Pronai Therapeutics Inc.'s DNA interference (DNAi) technology charmed Wall Street enough to let the company pull off a $137.7 million IPO and end the day with newly traded shares (NASDAQ:DNAI) selling for $30.80, up $13.80, or 81.2 percent. Read More
The Senate Appropriations Committee held its July 16 mark-up of the appropriations bill for FDA and related agencies, and the minority party again raised the specter of a government shutdown over the sequester. Read More
Five Prime Therapeutics Inc. has agreed to pay Inhibrx LLC $10 million for global rights to use antibodies that bind to glucocorticoid-induced tumor necrosis factor receptor (GITR) either alone or, more likely in combination with potential immuno-oncology therapies, such as its own phase I FPA-008, targeting tumor-associated macrophages. Read More
LONDON – With the amount of funding available for biotech in the UK finally rebounding from the financial crisis, there is now a push to extend the timelines over which it is made available, to better accommodate the 10 to 15 years it takes to develop a drug. Read More
The EMA is seeking industry comment on product-specific guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin and zonisamide. Besides being required for generic drugs, the studies may be necessary to support applications for marketing authorization variations, fixed-dose combinations, indication extensions and hybrid applications. Read More
Aslan Pharmaceuticals Pte. Ltd., of Singapore, and National Cancer Centre Singapore (NCCS) have agree to initiate a number of collaborative projects focused on increasing the understanding of novel combinations of known therapeutic agents, including Aslan's clinical development programs ASLAN001 and ASLAN002, through preclinical research involving patient-derived cell lines and xenograft models. Read More
Carbylan Therapeutics Inc., of Palo Alto, Calif., said unforeseen delays in connection with the transfer of its drug manufacturing processes to two contract manufacturers delayed the timetable for the second phase III trial, COR1.2, of its Hydros-TA candidate, which is now expected to begin enrolling patients early next year. Read More
