GSK’s Rotarix associated with pediatric convulsions, pneumonia
According to a review by the Food and Drug Administration, GlaxoSmithKline’s rotavirus vaccine, called Rotarix, is associated with an increased risk of convulsions and pneumonia-related deaths in children taking the drug.
Rotavirus is the most common cause of severe diarrhea and dehydration among infants and young children.
The study, which enrolled about 63,000 children, found a significant increase in convulsions and deaths related to pneumonia compared with a placebo, the review says.
The staff review is one consideration among many that an expert panel at the FDA will weigh when deciding whether to approve the drug.
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.