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The Motley Fool March 18, 2008 Brian Orelli	Dynavax Gets Held Up The FDA puts a clinical hold on Dynavax Technologies hepatitis B vaccine. Investors, take note.
The Motley Fool May 10, 2011 Brian Orelli	Pfizer's Multibillion-Dollar Blockbuster Set to Grow Pfizer will make money off old people, too.
The Motley Fool December 4, 2006 Brian Lawler	Success for Dynavax Solid results from the first of three phase III trials cause the biopharmaceutical Dynavax's shares to rise.
The Motley Fool February 28, 2007 Brian Lawler	Dynavax Down but Not Out Drug developer Dynavax gives guidance for 2007 after its lead drug candidate fails in clinical testing.
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 November 27, 2006 Brian Lawler	Pharmaxis Gets Good News From the FDA Fast-track designation gives this pharmaceutical stock a bump.
The Motley Fool November 19, 2009 Brian Orelli	Pfizer Dodges a Bullet The drugmaker slips through an advisory committee unscathed.
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 February 25, 2010 Brian Orelli	13 Is Pfizer's Lucky Number Inherited from Wyeth, Prevnar 13 could be a goldmine for Pfizer.
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 August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
The Motley Fool May 9, 2007 Brian Lawler	Diagnosing Dendreon Postmortem The FDA issues an approvable letter for Dendreon's top compound. Investors, take note.
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 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 September 16, 2008 Brian Lawler	Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site.
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.
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 March 3, 2009 Brian Orelli	A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals.
The Motley Fool June 29, 2004 Charly Travers	Antegren Gets Priority Review The FDA steps up the drug's time line for approval.
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, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
The Motley Fool June 16, 2011 Brian Orelli	Are Two FDA Approvals in One Week a Positive Sign? Bristol-Myers Squibb received Food and Drug Administration approval for its kidney transplant drug Nulojix yesterday, marking the second approval this week from the FDA.
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 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 May 11, 2010 Brian Orelli	Swine Viruses Strike Again In March, the FDA recommended that doctors stop using GlaxoSmithKline's Rotarix, but still hasn't made a final decision on the drug.
The Motley Fool January 15, 2010 Brian Orelli	Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all.
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 May 31, 2011 Brian Orelli	Pay Attention, Biotech Investors Competitors and partners can't be ignored.
The Motley Fool March 10, 2008 Brian Orelli	A Drug to Wake Up Schering Bridion gets an FDA panel review.
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 Brian Orelli	3 More Stock-Moving Binary Events to Watch in 2012 There are a lot of drugs that will face binary events in 2012 -- here are three to watch.
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 November 8, 2007 Charly Travers	BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent.
The Motley Fool May 13, 2011 Brian Orelli	FDA Advisory Panel Positive! Shares Punished. Despite the positive recommendation, investors aren't convinced BioMimetic's Augment will be approved.
The Motley Fool August 11, 2004 Charly Travers	Utah Medical Slapped by the FDA In this suit, the FDA is seeking to bar the company from manufacturing and distributing medical devices until it complies with the FDA's Quality System regulation (QSR). This event rocked the stock, sending it down nearly 33% for the day.
The Motley Fool April 4, 2007 Brian Lawler	Novartis Gets Nicked Novartis pulls one of its top-selling drugs from the market. Investors should come to expect drug delays or similar issues popping up from time to time when doing their analysis of large pharmas.
Bio-IT World September 16, 2004 Paul King	Growing Gains When it comes to information technology requirements, the biotech industry is unlike any other. A key enabler of efficient and effective growth is the adoption of IT strategies specific to each of four key stages.
The Motley Fool December 5, 2006 Matt Koppenheffer	The 5-Sigma Report What caused the biggest moves of the week? Abington Community Bancorp... Dress Barn... Dynavax Technologies... DSW...
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 November 3, 2009 Brian Orelli	A Little Distracted, Are You, Merck? The FDA rejects its latest application.
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
The Motley Fool May 30, 2008 Brian Orelli	No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil.
The Motley Fool December 31, 2009 Brian Orelli	2010 FDA Decisions to Watch It's a pivotal year for these drugmakers.
The Motley Fool May 15, 2006 Brian Gorman	AstraZeneca's Peer-Pressure Purchase The drug company seems to be paying a lot for Cambridge Antibody. Perhaps AstraZeneca didn't want to be left behind as its rivals bought up biotech technology -- but in its haste, it may be paying a steep price for what it's getting. Investors, take note.
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 January 4, 2012 Brian Orelli	This Biotech's Obese To-Do List Is Done Arena resubmits lorcaserin for FDA approval.
The Motley Fool September 30, 2008 Brian Lawler	No Approval for You ... Yet The FDA makes Eli Lilly wait for word on a lead drug.
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 February 21, 2008 Brian Lawler	A Bit of Irony From the FDA The agency has a mixed message on drug importation, as evidenced in the recent possible contamination of China-produced Heparin.
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.