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BusinessWeek April 11, 2005 Amy Barrett |
A Prescription For Trouble At J&J? Johnson & Johnson faces controversy over its heart failure drug Natrecor. |
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 December 22, 2006 Stephen Albainy-Jenei |
Is Off-Label Off-Base? Off-label prescriptions for uses lacking scientific support account for billions in drug revenue for Eli Lilly. If the FDA takes an aggressive stance on off-label-use marketing, it could significantly shrink drug sales for companies whose revenues are derived largely from such off-label use. |
BusinessWeek March 11, 2010 Margaret Cronin Fisk et al. |
Did J&J Plan to Break Rules? Its aggressive marketing campaign for Risperdal has caused an explosion of litigation. |
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 December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
BusinessWeek October 18, 2004 John Carey |
"Off-Label" -- And Out Of Bounds? When drugmakers promote products for unproven uses, they may be courting trouble. How restrictive should the regulations be? |
The Motley Fool December 3, 2007 Brian Orelli |
More Heartburn From J&J's Natrecor The company takes a $440 million writedown as the heart drug continues to falter. Investors, Johnson & Johnson has a way to go before it can turn things around. |
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 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 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 December 4, 2007 Brian Orelli |
An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications. |
The Motley Fool November 16, 2010 Luke Timmerman |
Dendreon Prepares to Take Some Heat Over Cancer Drug Prices Dendreon looking for off-label uses for its prostate cancer drug. |
Chemistry World November 11, 2013 Sarah Houlton |
Mis-selling lands J&J with $2.2bn fine Johnson & Johnson has been given a hefty fine in the US for mis-selling three drugs. The company, and its subsidiaries Janssen and Scios, will pay $2.2 billion. |
The Motley Fool June 11, 2009 Brian Orelli |
Kids, Take Your Antipsychotics! Drugs to combat mental illness might gain FDA approval for children. |
The Motley Fool April 7, 2011 Brian Orelli |
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. |
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 March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
The Motley Fool November 22, 2006 Brian Lawler |
How to Market a Drug Too Well Cephalon's promotion of its pain drug Actiq might have crossed the line. |
The Motley Fool February 23, 2009 Brian Orelli |
The DOJ v. Johnson & Johnson The U.S. Department of Justice is joining a lawsuit against the health care giant over the company's marketing of heart failure drug Natrecor. |
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 May 14, 2015 Rebecca Trager |
FDA accused of violating drug company's freedom of speech The US Food and Drug Administration is under pressure to reconsider its policy prohibiting pharmaceutical companies from promoting 'off-label' uses of their products. |
Managed Care August 2006 Martin Sipkoff |
Off-Label Use Often Presents Conundrum for Health Plans Insurers recognize the clinical importance of off-label prescribing, but criteria are needed to avoid over-utilization. |
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 September 30, 2010 Brian Orelli |
Avoid This Multibillion-Dollar Market It's just too crowded, but there's no doubt that psychiatric drugs are big business for some drugmakers. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
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 May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
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 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 January 31, 2011 Brian Orelli |
5 Drugmakers Headed Back to the Drawing Board Sometimes an FDA rejection is more of a to-do list. |
The Motley Fool June 29, 2010 Brian Orelli |
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. |
Chemistry World May 27, 2015 Phillip Broadwith |
Label laundry It's been an interesting month in the world of off-label pharmaceuticals. |
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. |
The Motley Fool January 29, 2010 Brian Orelli |
How to Make Billions of Dollars Without Really Trying Lackluster Alzheimer's drugs have been doing it for years. |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
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. |
BusinessWeek December 11, 2006 Michael Arndt |
Kills Pain, Cures Rabies, And Grows Hair The prescription drug market is one part Big Brother and one part Wild West. |
The Motley Fool January 31, 2011 Brian Orelli |
Drug Approved! Now Who's Going to Launch It? Depomed gets pain-free news from the FDA. |
The Motley Fool October 9, 2008 Brian Orelli |
When Science, Marketing, and Investing Collide How a pharmaceutical tries to sell more drugs can provide clues about its management. |
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 August 18, 2010 Brian Orelli |
No Pain Here as Jazz Shares Rocket Investors are all jazzed up about Jazz Pharmaceuticals |
The Motley Fool September 8, 2010 Jim Mueller |
3 Stocks to Play Biotech Three promising ideas for investing in this exciting area. |
The Motley Fool November 11, 2010 Brian Orelli |
Moderate Results, Moderate Rally for Dendreon Sometimes good enough really is good enough. |
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. |
Chemistry World June 6, 2013 Phillip Broadwith |
Big data to sniff out drug marketing fraud The US Food and Drug Administration is offering a contract for a company to collect and analyze data on pharma companies' promotional activities. The aim is to use this big data approach to spot off-label marketing and other forms of marketing fraud. |
The Motley Fool February 18, 2010 Brian Orelli |
Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance. |
The Motley Fool December 31, 2007 Brian Lawler |
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency. |
The Motley Fool September 29, 2011 Brian Orelli |
Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA. |
Pharmaceutical Executive May 1, 2006 Ron Feemster |
Teamsters v. Pfizer A New Jersey Teamsters local says Pfizer tricked them into paying for off-label Lipitor prescriptions. Do you have any questions about that? We do. |