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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 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.  |
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 January 31, 2008 Brian Lawler |
A Zettlement for Zyprexa? Eli Lilly may be close to resolving a government lawsuit over improper marketing.  |
The Motley Fool October 2, 2007 Billy Fisher |
Closure for Bristol-Myers Bristol-Myers will pay $515 million to resolve cases from state and federal authorities alleging that the company promoted products for uses that hadn't been approved by the FDA.  |
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 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 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?  |
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.  |
Chemistry World June 10, 2014 Anthony King |
Drug giants settle mismarketing lawsuits Pfizer and GlaxoSmithKline recently agreed to separate settlements over allegations of mismarketing drugs in the US.  |
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 11, 2009 Brian Orelli |
Kids, Take Your Antipsychotics! Drugs to combat mental illness might gain FDA approval for children.  |
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.  |
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 March 19, 2008 Brian Lawler |
InterMune Suffers a Postscript The former CEO is indicted, but that shouldn't hurt the drugmaker.  |
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 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.  |
Pharmaceutical Executive February 1, 2014 Longacre et al. |
Social Media: Have We Reached The Tipping Point? For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites. This month FDA released its draft guidance on the use of "Interactive Promotional Media."  |
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.  |
Pharmaceutical Executive January 1, 2006 Cinquegrana & Lloyd |
Legal: Shifting Perspective on Off-Label Promotion A recent court case points to the government's shifting perspective on how it prosecutes companies for promoting off-label. Instead of criminal charges, hefty corporate integrity agreements might be in store.  |
The Motley Fool November 3, 2009 Brian Orelli |
A Little Distracted, Are You, Merck? The FDA rejects its latest application.  |
The Motley Fool April 1, 2004 Charly Travers |
Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration.  |
The Motley Fool January 27, 2009 Robert Steyer |
Another Angle for Fibromyalgia In the past 18 months, the FDA has approved three drugs that can be used to treat the disease. Which pharma companies will benefit?  |
Pharmaceutical Executive February 1, 2013 Jill Wechsler |
Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending.  |
Pharmaceutical Executive January 1, 2012 |
Compliance: Getting Those Ducks in a Row Pharma must coordinate the efforts of medical, legal, HR, global partners and many other players in the regulatory compliance space to keep itself afloat in choppy seas.  |
The Motley Fool April 11, 2008 Brian Lawler |
Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.  |
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 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 August 23, 2004 Ben McClure |
Rethinking Big Pharma Risk is knocking Big Pharma stocks down. They won't be getting up anytime soon. Competition, soaring R&D costs, shifting business models, and political meddling combine to make drug stocks a riskier place to invest.  |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site.  |
BusinessWeek February 16, 2004 Catherine Arnst |
Medicare vs. Cancer Patients Refusing to reimburse off-label treatment is far from the best way to cut costs.  |
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin |
Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.  |
Chemistry World December 22, 2010 Sarah Houlton |
Fines, Flu and an Uncertain Future It was another tough year for the pharma industry, with downsizing, pricing concerns and the impending expiration of patents on many products. But some of the biggest headlines were caused by eye-watering fines dished out in the US.  |
Pharmaceutical Executive October 1, 2011 Jill Wechsler |
"Representing" Healthcare to the Fullest Since coming to Congress about 35 years ago, Henry Waxman, Congressional Representative from Los Angeles, California, has been pivotal in shaping legislation on health and drug regulatory issues.  |
Chemistry World June 22, 2011 Sarah Houlton |
US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe.  |
The Motley Fool November 18, 2008 Brian Orelli |
Genzyme Grounded for Thanksgiving The biotech won't get a decision on Myozyme until February.  |
The Motley Fool November 14, 2007 Brian Lawler |
Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years.  |
The Motley Fool January 8, 2008 Brian Orelli |
A Painful Reminder From the FDA The agency issues a reminder that osteoporosis drugs can cause severe pain.  |
BusinessWeek April 25, 2005 Barrett & Carey |
"Off-Label" Drugs: J&J Is Pushing The Envelope Recommending uses for its drugs not intended when approved by the FDA.  |
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.  |
The Motley Fool December 31, 2007 Brian Lawler |
Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners.  |
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.  |
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.  |
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.  |
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.  |
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 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 September 12, 2005 M.D. Mitchell |
Big Problems for Big Pharma Creating new drugs is never easy, but the companies that excel in three key areas are the ones for investors to watch.  |
The Motley Fool June 24, 2011 Brian Orelli |
Come on, Pfizer, Not Even a Little Hint? Remoxy is rejected, but why?  |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.  |