Salix Pharmaceuticals (Nasdaq: SLXP) $29.42, Up $5.17. Announced yesterday that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).
“We are very pleased with the advisory committee’s support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years,” stated Bill Forbes, Pharm.D., Senior Vice President Research and Development and Chief Development Officer, Salix. “We believe the availability of XIFAXAN 550 mg has the potential to change the treatment paradigm for HE. Today’s independent recommendation from the outside experts comprising the advisory committee reinforces the Company’s confidence in the potential for XIFAXAN 550 mg to provide a solution for patients suffering from this serious condition.”
The committee reviewed data from the Company’s 299-subject, double-blind, placebo-controlled, multinational, Phase 3 study. This study demonstrated a statistically significant and clinically meaningful reduction in the risk of recurrent overt HE.1 The primary endpoint – the risk of experiencing a breakthrough overt HE episode – was reduced by 58 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p<0.0001). The key secondary endpoint – risk of experiencing HE-related hospitalization – was reduced by 50 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p=0.0129). The committee also reviewed supporting evidence from the Company’s long-term, open-label, Phase 3 study, as well as evidence derived from clinical studies in acute HE, three-month and six-month studies from the published literature and meta-analyses.
What They Do: Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.
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PositiveID Corporation (Nasdaq: PSID) Trading at $1.85, Up $0.68. Today announced that it has entered into a partnership with FIS, one of the world’s largest providers of banking and payments technology, to launch the Company’s next generation Health Link personal health record (“Health Link”). The new Health Link, which is now live, will be interoperable with Microsoft HealthVault and Google Health, as well as numerous electronic medical records systems in use throughout the country.
To launch the next generation of Health Link, PositiveID partnered with FIS and their HealthManager product to build a robust, interoperable personal health record to offer patients the best of breed for storing and accessing their vital data. Health Link connects patients to a multitude of customized material such as personalized health education and online connectivity to caregivers. Through reminders and alerts that can be tailored to suit an individual’s unique circumstances, members are reminded of important actions and receive suggestions to better manage their health. This includes everything from refilling prescriptions on time, appointment reminders, drug interaction warnings, and tips for preventative actions.
What They Do: PositiveID Corporation develops and markets healthcare and information management products through its RFID-based diagnostic devices and identification technologies, and its proprietary disease management tools.
VocalTec Communications Ltd. (
The initial order, representing the first stage of the deployment, includes the delivery of VocalTec’s Essentra BAX Large-Scale Class-5 solution supporting over 100,000 subscribers. The system is dimensioned to provide service to a much larger user base in support of the customer’s future expansion plans.
What They Do: VocalTec Communications is a global provider of carrier-class Voice-over-IP and Convergence solutions for fixed and wireless service providers. A pioneer in VoIP technology since 1994, VocalTec develops and markets an extensive VoIP offering enabling the flexible deployment of next-generation networks (NGNs).
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