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PAX debuts new PAX Era device and High Purity THC

Offers consumers the perfect blend of potency and flavor, at an accessible price

 

SAN FRANCISCO — (BUSINESS WIRE) — #PAXlife—PAX, a leading global cannabis brand, today announced the launch of its latest cannabis experience—the all new PAX Era vaporizer device and High Purity THC pod, the fourth cannabis product to come to market from PAX this year. Designed to work perfectly together, the new Era lineup offers consumers more vapor and a new anti-clog feature, while PAX High Purity THC pods offer a high potency experience at the brand’s most accessible price point to date.


“We’re excited to continue to expand our cannabis offerings to better meet the needs and lifestyles of our customers, especially those who want the clean, high quality products PAX has staked its reputation on,” said Steven Jung, Chief Operating Officer at PAX. “In this case, we’re delivering a high performing closed-loop system, paired with our High Potency THC, to provide the perfect blend of unique flavors and potency at an accessible price.”

 

PAX Era

Building on more than a decade of innovation and industry leading standards, the newest device from PAX’s rechargeable closed-loop battery and pod system, PAX Era, has been re-engineered to heat faster and produce more vapor, delivering hits up to 50% bigger than previous generations. An intuitive new anti-clog feature works automatically to prevent clogs. PAX’s patented temperature control heats, and never burns, for consistent flavors and aromas from start-to-finish for every pod. All devices are backed by a 1-year limited warranty.

 

The lineup offers three vibrant new colorways, Ultra Pink, Ultra Blue, and Ultra Green, in addition to a classic Black, with a MSRP starting at $35. PAX Era devices are available to consumers on pax.com or through licensed retailers in 20 states, including Arizona, California, Colorado, Connecticut, Florida, Illinois, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Jersey, New Mexico, Oklahoma, Oregon, Pennsylvania, Rhode Island, Utah and Washington.

 

PAX High Purity THC

PAX’s High Purity THC pods are California cannabis oil, sourced for purity and potency, enhanced with a blend of terpenes to bring out unique flavor and taste profiles. Available in six flavor-forward cultivars, including Limoncello Haze (Sativa), Strawberry Créme (Sativa), Berry Gelato (Hybrid), Forbidden Fruit (Hybrid), London Pound Cake (Indica), and GMO Cookies (Indica) each with 85%+ THC. All PAX pods are made with food grade materials and tested to medical standards, certified free from residual solvents, cutting agents, harmful heavy metals, toxins and contaminants. Available across California, PAX’s High Purity THC starts at $30 for 1G, providing the lowest-cost introduction to the PAX platform.

 

PAX is a leading global cannabis brand on a mission to enhance people’s lives through exceptional cannabis experiences. PAX’s curated set of pure, full-flavor products and award-winning devices make enjoying cannabis clean, simple and safe. For more than a decade, PAX has created high performance devices that deliver enduring quality through innovations in design and technology, and remain trusted by millions of consumers nationwide. The PAX brand believes in creating sustainable well-being and building opportunity through cannabis. pax.com

 

NOT FOR SALE TO MINORS. Final Bell Lic. No. C12-0000266-LIC. © 2022 PAX Labs, Inc. All Rights Reserved. PAX, X, and ERA are all trademarks of PAX Labs, Inc. Patents and Trademarks: pax.com/IP.

Contacts

press@pax.com

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Business Healthcare Science

Tevogen Bio to study its investigational COVID-19 T cell therapy in immunocompromised patients who are unable to benefit from currently available prevention or treatment options

  • Tevogen’s investigational precision T cell product, TVGN-489, is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple precise targets across the entire SARS-CoV-2 genome.
  • The immunocompromised COVID-19 patients who are unable to take or unlikely to benefit from currently available prevention or treatment strategies are amongst the most vulnerable.
  • Given that no dose limiting toxicities or treatment-related adverse events were observed in the TVGN 489 POC trial, half of whom were immunosuppressed patients, Tevogen now plans to move forward with a clinical trial to study the efficacy of its product in this patient population.
  • Tevogen’s research pipeline includes cell therapies for treatment of COVID-19, long COVID, viral-induced cancers and neurologic diseases, including multiple sclerosis; and several non-virally induced cancers.

 

WARREN, N.J. — (BUSINESS WIRE) — #COVID19—Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology today announced its intention to study the potential therapeutic use of its investigational COVID-19 T cell therapy, TVGN-489, in immunocompromised patients.

“I’m greatly encouraged by the POC trial experience of TVGN 489 and highly optimistic that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of high-risk COVID patients.” said Dr. Dolores Grosso, Tevogen’s Clinical Development Lead.

 

There exists a significant unmet need for the treatment of COVID-19 in immunocompromised patients. Currently, there are very few treatment options that have not been impacted by variants or are suitable for this patient population due to possible medication interactions. A comprehensive review, completed by the company’s Research and Development team, led by Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer, found that TVGN-489 is expected to retain activity against recent variants, including XBB and BQ and its subtypes, which appear to have the ability to evade some existing prophylactic options and immunity. “The lack of treatment options places immunocompromised patients at higher risk of developing poor outcomes if infected with SARS-CoV-2,” said Dr. Flomenberg.

 

“It is everyone’s responsibly to step up during a moment of crisis, and for those of us in the medical innovation industry, it is our moral obligation. And we will do everything in our power to save as many lives as we can,” said Tevogen CEO Ryan Saadi, M.D., M.P.H.

 

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.

 

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.

 

Tevogen announced the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.

 

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 genome.

 

About Tevogen Bio

Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

 

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company”) and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

Contacts

Tevogen Communications

T: 1 877 TEVOGEN, Ext 714

Communications@Tevogen.com

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Culture Education Healthcare Lifestyle Local News

Amid Prez Biden’s cannabis possession pardons, students and faculty from a leading NJ public health program educate state-wide organizations on decriminalization

TCNJ’s public health program educates community groups and municipal organizations across NJ about decriminalization.

Decriminalizing drugs as a harm-reduction approach is an evidence-based public health strategy…

Dr. Natasha Patterson, Assistant Professor of Public Health, TCNJ

EWING, N.J. — In early October, President Biden announced pardons for thousands of people convicted of federal cannabis possession charges.

The move comes after decades of what many call a failed war on drugs and a snowballing opioid addiction crisis throughout the U.S.

With 2022 setting a grim record of 3,000 overdose deaths so far in New Jersey, public health students and faculty in the newly rebranded School of Nursing and Health Sciences (SNHS) at The College of New Jersey (TCNJ) educate state-wide law enforcement and community organizations about treating addiction as an illness — not a crime.

Partnering with theOpen Society Foundations, TCNJ faculty members Dr. Natasha Patterson, Assistant Professor ofPublic Health, Dr. Michael Mitchell, Assistant Professor of Criminology and African American studies, and Dr. Sandy Gibson, Professor and Clinical Coordinator in Counselor Education, brief key community stakeholders on the repercussions the war on drugs has had on health systems, the criminal justice system and other critical sectors of society.

“Decriminalizing drugs as a harm-reduction approach is an evidence-based public health strategy and the first step in correcting a wrong that has been in place since the beginning of the war on drugs,” Dr. Patterson explains.

Concluding in December 2022, Dr. Patterson plans on drawing from the state-wide decriminalization workshops, as well as another research project focused on harm reduction awareness among peer recover specialists and patient navigators, to establish a five-course harm reduction certificate for students and community members.

Former graduate student, Jordyn Block, Class of 2021, helped organize these workshops with TCNJ faculty.

She reflects on her experience, explaining, “As a grad student, I applaud the work being done to educate others on the benefits of decriminalization. It’s opening up conversations that we should have had long ago, and giving individuals an opportunity to be honest about how they feel on the subject. In my opinion, it was not many years ago that these conversations were only spoken about behind closed doors. Let’s continue to discuss these issues, because they benefit not only me, as a student, but the generations before and after me.”

Discussing the nation’s current approach to opioid addiction, Dr. Michael Mitchell says, “Despite the implementation of harm reduction strategies to help prevent drug overdoses, its practice is not universally accepted. In the U.S., our established drug policies are still largely politically driven rather than informed by empirical evidence.”

And explaining how the decriminalization workshops have been received by community groups, Dr. Sandy Gibson, remarks, “Too often, people are unaware of the history of our drug policy or the racial discrepancy with which it is policed today. If you ask people if they care about someone who uses drugs, almost everyone says yes. If you ask them if they believe this person they care about belongs in a cage for years, or even decades, the answer is always no.”

TCNJ’s School of Nursing and Health Sciences’ Dean Carole Kenner explains, “Our faculty and students continue to embody scholarship in action, bringing innovative ideas and cutting-edge research beyond the borders of the College. We stay committed to using our scholar-mentorship model to not only deliver top-of-class education, but to help communities across New Jersey.”

 

The school rebranded in 2022 to reflect its robust and diverse, cross-disciplinary health science curricula.

TCNJ’s School of Nursing and Health Sciences educates aspiring health professionals to become future leaders across the healthcare industry. Faculty work closely with local healthcare partners to provide students with applicative skills and foundational knowledge. The nationally acclaimed school is dedicated to preparing individuals — through programs in nursing, public health, exercise science, and physical education teaching — for the many rewards of guiding people, communities, and populations toward improved health outcomes. The School is nationally recognized as a Healthy People 2030 Champion.

Contact Information

Crothers Consulting | info@crothersconsulting.co | (800) 831-3840

Source: TCNJ School of Nursing and Health Sciences

Categories
Healthcare Lifestyle

Pinnacle Treatment Centers opens Lacey Treatment Services in New Jersey to provide opioid addiction treatment

LANOKA HARBOR, N.J. — (BUSINESS WIRE) — Pinnacle Treatment Centers, a leader in providing accessible, affordable care for people seeking treatment for opioid use disorder, has opened Lacey Treatment Services in New Jersey. Located at 411 Route 9, Suite 1, the community-based program serves as Pinnacle’s 11th outpatient location in the Garden State.


According to the office of the Chief State Medical Examiner, Ocean County remains as one of the top three counties in New Jersey for suspected overdose deaths, behind Camden and Essex counties.

 

Medicaid-friendly, Lacey Treatment Services will offer medication-assisted treatment (MAT) for adult men and women, including FDA-approved medicines such as methadone and buprenorphine, which curb withdrawal symptoms from heroin and opioid addiction; prevent relapse; and help ease the physical discomfort that accompanies opioid recovery. Individual counseling, group counseling and peer support services are provided as part of a holistic approach to patient care.

 

MAT is proven to be clinically effective and significantly reduces the need for inpatient withdrawal management services, which means lower costs to payors and less disruption in the lives of patients seeking recovery.

 

Lacey Treatment Services’ treatment team is comprised of seasoned doctors, registered nurses, and credentialed clinical therapists who have all worked in medication-assisted treatment and bring a wealth of knowledge and experience to the team. “The team we have assembled to treat this community brings a wealth of knowledge and long-time experience working in MAT. We are incredibly proud of this team and their drive to provide much needed services locally,” said Regional Vice President, Chris White. Lacey Treatment Services Assistant Executive Director, Dana Mills is motivated to get patients on track “We are here to be helpful and caring to the patients that need our services. In addition to medication and counseling, we will be able to provide peer support and case management services to eligible patients. This will allow us to connect these patients to resources who can assist with areas they may be struggling with, such as housing, health or dental services, employment, education, and other social services. Our goal is to give our patients the best chance possible at restoring their lives.”

 

Lacey Treatment Services accepts Medicaid, commercial insurance, and offers reasonable self-pay rates. The center is open Mondays through Fridays, 5:30 a.m.- 12 p.m., and on Saturdays, 5:30 a.m.- 12 p.m. Individuals can call 609-357-4428 for a free, confidential assessment.

 

Pinnacle’s 11 addiction treatment centers in New Jersey include:

  1. Delaware Valley Medical (Pennsauken)
  2. Hamilton Treatment Services
  3. Middletown Medical and Suboxone Services of Monmouth County
  4. Ocean Medical Services (Toms River)
  5. Ocean Monmouth Care (Brick) and Suboxone Services of Brick
  6. Pennsville Treatment Services
  7. Stateline Medical (Phillipsburg) and Suboxone Services of Phillipsburg
  8. Suboxone Services of Manahawkin
  9. Suboxone Services of Toms River
  10. Vineland Treatment Services
  11. Lacey Treatment Services

 

About Pinnacle Treatment Centers

Headquartered in Mount Laurel, New Jersey, Pinnacle Treatment Centers is a recognized leader in comprehensive drug and alcohol addiction treatment serving more than 35,000 patients daily in California, Georgia, Indiana, Kentucky, North Carolina, New Jersey, Ohio, Pennsylvania, and Virginia. With more than 135 community-based locations, Pinnacle provides a full continuum of quality care including medically-monitored detoxification/withdrawal management, Acute psychiatric stabilization for individuals with co-occurring substance use and mental health (dual diagnosis) treatment., residential treatment, partial hospitalization, recovery residences, intensive and general outpatient programming, and outpatient medication-assisted treatment (MAT) for opioid use disorder. For more information, visit pinnacletreatment.com.

Contacts

Media:
Jules Czukor

Director of Marketing

Pinnacle Treatment Centers

215-630-5006 | jules.czukor@pinnacletreatment.com

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Business Healthcare

AM Best removes from under review with developing implications and downgrades credit ratings of Western Health Advantage

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has removed from under review with developing implications and downgraded the Financial Strength Rating to B (Fair) from B+ (Good) and the Long-Term Issuer Credit Rating to “bb+” (Fair) from “bbb-” (Good) of Western Health Advantage (WHA) (Sacramento, CA). The outlook assigned to the FSR is stable while the outlook assigned to the Long-Term ICR is negative.

The Credit Ratings (ratings) reflect WHA’s balance sheet strength, which AM Best assesses as very weak, as well as its adequate operating performance, limited business profile, appropriate enterprise risk management and support of the two long-term health care delivery system sponsors, Dignity Health and NorthBay Healthcare System.

 

This rating actions reflect recent declines in absolute and risk-adjusted capitalization and lack of material improvement projected in the near term. This deterioration was driven by considerable losses in 2022, and partially driven by COVID-19-related costs and risk-adjustment payments related to its Covered CA exchange business. While the company operates under global capitation agreements, these arrangements have not prevented the recent operating losses, due partially to uncovered pharmacy and out-of-network claims.

 

In addition, capitalization remains pressured, as WHA historically has managed to low absolute and risk-adjusted levels of capitalization, based on state minimum requirements. To support capitalization, the company has received explicit financial support from its sponsors, which has come in the form of promissory notes during fiscal-year 2022. The notes are allowed to be included in California’s minimum tangible net equity calculation; however, AM Best remains concerned as this is significantly lower than NAIC risk-adjusted capitalization and Best’s Capital Adequacy Ratio (BCAR) levels. Therefore, balance sheet strength assessment is not expected to improve materially in the near term. Additionally, AM Best considers WHA’s financial leverage to be high due to additional borrowings during fiscal-year 2022. The potential for volatility in operating performance further impacting capitalization also supports the negative Long-Term ICR outlook. AM Best also notes that the company remains concentrated geographically, operating in just nine California counties due to its focus on its sponsors’ footprint. Furthermore, WHA operates in the concentrated and very competitive and price sensitive group employer market.

 

AM Best also notes that the company’s ratings are further supported by its relatively lower-risk business profile, supported by the global capitation by its sponsors for most of its business and establishing its medical loss ratio for its core lines of business at less than 92%. WHA plays a strategic role as the health plan for the sponsors, directing members to the sponsors’ facilities. The ratings also take into consideration the two sponsor’s overall creditworthiness and network, which supports WHA’s operations.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Jennifer Asamoah
Senior Financial Analyst
+1 908 439 2200, ext. 5203
jennifer.asamoah@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Joseph Zazzera
Director
+1 908 439 2200, ext. 5797
joseph.zazzera@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Healthcare Local News

Reach out to ‘988’ if holiday blues begin to overwhelm

The holidays are usually viewed as a time of happiness and rejoicing. But for some people, it can be a period of painful reflection, sadness, lonlieness, anxiety and depression.

 

Even people who love the holidays can experience the blues during this busy season. They can be a time of high emotions and demands, which can leave a lot of people feeling stressed and exhausted.

 

The new 3-digit dialing code, 988, is for mental health crisis and suicide prevention.  This 988 number will connect people to the existing National Suicide Prevention Lifeline.

 

Compassionate, accessible care and support will be available for anyone experiencing mental health-related distress, thoughts of suicide, mental health or substance abuse crisis. People can also dial 988 if they are worried about a loved one who may need crisis intervention support.

 

The 988 line will operate 24 hours a day, 7 days a week for calls, texts, and chat. Learn more at www.nj.gov/humanservices/dmhas/initiatives/988

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Business Healthcare

AM Best comments on credit ratings of Nan Shan General Insurance Co., Ltd.

HONG KONG — (BUSINESS WIRE) — #insurance — AM Best has commented that the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Rating of “a-” (Excellent) of Nan Shan General Insurance Co., Ltd. (Nan Shan General) (Taiwan) remain unchanged in view of the negative impact from pandemic insurance claims on the company’s financials as of the end of September 2022, based on AM Best’s expectation of the company’s business and capital plans over the short to intermediate term.

Nan Shan General’s reported capital and surplus declined by more than half during the first nine months of 2022 to TWD 2.0 billion. The main drag was a net loss of TWD 1.3 billion attributable to significant claims related to pandemic insurance products, as well as negative changes in other comprehensive income due to unfavourable capital market conditions. Nonetheless, the company’s local solvency ratio remained above the regulatory minimum as of the end of September 2022.

 

The company has experienced material adverse claims arising from pandemic insurance products and has provisioned additional claims reserves in the third quarter of 2022 for its in-force pandemic products based on more conservative assumptions. Nan Shan General’s ultimate claims amount remains uncertain and depends on Taiwan’s infection rate development and potential changes in the government’s pandemic policies in the next few months. AM Best expects the company will continue to maintain its solvency ratio above the regulatory minimum over the short to intermediate term as its risk-adjusted capitalisation remains supportive of the business plan.

 

Nan Shan General’s business scale is small within its parent, Nan Shan Life Insurance Co., Ltd, but it benefits from the distribution support from the parent’s life agency force in sourcing the majority of its premium revenue, in particular for personal line products such as voluntary motor. Moreover, AM Best views the parent as resourceful and willing to provide explicit and implicit financial support to Nan Shan General when needed.

 

AM Best will continue to monitor closely the pandemic insurance claims development and hold discussions with Nan Shan General’s management to evaluate any subsequent implications on the company’s rating fundamentals. Negative rating actions could occur if the company’s business and capital plans adversely deviate from AM Best’s expectation, to a point that the company’s risk-adjusted capitalization no longer supports the very strong balance sheet strength assessment.

 

Ratings are communicated to rated entities prior to publication. Unless stated otherwise, the ratings were not amended subsequent to that communication.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

James Chan
Associate Director, Analytics
+852 2827 3418
james.chan@ambest.com

Christopher Sharkey
Manager, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Christie Lee
Senior Director, Analytics
+852 2827 3413
christie.lee@ambest.com

Al Slavin
Communications Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Education Healthcare Local News Science

Leading NJ health school’s groundbreaking AmIOK program awarded $1 million to expand trauma-informed campus model to other colleges

TCNJ’s AmIOK program receives another round of funding from the Victims of Crime Act (VOCA) to spread its trauma-informed campus model.

 

 

Our program has given students a voice on campus.

Tulika Desai, TCNJ Nursing major, 2023

 

EWING, N.J. —  The newly rebrandedSchool of Nursingand Health Sciences (SNHS) at The College of New Jersey (TCNJ) today announced its trauma-informed campus initiative, AmIOK, has been awarded another $1 million Victims of Crime Act (VOCA) grant to expand to other colleges in the Mercer County, NJ area.

“We’re expanding services provided by the AmIOK program to other colleges to share our work with higher education institutions that might not have the resources to develop a trauma-informed campus community. In a recent college-student survey, 95% of respondents reported negative mental health symptoms due to the COVID-19 pandemic, and those with previous trauma caused by experiencing a criminal act are likely to have even higher rates. Our vision is to cultivate a trauma-informed campus community that supports and promotes healing for all,” says Dr. Dara Whalen, TCNJ Assistant Professor of Nursing and AmIOK Executive Director.

Along with colleagues, Dr. Whalen presented on the AmIOK model at the 2022 Philadelphia Trauma Training Conference and the 2022 Sigma International Nursing Research Congress in Edinburgh, Scotland.

Dr. Whalen and other healthcare experts at TCNJ developed AmIOK in 2021. The program provides college students and residents in the greater Mercer County area who experience a crime or traumatic event with a 24-hour confidential hotline operated by trained counsellors and nurse practitioners. AmIOK also supports peer-to-peer campus initiatives, including a student-run racial trauma workshop and art-themed healing events.

TCNJ student and AmIOK volunteer, Tulika Desai, Nursing major 2023, explains, “Our program has given students a voice on campus. They have the space to share their own experiences, and feel in control of their own care when their autonomy has been stripped from them.”

Adverse childhood experiences (ACEs) are potentially traumatic events experienced at a young age that can impact personal health outcomes. The Center for Disease Control (CDC) claims ACEs can increase chances of illness, early mortality, injury, involvement in criminal acts and chronic diseases. Trauma-informed care is a human service framework that promotes understanding trauma’s influence on people’s lives to encourage healing.

AmIOK Program Director and Clinical Supervisor, Liza Woods, adds, “The program’s impact goes far beyond the walls of TCNJ classrooms and even beyond the borders of our campus. Our culture and mindset are all about creating a space to heal now, while also educating to intervene and stop the systemic cycles of trauma. Our students learn skills that influence how they operate in the world and how they advocate for themselves and others. AmIOK refuses to accept the status quo and recognizes the changes that need to be made in our communities to address trauma.”

The Victims of Crime Act (VOCA) is a 1984 law enacted to assist crime victims through resources outside of the justice system. VOCA established the Crime Victim’s Fund, a funding source for crime victims throughout the nation.

TCNJ’s School of Nursing and Health Sciences’ Dean Carole Kenner explains, “Dr. Whalen’s efforts to export the successful AmIOK model to other college campuses in New Jersey inspires not just our School, but healthcare professionals across the nation and the globe. TCNJ’s School of Nursing and Health Sciences is honored to take the lead on the world stage in elevating trauma awareness and shaping healthier environments for future generations.” The School rebranded in 2022 to reflect its robust and diverse, cross-disciplinary health science curricula.

TCNJ’s School of Nursing and Health Sciences educates aspiring health professionals to become future leaders across the healthcare industry. Faculty work closely with local healthcare partners to provide students with applicative skills and foundational knowledge. The nationally acclaimed school is dedicated to preparing individuals—through programs in nursing, public health, exercise science and physical education teaching—for the many rewards of guiding people, communities, and populations toward improved health outcomes. The School is nationally recognized as a Healthy People 2030 Champion.

Contact Information

Crothers Consulting | info@crothersconsulting.co | (800) 831-3840

Source: TCNJ School of Nursing and Health Sciences

Categories
Business Healthcare Science

Lazurite™ and Hospital for Special Surgery announce a collaboration agreement focused on Lazurite’s ArthroFree™ wireless surgical camera system

CLEVELAND — (BUSINESS WIRE) — #Biomedevice — Medical device and technology company Lazurite and Hospital for Special Surgery (HSS), the world’s leading academic medical center focused on musculoskeletal health, today announced a new collaborative relationship based on Lazurite’s ArthroFree™ Wireless Surgical Camera System, the first wireless surgical camera system to receive market clearance from the U.S. Food and Drug Administration for arthroscopy and general endoscopy.


Through the HSS Innovation Institute, HSS and Lazurite will collaborate to advance surgical technology and techniques, including evaluation of specific aspects of ArthroFree and potential co-development of new arthroscopic technologies. HSS will conduct training sessions at the HSS Simulation Learning and Training Center and may also work with Lazurite on the co-development of future technologies that leverage the ArthroFree wireless camera and proprietary Meridiem™ light technology.

 

By eliminating conventional camera cables that tether surgeons to the surgical tower and hinder their movement, the ArthroFree System is expected to increase OR efficiency, improve OR safety and lower customer costs. With its solid-state, low-heat, high-efficiency Meridiem light technology, the system also promises to eliminate camera-related patient burns and OR fires. The modular system is designed to be drop-in compatible with existing patient data consoles, surgical displays and endoscopes found in minimally invasive operating rooms.

 

“HSS is excited to collaborate with Lazurite to evaluate the ArthroFree Wireless Surgical Camera System, provide insights into a next generation of the existing device, and potentially co-develop other medical device products utilizing this technology,” said Michael P. Ast, MD, Chief Medical Innovation Officer and a joint replacement surgeon at HSS. “As HSS physicians and innovators, our goal of continuously improving patient care and outcomes includes identifying and pursuing new technologies and developing partnerships that leverage HSS’s expertise and innovative spirit with cutting-edge industry advancements to drive new innovation forward.”

 

“Given HSS’s substantial capabilities in research, including the experience and expertise of its medical staff and the volume of orthopedic surgeries performed there, we believe that HSS is a great partner to conduct the various non-clinical assessments and other collaborations outlined in the agreement,” said Lazurite Board Chair Mark Froimson, MD.

 

“We’re pleased that a world-class clinical organization like HSS sees the potential for the ArthroFree System to become the standard of care in the minimally invasive OR,” Lazurite President and General Counsel Leah Brownlee said. “HSS has been a pioneer in orthopedic research and innovation for decades. The hospital performs more than 32,000 surgical procedures annually, including more hip surgeries and more knee replacements than any other hospital in the country. We believe this will be a beneficial experience for both HSS and Lazurite.”

 

About HSS

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 13th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2022-2023), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2022-2023). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked No. 1 in orthopedics for a third consecutive year (2023). Founded in 1863, the Hospital has the lowest complication and readmission rates in the nation for orthopedics, and among the lowest infection rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 145 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

 

About Lazurite

Lazurite is a medical device and technology company. Its ArthroFree™ System—the wireless camera for arthroscopy and general endoscopy—is designed for surgeons seeking surgical tools for greater agility in the OR. ArthroFree is drop-in compatible with current OR technologies, and it promises to eliminate cable-related patient burns, OR fires, and staff trips and falls. With the ArthroFree System, Lazurite ushers in the wireless era of surgical visualization. Lazurite’s intellectual property portfolio also includes the low-heat Meridiem light technology and products in development. The pre-revenue company is located in Cleveland, OH (est. 2015), and to date has raised ~$25M from institutional investors, family offices, and more than 75 physician champions. The mission: solve impossible problems to improve people’s lives. The 10-year vision: better outcomes for 10 million patients—and thousands of clinicians, too. For more information, see: https://lazurite.co.

 

Forward-Looking Statements

This press release includes “forward-looking statements.” Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “believe,” “project,” “estimate,” “expect,” “may,” “should,” “will,” “designed,” “milestone,” “promises,” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the expected impact of the ArthroFree System on the field of minimally invasive surgery, and particularly arthroscopic surgery, and our future sales of the ArthroFree System. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

Lazurite™, ArthroFree™, and Meridiem™ are trademarks of Lazurite Holdings LLC.

 

Media Center

Visit lazurite.co/media for videos, logos, images, fact sheets, bios and more.

Contacts

Patrick Gallagher

+1 (216) 233-7473

p.gallagher@lazurite.co

Lazurite:

+1 (833) 214-4234

contact@lazurite.co

Categories
Business Healthcare Science

Amneal launches second Biosimilar with RELEUKO® (filgrastim-ayow) in the United States

Second of three approved U.S. oncology biosimilars Amneal expects to launch

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois.

 

“RELEUKO is our second U.S. biosimilar launch and represents the next step in building out our biosimilars business. This product is another important oncology therapeutic offering for providers and their patients as we look to make essential medicines more accessible for all,” said Harsher Singh, SVP of Amneal Biosciences division.

 

According to IQVIA®, U.S. annual sales for filgrastim for the 12 months ended August 2022 were $390 million, of which $272 million represented biosimilar sales.

 

About RELEUKO

RELEUKO® in the U.S. is indicated:

  • To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
  • To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
  • To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
  • To reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

 

IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

 

Before you take RELEUKO®, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

 

WARNINGS AND PRECAUTIONS

  • Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
  • Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO® in patients with ARDS.
  • Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO®. Discontinue RELEUKO® if sickle cell crisis occurs.
  • Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO® in patients with serious allergic reactions.
  • Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO®. Consider dose-reduction or interruption of RELEUKO® in patients with kidney injury.
  • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO® in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
  • Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.

 

ADVERSE REACTIONS

Most common adverse reactions in patients:

  • With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
  • With AML are pain, epistaxis and rash.
  • With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
  • With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.

 

For full prescribing information, see package insert located here.

 

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.

 

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance, the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words are intended to identify estimates and forward-looking statements.

 

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

 

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry, in general, specifically from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; existing and future legal proceedings, the outcome of which are uncertain and may divert management resources and require us to incur substantial defense or settlement payments and costs; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the impact of severe weather; the impact of the ongoing COVID-19 pandemic, and the emergence of variant strains; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration (“FDA”) product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn, inflation and rising interest rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Contacts

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com