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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 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. |
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 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. |
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. |
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 June 8, 2009 Brian Orelli |
For the RECORD... Avandia's not going to make a comeback for GlaxoSmithKline. |
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 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 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 14, 2007 Brian Lawler |
Dueling Fools: GlaxoSmithKline Bull Shares of the pharmaceutical may be temporarily down, but it's not out. |
The Motley Fool December 12, 2008 Brian Orelli |
Amylin Gets Some FDA Love Amylin's once-weekly diabetes drug Byetta gets a green light from the FDA. |
The Motley Fool January 20, 2012 Brian Orelli |
19 Clinical Trials Aren't Enough The FDA rejects Bristol-Myers and AstraZeneca's dapagliflozin. |
The Motley Fool August 21, 2007 Brian Orelli |
Sweet Phase 3 Data Although diabetes drugs have come under fire lately, insulin maker Novo Nordisk is moving full steam ahead with its newest drug to help fight type 2 diabetes. |
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. |
Chemistry World October 17, 2012 Maria Burke |
GSK pledge on trials transparency GlaxoSmithKline has announced a series of initiatives to make clinical trial data publically available that could set a precedent in an industry not known for its transparency. |
Pharmaceutical Executive July 30, 2007 Richard Altus |
Avandia Sales Away What did you do when you heard the safety news about Avandia? Here's what the rest of the market did, and why it matters to you. |
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. |
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 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 12, 2007 Brian Lawler |
Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg. |
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 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
BusinessWeek May 27, 2010 Michelle Cortez |
Karo Bio's Prescription: Cheaper Drug Approval A Swedish company seeks a lower-cost review for its cholesterol drug. |
The Motley Fool February 27, 2008 Brian Orelli |
Everyone's Picking on Anemia Drugs A new study in The Journal of the American Medical Association is adding fuel to the fire about Amgen's and Johnson & Johnson's anemia drugs. Should investors worry? |
Pharmaceutical Executive July 3, 2007 Walter Armstrong |
Back Page: Oh Man, Avandia Think you know the Avandia story? Pharma execs should take this test to see what they missed. |
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. |
Chemistry World October 8, 2014 Phillip Broadwith |
EMA finalizes trial transparency rules The European Medicines Agency has finalized its policy for sharing data from clinical trials. |
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. |
Managed Care July 2005 Martin Sipkoff |
Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules. |
The Motley Fool November 3, 2011 Frank Vinluan |
GSK Settles With Uncle Sam for $3B GSK said the settlement will reduce financial uncertainty for the company and is in the best interest of shareholders. |
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 June 29, 2010 Brian Orelli |
Diabetes Drug Development Pops and Drops When companies present at a major meeting, there's bound to be both. |
Chemistry World July 2, 2012 Andrew Turley |
$3bn GSK fine sets new industry record The GlaxoSmithKline fine, which relates to antidepressant brands Paxil (paroxetine) and Wellbutrin (bupropion) and diabetes brand Avandia (rosiglitazone), is the largest payment ever made by a drug company. |
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. |
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. |
BusinessWeek December 19, 2005 Amy Barrett |
Big Pharma's Favorite Gadfly Steven Nissen's pharmaceutical industry ties don't stop him from questioning drugs like Celebrex. |
The Motley Fool January 21, 2009 Brian Orelli |
Pharma Foe Speaks Up for Investors Some good ideas for President Obama's new Food and Drug Administration chief that would benefit investors in drug companies. |
The Motley Fool December 22, 2003 Alyce Lomax |
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. |
BusinessWeek December 13, 2004 John Carey |
How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs. |
The Motley Fool December 31, 2011 Brian Orelli |
3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012. |
The Motley Fool March 27, 2008 Brian Orelli |
I Heart the ACC What can investors expect from this weekend's blood-pumping American College of Cardiology scientific meeting? |
The Motley Fool March 7, 2005 Brian Gorman |
Glaxo in Hot Water Glaxo's problems with the FDA could have been avoided. Investors can only hope that the FDA is in a forgiving mood. |
The Motley Fool March 28, 2008 Brian Orelli |
Allergic Reaction to Singulair News? The FDA warns the public about potential side effects of Merck's allergy treatment Singulair. |
The Motley Fool June 30, 2010 Brian Orelli |
When Researchers Attack, Investors Lose Drug investors have to watch out for a lot of things that can change their stock's price: earnings reports, clinical trial results, competitor's results, and FDA decisions. |
The Motley Fool April 17, 2008 Brian Orelli |
FDA and Health Insurers Take On Drugmakers The FDA is teaming up with health insurer WellPoint to use the company's vast database of 35 million members' medical records to try find drugs' side effects. |
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 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 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. |