Canadian biotechs QLT Inc. and Cardiome Pharma Corp. disclosed significant downsizings Monday, but the same strategic move put the companies on opposite business trajectories. Read More
Nearly two years after a complete response letter (CRL) delayed Lux Biosciences Inc.'s plans for oral voclosporin in noninfectious uveitis, the Jersey City, N.J.-based biotech completed patient enrollment in a new Phase III study aimed at addressing the FDA's request for additional clinical data. Read More
LONDON – PsiOxus Therapeutics Ltd. has raised £22 million (US$34 million) in its Series B round to finance the first clinical trial of its systemically acting oncolytic virus ColoAd1, in a 132-patient colorectal cancer study that will get under way in September. Read More
Audeo Oncology Inc. filed for a $60 million initial public offering (IPO) to support clinical trials of its products based on hyaluronic acid chemotransport technology (HyACT) for cancer. The HyACT platform is designed to boost the effectiveness of cancer drugs without increasing toxicity. Read More
In the latest salvo against the growing problem of prescription drug abuse and misuse, the FDA approved a classwide risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioid drugs. Read More
Opting for cash now rather than product sales later, Wilex AG decided to take a payment of $17.5 million as part of the deal it entered last year on the U.S. rights to its Phase III cancer antibody Rencarex (girentuximab) with Prometheus Laboratories Inc. It also stands to get another $2.5 million as part of a revised milestone payment that is contingent on a regulatory filing for the drug. Read More
• Cangene Corp., of Winnipeg, Manitoba, granted Camurus AB, of Lund, Sweden, exclusive U.S. commercialization rights for episil in managing pain associated with oral lesions, including oral mucositis, resulting from cancer therapy and other causes. Financial terms were not disclosed. Read More
• OncoSec Medical Inc., of San Diego, received Investigational Review Board (IRB) approval at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center for a Phase II trial evaluating OncoSec's OMS ElectroImmunotherapy to treat cutaneous T-cell lymphoma. Read More
• Eli Lilly and Co., of Indianapolis, and Bristol-Myers Squibb Co., of New York, said Erbitux (cetuximab) in combination with chemotherapy regimen Folfiri (irinotecan, 5-fluorouracil, leucovorin) is the first biologic treatment regimen in nearly a decade to receive FDA approval for newly diagnosed metastatic colorectal cancer. Read More
• Bayer HealthCare Pharmaceuticals Inc., a Wayne, N.J.-based subsidiary of Bayer AG, began enrolling patients in an international Phase II/III trial to evaluate BAY94-9027 as a prophylactic and on-demand treatment of hemophilia A. Read More
