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The Motley Fool May 27, 2010 Brian Orelli |
This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do. |
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 March 31, 2011 Brian Orelli |
Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good. |
The Motley Fool September 15, 2010 Brian Orelli |
Drug Approved. Now Let's Sell This Baby! With ink still wet on its FDA approval, Savient continues its plan to find a buyer. |
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. |
Pharmaceutical Executive April 1, 2011 |
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help. |
The Motley Fool July 15, 2010 Brian Orelli |
The Blockbuster Drug Survives Another Body Blow Avandia is still standing. |
The Motley Fool May 26, 2011 Brian Orelli |
Congress Sets Bad Precedent With AVANIR What happened to free markets? |
The Motley Fool December 10, 2010 Brian Orelli |
Was This Drug Destined for Failure? Pfizer announces that it's pulling Thelin off the market, and withdrawing the marketing application with the Food and Drug Administration, because a new side effect was discovered. |
The Motley Fool August 22, 2007 Brian Orelli |
Regulating the Drug Pushers The FDA might get a little tougher on drug ads, following a report that they may not be watching advertisers claims closely enough, or warning patients about side effects strongly enough. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
The Motley Fool July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
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 November 18, 2010 Ned Stafford |
New drug pricing rules in Germany The law was approved on 11 November and will take effect from 1 January as part of an effort to rein in exploding costs for Germany's massive public health insurance system. |
The Motley Fool November 30, 2010 Brian Orelli |
A Witty Response to Pharma's R&D Dilemma According to GlaxoSmithKline CEO Andrew Witty, the pharmaceutical industry is a mess. That's the basic gist of his opinion piece in The Economist. |
The Motley Fool August 31, 2010 Brian Orelli |
Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior. |
Searcher June 2012 Stephanie C. Ardito |
The Medical Digital: How Safe Are the Prescription Drugs we Take? Monitoring Adverse Events and Recalls For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations. |
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 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. |
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. |
BusinessWeek March 7, 2005 Amy Barrett |
Will Drugmakers Back Off The Hard Sell? Drug ads need to return to more balanced communication of risks and benefits and not depend so much on catchy phrases and images. The question is whether the industry is ready to take that lesson to heart. |
The Motley Fool January 25, 2010 Brian Orelli |
No Way to Hide This Drug Approval FDA trumps Acorda on its good news. The biotech announced Food and Drug Administration approval of Ampyra, its drug to help multiple sclerosis patients walk better after the markets closed on Friday. |
The Motley Fool October 18, 2010 Brian Orelli |
Pfizer Flexes Its Generic Muscles The pharma giant moves farther into generic drugs. |
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 January 7, 2010 Brian Orelli |
Pfizer Strides Farther Into Generics Pfizer's new look might be just what the doctor ordered. |
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 April 26, 2011 Brian Orelli |
We Hate Your Drug. And That's a Good Thing. This one's a pain for the clinical trial participants. |
The Motley Fool May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
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 February 25, 2010 Brian Orelli |
Transplanting Future Revenue Bristol-Myers Squibb waits for experts to decide the fate of its kidney cancer drug. |
The Motley Fool July 30, 2010 Anand Chokkavelu |
5 Stocks to Consider Before Buying Pfizer If you like Pfizer, you may like these five insurance and medical stocks better. |
The Motley Fool September 2, 2010 Brian Orelli |
Pfizer Takes an Orphan Into the Fold Pfizer is likely pursuing FoldRx's pipeline and expertise in rare diseases. |
The Motley Fool January 28, 2010 Brian Orelli |
How to Make a Billion Bucks in Biotech Drug companies and investors alike have to balance the risk and reward. |
The Motley Fool April 25, 2011 Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it? |
The Motley Fool April 22, 2011 Sean Williams |
Pharma's Most Perilous Pipelines Patent expirations expose weaknesses for these Wall Street darlings. |
The Motley Fool May 21, 2010 Brian Orelli |
And You Thought Biotech Was High-Risk, High-Reward Large clinical trials make cardiovascular drugs risky, but the rewards are there, too. |
The Motley Fool September 24, 2010 Brian Orelli |
Prepare for This $12 Billion Whoosh Pfizer's Lipitor is the top-selling cholesterol drug -- in fact, it's the top selling drug period -- but it'll start to see generic competition in a little over a year. |
The Motley Fool March 3, 2011 Brian Orelli |
3 Cheers for an FDA Rejection German drugmaker Merck said that the Food and Drug Administration had turned down its multiple sclerosis drug cladribine. The pill would have competed with Novartis' Gilenya, which gained FDA approval last year. |
The Motley Fool April 7, 2011 Brian Orelli |
When Zombies Attack, Investors Win Novartis is hoping that Prexige has as much success coming back from the dead as Tysabri has. |
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. |
Reason April 2008 Ronald Bailey |
Medical Speech As a 1997 law expires, the FDA is mulling a plan allowing companies to disseminate unabridged reprints of "truthful and non-misleading" medical journal articles describing "off-label" uses of approved medications to physicians. |
The Motley Fool January 15, 2010 Brian Orelli |
Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all. |
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. |
BusinessWeek March 7, 2005 John Carey |
Side Effects Of The Drug Scares New fears give rise to a more honest look at the risks for a pill-popping nation. |
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 July 11, 2008 Brian Orelli |
Pfizer Looking at a Level Playing Field An advisory panel says that epilepsy drugs don't need a black-box warning, news that is positive for drug companies -- that is, those other than Pfizer. |
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 April 11, 2011 Brian Orelli |
A Double Dose of Trouble for Big Pharma? Pfizer's Sutent and Novartis's Afinitor head in front of an FDA advisory panel. |
The Motley Fool July 12, 2010 Ryan McBride |
Synta Pharma CEO Trumpets New Top Cancer Drug Synta Pharmaceuticals has been climbing back from one of the Boston area's highest-profile clinical trial failures of 2009. |
The Motley Fool February 10, 2011 Brian Orelli |
Breathe Easier, Join the Competition Novartis' strategy is a good one. |