• Legislation to reauthorize the Small Business Innovation Research and the Small Business Technology Transfer programs has been passed by the Senate Committee on Small Business and Entrepreneurship. Those programs fund more than $2 billion annually in early-stage R&D projects at small technology companies, including biotechs. If not reauthorized, the SBIR program will sunset July 31, while the STTR program is set to end Sept. 30.

 

The FDA said results of meta-analyses conducted by the agency indicated that Elan Corp. plc's Maxipime (cefepime), a broad-spectrum cephalosporin antibacterial, remains an appropriate therapy to treat Gram-negative and Gram-positive infections due to susceptible strains of microorganisms. However, regulators said they were continuing to review the drug's safety. Regulators conducted the meta-analyses after questions were raised about increased deaths linked to use of the drug.

 

Legislation has been introduced in the Senate aimed at providing patients with a safe, legal way to dispose of outdated or unused prescription drugs. A companion bill was introduced in March in the House. While the law could make it easier for people to legally and safely dispose of their prescription drugs, it is unclear how such a program would be paid for, and if drugmakers or the pharmacy community will be asked to foot the bill or chip in on the costs.

 

Senate Finance Committee Chairman Max Baucus (D-Mont.), with assistance from the White House, struck an $80 billion deal with the Pharmaceutical Research and Manufacturers of America in which drugmakers will cover up to 50 percent of the cost of brand-name medicines for some seniors in the Medicare Part D program. The agreement, which includes biotechnology drugs, is intended to narrow the coverage gap in Medicare Part D, known as the doughnut hole.