Novel health innovation program, launchibiliti, joins NCHA Strategic Partners.

This program helps health systems identify,develop and launch transformational
innovations to benefit patients.
To read the entire story click here

BioDelivery Sciences Announces FDA Acceptance of BUNAVAIL NDA for Filing

BioDelivery Sciences International, Inc announced today that its New Drug Application (NDA) for BUNAVAIL (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence has been accepted for filing by the U.S. Food and Drug Administration (FDA), indicating that the application is sufficiently complete to permit a substantive review. Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the BUNAVAIL NDA is expected to be completed by early June 2014.
BUNAVAIL utilizes BDSI's proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid dependence, along with the opioid antagonist naloxone, which is intended to serve as an abuse deterrent. BUNAVAIL was designed to efficiently and conveniently deliver buprenorphine while potentially overcoming some of the challenges with other dosage forms.

SafeStitch Medical raises $160 million for its hernia fixation device from backers including Intersouth Partners, Aisling Capita

A month after its merger with TransEnterix, SafeStitch Medical (OTC:SFES) has drummed up a whopping $160.4 million funding round from 43 investors including a clutch of venture capital shops, according to regulatory filings.
SafeStitch and TransEnterix inked their merger deal last month, saying SafeStitch would move from Miami to Research Triangle, N.C., but keep its name, stock symbol and place on the OTC exchange.
TransEnterix CEO Todd Pope is at the helm of the new SafeStitch, with medtech veteran Paul LaViolette as board chairman. SafeStitch chairwoman Jane Hsiao and OPKO Health chairman Phillip Frost also have seats on the new entity's board, the company said at the time.
To read the entire story click here

Heart Imaging Technologies Wins $2.5M NIH Grant for Clinical Trials

HeartIT, the global leader that pioneered the first FDA approved zero-footprint medical imaging workstation, announced today that it has received a $2.5M grant from the NIH in order to develop the "Cloud Based Corelab of the Future."
Medical drugs and devices are regulated by the U.S. Food and Drug Administration (FDA) based on data from multicenter clinical trials. Over the past decade the efficiency of clinical trials has been improved by electronic data capture (EDC) systems, whose use has increased from 38% to 61% from 2006 to 2011. While medical imaging plays a key role in clinical trials, often serving as the basis for study end-points and/or safety evaluations, few if any EDC systems integrate imaging corelab workflows such as image quality assurance, site queries, and reporting of end-point analyses.

DHMRI and Metabolon Announce Strategic Partnership to Provide Expanded Metabolomics Capabilities

The David H Murdock Research Institute (DHMRI) at the North Carolina Research Campus and Metabolon, Inc., announced today that they have entered into a strategic agreement to align metabolomics research services. Metabolon is a pioneering leader in discovery metabolomics and specializes in rapidly assessing metabolism in biological samples to quickly identify prospective biomarkers and to understand metabolic effects of treatments, interventions, nutritionals, etc. The agreement complements DHMRI’s mass spectrometry and NMR-based metabolomics services through access to Metabolon’s industry-leading high-throughput biomarker discovery and profiling platform which provides an extensive, untargeted, broad metabolite survey of more than 4000 biochemicals.

Medical device firm TransEnterix merging with Florida company

SafeStitch Medical, today announced that it has entered into a definitive agreement to merge with TransEnterix, Inc., a privately-held, medical device company with advanced technology in the use of flexible devices and robotics for minimally invasive surgery.
Commenting on the merger, Dr. Jane Hsiao, Chairwoman of SafeStitch Medical stated, "We are excited about the breadth of the management team of TransEnterix. There are compelling advantages to innovative flexible technologies and robotics for less invasive surgical interventions, such as our proprietary trans-oral device. This merger will provide greater resources to help bring the pipeline products of the combined company to market and offer our shareholders an excellent opportunity to realize significant value of their investment."

Quintiles buying Novella is major clinical research deal

Triangle-based clinical research giant Quintiles announced Wednesday it is buying Novella Clinical, another Triangle-based firm in the burgeoning clinical research industry.
Novella is a full-service clinical research organization focused largely on oncology.
"The expertise and insight the Novella team brings will be a strong addition to our existing capabilities and help further differentiate Quintiles in an increasingly competitive marketplace," said Paula Brown Stafford, president of Clinical Development at Quintiles. "Novella's understanding of emerging companies, as well as our shared commitment to quality, customer service, and above all, the patients we ultimately serve, makes this acquisition a good fit for both organizations."
Novella said that by joining Quintiles, it can continue its specialized focus while taking advantage of Quintiles' global focus.

Medical device developer TransEnterix raising $2.5M

Medical device company TransEnterix is on its way to securing another $2.5 million in financing.
The Research Triangle Park company has raised just shy of $2 million in funding, a mix of debt, options and warrants, according to securities filings. A total of nine investors so far have participated in the offering, which started on Aug. 5.
TransEnterix has already commercialized a minimally-invasive surgical system. The SPIDER surgical system requires only a small incision in the belly button to give surgeons access to the abdomen to perform a variety of procedures. The company is now testing a new system, SurgiBot, a surgical system that brings robotic capabilities to TransEnterix’s approach to surgery; in contrast, the SPIDER system is operated manually by a surgeon.
TransEnterix in June said the company expects SurgiBot to be ready for regulatory review by the Food and Drug Administration next year.

Illumina Acquires Advanced Liquid Logic, Leader in Digital Microfluidics Solutions

 Illumina, Inc today announced that it has acquired Advanced Liquid Logic (ALL), a leading provider of liquid handling solutions. ALL, now a wholly owned subsidiary of Illumina, has developed a proprietary “digital microfluidics” technology based on electrowetting that precisely manipulates small droplets within a sealed disposable cartridge to perform complex laboratory protocols. This proven technology will enable Illumina to deliver the simplest and most efficient sample-to-answer next-generation sequencing (NGS) workflow.

Micell Technologies Receives CE Mark Approval for MiStent SES

Micell Technologies, Inc received CE (Conformite Europeenne) Mark approval for its MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) introducing a thin-strut stent that features elimination of the coating from the stent in 45-60 days and the complete absorption of the polymer coating within 90 days. The MiStent SES is unique in providing local drug delivery both during and after the period of polymer absorption, thereby eliminating long-term polymer exposure, a potential cause of delayed healing and late adverse events.
Micell's Chief Executive Officer, Arthur J. Benvenuto, commented, "The MiStent SES brings a new paradigm of safety without compromise to efficacy or deliverability. With polymer absorption faster than any other DES currently available, we believe the MiStent SES provides a long-term safety profile of a highly deliverable bare metal stent."

Syndicate content