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March 10, 2023

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Welcome to the latest edition of the BioLines Weekender...


Right now, there are middlemen in the healthcare system – known as pharmacy benefit managers or PBMs – playing a significant role in how Patients access and afford their prescription medications. While they operate with little to no transparency, these PBMs contribute to lower levels of treatment adherence and worse healthcare outcomes for Patients living with complex conditions such as autoimmune diseases, HIV and cancer.

 

In a new BioNJ guest blog, Molly Murray, President & CEO of the Autoimmune Association, shines a light on the largely behind-the-scenes role that these middlemen play in driving up Patient out-of-pocket costs. Through deceptive practices, PBMs are turning significant profits as many Patients struggle to afford the treatments they need to manage and treat their conditions.

 

“With more than 7% of all Americans living with an autoimmune disease, addressing access and affordability challenges created by PBMs benefits not only Patients living with these conditions, but also the broader healthcare system, the economy and society as a whole.” ~Molly Murray, President & CEO, Autoimmune Association

 

Click here to read "Pharmacy Benefit Manager Practices: Creating Barriers to Treatment for Patients Living With Autoimmune Disease."


The 24 million Americans currently living with an autoimmune disease, alongside millions more living with other chronic and complex conditions, rely on prescription medications to manage their symptoms. As lawmakers and regulators seek to ensure that Patients can access and afford these essential medicines, they must turn their focus to addressing the negative impacts of burdensome practices of private insurers and PBMs.


Join BioNJ in our efforts to protect medical innovation and access to life-changing treatments for New Jerseyans and all Americans. Sign up and we’ll send you email opportunities to take action online and in your community. Click here to learn more. Let's make a difference together.



Because Patients Can't Wait®,

Debbie Hart

President and CEO

BioNJ

Welcome New Members

 Learn more at www.BioNJ.org/Membership.

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Upcoming BioNJ Events

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Webinar: What Life Sciences CFOs Need to Know in 2023: A Life Sciences CFO Roundtable 

Register Today!

March 21, 2023

BioNJ's 13th Annual BioPartnering Conference

Register Today!

April 17-21, 2023

BioNJ's HR Conference

Kean University

Save the Date!

June 13, 2023

BioNJ's Manufacturing Briefing

Rutgers University

Save the Date!

September 13, 2023

BioNJ's C-Suite Summit

Bridgewater Marriott

Save the Date!

October 6, 2023

Putting Patients First:

The Value of Medical Innovation

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Insurer and PBM Tactics Are Shifting Higher Costs to Patients With Chronic and Complex Conditions

Health plans are increasingly using deductibles and coinsurance to shift more of the cost of care to chronically ill patients taking brand medicines. As data from IQVIA show, this alarming trend is especially burdensome for patients with cancer, who pay nearly 10X more on average per year for their medicines when they face deductibles and coinsurance versus patients with only fixed copays. Out-of-pocket costs for patients with deductibles and coinsurance are often based on the list price, not the lower price their health plans and PBMs usually pay.

Innovating to Help Patients With Rare Diseases

In America, 25-30 million people, many of them children – live with a rare disease. Rare diseases are conditions that affect fewer than 200,000 people nationwide, and they are often difficult to treat and diagnose. Rare Disease Week serves as a reminder of their many needs and challenges and the work that researchers, clinicians, and our member companies do to bring these patients more advanced treatments. In recent years, we have seen significant progress. Innovations such as monoclonal antibodies and cell and gene therapies are making a huge difference. Since 1983, more than 400 drugs and biologic products for rare diseases have been brought to market, a contrast from the fewer than 10 in the decade before that. 

BioNJ in the News

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5 Women Leading the Way in Biotech


Although regarded as a booming industry, the number of women recruits in biotech, let alone in high-ranking positions, is low. Despite progress over the years, a recent report states that only 34% of executive teams and 20% of CEOs are reported to be women in the biotech industry, with even lower figures for women of color and LGBTQ+ women. Owing to a gender disparity in pay, burnout, biases and a lack of funding for women-led biotech among other challenges, there is potentially a crisis with women more likely to not be retained within the sector. Despite these challenges, women leaders in the biotech sector are emerging stronger and being regarded as role models for those who want to establish a career in biotech research and development. As we celebrate International Women’s Day on March 8, here are five women who are not only making a difference in research and innovation in the biotech industry, but also leading the way and proving that women can really do it all. Congratulations to BioNJ Vice Chair and President and CEO of PsychoGenics Dr. Emer Leahy for making this noteworthy list of women leaders.

ROI Influencers: Power List 2023; Associations & Organizations

There are nonprofits that help serve a particular movement — or commit themselves to

helping other organizations that do. There are associations and organizations that advocate for and help train and lead sectors such as health care, food, banking, accounting, manufacturing, life sciences and many more. And, of course, there are chambers of commerce that serve the state, a particular region or a minority group. No one can do it alone. The heads of these groups aim to provide a guiding hand. Congratulations to BioNJ President and CEO Debbie Hart for being named on ROI-NJ's Influencer List. As cited: "Debbie Hart has her finger on the pulse of the life sciences and pharma industries — still an incredibly important sector of the N.J. economy."

ROI Influencers: Women in Business

It’s 2023. And it’s time to realize: The future is female — and the future already is here. We’re tired of hearing from people who say they can’t find women to run their company, sit on their board, take a top leadership role or even simply be on a panel of thought leaders. It’s shameful. And, once again, with the release of the 2023 ROI Influencers: Women in Business, we’re proving that the state is overflowing with qualified female leaders who are ready, willing and eager to do all of the above. Congratulations to BioNJ President and CEO Debbie Hart and Vice President, Innovation and Entrepreneurship Pavita Howe for being honored on ROI-NJ's Influencers list.

BioNJ Announces Details for Upcoming BioPartnering Conference

BioNJ revealed more details for its 13th Annual BioPartnering Conference, which returns in person after three years April 18 at The Palace at Somerset Park. The event brings together stakeholders throughout the life sciences sector with a robust schedule that BioNJ says is designed to foster productive partnerships, create meaningful opportunities, grow the life sciences ecosystem, and bolster medical innovation. “We’re thrilled to partner once again with J.P. Morgan and Johnson & Johnson Innovation on BioNJ’s BioPartnering Conference, and are ecstatic to have Morgan Lewis join this elite group of Conference Partners for 2023,” said Debbie Hart, President and CEO, BioNJ. The conference will offer networking opportunities, one-on-one partnering, a record number of company and startup pitches, exhibits and plenary sessions, with an impressive roster of industry thought leaders.

NJ Company News

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Celldex Therapeutics Presents Positive Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at AAAAI 2023

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced updated data from the company’s Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Meaningful symptom improvement as measured through the urticaria activity score over 7 days (UAS7) was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels, consistent with the profound and sustained reduction of tryptase associated in these groups. 

Amarin and CSL Seqirus Announce Exclusive License and Distribution Agreement to Commercialize VAZKEPA® (Icosapent Ethyl) in Australia and New Zealand

Bridgewater-based BioNJ Member Amarin Corporation and CSL Seqirus announced that the two companies have entered into an exclusive license and distribution agreement under which Amarin will license exclusive rights to VAZKEPA to CSL Seqirus to secure pricing and reimbursement and commercialize the product across Australia and New Zealand. “CSL Seqirus’ highly experienced market access and commercialization teams in Australia and New Zealand are well-positioned to support the pricing and reimbursement efforts, particularly with their strong record in successfully supporting pharmaceutical benefits listings, and eventual marketing and promotion for VAZKEPA and help us to deliver this important medicine to patients in these countries,” said Karim Mikhail, President & CEO, Amarin. 

Mitsubishi Tanabe Pharma America Announces 48-Week Results from Global, Open-Label, Phase 3 Trial of RADICAVA ORS® (edaravone) in ALS

Jersey City-based BioNJ Member, Mitsubishi Tanabe Pharma America announced the publication of results from the global, multi-center, open-label, Phase 3 clinical trial (MT-1186-A01) evaluating the long-term safety and tolerability of RADICAVA ORS® (edaravone) in the treatment of amyotrophic lateral sclerosis (ALS) over 48 weeks of treatment. Results from the study, which was completed in March 2022, showed RADICAVA ORS was generally well tolerated during the treatment period, with no new safety signals identified. Study findings were published in Muscle & Nerve. Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA, said, “These data build upon the study’s 24-week findings that supported the FDA approval of RADICAVA ORS and underscore our commitment to growing our body of knowledge regarding the use of this treatment in people with ALS.”

Completed XTEND-Kids Phase 3 Study Strengthens Potential of ALTUVIIIO™ to Redefine Expectations for Treatment of Children <12 Years of Age With Hemophilia A

Bridgewater-based BioNJ Member Sanofi announced the XTEND-Kids Phase 3 pivotal study evaluating the safety, efficacy and pharmacokinetics of ALTUVIIIO as once-weekly prophylaxis in previously treated patients <12 years of age with severe hemophilia A met its primary endpoint of safety, with no FVIII inhibitors detected in 74 children, with more than 50 children experiencing at least 50 exposure days, nearly a full year of treatment. The completion of XTEND-Kids represents the final milestone needed for regulatory submission in the EU. ALUTVIIIO is a first-in-class, high-sustained FVIII therapy approved by the U.S. Food and Drug Administration (FDA) for routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in adults and children in February 2023. 

For Sanofi, Move to Morristown is Commitment to its Workforce — and N.J.

Calling it a more collaborative and digitally connected workspace that will help improve engagement and innovation — and do it in an environment conducive to a hybrid workforce — officials at BioNJ Member Sanofi celebrated the announcement that the company is moving 1,900 employees from Bridgewater to M Station in Morristown. “The relocation of Sanofi’s flagship location within New Jersey gives us the opportunity to provide our people with more collaborative and digitally connected workspaces,” the company said in a statement. “This exciting move will allow us to improve our engagement, innovation and patient-centered solutions, while incorporating our flexible work environment. Sanofi also said the move shows the company’s commitment to New Jersey. “Sanofi has long been an integral part of New Jersey’s vibrant life sciences industry, and our continued investment with these two new, modernized workspaces reaffirms our commitment to the state,” it said.

Dupixent® (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Accepted for FDA Review

The U.S. Food and Drug Administration (FDA) has accepted, for review, the supplemental Biologics License Application (sBLA) for Bridgewater-based BioNJ Member Sanofi’s Dupixent® (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22, 2023. CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin. CSU is typically treated with H1 antihistamines, medicines that target histamine-1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled in up to 50% of patients, who are left with limited alternative treatment options.

Aflibercept 8 mg BLA for Treatment of Wet Age-Related Macular Degeneration and Diabetic Macular Edema Accepted for FDA Priority Review

BioNJ Member Regeneron Pharmaceuticals, with a site in Basking Ridge, announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg for treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy. The FDA target action date is June 27, 2023 following the use of a priority review voucher. The BLA is supported by positive data from two pivotal trials – PULSAR in wAMD and PHOTON in DME. In both trials, patients treated with aflibercept 8 mg (PULSAR n=673; PHOTON n=491) met the primary endpoint of non-inferiority in vision gains for both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to patients treated with an EYLEA® (aflibercept) Injection (PULSAR n=336; PHOTON n=167) 8-week dosing regimen. 

Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults With Ultra-rare CHAPLE Disease Accepted for FDA Priority Review

BioNJ Member Regeneron Pharmaceuticals, with a site in Basking Ridge, announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a treatment for adults and children as young as 1 year of age with CHAPLE disease (also known as CD55 deficiency with Hyperactivation of complement, Angiopathic thrombosis and Protein Losing Enteropathy or CD55-deficient protein-losing enteropathy). There are currently no approved treatments for CHAPLE, an ultra-rare and life-threatening hereditary immune disease driven by an overactivation of the complement system. Pozelimab is an investigational fully human monoclonal antibody designed to block the activity of complement factor C5, a protein involved in complement system activation. 

Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients With Polymyalgia Rheumatica

BioNJ Member Regeneron Pharmaceuticals, with a site in Basking Ridge, BioNJ Member Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. The FDA evaluated the Kevzara application for PMR under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Kevzara was previously approved for the treatment of moderately-to-severely active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

Libtayo® (cemiplimab) in Combination With Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)

BioNJ Member Regeneron Pharmaceuticals, with a site in Basking Ridge, announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Libtayo® (cemiplimab) in combination with platinum-based chemotherapy. Specifically, the CHMP recommended the Libtayo combination be approved in the European Union (EU) for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation. The European Commission is expected to make a final decision on the application in the coming months. 

Bristol Myers Squibb Named to 2023 World’s Most Innovative Companies List

BioNJ Member Bristol Myers Squibb has been named to Fast Company magazine’s 2023 list of the World’s 50 Most Innovative Companies, a ranking that recognizes businesses that are reshaping industries and culture. BMS was recognized by Fast Company for its success in developing novel treatments and investing millions of dollars in clinical trial equity efforts. The company, which has research and development facilities in Lawrenceville and New Brunswick, had three drugs approved by the FDA in 2022: Opdualag, a first-line treatment for advanced melanoma; Camzyos, a first-in-class cardiac drug for symptomatic obstructive hypertrophic cardiomyopathy; and Sotyktu, the first new oral treatment for moderate-to-severe plaque psoriasis in nearly 10 years. 

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the Type II Variation Marketing Authorization Application (MAA) for Opdivo® (nivolumab) as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. In the U.S., the FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023. In Europe, the EMA’s validation of the application confirms the submission is complete and begins the start of the EMA’s centralized review process. 

Bristol Myers Squibb Receives European Commission Approval of Reblozyl® (luspatercept) for Anemia in Adult Patients With Non-Transfusion-Dependent Beta Thalassemia

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has granted full Marketing Authorization for Reblozyl® (luspatercept), a first-in-class therapeutic option, for treatment in adult patients of anemia associated with non-transfusion-dependent (NTD) beta thalassemia. Reblozyl is currently approved in the European Union (EU), United States and Canada to address anemia associated with transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes. The centralized Marketing Authorization approves use of Reblozyl in all EU member states, as well as Norway, Iceland and Liechtenstein. The EC approval of Reblozyl was based on results from the Phase 2 BEYOND study, evaluating the efficacy and safety of Reblozyl versus placebo in 145 adults with NTD beta thalassemia. 

The Bristol Myers Squibb-Janssen Collaboration Launches Pivotal Phase 3 Librexia Clinical Trial Program Evaluating Milvexian, an Investigational Oral Factor XIa Inhibitor

Princeton-based BioNJ Member Bristol Myers Squibb in collaboration with BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the launch of the Phase 3 Librexia program studying milvexian, an investigational oral factor XIa (FXIa) inhibitor (antithrombotic). The Librexia program is unrivaled as the most comprehensive FXIa development program to date and will provide important data from nearly 50,000 patients across three indication-seeking studies: Librexia STROKE, Librexia ACS and Librexia AF. Enrollment has begun for the Librexia STROKE trial, which is evaluating milvexian in addition to standard of care antiplatelet therapy for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack. 

New STELARA® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced final pooled long-term safety results for STELARA® (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease (CD) and four years in adults with moderately to severely active ulcerative colitis (UC), as well as final four-year clinical and endoscopic outcomes from the UNIFI long-term extension (LTE) study evaluating the efficacy of STELARA for the treatment of adults with moderately to severely active UC. “These data reinforce the known efficacy and safety profile of STELARA, and demonstrate it can be an effective long-term treatment option for patients living with moderately to severely active ulcerative colitis,” said Waqqas Afif, M.D., Associate Professor, Department of Medicine, Division of Experimental Medicine and Division of Gastroenterology at McGill University Health Centre in Montreal, Canada

Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients With BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for AKEEGA® (niraparib and AA), in the form of a DAT, given with P or prednisolone, for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Niraparib is a highly selective poly adenosine diphosphate-ribose polymerase (PARP) inhibitor. Together with AA, a cytochrome P450 17α-hydroxylase (CYP17) inhibitor, the combination DAT regimen targets two oncogenic drivers (mutations responsible for both the development and maintenance of prostate cancer) in patients with mCRPC, namely androgen receptor axis (AR-axis) and BRCA1/2 gene mutations. 

New VOYAGER PAD Analysis Confirms Consistent Benefit of XARELTO® (rivaroxaban) Plus Aspirin Following Lower Extremity Revascularization (LER)

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of the VOYAGER PAD study showed XARELTO® plus aspirin resulted in a 33 percent reduction in acute limb ischemia and a 15 percent reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT). 

Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics Versus Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase 3 A DUE study (NCT03904693), which showed an investigational once-daily, single tablet combination therapy, also known as fixed dose combination, of macitentan 10 mg and tadalafil 40 mg (M/T STCT), significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in pulmonary arterial hypertension (PAH) patients with World Health Organization (WHO) functional class (FC) II or III. PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure. 

Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients With Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alteration. “The data supporting this submission reinforce the importance of biomarker testing to identify the subgroups of patients that are most likely to respond to a targeted treatment option,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. 

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Advanced Malignant Pleural Mesothelioma

Rahway-based BioNJ Member Merck & Co. and the Canadian Cancer Trials Group (CCTG) announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. IND.227 was sponsored by CCTG, in collaboration with investigators in Italy (co-sponsored by National Cancer Institute of Naples - NCIN), and France (co-sponsored by The French Cooperative Thoracic Intergroup - IFCT); Merck provided KEYTRUDA and support for the trial. At the final analysis of the study, KEYTRUDA plus chemotherapy showed a statistically significant and clinically meaningful improvement in OS compared to chemotherapy alone in these patients. 

U.S. FDA Approves Intramuscular Administration for Merck’s MMRV Family of Vaccines: M-M-RII (Measles, Mumps, and Rubella Virus Vaccine Live), VARIVAX (Varicella Virus Vaccine Live), and ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved the addition of the intramuscular (IM) route of administration to the United States Product Insert (USPI) for Merck’s MMRV family of vaccines: M-M-R®II, VARIVAX®, and ProQuad®. While these vaccines have a long history in the U.S., until now they have only been administered via subcutaneous (SC) injection. “Building on our history of innovation in the world of vaccines, we’re proud to introduce another method of administration for M-M-R®II, VARIVAX®, and ProQuad® vaccines, which have been important in the fight against measles, mumps, rubella, and varicella in the U.S.,” said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. 

Merck’s Investigational Activin Signaling Inhibitor Sotatercept Improved Six-Minute Walk Distance by 40.8 Meters at Week 24 Versus Placebo in Adults With Pulmonary Arterial Hypertension on Background Therapy

Rahway-based BioNJ Member Merck & Co. announced full results from the Phase 3 STELLAR trial, which evaluated sotatercept, Merck’s novel investigational activin signaling inhibitor biologic, in combination with stable background therapy for the treatment of adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1). Sotatercept significantly improved exercise capacity, increasing 6-minute walk distance (6MWD) by 40.8 meters (95% CI, 27.5-54.1; p<0.001) from baseline at week 24, the study’s primary endpoint. “The results from the Phase 3 STELLAR trial are immensely important to physicians and patients and highlight the critical role sotatercept may play in improving exercise capacity and other meaningful clinical outcome measures for patients with PAH,” said Dr. Dean Y. Li, President, Merck Research Laboratories. 

Merck’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients With Hypercholesterolemia in Phase 2b Study

Rahway-based BioNJ Member Merck & Co. announced results from the Phase 2b clinical trial evaluating MK-0616, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in adults with hypercholesterolemia. The primary objective of the study was to evaluate the percent change in low density lipoprotein cholesterol (LDL-C) from baseline to week 8 for 4 doses of MK-0616 (6, 12, 18 and 30 mg) versus placebo. At week 8, all doses of MK-0616 significantly reduced LDL-C compared to placebo and the placebo-adjusted reduction from baseline ranged from 41.2% (6 mg, CI 95%, -47.8 to -34.7; p <0.001) to 60.9% (30 mg, 95% CI, -67.6 to -54.3; p<0.001). MK-0616 was generally well-tolerated at all 4 doses studied. 

Merck Announces Phase 3 KEYNOTE-671 Trial Met Primary Endpoint of Event-Free Survival (EFS) in Patients With Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer

Rahway-based BioNJ Member Merck & Co. announced that the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints, event-free survival (EFS), as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). A perioperative treatment regimen includes treatment before surgery (neoadjuvant) and continued after surgery (adjuvant). The trial will continue to evaluate the other dual primary endpoint of overall survival (OS). At a prespecified interim analysis conducted by an independent Data Monitoring Committee, neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant single-agent KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in EFS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo. 

Merck and AstraZeneca Provide Update on U.S. Regulatory Review of LYNPARZA® (olaparib) for Use in Combination With Abiraterone and Prednisone or Prednisolone for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Rahway-based BioNJ Member Merck & Co. and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for use of LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The sNDA is based on the results of the Phase 3 PROpel trial. LYNPARZA in combination with abi/pred is approved in the European Union and several other countries for the treatment of adult patients with mCRPC, based on the PROpel trial.

Lilly Cuts Insulin Prices by 70% and Caps Patient Insulin Out-of-Pocket Costs at $35 Per Month

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month. Lilly is taking these actions to make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system that may keep them from getting affordable insulin. "While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change," said David A. Ricks, Lilly's Chair and CEO. 

Intensive Education at Clinics About Multidisciplinary Care Improved Likelihood That Adults With Type 2 Diabetes and Cardiovascular Disease Were Receiving Guideline-Directed Medicines, According to Real-World Study

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that providing clinics with a coordinated, multifaceted intervention, with assessment of barriers, care pathways and feedback, improved the likelihood that adults with type 2 diabetes and cardiovascular disease were receiving guideline-directed medical therapy after one year versus usual care. The results, from COORDINATE-Diabetes (COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs), were published in Journal of the American Medical Association. COORDINATE-Diabetes is led by the Duke Clinical Research Institute (DCRI) and funded by BioNJ Members Boehringer Ingelheim and Eli Lilly and Company.

U.S. FDA Broadens Indication for Verzenio® (abemaciclib) in HR+, HER2-, Node-Positive, High Risk Early Breast Cancer

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Verzenio® (abemaciclib), in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at a high risk of recurrence. High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade (4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3). This expanded adjuvant indication removes the Ki-67 score requirement for patient selection.

U.S. FDA Accepts Supplemental New Drug Application for Jardiance® for Children 10 Years and Older With Type 2 Diabetes

BioNJ Members Eli Lilly and Company, with a site in Branchburg, and Boehringer Ingelheim, with a site in North Brunswick, announced the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes. “There are clear unmet needs for young people living with type 2 diabetes, which has nearly doubled in prevalence in people aged 10-19 over the past two decades," said Mohamed Eid, M.D., M.P.H., M.H.A., Vice President, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals. 

U.S. FDA Advisory Committee Votes to Support Effectiveness and Safety of GSK’s Respiratory Syncytial Virus Older Adult Vaccine Candidate

Warren-based BioNJ Member GSK announced that the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and effectiveness of GSK’s respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety. The Committee based its vote on the robust data package supporting the vaccine candidate. This includes results from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase III trial, recently published in the New England Journal of Medicine. 

Pfizer Receives Positive FDA Advisory Committee Votes Supporting Potential Approval for Vaccine Candidate to Help Combat RSV in Older Adults

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that available data is adequate to support the safety and effectiveness of its respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF. The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness. The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older. The VRBPAC based its recommendation on the scientific evidence shared by Pfizer, including interim data from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease). 

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years

BioNJ Member Pfizer, with a site in Peapack, and BioNTech, announced they have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a booster (fourth) dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years). The Omicron BA.4/BA.5-adapted bivalent vaccine is currently authorized as the third dose of the three-dose primary series for children in this age group. Authorization of a booster dose would give families the option to further protect their young children against more recently circulating Omicron sublineages.

EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. Edison announced that the European Patent Office has granted European Patent No. EP 3886813, covering the innovative formulation of Helion’s lead cyclophilin inhibitor, rencofilstat. The newly granted European patent also significantly extends the time period of Hepion’s patent exclusivity for rencofilstat. The company’s original composition-of-matter patent estate, comprising 52 patents issued in every major market throughout the world, are expected to provide exclusivity to 2036. The newly granted rights, which will encompass 38 European countries, are expected to extend the drug candidate’s patent life by approximately eight years, to 2044. In addition to the indications covered in the original composition-of-matter patents (viral, cardiovascular, neurological and inflammatory diseases), Hepion has also filed various method-of-use patent applications covering a variety of additional indications (fibrosis, cancer and thrombosis).

Biologics License Application for LECANEMAB Designated for Priority Review by China National Medical Products Administration

Nutley-based Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened. In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022. 

ENHERTU® Approved in China for Patients With HER2 Positive Metastatic Breast Cancer Treated With One or More Prior Anti- HER2-Based Regimens

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval by China’s National Medical Products Administration (NMPA) is based on the results of the DESTINY-Breast03 Phase 3 trial, where ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1) (hazard ratio [HR] = 0.28; 95% confidence interval [CI]: 0.22-0.37; p<0.000001) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. 

ENHERTU® Showed Clinically Meaningful and Durable Responses Across Multiple HER2 Expressing Tumor Types in DESTINY- PanTumor02 Phase 2 Trial

Basking Ridge-based Daiichi Sankyo announced positive topline results from an analysis of the ongoing DESTINY-PanTumor02 Phase 2 trial showed treatment with Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) met the pre-specified target for objective response rate (ORR) and demonstrated durable response across multiple HER2 expressing advanced solid tumors in heavily pre-treated patients. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The DESTINY-PanTumor02 Phase 2 trial is evaluating the efficacy and safety of ENHERTU in patients with previously-treated locally advanced, unresectable or metastatic HER2 expressing solid tumors not eligible for curative therapy, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and rare cancers.

Dr. Reddy’s to Acquire Mayne Pharma’s U.S. Generic Prescription Product Portfolio for $105M

Princeton-based Dr. Reddy’s Laboratories announced it will acquire the U.S. generic prescription product portfolio of Mayne Pharma Group Ltd. for $105 million, which includes an upfront payment of around $90 million in cash and contingent payments of up to $15 million. The portfolio includes approximately 45 commercial products, four pipeline products and 40 approved nonmarketed products, including a number of generic products focused on women’s health. Dr. Reddy’s said the approved high-value products include a hormonal vaginal ring, a birth control pill and a cardiovascular product. The acquisition will complement Dr. Reddy’s U.S. retail prescription pharmaceutical business with limited competition products. It also supports Dr. Reddy’s efforts to accelerate and expand affordable medications for patients.

Bellerophon Therapeutics Announces $5 Million Registered Direct Offering

Warren-based Bellerophon Therapeutics, Inc. announced that it has entered into a subscription agreement with a life sciences-focused institutional investor to sell, in a registered direct offering, 718,474 shares of common stock at a price of $2.00 per share and 1,781,526 prefunded warrants at a price of $1.99 per pre-funded warrant for total gross proceeds of approximately $5 million, before deducting estimated offering expenses. The company intends to use the proceeds of this $5 million offering to complete the company’s REBUILD Phase 3 study and for working capital and general corporate purposes. The REBUILD study is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical trial evaluating the safety and efficacy of pulsed inhaled nitric oxide (iNO) in patients at risk for pulmonary hypertension associated with pulmonary fibrosis on long-term oxygen therapy. 

Sun Pharma Completes Acquisition of Concert Pharmaceuticals

Sun Pharmaceutical Industries, with a site in Princeton, announced the successful completion of its acquisition of Concert Pharmaceuticals, Inc., a late-stage clinical biopharmaceutical company that is developing deuruxolitinib, a novel, deuterated, oral JAK1/2 inhibitor, for the potential treatment of adult patients with moderate to severe alopecia areata. “We are excited to add deuruxolitinib, a late-stage, potential best-in-class treatment for alopecia areata, to our growing global dermatology portfolio,” said Abhay Gandhi, CEO North America, Sun Pharma. “By bringing together Concert’s talented team with Sun Pharma’s global reach and commercial capabilities, this acquisition is an opportunity to bring deuruxolitinib to market globally and make a meaningful difference to alopecia areata patients around the world.”

Bayer Fund Awards More than $13M to Nonprofits

Bayer Fund, a philanthropic arm of Bayer in the U.S., has provided a total of $5.2M in grant funding, spanning across 600 organizations, in the second half of 2022. This latest round of grants raised Bayer Fund’s 2022 giving total to more than $13.4 million across 2,700 charitable and nonprofit organizations to help address essential needs in Food and Nutrition, STEM Education and Health & Wellness. “Each Bayer Fund grant goes towards programs that help solve some of the country’s – and world’s – biggest challenges, including access to food and nutrition, STEM education and health and wellness. Bayer Fund is excited to give back to communities by providing funding that helps strengthen organizations through impactful programs that align with our primary giving priorities,” said Al Mitchell, President, Bayer Fund.

Gates Foundation Awards Zoetis $15.3M for Livestock-Health Initiative

The Bill & Melinda Gates Foundation awarded Parsippany-based animal health company Zoetis a $15.3 million grant to further advance veterinary care and diagnostic services to improve livestock health and productivity in Sub-Saharan Africa. The funding will support the company’s new five-year African Livestock Productivity and Health Advancement Plus (A.L.P.H.A. Plus) initiative, an expansion of Zoetis’ original A.L.P.H.A. program, which launched in 2017. The goal of the expanded program – part of the company’s Driven to Care commitments – is to improve veterinary health and food security, focusing on dairy and beef production, poultry and aquaculture in Ethiopia, Nigeria, Tanzania, Uganda, as well as seven additional markets including Kenya, Ivory Coast and others in West, East and Central Sub-Saharan Africa.

Elevar Therapeutics Moves Corporate HQ to Fort Lee from Utah

Elevar Therapeutics has relocated its headquarters from Salt Lake City to Fort Lee. The fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients said the move comes as it prepares to file a New Drug Application with the U.S. Food and Drug Administration for rivoceranib. Elevar and its parent company, HLB, are developing rivoceranib in combination with Hengrui Pharma’s PD-1, camrelizumab, as a treatment option for hepatocellular carcinoma, the most common type of liver cancer. “Elevar is excited to debut our U.S. headquarters in New Jersey as we move closer to an NDA for rivoceranib in combination with camrelizumab as a treatment option for patients with unresectable HCC,” Saeho Chong, CEO of Elevar, stated. “Now is the right time to make this move, establishing Elevar’s presence amid some of the biggest pharmaceutical companies in the world, and some of the best talent.”

Approval of Incentives to Bring Woman-Led Company EpiBone to Jersey City

The Board of the New Jersey Economic Development Authority approved EpiBone, Inc. to receive up to $3.5 million over seven years in Emerge tax credits to secure the Brooklyn-based biotechnology company’s commitment to move to Jersey City, where it expects to create 90 full-time jobs. The project is expected to yield a net benefit greater than 300 percent to the state over its 11-year commitment period. EpiBone grows bone and cartilage for skeletal reconstruction using stem cells to create new healthy bone, cartilage and compound (bone and cartilage) products in a lab. EpiBone is a clinical stage company with one product in clinical trials, and two products in various phases of clinical development, requiring it to take on additional space, including a clean room, and hire more support staff.

People in the News

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Novo Nordisk Announces Changes in Executive Management

Plainsboro-based BioNJ Member Novo Nordisk announced the following changes in Executive Management. Monique Carter, Executive Vice President (EVP), Global People & Organization, has decided to leave Novo Nordisk to pursue an external opportunity, allowing her to be closer to her family in the UK. Tania Sabroe is promoted to EVP, Global People & Organization, and will join Executive Management with immediate effect, succeeding Monique Carter. Tania Sabroe joined Novo Nordisk in August 2007 and comes from a position as SVP in Global People & Organization. Dave Moore is promoted to EVP, Corporate Development and will join Executive Management. Dave Moore joined Novo Nordisk in September 2022 as SVP for Corporate Development with the responsibility for strategy and business development. 

ESG Best Practices

Board Governance Structures and ESG

Written by BioNJ Member Deloitte | As published in NACD’s ‘Directorship' magazine, 2023 Governance Outlook

Companies are facing increasing pressure to manage a growing range of risks as a result of rapidly evolving environmental, social and governance (ESG) issues. Climate-related factors have gained a great deal of attention among ESG matters, but the scope of ESG is much broader, including social aspects of a company’s relationships with its stakeholders and a growing demand for effective governance and transparency. As disruptive forces accelerate change and elevate expectations, many companies are facing challenges in protecting and promoting a sense of trust among their stakeholders, safeguarding their brands and reputations and fostering business resilience. The increasing volume and complexity of challenges are causing an increase in the number and variety of issues landing on corporate board agendas.

Funding

CSIT Announces $2.4M+ Awarded Since Small Business Assistance Program Launched

The New Jersey Commission on Science, Innovation and Technology (CSIT) has awarded a total of $2.425 million in matching grants to more than 80 start-ups since 2020 through its NJ Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Direct Financial Assistance Program. The program supports start-ups that are receiving funding from highly competitive federal research and development (R&D) grant programs as they work toward commercialization. The $2.425 million in funding includes $525,000 that was awarded to 17 start-ups through the program’s fourth funding round.


“This grant program is specifically designed to support the smallest of startups competing in the global marketplace,” said CSIT Chair Debbie Hart. “By helping grantees maximize their federal funds, we are enabling them to scale their operations and focus on commercializing their products. This, in turn, will lead to grantees expanding their presence and creating good paying jobs in the Garden State.”

NJEDA Opening Innovation Fellows Application on March 14

The New Jersey Economic Development Authority (NJEDA) will open the application for the New Jersey Innovation Fellows (NJIF) program on March 14 at 10:00 a.m. This program levels the playing field for first-time entrepreneurs in underrepresented groups looking to start businesses in New Jersey. Start-up groups of three or more members can apply for a two-year grant to help start a business in a targeted industry. The funding is intended to serve as income replacement, which should entice those who would normally be unable to commit full-time efforts to entrepreneurship due to financial constraints. Groups are eligible for $200,000 in funding, which can increase with the inclusion of residents of Opportunity Zones, graduates of New Jersey colleges and universities, as well as females and minority entrepreneurs. The maximum grant awarded will be $400,000.

Academia/Institutions/Incubators

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Rutgers Office for Research Enters Technology Transfer Partnership With New Jersey Association of State Colleges and Universities

In an effort to expand and enhance New Jersey’s research and innovation ecosystem, Rutgers Office for Research’s Innovation Ventures will participate in a technology transfer partnership with the New Jersey Association of State Colleges and Universities (NJASCU). Innovation Ventures, part of the Office for Research (OfR) and responsible for all Rutgers’ technology commercialization and transfer, will provide information and guidance to eight New Jersey state colleges and universities: Kean University, Montclair State University, New Jersey City University (NJCU), Ramapo College, Stockton University, The College of New Jersey (TCNJ), Thomas Edison State University and William Paterson University. The partnership aims to advance these schools’ entrepreneurial efforts for the research conducted on their campuses.

Hackensack Meridian Launches AI-Powered Brain Cancer Treatment

Hackensack Meridian Health and medical tech company Neosoma Inc. are teaming up on artificial intelligence-powered brain cancer treatment and research. The collaboration with the Massachusetts-based company will include clinical data sharing, research and strategic investment from Hackensack Meridian to support Neosoma’s method of imaging, tracking and collecting data on numerous types of brain tumors, including glioblastomas. In September 2022, Neosoma received U.S. Food and Drug Administration 510(k) clearance for its first AI-based neuro-oncology software device, Neosoma HGG (High-Grade Glioma). The technology produces more accurate brain tumor analysis on MRIs, guiding physicians’ treatment decisions. Benefits of the advanced Neosoma technology include helping physicians to better plan procedures, assess post-procedural results, guide chemo and immunotherapy treatments and more. Physicians at Hackensack Meridian JFK University Medical Center in Edison will be the first in the network to use the software in clinical practice and will provide feedback for future versions.  

Rowan, Durin Technologies Design Blood Test for Alzheimer’s Disease That Can Detect it up to 10 Years Before Symptoms


A team of researchers from Rowan-Virtua School of Osteopathic Medicine and Mullica Hill-based Durin Technologies announced the results of a newly designed blood test that can detect the presence of Alzheimer’s disease-related pathology up to 10 years before symptoms arise with a nearly 97% accuracy rate. The study involved 328 blood samples with the goal of determining if a test that monitors a small number of a patient’s autoantibodies can detect Alzheimer’s disease-related pathology at presymptomatic, prodromal (i.e., mild cognitive impairment) and mild-moderate stages of the disease. The research team showed the test, using just eight autoantibody biomarkers, could accurately identify the presence of Alzheimer’s disease pathology across the disease’s progression, including among those originally determined to have no trace of the disease.

Stockton University Appoints Bertolino as Next President

Stockton University Board of Trustees appointed Dr. Joe Bertolino as the university’s next President. He will take office on July 1. Dr. Bertolino is the current President of Southern Connecticut State University and brings more than 30 years of experience in higher education. Prior to joining Southern in 2016, he held roles as President of Lyndon State College in Vermont, Vice President for Enrollment Management and Student Affairs at Queens College/City University of New York, and Dean for Community Development at Barnard College in New York. Stockton has seen a rise in ranking and reputation in recent years, including being named one of the Top 100 Public National Universities in the 2023 U.S. News & World Report College Rankings. Born and raised in Glendora, Dr. Bertolino said he felt he was returning “home” in joining Stockton, where his mother, Eileen, graduated in 1977. 

Thought Leaders

State of New Jersey Manufacturing Industry Report 2023

2023 is a pivotal year for every manufacturing business in the United States. New Jersey manufacturers in particular faced tremendous challenges and overcame incredible odds as they shifted production to offset the damage caused by COVID-19 while supporting the nation as a whole. The 2023 Manufacturing Industry Report is here! You now have access to the latest data and can see for yourself how manufacturing is performing here in the Garden State.

Industry Events

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Use of Academic and Federal Core Research/Lab Facilities in New Jersey

Hosted by Princeton Innovation Center BioLabs | March 14, 2023

Learn how to access NJ academic, federal and nonprofit core labs to accelerate your R&D through the New Jersey Commission on Science, Innovation and Technology (CSIT) voucher programs. The discussion will provide an overview of the CSIT Catalyst R&D Voucher Grant Program, current Voucher projects and other resources from CSIT and the New Jersey Economic Development Authority.

IP & Licensing Basics: A One Day Review

Hosted by LES | March 20, 2023

Whether you are an entrepreneur in the making, a principal investigator or student at any level who wants a better grasp of the basics, or an aspiring technology transfer professional, this course will give you the tools you need to understand and participate effectively in the process of protecting IP and facilitating its commercialization. Delivered over one day, this course consists of 4 modules: IP Basics; IP Commercialization Basics; Licensing Fees & Royalty Rates and Managing Risk.

Stand Up for Science at BIO 2023 Hosted by BIO International Convention

June 5-8, 2023

Stand up for innovation. Stand up for truth. And stand up for science. It’s time to inspire, honor and recognize the true value of the breakthrough work biotech performs for society. Today. And every day. Well into the future. Join the global power players in the biotech and pharma industry at the world's most influential biotech meeting! Sign up for updates to receive everything you need to know about the BIO International Convention.

ON Helix Hosted by One Nucleus

July 6, 2023

This one-day conference will address key bio innovation trends, from developments in life sciences and technology research to their translation into new diagnostics, prevention tools or treatments. Delegates and Supporters will connect with the One Nucleus network to explore New Horizons for Bio Innovation. BioNJ Members enjoy a 10% discount. Contact RBromberg@BioNJ.org for the discount code.

Partner Spotlight

Email DSacco@BioNJ.org to connect you to this partner. 

For more information reach out to Save@BIO.org.

Please contact BioNJ with any questions.

BioNJ@BioNJ.org  | 609-890-3185 | www.BioNJ.org

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