• Bioheart Inc., of Sunrise, Fla., published the results of its MARVEL trial of skeletal myoblast implantation for chronic heart failure in the American Heart Journal on Sept. 12, 2011. The trial showed sustained improvements in six minute walking distance with myoblast therapy.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed two pivotal trials of LibiGel (testosterone gel) for female sexual dysfunction. It is collecting data from its 141 investigative sites and expects to report top-line efficacy data in the fourth quarter. A third pivotal study for cardiovascular and breast cancer safety is ongoing.

• Karo Bio AB, of Huddinge, Sweden, has enrolled its first patient in a trial of perotirome for heterozygous familial hypercholesterolemia. The trial will include 630 patients with the condition, and it will evaluate safety and efficacy of perotirome for long-term treatment. An interim analysis is planned for the second quarter of 2012.

• Transcept Pharmaceuticals Inc., of Point Richmond, Calif., received notification from the FDA that its new drug application for Intermezzo (zolpidem tartrate sublingual tablet) has been reclassified as a complete Class 1 reponse with a PDUFA date of Nov. 27. (See BioWorld Today, Sept. 16, 2011.)