Eli Lilly said it will withdraw severe sepsis treatment Xigris from all markets following results of a recent study, in which the drug did not show a statistically significant reduction in mortality among patients with septic shock. Xigris generated $104 million in global sales last year ($57.3 million in the US), according to Lilly, and the drugmaker will take a fourth-quarter after-tax charge of about $75 million to $95 million, or $0.05/share.
The CDC's Advisory Committee on Immunization Practices backed a draft recommendation to make vaccination with Merck's Gardasil routine for 11- and 12-year-old boys to protect against human papillomavirus (HPV). If approved by the CDC, the proposal would make the vaccination part of the routine childhood immunization schedule. CDC said the vaccine will afford protection against certain HPV-related conditions and cancers in males and may also provide indirect protection of women by reducing HPV transmission. GlaxoSmithKline's Cervarix is not approved in males.
HealthiNation announced a new series of videos in recognition of Diabetes Awareness Month in November. Programming will be available across the firm's platforms—including online, digital cable television and connected TV—and will kick off with a profile of diabetes patient and social media activist Manny Hernandez, founder of the Diabetes Hands Foundation as well as online communities tudiabetes.org and estudiabetes.org. Four new programs will appear online each week during the month, HealthiNation said, focusing on different aspects of living with diabetes.
In a review of two studies assessing risk of neuropsychiatric adverse events with Pfizer
smoking-cessation drug Chantix
, neither study found a difference in risk of hospitalizations between Chantix and nicotine replacement therapy, the FDA said. However, both studies were limited to only assessing neuropsychiatric events that resulted in hospitalization and did not have a large enough sample size to detect rare adverse events, the agency noted.