• Accentia Biopharmaceuticals Inc., of Tampa, Fla., said its majority-owned subsidiary, Biovest International Inc., received FDA fast-track status for BiovaxID, its personalized biologic therapeutic for follicular non-Hodgkin's lymphoma. The product is in a pivotal Phase III program. Fast-track designation would allow the company to submit a biologics license application on a rolling basis and to apply for the expedited review of its BLA.

• Medivation Inc., of San Francisco, received a letter from the FDA expressing the need for additional rat toxicology data before human clinical trials can begin with the company's product Dimebon for Huntington's disease. The agency is concerned that the dose levels of Dimebon used in one of Medivation's rat toxicology studies did not result in sufficient toxicity to define a maximum tolerated dose. Medivation started additional rat toxicology studies in March and expects to have sufficient data in the third quarter to enable the company to start a Phase I/IIa study.

• Neurogen Corp., of Branford, Conn., said top-line results of NG2-73 in a Phase II trial in transient insomnia showed the drug significantly reduced time to onset of persistent sleep vs. placebo at all doses tested. The study involved 369 subjects. NG2-73 was well tolerated at all doses and had no drug-related serious adverse events or drug-related premature subject withdrawals.