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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.
Bio-IT World December 15, 2003 Kevin Davies	The Road to Personalized Medicine FDA guidance on the road to genomic medicine is a welcome first step in what promises to be a contentious debate on how to integrate pharmacogenomics into routine medical practice.
Bio-IT World June 12, 2002 Malorye Branca	FDA Fosters Pharmacogenomics One reason pharmaceutical companies have been slow to embrace pharmacogenomics is the fear that it will be difficult to get such products through the FDA. Lawrence J. Lesko, director of the FDA's Office of clinical pharmacology and biopharmaceutics, talks about his hopes for the field.
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 October 27, 2010 Ralph Casale	Companion Diagnostics in Cancer Drug Development Diagnostic companies partnering with drug developers can make for an attractive investment segment.
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.
Pharmaceutical Executive March 1, 2011 Jerry Coamey	Engage the Physician! New research shows that gauging the mind of the clinician is crucial to timely uptake of the new diagnostic tools offered by the genomic revolution
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.
Pharmaceutical Executive November 1, 2012 Sue Barrowcliffe	Real World Insights Commercial teams as well as patients can benefit from managed access programs, which are designed to provide access to medicines outside of the clinical and commercial setting, for patients who have no other available treatment options.
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 December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
Pharmaceutical Executive September 1, 2010	The Testing of the Tests FDA seeks to regulate genetic tests more actively, while encouraging diagnostic development.
The Motley Fool May 11, 2010 Ryan McBride	Clinical Data Seeks to Challenge Lilly, Pfizer in Antidepressant Market The tiny drug developer has no problem going up against bigger rivals.
The Motley Fool December 31, 2010 Brian Orelli	2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions.
Bio-IT World September 9, 2002 Malorye Branca	The New, New Pharmacogenomics The field of pharmacogenomics proves valuable in the battle against toxicity and late-stage drug failure -- one of the pharmaceutical industry's biggest problems.
Chemistry World February 25, 2015 Rebecca Trager	US opens up home DNA screening The US Food and Drug Administration has, for the first time, authorized a genetic test to be sold directly to consumers. The agency plans to ease the regulatory path for similar screening tests.
The Motley Fool June 14, 2010 Bruce Bigelow	Genetic Testing Companies in San Diego, Boston, and San Francisco Studying FDA Letters The letters notify the companies that genome-sequencing tests they offer to consumers are medical devices that require the agency's approval.
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 September 1, 2011 Don Creighton	Bridging the Hidden Hurdle in Cancer Cures Diagnostics can boast the efficacy of drug treatments, but delivering the promise depends on a predictable pathway to reimbursement.
Chemistry World July 2010 Anna Lewcock	Medicine made to measure Healthcare tailored to suit the genetic makeup of the patient is finally coming to fruition.
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 June 1, 2014 Jill Wechsler	Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.
Bio-IT World November 12, 2002 James Golden	The Business of Bioinformatics The industry has reached an interesting crossroads. As an academic branch of learning, bioinformatics remains mostly what it always was, a cross-disciplinary endeavor between computer science and molecular biology. But bioinformatics as a money-making proposition has different criteria for success.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
Bio-IT World March 8, 2005 Patricia Reilly	Biomarkers: Trends and Potential Companies are centralizing biomarker research to help reduce spending.
Pharmaceutical Executive September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
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 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 April 5, 2010 Brian Orelli	Up 30%? What Are You People On? Fast-track designations aren't worth much more than the paper they're printed on.
The Motley Fool October 8, 2010 Luke Timmerman	Onyx Delays Cancer Drug Application As FDA Asks for More Data Shares fell about 7% in after-hours trading Thursday evening.
CIO March 15, 2006 Allan Holmes	Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market.
BusinessWeek September 5, 2005	Putting the FDA Out Front Deputy Commissioner Dr. Janet Woodcock explains how the agency has led the drive for personalized medicine.
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 March 8, 2010 Brian Orelli	Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting.
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.
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.
Pharmaceutical Executive December 1, 2011 Lujing Wang	The Payoff for Payers Thorough risk assessment is essential before placing bets on good evidence that clears a path to approval.
The Motley Fool July 29, 2010 Brian Orelli	This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either.
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 August 27, 2010 Brian Orelli	Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen.
Bio-IT World November 2005 Khaleeli & Fernandez	Patent Prosecution and Enforcement in Pharmacogenomics Patenting the composition of an isolated nucleic acid sequence, an isolated protein, and small molecules is possible, but there are challenges claiming that they resulted from pharmacogenomic research.
Pharmaceutical Executive September 1, 2011 Jill B. Conner	Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs.
Pharmaceutical Executive February 1, 2014 Longacre et al.	Social Media: Have We Reached The Tipping Point? For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites. This month FDA released its draft guidance on the use of "Interactive Promotional Media."
The Motley Fool January 25, 2010 Brian Orelli	No Way to Hide This Drug Approval FDA trumps Acorda on its good news. The biotech announced Food and Drug Administration approval of Ampyra, its drug to help multiple sclerosis patients walk better after the markets closed on Friday.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
American Journal of Nursing October 2009	Pharmacogenomics: Personalizing Drug Therapy Pharmacogenomics is a rapidly growing field of research into the ways in which genetic variation affects drug response.
The Motley Fool March 10, 2010 Brian Orelli	Up 160% With Room to Run You've got to love biotech and InterMune.
The Motley Fool February 22, 2011 Ryan McBride	Forest Labs Snaps Up Clinical Data This deal is the latest proof that drug developers with FDA-approved treatments remain hot buyout targets in a pharma industry that is starved for new products to replace brand-name drugs.
The Motley Fool February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
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.