Purdue Pharmaceutical Products LP will commit $19 million to a six-month direct-to-consumer (DTC) advertising program for Intermezzo (zolpidem tartrate), the insomnia drug developed by Transcept Pharmaceuticals Inc., which is kicking in an additional $10 million toward the effort.

Four weeks after Hurricane Sandy slammed into the Eastern U.S., the full scope of the superstorm's impact on one of the busiest clinical trials centers in the world remains unknown. The discovery of thousands of drowned lab mice in the bowels of New York University's (NYU) Smilow Research Building following Sandy's storm surge the night of Oct. 29 suggested the region's medical infrastructure would be damaged beyond bricks and mortar.

Spun out in 2006 from French diagnostics firm BioMérieux SA with the help of Swiss bioincubator Eclosion, GeNeuro SA has slowly but steadily progressed its monoclonal antibody (mAb) technology – initially to prevent the inflammatory and autoimmune cascades induced by the multiple sclerosis-associated retrovirus (MSRV).

A pair of new reports on the pharmaceutical industry portrays a mixed bag of opportunity and challenge as the global giants wrestle with fragmented marketplaces, stagnating management cultures, shrinking pipelines and growing price controls.

After toiling in the trenches for nearly five years, specialty pharma AcelRx Pharmaceuticals Inc. reported a breakthrough with positive top-line data from the first Phase III study of its lead product candidate, the sublingual Sufentanil NanoTab PCA System (ARX-01), compared to intravenous morphine in postoperative pain.

Based on discoveries licensed from the University of North Carolina at Chapel Hill, privately held G1 Therapeutics Inc. is trained on the discovery and development of small molecules targeting proteins associated with cell proliferation and growth – specifically, in cancer therapy and biodefense.

In questioning by members of the House Energy and Commerce Committee, FDA Commissioner Margaret A. Hamburg was hammered for more than four hours Wednesday about the agency's failure to communicate proactively with the Massachusetts Department of Public Health or to provide adequate oversight of the New England Compounding Center, which has been implicated in 32 deaths and more than 400 additional illnesses from a fungal meningitis outbreak across 19 states.

Privately held Colby Pharmaceutical Co. continued a wave of wheeling and dealing by paying up to $140 million in up-front and milestone payments to MannKind Corp. for disease-specific antigen compounds and intra-lymph node injection (INLI) technologies from its MKC1106 cancer vaccine program.

The FDA threw a wrench into the fireworks for AstraZeneca plc and Nektar Therapeutics Inc. after the companies reported positive top-line findings from two Phase III studies and a safety extension trial of naloxegol (NKTR-118) in noncancer-related pain and opioid-induced constipation (OIC).