| Baxter to Recall Drug-Infusion Devices Baxter International said it would recall 200,000 Colleague brand drug-infusion pumps on the market, after years of malfunctions with the device, along with patient injuries and deaths. online.wsj.com |
Utah Plans for Health Law They Dislike Gov. Gary R. Herbert announced a major step towards implementing the federal health law in Utah—running its own insurance pool to cover high risk people—even as it continues to fight against the law. online.wsj.com |
Reckitt to Buy Durex Maker SSL U.K. consumer-goods firm Reckitt Benckiser, which owns Clearasil and Mucinex, agreed to acquire SSL, maker of Durex condoms, in a deal valued at $3.88 billion. online.wsj.com |
GSK's Diabetes Drug Continues to Face Scrutiny: Biotech's Latest Mishaps The Burrill Report submits: GlaxoSmithKline’s (GSK) diabetes drug Avandia is once again under regulatory scrutiny—this time it’s in Europe where the European Medicines Agency met to discuss whether Avandia should continue to be marketed. The agency in a press statement said that no final decision has been made about the drug. It said it has further questions for GSK before deciding whether and what action needs to be taken. A final decision is expected by September 23. The meeting took place as a controversy erupted in the United Kingdom over a recommendation made at the end of July by the UK Commission on Human Medicines, according to TheHeart.Org. The commission unanimously voted that Avandia should be withdrawn. Though it informed the Medicines and Healthcare Products Regulatory Agency, the agency responsible for licensing drugs in the United Kingdom, its decision was not made public. Instead the agency sent letters to doctors restating safety information about the drug and suggesting they consider alternatives. Because the drug was approved by the European Medicines Agency, only it can revoke the license for the drug. Roche (RHHBY.PK) said it halted dosing of patients in a late-stage trial of its experimental diabetes drug taspoglutide because side effects including nausea and vomiting resulted in many participants in the study to drop out of it, Bloomberg reported. The company is trying to determine what caused the side effects and see if it can reformulate the medication to reduce the risk, a spokeswoman told Bloomberg. Because a large number of patients dropped out of the study, the company said it would be difficult to determine whether the drug is effective.Complete Story » seekingalpha.com |
Investment Risk in Cleveland BioLabs Has Been Wiped Off the Table M.E. Garza submits: A couple of hours into the trading day on Wednesday, Cleveland BioLabs, Inc. (NASDAQ:CBLI) announced top line results of the second human safety study for CBLB502, a drug under development for the treatment of Acute Radiation Syndrome. The results of that study have not been fully digested by Wall Street, but the development has set into motion future events that will impact CBLI's share price.CBLB502 is the same drug for which the Company just recently received a $45 million contract from the U.S. Department of Defense Chemical Biological and Medical Systems Medical Identification and Treatment Systems to be developed and stockpiled as a medical radiation countermeasure.Complete Story » seekingalpha.com |