The Biotechnology Industry Organization is critical of the timing and lack of specificity in the release of the draft version of PCORI’s national priorities and research agenda.
FDA is seeking public comment on a study it plans to examine how corrective advertising may impact consumer misperceptions about prescription drug product safety and efficacy.
The launch of Benlysta for systemic lupus erythematosus has not been a rousing success to date, but Human Genome Sciences says its drug is growing in use and sales month-by-month as rheumatologists get to know the product. On Feb. 27, HGS announced that Benlysta yielded net sales of $52.3 million in 2011, reflecting about seven months on the market.
With positive results for both acute exacerbation of schizophrenia and bipolar mania in hand, Forest Laboratories and partner Gedeon Richter plan to file an NDA for their novel atypical antipsychotic cariprazine in both indications this year. Positive results in ongoing studies for add-ons in bipolar depression and treatment resistant major depressive disorder could make it the only drug in the class with all four claims.