Medical marketing skyrockets over past two decades, but oversight remains limited

Healthcare Finance | January 09, 2019

Healthcare spending in the U.S. is the highest in the world, totaling $3.3 trillion -- or 17.8 percent of the GDP -- in 2016. To capture market share, and to expand the market, drug companies and healthcare organizations use a wide array of promotional activities, including TV and digital advertising, social media, disease awareness campaigns targeting consumers, and marketing to professionals via free drug samples or consulting payments. In an article recently published in the Journal of American Medical Association, researchers reviewed medical marketing -- the marketing of prescription drugs, disease awareness, laboratory tests and health services to consumers and professionals -- over a 20-year period from 1997 through 2016.

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MEDICAL DEVICES

Extremity Medical Files Patent Infringement Lawsuit Against Nextremity Solutions, Zimmer Biomet Holdings and Zimmer, Inc.

Extremity Medical, LLC | April 07, 2022

Extremity Medical, LLC, a global medical device company focused on the development of innovative implants and instruments for upper and lower extremities, announcedthat it filed a lawsuit against Nextremity Solutions, Inc.; Zimmer Biomet Holdings, Inc.; and Zimmer, Inc., alleging infringement of an Extremity Medical patent* for its intraosseous fixation platform arising from the marketing of the InCore® Lapidus System by these companies. The complaint was filed in the U.S. District Court for the District of Delaware. Extremity Medical has amassed an intellectual propertyportfolio that includes 49 patents in the U.S. and several foreign countries. The novel and patented technology of Extremity’s intraosseous fixation platform provides surgeons with a zero-profile solution for fusion and fixation of bones within the upper and lower extremities, with the ability to be implanted through minimal incisions. This technology is currently marketed globally by Extremity under the trade names IO FiX, IO FiX Plus, IO FiX 2.0, IO Freedom, CarpalFiX, ApeX and XMCP. “Extremity Medical has invested a tremendous amount of effort and resources in research and development to create innovative technology to improve the lives of patients and meet surgeons’ needs. Our intellectual property is a critical component in making such advancements possible and we are committed to protecting it,” Matthew Lyons, Extremity Medical Chief Executive Officer, Founder and Chairman of the Board About Extremity Medical, LLC Extremity Medical, was founded in 2008, and is a privately-held medical device company based in Parsippany, NJ. The company is known for creating innovative implants and instruments for upper and lower extremity orthopedic procedures, including fusion and motion preservation. The company is focused on developing solutions for challenging cases that promote better outcomes, especially in patients with poor bone quality.

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HEALTH TECHNOLOGY

Ivenix to be Acquired by Fresenius Kabi

Ivenix | April 01, 2022

Ivenix, Inc. announced that it has entered into a definitive agreement to be acquired by Fresenius Kabi, a global health care leader specializing in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Ivenix’s advanced infusion system combined with Fresenius Kabi’s intravenous fluids and infusion therapy offerings will bring a comprehensive portfolio of infusion products to U.S. hospitals. The purchase price will be a combination of US$240 million upfront payment and milestone payments linked to achievements of commercial and operating targets. The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close by mid-2022. The transaction is designed to Create a comprehensive portfolio that joins the industry’s most advanced infusion pump technology with the newest source of intravenous fluids, infusion supplies and accessories. Accelerate operational and commercial growth and scale providing a platform for rapid expansion. Build on a shared culture of exceptional customer service. Establish Fresenius Kabi as a leader in the approximately $5 billion infusion segment. This pivotal transaction will accelerate innovation, expand our combined infusion therapy portfolio and enhance our infusion capabilities, resulting in improved medication safety and operational efficiency. “We’re very pleased to partner with Fresenius Kabi, a leading global health care company. Together, we intend to transform the standard of care for North American health care providers and patients by providing the highest level of safe and effective integrated infusion care,” Jorgen B. Hansen, Ivenix’s Chief Executive Officer The Ivenix Infusion System includes a large-volume infusion pump with administration sets, infusion management tools, and analytics to inform care and advance efficiency. Ivenix centered the system around the patient and clinician and designed it to reduce infusion-related errors and drive down the total cost of ownership. After receiving U.S. Food and Drug Administration (FDA) clearance, Ivenix successfully launched the infusion system in 2021. “Combining Ivenix’s expertise in pump technology and software with our infrastructure, portfolio, and presence in hospital settings represents an ideal opportunity. We intend to scale the launch of Ivenix’s next-generation infusion system while driving growth opportunities in the United States. With today’s announcement, Fresenius Kabi expects to create a leading, comprehensive infusion therapy offering,” said Michael Sen, President and CEO, Fresenius Kabi. About Ivenix Ivenix, Inc. is a medical technology company with a vision to eliminate infusion-related patient harm. The company was founded to develop innovative solutions that transform infusion delivery. Ivenix designed an infusion system from the ground up to streamline medication delivery and bring infusion technology into the digital age. The Ivenix Infusion System includes a large-volume infusion pump supported by a robust infusion management system designed to set new standards in simplicity, intelligence, and reliability. For more information, visit ivenix.com. The Ivenix Infusion System is cleared by the FDA.

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FUTURE OF HEALTHCARE

NextGen Healthcare Partners with Circuit Clinical to Bolster Diversity in Clinical Trials by Extending Access to Underserved Communities

NextGen Healthcare, Inc. | May 05, 2022

NextGen Healthcare, Inc. a leading provider of innovative, cloud-based healthcare technology solutions, announced a partnership with Circuit Clinical to bring clinical trial access to patients of Federally Qualified Health Centers through over 14,000 providers that utilize NextGen Healthcare solutions. Historically, these underserved communities have not had easy access to participate in transformative clinical research that can provide enhanced treatment options. Such research-as-care can also improve health outcomes and offers revenue generation for the clinics that participate. NextGen Healthcare’s innovative collaboration with Circuit Clinical, whose mission is to transform how patients find and choose clinical trials by bringing them to the doctors they know and trust, will improve the participation of diverse patients in clinical trials and provide greater health equity by facilitating access to the underserved. “This partnership underscores NextGen Healthcare’s commitment to FQHCs and highlights our commitment to serving diverse patient populations. NextGen Healthcare’s technology is empowering providers to build healthier communities. Our work with Circuit Clinical is a milestone that provides real impact for our clients and their patients, and delivers on our pledge to facilitate better healthcare outcomes for all.” Srinivas (Sri) Velamoor, chief growth and strategy officer at NextGen Healthcare The collaboration contributes to the vision of the NextGen® Community Health Collaborative, a first-of-its-kind initiative announced late last year that offers data benchmarking, comparative analytics and reporting services, plus a forum for members to connect and share best practices to advance the mission of community health and health equity among underserved populations. NextGen Healthcare-powered practices, in conjunction with Circuit Clinical, will now be able to offer clinical trial patient recruitment, referral and enrollment services, eliminating obstacles to such care. Furthermore, participation provides tangible benefits to participants, including extra care visits without co-pays, therapeutic improvement on a better regimen, and patient stipends. “Our partnership with NextGen Healthcare will create a comprehensive solution for improving access to clinical trials for diverse communities across the country,” said Dr. Irfan Khan, founder and chief executive officer of Circuit Clinical. “Combining NextGen Healthcare’s comprehensive data insights and national reach with Circuit Clinical’s expert ecosystem offers pharmaceutical, biotech and vaccine companies a groundbreaking opportunity for accelerating therapeutic development and improving diversity in clinical trials.” In April, the Food & Drug Administration (FDA) issued updated guidance to provide recommendations to those developing medical products on the approach for developing a Race and Ethnicity Diversity Plan to help enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations. Adequate representation in clinical trials helps ensure that the data generated reflects the racial and ethnic diversity of the intended use population and may potentially identify safety or efficacy outcomes, the FDA said. About NextGen Healthcare, Inc. NextGen Healthcare, Inc. is a leading provider of innovative healthcare technology solutions. We are reimagining ambulatory healthcare with award-winning solutions that enable high-performing practices to create healthier communities. We partner with medical, behavioral and dental providers in their journey toward whole-person health and value-based care. Our highly integrated, intelligent and interoperable solutions go beyond EHR and Practice Management to increase clinical quality and productivity, enrich the patient experience and drive superior financial performance. We are on a quest to achieve better healthcare outcomes for all. About Circuit Clinical Circuit Clinical®, one of the largest integrated research organizations in the USA, is dedicated to empowering patients to choose clinical research as a care option. Circuit Clinical® is committed to transforming the way physicians and their patients find, choose, and participate in clinical research. The company delivers clinical research services and an award-winning patient engagement platform, trialjourney.com.

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HEALTH TECHNOLOGY

Texas Children's Hospital And Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization In India

Texas Children Hospital | December 29, 2021

Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow. Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. "Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production." The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries. "This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow." "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge". Mahima Datla, Managing Director, Biological E. Limited ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BCM VENTURES Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

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To reach healthcare professional audiences, we researched the topic of e-health in a healthcare environment and we collected data and information from different sources to present this infographic about digital transformation trends in the Healthcare Industry.

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