FDA approves Visensia Alert for market
The Food and Drug Administration has given 510(k) clearance to OBS Medical to market its Visensia Alert product in the United States, OBS announced Wednesday.
Visensia, trademarked as VitalAlert, fuses up to five vital signs into a numerical index, including heart rate, respiration rate, body temperature, oxygen saturation and blood pressure. The index indicates a patient’s wellness and can enable significant improvement in clinical outcomes and help optimize a hospital’s resource utilization, the company said.
“Clinical workflow today’s hospital is stricken by high rates of monitor false alarms, compromising patient safety and increasing operational costs,” OBS president and chief executive officer Frank Cheng said. “As confirmed by recently published data from a large-scale, award-winning clinical study, Visensia VitalAlert can enable a high-precision alerting process resulting in reliable identification of patient crisis.”
Bristol-Myers Squib ups off for ImClone buyout
NEW YORK Bristol-Myers Squibb announced Monday that it would increase its offer for ImClone after the biotech rejected a previous offer as too low.
Bristol had previously offered $60 a share for the company, but has increased its offer to $62 a share, or $4.7 billion. That’s still far below the $70 a share that ImClone chairman Carl Icahn has said an unnamed pharmaceutical company has offered.
ImClone and Bristol jointly market the cancer drug Erbitux (cetuximab), and Bristol owns 16.6 percent of ImClone’s stock.
Roche assures flu vaccines will be in stock for season
NUTLEY, N.J. Ample supplies of the flu drug Tamiflu will be available throughout the country during the flu season, manufacturer Roche said Tuesday.
The vaccine, known generically as oseltamivir phosphate, is approved for treating and preventing influenza in adults and children aged 1 and older.
The Centers for Disease Control and Prevention considers it an important second line of defense against the flu.
“We understand that pharmacists do their best to stock appropriate amounts of antiviral medications, such as Tamiflu, for use during the flu season,” Roche medical director Dominick Iacuzio said. “However, the incidence and severity of seasonal flu remains unpredictable from year to year, and some pharmacies may still be faced with greater-than-expected demand during the season.”