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IC 93 articles

FDA makes blunder during hiring of PR firm to improve image

Every company can use a good spin doctor from time to time, and it looks like the Food and Drug Administration (FDA) is no exception. Last month I told you that California Rep. Harry Waxman, who serves as head of the House Oversight and Government Reform Committee, raised concerns that items outlined on the FDA’s 2007 priorities list appeared to prioritize industry desires over consumer protection. This, just months after more than 80 American deaths were linked to tainted heparin that was made in Baxter International Inc.’s facility in China. FDA officials later acknowledged they had not inspected that facility ... Read More

Synthetic heparin expected to launch early 2009

Australia-based Alchemia, a biotechnology company specializing in synthesis and manipulation of carbohydrates, announced on its Web site that it is on target to launch its antithrombotic drug, generic fondaparinux. Generic fondaparinux targets the multi-billion dollar heparin drug market. The company claims fondaparinux has a superior safety and efficacy profile to the market-leading drug Lovenox. Meanwhile, the brand-name fondaparinux drug Arixtra, made by GlaxoSmithKline (GSK) continues to gain market share. Alchemia’s CEO, Dr Peter Smith said “The impending commercialization of generic fondaparinux and anticipated revenues in calendar year 2009 will form a strong financial base for Alchemia. This will enable the ... Read More

French Lovenox brand heparin recall

There has been yet another report of heparin being pulled off the market for fear it may harm people. This week, French drug maker Sanofi-Aventis recalled the remaining batches of its heparin medicine distributed before May 2008, Lovenox, based on a recommendation by French drug regulator Afssaps. Lovenox, the company’s number one selling medicine, was first recalled last June after some batches of its pre-filled injectible solution were found to be contaminated with trace amounts of oversulphated chondroitin sulphate, according to Reuters. Oversulphated chondroitin sulphate is the same contaminate found last March by the Food and Drug Administration (FDA) in batches ... Read More

China-made products cause safety concern

Heparin isn’t the only China-made product that has turned up contaminated and, in many cases, harmed others. Last March, a contaminant was found in batches of Heparin, supplied to Baxter International by its Chinese plant. The over-sulfated chondrotin sulfate in the heparin is blamed for causing more than 80 deaths and breathing problems in another 700 in the United States. In recent weeks, according to a Reuters/The Epoch Times, three children and more than 6,000 infants have become ill after consuming infant formula contaminated with toxic melamine, according to Reuters/The Epoch Times. Let’s recap some of the other made-in-China scares ... Read More

Candidates review reimportation of prescription drugs

Recent scares of tainted medicines and goods from foreign countries, such as contaminated batches of heparin from China, have spurred presidential nominees Sen. Barak Obama and Sen. John McCain to review their support for individuals to import cheaper drugs from other countries, Reuters/Boston Globe reported today. According to the report, aides for both candidates said that recent health scares had dampened their candidates’ enthusiasm of reimportation. Neither candidate has abandoned the prospect; however, they admit it has become a more controversial subject. Other countries, such as Canada, have government price controls that keep prescription drug costs down, making reimportation of ... Read More

Lawmaker questions FDA priorities, suggests industry ties

Tainted batches of heparin may have raised concerns with the general public, but a recent Reuters report suggests the U.S. Food and Drug Administration (FDA) would rather focus on giving product promotion advice to companies and journal reprints to physicians than food and drug safety scares. The FDA also planned to change its regulations to protect device makers’ FDA-approved products from lawsuits with a so-called preemptive clause, according to Reuters. The news agency says that in a letter from California Rep. Henry Waxman, to FDA Commissioner Andrew von Eschenbach, Waxman raised concerns that the items outlined on the FDA’s 2007 priorities ... Read More

Heparin utilized in nanotechnology

Recently, we reported about the development of synthetic heparin as a safer alternative to today’s heparin, which is manufactured from the intestines of animals. The work is a project of Robert Linhardt, a professor at Rensselaer Polytechnic Institute in Troy, New York. Recently, Linhardt presented information about his work on the synthetic heparin, as well as findings in a new project using heparin to create a “paper battery,” at the NanoBioTech forum. The NanoBioTech 2008 conference was held Monday at the Institute, and addressed topics including the developments in nanotechnology law, protecting intellectual property, and attracting investors, according to an ... Read More

Fresenius buys heparin maker APP

The Associated Press reported today that German dialysis clinic operator Fresenius has been approved to purchase APP Pharmaceuticals. APP makes injectable drugs, including heparin, and just announced its plans to begin manufacturing heparin at its Puerto Rico facility after receiving approval by the U.S. Food & Drug Administration (FDA). According to information on its web site, Fresenius, based in Hamburg, Germany, is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure. It estimates more than 1.6 million people are affected by kidney failure worldwide. The AP says the purchase of APP ... Read More

APP ok to make heparin in Puerto Rico

This week APP Pharmaceuticals, headquartered in Schaumberg, Ill., announced it has gotten FDA approval to manufacture heparin at its Barceloneta, Puerto Rico, facility. The facility will manufacture three product codes of heparin sodium injection, USP. According to a report in the Pharmaceutical Business Review, APP currently manufactures nine products at its Puerto Rico facility, including doxycycline, azithromycin and diphenhydramine. The report says the company plans to manufacture more than 19 million units in Puerto Rico during 2008 and to eventually transfer more than 25 additional product codes to the facility. The recall of contaminated heparin manufactured in China has affected ... Read More

synthetic heparin in development

Robert Linhardt, a scientist at Troy, New York-based Rensselaer Polytechnic Institute, is leading a team of researchers who have developed a fully synthetic version of the blood thinner heparin. While the group has only produced a few milligrams of the substance, it is the first step in eliminating the risk of contamination currently associated with the drug, which is manufactured primarily from pig intestines. Linhardt was among the researchers who discovered the source of tainted heparin that was responsible for at least 149 deaths since the beginning of 2007. Manufacturer Baxter International, which supplies about half of the heparin used ... Read More