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Pharmaceutical Executive
September 1, 2008
Melanie North |
Publish or Perish FDAAA means that companies need to register clinical trials; and not only for publication planning.   |
Pharmaceutical Executive
October 1, 2005
Lisa Grimes |
Clear Road Ahead An industry standard for publicizing clinical-trial results is a ways off. But pharma's openness to more transparent procedures is moving things in the right direction. |
Bio-IT World
March 8, 2005
Mark D. Uehling |
Is That a Target on Her Back? Q&A with Deborah Zarin, head of ClinicalTrials.gov, the matchmaking Web site for patients seeking to participate in federally sponsored clinical trials. |
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
April 1, 2012
Jill Wechsler |
Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors. |
Managed Care
July 2005
Martin Sipkoff |
Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules. |
Pharmaceutical Executive
March 1, 2007
Jill Wechsler |
Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process. |
Information Today
October 4, 2004
Susanne Bjorner |
A Tough Test for PhRMA's New Clinical Study Results Database The announcement the day before of a worldwide withdrawal of Merck & Co.'s popular arthritis and acute pain medication Vioxx, created a high-bar test that shows the holes in the new database concept. |
The Motley Fool
December 31, 2010
Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
Pharmaceutical Executive
November 1, 2013
Jill Wechsler |
Transparency Troubles for Pharma High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise. |
Bio-IT World
July 2005
Kevin Davies |
Trial Registries on Trial A group of influential editors from some of the world's boutique medical journals begin enforcing a new policy that would bar drug companies from publishing clinical trial data unless those trials are registered in a suitable public database. |
Pharmaceutical Executive
September 1, 2005
Jill Wechsler |
Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency. |
BusinessWeek
December 13, 2004
John Carey |
How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs. |
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. |
Pharmaceutical Executive
March 1, 2014
Jill Wechsler |
Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance. |
Pharmaceutical Executive
June 1, 2005
Joanna Breitstein |
Turn the Page Changes in ethics and expectations are driving the way pharma interacts with medical publishers. |
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. |
Pharmaceutical Executive
February 1, 2011
Jill Wechsler |
Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency |
Reason
October 2007
Ronald Bailey |
Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest." |
Pharmaceutical Executive
April 1, 2006
Jill Wechsler |
Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf? |
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
August 27, 2010
Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. |
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. |
Pharmaceutical Executive
July 1, 2014
Jill Wechsler |
Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace. |
Pharmaceutical Executive
January 1, 2011
Jill Wechsler |
Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead. |
The Motley Fool
March 1, 2007
Brian Lawler |
Know Your Drug Stock ABCs: Part 2 Investing in the pharmaceutical and biotechnology industries can be difficult. Here are terms investors should know to better understand how the clinical trial process involved with bringing a drug to market works. |
Pharmaceutical Executive
November 1, 2008
Jill Wechsler |
Resolving Conflicting Interests The Physician Payment Sunshine Act would require pharmaceutical and medical device companies to disclose payments of more than $500 to doctors. |
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. |
The Motley Fool
May 31, 2011
Brian Orelli |
5 Biotechs With Upcoming Clinical Trial Results Investors willing to stay in these stocks a little while could see substantial gains well ahead of FDA approvals. |
The Motley Fool
May 15, 2008
Brian Lawler |
You're Kidding Me, Cardiome! Canadian pharmaceutical company Cardiome is still awaiting an FDA decision on its lead drug. |
The Motley Fool
February 1, 2011
Brian Orelli |
Orexigen Falls Short Its obesity drug fails in the final mile of the drug-development marathon. |
The Motley Fool
November 30, 2007
Brian Orelli |
Clinical Trial Failures Don't Bother These Companies Contract research organizations, outsourcing companies hired by pharmaceutical and biotech companies to run pre-clinical tests and clinical trials for them, succeed even when drugs fail, and more work may be coming their way. |
Pharmaceutical Executive
August 1, 2012
Jill Wechsler |
Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act. |
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. |
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. |
Chemistry World
September 30, 2014 |
Transparency measures forced on pharma Previous misdemeanors are compelling the pharmaceutical industry to be more open with financial information and clinical data. |
Bio-IT World
August 13, 2002
Mark D. Uehling |
Clinical Trial Data Management: Tortured by Paper Reams of paper stuffed into boxes and shipped to the FDA by the truckload is hardly the best approach to drug approval. But what's the right way? |
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. |
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. |
Pharmaceutical Executive
September 1, 2013
Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
The Motley Fool
March 21, 2011
Brian Orelli |
Let's See Some Data, Curis Curis investors seem to have shrugged off the multiple unknowns and embraced the potential for the company's skin cancer drug. |
The Motley Fool
January 28, 2005
Karl Thiel |
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous. |
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
March 11, 2010
Jim Mueller |
Is Medivation a Buy? What is the thinking with regards to Medivation today? It already got a big haircut last week. Is it worth investing in at these lower prices? |
Pharmaceutical Executive
July 1, 2009
Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
The Motley Fool
December 27, 2010
Brian Orelli |
Painful Clinical Hold? Not Really. Regeneron offers the benefits of a full pipeline. |
Bio-IT World
April 2006
Mark D. Uehling |
Debating Clinical Registries and Databases The pharmaceutical industry has been forced by medical journal editors and Congress to make public more data about clinical trials. Registries are here, most people are used to them, and they're not going away. But can the industry do registries and databases better? |
Chemistry World
September 5, 2014
Emma Stoye |
Servier to appear in adverts over lack of transparency European pharma group Servier Laboratories is to appear in adverts for breaching the Association of the British Pharma Industry code of practice by failing to publish clinical trial results. |
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
November 17, 2010
Brian Orelli |
52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval. |
