9 January

Baxter to acquire two Mallinckrodt’s surgical products for $185m

Medical products firm Baxter International has signed an agreement to purchase RECOTHROM and PREVELEAK surgical products from Mallinckrodt for a total consideration of around $185m, with $153m upfront. The acquisition is expected to bolster Baxter’s surgical solutions portfolio for addressing intraoperative bleeding and expanding options for surgeons.

RECOTHROM is a thrombin-based topical product designed to assist haemostasis in case of available access to oozing and minor bleeding, and when control of bleeding by conventional surgical methods is ineffective or impractical in adults and paediatrics aged one month or above. PREVELEAK is a surgical sealant indicated for the mechanical closing of suture holes to obtain adjunctive haemostasis in surgical vascular reconstructions. The total sales of these products were reported to be around $56m in the 12 months before 29 September 2017.

Baxter Advanced Surgery business president Wil Boren said: “As a leading provider of advanced haemostats and sealants, Baxter is focused on continually identifying solutions to help meet surgeons’ varying needs.

“We are excited about the addition of RECOTHROM to help surgeons address less severe intraoperative bleeding and PREVELEAK to complement Baxter’s existing portfolio of sealants for cardiovascular and other surgical specialties.”

Mallinckrodt will, however, retain another fibrin sealant product RAPLIXA, and intends to discontinue its marketing after closing the deal with Baxter. The deal is subject to customary closing conditions and is expected to be concluded in the first half of this year.

9 January

Researchers develop new algorithm for microbeam radiation therapy

Physicists from the Institute of Cancer Research (ICR) in the UK have collaborated with the German Cancer Research Centre and the University of Munich to develop a new mathematical algorithm to advance microbeam radiation therapy (MRT) for the treatment of cancer.

MRT employs high-energy X-ray beams to target tumours with radiation while having a mild effect on healthy tissue. The therapy is said to enable treatment of tumours that cannot be removed with surgery such as those in the brain or lungs. While MRT has the potential for cancer treatment in the future, existing methods used for planning the correct treatment doses are reported to take days to process for computers.

The new algorithm is designed to take more three minutes, as opposed to 100 hours. It is expected to aid in providing cancer patients with a quick, safe and accurate treatment using MRT. The mathematical tool is currently being used in treatment planning at France’s European Synchrotron Radiation Facility (ESRF) with a radiation machine that produces high-energy X-rays.

ICR Radiotherapy Physics Modelling post-doctoral training fellow Dr Stefan Bartzsch said: “Our algorithm can calculate dose distributions in treatment planning in minutes. It has already been incorporated into treatment planning systems for more testing and we hope it will bring forward the treatment of patients with MRT through the first clinical trials of this pioneering technology.”

9 January

Roche and GE Healthcare to create digital diagnostics platform

Roche has signed a strategic collaboration with GE Healthcare to co-develop and co-market digital clinical decision support solutions to improve treatment for oncology and critical care patients. The long-term partnership will use advanced analytics to develop a digital platform for providing workflow solutions and applications that support clinical decisions.

Through the new platform, the firms intend to enable optimised integration and analysis of in-vivo and in-vitro data, medical best practice, patient records, real-time monitoring, and latest research outcomes. These insights will provide clinicians with comprehensive decision support to deliver the right treatment and quality of care.

Roche Diagnostics CEO Roland Diggelmann said: “This unique partnership will deliver innovative solutions and insights in clinical decision-making.

“Our goal is to support clinicians and other relevant stakeholders for the benefit of patients by providing the right decision support at the right time and through comprehensive digital offerings.”

The platform will provide a comprehensive data dashboard that can be used by multiple specialists in an oncology care team for review, collaboration and alignment of treatment decisions for patients at each stage of their disease. In a critical care setting, the digital platform could be used to integrate data from a patient’s hospital monitoring equipment with their biomarker, genomic and sequencing data. This integration is expected to aid in the identification or prediction of severe complications prior to occurrence.

GE Healthcare president and CEO Kieran Murphy said: “This is the first time that two major players in healthcare have combined digital, in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry.”

8 January

LivaNova starts study of VNS Therapy System for depression

UK-based firm LivaNova has started the RESTORE-LIFE study to investigate the use of its Vagus Nerve Stimulation (VNS) Therapy System for treatment-resistant depression (TRD). The VNS system comprises a programmable electronic pulse generator connected to a bipolar electrical lead that sends mild pulses to trigger the vagus nerve at regular intervals throughout the day.

The global prospective, multi-centre, observational, post-market study will evaluate the short, mid and long-term effectiveness and efficiency of VNS therapy as an adjunctive treatment in real-world patients. LivaNova plans to enrol at least 500 participants, who could not experience an adequate response to standard psychiatric management, at around 80 sites across various countries.

The first patient for the study has been already recruited at the Universitätsklinikum Jena in Germany. During the study, patients will be implanted with the therapy and undergo follow-up for a minimum of three years and a maximum of five to monitor changes in clinical symptoms due to the VNS Therapy.

The study will measure response at one year as the primary endpoint, along with secondary endpoints and factors such as quality of life, patient function and adjunctive antidepressant treatments.

LivaNova Clinical, Regulatory and Quality senior vice-president Bryan Olin said: “This post-market study will allow us to have a better understanding of this treatment-resistant patient population and the significant role VNS Therapy can play in the overall management of this disease.

“RESTORE-LIFE is unique in the fact that clinical response, patient functioning and resource utilisation will be followed up globally for five years, amassing high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for difficult-to-treat depression.”

8 January

J&J signs 15 deals for new healthcare solutions

Johnson & Johnson (J&J) has signed 15 new partnerships to explore, develop and advance new medical devices, therapeutics and consumer health solutions. Formed through Johnson & Johnson’s Innovation arm, the collaborations include use of artificial intelligence by Canada-based WinterLight Labs for the early detection of neurodegenerative disorders, including Alzheimer’s disease.

Johnson & Johnson Innovation and Janssen Pharmaceuticals (JPI) penned an exclusive research collaboration to use University of Pennsylvania’s adeno-associated virus (AAV) vectors delivery for the treatment of the disease. Johnson & Johnson Innovation and JPI also partnered with the Northern California Institute for Research and Education and the San Francisco Veterans Affairs Medical Center to monitor brain health in elderly people.

An alliance with Queensland University of Technology (QUT) will involve the development of a saliva-based diagnostic test to identify throat cancers early.

J&J will also work with the Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology (MIT) to prevent, intercept and cure lung cancer, and with Singapore-based MiRXES to develop a new diagnostic for early detection of the cancer.

With MiNDERA, the firm is advancing a minimally invasive microneedle device being developed for the research, diagnosis and treatment of inflammatory skin diseases. Johnson & Johnson Vision and Narayana Nethralaya Foundation and Medical Research Foundation partnered for the discovery and validation of diagnostic tools to identify individual vision-care needs.

The collaborations also include microbiome therapeutics developer Holobiome for the treatment of central and enteric nervous system diseases. The firm has also partnered with various organisations to work on treatments for a variety of other diseases, including skin conditions, psoriasis, and metabolic diseases such as obesity and myopia.

J&J executive vice-president and chief scientific officer Paul Stoffels said: “By advancing transformative healthcare innovations together with entrepreneurs, academic centres and institutions, we are one step closer to addressing many pressing global healthcare challenges.”

8 January

Illumina and KingMed to develop oncology diagnostics in China

US-based gene sequencing firm Illumina has signed an agreement with Guangzhou KingMed Diagnostics Group to co-develop new oncology and hereditary disease testing applications in China. Under the collaboration, Illumina’s next-generation sequencing (NGS) technology will be used to create an integrated NGS system to provide cost-effective and ready-to-use in-vitro diagnostic (IVD) assays for testing molecular oncology and hereditary cancer.

The system will integrate Illumina’s MiniSeq System and associated sequencing consumables with KingMed’s testing components such as library preparation kits and software for analysis.

Illumina Greater China vice-president and general manager Ruilin Zhao said: “This agreement is a clear demonstration of our commitment to working with broader clinical testing service providers in China who want to develop and commercialise IVDs based on NGS.
“As we continue to expand our clinical partner networks, we are focused on providing the best healthcare solutions to patients throughout China.”

Intended to deliver precision medicine to patients, the system will be available through KingMed’s clinical network, after review and approval by the China Food and Drug Administration (CFDA).

KingMed Diagnostics chairman and CEO Yaoming Liang said: “Our mission is to bring state-of-the-art technology to Chinese patients by enhancing their standard of care and improving their outcomes.

“Illumina is the ideal collaborator because they have a proven track record of working with multiple domestic companies in China, in addition to being the first company with a US FDA-cleared, next-generation sequencing instrument.”

5 January

Microsoft and Adaptive Biotech to create universal blood test using AI

Microsoft has partnered with and invested in US-based Adaptive Biotechnologies to map the human immune system genetics using artificial intelligence (AI) for early detection and diagnosis of multiple diseases, including cancer. The partnership will see a combination of Microsoft’s research and large-scale machine learning, and cloud computing capabilities with Adaptive’s immune sequencing technologies.

This integration of technologies is expected to aid in the development of individual disease diagnostics and eventually a universal diagnostic test. The firms intend to translate genetic code of the body’s immune system into simple, easily accessible blood-based diagnostics.

Adaptive Biotechnologies president, CEO and co-founder Chad Robins said: “We now have the technology to be able to do what we’ve been talking about for the past decade – develop a universal TCR antigen map that presents an opportunity to help patients at an unprecedented scale.

“Some conditions like cancer or autoimmune disorders can be difficult to diagnose, but this universal map of the immune system will enable earlier and more accurate diagnosis of disease, potentially helping physicians to connect the dots to understand the relationship between disease states and eventually lead to a better understanding of overall human health.”

The alliance is part of Microsoft’s Healthcare NExT initiative that was introduced last year to enhance AI and cloud computing for bolstering healthcare innovation and enabling lifesaving discoveries.

Microsoft AI and Research corporate vice-president Peter Lee said: “We are very excited and inspired by our collaboration with Adaptive Biotechnologies, as it clearly advances our mission to use cloud and AI technologies to transform healthcare and improve the lives of people around the world.”

4 January

Australian researchers develop portable brain scanner

Researchers at the University of Queensland (UQ) and EMvision Medical Devices in Australia have developed a portable, non-invasive brain scanner to obtain three-dimensional (3D) images of the brain. Designed using technology licensed to EMvision by the university’s UniQuest firm, the new device uses an algorithm to map the brain tissue with safe, low-power microwaves for delivering 3D images. The scanner is anticipated to accelerate diagnosis of brain injuries and stroke, as well as reduce brain damage and related rehabilitation costs.

EMvision Medical Devices CEO John Keep said: “In the case of stroke, the 3D image would enable medical professionals to quickly identify if damage is a haemorrhage or clot and to treat the patient accordingly, saving precious time.

“The difference between permanent disability or death and a positive recovery is timely diagnosis and treatment. Every hour appropriate treatment is delayed, the brain ages by about 3.6 years.”

EMvision is currently refining the prototype of the device to meet safety and efficacy requirements, as well as allow easy integration into clinical pathways. The firm intends to carry out a pilot clinical trial at the Princess Alexandra Hospital in the coming months. Researchers expect that the device with life-saving potential will be useful in emergency departments, ambulances and remote locations.

UniQuest CEO Dr Dean Moss said: “The portability, cost-effectiveness and safety of this device is a very attractive proposition for the healthcare industry, with potential for use in both hospitals and ambulances throughout the world.

“It is also ideal for use in rural and remote areas. In Australia, rural and remote stroke patients are 20% more likely to die than their metropolitan counterparts due to delayed diagnosis.”

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