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The Motley Fool August 1, 2008 Brian Lawler	Holy Moley, CV Therapeutics! With big successes on the regulatory and financial fronts, CV Therapeutics has had a quarter where everything went right.
The Motley Fool April 17, 2008 Brian Lawler	CVT's Copacetic Cash Management Drugmaker CV Therapeutics signs away a little portion of its royalty stream from a recently approved drug, in order to get a lot back.
The Motley Fool August 1, 2007 Brian Lawler	CV Therapeutics' Turnaround Quarter Putting a close to a turnaround second quarter, CV Therapeutics announced its financial results recently. It looks like shareholders are in for some good times.
The Motley Fool February 13, 2007 Brian Lawler	CVT, We Wait for Thee CV Therapeutics' angina treatment could be set for a big boost. But what investors are getting with CVT today is a specialty pharma that is rapidly burning the cash on its balance sheet.
The Motley Fool April 28, 2008 Brian Lawler	CV Therapeutics Feels the Love CV Therapeutics announces its second regulatory thumbs-up this month, after its lead drug Ranexa was essentially approved in the European Union.
The Motley Fool August 14, 2008 Brian Lawler	A Potentially Painless PDUFA Date King Pharmaceuticals and Pain Therapeutics get an appointment with the FDA.
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 July 10, 2006 Brian Lawler	CV Therapeutics Gets Greenlighted A final trial could secure full FDA approval for angina drug Ranexa. Investors, take note.
The Motley Fool March 7, 2007 Brian Lawler	A CV Therapeutics Buying Opportunity? Shares of CV Therapeutics tank after reporting mixed results from a pivotal clinical trial for its lead drug.
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 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.
The Motley Fool April 4, 2005 Karl Thiel	CV Therapeutics' Great Resume With biotechs in the doldrums, this investor goes hunting.
The Motley Fool December 9, 2008 Brian Orelli	The FDA Can't See the Forest or the Trees Forest Laboratories and Cypress Bioscience are still waiting for FDA approval, but now they've got more data to prove their point.
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 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 September 17, 2008 Brian Lawler	CV Therapeutics Expands Ranexa's Reach CVT announces that it has finally found a European marketing partner for its angina treatment Ranexa.
The Motley Fool January 28, 2011 Brian Orelli	Value Investing, Biotech Style Biotech investors should regard every binary event as a varying degree of confidence in a positive or negative result.
BusinessWeek February 2, 2004 Gene G. Marcial	CV Investors: Take Heart Lately, CV Therapeutics is bouncing around on rumors of what the Food & Drug Administration might do about Ranexa, CV's angina treatment. One New York fund manager, who asked not to be identified, is buying shares because he expects a takeover bid.
The Motley Fool November 7, 2007 Brian Lawler	Turnaround Time for CVT CV Therapeutics announces in its third-quarter financial results that it plans to have a better 2008; its angina drug shows promise for treating diabetics. Investors, take note.
The Motley Fool December 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
The Motley Fool September 26, 2006 Brian Lawler	CVT's Looming Date With Destiny A pivotal trial for its lead drug, Ranexa, is nearing completion. Investors, take note.
The Motley Fool December 30, 2008 Brian Orelli	The FDA Needs a Bake Sale Money seems to be at the root of the problem with the FDA right now. It's pretty clear that fees, even though they're up to over $1 million per marketing application, aren't enough to get things done in a timely manner.
The Motley Fool January 28, 2009 Brian Orelli	M&A Off the Beaten Path CV Theraputics gets courted.
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.
The Motley Fool September 29, 2011 Brian Orelli	Investors Guide to the New PDUFA Changes are in the air for drugmakers and the FDA.
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 May 4, 2011 Brian Orelli	Cell Therapeutics: Denied but Not Rejected Cell Therapeutics' ball may be headed for the end zone, but the FDA has an eight-foot free safety ready to bat it down.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool December 31, 2011 David Williamson	2011 Review: Cell Therapeutics After starting the year at a split-adjusted $2.22 a share, Cell Therapeutics stock lost almost 50% of its value by the end of December, closing at $1.16. How did we get here?
The Motley Fool September 14, 2010 Luke Timmerman	Arena Obesity Drug Effective by "Slim Margin"; Shares Tumble The market is reacting negatively to news about the company's weight-loss drug.
The Motley Fool November 1, 2006 Brian Lawler	Waiting for CVT's Trial Results The biopharm reported third-quarter 2006 earnings that were mostly as expected. Investors are just awaiting the clinical trial results from the company's large phase 3 Merlin study testing its marketed angina drug, Ranexa.
The Motley Fool January 14, 2008 Brian Lawler	Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.
The Motley Fool December 5, 2007 Brian Lawler	The FDA Says It Needs a Pep Pill Drugmakers offering new treatments might be discouraged by the FDA's latest report, in which the agency makes its case for additional funding from Congress.
The Motley Fool October 10, 2005 Stephen D. Simpson	The FDA: Boon, Bane, Whipping Boy Everyone wants the FDA to be faster, better, and cheaper, but that may not be a credible expectation. Investors would do well to keep an eye on the FDA because its policies and pressures ultimately filter down to our medicine cabinets, wallets, and portfolios.
The Motley Fool March 31, 2008 Brian Lawler	FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog.
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.
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
Pharmaceutical Executive August 1, 2012 Jill Wechsler	Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.
The Motley Fool March 12, 2009 Brian Orelli	2 Suitors Are Better Than 1 Recent drug company acquisitions prove that competition benefits shareholders.
The Motley Fool October 5, 2011 Brian Orelli	1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response.
The Motley Fool May 20, 2010 Brian Orelli	FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down.
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 February 1, 2012 Jennifer Ringler	Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines.
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, 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.
Pharmaceutical Executive January 1, 2009 Jill Wechsler	FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order?
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 October 1, 2008 Walter Armstrong	Global Warming Japanese Pharma is playing a game of catch-up, dropping big cash on biotechs and risky acquisitions. But with patents expiring and sales falling, can they really pay their way to global success?