Shares of AbbVie Inc (NYSE:ABBV) ended Tuesday session in red amid volatile trading. The shares closed down -0.23 points or -0.36% at $63.00 with 4.72 million shares getting traded. Post opening the session at $63.31, the shares hit an intraday low of $62.55 and an intraday high of $63.53 and the price vacillated in this range throughout the day. The company has a market cap of $102.86 billion and the numbers of outstanding shares have been calculated to be 1.63 billion shares.
AbbVie Inc (ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.
The BTD is supported by positive results seen in AbbVie’s Phase 2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.
“AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The FDA’s Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients.”
Shares of Medtronic PLC (NYSE:MDT) ended Tuesday session in red amid volatile trading. The shares closed down -0.28 points or -0.32% at $86.11 with 4.09 million shares getting traded. Post opening the session at $86.51, the shares hit an intraday low of $85.83 and an intraday high of $86.62 and the price vacillated in this range throughout the day. The company has a market cap of $119.00 billion and the numbers of outstanding shares have been calculated to be 1.38 billion shares.
Medtronic PLC (MDT) announced that two previously communicated global voluntary recalls related to the HeartWare International (HeartWare) HVAD® System have been classified as Class 1 by the U.S. Food and Drug Administration (FDA). Class 1 recalls describe situations where there is reasonable risk of serious adverse health consequences or death.
In a safety notification letter distributed globally in May and June 2016, HeartWare® notified physicians regarding potential damage to controllers from exposure to moisture through loose power and data connectors. In the U.S., all clinician notifications have been acknowledged, and globally 99 percent of clinician notifications have been acknowledged.
Hospital clinicians were advised to inspect patients` HVAD HeartWare Controllers for loose connectors at patients` regularly scheduled appointments and to replace affected controllers with a new controller at the clinicians` discretion. Clinicians also were advised to remind patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources. Damage to the controllers from this issue could cause loss of communication between the controller and monitor, reduced ability to detect alarms or interruption of circulatory support due to pump stop, which could lead to serious injury or death.