Akorn to open state-of-the-art facility in Illinois
BUFFALO GROVE, Ill. Akorn has signed a 10-year operating lease for a newly constructed product development facility located in Gurnee, Ill. This facility will represent the focal point for centralizing Akorn’s new product development activities.
This will consolidate development efforts that are presently managed in Decatur, Ill., and Somerset, N.J.
According to Shawn Silvestri, vice president of new product development, “This new, state-of-the art facility will position Akorn to compete on a global basis, enabling us to attract and recruit top-tier scientific talent. The facility will conform to the tenets of current good laboratory practices for research and development activities and will fulfill all requirements for the development of Akorn’s pipeline of NDA and ANDA filings for prescription drug products.”
The company’s over-the-counter products include AKWA tears in a solution and ointment as well as sodium chloride in ophthalmic ointment and solution.
GSK ready to cut jobs following quarterly losses
PHILADELPHIA GlaxoSmithKline is ready to let some of its workers go to make up for its recent report of lost earnings.
The company reported that total pharmaceutical turnover for the third quarter fell by 2% to $9.4 billion. In the United States, turnover fell 7% to $4.5 billion, impacted by continued generic competition and largely because of a 38 percent drop in sales of its diabetes drug Avandia.
The plan is a three-year $1.4 billion move that includes job cuts, most likely starting at its Avandia sales force. According to the London Times, the company is awaiting what the Food and Drug Administration will report about their findings on Avandia and if it should receive a “black box” warning for heart attack risks.
FDA approves Marillion NDA for novel cancer treatment
MALVERN, Pa. Marillion Pharmaceuticals has received approval from the Food and Drug Administration for it investigational new drug application for its lead product candidate MN-201, a vitamin D5 analog for the treatment of cancer.
The drug will now proceed to Phase 1 human clinical trial for patients with advanced tumors in various cancers.
In preclinical studies, MN-201 performed well against cancer cells. In animal models, MN-201 also resulted in anti-tumor activity including tumor regression in xenograft models of major solid tumor types. In contrast to treatment with other vitamin D(3) analogs and the naturally occurring vitamin D hormone, calcitriol, favorable anticancer effects with MN-201 were observed in the absence of significantly raised calcium levels.