FRANKLIN LAKES, NJ - BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

The test, which has been available in the United States since February through an Emergency Use Authorization (EUA) from FDA, uses a single nasal swab or a single nasopharyngeal swab sample to determine if a patient has COVID-19 or the flu or RSV. The BD RVP test helps eliminate the need for multiple individual tests or doctor visits and can help clinicians implement the right treatment plan quickly. The co-testing approach also helps increase testing capacity during the busy flu season and speed up the time for diagnosis.

"Last year, we experienced a threat of a 'tripledemic' with COVID, flu and RSV circulating simultaneously, and that threat remains for the coming respiratory season," said Nikos Pavlidis, vice president and general manager for Diagnostics at BD. "As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients, and help manage the spread of the infections. The advanced robotic architecture of the BD MAX™ System automates manual, time-intensive processes, which has never been more important than in today's environment of staffing shortages and laboratory scientist burnout."

The BD MAX™ System, a molecular diagnostic platform, is already in use at thousands of hospitals and medium-throughput laboratories worldwide, and each unit is capable of analyzing hundreds of samples over a 24-hour period. The BD MAX™ RVP test is an RT-PCR assay that detects and differentiates the RNA of SARS-CoV-2, flu A, flu B and RSV in approximately two hours, with the simple and automated "walkaway workflow" of the BD MAX™ System that requires minimal human interaction.

The BD Respiratory Viral Panel for BD MAX™ System was CE marked under the IVD directive 98/79/EC in May of 2022, and now with the 510(k) clearance, BD will discontinue the BD RVP EUA version and replace it with the 510(k) version, with no gaps in availability of the test.

The respiratory viral panel is an important addition to the extensive number of assays available on the BD MAX™ System across respiratory infections, sexually transmitted infections, gastrointestinal infections, women's health and health care associated infections. The BD MAX™ open system also allows customers to leverage research use only (RUO) assays and user-defined protocols (UDP) to address emerging needs quickly.

Development of this combination test has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121C00025.

LOUISVILLE, KY – UofL Health – Mary & Elizabeth Hospital has opened the doors of its full-service community pharmacy to provide medication and pharmacy needs in South Louisville. The pharmacy opening in this medically underserved area is not only necessary, but critical given the closures of nearby pharmacies in recent years.

“We are so excited to bring this service back to our community in need,” said Melisa Adkins, CEO, Mary & Elizabeth Hospital. “Not only does this pharmacy increase access to prescriptions, but it ensures Mary & Elizabeth’s promise to provide the highest quality of care here in South Louisville.”

“This addition of the pharmacy here at Mary & Elizabeth Hospital creates a one-stop-shop experience for health care and prescription needs,” said Bob Fink, UofL Health System Vice President, Pharmacy Services. “For current patients, our pharmacists have easy access to your medical records and strong relationships with medical staff under the same roof, helping to provide a greater continuity of care. The full-service pharmacy, though, is offered to our surrounding community, ultimately filling the void left by the chain stores that have recently closed.”

The full-service community pharmacy is equipped to provide a comprehensive range of services including:

• Retail Pharmacy: Fill maintenance- or acute-need prescriptions on-site
• Specialty Pharmacy: The sole local provider for specialty medications
• Immunizations: Providers on-site to provide vaccinations during all hours
• Infusion Services: Deliver high-quality infusion on an outpatient basis
• Tobacco Cessation: Sessions for those who want to quit smoking offered for free
• Board of Pharmacy Approved Protocol: Diabetes testing supplies, tobacco cessation, opioid use disorders, opioid overdose antidote Naloxone and acute antiviral therapy
• Curbside Rx: Prescriptions delivered to your car

This represents Mary & Elizabeth Hospital’s ongoing commitment to add specialty services that benefit our South Louisville neighbors, including but not limited to the Medical Detox Unit, the Center for Women’s Health and an expansion to Family Medicine practices.

Visit UofLHealth.org/pharmacy for more information.

IRVING, TX - The End Drug Shortage Alliance, today announced recommended actions healthcare industry stakeholders should immediately take to help minimize supply chain disruptions of sterile injectable medications in the wake of the tornado that hit Pfizer’s Rocky Mount, North Carolina facility. The plant was both a production facility and a warehouse for finished products including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blocker product categories.

Pfizer’s website currently states that 200 million units are shipped globally every year from their Rocky Mount facility. Pfizer’s press release from earlier today also states that the Rocky Mount facility currently manufactures nearly 8% of all sterile injectable medication utilization in U.S. hospitals. However, overall market share for each individual product or presentation (vial size) can vary and the impact to supply remains unknown at this time.

Sterile injectable manufacturers and 503b compounders of impacted products categories should evaluate their ability to increase production in order to help meet current demand levels for products. As impacted product lists become available 503bs should review their formularies and shift production to impacted essential medications where possible.

Wholesalers should communicate with manufacturers and establish proactive protective 120% allocations for medications in the product categories to ensure the product is available for patient care and refine as more information is available. We also suggest establishing a small reserve inventory in the event emergency supply is needed.

The U.S. Food & Drug Administration (FDA) is encouraged to expedite the review and evaluation of the impacted plant. As information becomes available of impacted products, expedite the approval of any applications for the products affected by this plant disruption. Expedite the review and update the FDA Drug Shortage Database to allow for prompt 503b production.

Group Purchase Organizations (GPOs) should consider novel sourcing strategies to provide their members with additional redundancy for essential medications to minimize potential patient care disruption. Further, we recommend they communicate regularly with supply chain leaders to support access and resiliency.

Providers and clinicians should exercise a stewardship mindset when ordering, prescribing and administering medications affected by supply constraints to preserve availability for vulnerable patient populations. Alert your regulatory community with any price gouging or predatory activity.

The End Drug Shortages Alliance’s Rapid Response Team will continue to continue to closely monitor this situation and the products that may be impacted and share updates as new information becomes available.

Organizations interested in joining the End Drug Shortages Alliance to collaborate and support patients during a disruption by being stewards of supply can learn more here: https://www.enddrugshortages.com/.

NEW YORK - Pfizer Inc. (NYSE: PFE) today announced the company’s immediate efforts to provide relief and repair the damage caused to its manufacturing facility in Rocky Mount, North Carolina after a violent tornado swept through the town on Wednesday, July 19. All 3,200 local Pfizer colleagues reporting to this manufacturing site are safe and accounted for after excellent implementation of the site’s long-standing evacuation plan. Crews are working around-the-clock to restore power, assess the structural integrity of the building and move finished medicines to nearby sites for storage.

Pfizer also announced a donation to the American Red Cross North Carolina Chapter and United Way Tar River Region to support the relief and recovery needs. Additionally, the Pfizer Foundation will match employee donations to these organizations.

“Clearly nature is strong. So too is ingenuity and the human spirit. A great deal of work needs to be done, but I assure everyone, most importantly the people of the Rocky Mount community, that we will put Pfizer’s full power behind this effort,” said Dr. Albert Bourla, Chairman and CEO, Pfizer Inc. “We will work in lockstep with our partners and local authorities to restore and rebuild the site and the community.”

The site is closed while the damage is assessed. Pfizer is committed to rapidly restoring full function to the site, which plays a critical role in the U.S. healthcare system. This effort is in close partnership with the U.S. Food and Drug Administration Commissioner Robert Califf, North Carolina Governor Roy Cooper as well as other state, local and federal officials.

Most of the damage was caused to the warehouse facility, which stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance. Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies. Pfizer is also exploring alternative manufacturing locations for production across our significant manufacturing presence in the U.S. and internationally and across the company’s partner network. After an initial assessment, there does not appear to be any major damage to the medicine production areas.

Since 1968, the Rocky Mount facility has been a key producer for sterile injectables. Currently, it is responsible for manufacturing nearly 25 percent of all Pfizer’s sterile injectables – including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers – which is nearly 8 percent of all the sterile injectables used in U.S. hospitals. The site is one of 10 Pfizer manufacturing sites located in the United States.

LOUISVILLE, KY – Baptist Health’s specialty pharmacy services have achieved accreditation through the Accreditation Commission for Health Care (ACHC).

The accreditation, with distinction in cancer care, includes Baptist Health’s system call center, special pharmacy clinics in the Lexington area and Baptist Health Lexington Community Pharmacy. Accreditation of the Lexington pharmacy not only benefits patients in that community, but also patients receiving care from Baptist Health’s specialty pharmacies in Corbin, Richmond, Elizabethtown, La Grange, Louisville, Paducah, Madisonville in Kentucky and New Albany, Indiana.

The distinction in oncology is awarded to facilities that demonstrate an outstanding commitment to ensuring cancer patients receive oral cancer drugs and ancillary oral therapies in a safe, reliable, accessible and affordable environment that is integrated with an overall plan of care.

“Accreditation by ACHC reflects our organization’s dedication and commitment to meeting national standards that translate to a higher level of performance and patient care,” said Leslie Hurst, Baptist Health system director of Ambulatory & Specialty Pharmacy. “We are extremely proud of this achievement and the exceptional level of care our pharmacy teams are providing to our patients.”

Kentucky’s largest health system, Baptist Health has built a Specialty Pharmacy program that incorporates a multidisciplinary approach to caring for patients with complex or chronic medical conditions, such as cancer, multiple sclerosis, rheumatoid arthritis, hepatitis C and transplants.

ALEXANDRIA, VA / CHESHIRE, CT / SAN FRANCISCO, CA - Thoma Bravo, a leading software investment firm, today announced the closing of a strategic growth investment in Bluesight, the Medication Intelligence™ Company. The investment is expected to further enhance Bluesight's drug diversion prevention offerings through its acquisition of Medacist, a pioneer in drug diversion monitoring, and continue to grow Bluesight's inventory management and spend optimization offerings. Current investor New Leaf Ventures will remain invested in the business. Financial terms of the transaction were not disclosed.

Bluesight's vision is to transform the hospital pharmacy supply chain through software. Today, the company supports health systems with automated RFID-enabled kit and tray management through KitCheck™, controlled substance diversion management through ControlCheck™ and drug purchasing optimization through CostCheck™. Additional resources from Thoma Bravo will help accelerate the realization of Bluesight's vision and are expected to significantly benefit its customers.

Bluesight's acquisition of Medacist combines two innovators in drug diversion analytics and medication management solutions that together will serve more than 2,000 hospitals across North America. Bluesight's advanced auditing capabilities and visibility across all hospital care areas complements Medacist's streamlined reporting and visibility tools across the health system. Healthcare organizations will have a single source of software solutions that provides insights into medication usage and diversion to allow for the most accurate predictions, targeted interventions and, ultimately, improved patient outcomes.

Kevin MacDonald, Co-Founder and CEO of Bluesight, will lead the combined organization.

"Technological advancements, including artificial intelligence, are digitizing healthcare and driving demand for software innovations in medication management. Health system pharmacies are looking for solutions that lower costs, increase efficiency, and improve compliance," said Kevin MacDonald. "Partnering with Thoma Bravo enables us to increase our investment in Medication Intelligence™ and serve our health system customers more completely across the drug lifecycle. Joining forces with Medacist allows us to better support healthcare organizations in their effort to identify and prevent acts of drug diversion and creates a leading software platform providing seamless, secure and efficient medication surveillance and predictive analytics solutions."

David Brzozowski, Sr., President & CEO of Medacist, commented: "More than 25 years ago, we embarked on a mission to revolutionize healthcare with a new approach to identifying and preventing drug diversion. Since its inception, Medacist has been a trailblazer, helping to identify potential cases of drug diversion across thousands of healthcare organizations. Medacist is thrilled to partner with Bluesight and Thoma Bravo to accelerate our impact."

"The combination of Bluesight and Medacist capitalizes on the growing demand for software solutions that transform how health system pharmacies manage medication inventory and compliance," said Carl Press, a Partner at Thoma Bravo. "In particular, drug diversion costs the healthcare system billions of dollars each year and presents a significant challenge that can only be addressed with deep industry knowledge and advanced technical capabilities, including machine learning. We believe the combined company is uniquely positioned to tackle this challenge and others, and we are thrilled to partner with Kevin and team to accelerate innovation and growth at Bluesight."

"With increased scale and enhanced capabilities, Bluesight and Medacist will have a differentiated market position within this critically important segment of the healthcare market," said Sam Yules, a Vice President at Thoma Bravo. "We are excited to work with both of these organizations on the next phase of their growth journey."

Piper Sandler & Co. served as financial advisor to Bluesight and Taft, Stettinius and Hollister LLP served as legal counsel. Provident Healthcare Partners served as financial advisor to Medacist and Robinson & Cole LLP served legal counsel. Kirkland & Ellis LLP served as legal counsel for Thoma Bravo. Committed financing for the transaction was led by Monroe Capital LLC.

LOUISVILLE, KY - Baptist Health, Kentucky’s largest health system, has announced a partnership with MediLedger to pioneer a new era of contract management within healthcare.

Baptist Health is the inaugural hospital system to utilize MediLedger's groundbreaking blockchain technology solution to ensure pharmaceuticals bought by the nine-hospital system are correctly priced.

“With more than 400 locations that purchase pharmaceuticals, and over 40,000 pharmaceuticals available for purchase on each of those accounts, Baptist Health was looking for a turnkey solution to smooth the lines of communication and ensure we receive the correct negotiated contracted prices for pharmaceutical products in a timely fashion,” said Thomas Matanich, system director of pharmacy contract management for Baptist Health.  

Matanich said the current process is cumbersome, opaque, and often resulted in lengthy claims reprocessing work, creating cash flow issues.

“The industry needed a real-time environment for all parties to partner and eliminate costs associated with claims rework,” Matanich added. “MediLedger and blockchain technology will allow us to collaborate in real time with the Premier group purchasing organization, manufacturers, and wholesalers to identify price discrepancies at the beginning of the purchasing process, addressing any potential pricing discrepancy before a purchase is made and subsequent claims rework required.”

MediLedger's platform transforms the traditional approach to managing contracts, proactively identifying discrepancies and automating alignment between trading partners and customers. With MediLedger, contracts among group purchasing organizations, manufacturers, wholesalers, and health sytems such as Baptist Health are synchronized, maintaining accurate pricing across all sites. This pricing transparency, coupled with the ability to publish rosters directly to all parties involved, ensures up-to-date and accurate information sharing, leading to more informed decision-making.

MALVERN, PA - Baudax Bio, Inc. (Nasdaq:BXRX) (“Baudax Bio” or the “Company”), a pharmaceutical company focused on innovative products for acute care and related settings, today announced the acquisition of TeraImmune, a privately held a biotechnology company focused on discovery and development of novel Treg-based cell therapies for autoimmune diseases.

“This combination blends the world class scientific expertise of the TeraImmune team with the Baudax team’s proven ability to execute clinical development programs, which we believe is a win for the shareholders of both companies,” said Ms. Henwood. “This merger adds TeraImmune’s TI-168 asset to the Baudax portfolio—a promising next-generation, autologous FVIII TCR-Treg cell therapy candidate to eliminate clotting factor VIII (FVIII) inhibitors in Hemophilia A patients. Hemophilia A is a rare genetic bleeding disorder that is caused by a lack of FVIII, with an Investigational New Drug (IND) application already FDA-cleared. We believe this combination can enable, with a modest initial budget, activating the Phase 1/2a Clinical Trial of TI-168 for Treatment of HA. We believe this is an attractive therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in hemophilic animal models. We believe this platform, with customization to the target condition, has potential for clinical application in management of Myasthenia Gravis, Pemphigus Vulgaris and combination therapies for other conditions such as Organ Transplantation, MS and other auto-immune disorders.”

“Concurrently, we intend to continue to progress the development of our existing Neuromuscular Blockade (NMB) portfolio at a prudent pace,” continued Ms. Henwood. “With the positive data obtained from our Phase 2 trial of BX1000, we continue to believe that when combined with our reversal agent BX3000 our NMB regimen may provide improved control of neuromuscular paralysis for surgical patients and deliver the first innovation in NMB in decades.”

“With IND clearance from the FDA already in hand for TI-168, this transaction permits the continued development of this promising asset,” said Yong Chan Kim, PhD, Co-Founder of TeraImmune. “We are looking forward to working with Gerri Henwood and the excellent clinical development team at Baudax to advance this asset to its full potential,” said Jihoon (Jay) Park, PhD, Co-Founder of TeraImmune. Daniel Chai, former Board Member of TeraImmune and managing partner of Turret Capital Management said, “We are very excited to see the results that will be driven by the combination of an impressive leadership team and how many lives that can be impacted by the development of this platform technology.”

Gerri Henwood, President and Chief Executive Officer of Baudax Bio, will continue as CEO of the combined entity. In conjunction with the transaction, Yong Chan Kim, Ph D, former Chief Executive Officer of TeraImmune, will be appointed to the Board of Directors of Baudax.

FRANKLIN LAKES, NJ – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that Laura Boros has been named president of Pharmaceutical Systems (PS), effective today.

Boros will be responsible for driving global strategic, operational and commercial performance of the PS business unit and will report to Mike Garrison, executive vice president (EVP) and president of the Medical segment. Boros succeeds Eric Borin, who was named to president of Medication Delivery Solutions (MDS) in late 2022. Since 2020, Boros has served as senior vice president of global nutrition at Reckitt, a leader in hygiene, health and nutrition brands. 

“Laura has more than 25 years of progressive leadership experience and is uniquely suited to lead PS, one of BD’s highest growth businesses,” said Garrison. “Her global experience, coupled with her track record of driving innovation across the healthcare and consumer industries, will support the next generation of PS growth as it continues to enhance the delivery of medications for the pharmaceutical industry and patients around the world.”

Boros started her career at Procter & Gamble in various country, regional and global roles before joining Hertz as regional vice president for Europe. She then held leadership positions within the pharmaceutical industry at both Novartis and GlaxoSmithKline in high-growth categories. Most recently, she led the global nutrition business at Reckitt and oversaw several strategic M&A projects for the company. She holds a Master of Electrical Engineering degree from Politehnica University in Bucharest, Romania and a Master of Business Administration from Emory Business School in Atlanta, Georgia.

PITTSBURGH, PA / BOCA RATON, FL - As part of its goal of transforming care for its patients through translational research, UPMC today announced a collaboration with PharmaLogic Holdings Corp. to facilitate the development of novel radiopharmaceuticals for the diagnosis and treatment of cancer and other diseases. The partners will jointly construct a world-class radiopharmaceutical research, production and distribution facility in Pittsburgh, expected to be one of the largest such centers in the United States. 

Under the terms of the non-exclusive agreement, PharmaLogic and UPMC will translate investigational radiopharmaceuticals into clinically relevant drugs for the diagnosis and treatment of cancer, cardiovascular and other diseases. The partnership will provide access to novel diagnostic and therapeutic agents not currently available to the communities surrounding UPMC, benefiting patients and clinicians alike.

"This innovative partnership will allow us to produce cutting-edge therapies that, due to their nature, can't be brought in from distant facilities and, therefore, aren’t currently available for patients in our communities," said Alfred L’Altrelli, Pharm.D., senior director of pharmacy at UPMC. “Even beyond the immediate benefit to our patients, this collaboration will transform our clinical research infrastructure, allowing us to not only discover new molecules but also take them through all phases of research and development into mainstream production for future patients.”

PharmaLogic will manage and co-fund a world-class Current Good Manufacturing Practice (cGMP) facility on the UPMC campus in the Oakland neighborhood of Pittsburgh. As a well-established and highly experienced contract development and manufacturing organization, PharmaLogic possesses the expertise necessary to build, outfit and manage a successful radiopharmaceutical production facility. In addition to investing in the facility, UPMC will be the anchor clinical customer and provide strategic, research and operational support in a market expected to grow at double-digit rates through the end of the decade.

“It is a privilege for PharmaLogic to participate in this partnership with UPMC, which will provide patients and clinicians with first-in-line access to novel radiopharmaceuticals,” said Scott Holbrook, chief strategy officer and general manager for PharmaLogic. “The establishment of this partnership marks a significant milestone for our organization toward achieving the goal of collaborating with leading health care institutions. Given the expertise and reputation of UPMC, this facility will serve as a center of excellence globally for years to come.”

Timothy R. Billiar, M.D., UPMC executive vice president and chief scientific officer, said, “UPMC is dedicated to providing the highest quality, affordable care to our patients and communities. By collaborating with PharmaLogic, we can offer our patients the latest therapeutic options in this area of high unmet clinical need. We will continue to work with our research colleagues at the University of Pittsburgh and with support from UPMC Enterprises to keep us at the cutting edge of this rapidly evolving field of medicine.”