FDA approves Perrigo and Teva’s generic nasal spray
ALLEGAN, Mich. The Food and Drug Administration has given final approval for the marketing of a generic version of an allergy drug.
Perrigo Co. and Teva Pharmaceutical Industries announced Monday that they had received approval for triamcinolone acetonide nasal spray, a generic version of Sanofi-Aventis’ Nasacort AQ.
The drug is used to treat seasonal and year-round allergies in patients aged 6 and older. Nasacort AQ had sales of about $305 million during the 12 months ending in June, according to Wolters Kluwer data.
Under the terms of a previous court settlement, Perrigo will manufacture and Teva will begin marketing their generic Nasacort AQ on June 15, 2011.
GSK: Rheumatoid arthritis treatment meets trial goals
LONDON A late-stage clinical trial of a biotech drug for rheumatoid arthritis has met its goals, the drug’s developers announced Wednesday.
British drug maker GlaxoSmithKline and Danish drug maker Genmab announced that patients in a phase 3 trial taking ofatumumab experienced a 20% improvement in the number of swollen and tender joints, as the companies expected.
In the 260-patient study, the 129 patients taking ofatumumab had a 50% response rate, compared to 27% of those taking placebo. The companies also said there were no unexpected safety problems, but 5% of patients experienced rash, hives, throat irritation and other side effects.
“We have always believed in ofatumumab’s potential to make a difference in patients’ lives,” Genmab CEO Lisa Drakeman said in a statement. “We are pleased with the results of this study, supporting the further investigation of this antibody’s promise in the treatment of RA.”
Medarex reports narrowed loss, nearly doubled revenue for Q2
PRINCETON, N.J. Biotech drug maker Medarex reported a less severe drop in second-quarter loss, while its revenue almost doubled from last year.
The Princeton, N.J.-based Medarex reported losses of $29.2 million compared with a loss of $53.1 million in the same quarter last year.
This year’s revenue was up 96% from last year’s $10 million to $19.5 million.
New York-based Bristol-Myers Squibb, the maker of blood thinner Plavix, put forth $2.1 billion to acquire Medarex.