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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 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 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 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 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 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 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 March 30, 2010 Brian Orelli	FDA Lags, Investors Flee Cephalon gets no love from the FDA. The agency failed to expand Cephalon's Nuvigil for the treatment of jet lag.
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 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 December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool April 4, 2005 Karl Thiel	CV Therapeutics' Great Resume With biotechs in the doldrums, this investor goes hunting.
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 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.
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.
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 December 27, 2010 Brian Orelli	FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered.
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 14, 2008 Brian Lawler	A Little Delay Goes Away for CVT CV Therapeutics can move ahead, now that it has won marketing approval for its cardiac stress agent regadenoson.
The Motley Fool April 28, 2011 Brian Orelli	Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval.
The Motley Fool August 23, 2010 Brian Orelli	No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week.
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 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 December 31, 2011 Brian Orelli	3 Stock-Moving Binary Events to Watch in 2012 Binary events, FDA decisions, and clinical trial results, are the lifeblood -- and death wish -- of the biotech industry. Here are three to watch in 2012.
The Motley Fool June 26, 2008 Brian Orelli	The FDA's Latest Victim Merck fails to get its Gardasil vaccine approved to treat older women.
The Motley Fool January 28, 2009 Brian Orelli	M&A Off the Beaten Path CV Theraputics gets courted.
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 December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool November 27, 2006 Brian Lawler	Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump.
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 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 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 March 31, 2011 Brian Orelli	Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good.
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.
The Motley Fool December 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
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 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 February 18, 2010 Brian Orelli	Still Restless for an Approval The FDA is like a box of chocolates: You never know what you're going to get -- rejection or acceptance.
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 April 3, 2009 Brian Orelli	Gilead: Helping Investors Cope With the Market Diversifying seems to be paying off for the drugmaker.
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 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 May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
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 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, 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 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 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 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 July 3, 2007 Louis A. Morris	Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way.