Philips, Jackson Health sign 11-year Enterprise Monitoring as a Service pact

Royal Philips (NYSE: PHG, AEX: PHIA) a leading health technology company, and Jackson Health System, one of the nation’s largest public health systems in the U.S., today announced the world’s first, long-term strategic partnership based on an Enterprise Monitoring as a Service (EMaaS) model.

Designed to support Jackson’s efforts to enhance patient safety and continuous monitoring across the network, the partnership will pioneer EMaaS and allow the health system to adopt state-of-the-art patient monitoring systems for a per-patient fee.

This unique new business model will eliminate up-front costs while allowing Jackson to standardize patient monitoring at all acuity levels for each care setting across its network. Creating a more seamless experience for patients and staff to deliver the right care at the right time, the partnership will help Jackson further expand its already impressive quality of care for residents of Miami-Dade County.

An integrated healthcare delivery system, Jackson Health System consists of its centerpiece, Jackson Memorial Hospital, Jackson South Medical Center, Jackson North Medical Center, Holtz Children’s Hospital, Jackson Rehabilitation Hospital, Jackson Behavioral Health Hospital; a network of UHealth Jackson Urgent Care centers; multiple primary care and specialty care centers and two long-term care nursing facilities. The new Jackson West Medical Center campus is under development in the City of Doral, and will feature adult and pediatric emergency rooms and outpatient services.

Unlike traditional business models where a hospital may purchase and own the patient care monitoring system and is responsible for ongoing upgrades across its network, this new model keeps the ownership with Philips, including all current and future hardware, software, and networking solutions. In addition, Philips will provide technical support, help identify clinical workflow optimization opportunities, continuing education, asset and data management. Philips will also help Jackson to design solutions that integrate with core IT systems, such as Jackson’s Electronic Medical Record (EMR).

https://bit.ly/2MI6zUM

LabCorp Launches Assay for HCV, HIV-1, HIV-2 and HBV

LabCorp (NYSE: LH), a leading global life sciences company, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the UltraQual Multiplex PCR Assay for HCV, HIV-1, HIV-2 and HBV for screening of donated blood plasma.

This innovative assay, which was developed and will be exclusively offered by its National Genetics Institute (NGI) laboratory, builds upon LabCorp’s rich history in the development and commercialization of novel diagnostic tests.

The UltraQual Multiplex PCR Assay enables the simultaneous and sensitive detection of four viral targets (HCV, HIV-1, HIV-2 and HBV) in a single sample. Coupled with NGI’s previously FDA-approved and exclusive process to greatly increase testing throughput, the new UltraQual Multiplex PCR Assay provides enhanced turnaround time and value to the rapidly growing biologics sector of the biopharmaceutical industry.

According to the FDA, biologics products include vaccines, blood and blood components, allergenics, gene therapies, somatic cells, tissues and recombinant proteins. Biologics therapies derived from plasma treat well-defined medical conditions, replacing missing or deficient proteins found in an individual’s plasma and allowing patients to lead healthier and more productive lives through the benefits of the therapy. Biologics therapies make up more than one-third of the biopharmaceutical industry pipeline, and this new test is available to all biopharmaceutical companies involved in the manufacturing of plasma-derived therapies to enhance the safety and availability of these important medicines.

‘We are excited to receive FDA approval for the UltraQual Multiplex PCR Assay, as it demonstrates LabCorp’s continued commitment to delivering world-class diagnostic solutions that help to bring new medicines to patients faster, thereby improving health and improving lives,’ said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. ‘This next-generation technology offers the international biopharmaceutical industry a differentiated solution to improve plasma donor collection programs and the manufacturing of plasma protein therapies for a variety of life-threatening conditions including bleeding, immune, cardio/pulmonary, and neurological disorders.’

On March 9, 2018, LabCorp announced that its Covance Drug Development business formed a global immunology and immunotoxicology (I&I) unit dedicated to the specific needs of biologic drug development. The formation of this unit, along with Covance’s doubling of its I&I laboratory footprint and LabCorp Diagnostics’ expanding suite of biologic therapeutic drug monitoring tests, illustrate LabCorp’s expanding expertise and leadership in the development and commercialization of new services to support the rapidly growing biologics market.

Octapharma Plasma (OPI), a company that collects donated blood plasma for use in the creation of life-saving medicines, expressed early interest in using the UltraQual Multiplex PCR Assay.

‘OPI is looking forward to transitioning to NGI’s FDA-approved UltraQual Multiplex PCR Assay for our donor plasma screening programs,’ said Judy Smith, chief operating officer of OPI. ‘This new assay provides OPI with enhanced sensitivity, specificity, turnaround time, and overall value, providing a best-in-class solution to better advance our strategic goal of enhancing the collection of plasma used to create life-saving medicines for patients around the world.’

https://bit.ly/2NfSAGC

Lonza Launches New Bioscience Website

Lonza Bioscience is inviting visitors to explore its new dedicated website: bioscience.lonza.com.

Filled with detailed application and product information, the website has been designed to support the work of scientists across the bioresearch, drug discovery and pharmaceutical manufacturing fields. Not only is the new website user friendly and mobile optimized, but it also offersecommerce functionality, including punch-out capability and mass ordering via upload of Excel files.

The new Lonza Bioscience website is easy to navigate and features an enhanced search bar with autocomplete suggestions, making it quicker for customers to find the desired information. For extra ease of reference, registered users can bookmark pages to the ‘Favorites’ section in their account.

Comprehensive product pages contain a wealth of useful information, including scientific data, product instructions, data sheets and educational materials like white papers and webinars, as well as links to other related products. These pages offer scientists a valuable educational resource beyond simply providing product information.

Visitors can enjoy a more personalized experience with country recognition, which means that prices are automatically shown in the correct currency and that Lonza contact details will default to those of the local Customer Service, Scientific Support and Sales representatives. All registered users will also be able to track their orders, download receipts and request repeat orders via the new ‘My Account’ section.

Katrin Hoeck, Head of Marketing Analysis & Testing, Lonza Bioscience, said, ‘Following an independent survey and a detailed customer journey exercise, the new website has been developed to meet the specific needs of our customers. It offers a more-streamlined user experience, enabling scientists and purchasers to find the information they need more quickly and easily.’

More information is available at bioscience.lonza.com.

https://bit.ly/2KCsG1u

Nymox details expansion plans

Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today that following the recently announced increased manufacturing capabilities, the Company has formally decided to expand its European marketing plans for Fexapotide Triflutate (FT) to all countries in the European Community.

Earlier this month Nymox announced that it had successfully accomplished important milestones relating to manufacturing scale-up for FT. Consequently, the Company is now in the enhanced position to have sufficient manufacturing capacities in place to be able to realistically meet anticipated physician demand for FT upon approval.

Dr. Suresh Kalbag, Nymox Head of Manufacturing Operations, commented: “Validated FT active pharmaceutical ingredients in quantities of 50 grams per batch (equivalent to approximately 18,000 to 20,000 units of 2.5 mg per batch) has been achieved. In addition, sterile processing of similar sized batches (>16,000 units per batch) of filled and finished drug product vials has also been accomplished. The scaled up sterile injectable FT (finished product) is manufactured as a lyophilized powder which has excellent shelf life when stored at room temperature, frozen or refrigerated. The active pharmaceutical ingredient (contained in the finished product) can be stored frozen in bulk and is also highly stable”. Marketing requires approvals from regulatory authorities, which has not yet been granted.

The Company has initiated the process and is taking the necessary steps to submit an expanded application for FT to the European Medicines Agency for approval. The prior application in the EU will be replaced by the new expanded application. The expanded application upon marketing approval will also greatly facilitate the overall drug-distribution logistics as well as the annual post-marketing safety filing requirements in Europe.

Dr. Paul Averback, CEO and President of Nymox commented, “Management is excited by the opportunity to expand the application leading to full EU market access. We believe FT will now become available to patients across Europe earlier than in our previously projected plans. The increased manufacturing capacity will be necessary to meet the anticipated demand across all European jurisdictions and worldwide. We all look forward to continue to update our shareholders on our progress going forward”.

The Company held a pre-NDA meeting with FDA earlier in 2018 and expects to file for approval in the US later in 2018.

Nymox has recently announced 18.25 million USD in funding from long-term shareholders.

Nymox’s Fexapotide has been shown to produce long-term improvements in lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), a problem that afflicts an estimated 100 million or more men in the world. Fexapotide does not cause the annoying side effects and risks found with available treatments for BPH and has also been shown to lower the occurrence of surgery for BPH. Fexapotide is also in development for low grade prostate cancer. Fexapotide has been shown in 9 clinical trials and numerous long-term extension studies involving over 1700 injections, to be very safe and well tolerated.

https://bit.ly/2lOa4O3

UCB Parkinson’s treatment OKd in China

• NEUPRO now approved in China for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s Disease as monotherapy (i.e. without levodopa) or in combination with levodopa
• NEUPRO approval in China reinforces UCB’s ongoing commitment to supporting patient value across China and to offering Chinese patients additional treatment choice to help manage their disease

Belgium-based global bio-pharmaceutical company UCB today announced it has received an Import Drug License (IDL) from the China Food and Drug Administration (CFDA), creating a pathway to make the company’s 24-hour continuous delivery transdermal rotigotine patch NEUPRO^® available to patients in China.

Parkinson’s disease (PD) is a chronic, degenerative neurological disease with an estimated prevalence of 1.7% in China in people aged 65 years and older.¹ Estimates suggest that around 3 million people in China are affected by the condition.²

With this IDL, NEUPRO is now indicated in China for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s Disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).

NEUPRO is designed to support and improve individual patient treatment experiences for people living with Parkinson’s Disease. The product’s unique transdermal patch formulation is administered once daily, providing a continuous release of rotigotine over a 24-hour period.

‘The availability of NEUPRO^® in China is testament to UCB fulfilling our commitment to provide additional value to patients around the world.’ said Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. ‘We know the significant impact Parkinson’s can have on the lives of patients and their family members, and how important it is to effectively manage symptoms to allow patients to keep their independence and maintain their quality of life. With the approval of NEUPRO^® in China, we are very excited that we will be able to make this medicine available to the millions of people affected by Parkinson’s Disease in the country, providing them with a convenient treatment option to help them to manage their condition.’

As a result of the IDL, UCB will now progress with NEUPRO launch planning, to ensure patients in China with Parkinson’s are able to benefit from this approval as quickly as possible.

UCB has been present in China since 1996 and has a prominent presence in the country, having launched Keppra for the treatment of some forms of epilepsy in 2007. This important landmark helped established the company’s reputation as a leader in neurology. Additionally, in 2014, UCB inaugurated a new state of the art 13,000 m² manufacturing site in Zhuhai, which strengthened our footprint in the country.

Alongside approval for NEUPRO, these activities reinforce UCB’s ongoing commitment to supporting patients with severe diseases in China.

https://bit.ly/2KGluRV

Valneva Announces Significant Progress of its Lyme Disease Vaccine Candidate

Valneva SE (“Valneva” or “the Company”), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, announced today a further update for its Lyme disease vaccine candidate, VLA15. The Company has successfully concluded the end of Phase 1 process for this candidate with the Food and Drug Administration (FDA) and has obtained alignment with regard to its Phase 2 strategy.

Valneva is now finalizing the detailed Phase 2 protocol and, subject to requisite regulatory approvals, expects to enter Phase 2 clinical development by the end of 2018.

Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva commented “We appreciate the valuable and constructive guidance the FDA has provided and are looking forward to progressing into Phase 2. Lyme is a vaccine preventable disease. We are strongly committed to advancing our Lyme disease vaccine candidate as quickly as possible with the aim of preventing this severe and often debilitating infection.”

The Company will provide a full update on its Lyme program during the publication of its H1 results on August 2^nd, 2018.

https://bit.ly/2NmmKZ4

Merck, AstraZeneca wins speedy approvals for cancer drugs in Japan

AstraZeneca has won rapid regulatory approval for new uses of two of its important cancer drugs in Japan, less than six months after the first global approvals in Western markets.

The decisions by the Japanese Ministry of Health, Labour and Welfare reflect an increased urgency by officials in the country to access modern medicines, after many years of slow adoption.

AstraZeneca said on Monday that its Imfinzi immunotherapy drug had been approved for use in lung cancer patients with inoperable disease that had advanced locally but not spread widely around the body.

Imfinzi was only given a U.S. green light for treating such stage III lung cancer in February and it is still awaiting approval in the European Union.

Japan also approved Lynparza, which AstraZeneca markets with Merck & Co, for breast cancer.

https://bit.ly/2z03DAR