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The Motley Fool February 23, 2005 Stephen D. Simpson |
Take Two on COX-2 FDA panel recommendations breathe new life into Merck and Pfizer's COX-2 pain medications. Looking ahead, investors should give a good, long look to the drug sector. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
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. |
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. |
BusinessWeek December 13, 2004 Carol Marie Cropper |
The Inside Dope on Drugs Watchdog Web sites can tip you off to concerns that may not be on the label. Still, before you hit the Net, start with your doctor. And don't overlook the FDA's home page. |
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. |
The Motley Fool January 31, 2007 Brian Lawler |
FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer. |
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 October 7, 2004 Brian Gorman |
Pfizer Will Weather the Storm The company will likely come out on top regardless of the outcome of the latest controversies. Pfizer remains a quality choice for long-term investors. |
BusinessWeek June 2, 2011 Kresge & Connolly |
A New Pricing Game for Drugmakers in Europe Germany's new rules tying pharmaceutical prices to greater efficacy is worrying companies. |
The Motley Fool November 23, 2004 W.D Crotty |
5 Drugs to Worry About? The recall of Merck's Vioxx raises concern among investors that there may be other pharmaceutical companies with potential legal exposure. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
BusinessWeek April 23, 2007 Alex Halperin |
Vioxx Casts A Long, Long Shadow More than two years after Merck & Co. pulled its Vioxx painkiller from shelves over heart attack and stroke risks, the Food & Drug Administration is still skittish about the safety of drugs currently on the market and those coming up for review. |
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 April 8, 2005 Charly Travers |
The FDA Hammers Pfizer Regulatory agency orders a billion dollar blockbuster off the market. Should investors care? |
CIO March 15, 2006 Allan Holmes |
Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market. |
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. |
Pharmaceutical Executive January 1, 2011 Jill Wechsler |
Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead. |
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 November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. |
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. |
Pharmaceutical Executive December 1, 2010 |
The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator The European Medicines Agency is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs. |
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 January 19, 2005 Stephen D. Simpson |
Pfizer Doesn't Give Much Fizz The company reports mediocre earnings as investors remain nervous about the drug sector. |
The Motley Fool November 8, 2004 Brian Gorman |
Pfizer's Gloom Factor The stock will continue to be depressed, but things will improve if Celebrex's safety is proven. |
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. |
Pharmaceutical Executive July 1, 2009 Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
Pharmaceutical Executive October 1, 2011 Jill Wechsler |
At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system. |
Pharmaceutical Executive April 1, 2006 Jill Wechsler |
Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf? |
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 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. |
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 April 26, 2011 Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
Chemistry World April 24, 2008 James Mitchell Crow |
FDA takes tough line on biologic drug The US Food and Drug Administration has rejected an application from biotechnology firm Genzyme to make its already-approved, protein-based drug Myozyme in larger batches. |
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 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 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 January 15, 2010 Brian Orelli |
Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all. |
The Motley Fool November 16, 2007 Brian Lawler |
Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx. |
The Motley Fool January 28, 2005 Karl Thiel |
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous. |
The Motley Fool June 3, 2011 Luke Timmerman |
Orexigen, Facing High Hurdle at FDA, Puts Obesity Drug Development on Hold The close attention paid to safety makes this drug difficult to get right. |
The Motley Fool December 27, 2004 W.D. Crotty |
Drug Safety: Investors Beware Will AstraZeneca become the latest casualty in the drug safety debate? |
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. |
Bio-IT World December 15, 2004 Kevin Davies |
Patients Before Profits? After the Vioxx disaster, Pharma needs to reassure patients that they come first. |
The Motley Fool February 22, 2005 Charly Travers |
Is Big Pharma a Bargain? While much of the drug sector is looking pretty tasty, Pfizer, with its attractive relative valuation, dominant marketing presence, and willingness to buy up blockbuster drugs, heads the list. |
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. |
Pharmaceutical Executive December 1, 2010 William Looney |
In Through the Out Door The end of anther year is an appropriate time to highlight the march of time and the transitions that accompany it in Europe and in China. |
The Motley Fool July 14, 2010 Luke Timmerman |
Vivus Faces Turning Point Tomorrow Thursday's the big day. All eyes will be on Vivus and the FDA's decision on their new obesity drug |
Pharmaceutical Executive April 1, 2005 |
Thought Leader: Better Business: Balancing Benefit, Risk, and Cost An interview with author and Harvard Medical School professor Dr. Jerry Avorn on how losing track of patient welfare and failing to address important safety problems isn't just bad science and bad ethics, it's also bad business. |
The Motley Fool September 14, 2010 Luke Timmerman |
Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug. |