NEW YORK - Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.

“ABRYSVO’s approval as the first and only maternal immunization to help protect newborns immediately at birth through six months from RSV marks a significant milestone for the scientific community and for public health,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available. Today, a long-sought-after goal to deliver a maternal vaccine that will help protect infants six months of age or younger – when they are at greatest risk of possible serious consequences from RSV – has been achieved.”

The FDA’s decision is based on the data from the pivotal Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy), a randomized, double-blinded, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and immunogenicity of the vaccine against LRTD and severe LRTD due to RSV in infants born to healthy individuals vaccinated during pregnancy. These results were published in The New England Journal of Medicine in April 2023.

“Newborns and young infants – whose immune systems are still developing and are not yet strong enough to defend against infections – may now be protected from RSV from the moment of birth through maternal immunization,” said Eric A.F. Simões, M.D., Clinical Professor, Pediatrics-Infectious Diseases, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora. “The approval of Pfizer’s ABRYSVO is a major triumph as it helps ensure no delay in potential RSV protection during an infant’s most vulnerable first six months of life and offers healthcare providers a new opportunity to help prevent severe RSV.”

RSV is a contagious virus and a common cause of respiratory illness worldwide.1 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.2,3,4 The disease burden of RSV in young children is staggering with virtually all children getting an RSV infection by the time they are two years old.5 In the United States, approximately 500,000 to 600,000 infants experience LRTD due to RSV each year and it is a leading cause of hospitalization in children less than one year of age. 6,7

About ABRYSVO

On March 2, 2022, Pfizer announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ABRYSVO for prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women. This decision was followed by the FDA’s acceptance of ABRYSVO’s Biologics License Application (BLA) under priority review for infants in February 2023.

Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as help protect infants through maternal immunization. In May 2023, the U.S. Food and Drug Administration (FDA) approved RSVpreF under the name ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. The approval was followed in June by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) official recommendation for the vaccine for use in adults 60 years of age and older.

In July 2023, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the granting of a marketing authorization for the RSV vaccine candidate, PF-06928316 or RSVpreF, to help protect older adults and infants through maternal immunization from RSV. The CHMP’s positive opinion is being reviewed for each indication by the European Commission (EC). The EC will decide whether to approve RSVpreF, whose European Union (EU) trade name will be ABRYSVO.

In February 2023, Pfizer Japan announced an application was filed with the Ministry of Health, Labor and Welfare for RSVPreF as a maternal immunization to help protect infants against RSV. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV.

Pfizer has initiated two additional clinical trials evaluating ABRYSVO. One trial is being conducted in children at higher risk for RSV disease ages 2-<18.8 A second trial is evaluating adults ages 18-60 at higher risk for RSV due to underlying medical conditions, such as asthma, diabetes and COPD, and adults ages 18 and older who are immunocompromised and at high-risk for RSV.8 Pfizer also plans post-marketing studies and surveillance programs to further describe the safety of the vaccine.

INDICATIONS FOR ABRYSVO

ABRYSVO^TM is a vaccine indicated for:

• the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
• pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

IMPORTANT SAFETY INFORMATION FOR ABRYSVO

• ABRYSVO should not be given to anyone with a history of severe allergic reaction (eg, anaphylaxis) to any of its components
• For pregnant individuals: to avoid the potential risks of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
• Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
• Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
• Vaccination with ABRYSVO may not protect all people
• In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain
• In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, nausea
• In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo

View the full Prescribing Information. If maternal immunization details are not currently available via this link, it will be visible as soon as possible as we work to finalize the document. Please check back for the full information shortly.

OAKLAND, CA - Blue Shield of California today announced a new pharmacy care model that is designed to fix problems in today's broken prescription drug system. The nonprofit health plan is transforming how medications are purchased and supplied to its 4.8 million members by selecting organizations that share Blue Shield's vision for more affordable and transparent pharmacy services.

Today's announcement is a major milestone in Blue Shield's Pharmacy Care Reimagined initiative, which will help provide its members with convenient, transparent access to medications while lowering costs. Once Blue Shield's multi-year strategy is fully implemented, the health plan expects to save up to $500 million in annual drug costs.

Most American adults take at least one prescription drug annually, with more than a third of adults taking at least three medications per year. Already a significant cost, total prescription drug spend in the United States is consistently rising. In 2021, the American healthcare system spent more than $600 billion on prescription drugs – about $1,500 per person, per year.

The current pharmacy care system rewards some stakeholders for selling more drugs at higher costs. Blue Shield is seeking to transform the system into a value-based model that provides members with the medications they need at a more affordable cost.

"The current pharmacy system is extremely expensive, enormously complex, completely opaque, and designed to maximize the profit of participants instead of the quality, convenience and cost-effectiveness for consumers," said Paul Markovich, president and CEO of Blue Shield of California. "That is why we are working with like-minded partners to create a completely new, more transparent system that gets the right drugs to the right people at the right time at a substantially lower cost."

WEST COLUMBIA, SC - Nephron Pharmaceuticals Corporation today announced Julie Rameas as Chief Procurement Officer. In her new role, Rameas will oversee all strategic sourcing and procurement activities.

"We could not be more excited to welcome Julie to the team. Her rock star resume and body of work speaks for itself," said Nephron CEO and Owner Lou Kennedy. "From leading manufacturers to global success to blazing trails in textiles, Julie is precisely the kind of professional, who will help lead the continued growth and expansion of our company, and that is a great thing for those who depend on Nephron for life-saving medications."

Rameas is an experienced professional with proven success in the pharmaceutical, medical device, metal, electronic, aerospace, automotive, and textile manufacturing industries.

Before joining the Nephron team, Rameas served as Senior Director of Global Strategic Procurement at Thermo Fisher Scientific, where she led spending activities for over 800 global sites, and managed multiple global expansion and construction projects.

She has held key global director roles at Lear Corporation, managing all aspects of global strategic procurement activity for seven manufacturing sites, and BioMerieux, where she led spending on all chemicals, biologics and controlled substances.

Rameas received her Bachelor of Science in chemistry from Indiana University of Pennsylvania.

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes, luer-lock vials, IV bottles and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. For more information, please visit www.nephronpharm.com.

FALLS CHURCH, VA - Response Pharmaceuticals, Inc. today announced the successful completion of its Phase 1B clinical trial for the company's lead drug candidate, RDX-002, a first-in-class inhibitor of intestinal microsomal triglyceride transfer protein (iMTP). While full results are being analyzed, RDX-002 was generally well tolerated, and the study met its primary objective. The company is working with its scientific team and advisory board to complete the data analysis and prepare the final full results.

Response Pharmaceuticals' Phase 1B trial was a 2-week open-label study in antipsychotic-naïve, healthy volunteers. All subjects were initially treated with olanzapine, a widely used anti-psychotic with a well-documented side effect of weight gain, for one week, before one cohort continued to receive olanzapine alone and the second cohort received RDX-002 and olanzapine. The study's primary objective was to measure the effect of RDX-002 on postprandial triglyceride levels. The study's results will be used to direct the design of a robust Phase 2 study where RDX-002 will be co-administered in patients with schizophrenia initiating treatment with olanzapine.

"We are extremely excited about completing this first clinical trial of RDX-002 for the indication of antipsychotic-induced weight gain. This serious side effect is commonly observed with multiple antipsychotic drugs which treat debilitating mental diseases and often results in non-compliance with treatment." said Chief Medical Officer Bill Sasiela, who continued "Intestinal MTP is an exciting therapeutic target with potential to address unmet needs in a wide range of metabolic indications. We are extremely pleased that we have met our primary objective in this first trial and are working to complete analysis of the complete data package."

The Company expects to be able to report complete trial results and Phase 2 development plans in September 2023.

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.