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June 26, 2017

FDA Accepts AMAG Pharmaceutical’s sNDA

AMAG Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug application (sNDA) for the Makena subcutaneous auto-injector, a drug-device combination product. The agency has established a Prescription Drug User Fee Act (PDUFA) target action date of February 14, 2018. The FDA acknowledged that it had previously communicated a 6-month review to the company for this sNDA, but it has now determined that the filing is subject to a standard 10-month review.


The Makena subcutaneous auto-injector is a pre-filled, single-use, ergonomic subcutaneous auto-injector that administers a once-weekly dose of Makena, also known as 17 Alpha-Hydroxyprogesterone caproate (17OHP-C). It is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17 Alpha-hydroxyprogesterone formed from caproic acid (hexanoic acid).


Makena is indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have spontaneously delivered one preterm baby in the past.


See more about the Makena Subcutaneous Auto-Injector on Meddevicetracker. As this product is a drug-device combination product, the full regulatory and clinical history of Makena (17OHP-C) can be seen in the Biomedtracker profile.



Medtronic Signs Agreement with Aetna

Medtronic announced a new outcomes-based agreement with Aetna for Type I and II diabetes patients currently on multiple daily insulin injections for their diabetes management. The agreement will measure health outcomes for those patients that choose to transition to pump therapy using a Medtronic insulin pump featuring SmartGuard Technology, including the new MiniMed 670G system.


This outcomes-based agreement continues to provide Aetna members access to Medtronic's advanced diabetes technologies and comprehensive support services, including the new MiniMed 670G system. The agreement ties a component of Medtronic's reimbursement to successfully meeting agreed-upon clinical improvement thresholds for Aetna members with Type I and II diabetes who choose to transition from multiple daily injections to a Medtronic insulin pump, with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care.


The deal is the first phase of a plan to move patients who take daily insulin injections to Medtronic insulin pumps. Under the agreement, Medtronic intends to use A1C measures, which reflect average blood glucose levels, to determine whether patients using the Medtronic pumps are maintained within an acceptable blood-sugar range. If patients fall outside of that range, the company will pay Aetna a rebate. Medtronic entered into a similar four-year deal with United Health Care a year ago, and if all goes well, the company is hoping to work with other insurance providers as well.


See more about the MiniMed 670G on Meddevicetracker.


June 27, 2017

Cancer Genetics Launches Companion Diagnostic for NSCLC

Cancer Genetics (CGI) announced the launch of Thermo Fisher Scientific's (Thermo Fisher) Oncomine Dx Target - the first next-generation sequencing (NGS)-based Companion Diagnostic (CDx) test that simultaneously screens tumor samples for biomarkers associated with three United States Food and Drug Administration (FDA)-approved therapies for non-small cell lung cancer (NSCLC). CGI is among the first of three laboratories in the United States to offer Thermo Fisher’s Oncomine Dx Target Test.


All tests will be run on Thermo Fisher's Ion PGM Dx System, which received FDA 510(k) clearance in parallel for use on formalin-fixed, paraffin-embedded (FFPE) tissue samples. The Oncomine Dx Target Test is a kit and requires as little as 10 nanograms of DNA from FFPE tissues samples - a critical advantage of the test, given the challenge of NSCLC patient samples often being of limited quantity.


The test report will not only indicate whether patients have ROS1, EGFR, and BRAF alterations linked to the three FDA-approved treatments, but also the presence or absence of gene variants in 20 other genes associated with NSCLC that are currently investigated in clinical trials and potentially actionable in the future.
According to Thermo Fisher, this initial approval will enable the company to work to expand the test's indications into new drug/biomarker combinations, including applications beyond lung cancer.



The Oncomine Dx Target Test is used in conjunction with the following therapeutics:



  •  Iressa, the first marketed epidermal growth factor receptor (EGFR) inhibitor.


  • Mekinist, an orally bioavailable inhibitor of mitogen-activated protein kinase (MEK MAPK/ERK kinase) with potential antineoplastic activity that specifically binds to and inhibits MEK 1 and 2, resulting in an inhibition of growth factor-mediated cell signaling and cellular proliferation in various cancers.


  • Tafinlar, an orally available bioavailable inhibitor of B-raf (BRAF) protein with potential antineoplastic activity that selectively binds to and inhibits the activity of B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene.


  • Xalkori, an oral ATP-competitive small-molecule c-met/hepatocyte growth factor receptor (HGFR) aminopyridine tyrosine kinase and ALK-1 (anaplastic lymphoma kinase-1) inhibitor.


See more about the Oncomine Dx Target Test on Meddevicetracker. For more information on the companion therapeutics, please see the respective Biomedtracker profiles. (Iressa, Mekinist, Tafinlar, Xalkori)


June 28, 2017

Medtronic Receives CE Mark for SureTune3

Medtronic announced it has received CE Mark for SureTune3 software for deep brain stimulation (DBS). SureTune3 provides patient-specific visualization of lead location and simulated volume of neural activation to help physicians make decisions on how to program - or tune - their patient's DBS therapy.


Medtronic DBS therapy has CE Mark approval for diseases such as Parkinson's disease and treats symptoms such as tremor via a surgically implanted medical device, similar to a cardiac pacemaker, that delivers mild electrical pulses to precisely targeted areas of the brain. Electrical stimulation of these areas normalizes the brain circuits that control symptoms. More than 10 million people worldwide are living with Parkinson's disease.


SureTune3's advancements streamline the physician's workflow and allow StealthStation surgical planning information to be imported. SureTune3 also contains a 3D deformable atlas to allow physicians to more precisely define anatomical structures, or the exact region in the brain that must be stimulated to alleviate symptoms. The SureTune3 system is fully downloadable with the option to work over a hospital's server so clinical multidisciplinary teams can work flexibly. SureTune3 is currently not approved in the United States.


See more about the Activa Neurostimulator on Meddevicetracker.


Philips to Acquire Spectranetics

Philips and Spectranetics announced that they have entered into a definitive merger agreement. Pursuant to the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of Spectranetics for USD 38.50 per share, to be paid in cash upon completion. This represents a 27 percent premium to Spectranetics closing price on June 27, 2017. The implied enterprise value is approximately EUR 1.9 billion, inclusive of Spectranetics’ cash and debt. The board of directors of Spectranetics has approved the transaction and recommends the offer to its shareholders. The transaction is expected to close in the third quarter of 2017.



The acquisition of Spectranetics will further expand and strengthen Philips’ Image-Guided Therapy Business Group. Spectranetics is a leader in vascular intervention to treat coronary and peripheral artery disease, and in lead management for the minimally invasive removal of implanted pacemaker and implantable cardioverter defibrillator (ICD) leads. Spectranetics is currently growing double digits and projects 2017 sales to be in the range of USD 293 million to USD 306 million.


Upon completion of the transaction, Spectranetics and its more than 900 employees will become part of the Image-Guided Therapy Business Group within Philips. Spectranetics’ standalone revenue growth is expected to be double-digit and adjusted EBITA to be positive by 2018. Philips sees sustained high sales growth through new product introductions across a synergistic therapy device portfolio. Moreover, the transaction will enhance the geographical expansion of Spectranetics’ products and commercialization opportunities in new, adjacent segments. As part of Philips, the Spectranetics business will benefit immediately from Philips’ platform enabling cost and working capital synergies.



As a result, the combined Spectranetics and Philips Image Guided Therapy Devices business (Philips Volcano), within the Image-Guided Therapy Business Group, is expected to grow to approximately EUR 1 billion by 2020. For the overall Image-Guided Therapy Business Group, Philips targets a high single-digit comparable sales growth and high-teens adjusted EBITA margin for the medium-term. In 2016, this business group reported sales of approximately EUR 1.9 billion of which approximately 20 percent was attributable to device sales. The transaction is expected to be accretive to Philips’ revenue growth, adjusted EBITA margins and adjusted EPS by 2018.



The transaction is structured as a cash tender offer by Philips for all of the issued and outstanding shares of Spectranetics, to be followed by a merger in which each share of Spectranetics not tendered in the tender offer will be converted into the USD 38.50 per share price paid in the tender offer. Pursuant to the merger agreement, the transaction is subject to customary closing conditions, including certain regulatory clearances in the U.S. and in certain non-U.S. jurisdictions. The tender offer is not subject to any financing conditions. Philips intends to finance the acquisition through a combination of cash on hand and the issuance of debt.



See more about Philips and Spectranetics on Meddevicetracker.


June 29, 2017

Varian Medical Receives 510(k) Clearance for Halcyon System

Varian Medical Systems announced it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Halcyon system, its new device for cancer treatment. Halcyon simplifies and enhances virtually every aspect of image-guided volumetric intensity modulated radiotherapy (IMRT).


Halcyon is an advanced system that is more comfortable for the patient while delivering ease of use for healthcare providers, accelerated installation timeframes, expedited commissioning, simplified training, and automated treatment. With its streamlined workflow, the system only requires nine steps from the start to the end of treatment compared to up to more than 30 steps with older technologies. Halcyon is well suited to handle the majority of cancer patients, offering advanced treatments for prostate, breast, head & neck, and many other forms of cancer.


With 510(k) clearance, Varian can begin selling the Halcyon system in the United States. The system requires Eclipse treatment planning software, which is currently 510(k) pending.


See more about the Halcyon System on Meddevicetracker.


Alcyone Lifesciences Partners with Pfizer

Alcyone Lifesciences announced that it has entered into a feasibility study agreement with Pfizer in the area of genetic therapy targeting rare and orphan neurological disorders. The feasibility study combines Alcyone's proprietary Pulsar Advanced Intrathecal Precision Delivery Platform Technology and Pfizer's Recombinant Adeno-associated Viral Vector (rAAV) gene therapy technology in an effort to develop a method of administering genetic therapies that may address neurological disorders more effectively.


Gene therapy is a potentially transformational therapeutic approach for patients suffering from certain rare and orphan neurological disorders, which focuses on the use of one-time treatments that may address the fundamental cause of the disease caused by genetic mutations. The potential of this therapy is dependent on the utilization of effective and reliable delivery technology, and biodistribution of the viral vectors, such as rAAV, that carry the corrective genetic material to the targets of interest in the CNS. This is particularly critical in CNS gene therapy, because there is one opportunity to get the appropriate concentration of active molecule to the right targets associated with the disease in order to achieve a successful procedure.


Alcyone's proprietary Pulsar advanced intrathecal precision delivery platform is an auto-intrathecal injector that utilizes cerebrospinal fluid dynamics along with convection-dispersion enhancements to deliver and biodistribute the viral vectors to targets of interest in the CNS. This platform has been demonstrated to increase the concentration of the vector to the targets of interest consistently and reliably. The platform is being designed to enable it to be easily deployed in the clinical setting and to allow for ease of use with custom infusion algorithms for treating CNS diseases.


See more about the Pulsar Advanced Intrathecal Precision Delivery Platform on Meddevicetracker.



June 30, 2017

Roche Acquires mySugr Diabetes Platform

Roche and mySugr announced that the two partners have signed an agreement under which Roche acquired all shares of mySugr GmbH. Counting more than one million users globally, mySugr is one of the leading mobile diabetes platforms in the market and will become an integral part of Roche’s new patient-centered digital health services platform in diabetes care. The acquisition allows Roche to expand its leading position in the area of diabetes management.


As a focal point for Roche`s integrated diabetes management strategy, mySugr is foreseen to remain a separate legal entity with an open platform for all diabetes devices and services. Users will continue to have the ability to automatically upload blood glucose data from their preferred device into the mySugr logbook app as well as the facilitated data sharing with healthcare professionals and caregivers. Healthcare providers can continue to utilize existing Accu-Chek tools to make better and faster therapy decisions while improving communication with their patients.


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