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Home » Newsletters » BioWorld

BioWorld

March 21, 2011

View Archived Issues

FDA Dings Imaging Agent for Lack of Training Program

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

Congress Tries Again to Till SBIR Program Soil

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

Corrections & Clarifications

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Other News To Note

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

Stock Movers

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Biotechs Racing to Produce Radiation Exposure Drugs

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 $50M+ Offering May Help Revive Peginesatide NDA

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

Clinic Roundup

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

Bench Press

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

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