FDA approves Johnson & Johnson’s Simponi to treat arthritis
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for treating three types of arthritis.
The agency announced Friday that it had approved Johnson & Johnson’s Simponi (golimumab), a once-monthly injection for treating moderate-to-severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis, an arthritis of the spine.
“[Today’s] approval provides another treatment option for patients with these three debilitating disorders,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class.”
Simponi, a monoclonal antibody made by J&J biologics division Centocor Ortho Biotech, is designed for use in combination with Barr Labs’ immunosuppressant drug Trexall (methotrexate) when treating rheumatoid arthritis, with or without Trexall when treating psoriatic arthritis and alone when treating ankylosing spondylitis.
Eli Lilly & Co. granted preliminary injunction against Teva
INDIANAPOLIS A U.S. District Court has granted drug maker Eli Lilly & Co. a preliminary injunction preventing the launch of a generic version of one of its drugs, Lilly announced Wednesday.
The company said the U.S. District Court for the Southern District of Indiana issued the injunction to prevent Teva Pharmaceuticals’ launch of raloxifene hydrochloride tablets, a generic version of Lilly’s osteoporosis drug Evista.
Patents on Evista begin expiring in 2012. The drug had sales of $700.5 million in 2008, according to Lilly financial data.
DFB Pharmaceuticals appoints new VP business development, corporate finance
FORT WORTH, Texas DFB Pharmaceuticals announced Thursday that it promoted Maxwell Lea to VP business development and corporate finance.
Lea most recently served as director of corporate development and finance for the company. As vice president, he will manage DFB’s capital raising and financing activities, business development initiatives and strategic planning. He will also be responsible for business development efforts for DFB affiliate Healthpoint.
“Since joining DFB in 2002, Maxwell has positively impacted every level of our company and its affiliate businesses,” CFO Michael Patterson said. “I can say without reservation that our companies have excelled due to his success.”