NYC Health + Hospitals today announced that Danielle DiBari, Pharm.D., Senior Vice President of Business Operations, Chief Pharmacy Officer, and Chief Procurement Officer for NYC Health + Hospitals, was recognized by The Journal of Healthcare Contracting in its 2023 ‘Women Leaders in Supply Chain’ list. Dr. DiBari manages the health system’s supply chain, pharmacy services, and business operations. The list recognizes women leaders who are instrumental in navigating the challenges facing supply chain teams as they contribute to the success of their organizations. The leaders are nominated by the readers of The Journal of Healthcare Contracting and selected by the editorial staff, who consider the nominee’s tenure in supply chain, commitment to continued learning, and recent responsibilities and projects. The Journal of Healthcare Contracting is a publication dedicated to the healthcare supply chain, focusing on the interactions of the four primary stakeholders in healthcare contracting: health systems and their facilities, manufacturers and suppliers, distributors, and group purchasing organizations (GPOs).

“Our health system is more resilient, efficient, and unified since Danielle DiBari has taken the helm as Senior Vice President of Business Operations, Chief Pharmacy Officer and Chief Procurement Officer for NYC Health + Hospitals,” said Mitchell Katz, MD, President and Chief Executive Officer of NYC Health + Hospitals. “We are grateful to The Journal of Healthcare Contracting for the recognition of her efforts, as we build a healthier, more equitable city for all.”

In her role, Dr. DiBari oversees supply chain, pharmacy, and business operations, which enable her to identify opportunities for innovation and find cost-effective solutions to any challenge. Through her tenure she overhauled how the health system manages, safeguards, and optimizes its supply chain. These changes have resulted in significant improvements in organizational productivity, positioning the health system for long-term success.

Dr. DiBari and her team are advancing NYC Health + Hospital’s efforts to work as one, unified health system. In 2022, the team received the Premier GPO Supplier Diversity Award for community involvement, diversity business outreach initiatives, and benchmarking and sharing of best practices. This year, the supply chain operation increased its M/WBE utilization from 5% in 2019 to more than 30%. NYC Health + Hospitals was awarded the prestigious GHX Best 50 Award this year, and was inducted into the GHX Millennium Club, joining a group of health care providers who demonstrate outstanding supply chain management to reduce costs and boost efficiency. The health system is again working toward being recognized by GHX in 2024, as it continues to make strides in the provision of high quality, cost-effective care.

“I am deeply honored and grateful to receive this recognition from The Journal of Healthcare Contracting. This acknowledgement is a reflection of the important work that we do to diversify our supply chain with a focus on equity while improving patient outcomes in the communities that we serve,” said Danielle DiBari, Pharm.D., Senior Vice President of Business Operations, Chief Pharmacy Officer, and Chief Procurement Officer for NYC Health + Hospitals.

Prior to joining NYC Health + Hospitals, Dr. DiBari served as SVP of Clinical Operations and Chief of Staff for the Mount Sinai Health System from 2015-2019, where she identified opportunities to drive efficiency throughout the health system. In this position, she was responsible for unifying, coordinating and overseeing the health system’s operational efforts to maximize their impact on the patients and communities they serve. Dr. DiBari joined the Mount Sinai System in 2015 from Northwell Health and prior, CVS/Caremark, where she held positions on the Corporate Management Team. Her varied career includes strategic planning, business unit development, project and product management, marketing and branding, system strategies, training and development program management and delivery, the management of multi-functional work teams, and customer service.

University Hospitals Plymouth NHS Trust is working on the development of a new and improved outpatient pharmacy due to open in Spring 2024.

The new pharmacy will double in size when it moves to a new location adjacent to Derriford hospital’s on-site Costa Coffee shop in the multi-story car park building.  

Chief Pharmacist & Clinical Director of Medicines Optimisation, Kandarp Thakkar, said: “We’re really excited about progress on the new pharmacy which serves thousands of outpatient appointments each week.

“As many who have used the pharmacy recently will know, we have outgrown our current space and this much improved facility will have room for more staff and stock, a better range of services and a much-improved experience for patients."

“We recognize there have been long queues at the pharmacy in recent weeks, so on behalf of UHP and Lloyds Pharmacy, I want to offer our sincere apologies. The level of service and disruption is not something that we expect or want for patients and we’re very sorry to anyone who has been inconvenienced.”

While work is ongoing on the new pharmacy, the Trust has implemented measures such as covered seating.

The new pharmacy will have extended opening times during the weekends to benefit patients who are unable to attend during the week. Demand for UHP outpatient pharmacy services has grown by 25%.

PRINCETON, NJ & SAN DIEGO, CA - Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (NASDAQ: RYZB) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and RayzeBio Boards of Directors.

RayzeBio is a clinical-stage radiopharmaceutical therapeutics (“RPT”) company with an innovation-leading position in actinium-based RPTs and a pipeline of potentially first-in-class and best-in-class drug development programs. Current pipeline programs are targeting the treatment of solid tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NETs), small cell lung cancer, hepatocellular carcinoma and other cancers. There remains a high, unmet need for more effective treatments in solid tumors, and RPTs enable a precision approach to patient treatment. RPTs bind to tumor cells and deliver targeted radiation to induce cancer cell death. Actinium-based RPTs offer potential advantages over currently available RPTs since the high potency and short firing range of the alpha-emitter create the possibility for stronger efficacy and more targeted delivery.

“This transaction enhances our increasingly diversified oncology portfolio by bringing a differentiated platform and pipeline, and further strengthens our growth opportunities in the back half of the decade and beyond,” said Christopher Boerner, Ph.D., Chief Executive Officer of Bristol Myers Squibb. “Radiopharmaceutical therapeutics are already transforming cancer care, and RayzeBio is at the forefront of pioneering the application of this novel modality. We look forward to supporting and accelerating RayzeBio’s preclinical and clinical programs and advancing its highly innovative radiopharmaceutical platform.”

“Acquiring RayzeBio’s differentiated actinium-based radiopharmaceutical platform will establish Bristol Myers Squibb’s presence in one of the most promising and fastest-growing new modalities for the treatment of patients with solid tumors – delivering radioactive payloads to cancer cells in a targeted manner,” said Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Drug Development of Bristol Myers Squibb. “In addition, RayzeBio’s platform has the potential to be a significant IND engine, generating several therapeutic candidates in the future by leveraging our global drug development capabilities and infrastructure.”

Ken Song, M.D., President and CEO of RayzeBio, said, “Despite therapeutic advances in recent years, the need for more effective treatments in solid tumors persists, and radiopharmaceutical therapeutics are positioned to be an important next wave of innovation in oncology therapy. Bristol Myers Squibb’s well-established presence in oncology and deep expertise in developing, commercializing and manufacturing treatments on a global scale makes it the ideal partner for RayzeBio at this important moment in our evolution. I am excited to see what our team achieves as part of Bristol Myers Squibb.”

RayzeBio’s portfolio includes:

• Lead program RYZ101 (²²⁵Ac-DOTATATE), targeting somatostatin receptor 2 (SSTR2), which is over-expressed in GEP-NETs and extensive stage small cell lung cancer (ES-SCLC). A Phase 3 clinical trial is currently enrolling patients to evaluate RYZ101 in patients with SSTR-positive GEP-NETs who have previously been treated with lutetium-177 based somatostatin therapies. RayzeBio previously reported the interim results of the Phase 1b portion of the ACTION-1 clinical trial, suggesting encouraging efficacy and tolerability. A Phase 1b clinical trial is also currently enrolling patients to evaluate RYZ101 as a first-line treatment of ES-SCLC in combination with standard-of-care therapy.
• RYZ801, RayzeBio’s novel proprietary peptide targeting glypican-3 (GPC3) for delivery of actinium- based radioactivity for the treatment of hepatocellular carcinoma (HCC). RYZ801 is currently in IND-enabling studies.
• Pipeline also includes an asset targeting CA9, which is expressed in renal cell cancer and is currently in IND-enabling studies.
• Multiple first-in-class preclinical assets to treat solid tumors.

RayzeBio is completing construction of a state-of-the-art in-house manufacturing facility in Indianapolis, Indiana, and GMP drug production is expected to begin in the first half of 2024.

The transaction is expected to be treated as a business combination and to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.13 in 2024. Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

Transaction Terms and Financing

Under the terms of the merger agreement, Bristol Myers Squibb will promptly commence a tender offer to acquire all of the outstanding shares of RayzeBio common stock at a price of $62.50 per share in an all-cash transaction for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired. RayzeBio’s Board of Directors unanimously recommends that RayzeBio’s shareholders tender their shares in the tender offer.

The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including the tender of a majority of the outstanding shares of RayzeBio’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, Bristol Myers Squibb will acquire all remaining shares of RayzeBio that are not tendered into the tender offer through a second-step merger at the same price of $62.50 per share.

PRINCETON, NJ & BOSTON, MA - Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.

Karuna is a biopharmaceutical company driven to discover, develop and deliver transformative medicines for people living with psychiatric and neurological conditions. Karuna’s lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease. Bristol Myers Squibb believes KarXT represents a significant revenue contribution opportunity. Bristol Myers Squibb also sees potential from Karuna’s early-stage and pre-clinical pipeline.

“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade,” said Christopher Boerner, Ph.D., Chief Executive Officer of Bristol Myers Squibb. “This transaction fits squarely within our business development priorities of pursuing assets that are strategically aligned, scientifically sound, financially attractive, and have the potential to address areas of significant unmet medical need. We look forward to welcoming the talented Karuna team to Bristol Myers Squibb.”

“Schizophrenia and Alzheimer’s disease psychosis affect millions of people worldwide, with limited to no treatment options. KarXT’s novel mechanism has resulted in a transformational profile in schizophrenia, with compelling efficacy and a differentiated safety profile,” said Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Drug Development of Bristol Myers Squibb. “KarXT also has the potential to deliver meaningful benefits to patients as an adjunctive treatment for patients with schizophrenia and as a first treatment for Alzheimer’s disease psychosis.”

Bill Meury, President and Chief Executive Officer of Karuna Therapeutics, said, “Karuna’s portfolio offers advancements in treatment not seen in many years. With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale and legacy in neuroscience, KarXT and the other assets in our pipeline will be well-positioned to reach those living with schizophrenia and Alzheimer’s disease psychosis. This announcement is a testament to the Karuna team’s talent, hard work, and innovation.”

Delivering Meaningful Benefits to Patients with KarXT

KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments, including weight gain, extrapyramidal symptoms, increased prolactin levels, akathisia and/or sedation.

Given this differentiated profile, KarXT has meaningful and expanding revenue potential in schizophrenia and with upside in additional indications and geographies:

• Schizophrenia: KarXT is expected to launch in late 2024 in the U.S. as a treatment for schizophrenia in adults. There are approximately 1.6 million¹ people treated for schizophrenia in the U.S., a significant portion of whom do not respond to currently available therapies and experience unacceptable side effects.
• Adjunctive schizophrenia: A registrational clinical trial is currently underway evaluating KarXT as adjunctive treatment with current standard of care agents for the treatment of schizophrenia, with data expected in 2025.
• Alzheimer’s disease psychosis: Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026. There are more than 6 million² people living with Alzheimer’s disease in the U.S. There are currently no approved treatments for Alzheimer’s disease psychosis.
• Additional indications: Bristol Myers Squibb believes KarXT also has potential in additional indications, including Bipolar I disorder, which impacts approximately 1.4 million¹ people in the U.S., and Alzheimer’s disease agitation.

The transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately $0.30 in 2024 from the financing cost of the transaction, as Bristol Myers Squibb expects to offset the operational expenses of the transaction through continued resource allocation, cost efficiencies and portfolio prioritization. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction. Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance. Bristol Myers Squibb’s cash flows and strong financial profile enable continued commitment to strong investment-grade credit ratings and investment for growth through business development opportunities and distributions to shareholders through ongoing dividends and share repurchases.

Transaction Terms and Financing

Under the terms of the merger agreement, Bristol Myers Squibb will acquire all outstanding shares of Karuna common stock for $330.00 per share in cash representing an approximately 53% premium to Karuna Therapeutic’s closing stock price on December 21, 2023, for a total equity value of approximately $14.0 billion, or $12.7 billion net of estimated cash acquired.

The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including approval of Karuna stockholders and receipt of required regulatory approvals.

DUBLIN - Theravance Biopharma, Inc. ("Theravance" or the "Company") (NASDAQ: TBPH) today announced the appointment to its Board of Directors of Jeremy Grant, who serves as a Special Advisor to Irenic Capital Management LP ("Irenic"). With the addition of Mr. Grant, Theravance has appointed four new directors to the Board since 2020. 

"We are pleased to welcome Jeremy to the Theravance Board as a new independent director," said Rick E Winningham, Chairman and CEO of Theravance. "Jeremy's appointment underscores that Theravance values the perspectives of its investors and that the Board and management team are focused on our shared goal of maximizing value for shareholders. We look forward to benefitting from Jeremy's financial background and perspectives as a seasoned investor." 

"I am excited to join the Theravance Board at this time," said Mr. Grant. "Theravance is operating from a position of strength, and I look forward to working with my fellow directors to deliver value to shareholders." 

With the appointment of Mr. Grant, the Theravance Board will temporarily increase to 10 directors. As previously announced, Dr. Burton Malkiel has informed the Company that he does not intend to stand for re-election at the 2024 Annual General Meeting of Shareholders (the "2024 AGSM"), which is scheduled for May 8, 2024. Following the 2024 AGSM, the Board will comprise nine directors, eight of whom are independent. 

In connection with today's announcement, Theravance has entered into a cooperation agreement (the "Agreement") with Irenic. Pursuant to the agreement, Irenic has agreed to customary standstill and voting commitments, among other provisions. The Agreement will be filed on a Current Report on Form 8-K with the U.S. Securities and Exchange Commission (the "SEC"). 

"We appreciate the productive discussions we've had with Irenic and are pleased to have reached this agreement," Mr. Winningham continued. "Since mid-2022, we have returned over $300 million to shareholders, reduced shares outstanding by approximately 35%, eliminated debt, enhanced governance, progressed ampreloxetine into Phase 3 and grown YUPELRI sales while streamlining our expense base. Theravance is committed to maximizing shareholder value and plans to maintain our disciplined approach to expense management and implement cost-cutting initiatives within G&A. As we did earlier this year in increasing our capital return program from $250 million to $325 million, our Board is pleased to reaffirm our commitment to return all excess capital to shareholders through repurchases or dividends." 

"Irenic invested in Theravance because we believe Rick and the team are well-positioned to complete the Phase 3 trial of ampreloxetine successfully and deliver value to shareholders from its market-leading respiratory portfolio," said Adam Katz, Co-founder and Chief Investment Officer of Irenic. "We believe Theravance is committed to operating in a disciplined manner and delivering enhanced value to shareholders." 

About Jeremy Grant 

Mr. Grant is the Founder and Managing Partner of Harbor Ridge LP, an investment firm, and a Special Advisor to Irenic Capital Management LP. He was previously an Associate Portfolio Manager at Elliott Management Corporation. Prior to Elliott, he worked as an investment professional at Oak Hill Advisors and as an analyst at Credit Suisse. Mr. Grant currently serves on the board of directors of Acosta Inc. and as an observer of the board of directors of Arconic Corporation. He is a CFA charterholder and graduated from the Wharton School at the University of Pennsylvania with a B.S. in Economics. 

About Theravance Biopharma 

Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension, has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in multiple system atrophy patients. The Company is committed to creating/driving shareholder value. 

For more information, please visit www.theravance.com. 

TAMPA, FL - Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that its Board of Directors (the “Board”) has appointed Frank D. Lee as Chief Executive Officer and a member of the Board, effective January 2, 2024. As previously announced in September 2023, David Stack will retire from his roles as Chief Executive Officer and Chairman of the Board, effective January 1, 2024, and will remain with the company through August 2025 in an advisory capacity to help ensure a smooth transition. In connection with Mr. Stack’s retirement, the Board has elected Paul Hastings, Lead Independent Director, as Chair of the Board, also effective January 2, 2024.

Mr. Lee brings more than three decades of global experience and a strong track record of product development and commercial leadership success across a wide range of therapeutic areas within the biotech and pharmaceutical industry. Most recently he served as Chief Executive Officer and member of the board of directors of Forma Therapeutics from March 2019 through its acquisition by Novo Nordisk in October 2022. During his tenure at Forma, Mr. Lee transformed the company from an early-stage drug discovery company into one focused on the clinical development of lead assets in rare hematologic disorders and cancer.

“Following a comprehensive executive search process, we are delighted to welcome Frank as our new CEO and are confident he is the ideal leader for our next phase of growth and value creation,” said Paul Hastings, Chair elect of Pacira BioSciences, Inc. “Frank is a proven leader who has distinguished himself over the course of his career as a disciplined executive with a focus on revenue growth and cost management, having built successful patient-focused organizations driving product growth to blockbuster and multi-blockbuster status across a wide range of therapeutics areas and treatment settings. He has a proven ability to forge partnerships with key stakeholders and to deliver creative solutions that provide value and improve patients’ lives. We believe he has the relevant skills and experience to continue the execution of our strategy to maximize shareholder return and unlock the significant untapped potential within our best-in-class opioid-sparing commercial portfolio.”

“I am excited to join Pacira to continue advancing the company’s important mission to expand patient access to non-opioid pain management,” said Mr. Lee. “The efforts that Dave and his team have made establishing Pacira as a leader in opioid-sparing innovation are exceptional and I am eager to work with the team to capitalize on the significant opportunities ahead. I look forward to working closely with Dave to ensure a smooth transition, and to partnering with the entire Board and leadership team to build upon our strong foundation and deliver value for all Pacira stakeholders.”

Mr. Hastings concluded, “On behalf of the entire Board, I want to thank Dave for his visionary leadership and numerous contributions to Pacira. As CEO for the last 16 years, Dave has transformed Pacira into a leader in non-opioid pain management and positioned the company for future success. We wish him the best in his well-deserved retirement.”

Prior to Forma, Mr. Lee most recently served as Senior Vice President, Global Product Strategy and Therapeutic Area Head for Immunology, Ophthalmology and Infectious Diseases at Genentech, a member of the Roche Group. At Genentech, he was responsible for driving development and commercial strategy for a broad portfolio of molecules in development and for global in-line product sales of more than $11 billion. His 13-year career path at Genentech included leadership positions of increasing scope and responsibility for delivering transformative medicines to patients.

Prior to joining Genentech, Mr. Lee spent approximately 13 years across Novartis, Janssen and Eli Lilly in engineering, manufacturing, sales/marketing and business development. Mr. Lee received a bachelor’s degree in chemical engineering from Vanderbilt University and an MBA in marketing and finance from the Wharton Graduate School of Business. He currently serves as executive chairman of the board of directors of privately held Therini Bio, Inc. and chairman of the board of privately held Catamaran Bio, Inc. He is also a member of the board of directors of Bolt Biotherapeutics, Inc. (Nasdaq: BOLT).

On December 20, 2023, in connection with Mr. Lee’s appointment as Chief Executive Officer, the Board approved the grant of inducement awards to Mr. Lee. The awards were made pursuant to the Pacira BioSciences, Inc. Amended and Restated 2014 Inducement Plan, which was approved by the Board without stockholder approval pursuant to, and in compliance with, Rule 5635(c)(4) of the Nasdaq Listing Rules.

Mr. Lee’s inducement awards included (i) a non-qualified stock option to purchase an aggregate of 692,512 shares of Pacira’s common stock with an exercise price per share equal to the closing price of Pacira’s common stock as reported on the Nasdaq Global Select Market on January 3, 2024, and, subject to continued service with Pacira as of each vesting date, such option will vest and become exercisable as to 25% of the option shares on January 3, 2025, and vest as to the remaining shares in successive equal quarterly installments over the subsequent three years, and (ii) a restricted stock unit award for 99,520 shares of Pacira’s common stock, subject to continued service with Pacira as of each vesting date, to vest in four equal annual installments beginning on January 2, 2025, in each case, pursuant to the terms and provisions of the Inducement Plan.

RAHWAY, NJ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.

“Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease. We look forward to discussing the data that support our filing with the FDA and are working with urgency to bring this potential new preventative measure to adult patients.”

The BLA for V116 is based, in part, on data from STRIDE-3, a pivotal Phase 3 trial which evaluated the immunogenicity, tolerability and safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in adults who had not previously received a pneumococcal vaccine. Results from the STRIDE-3 trial were presented at the World Vaccine Congress West Coast in November 2023. The BLA for V116 is supported by results from multiple Phase 3 clinical studies evaluating V116 in both vaccine-naïve and vaccine-experienced adult patient populations, including STRIDE-3, STRIDE-4, STRIDE-5 and STRIDE-6. Results from additional trials will be shared with the scientific community at future congresses. An overview of the V116 late-stage development program is available here.

According to CDC data from 2018-2021, the serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older. V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, which were responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data.

DEERFIELD, IL - Baxter International Inc. (NYSE:BAX), an innovative leader in infusion therapies and technologies, announced the completion of the first phase of its intravenous (IV) bag recycling program pilot. Launched in conjunction with Northwestern Medicine, a premier integrated academic health system in Chicago, more than six tons (or 12,000 pounds) of polyvinyl chloride (PVC) IV bag waste — enough to cross the city of Chicago if bags were laid end-to-end — has been successfully diverted from landfill to be recycled for a useful second life. This program is the first of its kind to launch in the U.S.

“Across the country, hundreds of thousands of IV bags are used every day. Baxter is a proud manufacturer and supplier of these bags, which are ubiquitous in hospital care—particularly single-use plastic containers that provide patients clinically essential solutions including fluids, nutrition and medicines,” said Cecilia Soriano, president of Baxter’s Infusion Therapies and Technologies division. “In line with Baxter’s commitments as a responsible corporate citizen, we believe this pilot helps pave the way for meaningful, long-term waste reduction.”

Unlike other medical equipment products such as syringes and needles, which have established post-use collection methods, standard practice for non-hazardous IV bag removal includes draining of residual fluid and disposing as waste that ultimately ends up in a landfill. Through this pilot program, stakeholders from several Northwestern Memorial Hospital departments — including nursing, supply chain and environmental services — were engaged to help develop a new process that enables the incorporation of material separation for recycling into nursing workflow while also managing space constraints common to hospital settings. With dedicated third-party logistics and recycling partners, collected IV bags are transported and inspected to ultimately be recycled into products such as industrial floor mats and protective edging for docks and landscaping. All IV bags involved in this pilot were made of PVC, one of the most widely used plastic materials in medical products.

“We are proud to pilot this program with Baxter to be the first health system in the nation to begin recycling PVC IV bags,” said Jeff Good, Northwestern Medicine’s first chief sustainability executive and vice president of operations. “What started as a single-unit pilot is now standard practice across several of our inpatient units within Northwestern Memorial Hospital and has resulted in the recycling of more than 170,000 IV bags. Our health system understands the environmental importance of this pilot program and we are dedicated to creating initiatives that support our overarching sustainability goals to reduce our carbon footprint and eliminate unnecessary waste.”

As a company focused on waste reduction, Baxter’s objective for the pilot’s first phase was to establish proof of concept for a program that assists hospitals in recycling plastic IV bags manufactured by Baxter. Following the successful conclusion of the pilot phase, Northwestern Medicine will continue to implement the program and will explore expanding the program throughout the health system. Baxter is now actively seeking to engage additional health system participants in the Chicago area to further validate the process and economic feasibility. Doing so will support long-term, large-scale implementation with potential roll out to other health systems across the country.

This program builds on Baxter’s innovative experiences partnering with hospitals and waste collection companies outside of the U.S. to recycle valuable materials at the end of product life. In recent years, Baxter has introduced several programs to facilitate recycling for patients and hospitals in Australia, New Zealand, Guatemala and Colombia.
 

CHICAGO, IL - Long Grove Pharmaceuticals, LLC, a manufacturer of differentiated pharmaceuticals, is filling a critical supply shortage of Fluorescein Injection, USP. In June 2023, Long Grove Pharmaceuticals acquired the New Drug Application (NDA) for AK-FLUOR. The company has reached a distribution agreement with the Food and Drug Administration (FDA) Office of Drug Shortages to make available existing inventory of AK-FLUOR, Fluorescein Injection, USP manufactured by Akorn Pharmaceuticals. 

AK-FLUOR is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. It is currently available in the following presentations:

• 10% (100mg/mL 5mL vials) 12 pack
• 25% (250mg/mL 2mL vials) 12 pack

Fluorescein Injection, USP is currently impacted by a supply shortage resulting from Akorn Pharmaceuticals’ exit from the U.S. market. To ensure the consistent availability of Fluorescein Injection, USP prior to its relaunch as a Long Grove Pharmaceuticals product, Long Grove Pharmaceuticals will make available the existing AK-FLUOR inventory manufactured by Akorn Pharmaceuticals in both 10% and 25% solutions.

“Our goal is to provide the market a consistent supply of this essential medication now and after its relaunch as a Long Grove-labeled product,” said Peter Karas, Chief Commercial Officer at Long Grove Pharmaceuticals. “Until we can fill the gap in supply through our own manufacturing, the existing Akorn-manufactured product will assist in easing procurement burdens for ophthalmic providers and health systems.”

For more information about Long Grove Pharmaceuticals and AK-FLUOR, visit www.longgrovepharma.com.

CHICAGO, IL - Long Grove Pharmaceuticals, LLC, a manufacturer of differentiated pharmaceuticals, is expanding its product offerings through a strategic in-licensing of Cyclophosphamide for Injection, USP from Sunny Pharmtech, Inc. Cyclophosphamide for Injection, USP will be manufactured by Sunny Pharmtech, Inc. in Taiwan. The product is an APrated generic product and Trade Agreement Act (TAA) compliant. 

Cyclophosphamide for Injection, USP is an antineoplastic chemotherapy medication that slows the growth of cancer cells. It is used to treat multiple malignant diseases, including blood cancers and solid tumors. Sunny Pharmtech, Inc. received Food and Drug Administration (FDA) approval for the drug through an Abbreviated New Drug Application (ANDA) in October 2023. It is currently available in 500 milligram, 1 gram and 2 gram dry powder vials. 

“Our team at Long Grove Pharmaceuticals has a long history of collaboration with Sunny Pharmtech, Inc,” said Peter Karas, Chief Commercial Officer at Long Grove Pharmaceuticals. “This current opportunity to jointly offer cyclophosphamide continues our commitment to improving customer choice by increasing access to generics.” 

“Our partnership with Long Grove Pharmaceuticals helps ensure we can successfully bring cyclophosphamide to market in the U.S.,” said Yon-Lian Wu, Ph.D., Founder, Chairman and Chief Executive Officer at Sunny Pharmtech, Inc. “We’re excited about the launch of cyclophosphamide, but also by the continued opportunity to collaborate on pharmaceutical products that save and improve lives.” 

For more information about Long Grove Pharmaceuticals and Cyclophosphamide for Injection, USP, visit www.longgrovepharma.com.