The Burrill Report

Cleveland BioLabs’ shares fell as much as 35 percent after The Biomedical Advanced Research and Development Authority, known as BARDA, discontinued funding Cleveland BioLabs’ experimental treatment for radiation poisoning, CBLB502. BARDA has previously expressed dissatisfaction with Cleveland’s study design. Despite the setback, Cleveland said in a statement that it plans to continue the development of CBLB502 as a radiation countermeasure without interruption. It also plans to keep pursuing additional funding from various governmental agencies, including BARDA and their existing Department of Defense funding partners at the Chemical Biological Medical Systems and Defense Threat Reduction Agency.

Thoratec’s shares initially slipped 13 percent and finished down 4 percent on April 4 after the U.S. Food and Drug Administration decided to repost its decision to place the most serious recall classification on Thoratec’s HeartMate II due to blood-flow problems. Thoratec initially notified doctors about a problem with HeartMate II on February 23 and has since revised the device’s label to include a caution statement, as well as instructions on how to properly implant the device to maintain proper blood flow. Despite the FDA’s label, the HeartMate II is not actually being recalled and patients already using the device may continue to do so. However, future procedures to implant the device should follow the new instructions and warnings, says the FDA. Thoratec says it doesn’t anticipate any material financial impact from the recall, which the FDA labeled as a Class I recall.

The U.S. Food Drug Administration reviewers said Astellas Pharma’s experimental overactive bladder therapy worked, but also raised questions about the safety of the drug. The U.S. Food and Drug Administration says that the once-daily tablet was successful in reducing frequent urination and the inability to control it, but the pill was also tied to liver and heart safety issues, higher rates of tumors, urinary tract problems, and hypersensitivity reactions. “The special safety concerns, especially the increases in blood pressure and pulse require additional consideration relevant to their potential negative public health effects,” said the FDA in a statement. An FDA advisory panel voted 7-4 to recommend approving the drug two days after the drug reviewers brought forward their concerns. The FDA will make a final decision on whether or not to approve the drug by June 29.

Sanofi and Regeneron Pharmaceuticals reported mixed results for its oncology drug Zaltrap. Despite receiving a priority review from the U.S. Food and Drug Administration to examine Zaltrap for the treatment of colon cancer, the companies found the drug failed to meet end-point targets in a late-stage study for the treatment of prostate cancer. No data was released, but investigators noted that they would review the results at a later scientific meeting. Sanofi remained focused on the positive news. “Sanofi and Regeneron are committed to the continued development of Zaltrap and we are very pleased that the FDA has chosen to grant priority review to Zaltrap in metastatic colorectal cancer,” said Debasish Roychowdhury, senior vice president of Global Oncology at Sanofi.

Counterfeit versions of Roche’s cancer drug, Avastin, have resurfaced once again. According to the U.S. Food and Drug Administration, the new batch of fake Avastin came from overseas supplier, Richards Pharma (also known as Warwick Healthcare Solutions, Ban Dune Marketing, and Richards Services). Like previous batches of counterfeit Avastin, the latest batch contained none of the real drug’s active ingredient and medical practices in the United States bought it. In February of this year, The FDA first warned healthcare providers about counterfeit Avastin in the United States in February. That supply was traced back to networks of firms in Canada, Barbados, the United Kingdom, Denmark, Switzerland, and Egypt.

Eisai’s breast cancer treatment, Halaven was once again turned away by the National Institute for Health and Clinical Excellence despite a reported concession on the drug’s price by Eisai. Even with the discount, NICE estimated Halaven’s cost-per-quality-adjusted life year at more than $109,000. NICE also documented that the side effects of Halaven include fatigue, hair loss, nausea, anemia, and peripheral neuropathy. “Although the evidence indicated that [Halaven] may help some patients live for a little longer, it also caused more undesirable side effects than other treatments already available,” agency chief Andrew Dillon said. Eisai said it was dismayed by NICE’s decision and believes that NICE is not giving enough support to women with advanced breast cancer.



April 06, 2012
http://www.burrillreport.com/article-barda_cuts_funding_for_radiation_poisoning_treatment.html