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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. |
Pharmaceutical Executive July 1, 2009 Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
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. |
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. |
The Motley Fool May 14, 2007 Mike Havrilla |
A Weaker Amgen Amgen's stock is trading lower after an FDA panel balked at two anemia drugs. |
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. |
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. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
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? |
The Motley Fool September 6, 2005 Stephen D. Simpson |
FDA's Eye on 2 Potential Blockbusters This week, FDA advisory panels will consider the marketing approval applications of Exubera, the inhaled insulin from Pfizer/Sanofi/Nektar, and Pargluva, the dual PPAR agonist, taken in pill form, from Bristol-Myers and Merck. Investors, take note. |
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. |
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. |
Managed Care February 2007 MargaretAnn Cross |
How Much Trouble Does Health Care Marketing Cause? Whether for drugs, imaging, surgery, or emergency services, direct-to-consumer advertising sparks lively debate. |
Reason September 2005 Kerry Howley |
Locking Up Life-Saving Drugs U.S. prescription laws make us sicker and poorer because the system that puts drugs over the counter is driven by profits and patents. |
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. |
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. |
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. |
Searcher June 2012 Stephanie C. Ardito |
The Medical Digital: How Safe Are the Prescription Drugs we Take? Monitoring Adverse Events and Recalls For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations. |
The Motley Fool November 30, 2007 Brian Orelli |
Clinical Trial Failures Don't Bother These Companies Contract research organizations, outsourcing companies hired by pharmaceutical and biotech companies to run pre-clinical tests and clinical trials for them, succeed even when drugs fail, and more work may be coming their way. |
Pharmaceutical Executive December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. |
Managed Care April 2004 John Carroll |
$50M for Drug Comparisons Could Produce Valuable Results The Medicare amendment adopted late last year contains a provision that could help P&T committees, not to mention consumers, evaluate competing drugs. |
Reason October 2007 Ronald Bailey |
Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest." |
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. |
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. |
Pharmaceutical Executive July 1, 2012 Jill Wechsler |
Who Will Pay for New Drugs? Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies. |
Chemistry World May 15, 2009 Katrina Megget |
Tripping over red tape The UK may be moving a step closer to allowing the use of a cannabis-based drug to treat the symptoms of multiple sclerosis |
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 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. |
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. |
BusinessWeek July 2, 2007 Arlene Weintraub |
Lifestyle Drug Binge The huge profits in weight-loss and other treatments makes them hard for drugmakers to resist. But safety risks abound. |
Pharmaceutical Executive September 1, 2013 Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
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? |
Pharmaceutical Executive July 1, 2014 Jill Wechsler |
Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace. |
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. |
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. |
Bio-IT World August 13, 2002 Mark D. Uehling |
Clinical Trial Data Management: Tortured by Paper Reams of paper stuffed into boxes and shipped to the FDA by the truckload is hardly the best approach to drug approval. But what's the right way? |
Pharmaceutical Executive March 1, 2012 Ron Cohen |
FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership. |
Pharmaceutical Executive January 1, 2012 Jill Wechsler |
New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation. |
The Motley Fool November 12, 2009 Brian Orelli |
The Life-and-Death Situation That Isn't Branded-drug makers aren't playing fair because they refuse to sell samples to generic drug makers. |
Pharmaceutical Executive January 1, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
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 September 10, 2007 Brian Lawler |
Get a Glimpse of Amgen's Future Investors will want to pay attention to an FDA advisory panel meeting discussing new labeling recommendations for Amgen's anemia medications. The two drugs represented 44% of the pharmaceutical company's second-quarter revenue. |
Pharmaceutical Executive November 1, 2013 Jill Wechsler |
Transparency Troubles for Pharma High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise. |
AskMen.com Richard Stevens |
Participating In Clinical Trials Check out what participating in clinical trials involves and how you can join a study. You may even make some cash in the process. |
The Motley Fool April 14, 2008 Brian Orelli |
Stem Cells Show Off The FDA moves closer to setting up stem cell clinical trials, setting guidelines that put treatment safety first and foremost. |
Pharmaceutical Executive June 1, 2012 Jill Wechsler |
Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market. |
The Motley Fool December 11, 2006 Michael P. Cecil |
Why Doesn't Buffett Buy Drug Companies? Investors, how do you estimate the amount of money that a drug company, or perhaps more simply one of its drugs, will produce over its lifetime? |
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 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 January 26, 2005 Stephen D. Simpson |
The Pipeline to Biotech Success Looking at drug R&D is the best way to begin assessing biotech companies as possible investment opportunities. |