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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.
Comment Mentions: FDA National Institutes of Health NIH
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FDA unveils biosimilars guidance
Explore Nature Publishing Group (Feb 9 2012)
Move could open the door to cheaper generic versions of biological drugs.
Comment Mentions: FDA European Medicines Agency
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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?
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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.
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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.
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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.
Comment Mentions: SAP Kevin Davies, Ph.D. Medidata
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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."
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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.
Comment Mentions: FDA The Food and Drug Administration
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The Perfect Pair: Drugs and Companion Diagnostics
Explore Bio-IT World (Dec 29 2011)
New York Times | More and more often, the FDA is requiring personalized drugs to have companion diagnostic tests associated with them before approval. The trend has prompted some awkward partnerships in drug discovery.
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Delcath's Ireland Operations Achieves ISO 13485 Certification
Explore Applied Clinical Trials (Dec 28 2011)
/PRNewswire/ --Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Company's location has achieved ISO 13485:2003 Certification—an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality management systems in place to safely design, develop, manufacture and distribute medical devices in the European Union (EU). ISO 13485 Certification is a regu
Comment Mentions: European Union FDA Securities and Exchange Commission
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2011 No Dreamboat for MannKind
Explore Fool.com (Dec 27 2011)
An FDA rejection and a long wait is a bad combination.
Comment Mentions: FDA Pfizer Inc Novo Nordisk A/S
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Do It Yourself Drug Development — With Some Help
Explore WSJ Blogs (Dec 27 2011)
The idea behind Dart Therapeutics, says Tracy Seckler, was to create a vehicle to identify potential compounds, make deals, and develop the drugs.
Comment Mentions: FDA Genzyme Corp
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Pfizer R&D pact could inject $217M into Karo Bio
Explore fiercebiotech.com (Dec 27 2011)
Swedish biotech Karo Bio's ($KARO) shares spiked after the company revealed a new research and development deal focused on autoimmune diseases with U.S. drug giant Pfizer ($PFE). Karo, which has been planning cutbacks and a spin-off, could reap as much as $217 million in upfront and milestone fees as well as royalties from Pfizer in the deal, Karo announced on December 24. Bloomberg reported that Karo's shares surged 80% after the announcement, the biggest jump since the stock hit the public market in 1998. The upbeat news comes amid upheaval at the Huddinge, Sweden-based company, which announced ...
Comment Mentions: FDA GlaxkSmithKline plc Pfizer Inc
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Insight: FDA warned PIP on implant safety in 2000
Explore reuters.com (Dec 27 2011)
WASHINGTON (Reuters) - As early as 2000, U.S. health authorities raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. That was almost ten years before the company came under scrutiny from European regulators.
Comment Mentions: FDA Johnson & Johnson Allergan Inc
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Intravenous Remodulin Approved for the Treatment of Pulmonary Arterial Hypertension in Most of the European Union
Explore Applied Clinical Trials (Dec 27 2011)
/PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) and its wholly-owned subsidiary, United Therapeutics Europe, Ltd., announced today that the French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has approved intravenous use of Remodulin® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). Remodulin is alr
Comment Mentions: European Union FDA Securities and Exchange Commission
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