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The Motley Fool
May 21, 2010
Brian Orelli |
And You Thought Biotech Was High-Risk, High-Reward Large clinical trials make cardiovascular drugs risky, but the rewards are there, too.   |
The Motley Fool
November 30, 2010
Brian Orelli |
A Witty Response to Pharma's R&D Dilemma According to GlaxoSmithKline CEO Andrew Witty, the pharmaceutical industry is a mess. That's the basic gist of his opinion piece in The Economist. |
Pharmaceutical Executive
April 1, 2011 |
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help. |
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 28, 2010
Luke Timmerman |
Future Biotech Winners Will Help Nurses Clean Up Less (Stuff) It's not enough anymore to prove your drug is safe and effective enough to pass muster with the FDA. Now it's also about proving a drug can generate savings and value for the health care system. |
The Motley Fool
June 3, 2011
Brian Orelli |
FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully. |
The Motley Fool
March 31, 2011
Brian Orelli |
Hepatitis C Drugs Heat Up The current hepatitis C drugs stink. Who's ahead in the race to find new ones? |
Pharmaceutical Executive
June 1, 2006
Jill Wechsler |
Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules. |
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, 2014
Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
Chemistry World
May 8, 2008
Hepeng Jia |
China to fast track pioneering drugs China is to speed up the approval of groundbreaking new drugs in an effort to encourage innovation in its pharmaceutical sector, a State Food and Drug Administration (SFDA) official has revealed. |
Pharmaceutical Executive
October 1, 2010 |
Taking a Less-Generic Route to Generics A leading pharmaceutical industry player speaks out on what is fueling success in the sector. |
BusinessWeek
May 27, 2010
Michelle Cortez |
Karo Bio's Prescription: Cheaper Drug Approval A Swedish company seeks a lower-cost review for its cholesterol drug. |
The Motley Fool
July 12, 2010
Ryan McBride |
Synta Pharma CEO Trumpets New Top Cancer Drug Synta Pharmaceuticals has been climbing back from one of the Boston area's highest-profile clinical trial failures of 2009. |
Chemistry World
September 11, 2012
Maria Burke |
Orphan drugs set for 'tremendous growth' A new report by Thomson Reuters offers clear confirmation that developing drugs for rare, or orphan, diseases is economically attractive, despite the smaller patient pool. |
Bio-IT World
September 2006
Kevin Davies |
The $2 Billion Pill? Challenges and opportunities facing the drug industry were recurring themes in the quartet of keynote speeches at the 2006 Drug Discovery Technology conference. |
The Motley Fool
July 1, 2011
Alex Crawford |
3 Biotech Drugs With Promising Phase III Data, Moving Into FDA Review Do these drugs have a chance of FDA approval? |
Chemistry World
March 27, 2013
Eugene Gerden |
Russian investment vehicle sets sights on innovative drugs Russian state-owned nanotechnology giant Rusnano is hoping to break into the pharmaceutical sector with sizeable investments in firms seeking to produce innovative drugs. |
The Motley Fool
August 31, 2010
Brian Orelli |
Drugmakers May Lose a Back Door for Drug Approval Non-inferiority trials may be inferior. |
Pharmaceutical Executive
January 1, 2006
Clinton & Wechsler |
What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay? |
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 20, 2010
Brian Orelli |
Potential Blockbuster, No Me-Too About It A diabetes-fighting duo do it right this time. |
The Motley Fool
April 25, 2011
Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it? |
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
April 26, 2011
Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
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. |
Bio-IT World
August 13, 2003
John Rhodes |
Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert. |
Pharmaceutical Executive
September 1, 2005
Parker & Amar |
Building Blockbusters The most lucrative new drugs are often less glamorous than first-in-class new molecular entities. And they are much less risky. |
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. |
The Motley Fool
September 7, 2010
Luke Timmerman |
Vertex Nails Third Big Trial With Hepatitis C Drug And in the toughest patients to treat, too. |
The Motley Fool
May 17, 2010
Luke Timmerman |
Vertex Awaits Final Proof that Hepatitis C Drug Works For this drug researcher, the proof is in the telaprevir. |
The Motley Fool
September 8, 2010
Brian Orelli |
You Must Realize This Drug Works by Now Vertex concludes its phase 3 trials with another win. |
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. |
Chemistry World
September 24, 2010
Andrew Turley |
End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use. |
The Motley Fool
July 28, 2010
Jordan DiPietro |
3 Biotechs on Your Radar Screen It's not easy keeping track of all the drugs coming in and out of the development pipeline, but if you can stay up to date, you often have an advantage |
Pharmaceutical Executive
September 1, 2013
Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
The Motley Fool
August 24, 2011
Brian Orelli |
Can Roche and Merck Succeed Where Pfizer Failed? CETP inhibitors are lucrative but risky. |
The Motley Fool
September 23, 2010
Brian Orelli |
A Blockbuster in Due Time Novartis' new multiple sclerosis drug, Gilenya, isn't king yet. |
BusinessWeek
August 26, 2010
Tom Randall |
Cocktails Are Next For Cancer-Drug Makers Taking a cue from the cocktails of drugs that have made AIDS survivable, drugmakers are pursuing combination therapies against cancer. |
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. |
Chemistry World
November 2010 |
Column: In the Pipeline Should drug companies focus on big markets and the blockbuster dream? |
Pharmaceutical Executive
September 1, 2010 |
Explaining the Drug Drought Industry needs to engage in a broader public debate on ways to rekindle the innovative engine in new drug discovery and development. |
The Motley Fool
May 27, 2011
Brian Orelli |
Don't Believe the Obesity Hype Meta-analysis data isn't going to help Arena Pharmaceuticals' obesity drug. |
Pharmaceutical Executive
October 1, 2012
Jill Wechsler |
Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny. |
The Motley Fool
November 15, 2007
Charly Travers |
John Edwards, Frozen Caveman Lawyer Presidential hopeful John Edwards' health-care plans could destroy drug research and development in this country by removing the patent protection on breakthrough drugs. |
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 21, 2010
Brian Orelli |
Here's That Critical Merck Info You Missed Announcing clinical trial failures in a FAQ? Really? |
BusinessWeek
November 29, 2004
Catherine Arnst |
Big Pharma's Blinders Hugely profitable thanks to a few blockbusters, Big Pharma is far too focused on looking for the next best-seller, causing companies to pass up opportunities to deliver important breakthroughs. |
Pharmaceutical Executive
November 1, 2011
Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
The Motley Fool
April 13, 2011
Brian Orelli |
Abbott's Potential Billion-Dollar Problem Abbott's Humira forms antibodies in nearly a quarter of patients. |
