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Budget Woes Stall Clinical Trials and Stymie Sites
Explore Bio-IT World (Feb 20 2012)
Imagine buying a new car or a new house but not knowing the price until the papers have already been drawn up and it’s time to sign on the dotted line. According to Christine Pierre, President of RxTrials, that’s exactly the situation investigative sites face as they attempt to negotiate budgets and contracts for clinical trials.
(Read Full Article)
Deadly bird flu studies to stay secret for now: WHO
Explore reuters.com (Feb 17 2012)
GENEVA/LONDON (Reuters) - Two studies showing how scientists mutated the H5N1 bird flu virus into a form that could cause a deadly human pandemic will be published only after experts fully assess the risks, the World Health Organization (WHO) said on Friday. (Read Full Article)
Why Bristol-Myers Squibb Could Break Out This Year
Explore The Motley Fool (Feb 15 2012)
Comment Mentions: FDA Merck & Co Inc Bristol-Myers Squibb
How to Successfully Repurpose a Drug
Explore WSJ Blogs (Feb 14 2012)
As today’s WSJ reports, there is growing interest in running clinical trials that repurpose drugs that have already won FDA approval for another disease. (Read Full Article)
Comment Mentions: FDA National Institutes of Health NIH
FDA unveils biosimilars guidance
Explore Nature Publishing Group (Feb 9 2012)
Comment Mentions: FDA European Medicines Agency
Craig Lipset on the Recruitment Mind Shift
Explore Applied Clinical Trials (Feb 9 2012)
REMOTE is the first-ever randomized clinical trial under an investigational new drug (IND) application in which the study is managed entirely using electronic tools and allows subjects to participate in the clinical trial regardless of their proximity to clinical sites. Pfizer’s pilot project uses mobile phone and Web-based technology to collect necessary data for the trial, without clinic visits. The trial was announced last June. And this month ACT, Editor-in-Chief Lisa Henderson talked t (Read Full Article)
Comment Mentions: Pfizer Inc
Picture Perfect: Imaging in Drug Discovery and Translational Medicine
Explore Bio-IT World (Feb 7 2012)
Bio-IT World | Imaging in drug discovery has been rising to the forefront of conversations more and more recently. Managing editor Allison Proffitt spoke with Ken Kilgore, Director of Immunology Pharmacology at Janssen Research & Development (formerly Centocor Research & Development), a Johnson & Johnson company, about how—and why—imaging’s role is changing in drug discovery. (Read Full Article)
Comment Mentions: Novartis International AG Pfizer Inc Johnson & Johnson
Dana-Farber lands $10M for cancer research
Explore Business News (Feb 1 2012)
Dana-Farber Cancer Institute has been awarded a $10 million grant rom the Massachusetts Life Sciences Center to support the expansion of its cancer imaging research program, Mass High Tech reports. Funding for the grant comes from the state’s 10-year, $1 billion Life Sciences Initiative. The money will support the establishment of Dana-Farber's Molecular Cancer Imaging Facility, a $20 million research initiative in South Boston to develop new molecular imaging probes. As MHT reports, the imaging facility will expand several of Dana-Farber’s basic and clinical research enterprisesfocused on developing targeted cancer therapies. (Read Full Article)
Comment Mentions: Dana-Farber Cancer Institute
Bush Doctrine: The Pharmaceutical Safety Data Problem
Explore Bio-IT World (Jan 27 2012)
Bio-IT World | The Bush Doctrine: What the industry calls “safety data” covers everything from discovery-oriented in vitro or cell based studies to extensive GLP toxicology study data, voluminous clinical study records, and post-marketing/pharmacovigilance systems. It leads one to wonder: does anyone have informatics systems that allow safety investigators across the pharma enterprise to effectively mine this ocean of information? (Read Full Article)
Researchers defend benefits of mutant flu research
Explore Nature Publishing Group (Jan 25 2012)
A dire lack of global virus surveillance doesn't negate the potential of mutation monitoring, argue two researchers behind the mutant flu research. (Read Full Article)
Remedies for Safer Drugs
Explore Bio-IT World (Jan 21 2012)
Pharmacovigilance experts have an abundance of signal detection tools to sift through large quantities of data seeking causal relationships between adverse events (AEs) and experimental drugs. They also have an assortment of data mining tools capable of finding statistical associations suggestive of problems regarding approved drugs. All this technology is intended to safeguard clinical trial participants, patients, and the reputation of recall-weary drug developers. But drug safety specialists can’t be sure which technology or signal detection method is best. (Read Full Article)
Medidata: Integrating Infrastructure for Clinical Trials
Explore Bio-IT World (Jan 18 2012)
Bio-IT World | Glen de Vries thought he would be teaching biology or chemistry in college, but somewhere en route to a satisfying career in academic research, he got distracted. Bio•IT World chief editor Kevin Davies spoke to de Vries about the progress of Medidata and the state of e-clinical technology in general. (Read Full Article)
Comment Mentions: SAP Kevin Davies, Ph.D. Medidata
Biodesix Receives New EU and US Patents for Blood-based Oncology Tests
Explore businesswire.com (Jan 9 2012)
Biodesix has announced the issuance of three additional patents which provide intellectual property protection for head and neck tests, lung cancer patient selection, and monitoring. (Read Full Article)
FDA Has (Some) Social Media Advice For Pharma
Explore WSJ Blogs (Jan 9 2012)
Last month, the FDA released draft guidance on "responding to unsolicited requests for off-label information about prescription drugs and medical devices." (Read Full Article)
Knome’s New CEO Signals New Directions in Genome Interpretation
Explore Bio-IT World (Jan 9 2012)
Bio-IT World | Knome, the first company to offer direct-to-consumer genome analysis, has appointed neurologist and biotech executive Martin Tolar as its new CEO as it seeks to push further into two prime markets for genome interpretation software -- biopharma and clinical genomics. (Read Full Article)
Comment Mentions: Harvard Medical School Pfizer Inc Beckman Coulter
FDA Releases Social Media Guidelines
Explore Bio-IT World (Jan 9 2012)
News Brief | The Food and Drug Administration has released its guidelines for how pharma companies use social media to respond to questions about off-label use of drugs and devices. But they're still not as comprehensive as many hoped for. (Read Full Article)
Comment Mentions: FDA The Food and Drug Administration
Bristol-Myers buying Inhibitex for $2.5 billion
Explore MarketWatch (Jan 8 2012)
Bristol-Myers Squibb purchasing Inhibitex, a specialist in hepatitis C treatments, for $2.5 billion (Read Full Article)
Comment Mentions: Bristol-Myers Squibb Bristol-Myers
Quintiles consolidates patient communities into new Digital Patient unit
Explore pmlive.com (Jan 6 2012)
Contract research organisation Quintiles has combined its digital patient resources, including two online patient communities, into a single unit. The company’s new Digital Patient unit will bring together MediGuard.org and ClinicalResearch.com to offer its pharma clients a more efficient patient recruitment service. (Read Full Article)
Comment Mentions: Microsoft Corp Google Inc Quintiles
Lilly projects sharp drop in 2012 profit
Explore reuters.com (Jan 5 2012)
(Reuters) - Eli Lilly & Co forecast a sharp plunge in profits for 2012, the first full year its top-selling Zyprexa schizophrenia treatment faces generic competition, and its shares fell as much as 3.6 percent. (Read Full Article)
Comment Mentions: Thomson Reuters Pfizer Inc Eli Lilly and Company
Expect Measurable ROI of Innovation in 2012
Explore Bio-IT World (Jan 5 2012)
In 2011, biopharma sponsors continued to rely on an increasing number of contract research organizations (CROs) and eClinical technology solutions to support the research of drugs and related devices. Biopharma sponsors’ most precious asset: controlled access to clinical data throughout the course of trials, became more crucial and challenging than ever. Setting the stage for 2012, CROs are now not only responsible for executing studies and helping analyze and evaluate clinical data, but also offering access to data from all trials in one location. (Read Full Article)
Flurry Of Cancer Pacts
Explore Chemical & Engineering News (Jan 3 2012)
The year 2011 ended with multiple acquisitions and research partnerships through which the drug majors Takeda Pharmaceutical, Merck & Co., Eli Lilly & Co., and AstraZeneca gain access to compounds that biotech firms are developing for the treatment of cancer. (Read Full Article)
Comment Mentions: AstraZeneca Merck & Co. Eli Lilly & Co.
New year, new science
Explore Nature Publishing Group (Jan 2 2012)
Comment Mentions: US National Institutes of Health FDA NASA
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