The FDA issued a complete response letter to Eli Lilly and Co. and its wholly owned subsidiary, Avid Radiopharmaceuticals Inc., for its new drug application for Amyvid (florbetapir F 18 injection), an imaging agent to detect beta amyloid plaque in the brain. The FDA requested that Lilly provide a reader training program for marketing of the product to ensure accuracy and consistency in interpreting scans made with Amyvid. Read More
WASHINGTON – Hoping the legislative ground is fertile this go around, the Senate is debating a bipartisan bill that would sow more seed capital for small biotechs through the Small Business Innovation Research (SBIR) program. Read More
Quest Diagnostics Inc., of Madison, N.J., agreed to acquire Celera Corp., of Alameda, Calif., for $8 per share, or about $344 million, net of $327 million in acquired cash and short-term investments. The deal is expected to bolster Quest's molecular diagnostics work and add a pipeline of biomarkers for future development. Read More
WASHINGTON – Concerns about a nuclear meltdown in Fukushima, Japan, are producing a global reaction as countries rethink their use of nuclear technology and frightened consumers stock up on potassium iodide tablets, one of the only drugs available that can ward off a few of the health effects of exposure to excessive radiation. Read More
Affymax Inc. is reviving efforts to get FDA approval of peginesatide – previously known as Hematide – for treatment of anemia in chronic renal failure patients. Read More
Polaris Group, of San Diego, enrolled the first patient in a Phase II trial of ADI-PEG 20 (pegylated arginine deiminase), its enzyme-based treatment for malignant mesothelioma. Read More
Researchers from Massachusetts General Hospital and colleagues have gained additional insights into how elite controllers – people who manage to control HIV, and can survive infection indefinitely in the absence of antiretroviral treatment – hold the virus at bay. Read More
