-
Categories
-
Recent Posts
-
Recent Comments
- Joseph Francis on Europe’s Top Regulator Shows His Teeth
- Joseph Francis on Pfizer’s Virtual Trial Recruitment
- Nimer Yusef on Can “Clinical Data Integration on the Cloud” be a Reality?
Tags
CBI China conference CRO/Sponsor CROs data DIA drug development eClinical EDC EMA EU Europe European Medicines Agency facebook FDA IIR India IT JOhn Dalli Kayda Norman Ken Getz Lisa Henderson London oncology Oracle Partnerships in Clinical Trials patient/subject recruitment patients Peter O'Donnell Pfizer Pharmaceutical Executive Pharmaceutical Technology Philip Ward PRO R&D Regulatory REMS Sites social media subject recruitment subjects Tim Denman UK Wayne KubickJoin ACT for discussions, news, and more on
Author Archives: Pharmaceutical Executive
A New Approach to India and China?
Executives faced with mouth-watering growth rates in the Chinese and Indian pharmaceutical markets—as opposed to broad plateaus in the United States and Europe—should first think about what they have to offer, instead of what they can grab, according to panelists at the Center for Healthcare Innovation’s inaugural symposium.
Scarcity in both countries represents an entrepreneurial advantage, [...]
Posted in Uncategorized Leave a comment
Facebook: Should I Stay Or Should I Go?
We like to be heard if we’re willing to listen. And yet, until now, pharmaceutical companies with a presence on Facebook have understandably been reluctant to “listen” by allowing consumers to post comments on their Facebook pages.
That changes on Monday, August 15, and the change leaves many pharma companies facing a dilemma. Most people agree [...]
Posted in CRO/Sponsor, Regulatory Tagged facebook, FDA, News Feed, Omnicom Group, Pharmaceutical Executive, Regulatory, social media, technology, Thomas L. Harrison Leave a comment
Pfizer Asks Patients to Test Themselves
Can patients uphold the rigorous standards of clinical testing, outside of the clinic? Pfizer is betting that they can, at least for a drug that’s already spent a decade on the market.
Last week, Pfizer announced its new Research on Electronic Monitoring of OAB Treatment Experience (REMOTE) project—a clinical trial for already-approved overactive bladder medication Detrol LA [...]
CDER Addresses 'Challenges of Globalization' With a New Office
In recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to a memo sent by CDER Director Janet Woodcock.
Posted in Regulatory Tagged Ben Comer, CDER, FDA, Janet Woodcock, Pharmaceutical Executive Leave a comment
Former EMA Head Back in the Regulatory Saddle
His decade-long tenure as head of the European Medicines Agency (EMA) may have ended, but Thomas Lönngren is already back in the regulatory saddle as a strategic advisor to NDA Group, an independent consulting group focused on reducing wasted drug development costs, ensuring new medicines get to market faster, and “improving the performance of the [...]
Feds Threaten to Pull ProAmatine for Lack of Postmarket Data
Pharmaceutical Executive Online Content and News Editor, George Korenos, blogs about the FDA’s recent announcement to take ProAmatine off the market. Read his latest post here.
InterMune Denied Approval for Lung Treatment
Biotech firm InterMune took an ugly hit on Tuesday as news broke that its lung disease drug Esbriet (pirfenidone) will require additional clinical studies, and won’t be getting the seal of approval from FDA any time soon. The news caused InterMune’s stock to drop a staggering 78 percent, according to Reuters. Analysts have downgraded the [...]
Posted in CRO/Sponsor, Regulatory Tagged approval process, data, FDA, George Koroneos, InterMune, lung, lung treatment, Pharmaceutical Executive Leave a comment
Avandia Trial in Trouble
GSK’s Avandia just won’t stay out of the news. Now comes a report from The Wall Street Journal that the FDA is considering dealing the beleaguered diabetes drug another blow by stopping one of its safety trials.
Posted in CRO/Sponsor, Regulatory Tagged Actos, Avandia, FDA, Geodon, GSK, Oriana Schwindt, Pfizer, Pharmaceutical Executive, Takeda, US Senate Finance Committee Leave a comment
A Critical Path to New TB Treatments
FDA Commissioner Margaret Hamburg announced on March 18, a new joint initiative between industry, FDA, and non-profit organizations designed to fast-track modern combination treatments for tuberculosis. Where once it took more than two decades to create new therapies for TB, this collaboration is expected to produce working treatments in less than six years, providing much-needed [...]
Calculating the Cost of R&D: Defending Tufts Research