Under the terms of the agreement, Myovant will receive an upfront payment of $50 million and is eligible to receive commercial launch, sales-based and other milestones totaling up to $90.5 million. In addition, Myovant is eligible to receive tiered royalties from the high-teens to mid-twenties on net sales. Myovant will continue to lead the global development of relugolix and provide initial product supply to Accord. Accord will be responsible for certain local clinical development, all commercialization for its territories, and has the option to manufacture relugolix in the future.

“We’re delighted to join forces with Accord to make available the first and only oral androgen deprivation therapy for men with advanced hormone-sensitive prostate cancer in Europe,” said David Marek, Chief Executive Officer of Myovant. “Accord has a longstanding commitment to oncology with proven commercial capabilities that they will leverage to accelerate the launch to reach more patients with this meaningful therapy.”

“We are proud to launch ORGOVYX in Europe, as an addition to our specialty brand offerings,” said Binish Chudgar, Managing Director of Accord. “Accord currently supplies around 1 in 3 injectable oncology medicines in Europe and this agreement underpins our commitment to patients with cancer and our continued investment in novel therapies. With over 1.9 million men living with prostate cancer in Europe, our partnership with Myovant will provide men living with hormone-sensitive advanced prostate cancer a new oral treatment option.”

On April 29, 2022, the European Commission approved the marketing authorization application for ORGOVYX (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The decision applies to all 27 European Union member states plus Iceland, Norway, and Liechtenstein. The marketing authorization application for ORGOVYX is pending review by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). Accord expects to launch ORGOVYX in Europe in the second half of calendar year 2022.

Goldman Sachs & Co. LLC has acted as the exclusive financial advisor to Myovant and Sidley Austin LLP represented Myovant in the transaction.

About Prostate Cancer
In 2020, the total number of men in Europe with prostate cancer was approximately 1.9 million according to the World Health Organization Agency for Cancer Research WHO IntlAgencyCancerResearch PC.

The Clay Community Clinic first opened its doors in May 2016 and serves patients regardless of insurance status in the Athens and surrounding areas. Clinic services are for people 18 years of age and older and include regular check-up visits, sick visits, immunizations/vaccinations, management of chronic illnesses, behavioral health including depression and anxiety, and follow-up to hospital discharges.

“Expanding the services offered by the Clay Community Clinic to a second location creates more access to primary, patient-centered and community-based care close to home,” said Delena Brockmann, executive director of operations for Royston Health Campus.

Deputy CIO Paul Brubaker told lawmakers on the House Veterans’ Affairs Committee during a legislative hearing Thursday that the VA has contracted the Institute for Defense Analysis to analyze and provide a total lifecycle cost of the EHR modernization program — which was first pitched as a $10 billion project tag before ballooning to $16 billion, and likely more.

IDA will kick off its work later this month, and VA estimates it will be 12 months before it gets a full estimate, Brubaker said.

The VA hopes this will “make sure that for once and for all, we actually capture all of these end-to-end costs” associated with the development and deployment of the program, now three years into its rollout. The program is designed to be a complete overhaul of the VA’s health IT system, with a new cloud-based system from Cerner that should one day be interoperable with the Department of Defense’s own EHR.

Earlier this year, the VA came under fire after a series of reviews by its inspector general and Government Accountability Office found that the department underestimated the costs of infrastructure upgrades in the modernization program by billions of dollars, largely because of inconsistencies in how the department tracks the costs of the sprawling program across its offices and reports them to Congress.

This error led Congress to get involved, proposing the VA Electronic Health Record Transparency Act to force the VA to better account for its spending on the program and properly report it to lawmakers.

Telling lawmakers about the initial estimate, Brubaker said, “when that first cost estimate was scoped, it wasn’t scoped adequately.”

“The issue that we had initially is that we weren’t capturing all of the costs according to what would be a standard lifecycle cost estimate definition — we were only looking at those that were specifically related to deploying the EHRM technology,” he said.

For instance, there are infrastructure upgrades needed for the EHR program that will also support other parts of VA’s IT enterprise that were “assumed by VA’s Office of Information and Technology and the Veterans Health Administration,” as one of the IG reports put it, and thought to be outside the scope of the EHR program.

“What we have to do is we’ve got to understand the end-to-end costs and all the additional support costs that go into the definition of crafting an independent cost estimate, as well as a lifecycle cost estimate… [which] includes all funding regardless of sources necessary for implementation of the program,” Brubaker said. Later, he added, “we have to make sure that we’ve got a very defensible cost attribution model.”

Outside of the independent estimate that IDA will provide, the VA has also stood up an IT investment review board, which Brubaker said “has already established a number of significant criteria designed to get all of us much-improved fidelity over cost estimates.”

“We’re building the IT investment management processes and the governance in order to get you that baseline fidelity that will drive transparency and accountability,” Brubaker said.

“The current standard of care for people living with kidney disease falls short for most patients. We’ve set out on a mission to change that through predictive analytics, high-quality, compassionate care and partnerships with other forward-thinking technology companies,” said Chris Riopelle, CEO of Strive Health. “Kidney disease patients deserve access to better, intuitive technology. Solutions like Tablo will help us deliver on a differentiated patient experience.”

Designed for total care of chronic kidney disease (CKD) and end-stage renal disease (ESRD) in a value-based setting, Strive upends the traditional model for kidney care by combining predictive analytics with high-touch, compassionate care teams. Strive recently launched a dialysis facility in Owensboro, KY, focused on patient-centric holistic kidney disease management and home dialysis using Tablo.

“As a leader in whole-patient care, Strive shares our commitment to meeting the patient where they are, and empowering them with actionable data and support along the way,” said Leslie Trigg, CEO of Outset Medical. “Strive is a progressive thinker in the space. This sales agreement is intended to deliver on a shared vision of enabling more patients to enjoy the flexibility, convenience and clinical benefits of home dialysis.”

About Strive Health?

Strive Health is the national leader in value-based kidney care and partner of choice for innovative healthcare payors and providers. Strive’s model uses a unique combination of high-touch care teams, predictive analytics, advanced technology, seamless integration with local providers, and next-generation dialysis services to form an integrated care delivery system that supports the entire patient journey from chronic kidney disease (CKD) to end-stage kidney disease (ESKD). Strive partners with commercial and Medicare Advantage payors, Medicare, health systems, and physicians through flexible value-based payment arrangements, including risk-based programs. Backed by New Enterprise Associates, CapitalG, Red point, Town Hall Ventures, Echo Health Ventures, and Ascension Ventures, Strive delivers compassionate kidney care the way it should be done.

AboutOutset Medical, Inc.

Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care. Tablo is a registered trademark of OutsetMedical, Inc.

In the MOU, the Ministry of Health and GE committed to driving positive change in the Kingdom’s healthcare sector through digital solutions, directly supporting the National Transformation Plan and the aims of Saudi Vision 2030.

The key solution deployed as part of the MOU is the cloud-based Electronic Medical Record (EMR), a digital record of a patient’s entire healthcare journey, which replaces the manual, handwritten paper charts previously used. The solution will be on Predix, GE’s platform for Industrial Internet of Things applications. Predix is built to analyze large amounts of sensitive data, with the goal of realizing improved outcomes even in complex environments like healthcare facilities.

EMR is currently live in three MOH hospitals in the Kingdom: Al Kharj Maternity & Children’s Hospital, Al Bukayriyah General Hospital, and Yanbu General Hospital. With the digital solution, healthcare providers and patients have better access to a continuum of information for diagnosis and treatment, through an easy-to-access profile that records all touch points with different departments and facilities. Benefits include being able to see results over time to track progress of a medical condition; quickly identifying when patients are due for preventative visits or screenings; reducing the number of transcription errors; reducing report turnaround times; and providing a holistic view of patients’ visits, results, and conditions.

Since hospital employees are the key users of EMR, MOH and GE worked closely together to co-create a tailored tool that encourages fast adoption through ease-of-use. While some hospitals have as many as 200 disparate systems, EMR has integrated the clinical, laboratory, nursing, pharmacy, radiology, finance, and pathology departments into a single platform. MOH and GE have established a complete training program for users, including for vendors working within the hospital networks. The system is also flexible, allowing for change and growth as the needs of the facility, patients, and healthcare providers evolve.

H.E. Dr. Tawfiq Al Rabiah, Saudi Arabia’s Minister of Health said, “This is a significant step in the transformation of the Kingdom’s healthcare sector in line with the goals of our leadership to enhance patient care and deliver the highest quality of service. The welfare and well-being of our people is a fundamental priority of the leadership, and we see significant opportunity in leveraging digital solutions for boosting healthcare delivery. GE’s partnership with MOH is a pioneering example of how Saudi Arabia is redefining our healthcare landscape through best-in-class solutions.”

John Flannery, Chairman and CEO of GE, said, “EMRS was built to drive quantitative and qualitative improvements to the Kingdom’s healthcare sector through digital transformation. This new innovative technology will deliver tangible, game-changing results for healthcare providers and patients across the Kingdom. The more relevant information that healthcare providers have about their patients, the better positioned they are to serve their needs.”

Hisham Al Bahkali, President & CEO, GE Saudi Arabia & Bahrain said, “Saudi Arabia is shaping a new growth narrative led by Vision 2030 that places the welfare of its residents as the top-most priority. The Kingdom’s emphasis on diversification and partnerships offers a significant opportunity for companies like GE to partner in the growth vision of the Kingdom. This partnership is one way we are supporting the digital transformation of the healthcare sector, and implementing our advanced suite of solutions. This will be a game-changer for the healthcare sector and contribute to enhanced patient care.”

GE is proud to have partnered extensively with the Saudi Ministry of Health, supporting their work in improving access and efficiency, and delivering higher quality care through initiatives like the Saudi Breast Cancer Screening Program, the Healthcare Skills & Training Institute, and Ada’a Improvement Program. GE has also introduced its advanced digital capabilities into the Kingdom through several landmark partnerships and initiatives announced over the last year.

GE has over 80 years of partnership in the Kingdom with over 4,000 employees, including Baker Hughes, a GE company. Nearly 50 percent of our talent is employed in highly-skilled engineering and technology roles. GE has built an advanced industrial ecosystem that includes a growing local supply chain, with significant partnerships and investments in support of the Kingdom’s economic diversification goals, including building localized manufacturing competencies.

Following the completion of the sale, the director now owns 11,660 shares of the company’s stock, valued at $2,465,273.80. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is accessible through the SEC website.

Shares of Thermo Fisher Scientific Inc. (TMO) opened at $208.58 on Thursday. The company has a debt-to-equity ratio of 0.74, a quick ratio of 0.92 and a current ratio of 1.35. Thermo Fisher Scientific Inc. has a 52 week low of $151.74 and a 52 week high of $226.44. The stock has a market cap of $83,640.00, a P/E ratio of 34.19, a price-to-earnings-growth ratio of 1.57 and a beta of 1.11.

Thermo Fisher Scientific last released its quarterly earnings data on Wednesday, January 31st. The medical research company reported $2.79 earnings per share (EPS) for the quarter, topping the consensus estimate of $2.66 by $0.13. Thermo Fisher Scientific had a net margin of 10.64% and a return on equity of 16.01%. The company had revenue of $6.05 billion during the quarter, compared to the consensus estimate of $5.72 billion.

During the same period in the previous year, the firm earned $2.41 earnings per share. Thermo Fisher Scientific’s revenue for the quarter was up 22.1% on a year-over-year basis. sell-side analysts predict that Thermo Fisher Scientific Inc. will post 10.81 EPS for the current year.

The company also recently announced a quarterly dividend, which will be paid on Monday, April 16th. Stockholders of record on Thursday, March 15th will be given a dividend of $0.17 per share. This is a boost from Thermo Fisher Scientific’s previous quarterly dividend of $0.15. This represents a $0.68 dividend on an annualized basis and a dividend yield of 0.33%. The ex-dividend date of this dividend is Wednesday, March 14th. Thermo Fisher Scientific’s payout ratio is presently 9.84%.

Several hedge funds and other institutional investors have recently bought and sold shares of TMO. Ark Investment Management LLC lifted its position in shares of Thermo Fisher Scientific by 2.8% during the second quarter. Ark Investment Management LLC now owns 18,005 shares of the medical research company’s stock worth $3,141,000 after purchasing an additional 488 shares in the last quarter.

Ropes Wealth Advisors LLC lifted its position in shares of Thermo Fisher Scientific by 15.8% during the second quarter. Ropes Wealth Advisors LLC now owns 710 shares of the medical research company’s stock worth $124,000 after purchasing an additional 97 shares in the last quarter. Veritable L.P. lifted its position in shares of Thermo Fisher Scientific by 32.2% during the second quarter. Veritable L.P. now owns 19,152 shares of the medical research company’s stock worth $3,341,000 after purchasing an additional 4,668 shares in the last quarter. Bank of Hawaii lifted its position in shares of Thermo Fisher Scientific by 0.9% during the second quarter.

Bank of Hawaii now owns 18,105 shares of the medical research company’s stock worth $3,159,000 after purchasing an additional 163 shares in the last quarter. Finally, Voya Investment Management LLC lifted its position in shares of Thermo Fisher Scientific by 1.2% during the second quarter. Voya Investment Management LLC now owns 148,740 shares of the medical research company’s stock worth $25,951,000 after purchasing an additional 1,739 shares in the last quarter. 86.54% of the stock is currently owned by institutional investors and hedge funds.

The company didn’t disclose the nature of these observations.
A Form 483 is issued by the US FDA inspectors at the end of the inspection outlining any deviations from GMP.

The US FDA conducted Good Manufacturing Practices (GMP) inspection of Sun Pharma’s Halol facility from February 12 – 23.

The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. The company is committed to addressing these observations promptly,” said Sun Pharma in a statement to stock exchanges.
“The company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis,” the statement added.

The company’s founder and managing director Dilip Shanghvi expressed confidence about resolving the three issues pointed out by the American drug regulator.

Halol is critical for Sun Pharma as most of the complex pipeline that includes injectables, topical solutions and inhalation products are filed from this facility. Sun Pharma is banking on complex products to beat the pricing pressure it faces in the US market.

The current inspection was triggered after US FDA re-inspected the Halol facility from November 17, 2016 through December 1, 2016 and issued nine Form 483 observations.
The observations were related to data reporting standards, testing procedures, and lab controls.

Halol is an important plant for the company and contributed 10-15 percent to its US sales before the factory received a warning letter from the US FDA for violation of manufacturing norms in December 2015.

The warning letter blocked new product approval from that facility impacting the company’s US business.

Prior to the warning letter, Halol was contributing about USD 400 million to the company’s topline or nearly 12-15 percent of sales. Now the facility’s contribution has fallen to about USD 250 million.

Sun Pharma’s profit fell 75.2 percent to Rs 365.4 crore in the quarter ended December hit by plunging US sales and one-time deferred tax adjustment. Revenues from operations declined 16 percent to Rs 6,653.23

“The resolution of the facility is important if the company has to maintain USD 1.5 billion topline in US market,” said Amey Chalke, Research Analyst at HDFC Securities.

CLSA forecasts that incremental revenue from the clearance of Halol is expected to be at least USD 100 million and USD 150 million in years ending March 2019 and 2020, respectively, and even possibly go up to USD 200 million and USD 300 million, increasing its earnings per share by 4 and 10 percent.

Share of Sun Pharma rose 3.54 percent and were trading at Rs 561.35 on BSE at 2.44 pm, the benchmark index gained 0.98 percent to 34,145.43 points.

The findings, presented at the Society for Research on Nicotine and Tobacco 24^th Annual Meeting in Baltimore, Maryland, highlight the need to correct misperceptions about the harmfulness of nicotine so that adults can make informed decisions about use of nicotine-containing and lower risk tobacco products.

Nicotine is present in combustible cigarettes, e-cigarettes and FDA-approved nicotine replacement therapies used to help smokers stop smoking. The FDA^[1] and other authorities have concluded that there is a continuum of risk for nicotine and tobacco products, with combustible cigarettes by far the most hazardous and nicotine replacement therapies as the least hazardous. To examine adults’ knowledge of tobacco and nicotine harmfulness, researchers analyzed data from 1,736 US adults in the government-run 2017 Health Information National Trends Survey (HINTS-FDA Cycle 2).

Adults’ beliefs about nicotine and tobacco products are not completely wrong. For example, a majority of adults (84.7%) correctly knew that nicotine is the substance that makes people want to smoke, and 96.2% knew that cigarettes are harmful. On the other hand, other results revealed important misunderstandings that may have critical consequences for health.

Among all adults, 52.9% incorrectly believed that nicotine is the substance causing most of the cancer caused by smoking, and an additional 21.2% did not know whether nicotine causes most cancer caused by smoking. Cigarette smokers were significantly more likely than e-cigarette users to incorrectly believe that nicotine causes most of the cancer caused by smoking (52.5% vs. 14.6%). In addition, while experts continue to debate the magnitude of the difference in risk between e-cigarettes and cigarettes, just 31.6% of smokers agreed that e-cigarettes are less harmful than cigarettes—including only 3.4% who are plausibly “correct” in believing they are much less harmful than combustible cigarettes.

“That adults’ misperceptions about the health effects of nicotine persist despite the long-term availability of FDA-approved over-the-counter nicotine replacement products is troubling and needs to be addressed with clear communications to the public—especially smokers—that nicotine is not what is causing smoking-related disease,” said Karen K. Gerlach Ph.D., M.P.H., the lead author on the study. “Leading public health experts^[2] have called for trusted authorities to communicate clearly about nicotine to smokers, which should help them understand that there is a continuum of risk across nicotine-containing products and use that understanding to help them reduce risks to their health.”

Soothing, immersive, personalized experience
Philips’ Ambient Experience in-bore Connect solution provides patients with a soothing, immersive, personalized multi-media experience as they enter the bore of the MR scanner. When entering the scanning room, they are immediately engaged in the procedure by being given control over selection of the MR Ambient Experience theme. Coupled with clear instructions about what to do and what to expect during the scan, this in-bore experience supports patients who experience feelings of stress, and helps hospital staff improve workflows and reduce the number of rescans*.

Our team is now able to work smarter, faster and more efficiently,”said Christoph Wald, MD, PhD, MBA, FACR, Chairman, Department of Radiology at Lahey Hospital & Medical Center. “As a result, our patients are more comfortable and our technologists and radiologists can focus on delivering confident diagnoses.

Patients can feel stress, nervousness and anxiety when entering the bore of an MR scanner, especially when doing so head-first. By obscuring the internal surface of the scanner bore from the patient’s view and replacing it with soothing video images, the system helps patients deal with these feelings. The video can be themed according to patient choice (e.g. landscapes, seascapes, underwater marinescapes) and is accompanied by soothing head-phone delivered audio.

Many patients also find it challenging to know what to do during their scan, such as holding their breath and staying perfectly still when needed. To help them, the Philips system overlays the video with audio-visual prompts, so that patients know what they need to do and how long they need to do it, while a progress bar lets them know how the scan is progressing. Enhancing patient compliance reduces the need for radiology technician intervention and helps to support maximum scan quality.

Our Ambient Experience in-bore Connect solution is aimed at helping patients and staff to get the quality images they need,” said Werner Satter, General Manager Healthcare Experience Solutions at Philips. “The global adoption of our solutions to improve the patient experience showcases how the combination of a patient-centric approach, technology and design can work together to help improve imaging outcomes.

A study at Herlev Gentofte University Hospital in Denmark shows that the Ambient Experience in-bore Connect solution helped them reduce the number of rescans. The Herlev Gentofte University Hospital compared the number of interrupted examinations before and after installation of the Ambient Experience in-bore Connect solution with other scanners in the facility. The data shows their yearly average number of rescans decreased by 70%*. The same study showed that 84% of their patients felt more calm.

Further evidence of the benefits of enhancing the patient experience during imaging procedures was recently published in the Philips ‘Patient Experience in Imaging Study’ – a survey of 603 patients in the US and Germany about their satisfaction, expectations, preferences and unmet needs with diagnostic imaging procedures over the previous year. While most patients expressed feelings of being well taken care of, respected, and informed about their imaging procedures, many also cited feelings of nervousness, uncertainty and powerlessness during the procedure. In general, patients viewed safety and well-being throughout the imaging process as important, and valued speed and comfort during the procedure itself. Philips is designing its innovations with these patients’ needs in mind.

Ambient Experience
The Ambient Experience in-bore Connect solution is part of the company’s larger portfolio of Ambient Experience solutions. In the past decade, more than 1,250 Ambient Experience solutions have been installed in radiology departments, emergency departments and treatment rooms in more than 50 countries.

To learn more about how Philips is bringing together people, data and technology to power the ongoing evolution of radiology, visit booth #6735 at the Radiological Society of North America (RSNA) Annual Meeting, taking place Nov. 26 – Dec. 1, in Chicago, Ill., where Philips’ Ambient Experience in-bore Connect for MR will be on display. For more information on Philips’ full suite of integrated imaging systems, devices, informatics and services at #RSNA17, and for live updates from the event, follow @PhilipsLiveFrom or visit www.philips.com/rsna.

* At Herlev Gentofte University Hospital in Denmark. Compared to the average of the other 5 Philips MR scanners without Ambient Experience and In-bore Connect. Results from case studies are not predictive of results in other cases. Results in other cases may vary.

For further information, please contact:

Joost Maltha
Philips Group Press Office
Tel: +31 6 10 55 8116
E-mail: joost.maltha@philips.com

Kathy O’Reilly
Philips Group Press Office
Tel: +1 978 221 8919
E-mail: Kathy.oreilly@philips.com

About Royal Philips
Royal Philips is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips’ health technology portfolio generated 2016 sales of EUR 17.4 billion and employs approximately 73,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

These are just a few activities. The fact that all medical data is in one’s hand any where one is in the world so that it can be shared with care givers in any emergency is indeed revolutionary!

Click here for more details.