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Pharmaceutical Executive December 1, 2006 Jill Wechsler |
Washington Report: The New Agenda Democrats are back on top in Congress after more than a decade as underdogs. The new leaders are mapping out a broad agenda with drug pricing and access high on the list. |
The Motley Fool August 6, 2007 Brian Orelli |
Congress' Delay May Hurt Drugmakers The reauthorization of the Prescription Drug User Fee Act is delayed. If you're an investor in drug companies, now might be a good time to call your representatives and senators. |
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. |
Managed Care August 2000 |
Competing Bills Put Drug Benefit In Medicare Analysts say chances of a Medicare drug benefit passing the Senate are slim. The Senate began debate on competing bills after the House narrowly passed a Republican-backed prescription benefit proposal. |
Pharmaceutical Executive December 1, 2010 Jill Wechsler |
New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research |
Pharmaceutical Executive January 1, 2011 Jill Wechsler |
Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead. |
Pharmaceutical Executive January 1, 2006 Jill Wechsler |
Washington Report: PDUFA Blues The Prescription Drug User Fee Act is up for reauthorization. Let the games begin. |
The Motley Fool September 18, 2007 Brian Orelli |
PDUFA Reauthorization: Almost There Much to the applause of drug makers and those who invest in them, the Prescription Drug User Fee Act reauthorization looks like it could come out of a Congressional conference committee as early as this week. |
Pharmaceutical Executive September 1, 2011 Jill Wechsler |
Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight. |
Pharmaceutical Executive March 1, 2007 Jill Wechsler |
Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process. |
BusinessWeek May 21, 2007 John Carey |
A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it? |
Food Engineering September 1, 2006 |
Regulatory Watch Consumer advocates and a recently retired FDA official line up against the proposed National Uniformity for Food Act. |
The Motley Fool January 28, 2005 Karl Thiel |
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous. |
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. |
Pharmaceutical Executive January 1, 2007 |
Thoughtleader: Peter Pitts. DrugWonks.com Here, the chief voice of a blog hosted by the non-profit Center for Medicine in the Public Interest urges pharma to continuously plug its positions and get politics out of science, and offers some perspective on important regulatory reforms facing the FDA. |
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 August 17, 2011 Brian Orelli |
Generic-Drug Makers Pay for Speed Lower margins -- faster. |
U.S. Banker May 2009 Stacy Kaper |
Will Close Vote Doom Card Reform? Although the Senate Banking Committee has voted to adopt comprehensive credit card reforms, the close margin cast doubt on its odds for enactment. |
The Motley Fool January 21, 2011 Brian Orelli |
Mark Your Calendar, Drug Investors Vertex announces that the Food and Drug Administration has accepted its New Drug Application to market telaprevir. |
The Motley Fool March 10, 2010 Brian Orelli |
Up 160% With Room to Run You've got to love biotech and InterMune. |
Pharmaceutical Executive September 1, 2006 Jill Wechsler |
Pharm Exec Q&A: A Soft Spot for Whistleblowers FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive interview, he explains where the agency goes wrong and what he would do to fix it. |
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 April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. |
Chemistry World July 16, 2010 Matt Wilkinson |
Bittersweet victory for GSK's Avandia GlaxoSmithKline has received a muted 'thumbs up' from a US regulatory advisory panel for its much-maligned Type 2 diabetes drug Avandia (rosiglitazone), making it likely the US Food and Drug Administration will allow the UK-based pharma giant to continue selling the drug in the US. |
Pharmaceutical Executive March 1, 2013 Jill Wechsler |
Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year. |
Pharmaceutical Executive March 1, 2012 Jill Wechsler |
When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications. |
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? |
The Motley Fool April 29, 2008 Brian Orelli |
Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month. |
The Motley Fool May 25, 2011 Brian Orelli |
Optimer's Upcoming FDA Decision: Memorable or Memorial? We'll know on Memorial Day, plus or minus a few days. |
Pharmaceutical Executive September 1, 2005 Jill Wechsler |
Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency. |
The Motley Fool March 31, 2008 Brian Lawler |
FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog. |
Real Estate Portfolio Nov/Dec 2003 Matthew Bechard |
Sen. Edward Kennedy on Partisanship, Preserving Pensions and the Value of REITs As the senior Democrat on the Health, Education, Labor and Pensions Committee in the Senate, Kennedy is actively involved in shaping policy affecting education, health care and pension plans -- an issue of particular importance to the REIT industry. An interview. |
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. |
InternetNews July 1, 2005 Roy Mark |
Senators Prescribe Health IT Legislation Bill explores ways to apply latest information technology to nation's health records. |
The Motley Fool January 20, 2010 Brian Orelli |
Health-Care Reform: It's Not Over Yet Massachusetts has spoken with its election of Scott Brown to the Senate. What's up next? |
The Motley Fool December 9, 2008 Brian Orelli |
Presents or Coal From the FDA? Let's take a look at a few companies expecting FDA decisions this month and see whether they're more likely to get a present or a lump of coal in their marketing-application stockings. |
Pharmaceutical Executive May 1, 2005 Jill Wechsler |
Washington Report: The Pendulum Swings FDA cracks down on safety. Haven't we been here before? Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment. |
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 March 19, 2007 Brian Lawler |
Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note. |
Investment Advisor January 1, 2011 Melanie Waddell |
New Year Will Likely Include New Tax Scheme Odds favor both House and Senate passage of bipartisan tax package. |
Pharmaceutical Executive February 1, 2011 Jill Wechsler |
Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency |
The Motley Fool August 20, 2010 Brian Orelli |
Depression Is Painful. Advisory Panels More So. Eli Lilly's Cymbalta has a rough time in from of the panel of experts. |
The Motley Fool July 29, 2010 Brian Orelli |
This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either. |
The Motley Fool October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
The Motley Fool May 26, 2009 Brian Orelli |
When Higher Costs Are a Good Thing The Food and Drug Administration proposed its budget for the next fiscal year, including user fees for pharmaceutical companies. But GlaxoSmithKline, Merck, and the rest of the industry probably won't complain too loudly. |
Managed Care June 2006 John Carroll |
Association Health Bill Fails Despite Senators' Support Patient advocacy groups work overtime to kill legislation that businesses felt would have provided less costly coverage for their employees. |
Chemistry World March 6, 2014 Rebecca Trager |
Politicians accuse US food agency of illegally monitoring employees Republican leaders on two key congressional committees have concluded in a new report that the US Food and Drug Administration illegally monitored email communications sent by whistleblowers in the agency. |
The Motley Fool April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. |
The Motley Fool November 9, 2009 Brian Orelli |
Health-Care Reform: A Tale of Two Chambers Halfway done, but the battle is just heating up. |
Food Processing September 2010 Diane Toops |
Congress Scrambles to Pass Food Safety Legislation As Congress has argued over health care reform, financial reform, two wars, a mortgage crisis and unemployment, amending the U.S. food safety system was put on the back burner. |