BOTHELL, WA - Seagen Inc. (Nasdaq: SGEN) today announced that the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA^® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla^®) met its primary endpoint of progression-free survival (PFS). Patients in the trial had unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer and had received previous treatment with a taxane and trastuzumab.​ Overall survival (OS) data, a secondary endpoint, are not yet mature. Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals emerged for the combination.

“We are encouraged by these results for TUKYSA in combination with Kadcyla^®in metastatic HER2-positive breast cancer, including in patients with brain metastases,” said Roger Dansey, President of Research and Development and Chief Medical Officer at Seagen. “We plan to present the HER2CLIMB-02 data at an upcoming medical meeting and discuss the results with the FDA.”

About HER2CLIMB-02

HER2CLIMB-02 is a global, multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of tucatinib in combination with ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic or unresectable breast cancer (MBC) who have had prior treatment with a taxane and trastuzumab in any setting. Trial enrollment began in 2019. The primary endpoint of the trial is PFS per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator assessment. OS, PFS by blinded independent committee review (BICR), objective response rate, duration of response, PFS and OS in patients with brain metastases at baseline, and safety and tolerability of the combination regimen are secondary objectives.

About the TUKYSA Breast Cancer Development Program

TUKYSA is currently approved in the U.S. in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Seagen has a robust development program for TUKYSA, including a study with registrational intent in first-line maintenance with trastuzumab and pertuzumab (HER2CLIMB-05). Seagen is also supporting a cooperative group study in adjuvant high-risk HER2-positive breast cancer in combination with T-DM1.

About HER2-positive Breast Cancer

An estimated 300,590 people will be diagnosed with breast cancer in the United States this year.¹ Between 15 and 20 percent of breast cancer cases are HER2-positive, which means tumors have high levels of a protein called HER2 that promotes the growth of cancer cells.² Up to 50 percent of patients with HER2-positive MBC develop brain metastases over time.³

About TUKYSA (tucatinib)

TUKYSA (tucatinib) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. It is approved in more than 40 countries. Merck, known as MSD outside the U.S. and Canada, has exclusive rights to commercialize TUKYSA in regions outside of the U.S., Canada and Europe.

TUKYSA is approved in the U.S.:

• in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
   
• in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important U.S. Safety Information

Warnings and Precautions

• Diarrhea: TUKYSA can cause severe diarrhea including dehydration, hypotension, acute kidney injury, and death. If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Based on the severity of the diarrhea, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
  
  In HER2CLIMB, when TUKYSA was given in combination with trastuzumab and capecitabine, 81% of patients who received TUKYSA experienced diarrhea, including 0.5% with Grade 4 and 12% with Grade 3. Both patients who developed Grade 4 diarrhea subsequently died, with diarrhea as a contributor to death. Median time to onset of the first episode of diarrhea was 12 days and the median time to resolution was 8 days. Diarrhea led to TUKYSA dose reductions in 6% of patients and TUKYSA discontinuation in 1% of patients. Prophylactic use of antidiarrheal treatment was not required on HER2CLIMB.
  
  In MOUNTAINEER, when TUKYSA was given in combination with trastuzumab, diarrhea occurred in 64% of patients, including Grade 3 (3.5%), Grade 2 (10%) and Grade 1 (50%).
   
• Hepatotoxicity: TUKYSA can cause severe hepatotoxicity. Monitor ALT, AST, and bilirubin prior to starting TUKYSA, every 3 weeks during treatment, and as clinically indicated. Based on the severity of hepatotoxicity, interrupt dose, then dose reduce or permanently discontinue TUKYSA.
  
  In HER2CLIMB, 8% of patients who received TUKYSA had an ALT increase >5 × ULN, 6% had an AST increase >5 × ULN, and 1.5% had a bilirubin increase >3 × ULN (Grade ≥3). Hepatotoxicity led to TUKYSA dose reductions in 8% of patients and TUKYSA discontinuation in 1.5% of patients.
  
  In MOUNTAINEER, 6% of patients had a bilirubin increase > 3 × ULN (Grade ≥3), 6% had an AST increase > 5 × ULN, and 4.7% had an ALT increase > 5 × ULN. Hepatotoxicity led to dose reduction of TUKYSA in 3.5% of patients and discontinuation of TUKYSA in 2.3% of patients.
   
• Embryo-Fetal Toxicity: TUKYSA can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential, and male patients with female partners of reproductive potential, to use effective contraception during TUKYSA treatment and for 1 week after the last dose.

Adverse Reactions

In HER2CLIMB, serious adverse reactions occurred in 26% of patients; the most common (in ≥2% of patients) were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%). Fatal adverse reactions occurred in 2% of patients who received TUKYSA including sudden death, sepsis, dehydration, and cardiogenic shock. Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; the most common (in ≥1% of patients) were hepatotoxicity (1.5%) and diarrhea (1%). Adverse reactions led to dose reduction in 21% of patients who received TUKYSA; the most common (in ≥2% of patients) were hepatotoxicity (8%) and diarrhea (6%). The most common adverse reactions in patients who received TUKYSA (≥20%) were diarrhea, palmar-plantar erythrodysesthesia, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia and rash.

In MOUNTAINEER, serious adverse reactions occurred in 22% of patients; the most common (in ≥2% of patients) were intestinal obstruction (7%), urinary tract infection (3.5%), pneumonia, abdominal pain and rectal perforation (2.3% each). Adverse reactions leading to permanent discontinuation of TUKYSA occurred in 6% of patients; the most common (in ≥2% of patients) was increased ALT (2.3%). Adverse reactions leading to dosage interruption occurred in 23% of patients; the most common (in ≥3% of patients) were increased ALT and diarrhea (3.5% each). Adverse reactions leading to dose reduction occurred in 9% of patients; the most common (in ≥2% of patients) were increased ALT and diarrhea (2.3% each). The most common adverse reactions (≥20%) in patients treated with TUKYSA and trastuzumab were diarrhea, fatigue, rash, nausea, abdominal pain, infusion-related reactions and pyrexia. Other adverse reactions (<10%) include epistaxis (7%), weight decreased (7%), oropharyngeal pain (5%), oral dysesthesia (1%) and stomatitis (1%).

Lab Abnormalities

In HER2CLIMB, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased phosphate, increased ALT, decreased potassium, and increased AST. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

In MOUNTAINEER, Grade ≥3 laboratory abnormalities reported in ≥5% of patients who received TUKYSA were decreased lymphocytes, decreased sodium, increased AST, and increased bilirubin. The mean increase in serum creatinine was 32% within the first 21 days of treatment with TUKYSA. The serum creatinine increases persisted throughout treatment and were reversible in 87% of patients with values outside normal lab limits upon treatment completion. Consider alternative markers of renal function if persistent elevations in serum creatinine are observed.

Drug Interactions

• Strong CYP3A/Moderate CYP2C8 Inducers: Concomitant use may decrease TUKYSA activity. Avoid concomitant use of TUKYSA.
• Strong or Moderate CYP2C8 Inhibitors: Concomitant use of TUKYSA with a strong CYP2C8 inhibitor may increase the risk of TUKYSA toxicity; avoid concomitant use. Increase monitoring for TUKYSA toxicity with moderate CYP2C8 inhibitors.
• CYP3A Substrates: Concomitant use may increase the toxicity associated with a CYP3A substrate. Avoid concomitant use of TUKYSA with a CYP3A substrate, where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
• P-gp Substrates: Concomitant use may increase the toxicity associated with a P-gp substrate. Consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities.

Use in Specific Populations

• Lactation: Advise women not to breastfeed while taking TUKYSA and for 1 week after the last dose.
• Renal Impairment: Use of TUKYSA in combination with capecitabine and trastuzumab is not recommended in patients with severe renal impairment (CLcr < 30 mL/min), because capecitabine is contraindicated in patients with severe renal impairment.
• Hepatic Impairment: Reduce the dose of TUKYSA for patients with severe (Child-Pugh C) hepatic impairment.

For more information, please see the full Prescribing Information for TUKYSA here .

MALVERN, PA - Baudax Bio, Inc. (Nasdaq:BXRX) (“Baudax Bio” or the “Company”), is a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced results for the three and six months ended June 30, 2023 and provided a business update.

“Our second quarter was a transformative period for Baudax Bio, during which we announced positive top-line results from our Phase 2 BX1000 trial and capped off with our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio. “The transaction with TeraImmune adds the promising TI-168 clinical stage asset to our portfolio. TI-68 is a next-generation, autologous FVIII TCR-Treg cell therapy candidate to eliminate clotting factor VIII (FVIII) inhibitors in Hemophilia A patients — a rare genetic bleeding disorder that is caused by a lack of FVIII. We believe this is an attractive therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in Hemophilia A with inhibitors, animal models, and with an Investigational New Drug (IND) application already FDA-cleared. We believe we can, with a modest initial budget, activate the Phase 1/2a Clinical Trial of TI-168 for Treatment of hemophilia A with inhibitors. More broadly, we believe that this platform has potential for clinical applications, alone and in combination of, multiple other autoimmune disorders and therapeutic areas. By combining TeraImmune’s world class scientific team with Baudax Bio’s proven ability to execute clinical development programs, we believe we are well positioned to pursue development of TI-168 and realize its clinical potential, for one-time treatment, and further providing proof of concept for this TCR Treg approach.

“As noted above, we announced positive top-line data from our Phase 2 trial of BX1000 showing all patients in three BX1000 study cohorts were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds, and that study treatments were generally well tolerated with no occurrence of severe or serious adverse events,” continued Ms. Henwood. “Based on the strength of data from this program, which were highlighted in the Key Opinion Webinar we hosted, 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.”

“We believe the actions we’ve taken during our second quarter and recent weeks are a win for shareholders of both TeraImmune and Baudax Bio, and we look forward to working with our new colleagues to develop these assets to their full potential,” concluded Ms. Henwood.

Second Quarter 2023 and Recent Business Highlights

Acquisition of TeraImmune

• The acquisition of TeraImmune was structured as a stock-for-stock transaction whereby all TeraImmune outstanding equity interests were exchanged for a combination of shares of Baudax common stock and shares of newly designated convertible Series X Non-Voting Convertible Preferred Stock. Subject to shareholder approval of the conversion, each share of Series X Non-Voting Convertible Preferred Stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. On a pro forma basis and based upon the number of shares of Baudax Bio common stock and preferred stock issued in the acquisition, Baudax Bio equity holders immediately prior to the acquisition will own approximately 18% of the combined Company (on an as-converted, fully-diluted basis and excluding certain out-of-the-money warrants held by Baudax Bio’s equity holders) immediately after these transactions. The acquisition was unanimously approved by the Board of Directors of Baudax Bio and the Board of Directors of TeraImmune. The closing of the transaction was not subject to the approval of Baudax Bio shareholders.

   

• 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, PhD, former Chief Executive Officer of TeraImmune, was appointed to the Board of Directors of Baudax Bio in July.

   

• Nobel Capital provided a fairness opinion to the Baudax Bio Board of Directors.

TI-168 and other Potential Product Candidates

The most advanced of the TeraImmune TCR Tregs is TI-168, intended for one time treatment of Hemophilia A with inhibitors. An IND for a Phase 1/2a study of TI-168 in patients with Hemophilia A with inhibitors has been cleared by FDA. The Company is now in the process of speaking with prospective investigators and assessing the readiness of potential study site staff and logistics for support of the clinical trial. The Company intends to select study sites and file for IRB (Investigational Review Board) approval at those study institutions. Hemophilia A with inhibitors is an Orphan Condition (in terms of numbers of patients) and the Company estimates that the trial would be ready to open one or more initial study sites and begin to enroll patients in approximately Q1 of 2024.

In addition to the TI-168 clinical stage product candidate, the Company has begun research work on other potential candidates for the TCR Treg platform in conditions such as Myasthenia Gravis, which it believes can be advanced to IND stage by approximately the end of 2024/early 2025, as well as other earlier stage potential product candidates.

NMB Portfolio

• BX1000 Top-Line Data - The Company announced positive top-line results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery. Results of the study showed that BX1000 met the primary endpoint of readiness for intubation (evaluated as “Good” or “Excellent”) at all dose levels assessed. No severe adverse events were observed in any dose regimen.

   

• Results showed that all patients in three BX1000 study cohorts were observed to have met the criteria for Good or Excellent intubating conditions at 60 seconds. There was evidence of a dose-response across the three doses of BX1000, and the degree of blockade for the highest dose group appears comparable to that of the “standard” dose of rocuronium (0.6 mg/kg) employed in the study. Study treatments were generally well tolerated, with no occurrence of severe or serious adverse events. The frequency and severity of adverse events was similar across all four dose groups, and no notable events were aggregated in any one dose group.

   

• A further patient safety follow-up at 28 days after surgery, as well as additional analyses of EMG neuromuscular blockade data, showed a clear dose response for BX1000 on maximum T1 suppression with comparable results for the 1.5x ED95 dose of BX1000 and the 2X ED95 dose of rocuronium. An equivalent “time to 80% NMB” was also observed between the highest dose level for BX1000 (0.35 mg/kg) and rocuronium (0.66 mg/kg). Recovery measures showed equivalent time for “full recovery” for the highest dose of BX1000 (0.35 mg/kg) and rocuronium (0.60 mg/kg), but with tighter, thus more predictable, margins for BX1000.

   

• The Company intends to continue development of its NMB portfolio at a prudent pace while prioritizing development of TI-168.

Financial Results for the Three Months Ended June 30, 2023

As of June 30, 2023, Baudax Bio had cash and cash equivalents of $1.4 million.

Research and development expenses from continuing operations for the three months ended June 30, 2023 were $1.8 million compared to $0.9 million for the three months ended June 30, 2022. The increase of $0.9 million was primarily the result of an increase in clinical and preclinical trials costs associated with our NMB program.

General and administrative expenses from continuing operations for the three months ended June 30, 2023 were $2.3 million compared to $2.9 million for the same prior year period. The decrease of $0.6 million was primarily a result of a reduction in personnel costs of $0.6 million and a decrease in consulting expenses of $0.3 million, partially offset by an increase in public company costs of $0.3 million.

Baudax Bio reported net loss from continuing operations of $(7.3) million, or $(1.49) per share, for the three months ended June 30, 2023. Net loss from continuing operations for the three months ended June 30, 2022 was $(4.3) million, or $(24.20) per share.

Financial Results for the Six Months Ended June 30, 2023

Research and development expenses from continuing operations for the six months ended June 30, 2023 were $4.7 million compared to $1.6 million for the six months ended June 30, 2022. The increase of $3.1 million was primarily due to an increase in operational expenses associated with our NMB program, including clinical and preclinical trials costs, of $2.8 million and an increase in general expenses, including consulting and other outside service expenses, of $0.3 million.

General and administrative expenses from continuing operations for the six months ended June 30, 2023 were $4.0 million compared to $9.8 million for the same prior year period. The decrease of $5.8 million was primarily a result of a reduction in personnel costs of $4.1 million, a decrease in consulting expenses of $0.9 million, a decrease in public company costs of $0.4 million, a decrease of $0.2 million in patent legal expenses and a decrease of $0.2 million in other costs.

Baudax Bio reported net loss from continuing operations of $(14.7) million, or $(4.08) per share, for the six months ended June 30, 2023. Net loss from continuing operations for the six months ended June 30, 2022 was $(12.5) million, or $(89.40) per share.

PRINCETON, NJ - Bristol Myers Squibb (NYSE: BMY) announces induction into the Billion Dollar Roundtable, joining other Fortune 100 companies that have invested $1 billion with diverse-owned suppliers. This milestone highlights BMS' longstanding history of taking purposeful action to advance health equity, foster a diverse and inclusive workplace, improve and increase the diversity in its clinical trials and expand the diversity among its supplier base.

BMS established aspirational inclusion and diversity goals and health equity commitments in 2020 to address health disparities by 2025. In connection to these goals, BMS aspired to spend $1 billion with diverse and minority-owned businesses and has delivered on this important milestone ahead of its 2025 timeline. Sustaining and building on this achievement will remain a priority.

Investing in diverse-owned suppliers brings agility and innovation to BMS, while closing economic gaps as a social determinant of health in diverse communities. BMS has contracted with more than six hundred diverse suppliers owned by underrepresented groups, women, veterans, LGBTQ+, people with disabilities and other diverse populations; underscoring an unwavering dedication to creating opportunities and driving economic impact.

“Our investment reinforces our commitment to collaborating with industry leaders and driving business priorities,” said David Elkins, Executive Vice President and Chief Financial Officer, Bristol Myers Squibb. “We are proud of the meaningful progress we’ve made to meet our goal.”

BMS has cultivated powerful partnerships with a wide range of diverse-owned business partners and industry leaders to enhance its operations. BMS actively collaborates with renowned organizations such as the National Minority Supplier Development Council, Women's Business Enterprise National Council, National LGBT Chamber of Commerce, Disability IN, and the National Veteran Owned Business Association. By partnering with these organizations, BMS aligns with their shared objectives of economic development, wealth creation, and job opportunities for diverse suppliers and communities.

While joining the Billion Dollar Roundtable marks a significant achievement, BMS looks to build upon this success.

“We have increased our diverse spend by being purposeful and creating the right partnerships,” said Rondu Vincent, Executive Director, Global Supplier Diversity and Sustainability, Bristol Myers Squibb. “Inclusion is a BMS Value and at the end of the day, the numbers quantify our spend but the value is the impact we’re making in the communities we live, work and serve.”

BMS is expanding its spend globally by developing international contracting opportunities, including a partnership with Minority Supplier Development UK (MSDUK). BMS remains committed to championing supplier diversity as an essential element to our business growth strategy. By nurturing a diverse supplier base, BMS aims to increase innovation, foster economic growth, and drive equitable outcomes for patients and communities around the world.

INDIANAPOLIS, IN - Eli Lilly and Company (NYSE: LLY) today announced the successful completion of its acquisition of DICE Therapeutics, Inc. (NASDAQ: DICE). The acquisition expands Lilly's immunology portfolio to include DICE's novel oral therapeutic candidates, including oral IL-17 inhibitors currently in clinical development, to treat chronic diseases in immunology.

"Since our founding nearly 150 years ago, we've strived to make life better for people around the world – but we know that to achieve this goal, we have to bring the brightest minds to Lilly," said Ajay Nirula, Ph.D., senior vice president of immunology at Lilly. "With the passion and expertise of our new colleagues from DICE, we look forward to continuing our pursuit of discovering and delivering life-changing medicines for patients living around the world with chronic immunologic diseases."

The Offer and the Merger
Lilly's tender offer to acquire all of the issued and outstanding shares ("Shares") of common stock of DICE, at a purchase price of $48 per Share in cash, without interest and less any applicable tax withholding, expired as scheduled at one minute past 11:59 p.m., Eastern time, on Aug. 8, 2023 and was not further extended. Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Lilly that as of the expiration of the tender offer, 42,265,390 Shares were validly tendered and not properly withdrawn, representing approximately 88.4% of the issued and outstanding Shares. Such Shares have been accepted for payment and will be promptly paid for in accordance with the terms of the tender offer. Following completion of the tender offer, Lilly completed the acquisition of DICE through the previously planned second-step merger. DICE's common stock will be delisted from the NASDAQ Global Market.

For Lilly, Kirkland & Ellis LLP is acting as legal counsel. For DICE, Centerview Partners LLC is acting as exclusive financial advisor and Fenwick & West LLP as legal counsel.

KINGWOOD, WV - Mon Health System has recently announced the implementation of Pharmacy Keeper, a new pharmacy dispensing program for IV medications that utilizes barcoding and cameras to enhance the accuracy and compliance of sterile compounding and improve patient safety.

Pharmacy Keeper is a web-based software that is used to complete sterile compounding, which is the preparation of custom medications for patients in a sterile environment to prevent contamination and ensure patient safety. Pharmacy Keeper advances sterile compounding by automating workflow and providing a tool for real-time dose verification, a process that can decrease the risk of errors.

“At Mon Health System, we continue to prioritize the health and safety of our patients. This new barcoding pharmacy dispensing program will allow our staff to efficiently prepare medicine and improve communication throughout our pharmacies,” said David Goldberg, President and CEO of Mon Health System and Executive Vice President of Vandalia Health.

The new system not only improves patient safety, but also pharmacy compliance to recommendations from patient safety organizations, such as The Institute for Safe Medication Practices (ISMP), sterile compounding regulations, and state board requirements.

“Pharmacy Keeper will leave no room for uncertainty or human error,” said Brandon Crowe, Director of Pharmacy for Mon Health Medical Center. “The program ensures that each dose is accurately labeled and helps us identify potential hazards before they can occur.”

Mon Health Medical Center, Mon Health Stonewall Jackson Memorial Hospital, and Mon Health Preston Memorial Hospital are implementing this software together to enhance the health of the communities they serve, one person at a time.

CARLSBAD, CA -Thermo Fisher Scientific, the world leader in serving science, announced today a new line of Thermo Scientific^TM TSG Series Refrigerators to ensure the safe storage of critical vaccines and pharmaceuticals for laboratory, pharmacy and clinical* environments.

The World Health Organization estimates that up to 50% of vaccines are wasted each year globally, primarily due to temperature control, logistics and shipment-related issues. The result is less vaccine availability for patients and caregivers and financial loss to physicians, researchers and institutions. TSG Series Laboratory and Pharmacy Refrigerators provide safe, effective storage of vaccines and other pharmaceuticals with less vaccine waste for our customers and is manufactured at our zero-waste-to-landfill facility in Asheville, North Carolina.

This new TSG series complies with NSF 456 performance standards, an American national standard that helps ensure storage equipment performs as intended to preserve the viability of vaccine doses. Compliance requires that vaccine storage equipment is tested against a rigorous protocol for construction and performance. The TSG series achieves this through optimum temperature performance, enhanced sample security, and an extended warranty doubled over previous models with full parts and labor.

“At Thermo Fisher Scientific, we’ve been providing our customers with cold storage solutions they can rely on for more than 80 years,” said Carlos Sevilla, Vice President and General Manager, Controlled Temperature Technologies. “The TSG Series is cost-effective, reliable, and provides greater energy efficiency and less vaccine waste, enabling our customers to make the world healthier, cleaner and safer.”

TSG Refrigerators also provide a 10% reduction in energy usage from previous models. They are Energy Star, EU F-Gas and U.S. EPA SNAP compliant and designed and constructed sustainably at a zero-waste facility in the U.S., furthering Thermo Fisher’s commitment to achieve Net-Zero Carbon Emissions by 2050.

For detailed product information and to order it now, click here.

*Note: These products are not considered as medical devices and have not been evaluated for use in environment or applications involving the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals.

IRVING, TX – Vizient, Inc. projects a 3.42% increase in hospital pharmaceutical spend in its Summer Pharmacy Market Outlook, released July 31. The overall increase, forecasted for the year beginning January 2024, is being driven by specialty pharmaceuticals and medications in the neurology service line. In addition, the Outlook demonstrates the continued decline in demand for remdesivir, which topped the list of Vizient member spend during the height of the Covid-19 pandemic and has since fallen to No. 13. View the 2023 Summer Pharmacy Market Outlook.

Specialty drugs, which treat high-cost, complex or chronic conditions such as cancer, infectious-, autoimmune-, and pulmonary conditions, continues to see an expansion in the number of medications approved as treatment options. Not only are three of the top five medications in Vizient member spend classified as specialty — including adalimumab (Humira); ustekinumab (Stelara); and denosumab (Prolia, Xgeva) — two specialty oncology medications approved last year are already in the top 100 drugs of Vizient member spend: Teclistimab (Tecvayli) and tebentafusp (Kimmtrak).  The former is used in the treatment of adult patients with relapsed or refractory multiple myeloma; the latter is the only FDA-approved treatment for unresectable or metastatic uveal melanoma.

"Specialty medications overall accounted for 51% of spending in 2022," said Carina Dolan, associate vice president, clinical oncology, pharmacoeconomics & market insights.  "We're advising health systems to ensure their teams are positioned to manage both medical and pharmacy billing nuances of specialty pharmaceuticals, provide support for prior authorizations and patient financial assistance in multiple settings."

Neurology

The neurology service line is experiencing new drug development as well as increases in pricing, driving provider utilization and costs. Ocrelizumab (Ocrevus) has historically been a significant part of the overall Vizient member spend for the treatment of multiple sclerosis and is the seventh top drug by size of projected price increase. However, in December the FDA approved ublituximab (Briumvi), an anti-CD20- monoclonal antibody. With shorter infusion duration and a lower wholesale acquisition cost, it will be the lowest cost monoclonal antibody approved to treat relapsing forms of multiple sclerosis and may help healthcare organizations lower costs.

For migraine treatment, the calcitonin gene-related peptide class (CGRP) has grown over the past few years in spend and in treatment options.  Annual treatment cost of monoclonal antibody CGRP therapy is around $6,900, with a 73% increase in Vizient member spend from April 2021-March 2022 compared with April 2022-March 2023, the uptick indicating greater utilization.

Remdesivir declines in member spend

Since its debut on the top 10 drug list in Vizient member spend in summer 2021, remdesivir, used in the treatment of Covid-19, has reflected the nation's infection rate. While it retains its number one overall ranking in the acute care segment of the market, it has declined 65% in total Vizient member spend from its peak in the January 2022 Pharmacy Market Outlook, when it held the No. 1 spot, representing almost $1 billion in health system spend.

"The total decline in remdesivir spend for our Vizient pharmacy program participants is ultimately due to fewer adults and pediatric patients being treated for Covid-19 across the country," Dolan said. "The decline is good news for patients and the providers that serve them."

Biosimilars watch

The launch of adalimumab biosimilars in January marked the end of a 20-year competition-free period for Humira, an anti-inflammatory, and the top drug in Vizient member spend. There are two approved biosimilars in the market and eight ready to launch by the end of summer. Broad integration into hospital pharmacy formularies is expected six to 12 months following introduction. In oncology, three biosimilar monoclonal antibodies that launched in 2019 – bevacizumab (Avastin), trastuzumab (Herceptin), and rituximab (Rituxan) – have seen a significant uptake in the market.

Biosimilars account for nearly 25% of spend overall as compared to their originator products, the Outlook shows. Currently, there are 40 approved biosimilars with projected savings of $181 billion over the next five years, reaching across multiple services lines, according to the Center for Biosimilars.

Projections in the Vizient Pharmacy Market Outlook are based on the top 85% of Vizient Pharmacy Program participants' aggregated purchasing volume. Vizient is the largest member-driven healthcare performance improvement company in the nation. Learn more about the Vizient Pharmacy Market Outlook.

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/.