawler |
Dueling Fools: GlaxoSmithKline Bull Shares of the pharmaceutical may be temporarily down, but it's not out. |
Chemistry World July 2007 Victoria Gill |
Conflict of interest? The FDA has been questioned after a published study brought exposed cardiovascular risks associated with GlaxoSmithKline's diabetes drug, Avandia. |
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 June 12, 2007 Michael P. Cecil |
When Dr. Nissen Talks ... Congress and the FDA listen. The Avandia story is just beginning, and drug-safety issues were hard on the share prices of Merck when Vioxx was in the news, as well as Pfizer when torcetrapib was taken off the market. |
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 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 September 7, 2007 Brian Orelli |
Merck Says No to This Protein An FDA advisory panel recommends unanimous approval of a new HIV drug from Merck. The new class of HIV medications fight the virus by blocking one key protein from entering cells. |
The Motley Fool July 16, 2009 Brian Orelli |
Keep Your Chin Up, J&J An FDA advisory committee smacked down its drug candidate. |
Chemistry World December 2, 2013 Lanay Tierney |
US turnaround on Avandia restrictions Restrictions on the controversial diabetes medication Avandia (rosiglitazone) are to be lifted by the US Food and Drug Administration. |
The Motley Fool September 6, 2007 Brian Lawler |
Foolish Fantasy Football: GlaxoSmithKline on Defense In real life, defense wins championships. This stock analyst includes GlaxoSmithKline on his fantasy football investment team, to shield from a punishing sack by the market. |
The Motley Fool January 19, 2011 Cliff D'Arcy |
Glaxo Stung by Legal Bill GSK shareholders are hit by costly legal settlements. |
The Motley Fool May 22, 2007 Mike Havrilla |
Avandia Safety Concerns Weigh Down Glaxo Shares of GlaxoSmithKline dropped nearly 8%, after a study raised safety concerns about the company's widely used diabetes drug, Avandia. |
The Motley Fool April 29, 2010 Brian Orelli |
Earnings Up 17%, but Here's Why You Should Be Worried One-time sales are no way to run a pharmaceutical business. |
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 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 August 15, 2007 Billy Fisher |
Adversity Continues for Avandia Avandia and Actos receive black box labels from the FDA. The two diabetes medications have been linked to an increase in heart failure. |
The Motley Fool June 2, 2008 Brian Lawler |
Ligand's Hail-Mary Touchdown The drugmaker receives an unexpected advisory-panel surprise regarding its lead drug, Promacta. |
The Motley Fool August 31, 2009 Brian Orelli |
Good Luck, Genzyme -- You'll Need It The drugmaker faces an FDA advisory-panel showdown regarding its leukemia drug Clolar. |
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 March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool September 5, 2007 Billy Fisher |
Lilly's Pipeline Continues to Produce Another schizophrenia drug from the company shows promise in a clinical trial, prompting the company to plan additional trials. This is the latest good news in what has been a good year for Lilly. |
The Motley Fool December 14, 2007 Brian Orelli |
Panel Kills Merck's Hope of OTC Status An FDA advisory panel isn't convinced that Merck's cholesterol-lowering drug MEVACOR deserves OTC status. |
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 March 31, 2009 Brian Orelli |
Destiny for Diabetes Drugs The Food and Drug Administration has a two-day advisory panel lined up so that panelists can give their opinions on a pair of diabetic drugs. |
The Motley Fool April 10, 2008 Brian Lawler |
Glaxo Angers the FDA GlaxoSmithKline announces that the FDA has sent it a warning letter regarding its failure to meet certain post-marketing requirements for Avandia. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool November 17, 2010 Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |