FDA visits wrong facility in China, heparin goes uninspected
WASHINGTON The Food and Drug Administration never inspected the Chinese facility that supplies the active ingredient of the blood thinner heparin because the agency confused its name with another just like it, agency officials said.
The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden increase in serious problems with the drug.
More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous lowering of blood pressure, breathing difficulties and vomiting. Four patients who took the drug died. One of its two manufacturers, Baxter International, stopped selling its multiple-dose vials of heparin earlier this month, and yesterday the FDA advised doctors to prescribe alternatives. The agency and Baxter are investigating whether differences in the ingredients from China could have caused the dangerous reactions in some patients.
According to the FDA, Chinese drug regulators, who sometimes do not visit facilities manufacturing for foreign markets, have not inspected that plant. Baxter has said that it had sent its own representatives there to ensure proper manufacturing procedures were being followed six months ago. The FDA accepts previous positive inspections as sufficient proof that a company is doing a good job, and it can approve new drugs or drug ingredients based on that record.
Accu-Break issues two new patents for their tablet-making technologies
PLANTATION, Fla. Accu-Break Pharmaceuticals announced the recent issuance of two patents for its Accu-Break technologies on Thursday. Accu-Break is widely known for its innovation in tablet formation that includes customized and individualized dosing, for patients that need specific amounts of a drug inserted for certain medications.
The first-patent involves a tablet designed for patients with combination doses that allows them to ingest only one tablet with two different medications. The new technology enables the medications to be separated by splitting the tablet through a drug free layer. This would also be helpful in combining two different medications that are not necessarily compatible with one another, without mixing them together.
The second patent, according to published reports, will include divisible tablets which would provide an accurate partial-dose of active ingredients within the tablet, which is useful for titration and doseage adjustment.
“The Company views the issuance of these patents as key to both our own product development and the worldwide licensing of our innovative tablet technologies,” said ABP’s chief executive officer, Allan Kaplan. “The granting of these patents should bode well for additional pending applications that cover, among other things, new and complimentary tablet technologies.”
Financials show Icahn had sold his shares in Genzyme
CAMBRIDGE, Mass. Carl Icahn has apparently decided to leave Genzyme alone after regulatory filings released Thursday showed that the investor sold his shares in the company late last year, according to published reports.
Icahn’s investment firm, Icahn Capital Management, reported that it owned 1.5 million shares of Genzyme, or less than 1 percent of the stock, at the end of September, but sold its stake by the end of December. The filings didn’t indicate exactly when Icahn bought or sold the stock, but he likely turned a profit as Genzyme shares rose 20 percent in the fourth quarter, when Icahn sold his shares.
Genzyme had been getting pressure from Icahn to either sell off or break up the company, to which Genzyme chief executive Henri Termeer took offense and made it a priority to not bow down to Ichan.
Icahn, though, should not be worried; he has already won battles at some other biotech companies. He took control of ImClone Systems board in 2006. And last year, MedImmune agreed to sell itself to drug maker AstraZeneca for $15.6 billion after Icahn pushed for a sale. And now more recently, it is apparent he has his sights on Biogen Idec after he recently nominated three people for election to its board in late December.