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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. |
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 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 July 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
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 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 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 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 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 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 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 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. |
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 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. |
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 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 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. |
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 June 8, 2009 Brian Orelli |
For the RECORD... Avandia's not going to make a comeback for GlaxoSmithKline. |
The Motley Fool June 30, 2011 David Williamson |
Biotech Takes On the Next Big Problem The news coming out of this week's annual conference of the American Diabetes Association wasn't good. |
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 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 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. |
Chemistry World April 11, 2014 Andy Extance |
Missing safety risk emails draw $9bn Actos fine A US jury has fined Takeda and Eli Lilly $9 billion for causing a man's bladder cancer with their diabetes drug Actos (pioglitazone). |
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 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 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 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 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 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 June 3, 2011 Brian Orelli |
FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully. |
The Motley Fool August 27, 2008 Brian Orelli |
Amylin Answers, Investors Panic Amylin Pharmaceuticals' conference call about side effects of its diabetes treatment, Byetta, doesn't have the desired effect. |
The Motley Fool April 4, 2007 Brian Lawler |
Novartis Gets Nicked Novartis pulls one of its top-selling drugs from the market. Investors should come to expect drug delays or similar issues popping up from time to time when doing their analysis of large pharmas. |
Chemistry World May 3, 2013 Phillip Broadwith |
Judge reverses jury decision over $6.5m Takeda payout A judge has thrown out the jury's verdict in a case between Japanese drugmaker Takeda and a US man who claims that the company's drug caused his bladder cancer. |
The Motley Fool August 17, 2007 Brian Orelli |
FDA's Rigor May Boost Sales The FDA is updating labeling of certain blood-thinning drugs, indicating that patients may want to obtain a genetic test prior to taking the medication. This move may lead to increased testing, and hopefully increased prescriptions. |
The Motley Fool October 17, 2007 Brian Orelli |
FDA Warning Might Be a Buying Opportunity The 3%-4% drops in the stock prices of Amylin and Alkermes, Amylin's partner in the development of a sustained-release version of Byetta, could be a good buying opportunity for investors. |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
The Motley Fool June 5, 2008 Brian Lawler |
Cancer Concerns Fuel FDA Inquiry The agency examines a class of blockbuster drugs for a link to cancer in young patients. |
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 September 2, 2010 Luke Timmerman |
Orexigen Nabs $1B Deal With Takeda to Market Obesity Drug, Shares Climb San Diego-based Orexigen Therapeutics has found a partner to help it compete in the growing market for drugs to combat obesity, Japan-based Takeda Pharmaceutical. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
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. |
Pharmaceutical Executive May 1, 2005 Sarah Houlton |
Global Report: Iron Fist The United Kingdom is hardening its stance on pharma industry issues. |
The Motley Fool December 6, 2005 Stephen D. Simpson |
Tysabri Tries Again Will the FDA finally approve Elan's multiple sclerosis drug? Investors' fingers are crossed. |
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 September 28, 2007 Brian Lawler |
GSK Helps Secure Future of a Lead Drug GlaxoSmithKline settles a patent infringement case on a lead drug, Avandia, and with that challenger gone, the company is a step closer to securing one of its top franchises. |
The Motley Fool August 17, 2007 Brian Orelli |
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully. |
The Motley Fool December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
Chemistry World March 17, 2014 Phillip Broadwith |
UK to fast-track access to critical medicines Critically ill patients in the UK could receive new medicines before they are formally approved under a new scheme beginning in April. |
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. |