Is the US opioid litigation nearing an end game?

pharmaphorum | October 18, 2019

Drugmakers, wholesalers and lawmakers in the US are said to be thrashing out the details of a big settlement – maybe as much as $50 billion – to settle thousands of lawsuits related to the US opioid crisis. The frenzied negotiations are taking place ahead of the start of the first federal trial next week that will try to determine culpability for the epidemic of opioid addiction, overdoses and fatalities that has gripped the US in recent years. According to reports, the settlement offer has been made by pharma companies Teva and Johnson & Johnson, as well as the ‘big three’ US wholesale distributors AmerisourceBergen, Cardinal Health and McKesson. The deal includes $22 billion in cash as well as another $15 billion in drugs to treat opioid dependency and overdose and an estimated $14 billion allocated for distribution of those therapies, according to an Associated Press article. It says the wholesalers would contribute $18 billion over 18 years, J&J would contribute $4 billion, while financially troubled Teva would supply $15 billion in drugs over 10 years as well as distribution services – but no cash – to safeguard it from bankruptcy.

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As healthcare moves from fee for service to fee for value, health systems need to help their physicians maintain relationships with a broad range of patients. This means getting patients through the door and helping providers work efficiently.


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Hyfe Joins Forces with Merck to Deploy Its Artificial Intelligence-Powered Cough Detection and Counting Technology

Hyfe, Inc. | July 20, 2022

Hyfe, Inc., the global leader in AI-powered cough detection, tracking and classification, has entered into an agreement with Merck, known as MSD outside the United States and Canada, to integrate its artificial intelligence-powered (AI) cough tracker technology into Merck’s consumer disease educational efforts.. Hyfe’s AI-powered technology passively and remotely monitors the number of times a person coughs and the sound of the cough through any smart device, such as a mobile phone. This data collected over time provides the user with helpful information by revealing patterns and potential triggers like seasonal allergies that may be causing the cough that would otherwise go unnoticed or unaddressed. “The overwhelming majority of people cannot even come close to accurately estimating the number of times they cough per day. In order to help diagnose and treat patients, cough frequency and sound should be monitored and measured with the same accuracy as blood pressure, temperature, heartbeat and other biomarkers that are essential for assessing health and medical conditions.” Peter Small, M.D., chief medical officer of Hyfe, Inc Users of the app will be able to determine when and how long to track their coughing. The AI-powered technology records cough-related sounds and allows the user to compare the frequency and quality of their coughs against their own benchmark. This personalized approach provides users with more detailed information and confidential data about their individual situations to share with their health care providers. Hyfe, Inc. is the global leader in AI-powered cough detection and classification that provides insight into cough patterns and correlations that can greatly improve treatment and prevention. With more than 280 million samples, Hyfe maintains the largest cough dataset in the world enabling the building of powerful models to track, manage and diagnose respiratory illnesses. Hyfe provides platforms and data for pharmaceutical companies, medical researchers, government agencies, health care providers and patients and has partnerships with leading academic institutions including Johns Hopkins University and the University of California at San Francisco. The company was founded in 2020 and is headquartered in Wilmington, Delaware.

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DeepIntent Adds More Leading Data Providers to its Audience Marketplace, Simplifying Pharma Campaign Planning and Optimization

DeepIntent | July 14, 2022

DeepIntent, the leading healthcare advertising technology company built to influence better patient health and business outcomes announced the addition of audience segments from Redi-Data, MedFuse, HealthWise Data, Prognos Health, and TV viewership data from LG Ads Solutions to the DeepIntent Audience Marketplace. These segments are directly integrated into DeepIntent's demand side platform for immediate activation, with the ability to optimize campaigns in real-time toward audience quality and script performance using DeepIntent Outcomes™. Launched in September 2021, Audience Marketplace remains the industry's first and only healthcare-specific data marketplace with ready-to-activate and custom audience segments powered by a variety of medical and pharmacy claims, lab, genomic, contextual, and wellness data providers. In total, DeepIntent now offers hundreds of patients and HCP segments from leading digital health data providers and publishers, including HealthLink Dimensions, Fluent, Doc Delta, and ShareThis. Additionally, over two dozen leading pharmaceutical brands and advertising agencies have made use of custom or ready-to-activate segments available on the marketplace to simplify their campaign planning and tap into Outcomes to optimize their third-party segments. "Audience Marketplace meets an important need to have unique healthcare audience segments included in a healthcare-focused DSP with the ability to optimize towards pharma-specific KPIs, such as Audience Quality, all within a single platform. Many of our customers already use audience segments from our new partners, and their direct integration will make it much easier to execute, measure, and optimize campaigns." Jen Werther, chief strategy officer at DeepIntent Audience Marketplace users benefit from greater convenience, faster time-to-activation, and improved data integrity and reporting compared with conventional methods, which require the use of costly and time-consuming third-party platforms. Segments within the Audience Marketplace are also matched with DeepIntent's industry-leading identity graph to prepare advertisers for the cookieless future, and provide daily physician-level data reporting for healthcare provider audiences. "Using integrated health data and Prognos Clinical Truths™ to ensure relevancy, healthcare marketers can rest easy knowing their messages are reaching the right physicians at the right time. Our partnership with DeepIntent makes the process of onboarding and activating HCP segments from Prognos seamless, and segments can further be optimized toward script performance in real-time when leveraging the advanced machine learning capabilities of DeepIntent Outcomes," said Matt Apprendi, vice president of marketing and media solutions at Prognos Health. About DeepIntent DeepIntent is leading the healthcare advertising industry with data-driven solutions built for the future. Built purposefully for healthcare marketers, DeepIntent's platform is proven to drive higher audience quality and script performance. It enables marketers to plan, activate, measure, and optimize their campaigns all within a single platform. Conceived by former Memorial Sloan Kettering data scientists, DeepIntent empowers nine of the top ten pharmaceutical companies and the leading healthcare advertising agencies to improve patient outcomes through the artful use of advertising, data science, and real-world health data.

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IceCure Submits Regulatory Filing in Vietnam for Approval of ProSense®

IceCure Medical Ltd | August 30, 2022

IceCure Medical Ltd. developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing as an alternative to surgical tumor removal, announced it has submitted a regulatory filing with the Department of Medical Equipment and Construction of Vietnam's Ministry of Health for the ProSense System and accessories. The application covers indications including benign and malignant breast tumors, benign and malignant lung tumors, benign and malignant liver tumors, kidney cancer, ablation of cancerous or malignant tissue, musculoskeletal tumors, and other indications. Vietnam's medical device market was valued at $1.4 billion in 2019 and was projected to grow 10% annually through 2024, according to the U.S. Department of Commerce, with overall healthcare expenditures in the country totaling $17 billion. Liver, lung, and breast cancer were the three most prevalent cancers in Vietnam in 2020 according to the World Health Organization. "Asia is a significant market for ProSense and Vietnam is one of the fastest growing healthcare markets in the region. Having started the regulatory process in Vietnam, we anticipate high interest from potential distributors in the country. This comes on the heels of our recent successes in the region with Shanghai Medtronic Zhikang Medical Devices Co. Ltd. in China and Terumo in Japan, Singapore, and Thailand." IceCure CEO, Eyal Shamir About IceCure Medical Ltd. IceCure Medical Ltd. develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared to-date by the U.S. Food and Drug Administration and approved in Europe with the CE Mark.

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Titan Pharmaceuticals Announces Board Expansion and Management Changes

Titan Pharmaceuticals, Inc. | August 22, 2022

Titan Pharmaceuticals, Inc. announced that it has expanded its Board of Directors from five to eleven and appointed six new directors following their election at its special meeting of stockholders held on August 15, 2022. The new directors, which were on a nominee slate proposed by Activist Investing LLC are Avraham Ben-Tzvi, Peter L. Chasey, Eric Greenberg, David E. Lazar, Matthew C. McMurdo and David Natan. In addition, following the Special Meeting, Mr. Lazar was appointed interim Chairman and Chief Executive Officer, with a mandate to lead Titan's continuing review of strategic alternatives. Mr. Lazar succeeds Marc Rubin, M.D., who will no longer serve as Executive Chairman, but will remain on the Board. "As one of the largest investors in Titan, Activist Investing's goal is to help the Company unlock value for both ourselves and our fellow shareholders through a strategic transaction. I believe the reconstituted Board, which collectively possess decades of experience in pharmaceutical executive leadership, clinical research, strategic turnarounds, deal structuring, corporate governance, investment management, accounting, finance and corporate law, will be a tremendous asset in this endeavor." Mr. Lazar Biographies of Newly Elected Directors Avraham Ben-Tzvi is the Founder of ABZ Law Office, a boutique Israeli law firm specializing in outsourced general counsel services for publicly traded as well as private companies and corporations, Investments & Securities Laws, Commercial Law & Contracts and various civil law matters, which he established in January 2017. Mr. Ben-Tzvi served as Chief Legal Officer and General Counsel of Purple Biotech Ltd. (formerly Kitov Pharma Ltd.), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, from November 2015 until April 2020. Prior to that, Mr. Ben-Tzvi served as General Counsel and secretary at Medigus Ltd., a minimally invasive endosurgical tools medical device and miniaturized imaging equipment company, from April 2014 until November 2015. Mr. Ben-Tzvi is a member of the Israel Bar Association, and is also licensed as a Notary by the Israeli Ministry of Justice. Prior to that he served as an attorney at one of Israel's leading international law fi rms where, amongst other corporate and commercial work, he advised companies and underwriters on various offerings by Israeli companies listing in US and on various SEC related filings. Prior to becoming a lawyer, Mr. Ben-Tzvi worked in a number of business development, corporate finance and banking roles at companies in the financial services, lithium battery manufacturing and software development industries. Mr. Ben-Tzvi holds a B.A., magna cum laude, in Economics from Yeshiva University in New York and an LLB, magna cum laude with Honors, in from Sha'arei Mishpat College of Law in Hod HaSharon, Israel. Peter L. Chasey serves as the Owner of Chasey Law Offices, a law practice specializing in personal litigation, business litigation and commercial law, since founding the practice in 2005. Earlier in his career, Mr. Chasey served as staff counsel for one of the largest insurance companies in the world defending general claims against insured businesses and also served as a land surveyor. Mr. Chasey holds a B.S. in Political Science and Government from the University of San Diego and a J.D. from the University of San Diego School of Law. Eric Greenberg has over 40 years of capital markets experience. As a trader and portfolio manager at hedge funds, his areas of expertise included the development of trading strategies, portfolio management and deal structuring. Mr. Greenberg was Co-Founder of Blink Charging Co., a leader in the EV charging infrastructure industry. In addition, Mr. Greenberg provides investor relation and digital marketing services for companies across a variety of industries, such as life sciences, fintech, internet platforms and others. Mr. Greenberg holds a B.B.A in Finance from Baruch College and an M.B.A. in Finance from Baruch College Zicklin School of Business. David E. Lazar has served as the Chief Executive Officer of Custodian Ventures LLC, a company which specializes in assisting distressed public companies through custodianship, since February 2018, and Activist Investing LLC, an actively managed investment fund, since March 2018. Previously, Mr. Lazar served as Managing Partner at Zenith Partners International Inc., a boutique consulting firm, from July 2012 to April 2018. In his role as Chief Executive Officer of Custodian Ventures LLC, Mr. Lazar has successfully served as a custodian to numerous public companies across a wide range of industries. Mr. Lazar currently serves as an Advisor to PROMAX Investments LLC, a position he has held since July 2022, and as an Ambassador at Large for the Arab African Council for Integration and Development, since March 2022. Matthew C. McMurdo currently serves as Managing Member of McMurdo Law Group, LLC, a corporate and securities law practice, since 2010. Previously, Mr. McMurdo was a Partner at Nannarone & McMurdo, LLP, a boutique law firm, from 2008 to 2010. In addition, Mr. McMurdo served as General Counsel of Berkley Asset Management LLC, the general partner of a real estate fund focused on opportunistic and distressed real estate assets, from 2011 to 2013. Mr. McMurdo holds a B.S. in Finance from Lehigh University and a J.D., cum laude, from Benjamin N. Cardozo School of Law. David Natan currently serves as President and Chief Executive Officer of Natan & Associates, LLC, a consulting firm offering chief financial officer services to public and private companies in a variety of industries, since 2007. In addition, Mr. Natan currently serves as Executive Vice President and Chief Financial Officer for Airborne Motorworks, Inc., a privately-held aerospace transportation company, since April 2020. From February 2010 to May 2020, Mr. Natan served as Chief Executive Officer of ForceField Energy, Inc., a company focused on the solar industry and LED lighting products. From February 2002 to November 2007, Mr. Natan served as Executive Vice President of Reporting and Chief Financial Officer of PharmaNet Development Group, Inc., a drug development services company, and, from June 1995 to February 2002, as Chief Financial Officer and Vice President of Global Technovations, Inc., a manufacturer and marketer of oil analysis instruments and speakers and speaker components. Prior to that, Mr. Na tan served in various roles of increasing responsibility with Deloitte & Touche LLP, a global consulting firm. Mr. Natan currently serves as a member of the Board of Directors and Chair of the Audit Committee of Global Diversified Marketing Group, Inc., a manufacturer, marketer and distributor of food and snack products, since February 2021 and serves as a member of the Board of Directors and Chair of the Audit Committee of Sunshine Biopharma, Inc., a pharmaceutical and nutritional supplement company, since February 2022. Previously, Mr. Natan served as Chairman of the Board of Directors of ForceField Energy, Inc., from April 2015 to May 2020, and as a member of the Board of Directors of Global Technovations, Inc., from December 1999 to December 2001. Mr. Natan holds a B.A. in Economics from Boston University. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. In December 2021, Titan commenced a process to explore and evaluate strategic alternatives to enhance shareholder value.

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As healthcare moves from fee for service to fee for value, health systems need to help their physicians maintain relationships with a broad range of patients. This means getting patients through the door and helping providers work efficiently.

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