Still Not Skyrocketing: New CMS Data Reinforce the Truth About U.S. Drug Spending

The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which measures all U.S. spending on health care. These data provide our first official look at how the pandemic has affected U.S. health care spending. As you will see, outpatient drug spending remains a small — and shrinking — share of the $4.1 trillion spent on U.S. health care. What's more, drug spending again grew more slowly than overall health care spending. Meanwhile, consumers shoulder a much higher portion of this spending compared with their share of hospital spending. Demonizing pharmaceuticals as a driver of U.S. healthcare spending growth is simply inaccurate. 

Patients Need to Pay Less for Their Medicines. States Can Help

No one should struggle to afford the medicines they need. Unfortunately, some patients continue to bear more of their medicine costs at the pharmacy counter. Patients with deductibles have seen their out-of-pocket costs for brand medicines in some areas increase 50% since 2015. Today, more than half of every dollar spent on brand medicines goes to payers, middlemen, providers and other stakeholders in the supply chain. But due to insurance design, patients are often paying based off the list price of a medicine rather than the net price their insurer gets. 

Applying a Patient Risk Model to Drug Pricing Reform

The Biden administration and Congress have made clear the importance of investing in community well-being with passage in the House of Representatives of the Build Back Better Act and the now-signed-into-law bipartisan infrastructure bill. Transportation, education, childcare, broadband access, clean air and water, and affordable housing are all deemed priorities for the use of public resources. But contrary to the administration’s focus on equity issues, this act would actually deter efforts to protect underserved communities and hampers innovation critical to patients. Washington is squandering the opportunity to optimize a golden era of medical progress by supporting discriminatory drug price “negotiation” provisions. 

It’s a New Year, But Sadly Congress is Still Pursuing Flawed Price Setting Policies

As we kick off 2022, Congress has a number of priorities they are aiming to tackle, including the Build Back Better Act (BBBA). Unfortunately, the bill includes policies that would take the unprecedented step of allowing the government to set the price of certain medicines in Medicare. Here’s a refresher on why the drug pricing provisions in the BBBA are bad policy. Disincentivize further research after a medicine is approved. There appears to be a misconception that once a medicine is approved by the FDA, the work is done. In fact, many important lifesaving advancements have come from further research after a medicine is initially approved. 

New Poll of All 50 States and 435 Congressional Districts Shows Perils of So-Called Medicare “Negotiation”

A new large-scale survey of 20,000 Americans covering all states and Congressional districts shows a majority find health care coverage costs unreasonable and a top priority health care issue for policymakers to address today. At the same time, the survey conducted with Morning Consult also shows Americans reject so-called government “negotiation” once they learn it could restrict access and choice and chill the innovation of new treatments and cures. Over 6 in 10 Americans reject price setting policies such as government “negotiation” once they learn it could sacrifice access, innovation and choice.

Commercially Insured Patients With Chronic Conditions Face High Cost Sharing for Brand Medicines

Out-of-pocket spending for prescription medicines a decade ago consisted almost entirely of fixed co-payments, but use of deductibles and co-insurance in commercial health insurance has skyrocketed in recent years. This shift has resulted in many patients with chronic conditions being asked to pay a larger share of the cost of their medicines. Faced with increasing costs each year, a growing share of commercially insured patients rely on cost-sharing assistance programs offered by pharmaceutical manufacturers to help them pay their out-of-pocket costs at the pharmacy counter.

The Myth of Average: Why Individual Patient Differences Matter

Every person’s health needs are unique thanks to factors such as age, genetics, racial and ethnic background, chronic conditions, sex, gender, environment and socioeconomic circumstances. These factors can affect how patients respond to treatments. Yet health care and insurance coverage are often designed for the “average” patient, assuming all people have the same needs or the same treatment responses. This can create barriers for some patients in accessing the most effective care for them. The National Pharmaceutical Council’s updated booklet, “The Myth of Average: Why Individual Patient Differences Matter,” explores how patients, health care providers, insurers, and other decision-makers can better consider individual patient differences when navigating the complexities of health care and insurance.

FDA Grants Evrysdi® Priority Review Based on Results from Treating Pre-Symptomatic Infants With Spinal Muscular Atrophy

South Plainfield-based BioNJ Member PTC Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted priority review of a supplemental new drug application (sNDA) for Evrysdi® (risdiplam) to expand the indication to include pre-symptomatic infants under 2 months old with spinal muscular atrophy (SMA). If approved, Evrysdi would be the first medicine administered at-home for pre-symptomatic babies with SMA. Included in the sNDA submission was interim data from the RAINBOWFISH study, which showed 80 percent of pre-symptomatic infants with SMA treated with Evrysdi for at least 12 months achieved motor milestones such as sitting without support, rolling, crawling, standing unaided and walking independently.

Hillstream BioPharma and University of Massachusetts Chan Medical School Announce Research Collaboration using CRISPR and Computational Approaches to Advance the Hillstream Ferroptomic Atlas

Bridgewater-based BioNJ Member Hillstream BioPharma announced a collaboration with University of Massachusetts Chan Medical School to determine the chemogenetic interactions of HSB-1216, which utilizes the company’s novel Quatramer technology, to further advance The Hillstream Ferroptomic Atlas for development of novel targets, gene regulatory networks and biomarkers. The study will be a collaboration between Hillstream and Michael J. Lee Ph.D. Associate Professor, Department of Systems Biology at UMass Chan Medical School, a recognized leader in the fields of computational and systems biology. Dr. Lee’s research focuses on signaling pathways controlling the growth, survival and death of cancer cells, in order to identify sources of therapeutic variability and to clarify the “rules” that underlie the efficacy of drugs, both when used as single agents and when used in complex combinations. 

Evotec Enters iPSC-based Drug Discovery Partnership With Boehringer Ingelheim in Ophthalmology

Princeton-based BioNJ Member Evotec announced that the company has entered a target and drug discovery partnership with North Brunswick-based BioNJ Member Boehringer Ingelheim, focusing on induced pluripotent stem cell ("iPSC")-based disease modelling for ophthalmologic disorders. Millions of people are affected by vision-related diseases worldwide, and there is a high unmet need for novel therapeutic solutions. Through phenotypic screening of human iPSC-derived cells, supported by Evotec's PanOmics platform, Evotec will identify small molecules able to modulate disease phenotypes, and then validate the underlying promising targets for potential therapeutic interventions. Boehringer Ingelheim will then continue with the discovery and development of potential therapeutic candidates. 

CHMP Issues Positive Opinion to Expand Jardiance (Empagliflozin) Indication Based on Unprecedented Benefit in Adult Heart Failure Patients With Preserved Ejection Fraction

North Brunswick-based BioNJ Member Boehringer Ingelheim announced The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance® (empagliflozin) for the treatment of adults with symptomatic chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced. Empagliflozin was previously approved for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). If approved, the positive opinion would expand this indication to be applicable for adults across the full spectrum of left ventricular ejection fraction (LVEF), including preserved ejection fraction (HFpEF).

Updates on OLUMIANT® (Baricitinib) Phase 3 Lupus Program and FDA Review for Atopic Dermatitis

Bridgewater-based BioNJ Member Eli Lilly and Company announced updates on the Phase 3 development program for OLUMIANT® (baricitinib) in adults with active systemic lupus erythematosus (also referred to as SLE and lupus) and the status of the U.S. atopic dermatitis supplemental new drug application (sNDA). Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), Lilly has decided to discontinue the Phase 3 development program for OLUMIANT in lupus. In SLE-BRAVE-I, the baricitinib 4-mg oral dose met the primary endpoint, demonstrating a statistically significant reduction in disease activity as measured by the proportion of adults with active lupus who achieved an SRI-4 response (a composite measurement of overall disease activity) at Week 52 compared to placebo. 

Advaxis Prices Offering of $5,000,000 of Convertible Redeemable Preferred Stock Through a Private Placement

Princeton-based BioNJ Member Advaxis announced that the company entered into an agreement with certain institutional investors for the private placement of 1,000,000 shares of Series D convertible redeemable preferred stock. The shares to be sold will have an aggregate stated value of $5,000,000. Each share of the Series D preferred stock has a purchase price of $4.75, representing an original issue discount (“OID”) of 5% of the stated value. The shares of Series D preferred stock are convertible into shares of the company’s common stock, upon the occurrence of certain events, at a conversion price of $0.25 per share of common stock. Total gross proceeds from the offering, before deducting the financial advisor's fees and other estimated offering expenses, are $4.75 million.

Celsion Corporation Advances Proof of Concept to Non-human Primate Challenge Study Against SARS-CoV-2 With In-Process Vaccine Candidate

Lawrenceville-based BioNJ Member Celsion Corporation announced it has engaged BIOQUAL, Inc., a preclinical testing contract research organization, to conduct a non-human primate (NHP) challenge study with Celsion’s DNA-based approach for a SARS-CoV-2 vaccine. The NHP pilot study follows the generation of encouraging mouse data and will evaluate the Company’s lead vaccine formulations for safety, immunogenicity and protection against SARS-CoV-2. In completed preclinical studies, Celsion demonstrated safe and efficient immune responses including IgG response, neutralizing antibodies and T-cell responses that parallel the activity of commercial vaccines following intramuscular (IM) administration of novel vaccine compositions expressing a single viral antigen.

Thawing the Cold Chain: Princeton Technology for Room-Temperature Delivery of Vaccines and Biological Drugs Selected to Receive Science Center Innovation Funding

A Princeton-led technology to improve the storage and transport of vaccines and life-saving drugs at room temperature has been selected as one of three university innovations to receive funding for further development from the Philadelphia-based University City Science Center. The innovation, a system for rapid room-temperature dehydration of vaccines and biopharmaceuticals, uses ultra-fine-droplet aerosols to convert vaccines and drugs into dry form, eliminating the need for expensive refrigeration or freezing. The technology was developed by Princeton Research Scholar Maksim Mezhericher in collaboration with Howard Stone, Princeton’s Donald R. Dixon '69 and Elizabeth W. Dixon Professor of Mechanical and Aerospace Engineering.

Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory DLBCL, PMBCL and FL3B

Princeton-based BioNJ Member Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

Sanofi and Regeneron Provide Regulatory Update on Libtayo® (Cemiplimab-Rwlc) in Advanced Cervical Cancer

Bridgewater-based BioNJ Member Sanofi and Regeneron Pharmaceuticals announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo® (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was made after the companies and the U.S. Food and Drug Administration (FDA) were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the U.S. are ongoing. It is estimated that approximately 570,000 people are diagnosed with cervical cancer worldwide each year, with deaths exceeding 250,000. In the U.S. there are 14,500 new cases diagnosed annually and approximately 4,000 die each year.

CHMP Recommends Approval of Dupixent® (Dupilumab) for Children Aged 6 to 11 Years With Severe Asthma With Type 2 Inflammation

Bridgewater-based BioNJ Member Sanofi announced The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

A Newly Published Network Meta-Analysis (NMA) Found TREMFYA® (guselkumab) Ranked Highest for Overall Level of Skin Clearance and Provided Positive Joint Efficacy Among Active Psoriatic Arthritis (PsA) Therapies

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced a Network Meta-Analysis (NMA) comparing first-in-class interleukin (IL)-23 inhibitor TREMFYA® (guselkumab) to all advanced therapies approved for active psoriatic arthritis (PsA) using data from 33 Phase 3 randomized clinical trials (RCTs). The NMA concluded TREMFYA ranked highest for skin clearance based on Psoriasis (PsO) Area Severity Index (PASI) 90 response among 23 treatment regimens (15 unique treatments including IL-23 inhibitors like TREMFYA and risankizumab, subcutaneous [SC] tumor necrosis factor inhibitors [TNFi], and Janus kinase inhibitors [JAKi]). 

U.S. FDA Approves CABENUVA (rilpivirine and cabotegravir) for Use Every Two Months, Expanding the Label of the First and Only Long-Acting HIV Treatment

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved an expanded label for CABENUVA (rilpivirine and cabotegravir) to be administered every two months for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history.

Johnson & Johnson Marks More Than 2 Billion Doses of Medicine Donated to Date to Help Combat Intestinal Worms

In advance of World Neglected Tropical Diseases (NTD) Day, New Brunswick-based BioNJ Member Johnson & Johnson is pleased to announce it has now donated a total of more than 2 billion doses of mebendazole, its medicine to treat intestinal worm infections, to people in need in more than 50 resource-limited countries worldwide. This marks the latest achievement in Johnson & Johnson’s longstanding donation program aimed at helping children, who are especially vulnerable to intestinal worms, live healthier lives. NTDs are a group of 20 communicable, often-debilitating conditions that affect more than 1.7 billion people in nearly 150 countries around the world and disproportionately impact the world’s poorest and most vulnerable communities.

Organon Declares Paid Time Off for all Employees on International Women's Day

Global women’s health care company BioNJ Member Organon, and a spinoff of Merck & Co., is designating International Women’s Day on March 8 as a day to recognize the growing health disparities women face that have been exacerbated by the COVID-19 pandemic. Organon recognizes the need for a global effort to address women’s health and is starting with its own employees by providing paid time off this year for all employees to attend to their own health needs. The company invites organizations across the globe to join in raising awareness of the inequity in women’s health and to adopt initiatives that help women prioritize it. The company believes that, by improving the understanding of women’s health needs, we are one step closer to closing the inequity gap. Visit hereforherhealth.com/make-time to learn more.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. This approval is based on results from the Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) after a median follow-up of 23.9 months compared to placebo, in patients at increased risk of recurrence.

Merck and Ridgeback’s Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, Demonstrated Activity Against Omicron Variant in In Vitro Studies

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced data from six preclinical studies demonstrating that molnupiravir, an investigational oral antiviral COVID-19 medicine, was active against the SARS-CoV-2 variant Omicron (B1.1.529) in vitro. The in vitro studies were independently conducted by researchers from institutions in six countries including Belgium, Czech Republic, Germany, Poland, the Netherlands and the United States. The studies used established cell-based assays to evaluate the antiviral activity of molnupiravir and other COVID-19 antiviral agents against SARS-CoV-2 variants of concern, including Omicron. Molnupiravir has yet to be studied against Omicron in clinical studies. 

Pfizer and BioNTech Publish Data from Two Laboratory Studies on COVID-19 Vaccine-induced Antibodies Ability to Neutralize SARS-CoV-2 Omicron Variant

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced the publication of new results from two laboratory studies demonstrating that three doses of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) elicited antibodies that neutralize the Omicron variant. Data published in the peer-reviewed journal Science, includes readouts of sera data from 51 vaccinated individuals that received two or three doses of BNT162b2 as well as a study evaluating the neutralization potential of serum antibodies from a subset of vaccinated individuals against the live virus. Both data sets confirm previously announced initial study results demonstrating that serum antibodies induced by BNT162b2 neutralize the SARS-CoV-2 Omicron variant after immunization with three doses.

Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age. The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced that following a request from the U.S. Food and Drug Administration (FDA) the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age (6 months to <5 years of age), in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days. This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA.

Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment

BioNJ Member Pfizer, with offices in Peapack, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the conditional marketing authorization (CMA) of Pfizer’s PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19. The CHMP based its positive opinion on the scientific evidence supporting PAXLOVID, including data from the Phase 2/3 EPIC-HR trial, which enrolled non-hospitalized adults aged 18 and older with confirmed COVID-19 who are at increased risk of progressing to severe illness. 

European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer

BioNJ Member Pfizer, with offices in Peapack, announced that the European Commission (EC) granted marketing authorization for LORVIQUA® (lorlatinib, available in the U.S. under the brand name LORBRENA®) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. The approval for the first-line use of LORVIQUA was based on the results of the pivotal Phase 3 CROWN trial, in which LORVIQUA reduced the risk of disease progression or death by 72% compared to XALKORI® (crizotinib).

BeiGene Announces Acceptance of Supplemental New Drug Application in China for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia With Breakthrough Therapy Designation

Ridgefield Park-based BeiGene announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for BeiGene’s BTK inhibitor BRUKINSA (zanubrutinib) as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and granted BRUKINSA breakthrough therapy designation (BTD). The sNDA is supported by clinical results from the randomized, multicenter, global Phase 3 SEQUOIA trial (NCT03336333) comparing BRUKINSA to bendamustine in combination with rituximab (B+R) in patients with treatment-naïve CLL.

Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM®

Nutley-based Eisai and BioNJ Member Biogen announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease, including details of the study’s goal for diverse enrollment and primary endpoint. Biogen aims to enroll 18 percent of U.S. participants in ENVISION from Black/African American and Latinx populations. This goal is reflective of Biogen’s ongoing commitment to increase diversity in clinical trials. Biogen will implement multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer’s disease trials, such as, lack of access to medical centers, familiarity with benefit/risk profile of treatment, and financial or logistical burdens.

Lenvima® (Lenvatinib) in Combination With Keytruda® (Pembrolizumab）Approved in Taiwan for the First-Line Treatment of Patients With Advanced Renal Cell Carcinoma

Nutley-based Eisai announced that LENVIMA® (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with BioNJ Member Merck & Co.’s KEYTRUDA® (generic name: pembrolizumab) has been approved in Taiwan for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This marks the first approval for LENVIMA which will be used in combination with KEYTRUDA for advanced RCC in Asia. The approval is based on results from the CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination for the first-line treatment of patients with advanced RCC. In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in the primary efficacy outcome measure of progression-free survival (PFS), as well as the key secondary efficacy outcome measures of overall survival (OS) and objective response rate (ORR) versus sunitinib. 

Bright Cloud International & SAM Group Announce Strategic Partnership for Innovative Telerehab Solution: BrightBrainer™

North Brunswick-based Bright Cloud International and SAM Group are forming a strategic partnership to provide innovation for the $363B post-Acute market. Bright Cloud has secured nine patents for breakthrough technology for in-home Telerehab and post-acute digital health and has three more patents pending. They have conducted ten Phase 1 and 2 clinical trials, many of them first-in-class. This pioneering work benefited a variety of populations that exhibit upper extremity movement dysfunction and may have cognitive deficits. These include people post stroke, or traumatic brain injury, as well as those with dementia and chronic pain.

Eagle Pharmaceuticals on Track to Support Submission of New Drug Application in Second Quarter 2022 for Landiolol, a Beta-1 Adrenergic Blocker

Woodcliff Lake-based Eagle Pharmaceuticals announced that AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group, with whom it entered into a licensing agreement in August 2021, has engaged with the U.S. Food and Drug Administration (“FDA”) to obtain alignment on the content and format of the pre-clinical and clinical data required to support a new drug application (“NDA”) seeking approval of Landiolol, a novel therapeutic, for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter. Landiolol is a short-acting, ultra-high selective beta-1 adrenoceptor blocker developed by AOP Health that has a selective effect on heart rate over cardiac contractility. 

BD Board Approves Embecta Diabetes Business Spinoff

BD received approval from its board of directors for the planned spinoff of its diabetes care business, Embecta Corp. The Franklin Lakes-based company, also known as Becton, Dickinson and Co., confirmed in May 2021 that it planned to spin off its diabetes care business as an independent, publicly traded company during the first half of 2022 and in December 2021 it confirmed the naming of the new business as “embecta,” or Embecta Corp. The board voted unanimously to approve the spinoff, which is now set for April 1. The separation will also enhance the ability of Embecta to attract capital investment, recruit talent and allocate resources and efforts into its unique business development, innovation and product development programs to drive future growth, which ultimately benefits more people living with diabetes around the world.

BD Acquires Spain-Based Blood Cancer Diagnostic Company

Franklin Lakes-based BD announced it acquired Cytognos as a way to accelerate its strategy to support chronic disease management. The partnership expands BD’s portfolio of blood cancer diagnostics, immune assessment tests and informatics to address patient, clinician and care provider needs to better understand the immune system, immune response and minimal residual disease. Terms of the deal were not disclosed. The Spain-based Cytognos specializes in flow cytometry solutions for blood cancer diagnosis, MRD detection and immune monitoring research for blood diseases. By monitoring for MRD, lab managers and physicians can detect low levels of cancer cells following treatment that alerts them if the disease is still present or if there is a signal of recurrence.

Avison Young Facilitates 162,500 Sq. Ft. in Office, Industrial and Life Sciences Leases in Piscataway and Bloomfield

Avison Young’s New Jersey office announced that it arranged over 162,500 square feet in new office, industrial/flex and life sciences leases across private real estate holding company Shelbourne Global’s 631,784-square-foot commercial portfolio. “Although industrial has been a key driver of activity, there has also been a strong appetite from pharmaceutical manufacturing companies for premier lab, biotech and research space,” Ariel Brenner, Vice President of Leasing at Shelbourne, stated. Genscript inked a new 56,843-square-foot lease at Shelbourne’s 20 Kingsbridge Road in Piscataway for new office, research and lab space.

Global Skincare Company Opens R&D Facility in Florham Park

Beiersdorf unveiled its Innovation Center in Florham Park. The Hamburg, Germany-based skincare company, whose portfolio includes brands such as Aquaphor, Eucerin, NIVEA, La Prairie and Coppertone, opened the new Florham Park center as part of its global R&D strategy. The company said it chose Florham Park as the location of one of its only two state-of-the-art Innovation Centers because “this area of New Jersey is considered a ‘science hot bed,’ as it is also home to other large research and development centers, and has excellent access to talent and universities, suppliers and testing institutes.” The Garden State facility will employ 45 R&D scientists.

Pfizer Announces New Chief Development Officer

BioNJ Member Pfizer, with offices in Peapack, announced that William Pao, M.D., Ph.D., will join the company as Executive Vice President and Chief Development Officer. Dr. Pao will be a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Albert Bourla. He joins Pfizer from Roche, where he most recently served as the Head of Pharma Research and Early Development (pRED) and oversaw the discovery and early development of a portfolio of new molecular entities to treat diseases related to cancer, neuroscience, ophthalmology, rare diseases, immunology, infectious diseases, and rare blood disorders, across seven global sites. He was also a member of Roche’s Enlarged Corporate Executive Committee.

Nutley Pharma Company Adds to Leadership Team With New Head of Office, Government Affairs and Policy

Nutley-based Eisai Inc. announced it has expanded its leadership team to include Tricia Brooks as Vice President and Head of Office, Government Affairs and Policy. Ms. Brooks will be responsible for developing and leading the government affairs and public policy function, guiding, representing and growing the Nutley-based pharmaceutical company’s work to create a network of bipartisan relationships with key influencers and decision-makers that enables the company to build on the Eisai human health care mission. Ms. Brooks also will lead the development of federal and state government strategies, aligned to the achievement of corporate, disease and brand objectives.

Drs. Margaret Dugan and Alessandro Riva Appointed to BeiGene Board of Directors

Ridgefield Park-based BeiGene announced the appointment of Margaret Dugan, M.D., and Alessandro Riva, M.D., to its Board of Directors. Dr. Dugan will join the scientific advisory committee and Dr. Riva will join the nominating and corporate governance, and scientific advisory committees of the board. In addition, Jing-Shyh (Sam) Su will be stepping down from BeiGene’s board of directors after serving for almost four years. Dr. Dugan is currently Chief Medical Officer at Dracen Pharmaceuticals, a privately held pharmaceutical company based in New York that leverages immuno-metabolism in oncology. Dr. Riva is currently Chief Executive Officer of Intima Bioscience, a privately held clinical stage gene and cell therapy company.

Rutgers Team Develops Rapid Screening Test for Omicron and Other COVID Variants

A team at Rutgers New Jersey Medical School has developed a rapid test that detects all known COVID-19 variants. Using special probes called “sloppy molecular beacons,” the test can detect clinical samples that contain the SARS-CoV-2 virus with signature mutations for each known variant of concern — namely, the Alpha, Beta, Gamma and Omicron variants. The study demonstrates that the approach is 100% sensitive and specific for identifying the correct variant when tested on clinical samples. The Rutgers Genomics Center clinical lab team are now working to obtain rapid approval from the New Jersey Department of Health to use the new test on patients, where it could help determine the correct type of antibody therapy and potentially help identify patients at high risk for severe COVID-19.

New Jersey’s Only NCI-Designated Comprehensive Cancer Center Names Director for Phase I Clinical Trials and Investigational Therapeutics

Enhancing its commitment to providing the most advanced treatment options for cancer patients through clinical trials, Rutgers Cancer Institute of New Jersey has named Sanjay Goel, M.D., MS as Director of its Phase I/Investigational Therapeutics Program. He is also a professor of medicine at Rutgers Robert Wood Johnson Medical School. Dr. Goel will lead the Phase I/Investigational Therapeutics Program, which is a multidisciplinary scientific group designed to develop new methods for the treatment of cancer in collaboration with colleagues across the RWJBarnabas Health system. The Phase I/Investigational Therapeutics Program conducts clinical trials of novel targeted therapy approaches, including genomics-directed protocols and novel immuno-oncology approaches, as well as first-in-human trials of novel compounds.

Twelve Rutgers Professors Named Fellows of the American Association for the Advancement of Science

Rutgers faculty elected to the newest class of fellows for the American Association for the Advancement of Science (AAAS) are engaging in research to tackle some of the greatest mysteries of human health, build a better understanding of the body’s response to disease and advance the growth of green energy. Their work demonstrates the breadth of ongoing research at the university that is changing the world and making a difference in people’s lives. The dozen faculty members, the largest group ever selected from Rutgers, are working to restore the brain function of people suffering from ALS and Alzheimer’s disease, have been recognized for their efforts advocating for public health and are working to understand the causes of the long-term effects of COVID-19. 

Expansion Provides Capacity to Accommodate a Large Spike in The Demand for Process Development and Clinical Production of Cell and Gene Therapies Moving from Bench to Clinic

BioCentriq has completed the construction of a state-of-the-art GMP-ready clinical manufacturing facility in South Brunswick. The new facility is adjacent to its existing pilot plant and includes all the supporting infrastructure and lab space to support the clinical manufacturing of allogeneic and autologous cell therapies and gene therapies. “This expansion of our clinical production capacity allows us to meet the demands of our clients,” stated Haro Hartounian, Senior Vice President and General Manager of BioCentriq. “We understand the myriad of challenges our clients face when they are optimizing and scaling up their processes to prepare for clinical manufacturing. Our team’s cumulative expertise in process development and GMP manufacturing enables us to meet the growing demand in this space.”

The Art of Innovation: Christina Pellicane

Like a connoisseur of fine art, Christina Pellicane both understands and enjoys the details, technique and principles of commercialization. She’s spent most of her career on just that - making an impact through innovation. Her work is reminiscent of a Jackson Pollock painting - drips and splashes dotting the canvas -- it is purposeful and groundbreaking. Christina first thought about the impact of research when she worked at Venenum Biodesign, a company specializing in drug discovery. Inspired, Christina began to percolate on the idea of impact within the science community. Her journey took her to AlcheraBio as a clinical business administrator and study monitor, before she landed at the NYC Regional Innovation Node as executive manager. The NYC Regional Innovation Node afforded Christina the opportunity to build an entirely new program from scratch. She began training scientists and engineers on the National Science Foundation (NSF) Innovation Corps (I-Corps) process, an approach to early stage commercialization.

Rowan Launches New School of Innovation & Entrepreneurship

Rowan University has launched its School of Innovation & Entrepreneurship within the Rohrer College of Business (RCB), an entity designed to further opportunities for professional start-ups and a cross-campus entrepreneurial mindset. The school is the first of its kind in New Jersey and one of just a few university-based schools of innovation and entrepreneurship in the country. Though the new school is housed in the RCB, Provost and Senior Vice President for Academic Affairs Dr. Tony Lowman, a longtime educator, engineer and entrepreneur, said the school will help students pursue creative career paths to forge their own future, no matter their course of study.

Hackensack Meridian Mountainside Earns ACR Lung Cancer Screening Designation

The American College of Radiology has designated Hackensack Meridian Mountainside Medical Center as a Lung Cancer Screening Center. In order to receive this distinction, facilities must be accredited by the ACR in computed tomography in the chest module, as well as undergo a rigorous assessment of their lung cancer screening protocol and infrastructure. Also required are procedures in place for follow-up patient care, such as counseling and smoking cessation programs. “The Lung Cancer Screening Program gives our community convenient access to exceptional cancer care, should they need it,” said Tim O’Brien, CEO at Mountainside Medical Center. “This designation reinforces our commitment to provide quality services while maintaining a consistent approach to patient care.”

Xavier Named Chief Medical Officer at Hackettstown, Newton Medical Centers

Dr. Geralda Xavier has joined Atlantic Health System as Chief Medical Officer for Hackettstown and Newton medical centers. Dr. Xavier is a highly skilled physician executive with more than 15 years of experience in clinical care and medical staff leadership. She is a board-certified emergency medicine physician and maintains national certifications in clinical practice. She has a strong reputation for being a change management champion using robust process improvement, fostering team engagement and promoting psychological safety, across disciplines and departments. At Hackettstown and Newton medical centers, Dr. Xavier will play a pivotal role in supporting and advancing physician engagement, integration and alignment with both hospitals and within Atlantic Health System.

Cooper University Health Care Launches New Endocrine Surgery Subspecialty

Cooper University Health Care has launched a new Section of Endocrine Surgery and has appointed endocrine specialist Dr. Lisa Reid as its inaugural head. The new department will provide specialized treatment for patients with a wide range of endocrine diseases, including diabetes, Cushing’s syndrome, Grave’s disease, goiters, hyperthyroidism, hypothyroidism and adrenal and thyroid cancers, among other conditions. Dr. Reid has practiced at Cooper for 14 years and has led the development of the premier endocrine surgery practice in southern New Jersey.

Cooper University Health Care Donates 200,000 KN95 Masks

To help the community prevent the spread of COVID-19, Cooper University Health Care will provide 200,000 non-medical grade KN95 masks to be distributed throughout Camden with the assistance of the Camden County Metro Police and Sheriff’s Departments. The masks will be distributed through a variety of community organizations, schools, and senior centers among other locations with the assistance of officers from the Camden Metro Police and Sheriff’s Department. “As the Omicron variant continues to be present throughout the community, we want to provide residents with an additional measure of protection for themselves and others. Masks are a powerful weapon in our fight to slow the spread of this virus,” said Kevin O’Dowd, JD, co-CEO of Cooper.

Cooper University Health Wins National Award for Documentary Series on Health Care Workers During COVID

Cooper University Health Care was recently named the winner of Ragan Communications’ PR Daily Content Marketing Awards for the Best Video Series for “Stories in Care,” a 22-part documentary-style miniseries highlighting the powerful and emotional COVID-19 experiences of its frontline workers. Told in emotional, first-person accounts, “Stories in Care” captures the triumphs, tragedies and recollections of members of Cooper’s Critical Care team through one of the world’s most pressing public health crises in decades. “Years from now, when the pandemic is long over, we and future generations of health care workers will benefit from having a video history of the experiences of those who worked tirelessly on the front lines fighting COVID-19,” said Dr. Anthony Mazzarelli, co-CEO of Cooper.

Intro to Design & Manufacturing of Viral Vectors in Gene Therapy

February 14-17, 2022

This online virtual training course will provide a detailed understanding in upstream and downstream processing of viral vectors used in cell and gene therapy. The course will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics. The course is intended for scientists and engineers from the biopharma industry interested in learning about upstream and downstream processing of viral vectors. Attendees will need to have a basic understanding of cell culture, conventional culture methods and chromatography (affinity, protein capture).

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 [email protected], 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