Pfizer to Acquire FoldRx Pharmaceuticals

  • Author: Health Informer
  • Filed under: Health News
  • Date: Sep 2,2010

FoldRx Focused on First-in-Class, Disease-Modifying, Oral Therapeutics to Treat Diseases Caused by Protein Misfolding Lead Product Candidate, Tafamidis, in Registration in the European Union as First-in-Class Oral Therapy for Transthyretin Amyloid Polyneuropathy (ATTR-PN)

Pfizer Inc. and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical development company, announced that they have entered into an agreement under which Pfizer will acquire FoldRx.

FoldRx’s portfolio includes clinical and pre-clinical programs for investigational compounds to treat diseases caused by protein misfolding, which is increasingly recognized as an underlying cause in many chronic degenerative diseases. The company’s lead product candidate, tafamidis meglumine, is in registration as an oral, disease-modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option that is currently available.

FoldRx has filed a marketing authorization application (MAA) for tafamidis with the European Medicines Agency, and is currently in communication with the FDA to define its pathway for filing in the U.S. Tafamidis has orphan drug designation in both the U.S. and European Union (EU) and Fast Track designation in the U.S. for the treatment of ATTR-PN. Read the rest of this entry »

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FDA Launches New Organizational Performance Management System

  • Author: Health Informer
  • Filed under: Health News
  • Date: Sep 1,2010

FDA-TRACK monitors accountability, transparency; supports Open Government Initiative

The U.S. Food and Drug Administration launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government.

The system, called FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year. That data will be gathered monthly, analyzed and presented each quarter to FDA senior leadership. Importantly, the public will be able to track this data and the agency’s progress through the FDA-TRACK website.

“FDA-TRACK will bring the operations of this historically opaque Agency into the daylight and help us be even more responsive as we work to protect the public health,” said FDA Commissioner Margaret Hamburg, M.D.

FDA-TRACK is designed to be informative, encourage accountability among the people who work at the FDA, and make that work more transparent. It gives managers and employees a new way to measure their effectiveness in meeting goals to protect the public health and provides a way for the public to monitor agency activities.

Adapted from several successful state and local performance management models, FDA-TRACK hopes to set the standard for open government at the federal level. The system monitors performance indicators in four categories: Read the rest of this entry »


African-American race is among the risk factors for developing dangerous blood clots after receiving a drug-coated stent.

Despite taking anti-clotting medications as directed, African-Americans had more than double the rate of clotting compared to other races.

African-American race is a distinct risk factor for developing life-threatening blood clots after receiving a drug-coated stent, according to research reported in Circulation: Journal of the American Heart Association.

African-American race was the strongest predictor of clotting that occurs more than 30 days after implantation, researchers said.

For the study, researchers examined data on 7,236 patients who had stents, coated with clot-prevention drugs, implanted to prop open narrowing arteries. The drug-coated stents, also called drug-eluting stents, were implanted between mid-2003 and the end of 2008.

Even after considering other known risk factors — such as diabetes, hypertension and kidney problems — researchers found that African-Americans still experienced a higher rate of thrombosis or clotting.

The bottom line is this is not just because this population is sicker or less compliant, but there is something else there that needs to be explored,” said Ron Waksman, M.D., the study’s lead author. Read the rest of this entry »


A new international survey shows that over 90% of pharmacists believe they are key to improving patients’ health, and while most pharmacists surveyed see their responsibilities increasing, they voice concerns on training and pay.

The survey shows that almost 3 in 4 pharmacists (73%) now provide patients with health promotion and management services. Nearly all (9 in 10) pharmacists agree that more information and advice – including on specific medications and treatments – are expected from pharmacists than ever before. However most pharmacists (78%) say that they are asked to provide additional services, such as advice, without fair and proper compensation.

“Pharmacists’ roles are changing, and we find ourselves increasingly working with patients and other healthcare professionals to prevent and treat disease. This survey shows that pharmacists welcome this expanded role, as it highlights what they like doing most – helping deliver better patient outcomes – while increasing visibility of pharmacists’ expertise. However, we also see an education and income gap that will need to be closed to ensure the pressure on current pharmacists isn’t too great, and so that we can continue to attract the best and brightest to the profession in the future,” said Ton Hoek, Chief Executive Officer of the International Pharmaceutical Federation (FIP).Other results of the survey show the degree to which pharmacists are concerned about the counterfeit medicines issue. Read the rest of this entry »


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