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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 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. |
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. |
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 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. |
Pharmaceutical Executive September 1, 2008 Jeffrey S. Aronin |
The Orphan Opportunity The Orphan Drug Act was passed 25 years ago. But the challenge of actually getting rare disease drugs and therapies to patients still remains |
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. |
Pharmaceutical Executive July 30, 2007 Louis A. Morris |
Safety Net The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages. |
Pharmaceutical Executive April 1, 2012 Feam & Lagus |
Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help. |
Pharmaceutical Executive February 1, 2006 Jill Wechsler |
Washington Report: Cross-Agency Collaboration for Part D Medicare Part D gives CMS more clout over coverage, pricing, and even drug development. |
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. |
The Motley Fool April 1, 2004 Charly Travers |
Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration. |
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. |
The Motley Fool April 30, 2004 Charly Travers |
Sales Weakness From InterMune Biotechnology company InterMune would seem to be in good shape with a drug, Actimmune (which helps boost the immune system of cancer patients and others). The drug, however, has been showing quarterly sales weakness since early 2003, a trend that now seems like it may continue into the future. |
Managed Care March 2005 Martin Sipkoff |
Direct-to-Consumer Ads Garner Mixed Outcomes DTC advertising's reputation as a bully may be largely overstated. There's little evidence that sales of specific drugs increase, and there may be some benefit. |
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. |
The Motley Fool April 16, 2008 Brian Lawler |
Cephalon Convinces the Continent The pharmaceutical's lead pain drug gets approved for marketing in Europe. |
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. |
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. |
The Motley Fool December 4, 2007 Brian Orelli |
An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications. |
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? |
Pharmaceutical Executive March 1, 2006 Jill Wechsler |
Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too. |
The Motley Fool December 27, 2007 Brian Lawler |
A New Era at Millennium? Millennium Pharmaceuticals submits a supplemental New Drug Application with the FDA to expand the use of lead drug Velcade to patients with multiple myeloma. |
Pharmaceutical Executive June 1, 2005 Jill Wechsler |
Washington Report: "D" Is for Data It is critical for Medicare to address important questions on drug safety and utilization, and about how prescribing decisions affect health outcomes and costs. |
Pharmaceutical Executive June 1, 2006 Nancy Dreyer |
Personalized Medicine Meets the Real World A wave of genomic medicines is coming down the pipeline, and they're going to be expensive. Can companies prove they're worth it? Maybe: but the claims payers seek aren't coming from traditional clinical trials. |
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 May 10, 2011 Brian Orelli |
Uncontrolled Crying Over AVANIR's Prescription Data? It's been a slow start, but don't write off this company's pseudobulbar drug just yet. |
Managed Care September 2004 Thomas Morrow |
Orphan Drug Act Treatments Deserve Full Insurance Coverage An important federal law encourages development of drugs for populations so small that the market would otherwise ignore them. Should they not then be covered? |
Pharmaceutical Executive June 1, 2014 Jill Wechsler |
Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D. |
The Motley Fool March 1, 2007 Brian Lawler |
Know Your Drug Stock ABCs: Part 2 Investing in the pharmaceutical and biotechnology industries can be difficult. Here are terms investors should know to better understand how the clinical trial process involved with bringing a drug to market works. |
Reason Aug/Sep 2007 Kerry Howley |
Dying for Lifesaving Drugs Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments? |
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. |
The Motley Fool December 6, 2005 Stephen D. Simpson |
Tysabri Tries Again Will the FDA finally approve Elan's multiple sclerosis drug? Investors' fingers are crossed. |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
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 July 1, 2009 Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
Investment Advisor December 2005 Greg B. Scott |
Buying The Future Prudent investing in biotechnology can offer great returns for clients. It's also the wave of the future. Armed with a basic understanding of the dynamics of the industry and the valuation inflection points, intelligent investors can make significant returns. |
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. |
Pharmaceutical Executive November 1, 2012 Sue Barrowcliffe |
Real World Insights Commercial teams as well as patients can benefit from managed access programs, which are designed to provide access to medicines outside of the clinical and commercial setting, for patients who have no other available treatment options. |
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 September 14, 2006 Brian Lawler |
Close Failure for Genzyme Will Genzyme's Campath get approval? Investors shouldn't hold their breath. |
The Motley Fool June 4, 2007 Brian Orelli |
OXiGENE's Moving Ahead The drug maker reaches a deal with FDA on its lead compound. Investors, take note. |
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 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 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 16, 2007 Brian Orelli |
Not a Blockbuster -- Yet Merck gains marketing approval for its newest HIV drug. Investors, take note. |
BusinessWeek January 30, 2006 Catherine Arnst |
Going Broke To Stay Alive Rising prices for cancer treatments are making patients - and doctors - balk. |
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 September 13, 2007 Brian Orelli |
Progenics Progresses Progenics and partner Wyeth announce plans to start three new clinical trials on their constipation-relieving drug. The patient treatment time for the trials is relatively short, so investors won't have to wait too long to see how the drug performs. |
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. |