Takeda to Feature ALUNBRIG™ (brigatinib) Data from Pivotal Phase 2 ALTA Trial at 18th World Conference on Lung Cancer
Presentations Include Updated Trial Data and Results from Additional Analyses in Crizotinib-Refractory ALK+ Non-Small Cell Lung Cancer –− Data Highlight Takeda’s Strengthened Oncology Business and Diversification of Pipeline into Solid Tumors –September 27, 2017 06:00 PM Eastern Daylight Time CAMBRIDGE, Mass. & OSAKA, Japan--(EON: Enhanced Online News)--Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the company will present four company-sponsored abstracts, including one oral presentation, at the 18th World Conference on Lung Cancer (WCLC) of the International Association for the Study of Lung Cancer (IASLC), October 15-18, in Yokohama, Japan. Presentations at this year’s meeting will highlight Takeda’s progress in developing ALUNBRIGTM (brigatinib), an anaplastic lymphoma kinase (ALK) inhibitor in non-small cell lung cancer (NSCLC). As part of a deep commitment to advancing research and serving the needs of patients, Takeda aspires to develop best-in-class treatments for people living with NSCLC.“Updated data being presented at WCLC from the pivotal ALTA trial reinforces, with longer follow-up, the clinical findings previously reported. We are committed to continuing research and development in NSCLC to improve the lives of the more than 30,000 patients diagnosed with ALK+ NSCLC worldwide each year.” “The presentations at this year’s meeting support the role of ALUNBRIG as a targeted therapy for patients with advanced ALK-positive NSCLC,” said Jesus Gomez Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “Updated data being presented at WCLC from the pivotal ALTA trial reinforces, with longer follow-up, the clinical findings previously reported. We are committed to continuing research and development in NSCLC to improve the lives of the more than 30,000 patients diagnosed with ALK+ NSCLC worldwide each year.”During the oral presentation, Takeda will feature updated data from the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial, highlighting the efficacy and safety of ALUNBRIG at two separate dosing regimens in patients with advanced ALK+ NSCLC who have progressed on crizotinib. Additional efficacy and safety sub-analyses from the trial will also be presented.The four Takeda-sponsored abstracts accepted for presentation during WCLC 2017 include: Note: all times listed are in Japan Standard Time.Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Updated Efficacy and Safety Results From ALTA, a Randomized Phase 2 Trial. Abstract 8027. Oral presentation. Monday, October 16, 4:30 – 4:40 p.m., Room 301 & 302. Hypertension With Brigatinib: Experience in ALTA, a Randomized Phase 2 Trial in Crizotinib-Refractory ALK+ NSCLC. Abstract 8346. Monday, October 16, 9:30 a.m.- 4:00 p.m., Exhibit Hall (Hall B + C). Depth of Target Lesion Response to Brigatinib and Its Association With Outcomes in Patients With ALK+ NSCLC in the ALTA Trial. Abstract 8035. Monday, October 16, 9:30 a.m.- 4:00 p.m., Exhibit Hall (Hall B + C). Overall Survival (OS) After Disease Progression on Brigatinib in Patients With Crizotinib-Refractory ALK+ NSCLC in ALTA. Abstract 8546. Monday, October 16, 9:30 a.m.- 4:00 p.m., Exhibit Hall (Hall B + C). About the ALTA TrialThe Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial of brigatinib in adults is an ongoing, two-arm, open-label, multicenter trial, which enrolled 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Patients received either 90 mg of ALUNBRIG once daily (n=112) or 180 mg once daily following a seven-day lead-in of 90 mg once daily (n=110). The major efficacy outcome measure was confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as evaluated by an Independent Review Committee (IRC). Additional efficacy outcome measures included Investigator-assessed ORR, duration of response (DOR), intracranial ORR, and intracranial DOR.About ALK+ NSCLCNon-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85 percent of the estimated 222,500 new cases of lung cancer diagnosed each year in the United States, according to the American Cancer Society. Genetic studies indicate that chromosomal rearrangements in anaplastic lymphoma kinase (ALK) are key drivers in a subset of NSCLC patients. Approximately two to eight percent of patients with metastatic NSCLC have a rearrangement in the ALK gene.The central nervous system (CNS) is a frequent site for progression in ALK+ NSCLC, with brain metastases present in up to 70 percent of patients after treatment with crizotinib.About ALUNBRIG® (brigatinib)ALUNBRIG is a targeted cancer medicine discovered by ARIAD Pharmaceuticals, Inc., which was acquired by Takeda in February 2017. ALUNBRIG recently received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for ALK+ NSCLC patients who have progressed on or are intolerant to crizotinib. This indication is approved under Accelerated Approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.ALUNBRIG received Breakthrough Therapy Designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted Orphan Drug Designation by the FDA for the treatment of ALK+ NSCLC, ROS1+ and EGFR+ NSCLC. A Marketing Authorization Application (MAA) for ALUNBRIG was submitted to the European Medicines Agency (EMA) in February 2017.In the US, the recommended dosing regimen for ALUNBRIG is:90 mg orally once daily for the first 7 days; if 90 mg is tolerated during the first 7 days, increase the dose to 180 mg orally once daily. The ALTA clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with ALK+ NSCLC worldwide and the healthcare professionals who treat them. In addition to the ongoing Phase 1/2 and Phase 2 ALTA trial, brigatinib is also being studied in the Phase 3 ALTA 1L trial to assess its efficacy and safety in comparison to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have not received prior treatment with an ALK inhibitor.To learn more about ALUNBRIG, please visit www.ALUNBRIG.com or call 1-844-A1POINT (1-844-217-6468). For additional information on the brigatinib clinical trials, please visit www.clinicaltrials.gov.
Insulet Breaks Ground on New U.S. Manufacturing Facility
BILLERICA, Mass.--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), will host a groundbreaking celebration today at its new, state-of-the-art manufacturing facility on a 26-acre site in Acton, Massachusetts.“Insulet has called the Commonwealth home for nearly 20 years, investing in our communities, providing jobs and developing technologies and products that better serve patients around the globe.” Tweet this The new facility represents a significant investment in Massachusetts, is expected to create hundreds of local jobs, and will provide additional manufacturing capabilities closer to Insulet’s large and growing U.S. customer base. The new U.S. manufacturing operation is also expected to drive operating efficiencies and increase productivity. The Company plans to begin production at this location in 2019.Massachusetts Governor, Charlie Baker, will join Insulet speakers Patrick Sullivan, Chairman and Chief Executive Officer, and Shacey Petrovic, President and Chief Operating Officer, to celebrate the groundbreaking event. Other special guests include Travis McCready, Chief Executive Officer of the Massachusetts Life Sciences Center, dignitaries from the Commonwealth of Massachusetts, and members of Insulet’s loyal “Podder” (customer) community.“We are excited to see Insulet’s continued growth in Massachusetts, including the manufacturing jobs and innovations that will come from this new Acton facility,” said Governor Charlie Baker. “Insulet has called the Commonwealth home for nearly 20 years, investing in our communities, providing jobs and developing technologies and products that better serve patients around the globe.”“Investing in our state-of-the-art manufacturing facility allows us to increase our capacity to better support our Omnipod customers, create local jobs and further strengthen our commitment to Massachusetts,” said Patrick Sullivan, Chairman and Chief Executive Officer. “We are experiencing significant growth across our business, and this facility will help us achieve our long-term objectives. I am grateful to Governor Baker and his staff, as well as the Acton community, for supporting all of our efforts. We are committed to providing world-class service to our Podders and improving the lives of those living with diabetes.”About Insulet Corporation:Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Insulet seeks to expand the use of insulin pump therapy with its Omnipod Insulin Management System among people with insulin-dependent diabetes. The Omnipod System is a revolutionary and easy-to-use tubeless insulin pump that provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's Delivery Systems business partners with global pharmaceutical and biotechnology companies to adapt the Omnipod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. Founded in 2000, Insulet Corporation is based in Billerica, Massachusetts. For more information, please visit: http://www.myomnipod.com.
SciFluor Announces Positive Results of Phase 1/2 Study of SF0166 Topical Ophthalmic Solution in Diabetic Macular Edema Patients
CAMBRIDGE, Mass.--(EON: Enhanced Online News)--SciFluor Life Sciences, Inc. today announced positive top-line results of a Phase 1/2 study of SF0166, the company’s lead drug in development for the topical treatment of patients with diabetic macular edema (DME). The Phase 1/2 study assessed the safety and preliminary efficacy of SF0166 in 40 evaluable patients with DME who were randomized to one of two dose strengths (2.5% and 5.0% solutions) self-administered by patients as an eye drop twice-a-day for 28 days.The primary outcome measure of safety was achieved with no drug-related serious adverse events observed in the study throughout the 28-day course of treatment as well as during the 28-day follow-up period. Ocular adverse events were recorded in the treated eyes of 6 patients; all events were mild in severity, with one considered possibly drug-related.SF0166 demonstrated biological activity in both (2.5% and 5.0%) patient groups with 53% of the evaluable patients demonstrating a reduction in retinal thickness (RT) and improvements in visual acuity were also reported. Durability of RT response to the 28 day course of therapy was observed during the month after discontinuing treatment.There were no significant decreases in visual acuity in study eyes during treatment or follow-up and no patient required rescue treatment with an anti-VEGF injection during the treatment phase.“The safety and biological activity, clearly demonstrated in this first-in-patient study, supports continued clinical development of SF0166,” said David Boyer, MD, Retina-Vitreous Associates Medical Group of Los Angeles. “DME is a devastating condition that often results in vision loss. A safe and effective eye drop treatment for patients living with DME would be a major advance in the fight against this debilitating disease. A potential eye-drop treatment for DME may not only increase compliance, but also allow the opportunity to prevent vision loss by treating earlier in the disease pathway.”“We believe SF0166 represents an important breakthrough in the treatment of retinal disease given its unique mode of action and its administration as an eye drop,” said Omar Amirana, MD, SciFluor’s Chief Executive Officer and Senior Vice President at Allied Minds. “We look forward to further advancing SF0166. We would like to thank the patients who participated in this study and the investigators and study staff who share our commitment to advancing the treatment of DME.”About the Phase 1/2 Clinical Trial The Phase 1/2 study assessed the safety and preliminary efficacy of SF0166 in 40 evaluable patients with DME who were randomized to one of two dose strengths (2.5% and 5.0% solutions) self-administered by patients as an eye drop twice-a-day for 28 days. The patients were further assessed over an additional 28-day follow-up period off SF0166. The study was conducted at 6 sites in the US (clinicaltrials.gov ID#NCT02914613) and included treatment-naïve patients as well as patients with prior anti-VEGF treatment.About SF0166 SciFluor is developing SF0166, a novel, patented, potent and selective small molecule inhibitor of integrin αvβ3 with an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. It has been tested in an extensive set of pre-clinical assays and shown to reach the back of the eye and be effective in validated in vivo models of macular disease. SF0166 is also being studied in a separate multi-center, randomized, Phase 1/2 trial has been in patients with neovascular (wet) age-related macular degeneration (AMD) (clinicaltrials.gov ID#NCT02914639).About DME Diabetic Macular Edema (DME) is the swelling of the retina in diabetic patients due to the leakage of fluid from blood vessels within the macula. The macula is important for the sharp, straight-ahead vision. As macular edema develops, blurring occurs in the middle or just to the side of the central visual field. Visual loss from DME can progress over a period of months and make it impossible to focus clearly. Treatment options for patients with DME traditionally include anti-VEGF drugs, corticosteroid drugs, and laser surgery. The anti-VEGF drugs are administered by frequent intravitreal injections into the back of the eye. While the biology and pathology of DME have been generally understood, safe and effective topical therapy in the form of an eye drop has remained elusive. According to the U.S. Centers for Disease Control, approximately 30 million Americans are living with diabetes and approximately 4% of patients living with diabetes, or over 1 million diabetic patients, experience DME1.About SciFluor Life Sciences, Inc.SciFluor creates proprietary best-in-class drugs based on well-understood pathways in areas of significant medical need such as ophthalmology, neuroscience and fibrotic diseases. Our lead clinical drug candidate, SF0166, is an eye drop therapeutic for treating back-of-the-eye diseases.www.scifluor.com
Medrobotics® Submits Application to FDA for Clearance of Transabdominal Robotic Scope
Submission Accelerates Company’s Planned Entry Into General Surgical, Gynecological and Urological MarketsSeptember 28, 2017 12:01 AM Eastern Daylight Time RAYNHAM, Mass.--(EON: Enhanced Online News)--Medrobotics Corp., a medical robotics company, today announced that it submitted an application to the FDA for clearance of a flexible transabdominal robotic scope proposed to visualize anatomy in the thoracic and abdominal cavities. This submission reaffirms the Company’s commitment to develop products for single-port general, gynecological, and urological surgeries.Medrobotics markets the Flex® Robotic System globally for ScarfreeTM ENT and colorectal procedures through natural body orifices. The Company is also pursuing expansion of applications to other areas including transvaginal gynecologic procedures.About MedroboticsMedrobotics Corporation (www.Medrobotics.com) is a privately funded medical device company headquartered in Raynham, Massachusetts. It manufactures and markets the Flex® Robotic System, the world’s first robotic surgical platform with a steerable and shapeable robotic scope. The Flex Robotic System offers surgeons the unique ability to navigate complex anatomy through a single, small entry point while operating in hard-to-reach anatomical locations that might otherwise be inaccessible with straight, rigid surgical tools. The Company’s vision is to provide more patients with access to ScarfreeTM surgical options. Medrobotics received FDA clearances for the Flex Robotic System for ENT applications in July 2015 and for colorectal surgery in May 2017. The CE mark was issued in March 2014.ContactsFor Medrobotics: Kevin Knight, 214-732-9392
Medtronic HeartWare(TM) HVAD(TM) System Approved for Destination Therapy
Patients with End-Stage Heart Failure Now Have New Options for CareDUBLIN - September 27, 2017 - Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, helps the heart pump and increases the amount of blood that flows through the body. "LVADs are an effective and well-established treatment for patients who have progressed to advanced heart failure," said Joseph Rogers, M.D., interim chair of the Department of Medicine at Duke University, and a co-principal investigator for the ENDURANCE and ENDURANCE Supplemental trials. "In addition to its use as a bridge to heart transplantation, the HVAD System offers a promising option for a growing number of patients who are ineligible for transplant." FDA approval is based on results from the ENDURANCE and ENDURANCE Supplemental trials, which enrolled nearly 1,000 destination therapy patients. The data support the safety and effectiveness of the HeartWare HVAD System for patients with advanced, refractory left ventricular heart failure as a bridge to cardiac transplantation (BTT), or myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned. "We have been impressed with the overall clinical profile of the HVAD System, as evidenced by the ENDURANCE and ENDURANCE Supplemental trials, which affirmed its safety and effectiveness as a life-saving therapy for patients," said Francis D. Pagani, M.D., Ph.D., surgical director of the Adult Heart Transplant Program and director of the Center for Circulatory Support at the University of Michigan Health System, and a co-principal investigator for the ENDURANCE and ENDURANCE Supplemental trials. "The new indication is extremely important for patients with end-stage heart failure as the HVAD System offers significant survival and quality-of-life benefits." Heart failure occurs when the heart is unable to pump enough blood to meet the body's needs. It is a progressive condition, affecting more than 6.5 million people in the United States alone,1 a number expected to rise to 8.5 million by 2030.2 A mechanical, centrifugal flow pump, the HVAD System supports heart function and blood flow, continuously drawing oxygen-rich blood from the left ventricle to deliver to the rest of the body. The HVAD System received FDA approval in 2012 as a bridge to transplant in patients eligible for heart transplants. It also received European CE Mark that same year for patients at risk of death from refractory, end-stage heart failure, and it previously had received CE Mark for the bridge to transplant indication in 2009. "Heart failure continues to be a growing burden to millions of patients, caregivers and the healthcare system," said David Steinhaus, M.D., vice president and general manager of the Heart Failure business, which is part of the Cardiac and Vascular Group at Medtronic. "Medtronic strives every day to advance the field of mechanical circulatory support so we can offer physicians more solutions for patients who are living with this debilitating disease." About the HVAD System The HVAD(TM) System features the world's smallest centrifugal-flow VAD and is designed to reduce surgical invasiveness, improve patient recovery times and enhance patient outcomes. Weighing only 160 grams, the HVAD System's continuous flow pump is 30 percent thinner and has 38 percent less volume than other centrifugal devices.3,4 The pump features a unique integrated inflow cannula that is designed to treat more complex patients while maintaining stable inflow position and eliminating the need for abdominal surgery and device pockets.5-12 About the ENDURANCE Supplemental and ENDURANCE Trials The ENDURANCE Supplemental trial was a prospective, randomized, controlled, multicenter evaluation of the incidence of neurologic events in patients receiving the HVAD System as destination therapy who received improved blood pressure management. Between October 2013 and August 2015, 465 patients were randomly selected to receive either the HVAD System or, as part of a control group, an alternative LVAD approved by the FDA for destination therapy, in a two-to-one ratio. Patients will be followed long term, up to five years. This trial was a follow-up to the ENDURANCE Destination Therapy trial that implanted 445 patients between 2010-2012 who received either the HVAD System or an alternative LVAD approved by FDA for destination therapy in a two-to-one ratio. The ENDURANCE trial met its primary endpoint, demonstrating non-inferiority of the HVAD System to the control device; results were published in The New England Journal of Medicine. The Medtronic portfolio of therapies, diagnostic tools and services for patients suffering from heart failure includes the industry's leading cardiac resynchronization therapy devices, including MR-conditional CRT-defibrillators and -pacemakers; mechanical circulatory support therapy for advanced heart failure patients; heart failure diagnostics; and meaningful expert analysis through Medtronic Care Management Services, including the Beacon Heart Failure Management Service. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world. About Medtronic Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. -end- 1 Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics-2017 update: a report from the American Heart Association [published online ahead of print January 25, 2017]. Circulation. doi: 10.1161/CIR.0000000000000485. 2 Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail 2013;6:606-19. 3 HVAD System Instructions for Use. HeartWare, Inc., Framingham, MA, USA. 01/17. 4 HeartMate 3 Left Ventricular Assist System, Instructions for Use. Thoratec Corporation, Pleasanton, CA, USA (2/2015). 5 Abicht T, et al. Complex HeartMate II infection treated with pump exchange to HeartWare HVAD. ASAIO J. 6 Gregoric I, et al. Diaphragmatic implantation of the HeartWare ventricular assist device. J Heart Lung Transpl. 7 Takeda K, et al. Successful implantation of HeartWare HVAD left ventricular assist device with concomitant ascending and sinus of aneurysms repair. J Artif Organs 2012;15:204-206. 8 Garcia Saez D, et al. Successful replacement of a Heart Assist 5 ventricular assist device with a HeartWare without removal of the original sewing attachment rings: how to do it. Interact Cardiovasc Thorac Surg. 2013;16(6):888-889. 9 Palmen M, et al. Implantation of a left ventricular assist device in patients with a complex apical anatomy. Ann Thorac Surg. 2012;94:2122-2125. 10 Morshuis M, et al. A modified technique for implantation of the HeartWare left ventricular assist device when using bivalirudin anticoagulation in patients with acute heparin-induced thrombocytopenia. Interactive CardioVascular and Thoracic Surgery (2013) 1-2 doi: 11 Huang J, et al. HeartWare ventricular assist device placement in a patient with congenitally corrected transposition of the great arteries. J Thorac and Cardiovasc Surg. 2013;145(2) e23-25. Epub ahead of print 6 Dec 2012; doi:10:1016/j.jtcvs.2012.11.008. 12 Sorensen EN, et al, Computed tomography correlates of inflow cannula malposition in a continuous-flow ventricular-assist-device. J Heart Lung Transpl 2013;32 (6):654-657. Contacts: Tracy McNulty Public Relations +1-763-526-2492Ryan Weispfenning Investor Relations +1-763-505-4626
Geisinger and Boehringer Ingelheim collaborate to create a predictive model to help improve health outcomes for people with type 2 diabetes at greatest risk of serious long-term complications, including cardiovascular death
PRNewswire/ -- In an effort to improve health outcomes of people with type 2 diabetes, Geisinger and Boehringer Ingelheim, on behalf of its diabetes alliance with Eli Lilly and Company (NYSE: LLY), today announced a major collaboration to develop a risk-prediction model for three critical health outcomes commonly associated with type 2 diabetes that have long-term impact and cost-of-care implications: cardiovascular death, kidney failure and hospitalization for heart failure.The new model will allow healthcare professionals to predict which adults with type 2 diabetes are most at risk for developing these serious - and costly - health consequences. The model will be created using Geisinger de-identified electronic health record data (i.e., demographics, vital signs, medical history, current medications and laboratory tests). Ultimately, a successful model should allow for the development of more precise treatment pathways for people with type 2 diabetes; pathways that align with quality guidelines aiming to improve patient outcomes, quality and total cost of care.Approximately 30 million Americans have diabetes, and nearly 24 percent of Americans with diabetes are undiagnosed. People with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes. Approximately 68 percent of deaths in people with type 2 diabetes in the U.S. are caused by cardiovascular disease."Our partnership with Boehringer Ingelheim will use real-world data and predictive modeling to deploy precision healthcare strategies to bring the most value to the people we care for," said Brent Williams, Geisinger assistant professor of epidemiology. "We hope the knowledge gained from this predictive model can help healthcare providers better target their treatment recommendations for people with type 2 diabetes and, as a result, lower their risk for these serious diabetes-related consequences."Despite recent advances in treatment, cardiovascular disease remains the leading cause of death associated with diabetes, and diabetes is the number one cause of kidney failure in the U.S. The financial burden of healthcare for cardiovascular conditions in people with diabetes is also immense, costing the U.S. upwards of billion per year. Efforts such as this partnership may offer long-term savings and solutions that improve outcomes and lower total cost of care."Since people with diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes, novel approaches to mitigate cardiovascular risk and improve patient care continue to be a priority," said Christine Marsh, vice president, Market Access, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe this initiative to develop a predictive risk model is very timely, as recent research has provided more practical knowledge about how to reduce cardiovascular risk in people with type 2 diabetes. Boehringer Ingelheim and Lilly are proud to be a part of this collaboration, which will address a pressing need of people with type 2 diabetes and the healthcare community that cares for them."About Geisinger Geisinger is an integrated health services organization widely recognized for its innovative use of the electronic health record and the development of innovative care delivery models such as ProvenHealth Navigator®, ProvenCare® and ProvenExperience®. As one of the nation's largest health service organizations, Geisinger serves more than 3 million residents throughout 45 counties in central, south-central and northeast Pennsylvania, and also in southern New Jersey at AtlantiCare, a Malcolm Baldrige National Quality Award recipient. In 2017, the Geisinger Commonwealth School of Medicine became the newest member of the Geisinger Family. The physician-led system is comprised of approximately 30,000 employees, including nearly 1,600 employed physicians, 13 hospital campuses, two research centers, and a 551,000-member health plan, all of which leverage an estimated .5 billion positive impact on the Pennsylvania and New Jersey economies. Geisinger has repeatedly garnered national accolades for integration, quality and service. In addition to fulfilling its patient care mission, Geisinger has a long-standing commitment to medical education, research and community service. For more information, visit www.geisinger.org, or connect with us on Facebook, Instagram, LinkedIn and Twitter.Boehringer Ingelheim and Eli Lilly and Company In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.Given the critical connection between diabetes and cardiovascular disease, Boehringer Ingelheim and Lilly are committed to providing a wide range of diabetes therapies along with programs and support to raise awareness, understanding and action toward reducing the impact of cardiovascular disease in people with type 2 diabetes.
Baxter Launches DeviceVue Advanced Asset Tracking System for Sigma Spectrum Infusion System
Baxter becomes first infusion pump vendor to provide in-house, end-to-end asset tracking solution for infusion pumps Tagless tracking enables clinicians and biomedical engineers to find an unused pump quickly by displaying location and status of every pump DEERFIELD, Ill. --(BUSINESS WIRE)--Sep. 27, 2017-- Baxter International Inc. (NYSE: BAX), a leader in innovative technology for medication delivery, today announced the launch of DeviceVue, a comprehensive asset tracking solution available exclusively to hospitals using the Sigma Spectrum Infusion System. Designed to help enhance clinical and hospital efficiency, DeviceVue helps enable clinicians and biomedical engineers to quickly find unused pumps by viewing pump location and status data from their PC, iPad® or iPhone®. With DeviceVue, Baxter is the first and only smart infusion pump manufacturer to offer a tagless, end-to-end asset tracking application. "Healthcare leaders today are required to deliver clinical and financial return on every dollar spent," said Scott Luce , general manager, U.S. Hospital Products, Baxter. "Baxter is committed to continually enhancing the award-winning Sigma Spectrum Infusion System through technologies like DeviceVue that drive operational efficiencies and help facilities maximize clinical value." In place of the cost and labor associated with purchasing and installing external radio frequency identification (RFID) tags, DeviceVue receives a signal from the pump's wireless radio that provides location data, whether the pump is in use, and the status of the pump battery, wireless network connection, and drug library. This data is sent in near real-time to the DeviceVue PC or mobile application. DeviceVue is currently in use at multiple health systems across the country, including Mississippi Baptist Medical Center in Jackson, Miss. , a 564-bed, Magnet®-recognized facility. The Magnet designation represents the highest distinction for nursing excellence and patient care. In addition to asset tracking, DeviceVue's utilization reporting can help hospitals reduce costs by ensuring as many pumps as possible are put to use, while the ability to search for specific pumps by serial number can help biomedical engineers dramatically reduce the amount of time required to perform preventive maintenance. For more information on the Sigma Spectrum Infusion System, please visit www.sigmapumps.com. About Sigma Spectrum Infusion System Sigma Spectrum's hardware works in concert with the pump's software to encourage use of innovative features that are designed to help enhance patient safety and clinician efficiency. For example, the pumps automatically default to the installed drug library without requiring clinicians to take extra steps to "opt-in," and drug library updates can be delivered wirelessly to pumps in the facility without interrupting clinical workflow. Sigma Spectrum is the only pump to include a built-in Dose/Rate Change Error Prevention Feature, which helps clinicians protect high-risk infusions during titrations, and allows pharmacists to customize dose change limits for individual drugs. Sigma Spectrum also includes features like: integration with electronic health record (EHR) systems--including Cerner® and Epic®--to help streamline clinical workflow and improve accuracy of IV infusion documentation; DeviceVue, a tagless, end-to-end asset tracking solution that can help provide a significant boost to both clinical and operational efficiency; enhanced data analytics and use of single set technology that can help yield up to 53 percent cost savings in IV tubing sets and 30 percent reduction in IV tubing use.1 DeviceVue will work with any V8 and V6 Sigma Spectrum infusion pump that has a wireless radio and Master Drug Library v6.5.6 or later. Pumps must have at least 25% charge in order to continue providing data to DeviceVue. Sigma Spectrum Infusion System is Rx Only. For the safe and proper use of this device, refer to the appropriate operator's manuals.
Amgen And Simcere Announce Strategic Collaboration To Co-Develop And Commercialize Biosimilars In China
PRNewswire/ -- Amgen (NASDAQ: AMGN) and Simcere Pharmaceutical Group today announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China . The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. Under the terms of the agreement, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China , while Amgen will have a limited right to co-promote the products. The biosimilars included in the agreement are a part of Amgen's existing biosimilars portfolio. "We are pleased to enter this strategic collaboration with Simcere as we continue to enhance patient access through broader adoption of more competitive therapeutic options worldwide," said Scott Foraker , vice president and general manager of Biosimilars at Amgen . "This agreement brings together Amgen's long-standing development and biologics manufacturing expertise with Simcere's local development experience and strong commercial presence in China in the areas of inflammation and oncology." "This agreement furthers Amgen's efforts to reach more patients in Asia by bringing high quality biosimilars medicines to patients suffering from debilitating and potentially life-threatening conditions," said Penny Wan , regional vice president and general manager of Amgen's Japan and Asia-Pacific Region . "We look forward to working with Simcere on these four biosimilar programs where we can build on their network and experience in China to make a big difference for patients." "This strategic partnership between a world-renowned biotechnology company and a leading Chinese pharma will help to accelerate development and launch of United States and European approved biosimilars in China . By leveraging our sales network, it will also help to improve the accessibility of high quality therapeutic antibodies for Chinese patients," said Honggang Feng , president of Simcere. "This collaboration will allow both companies to further penetrate inflammation and oncology markets in China ." Dr. Hua Mu, chief scientific officer of Simcere said, "Recently, China Food and Drug Administration (CFDA) has formally joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and implemented major reforms on drug evaluation and approval systems, encouraging and supporting research and development of innovative, high quality medicines. This strategic alliance combines Amgen's leading global research and development capabilities in biosimilars and Simcere's domestic drug development and registration experience. It aims to bring more high quality and effective medicines to Chinese patients to meet the pressing unmet medical needs. It is also another important milestone in our international collaboration strategy to enrich Simcere's biologics pipeline." Specific financial terms of the agreement were not disclosed. About Amgen Biosimilars Amgen Biosimilars is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients suffering from serious illnesses. Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its more than 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide. For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. About Simcere Pharmaceutical Group Simcere is a research and development-driven Chinese pharmaceutical company committed to bringing high quality and more effective therapies to patients by combining in house R&D with partnerships. Simcere focuses its efforts on therapeutic areas of oncology, neurology, inflammation/immunology, cardiovascular and infectious diseases. Simcere is dedicated to research & development of innovative pharmaceuticals and branded generic drugs in China , with a State Key Lab of Translational Medicine and Innovative Drug Development. By leverage of its commercial capability, all top products of the company have leading market share in China . By leveraging partnering experience with multinational pharmaceutical companies and innovative biotech companies, Simcere continues to advance [international medical scientific achievements transformation] and create value for partners in China . For more information, visit www.simcere.com.
Novo Nordisk's new-generation basal insulin Tresiba® approved in China
Tresiba® has been shown to provide a significantly lower risk of overall, severe and nocturnal hypoglycaemiaBagsværd, Denmark, 27 September 2017 - Novo Nordisk today announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.1 Tresiba® provides significantly lower risk of overall, severe and nocturnal hypoglycaemia (low blood sugar) and comparable reductions of blood sugar levels vs. insulin glargine U100 in people with diabetes.1-4 Studies have also shown that Tresiba® provides significantly lower variability in blood sugar levels compared to insulin glargine U100 and U300.5,6 "There are more adults with diabetes in China than anywhere in the world, and we are delighted that the CFDA's approval brings the availability of Tresiba® in China one step closer," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "Tresiba® gives physicians and people with diabetes a new treatment option that provides equivalent reductions in blood glucose levels and significantly lower risk of hypoglycaemia." In the multinational, double-blinded Tresiba® cardiovascular outcomes trial, DEVOTE, reported earlier this year, Tresiba® demonstrated cardiovascular safety and a reduced rate of severe and nocturnal severe hypoglycaemia by 40% and 53% respectively compared to insulin glargine U100 in people with type 2 diabetes.4 In the double-blinded SWITCH trials, Tresiba® demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100 in the full treatment period in people with type 1 and type 2 diabetes.7,8 China has over 100 million people living with diabetes, and the number is expected to grow to more than 150 million people by 2040.9 Tresiba® is expected to launch in China in Q1 2018. About Tresiba® Tresiba® (insulin degludec) is a once-daily basal insulin that provides a duration of action beyond 42 hours with a flat and stable glucose-lowering effect.1,6 It provides low variability in blood glucose levels and a lower risk of overall, nocturnal and severe hypoglycaemia vs. insulin glargine U100.1,4 On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time with a minimum of eight hours between injections.1 Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 80 countries globally. It is now commercially available in more than 50 countries.
Bavencio (Avelumab) Approved for Merkel Cell Carcinoma in Japan
• First-ever treatment indicated for curatively unresectable Merkel cell carcinoma (MCC) and first anti-PD-L1 to be available in Japan • Japanese Ministry of Health, Labour and Welfare (MHLW) decision based on Javelin Merkel 200 study, the largest registrational trial for an immunotherapy in MCC • First Asian approval for Bavencio follows approvals in the US and EuropeDarmstadt, Germany, and New York, US, September 27, 2017 – Merck and Pfizer Inc. (NYSE: PFE) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO® (avelumab, genetically recombinant Injection 200mg/mL for intravenous use) as the first and only treatment indicated for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive skin cancer, in Japan.