In a double-blind, randomized controlled trial of Neurologix Inc.'s gene therapy NLX-P101, Parkinson's disease patients showed a statistically significant improvement in their scores on a scale used to measure motor symptoms six months after their surgery. Read More
A year after agreeing to a $10 million up-front, $15 million milestones deal with Biovail SRL to develop Ampakine compounds for respiratory depression treatments, Cortex Pharmaceuticals Inc. is getting back all of the Ampakine assets and intellectual property it sold. (See BioWorld Today, March 29, 2010.) Read More
Titan Pharmaceuticals Inc., of South San Francisco, entered a deal with Deerfield Management to provide Titan with $20 million in financing through a five-year senior secured credit facility. Read More
Repros Therapeutics Inc., of The Woodlands, Texas, dosed its first patients in a low-dose study of Proellex for uterine fibroids and endometriosis. Previous studies at a 50-mg dose were held when some subjects experienced severe liver toxicity. The new study will enroll five cohorts at doses from 1 mg to 12 mg per day, starting with the lowest cohort and not progressing to the next dose until an outside drug safety monitoring committee has reviewed the liver safety data from the previous. Read More
Fibrocell Science Inc., of Exton, Pa., submitted a study report to the FDA providing additional data to support the safety profile of azficel-T, an aesthetic treatment for nasolabial folds and wrinkles. The report covered a six-month histological study of skin after injection of azficel-T. Read More
Less than a week after Human Genome Sciences Inc. won FDA approval for the first new lupus therapy in almost 60 years – a multi-billion-dollar blockbuster – HGS has dipped into its coffers to the tune of a potential $495 million for FivePrime Therapeutics Inc.'s FP-1039 product for multiple cancers, a drug still in a small Phase I trial. Read More
Amylin Pharmaceuticals Inc. and Takeda Pharmaceutical Co. Ltd. have become the latest drugmakers to be stymied by safety signals in clinical trials of an obesity candidate. The companies have suspended an ongoing study of pramlintide/metreleptin for obesity. Read More
