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November 13, 2017

Nexstim Gains FDA Clearance to Commercialize it’s NBT System in the U.S. for the Treatment of Depression


Nexstim announced that the Food and Drug Administration (FDA) has cleared the company's NBT system for marketing and commercial distribution in the US for the treatment of Major Depressive Disorder (MDD).


The NBT system uses an unique method of TMS known as navigated Transcranial Magnetic Stimulation (nTMS) which allows for accurate, reproducible stimulation of the specific area of the brain associated with the treatment of depression.


Nexstim intends to begin marketing and sales of its NBT system in the US during the first half of 2018.



See more about the Navigated Brain Therapy System on Meddevicetracker.




CE Mark for MEVION S250i Proton Therapy System


Mevion Medical Systems announced that the MEVION S250i Proton Therapy System has achieved CE Marking clearance. CE Marking permits clinical use of the system within the European Union and any country that recognizes the CE Mark. The MEVION S250i system includes HYPERSCAN technology, the next generation of pencil beam scanning (PBS) for faster, sharper, and more robust proton treatments.



The first European MEVION S250i proton therapy system installation will be completed in 2018 at the Zuid-Oost Nederland Protonen Therapie Centrum (ZON PTC) at the Maastro Clinic in Maastricht, the Netherlands.



See more about the MEVION S250i on Meddevicetracker.



GSK Receives European Marketing Authorization for Self-Injectable Formulation of Benlysta for the Treatment of Systemic Lupus Erythematosus


GSK announced that the European Commission has approved a new subcutaneous (SC) formulation of Benlysta (belimumab), as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus(SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy.


The approval is for a single-dose prefilled syringe and a single-dose prefilled pen (autoinjector) presentation, administered as a once weekly injection of 200mg. The subcutaneous version of the medicine adds to the existing intravenous (IV) formulation, which was licensed for use in Europe in 2011.


The approval is based on results from the BLISS-SC Phase III pivotal study of more than 800 patients with active SLE, published earlier this year in Arthritis & Rheumatology. The study measured reduction in disease activity at Week 52 in patients receiving Benlysta plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus).



See more about the Benlysta SC Autoinjector at Meddevicetracker.




November 14, 2017


Otsuka and Proteus Announce the First U.S. FDA Approval of a Digital Medicine System: ABILIFY MYCITE (aripiprazole tablets with sensor)


Otsuka and Proteus announced that the United States Food and Drug Administration (FDA) has granted the approval of a digital medicine system, ABILIFY MYCITE (aripiprazole tablets with sensor), a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE Patch (a wearable sensor, developed by Proteus); the MYCITE APP, a smartphone application (app), used with a compatible smartphone to display information for the patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. Only functions of the app related to tracking drug ingestion have been approved by the FDA. ABILIFY MYCITE, an atypical antipsychotic, is indicated in adults for the treatment of schizophrenia, for the treatment of acute manic and mixed episodes, and maintenance treatment of bipolar I disorder as monotherapy, and as adjunctive therapy to lithium or valproate, and the adjunctive treatment of major depressive disorder. ABILIFY MYCITE is intended to track drug ingestion. The ability of ABILIFY MYCITE to improve patient compliance or modify aripiprazole dosage has not been established. The use of ABILIFY MYCITE to track drug ingestion in “real-time” or during an emergency is not recommended because detection may be delayed or not occur. 



Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY MYCITE is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Those on antidepressant therapy should be monitored closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. ABILIFY MYCITE is not approved for use in pediatric patients. 



Otsuka’s approach for this treatment is novel for a pharmaceutical company. As such, the launch of the ABILIFY MYCITE system will be conducted in close collaboration with only a select number of health plans and providers, who will identify a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder who may benefit from this new digital medicine system. This initial limited rollout will be a step in determining Otsuka’s broader go-to-market plan. 




Sagient Comment


This is a landmark approval potentially ushering in a new era of digital medicine. While the popular press raises some reasonable concerns over privacy and the misuse of ingestible sensors, the reality is a bit less sensational. Abilify Mycite is Abilify with a 1mm-sized ingestible sensor embedded in the tablet. Upon contact with gastric fluid, magnesium and cuprous chloride within the sensor react to activate and power the sensor. The sensor then transmits the ingestion data to a wearable sensor and associated computer-based apps. 


Of course, there is the potential for misuse of ingestible sensors to evolve to track more sensitive data than ingestion schedules. For now, though, we could see this technology rapidly gaining acceptance and being incorporated into more and more formulations where patient compliance is an issue. 



See more about the Proteus Digital Health Feedback System (MYCITE Patch) on Meddevicetracker.




Scilex Pharmaceuticals, a Sorrento Therapeutics’ Subsidiary, Files Marketing Authorization Application in the European Union for ZTlido


Sorrento Therapeutics announced that Scilex Pharmaceuticals filed the European Marketing Authorization Application (MAA) for its lead product candidate, ZTlido (lidocaine medicated plaster 1.8%), through a hybrid regulatory pathway with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).


The UK will be the reference member state, or lead review agency, with corresponding filings in multiple other countries including Germany, France, Spain, Italy and Ireland.
The review time for the MAA is 210 days with clock stops for information requests from agencies. Scilex expects to have a decision in the 4th quarter of 2018. 
The company is currently evaluating commercial options and partnerships for the EU, with a potential commercial launch date for Europe in 2019.
Scilex currently has a new drug application under review with the FDA in the US for ZTlido.



See more about the ZTlido Patch on Meddevicetracker.





November 15, 2017


FDA Grants Marketing Authorization of the First Device for Use in Helping to Reduce the Symptoms of Opioid Withdrawal



The U.S. Food and Drug Administration (FDA) granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. 


The NSS-2 Bridge device is a small electrical nerve stimulator placed behind the patient’s ear. It contains a battery-powered chip that emits electrical pulses to stimulate branches of certain cranial nerves. Such stimulations may provide relief from opioid withdrawal symptoms. Patients can use the device for up to five days during the acute physical withdrawal phase. Opioid withdrawal causes acute physical withdrawal symptoms including sweating, gastrointestinal upset, agitation, insomnia and joint pain. 


To permit marketing of this device for this use, the FDA reviewed data from a single-arm clinical study of 73 patients undergoing opioid physical withdrawal. The study evaluated patients’ clinical opiate withdrawal scale (COWS) score, which is a clinical assessment conducted by a health care professional that measures opioid withdrawal symptoms such as resting pulse rate, sweating, pupil size, gastrointestinal issues, bone and joint aches, tremors and anxiety. COWS scores range from 0 to more than 36 — the higher the number, the more severe the withdrawal symptoms are to a patient. 


Prior to using the device, the average COWS score for all patients was 20.1. Study results showed that all patients had a reduction in COWS of at least 31 percent within 30 minutes of using the device. Overall, 64 of the 73 patients (88 percent) transitioned to medication assisted therapy after five days using the device, along with any medications needed for persistent symptoms, such as nausea and vomiting.


The FDA reviewed the NSS-2 Bridge device through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.



The FDA permitted marketing of the NSS-2 Bridge device to Innovative Health Solutions, Inc.



See more about the NSS-2 BRIDGE on Meddevicetracker.



LabCorp Announces New Expanded Use for PD-L1 Test with Bristol-Myers Squibbs’s OPDIVO

LabCorp announced the U.S. availability of the PD-L1 IHC 28-8 pharmDx assay as a complementary diagnostic for two newly approved indications in connection with the use of Bristol-Myers Squibb’s OPDIVO (nivolumab) to treat patients with metastatic urothelial carcinoma, also referred to as bladder cancer, and squamous cell carcinoma of the head and neck. Although OPDIVO is approved for these indications without use of the test, the test provides physicians with important information about those patients who are most likely to respond positively to OPDIVO.



See more about the PD-L1 IHC 28-8 pharmaDx Test on Meddevicetracker.




November 16, 2017  


Insulia Receives FDA Clearance and CE Mark to Integrate Basaglar and Tresiba


Voluntis announced that Insulia has received FDA clearance and the CE Mark approval to integrate Basaglar (LY2963016) and Tresiba (NN1250). This now makes Insulia available for people using any brand of basal insulin including Lantus, Levemir, Toujeo, Tresiba, and Basaglar. Voluntis will continue to work to make Insulia available to those using other insulin therapies, including NPH insulin and GLP-1/basal insulin combinations, aiming for a release in 2018.


Insulia is a prescription-only digital companion for people with type 2 diabetes and their care teams that helps people get to the right dose, every day. Insulia combines a patient mobile app and health care practitioner (HCP) web portal. The mobile app provides real-time basal insulin dosing recommendations and educational coaching messages based on blood glucose values. The HCP web portal allows HCPs to configure personalized treatment plans and prescribe the app then follow their entire patient population remotely. Once a healthcare practitioner has issued the prescription, Insulia is available for download on the App Store and Google Play.


Insulia is currently available for patients throughout the US via prescription from their provider. Voluntis is contracting with commercial health plans, pharmacy benefit managers, and governmental payers to ensure expanded coverage of Insulia as well as collaborating with health systems and providers to drive utilization of the product.



See more about the Insulia Device on Meddevicetracker.



Propeller Health and Express Scripts Announce Partnership


Propeller Health and Express Scripts announced a strategic partnership to provide Propeller’s FDA-cleared digital solution to Express Scripts members using inhaler sensors and a mobile app to manage asthma or COPD. 


Propeller’s digital sensors enable remote monitoring for patients enrolled in Express Scripts’ Pulmonary Care Value Program (PCV), which combines specialized pulmonary pharmacist clinical support, patient engagement and pharmacy networks to improve patient care while lowering healthcare costs. 


Using Bluetooth technology, a Propeller digital sensor is attached to a patient’s inhaler and synced to his or her smartphone. The inhaler activity trends are reviewed by pulmonary pharmacists within Express Scripts’ Pulmonary Therapeutic Resource Center (TRC). When the Pulmonary TRC sees that a patient is overusing their rescue inhaler or is non-adherent with their controller medication, pulmonary pharmacists engage and perform counseling using patient-specific data. Through the Propeller mobile app, patients with asthma or COPD also can track their symptoms and triggers, monitor daily asthma condition forecasts and receive tips to encourage more effective self-management. 


Express Scripts members who participated in an early-stage version of this solution saw an 80 percent reduction in average rescue events per day and a significant improvement in adherence to their asthma controller medication. 



See more about the Propeller System on Meddevicetracker.



PAC-12 Partners with SyncThink to Further Support Student-Athlete Health and Well-Being


The Pac-12 Student-Athlete Health and Well-Being Initiative Board announced that it has approved the Pac-12 Brain Trauma Task Force’s Equipment Grant Proposal under which all member institutions will be eligible to receive SyncThink EYE-SYNC technology. SyncThink EYE-SYNC technology will serve as the Pac-12 Student-Athlete Health and Well-Being Initiative’s comprehensive brain health analytics platform. Additionally, the University of Colorado was selected to be the Pac-12 Concussion Coordinating Unit to create a Conference-wide foundation of reliable, consistent, and uniform basic-level clinical brain trauma and concussion data among all Pac-12 institutions.



EYE-SYNC technology, an FDA Class II medical device that is an integrated, head-mounted eye-tracking virtual reality system used for recording, viewing and analyzing eye movements in support of identifying visual tracking impairment. As a part of this program, each participating school will receive two EYE-SYNC devices to capture objective brain health metrics among its member institutions, and to support national research on concussion currently underway within the NCAA.



The NCAA and Department of Defense’s Concussion Assessment and Education (CARE) Consortium are supporting the Pac-12 Brain Trauma Task Force’s efforts by providing funding and establishing the Pac-12 as a CARE-Affiliated Program (“CAP”). The CARE Consortium was jointly created by the NCAA and Department of Defense, and similarly studies frameworks to assess athletes preseason acutely post-injury, and throughout recovery using neurocognitive and behavior testing.



The creation of the Pac-12 Concussion Coordinating Unit (PCCU) was included in the CAP. As the PCCU, Colorado acts as the Conference’s administrative and operations coordinating unit for collecting and storing data, and coordinating the various digital databases, equipment vendors, program, university research offices, and the NCAA to ensure the proper implementation of the program and data collection system.



This is the first year of the CAP/Equipment Program. First equipment deliveries of EYE-SYNC for review are being made this week and full roll out at the universities will be complete in January.



Joining Stanford University, Iowa State University, the University of Notre Dame, and the University of Texas as most recent adopters, University of Washington, Washington State University, University of Oregon, Oregon State University, University of California, USC, the University of Utah, the University of Arizona, Arizona State University, UCLA, and the University of Colorado will all receive the EYE-SYNC technology and begin data collection on its platform in January 2018. Each of the Universities will be able to integrate the objective assessments into their current baseline screening process, concussion management protocols, and reporting of brain health data.




See more about EYE-SYNC on Meddevicetracker. 




November 17, 2017

Amgen Launches the ENBREL Mini Single-Dose Prefilled Cartridge with the AutoTouch Reusable Autoinjector


Amgen announced that the ENBREL Mini with AutoTouch is now available in the United States.



The AutoTouch reusable autoinjector has an ergonomic design that includes features that were designed with patients in mind, including an ergonomic handle, a needle designed to stay hidden during the injection, a sensor to detect placement on skin, a speed switch with three injection speeds, a progress bar and a speaker. The AutoTouch reusable autoinjector is used with ENBREL Mini single-dose prefilled cartridges (50 mg/mL) that utilizes a new drug formulation, ENBREL, that was associated with substantially significant lower mean injection site pain than the current formulation.



ENBREL is an injectable biologic approved for the treatment of several chronic conditions including moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and moderate-to-severe plaque psoriasis (PsO) in patients four years or older.




See more about the Enbrel AutoTouch Reusable Autoinjector at Meddevicetracker. 






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