|Bristol-Myers' HIV-1 Drug Approved In Europe; St. Jude Medical Receives FDA Approval for the Spinal Cord Stimulation Trial System|
|By David Fowler|
|Thursday, 16 July 2015 23:52|
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 16, 2015.
Shares of Bristol-Myers Squibb Co (NYSE: BMY) were boosted higher on Thursday after the company announced the European Commission approved its Evotaz for the treatment of HIV-1 in adults.
Evotaz (atazanayir 300 mg and cobicistat 150 mg) is a daily tablet to be taken with other antiretroviral agents for the treatment of HIV-1 infected adults. There are an estimated 2.2 million people in the European region that live with the HIV virus, according to UNAIDS and WHO estimates and cited by the company in its press release.
The company continued that only one-third of diagnosed patients in Eastern Europe received antiretroviral therapy in 2012, a number that falls significantly short below WHO's goals of 80 percent coverage by 2015. Shares traded recently at $69.70, up about 0.6 percent.
"HIV remains a significant public health concern throughout the world, and the increase in new infections in recent years in Europe means that it is more important than ever to continue to deliver new treatment options to help patients achieve virologic suppression," said Murdo Gordon, Head of Worldwide Markets,Bristol-Myers Squibb. "By combining reduced pill burden with a low rate of virologic failure and no protease inhibitor mutations, Evotaz increases the possibility of suppressing HIV, and we are pleased to bring it to physicians and patients in the EU."
Bristol-Myer forged a licensing agreement with Gilead Sciences, Inc. (NASDAQ: GILD) in 2011 for the development and commercialization for what is now named Evotaz. Under the terms of the agreement, Bristol-Myers and its affiliates will handle formulation, manufacturing, registration, distribution and commercialization of Evotaz. Gilead retains the sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
The new wireless St. Jude Medical Invisible Trial System is designed to help chronic pain patients better assess spinal cord stimulation therapy prior to permanent implant
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, today announced FDA approval of the St. Jude Medical™ Invisible Trial System. The system, which received CE Mark in June 2015, is fully wireless and leverages Apple™ technology for both the patient and physician controllers. The system is designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.
With the Invisible Trial System, St. Jude Medical has removed traditional barriers to trialing spinal cord stimulation (SCS), allowing patients to more effectively evaluate their SCS therapy.
For many patients, SCS therapy can be an effective option for managing chronic pain. The therapy relies on a small implanted device and thin wires (known as leads) to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain, which reduces the sensation of pain. Prior to receiving a permanently implanted SCS device, patients undergo a minimally invasive "trial" period to evaluate the therapy. Yet for some patients, complex controllers and bulky programming cables can disrupt the trial experience and act as barrier to SCS therapy.
With the Invisible Trial System, St. Jude Medical has removed these barriers, allowing patients to more effectively evaluate their SCS therapy. The system relies on Bluetooth® wireless technology to provide patients a safe, secure and entirely wireless SCS trial experience. Rather than a complex controller, the St. Jude Medical Invisible Trial System provides patients with a more intuitive iPod touch™ digital device as a controller, while physicians will utilize an iPad mini™ digital device to program and evaluate their patient's therapy.
"Patients undergoing SCS trials consistently tell us about challenges they find in navigating the SCS trial system, from programming the device, to discomfort from the programming cables, to management of both issues. These hindrances may impede the integration of the technology into their daily activities, which shifts their focus away from evaluating the effectiveness of SCS therapy," said pain specialist Dr. Jason E. Pope, president of Summit Pain Alliance in Santa Rosa, Calif. "By providing a discreet trial system, St. Jude Medical will help patients focus more on their potential pain relief and functional improvements, and less about the burdens common to traditional trial systems."
One of the key system features of the St. Jude Medical Invisible Trial System is the use of a small external pulse generator (EPG) as the system's power source. Because the EPG uses Bluetooth wireless technology to communicate between the patient's iPod touch controller and the stimulation system, the overall device profile has been reduced so the system can be worn discreetly under a patient's clothing. The effect is that the system feels essentially "invisible" to the wearer, providing a more comfortable trial experience that allows patients to focus entirely on their system's therapeutic impact during their trial.
"When we developed the new Invisible Trial System, we took into account physician and patient feedback that current trial systems were in some cases preventing patients from adequately assessing their therapy," said Eric S. Fain, M.D., group president of St. Jude Medical. "By providing a more patient-friendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they're receiving from spinal cord stimulation."
The iPod touch controller offers patients a simple, familiar platform to adjust their therapy. An iPad mini tablet is used by the patient's physician to set the programming parameters. The programmer also displays trial usage data from the EPG and allows the physician to print or email the data in PDF format. Bluetooth wireless technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable and thus increasing the patient's comfort.
Note: Apple, iPod touch and iPad Mini are trademarks of Apple, Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.
Allscripts Healthcare Solutions, Inc. (Nasdaq:MDRX) today announced its preliminary financial results for the second quarter ended June 30, 2015.
AngioDynamics (NASDAQ:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the fourth quarter ended May 31, 2015.
BioMed Realty Trust, Inc. (NYSE:BMR) today announced it will report results for its second quarter ended June 30, 2015 after the market closes on Tuesday, July 28, 2015.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today that it has signed an agreement with Harvard Pilgrim Healthcare ("HPHC"), a health care network covering over one million people throughout Massachusetts, Connecticut and Maine.
Computer Programs and Systems, Inc. (NASDAQ:CPSI), a leading provider of healthcare information solutions, today announced that it will release its financial results for the second quarter and six months ended June 30, 2015, on Thursday, July 30, 2015, after the market closes.
Cryo-Cell International, Inc. (OTCQB:CCEL), the world’s first private cord blood bank to separate and store stem cells in 1992, announced results for the second fiscal quarter ended May 31, 2015.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range of solutions to advance life science, will announce results for its second quarter 2015 before market trading hours on Thursday, July 30, 2015.
IPC Healthcare, Inc. (Nasdaq:IPCM), a leading national acute hospitalist and post-acute provider organization, will report its financial results for the second quarter ended June 30, 2015 on Wednesday, July 29, 2015, after the market close.
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that it will report financial results for the second quarter ended June 30, 2015 after the market close on Wednesday, August 5, 2015.
Marrone Bio Innovations, Inc. (MBI), (NASDAQ:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, today announced that Health Canada's Pest Management Regulatory Agency approved the emergency use of REGALIA MAXX biofungicide for controlling downy mildew infections in hops.
NanoString Technologies, Inc., (NASDAQ:NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for breast cancer have been updated to acknowledge that the PAM50 gene signature, commercialized as the Prosigna® Breast Cancer Prognostic Gene Signature Assay, has been clinically validated for prediction of prognosis.
Perseon Corporation (NASDAQ:PRSN) (Perseon or the Company), a leading provider of medical systems that utilize energy to treat cancer, today announced financial results for the second quarter ended June 30, 20151.
PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that Dr. Manuel Hidalgo, one of Europe’s leading clinical and laboratory investigators in the field of pancreatic cancer, has joined PharmaCyte Biotech’s Scientific Advisory Board.
PRA Health Sciences, Inc. (NASDAQ:PRAH) announced today that it has adjusted the start time for its second quarter 2015 financial results conference call on Tuesday, July 28, 2015.
RedChip Companies, Inc., today announced it has issued a research profile on Apollo Medical Holdings, Inc. (OTC:AMEH), an integrated population health management company.
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced the pricing of its previously announced underwritten public offering, for a total amount of 2,462,000 American Depository Shares ("ADSs"), each representing ten of its ordinary shares, at an offering price of $16.25 per ADS.
SANUWAVE Health, Inc. (OTCQB:SNWV), a leading shock wave technology company, announced today the results of two poster presentations and a laboratory demonstration at the Center for Biofilm Engineering's 2015 Biofilm Science and Technology Meeting held at Montana State University in Bozeman, Montana on July 13-16, 2015.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of antibody therapeutics, announced the Company will host a conference call on Thursday, August 6, 2015, at 4:30 p.m. Eastern daylight time to discuss second quarter 2015 financial results and provide an update on gevokizumab's global clinical programs.