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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 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, 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.
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.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
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 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.
Managed Care June 2002	Oncologists: FDA needs to speed up approval of cancer-fighting drugs A Competitive Enterprise Institute survey of cancer specialists found that almost 8 of 10 oncologists think the FDA's approval process has "hurt their ability, at least once in their medical careers, to treat patients with the best possible care."
The Motley Fool April 1, 2004 Charly Travers	Atrix Batting 1.000 Atrix Laboratories' drugs have breezed past the Food and Drug Administration.
The Motley Fool November 19, 2004 Charly Travers	A New Drug for Lung Cancer Genentech and OSI's launch of Tarceva brings a new choice in the treatment of lung cancer.
Pharmaceutical Executive April 1, 2012 Feam & Lagus	Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help.
BusinessWeek February 16, 2004 Catherine Arnst	Medicare vs. Cancer Patients Refusing to reimburse off-label treatment is far from the best way to cut costs.
The Motley Fool November 29, 2011 Brian Orelli	Winners and Losers of Roche's Avastin Woes What the FDA giveth, the FDA can taketh away.
The Motley Fool April 7, 2011 Brian Orelli	Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market.
The Motley Fool January 29, 2008 Brian Lawler	Genentech Adds to Avastin's Arsenal Genentech's lead drug Avastin gains another use -- just not the one investors expected.
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 December 20, 2004 Charly Travers	More Trouble at Big Pharma AstraZeneca's lung cancer drug is not as effective as once hoped.
The Motley Fool June 18, 2010 Brian Orelli	Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday.
The Motley Fool June 4, 2007 Brian Orelli	OXiGENE's Moving Ahead The drug maker reaches a deal with FDA on its lead compound. Investors, take note.
The Motley Fool March 28, 2007 Brian Lawler	Nuvelo Gets Fast One of Nuvelo's compounds gets fast track designation. Investors, take note.
The Motley Fool November 17, 2006 Brian Lawler	Genentech Gets Another Approval Today, Genentech finally received formal approval to market its breast cancer therapy Herceptin for the early stages. Investors, take note.
The Motley Fool February 25, 2008 Brian Lawler	A Positive Surprise for Genentech Biopharma Genentech's lead drug gets a conditional OK to treat breast cancer.
The Motley Fool March 22, 2005 Charly Travers	Do Good Drugs Guarantee Investment Success? By the time you know a drug is good, are you late to the party? Instead of trying to catch a train that has already zipped by, try investing in drug programs well in advance of phase 3 trials.
The Motley Fool February 26, 2011 Brian Orelli	FDA Applications and a Look Ahead It isn't pretty.
The Motley Fool April 26, 2004 Alyce Lomax	Genentech's Lucky Day Genentech and OSI Pharmaceuticals jump in today's trading session after favorable trial results for a cancer drug.
Pharmaceutical Executive June 1, 2014 Jill Wechsler	What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices.
The Motley Fool May 27, 2009 Brian Orelli	It's Approved! Now Back to Work Now that Bristol-Myers has received approval on its cancer drug Sprycel, it can get back to working on getting it out of its niche market and approved to treat other types of cancer.
The Motley Fool January 31, 2008 Brian Lawler	Prioritizing Millennium The FDA grants a speedy review for Millennium Pharmaceuticals's lead multiple myeloma drug.
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.
Pharmaceutical Executive November 1, 2014 Jill Wechsler	Outrage Grows Over Drug Pricing Insurers, physicians attack high-cost therapies in anticipation of specialty drug surge.
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.
Pharmaceutical Executive June 1, 2007 Clinton & Wechsler	The View From Inside Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine.
HBS Working Knowledge August 10, 2015 Michael Blanding	New Medical Devices Get To Patients Too Slowly The FDA has streamlined drug testing to ensure new therapies come to market quickly. But when it comes to life-giving medical devices, approvals seem unnecessarily slow, according to research by Ariel Dora Stern.
Chemistry World February 14, 2012 Rebecca Trager	FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones.
The Motley Fool May 22, 2008 Brian Lawler	All Is Not Lost for AstraZeneca's Iressa AstraZeneca's Iressa gets a little pep back.
Pharmaceutical Executive February 1, 2006 Bryan Luce	Back Page: Taking Hold of the Wheel Healthcare decision makers do not consistently consider drugs' value. FDA needs to be pressured to change its stance on communicating economic evidence.
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.
The Motley Fool December 31, 2007 Brian Lawler	Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners.
The Motley Fool May 26, 2011 Brian Orelli	Congress Sets Bad Precedent With AVANIR What happened to free markets?
Pharmaceutical Executive May 1, 2007 Patrick Clinton	The Topic of Cancer What will tomorrow's cancer commercialization model really look like? We asked four heavyweights from the world of oncology what they thought.
The Motley Fool August 29, 2011 Brian Orelli	Drug Approved for Few Patients -- but That's OK The age of personalized medicine is upon us. Earlier this month, the FDA approved Roche's melanoma drug Zelboraf for patients with a specific mutation in BRAF. And on Friday, the agency approved Pfizer's Xalkori for lung cancer patients that are ALK-positive.
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.
BusinessWeek November 29, 2004 Carey & Barrett	Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do.
The Motley Fool September 27, 2010 Brian Orelli	Now That's What I Call a Drug That Works Seattle Genetics hits a home run -- and then some -- with its cancer drug Brentuximab vedotin.
BusinessWeek January 30, 2006 Catherine Arnst	Going Broke To Stay Alive Rising prices for cancer treatments are making patients - and doctors - balk.
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.
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.
Pharmaceutical Executive February 1, 2013 Jill Wechsler	Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending.
The Motley Fool July 6, 2009 Brian Orelli	Lilly Shows Us How It's Done The company announces that the Food and Drug Administration had expanded the approval of its cancer drug, Alimta, to include maintenance therapy for nonsquamous, non-small cell lung cancer.