Global Trends in R&D 2022 (Overview Through 2021)

This report assesses the trends in new drug approvals and launches, overall pipeline activity in terms of actively researched medicines, and the number of initiated clinical trials. It also profiles the state of R&D funding and the activity of companies of different types, and the results of research are compared to the input effort in a Clinical Development Productivity Index. The notable acceleration and adaptability of the innovation ecosystem is examined in terms of several accelerators of the innovation cycle, including dramatic reductions in so-called white space within clinical development timelines that have been achieved for COVID-19 vaccines and other medicines and suggests the kinds of optimization to expect in the future.

What If Groundbreaking Medicines Never Existed?

New research from the National Pharmaceutical Council (NPC) and RTI Health Solutions examines what patient health gains might have been lost without the introduction of influential drugs for six diseases: ischemic heart disease, lung cancer, breast cancer, HIV infection, type 2 diabetes, and rheumatoid arthritis. The study shows how major drug innovations changed the trajectory of patient outcomes for these diseases between 1990 and 2017. Because there is limited condition-related mortality associated with rheumatoid arthritis, the NPC-RTI study looked at functional ability for this condition, finding an 11.5% improvement in functional status per patient and a total of 50,600 quality-adjusted life years gained in the U.S. Policymakers should recognize the value of innovation in improving patient health and broaden their focus to consider spending on all health care services, not just drugs, in order to increase in health system efficiency. 

BioNJ Elects Board Officers and Trustees

BioNJ, the life sciences trade association for New Jersey, announced the election of its 2022 Officers and Board Members. The election preceded BioNJ's Annual Board Meeting on Wednesday, February 2, 2022. Re-elected Officers include Chair Will Lewis, J.D., MBA, Chair and CEO, Insmed; Vice Chair Angela Bechan, Vice President, Head of Communications & Corporate Social Responsibility North America, Sanofi; and Secretary Michele Korfin, R.Ph., MBA, Chief Operating Officer & Chief Commercial Officer, Gamida Cell. Newly elected was Treasurer Jeffrey A. Nau, Ph.D., M.M.S., President and CEO, Oyster Point Pharma. See the full list here.

The 2022 NJBIZ Power 100

COVID-19 pandemic has dominated public life in New Jersey for nearly two years. Businesses and government agencies at all levels have been forced to account for the virus before making nearly any decision. And with good reason – halting the pandemic was the most important task to not only protect public health but also to keep the economy growing. Is it time now to look beyond COVID-19 and consider what the state’s priorities should be in a post-pandemic world? The answer, as readers should see reflected in the latest NJBIZ Power 100 list, is a cautious yes. Congratulations to BioNJ President and CEO, Debbie Hart, as well as these BioNJ Members, for making the list: Tom Bracken, New Jersey Chamber of Commerce; Robert Davis, Merck; Joaquin Duato, Johnson & Johnson; Dale Florio, Princeton Public Affairs Group; Perry Halkitis, Rutgers School of Public Health; Jonathan Holloway, Rutgers University; Robert Garrett, Hackensack Meridian Health; Carl Goldberg, Rutgers Business School; Thomas Kendris, Novartis; Teik Lim, NJIT; Patrick Murray, Monmouth University; George Norcross, Conner Strong & Buckelew; Christopher Porrino, Lowenstein Sandler; Aaron Price, TechUnited New Jersey; Michele Siekerka, New Jersey Business and Industry Association; Gary Small, Hackensack University; Brian Strom, Rutgers School of Biomedical and Health Sciences; Tim Sullivan, NJEDA; and Michael Tardugno, Celsion Corporation.

ROI Influencers: Power List 2022

The Power List is our annual kickoff to our Influencer lists. It obviously is meant to recognize the top people overall — and in 14 individual categories. Since we are a business journalism platform, the list is meant to recognize those who are most influential in the business world. Because the State’s business community is so closely tied to government, there are plenty of elected (and appointed) government officials, too. Congratulations to BioNJ President and CEO, Debbie Hart, as well as these BioNJ Members, for making the list: Guillermo Artiles, McCarter & English; Joel Bloom, NJIT; Joe Boccassini, McCarter & English; Tom Bracken, NJ Chamber of Commerce; Chrissy Buteas, NJ Business & Industry Association; Nancy Cantor, Rutgers University; Francine Conway, Rutgers University; Tai Cooper, NJEDA; Kathleen Coviello, NJEDA; Robert Davis, Merck; Enrico Della Corna, PNC Bank; Alma DeMetropolis, J.P. Morgan Chase; Sven Dethlefs, Teva; Joaquin Duato, Johnson & Johnson; Michael Egenton, NJ Chamber of Commerce; Chris Eisgruber, Princeton University; Kenny Esser, Hackensack Meridian Health; Dale Florio, Princeton Public Affairs; Kate Foster, The College of New Jersey; Bob Garrett, Hackensack Meridian Health; Jim Gunton, Tech Council Ventures; Bill Hagaman, Withum; Haro Hartounian, BioCentriq; Jonathan Holloway, Rutgers University; Ali Houshmand, Rowan University; Patrick Leahy, Monmouth University; Neil Levine, Friedman; Jose Lozano, Hackensack Meridian Health; Lori Matheus, NJEDA; Wes Matthews, Choose New Jersey; George Norcross, Conner Strong & Buckelew; Simon Nynens, NJII; Joseph Nyre, Seton Hall University; Bill Palatucci, McCarter & English; Bill Pascrell III, Princeton Public Affairs; Chris Porrino, Lowenstein Sandler; Aaron Price, TechUnitedNJ; Rodney Priestly, Princeton University; Dana Redd, Rowan University; Lamont Repollet, Kean University; Steven Schinella, CohnReznick; Judith Sheft, NJ Commission on Science, Innovation and Technology; Lee Shields, Friedman; Steve Socolof, Tech Council Ventures; Angelo Stracquatanio, Apprentice.io; Tim Sullivan, NJEDA; and Diane Wasser, EisnerAmper.

Cove in Jersey City Aims to Be N.J.’S Next Great Life Science Hub

Progress is well underway at a 13-acre, mixed-use campus in Jersey City that biotech industry leaders anticipate will bolster the Garden State’s stature as a life sciences and medical innovator. That’s the still-in-the-works nexus for life sciences and innovation called the Cove. The collaborative project aspires to transform an urban site into a flagship destination for regional laboratory spaces and commercial life sciences offices. What this project intends to bring to the site, at least in its first phase, is two academic and laboratory facilities as well as a commercial life sciences building. The second phase will add another two combined laboratory-office structures. “We want to make sure that New Jersey is a robust life sciences ecosystem, and nothing speaks to the increasing robustness of that ecosystem than a brand-shiny-new development like this one,” said BioNJ President and CEO Debbie Hart. “It’ll be enormous and multifaceted — and exactly the kind of dynamic environment and central hub that we’ve all been hoping for in the State.”

SCYNEXIS Announces Positive Results from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections, Clearing the Way for Regulatory Submission and Potential Approval of Additional Indication by End of 2022

Jersey City-based BioNJ Member SCYNEXIS announced positive results from its global Phase 3 CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of recurrent vulvovaginal candidiasis (rVVC), also known as vaginal yeast infection. The company plans to submit the results to the U.S. Food and Drug Administration (FDA) in the first half of 2022 and anticipates receiving approval by year-end. This trial was conducted under a Special Protocol Assessment (SPA), a process in which sponsors work with FDA to reach agreement on the design and size of a clinical trial to adequately address scientific and regulatory requirements for a study that could support marketing approval.

Biotech Company Tevogen Opens New Corporate Hub in Warren

BioNJ Member Tevogen Bio, a clinical stage biotechnology company specializing in developing cell and gene therapies in oncology and viral infections, opened of its new corporate office at 15 Independence Boulevard, Warren. The facility, located in New Jersey’s biotech corridor, will serve as the company’s central location for corporate operations and was selected after thorough countrywide market research. Proximity to biopharma service providers in the area, a mature medical innovation ecosystem and access to the specialized talent pool within commutable distance from this location will support the company’s expected rapid expansion in cell and gene therapy business, according to Tevogen CEO, Ryan Saadi, M.D., M.P.H.

Hovione and Zerion Pharma Announce a Strategic Partnership to Market the Dispersome® Technology Platform

East Windsor-based BioNJ Member Hovione announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome®, Zerion´s proprietary solubility enhancement technology platform. Zerion´s innovative Dispersome® technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome® technology with Hovione’s unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, Hovione further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility.

Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study With GEN-1 in Advanced Ovarian Cancer

Lawrenceville-based BioNJ Member Celsion Corporation announced that following a pre-planned interim safety review of 81 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported.

Y-mAbs Announces Completion of Pre-BLA Meeting With FDA for Omburtamab

Nutley-based BioNJ Member Y-mAbs Therapeutics announced that it recently completed a Pre-Biologics License Application meeting with the U.S. Food and Drug Administration regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma. The company expects to resubmit the BLA for omburtamab by the end of the first quarter 2022. “We are pleased with the outcome of the pre-BLA meeting for omburtamab providing a clear regulatory path forward for the resubmission of the BLA. We believe omburtamab has the potential to make a meaningful impact in addressing a substantial unmet medical need for children suffering from high-risk neuroblastoma brain tumors and may potentially add an important treatment option to doctors and families facing this diagnosis,” said Thomas Gad, Founder, Chairman and President.

Merck and Ridgeback Announce That 3.1 Million Courses of Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Have Been Supplied to the U.S. Government for Use in the United States

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced that a total of approximately 3.1 million courses of molnupiravir, an investigational oral antiviral COVID-19 medicine, have been provided to the U.S. government for allocation across the country. The U.S. Department of Health and Human Services (HHS) has created a public website to help providers identify locations that have received shipments of government-procured COVID-19 therapeutics available under Emergency Use Authorization. In 2021, Merck entered a procurement agreement with the U.S. government under which the company agreed to supply approximately 3.1 million courses of molnupiravir to the U.S. government upon Emergency Use Authorization or approval from the U.S. Food and Drug Administration.

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Approve in Japan Radically Unresectable or Metastatic Renal Cell Carcinoma

Kenilworth-based BioNJ Member Merck & Co. and Eisai announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for radically unresectable or metastatic renal cell carcinoma (RCC). KEYTRUDA plus LENVIMA is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC. This marks the second approval of this combination in Japan; in December 2021, KEYTRUDA plus LENVIMA was approved for unresectable, advanced or recurrent endometrial carcinoma that progressed after chemotherapy. The approval is based on results from the pivotal Phase 3 CLEAR (Study 307) /KEYNOTE-581 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements versus sunitinib in the primary efficacy outcome of progression-free survival (PFS). 

LYNPARZA® (olaparib) Plus Abiraterone Reduced Risk of Disease Progression or Death by 34% Versus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer, Regardless of Biomarker Status

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that positive results from the Phase 3 PROpel trial showed LYNPARZA in combination with abiraterone plus prednisone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus abiraterone plus prednisone, a standard of care, as a first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations. PROpel is a randomized, double-blind, multi-center Phase 3 trial. In Sept. 2021, at a planned interim analysis, the Independent Data Monitoring Committee concluded that the PROpel trial met the primary endpoint of rPFS.

Pivotal Phase 3 Data for KEYTRUDA® (pembrolizumab) in High-Risk Early Stage Triple-Negative Breast Cancer (TNBC) Published in the New England Journal of Medicine

Kenilworth-based BioNJ Member Merck & Co. announced the publication of results from the Phase 3 KEYNOTE-522 trial in an edition of the New England Journal of Medicine. Results showed that neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen), significantly prolonged event-free survival (EFS) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early stage triple-negative breast cancer (TNBC). As previously reported, after a median follow-up of 39 months, the KEYTRUDA regimen reduced the risk of events or death by 37% versus the chemotherapy-placebo regimen.

Bristol Myers Squibb Awards Nearly $8 Million in New Health Equity Grants to Improve Access to Care for Medically Underserved Patients in U.S.

Princeton-based BioNJ Member Bristol Myers Squibb announced $7.965 million in new health equity grants to 24 U.S. non-profit organizations that aim to improve access and quality care to medically underserved patients and communities across oncology, cardiology, immunology and hematology therapeutic areas. These grants will bolster community outreach and education, increase patient support and care coordination services, and support diversity, cultural competency and collaboration among community health workers and patient navigators in communities across the U.S. To date, Bristol Myers Squibb’s total support in addressing health disparities as part of our 2020 Commitments is just over $39 million.

Lilly Will Supply Up to 600,000 Doses of Bebtelovimab to U.S. Government in Ongoing Effort to Provide COVID-19 Treatment Options

Bridgewater-based BioNJ Member Eli Lilly and Company announced an agreement with the U.S. government to supply up to 600,000 doses of investigational drug bebtelovimab for at least $720 million. The U.S. government will accept the doses of bebtelovimab if it is granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). Lilly has submitted a request for an EUA for bebtelovimab for the treatment of mild to moderate COVID-19 in certain high-risk patients to the FDA. Pseudovirus and authentic virus testing demonstrate that bebtelovimab retains full neutralizing activity against Omicron – currently the predominant variant in the U.S. 

Lilly's Bebtelovimab Receives Emergency Use Authorization for the Treatment of Mild-to-Moderate COVID-19

Bridgewater-based BioNJ Member Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant. Bebtelovimab can now be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. 

Lilly and Breast Cancer Advocacy Organizations Collaborate to Drive Awareness of the Complexities of Early Breast Cancer and the Risk of Recurrence

Bridgewater-based BioNJ Member Eli Lilly and Company launched a new education campaign in collaboration with Breastcancer.org, For the Breast of Us, Living Beyond Breast Cancer, and Susan G. Komen. This campaign aims to educate, support, connect, and empower people diagnosed with early breast cancer (EBC) that has a high risk of recurrence. More than 290,650 women and 2,710 men are expected to be diagnosed with breast cancer in the U.S. in 2022. Resources often describe early stage breast cancer as treatable and survivable. However, most people are at some risk of recurrence — and understanding individual risk factors is critical. 

Nearly Two-Thirds of Patients Respond to Mirikizumab Treatment at 12 Weeks in Lilly's First-in-Class Ulcerative Colitis Phase 3 LUCENT-1 Study

Patients with moderately-to-severely active ulcerative colitis who took mirikizumab achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking placebo in Bridgewater-based BioNJ Member Eli Lilly and Company's pivotal LUCENT-1 Phase 3 study. Patients who took mirikizumab also achieved statistically significant improvements across key secondary endpoints including clinical, symptomatic, endoscopic and histologic (cellular level of tissue) measures, compared to those taking placebo. This global study of 1,162 patients included patients who had never tried a biologic treatment (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed.

Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA. The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.

Pfizer and OPKO’s Once-Weekly NGENLA™ (somatrogon) Injection Receives Marketing Authorization in European Union for Treatment of Pediatric Growth Hormone Deficiency

BioNJ Member Pfizer, with offices in Peapack, and OPKO Health announced that the European Commission has granted marketing authorization for the next-generation long-acting recombinant human growth hormone NGENLA™ (somatrogon), a once-weekly injection to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. NGENLA provides pediatric patients, their caregivers and healthcare providers with a new treatment option for growth hormone deficiency (GHD) that reduces the frequency of required injections from once daily to once weekly. GHD is a rare disease characterized by the inadequate secretion of the growth hormone, somatropin, from the pituitary gland and affects one in approximately 4,000 to 10,000 children worldwide. 

Biohaven and Pfizer Announce Positive Top-Line Results of Pivotal Trial of Rimegepant for the Acute Treatment of Migraine in China and South Korea

BioNJ Member Pfizer, with offices in Peapack, and Biohaven Pharmaceutical Holding Company announced positive top-line results from an Asia-Pacific, Phase 3 clinical trial of rimegepant in 1,431 adults for the acute treatment of migraine. Led by BioShin Limited, a subsidiary of Biohaven in China and South Korea, the randomized, regional, multi-center study met the co-primary endpoints evaluating the efficacy and safety of the orally dissolving tablet (ODT) formulation of rimegepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist. This is the fourth positive Phase 3 study of rimegepant for the acute treatment of migraine and the first to be conducted in Asia Pacific.

European Medicines Agency Approves Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease and Pneumonia in Adults

BioNJ Member Pfizer, with offices in Peapack, announced that the European Medicines Agency (EMA) has approved the company’s 20-valent pneumococcal conjugate vaccine (PCV20), which will be marketed in the European Union (EU) under the brand name APEXXNAR. The vaccine is approved for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcuspneumoniae in individuals 18 years of age and older. The authorization follows the recent positive opinion from the EMA's Committee for Medicinal Products for Human Use. The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein and Norway.

Sandoz Launches Generic Lenalidomide in 19 Countries Across Europe, Expanding Access to Essential Oncology Medicine

Princeton-based BioNJ Member Sandoz announced the launch of generic oncology medicine lenalidomide, indicated for several haemato-oncology conditions as recommended by the latest European Society for Medical Oncology (ESMO) guidelines. The medicine will become available to patients in 19 countries across Europe. Affordability of and access to new multiple myeloma treatments pose a major challenge around the world. Cost savings from Lenalidomide Sandoz promise to expand access to treatment options for multiple myeloma patients. Similar to multiple myeloma patients, cost savings from Lenalidomide Sandoz will benefit previously treated follicular lymphoma patients, adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality, and relapsed or refractory mantle cell lymphoma patients.

FDA Approves Enjaymo™ (Sutimlimab-Jome), First Treatment for Use in Patients With Cold Agglutinin Disease

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has approved Enjaymo™ (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Enjaymo is the first and only approved treatment for people with CAD and works by inhibiting the destruction of red blood cells (hemolysis). CAD, a rare autoimmune hemolytic anemia, is caused by antibodies called cold agglutinins binding to the surface of red blood cells, which starts a process that causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). 

FDA Accepts Dupixent® (Dupilumab) for Priority Review in Children Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The target action date for the FDA decision on this investigational use is June 9, 2022. Dupixent remains the only biologic medicine approved for patients 6 years of age and older in this indication. 

Nirsevimab EMA Regulatory Submission Accepted Under Accelerated Assessment for RSV Protection in All Infants

Bridgewater-based BioNJ Member Sanofi announced the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for nirsevimab under an accelerated assessment procedure. Nirsevimab, the first investigational long-acting antibody designed to protect all infants against medically attended lower respiratory tract infections (LRTI) for the respiratory syncytial virus (RSV) season, is being developed by Sanofi and AstraZeneca. Nirsevimab is being investigated as a single dose for all infants experiencing their first RSV season. The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted nirsevimab accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. 

New Preclinical Tolebrutinib Data Demonstrated Superior Brain Penetration and Potency

New preclinical data demonstrated that tolebrutinib, Bridgewater-based BioNJ Member Sanofi’s investigational oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of multiple sclerosis (MS), was the only BTK inhibitor with sufficient central nervous system (CNS) exposure and potency to modulate BTK signaling pathways within the CNS, as compared with evobrutinib and fenebrutinib. Disability accumulation, or worsening of neurologic function, remains a reality for many people living with MS. Inhibition of BTK, an important intracellular signaling pathway within the CNS, is being investigated as an MS treatment strategy. However, to effectively inhibit BTK within the CNS, investigational therapies must cross the blood-brain barrier with sufficient exposure to engage targets and modulate signaling.    

Sanofi and GSK to Seek Regulatory Authorization for COVID-19 Vaccine

Bridgewater-based BioNJ Member Sanofi and Warren-based BioNJ Member GlaxoSmithKline announced that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. 

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. In participants who had received a primary series of an already authorized mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralizing antibodies of 18- to 30-fold across vaccine platforms and age groups. 

BeiGene Announces U.S. FDA Acceptance of Supplemental New Drug Application for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia

Ridgefield Park-based BeiGene announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA^® (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL is the most common form of adult leukemia. The Prescription Drug User Fee Act (PDUFA) target action date is October 22, 2022. The sNDA filing in CLL/SLL includes data from two pivotal randomized Phase 3 studies and eight supportive studies in B cell malignancies. The two global Phase 3 trials of BRUKINSA in CLL/SLL are: ALPINE (NCT03734016) comparing BRUKINSA to ibrutinib in relapsed or refractory (R/R) patients and SEQUOIA (NCT03336333) comparing BRUKINSA to bendamustine and rituximab in treatment-naïve (TN) patients. 

BeiGene Announces Approval for BRUKINSA (zanubrutinib) by Swissmedic for Treatment of Adult Patients With Waldenström’s Macroglobulinemia

Ridgefield Park-based BeiGene announced that BeiGene’s BTK inhibitor BRUKINSA (zanubrutinib) received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior line of therapy, or for treatment-naïve patients who are not suited for standard chemo-immunotherapy. BRUKINSA had previously been granted orphan drug status. The Marketing Authorization Application (MAA) is supported by data from the global Phase 3 ASPEN clinical trial, a Phase 3 randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). 

BeiGene Announces European Medicines Agency Acceptance of Applications for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma

Ridgefield Park-based BeiGene announced that the European Medicines Agency (EMA) has accepted for review two new indication applications for its BTK inhibitor BRUKINSA^® (zanubrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with marginal zone lymphoma (MZL). In November 2021, BRUKINSA received its first approval in the European Union (EU) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

Princeton Pharma Company Gets FDA Nod for Its Immunogenicity Simulator

The U.S. Food and Drug Administration announced it licensed Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics. The Princeton-based leader in biosimulation’s IG Simulator predicts the immune response of drugs in development, which is important to guide clinical and regulatory decision-making. Immunogenicity, or the tendency of a molecule to trigger an immune response, is a major problem with protein-based therapeutics such as antibody-based drugs or biological medicines that are engineered versions of naturally occurring human proteins. Immunogenicity has long been an area of keen research interest by the FDA and biopharmaceutical companies, as it can be challenging to predict and can negatively impact drug development projects late in the process that may be costly to rectify.

ENHERTU® Significantly Improved Both Progression-Free and Overall Survival in DESTINY-Breast04 Trial in Patients With HER2 Low Metastatic Breast Cancer

Basking Ridge-based Daiichi Sankyo announced positive topline results from the pivotal DESTINY-Breast04 Phase 3 trial which showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician’s choice of chemotherapy, which is the current standard of care. ENHERTU is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. All patients in the trial received a HER2 test and the results were centrally confirmed. HER2 low status was defined as an immunohistochemistry (IHC) score of 1+ or IHC2+ with a negative in-situ hybridization (ISH) score. 

East Windsor Pharma Manufacturer Acquired by APNAR Pharma

East Windsor-based Aurex Laboratories was acquired by APNAR Pharma LP for an undisclosed amount. With the addition of Aurex’s manufacturing and research & development capabilities, APNAR plans to transition into a fully integrated global company. The acquisition enhances APNAR’s scale and global footprint and broadens its pipeline. Not only does it add to APNAR’s commitment of having manufacturing in the U.S., it adds a state-of-the-art facility with the addition of Aurex Laboratories’ 68,000-square-foot site which sits within a 14-acre campus in “the medicine chest” of New Jersey. It also adds a team of experienced, highly capable and dedicated scientists, manufacturing, regulatory and project management personnel.

BD Collaborates With Returnsafe to Help Employers Manage COVID-19 Testing

Franklin Lakes-based BD, together with ReturnSafe, the all-in-one software solution for COVID-19 employee health, said they are collaborating to integrate the BD Veritor At-Home COVID-19 Test directly within the ReturnSafe testing management platform. Employers can benefit from the combination of interpretation and secure reporting, which will significantly reduce the potential for test results to be manipulated or misreported. Additionally, the addition of ReturnSafe simplifies and streamlines the management of testing results and workplace health and safety solutions. Employers can effectively collect test results, track who has completed testing requirements on time, quickly identify positive cases to act, manage isolation and quarantine workflows, as well as collect data for compliance reporting.

Glenmark Launches Nitric Oxide Nasal Spray (Fabispray®) in India for the Treatment of Adult Patients With COVID-19 in Partnership With Sanotize

Mahwah-based Glenmark Pharmaceuticals Limited announced launch of its Nitric Oxide Nasal Spray under the brand name FabiSpray® in India; for the treatment of adult patients with COVID-19 who have high risk of progression of the disease. Glenmark earlier received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS as part of the accelerated approval process. FabiSpray®, Nitric Oxide Nasal Spray, is designed to kill the COVID-19 virus in the upper airways. It has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. NONS when sprayed over nasal mucosa acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs.

Brainstorm Cell Therapeutics Announces Grant of a New Brazilian Patent Covering Methods of Manufacturing NurOwn®

Paramus-based Brainstorm Cell Therapeutics announced that the Brazilian Patent Office has granted the patent application titled: "A method of generating cells which secrete Brain Derived Neurotrophic Factor (BDNF), Glial Derived Neurotrophic Factor (GDNF), Hepatocyte Growth Factor (HGF) And Vascular Endothelial Growth Factor (VEGF), wherein said cells do not Secrete Nerve Growth Factor (NGF)." The granted claims cover a method of manufacturing MSC-NTF cells (NurOwn®). The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. 

Intercept Pharmaceuticals to relocate from NYC to Crum & Forster’s world-class HQ in Morristown

Morristown-based Intercept Pharmaceuticals inked a 26,174-square-foot office lease in the Crum & Forster-owned building in Morristown. The firm is relocating its global headquarters from 10 Hudson Yards in Manhattan to the 213,857-square-foot property located at 305 Madison Ave. “Intercept Pharmaceuticals’ relocation from New York City to Crum & Forster’s world-class headquarters in Morristown demonstrates the allure of premier office space and competitive rents that New Jersey has to offer,” said CBRE’s Conor Dolan.

Merck Announces New Leadership for Human Health Business

Kenilworth-based BioNJ Member Merck & Co. announced new leadership for its Human Health business. Arpa Garay will lead Human Health Global Marketing, Jannie Oosthuizen will lead Human Health U.S., and Merck is recruiting externally to fill the Human Health International role. In the interim, Deepak Khanna will lead Human Health International. These three positions will sit on the Executive Team and report directly to Robert M. Davis, Chief Executive Officer and President, Merck. “Our human health business has a remarkable track record of operational excellence, strategic execution and strong results, and our deep bench of global talent has made that possible,” said Mr. Davis. “These appointments will enable us to build on this momentum, develop our internal talent and expand our high performing senior leadership team.”

Honeywell’s Chairman and CEO Named to Board of Johnson & Johnson

New Brunswick-based BioNJ Member Johnson & Johnson named Darius Adamczyk, Chairman and CEO of Honeywell, to its board of directors. Mr. Adamczyk is a visionary who brings decades of global business leadership experience and operational and regulatory expertise. In his current role as Chairman and CEO of Honeywell, he has helped to bring solutions and technology to market that help to make the world safer, more productive and more sustainable, and built a culture of excellence. Before stepping into the CEO role, Mr. Adamczyk served as President and Chief Operating Officer. Prior to this, he served in multiple leadership roles across Honeywell’s business segments. 

BioAegis Therapeutics Announces Appointment of Two New Corporate Board Members

North Brunswick-based BioNJ Member BioAegis Therapeutics announces the appointment of Dr. Kerry Maguire and Kris Vinckier, to the Corporate Board. Dr. Kerry Maguire is a health care executive who most recently served as the Vice President for Clinical Operations at the Forsyth Institute in Cambridge, MA. As a public health professional, her focus has been on health disparities of vulnerable populations, primarily children and people living with HIV. Kris Vinckier is a Director and Co-Founder of Paradox Investment Management BV, which manages the investment fund, Paradox Investment Network BV, a Private Privak under Belgian Law. 

Sanofi’s Board of Directors Proposes the Appointment of Carole Ferrand, Emile Voest and Antoine Yver as Independent Directors

Bridgewater-based BioNJ Member Sanofi’s Board of Directors has decided to propose, on the occasion of its next General Shareholder Meeting, the renewal of the mandates of Paul Hudson, Christophe Babule, Patrick Kron and Gilles Schnepp and the appointment of Carole Ferrand, Emile Voest and Antoine Yver as independent Directors. Melanie Lee and Carole Piwnica will leave the Board of Directors. The Chairman thanked Carole Piwnica for her contribution to the transformation of the group during her almost 12 years in office, and Melanie Lee for her contribution to the scientific reorientation of the group and the creation of the Scientific Committee.

Cellectar Biosciences Announces Executive Leadership Changes

Florham Park-based Cellectar Biosciences named Chad Kolean as Chief Financial Officer and promoted Jarrod Longcor to the role of Chief Operating Officer. Mr. Kolean, a 30-year industry veteran, returns to Cellectar after having served as Chief Financial Officer to both Vivex Biologics, a regenerative medicine company, and Titan Spine, a spinal implant med-tech company sold to Medtronic. Mr. Longcor has been with the company for six years as both a consultant and Chief Business Officer. Mr. Longcor will lead and provide strategic oversight of the company’s key functional areas to ensure operational excellence as Cellectar progresses through its clinical development programs and advances towards commercialization.

Neal Rejoins BD as Chief People Officer

Franklin Lakes-based medical technology company BD appointed Shana Neal as chief people officer, effective April 4. Ms. Neal, who held HR leadership positions at BD from 2005 to 2018, will oversee its human resources, communications and social investing functions globally, including talent acquisition and management; HR operations; HR business partnering; and inclusion, diversity, equity and engagement. Ms. Neal rejoins BD from Owens & Minor, a Fortune 500 health care solutions company, where she served as Executive Vice President and Chief Human Resources Officer since 2018, as well as President of the Owens & Minor Foundation and the executive sponsor for Environmental, Social and Governance initiatives.

Bristol Myers Squibb Awards Nearly $8 Million in New Health Equity Grants to Improve Access to Care for Medically Underserved Patients in U.S.

Princeton-based BioNJ Member Bristol Myers Squibb announced $7.965 million in new health equity grants to 24 U.S. non-profit organizations that aim to improve access and quality care to medically underserved patients and communities across oncology, cardiology, immunology and hematology therapeutic areas. These grants will bolster community outreach and education, increase patient support and care coordination services, and support diversity, cultural competency and collaboration among community health workers and patient navigators in communities across the U.S. To date, Bristol Myers Squibb’s total support in addressing health disparities as part of our 2020 Commitments is just over $39 million.

Choose New Jersey Announces Record Job Growth in 2021 Annual Report

Choose New Jersey, New Jersey’s leading non-profit economic development organization, released its 2021 Annual Report today which highlights record job growth, as well as the organization’s efforts behind several major attraction projects. Nearly two years into the COVID-19 pandemic, the global economy continues to face challenges, yet Choose New Jersey’s efforts resulted in significant progress in 2021, assisting 32 companies in relocating or expanding to New Jersey, resulting in 7,629 new and retained jobs and generating $1.6B in capital investment.

“It is remarkable how much Choose New Jersey has achieved during the second year of a global pandemic,” said Ralph LaRossa, Chairman of Choose New Jersey and Chief Operating Officer of PSEG. “Not only did the team have a record year for job creation, but we were also able to raise the State’s presence internationally. Choose New Jersey facilitated several high-profile global business attraction projects demonstrating the advantages of New Jersey.”

Unleashing Innovation Through Incubators and Beyond

Princeton-based BioNJ Member Bristol Myers Squibb’s commitment to R&D innovation goes beyond its internal drug discovery engine and even beyond a vast network of external partnerships. To help accelerate the next wave of scientific breakthroughs, the company also supports life sciences start-ups and aspiring biotech entrepreneurs through a diverse and growing array of programs in the U.S. and abroad. The effort encompasses a company owned-and-operated incubator laboratory in New Jersey, a Golden Ticket program that awards lab space to young companies across the U.S., and a variety of initiatives in the U.K. and Europe for nurturing exciting early science across industry and academia. 

NJIT Reaffirmed as Elite Research University With R1 Status

The New Jersey Institute of Technology (NJIT) has reaffirmed its status among the nation’s most elite and productive research institutions by once again achieving an R1 status — the highest designation — by the Carnegie Classification. First published in 1973, the Carnegie Classification of Institutions of Higher Education is the primary measure used by rating organizations and governmental agencies to describe colleges and universities. NJIT’s continuing status as an R1 institution demonstrates the university’s sustained growth of research and innovation. NJIT’s ability to secure major research grants will continue to foster transformative discoveries in areas ranging from healthcare and medicine to sustainable technologies and data analytics.

Novel RNA Research, Invention, and Startup Born at Rutgers University Receives $75 Million in Series A Funding

A Rutgers professor’s novel research into targeting and silencing defective, disease-causing RNA molecules has led to the launch of Ceptur Therapeutics, a start-up that has raised $75 million in Series A funding. The initial research that led to the creation of Ceptur was conducted by principal investigator Samuel I. Gunderson, Ph.D., Associate Professor of Molecular Biology and Biochemistry at Rutgers-New Brunswick’s School of Arts and Sciences. Dr. Gunderson’s research focused on Ribonucleic acid (RNA), specifically how to manipulate and control RNA to understand its functions and treat different genetic diseases, such as certain blood cancers and neurological disorders.

Seton Hall President Nyre and His Wife Give Personal Gift of $500K to School

Like all university presidents, Seton Hall University’s Joseph Nyre talks about making a college education more affordable. Mr. Nyre showed he is making it a personal mission.

Mr. Nyre and his wife, Kelli Nyre, announced they are making a personal gift of $500,000 to the university. The donation will underwrite scholarships for students and innovative research and instructional activities of faculty. The Nyres, who meet regularly with Seton Hall donors across the country, said they are intimately familiar with the university’s priorities and the tremendous impact of philanthropic gifts on the university and its students and faculty.

Five New Jersey Schools Advance in Samsung’s $2 Million National Stem Contest

Five New Jersey schools are among the nation’s 100 State Winners in the 12th annual Samsung Solve for Tomorrow Education Contest. Solve for Tomorrow is a program that encourages 6th to 12th grade students and their teachers to creatively use science, technology, engineering and math (STEM) skills to tackle local issues of national importance, while keeping sustainability in mind. The State Winner teams were chosen based on their creative and strategic proposals for solving complicated issues that affect their communities by using STEM learning. Each State Winner will be awarded $6,500, to be redeemed from the website of DonorsChoose, a nonprofit organization, along with a video kit to help them with the next phase of the contest.

Task Force Delivers Recommendations on Technology Initiatives to Assist Workforce

The New Jersey State Future of Work Task Force released 19 core recommendations that underscore the State’s need to invest in policies, platforms and programs that respond to both the challenges and the opportunities technology creates to foster worker rights, worker safety and lifelong learning. The roadmap and recommendations highlight policies and initiatives that the Task Force has advanced since its formation by executive order. These include the nation’s first $10 million lifelong learning account pilot for low-wage workers, the creation of the nation’s first Future of Work Accelerator to incubate 20 innovative technologies or services designed to help workers in New Jersey and nationally, and the launch of the country’s first training transparency platform designed to help workers make more informed decisions about their lifelong learning.

Overlook Medical Center Enrolling Patients for New Brain Tumor Vaccine

Overlook Medical Center, part of Atlantic Health System, has been selected as the only site in New Jersey, and one of the first three in the nation, to participate in a clinical trial of a unique vaccine that targets the protein that keeps cancer cells alive in brain tumors. The “SURVIVE” Phase 2B trial, sponsored by MimiVax LLC, will allow doctors at Overlook to treat patients newly diagnosed with glioblastomas with SurVaxM, a first-of-its-kind vaccine that targets survivin, a cell-survival protein found in 95% of glioblastomas and many other cancers.

GoMo Health Expands Management Team Welcoming Lawrence H. Krampf, Healthcare Marketing Executive and Relationship Manager

Asbury Park-based GoMo Health is excited to welcome Larry Krampf as Chief Revenue Officer, joining corporate leadership in the growth expansion and business development efforts for GoMo Health, following inspiring strategic and tactical impact as an Advisory Board member of the company. A mission-driven marketer, Mr. Krampf strongly aligns with GoMo Health’s goal of making health care accessible, understandable and actionable for everyone. Serving the community has played a major part in his career. Mr. Krampf has chaired many community events over the years for the American Heart Association, Cancer Care, Foundation Fighting Blindness and was an advisor to the Health Care Quality Institute.

NJMEP - New Jersey Manufacturing Industry Report 2022

2022 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. There is a light at the end of the tunnel. However, looming disruptions

are set to make recovery only within reach for businesses that take a proactive approach

to progress. Manufacturers have an opportunity to leverage all the media attention and national recognition for their hard work over the past two years. These businesses were forced to speak up and make their presence known as they pulled the nation through an unprecedented

disaster. Collaboration and participation will be essential for any business looking to grow in

the new year. As supply chain disruptions, cyberthreats, workforce shortages and financial

pressures remain, only the strategic, productive and efficient will thrive.

NYC Tiger Entrepreneurs Conference

April 7-8, 2022

Princeton Entrepreneurship Council (PEC) is excited to invite you to join fellow alumni, students and faculty at the 2nd NYC Tiger Entrepreneurs Conference. The conference will kick off with a virtual Start-up Showcase featuring several exceptional alumni and faculty founders, to be held on Thursday evening, April 7. The following day, Friday, April 8, the conference will be an in-person event in midtown Manhattan featuring panel discussions, fireside chats, workshops and a closing reception. The 2022 NYC Tiger Entrepreneurs Conference will celebrate both Princeton entrepreneurship and Princeton's contribution to the vibrant NYC start-up scene.  

I-Corps Northeast Hub: New Training Program

April and May 2022

Researchers in the Northeast: Explore ways that your discovery can meet the needs of people and industries. Teams are eligible for grants of up to $3,000. The Hub emphasizes inclusive innovation and our programs are open to researchers at universities, colleges and research institutions throughout the Northeast. Our next training program for researchers will be held Tuesday, April 12, and Thursdays April 14, April 21 and May 5, from 1-4 p.m. ET online. Learn more and apply for the program at icorpsnortheasthub.org.

BIO 2022 in San Diego

June 13-16, 2022

BIO is thrilled to be back in person for the 2022 International Convention happening in San Diego, CA June 13-16, 2022. The Convention theme ‘LIMITLESS’ is BIO's commitment to unlocking possibilities for attendees while paving the path to the future of our industry. The BIO International Convention attracts 15,000+ biotechnology and pharma leaders who come together for one week of intensive networking to discover new opportunities and promising partnerships. BIO brings together a wide spectrum of life sciences and application, including drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy.

BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:



• Accounting Services
• Biobanking/Bioprocessing
• Clinical Research Centers
• Communications / Marketing / PR / IR
• Contract Manufacturing / Supply Chain & Logistics Management
• Contract Research Organizations & Consulting Services
• Digital Health & Life Sciences IT/Data Science Technologies
• Financial / Investment / Funding Sources and Services
• HR / Talent Acquisition / Professional Development
• Insurance Services
• IT/Data Management and Software Platform Technologies/Cybersecurity
• Laboratory Services
• Legal Services
• Other Services
• Publications
• Real Estate / Engineering and Construction / Property Development
• Supplies - Laboratory / Environmental / Research Instrumentation & Other