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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? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
The Motley Fool
August 31, 2010
Brian Orelli
Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
BusinessWeek
November 29, 2004
Carey & Barrett
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. mark for My Articles similar articles
The Motley Fool
July 17, 2007
Brian Orelli
An Investor's Guide to the New PDUFA It's important for investors in drug companies to keep up with the latest clinical trial news, but policy changes in Washington can affect companies' bottom lines just as much. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
July 29, 2010
Brian Orelli
Forget Respect -- Dendreon Needs Sales! Dendreon's Provenge was approved months ago, but the data from the clinical trial supporting the FDA's decision was finally published in the New England Journal of Medicine this week. mark for My Articles similar articles
The Motley Fool
May 14, 2008
Brian Lawler
Teaching Old Drugs New Tricks Pfizer's top drugs post mixed results in recent off-label studies. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
September 25, 2008
Brian Lawler
Eli Lilly's Dose of Disclosure The pharmaceutical pledges public reports of its dealings with doctors. mark for My Articles similar articles
Chemistry World
May 27, 2015
Phillip Broadwith
Label laundry It's been an interesting month in the world of off-label pharmaceuticals. mark for My Articles similar articles
The Motley Fool
November 29, 2011
Brian Orelli
Winners and Losers of Roche's Avastin Woes What the FDA giveth, the FDA can taketh away. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 13, 2009
Brian Orelli
Questioning Pfizer's Integrity Pfizer's epilepsy drug Neurontin has had generic competition for a few years, but it's still plaguing the pharmaceutical giant. mark for My Articles similar articles
The Motley Fool
June 11, 2009
Brian Orelli
Kids, Take Your Antipsychotics! Drugs to combat mental illness might gain FDA approval for children. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
March 28, 2011
Brian Orelli
Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
February 22, 2011
Brian Orelli
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
February 28, 2011
Brian Orelli
Rare Diseases, Big Opportunity "Orphan" drugs to keep your eye on. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
June 1, 2010
Brian Orelli
Save Your Money, Dendreon As much as doctors would like to prescribe Dendreon's Provenge for their patients, manufacturing limitations will keep demand outpacing supply for awhile. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
June 29, 2010
Brian Orelli
The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 31, 2011
Brian Orelli
3 More Stock-Moving Binary Events to Watch in 2012 There are a lot of drugs that will face binary events in 2012 -- here are three to watch. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
November 17, 2006
Brian Lawler
Genentech Gets Another Approval Today, Genentech finally received formal approval to market its breast cancer therapy Herceptin for the early stages. Investors, take note. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
February 26, 2011
Brian Orelli
FDA Applications and a Look Ahead It isn't pretty. mark for My Articles similar articles
The Motley Fool
April 28, 2011
Brian Orelli
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. mark for My Articles similar articles
The Motley Fool
May 21, 2008
Brian Orelli
OK, Last Vioxx Settlement, Honest! What's another $58 million when Merck's already forking over $4.85 billion? mark for My Articles similar articles
The Motley Fool
January 11, 2011
Brian Orelli
A Clear Drug-Development Path -- Times 2 The FDA throws a fork in the road for Isis and Genzyme. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
September 23, 2010
Brian Orelli
A Blockbuster in Due Time Novartis' new multiple sclerosis drug, Gilenya, isn't king yet. mark for My Articles similar articles
The Motley Fool
February 10, 2011
Brian Orelli
Breathe Easier, Join the Competition Novartis' strategy is a good one. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
August 27, 2010
Brian Orelli
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. mark for My Articles similar articles
The Motley Fool
June 28, 2007
Brian Orelli
Onyx's Hard at Work Onyx's future depends on getting Nexevar approved for new indications. The liver cancer expansion is a nice start, and it should bring Onyx into the black. Investors, take note. mark for My Articles similar articles
The Motley Fool
October 9, 2006
Brian Lawler
The Commandments of Biotech Investing, Part 2 It's a complex field, but it's not impossible for investors to master. The more in-depth your research of a potential biotech investment, and the more you remember to follow these commandments, the better your potential for success will be when investing in this fascinating field. mark for My Articles similar articles
Bio-IT World
August 13, 2003
John Rhodes
Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert. mark for My Articles similar articles