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August 26, 2022

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

On August 16, President Biden signed the Inflation Reduction Act into law legislation that is going to harm Patient access to innovative medicines by allowing government price setting on new treatments. Unfortunately, this legislation fails to address one of the true drivers of high costs in the healthcare system: industry middlemen known as pharmacy benefit managers (PBMs). PBMs negotiate rebates and fees with drug manufacturers, create drug formularies and reimburse pharmacies for Patients’ prescriptions. However, far too often, PBMs fail to pass along these manufacturer rebates and discounts to Patients at the pharmacy counter.


Just three PBMs, all owned by giant for-profit insurance companies, control approximately 80% of the entire PBM middleman industry in the U.S. PBMs have an enormous influence over the treatments that Patients can access, which can lead to higher costs for families when the most expensive drugs are prioritized in their formulary. Higher out-of-pocket costs can contribute to lower levels of treatment adherence and higher levels of treatment abandonment, leading to worse health outcomes for Patients with chronic and hard-to-treat conditions.


A new BioNJ infographic details the impact that PBMs have on Patients – from failing to pass along rebates to reduce Patient out-of-pocket costs to worsened health outcomes due to treatment abandonment. Click here to view and share this informative infographic. 

Join BioNJ in our efforts to educate on the enormous effect that PBMs have on Patients. State legislation requiring insurers and PBMs to share negotiated discounts and rebates at the pharmacy counter could save some New Jersey Patients nearly $1,000 each year.

Contact us at or visit to learn more. Plus, click here to receive important updates on how you can take action online and within your community. Together we can make a difference. Thank you. 

Because Patients Can't Wait®,

The BioNJ Team

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October 18, 2022

Putting Patients First:

The Value of Medical Innovation


Can Bureaucrats Really Lower Drug Prices?

A so-called prescription drug affordability board proposed in New Jersey (A1747) would stifle innovation for future cures and do nothing to ensure savings for patients. 

Frustrated Pharmacists Opting Out of Insurance System, Saving Some Customers Hundreds of Dollars a Month

With prescription drug prices continuing to go up, one pharmacist in Ohio found a way to lower those costs with a self-pay pharmacy where customers pay out of pocket and save hundreds without insurance.

HHS Probe: Insurer PBMs Pocket Rebates as Patients, Taxpayers Pay More

The practice of making drug makers give rebates to payers encourages Medicare Part D insurers to steer patients away from generic drugs that cost less, “resulting in beneficiaries paying thousands more out-of-pocket” and higher costs for the Medicare administration, according to a recent investigation by the Office of Inspector General (OIG) of the U.S. Health and Human Services (HHS) Department. “The large rebates offered by manufacturers for higher-cost hepatitis C drugs benefit plan sponsors but provide little relief to beneficiaries who received the drugs or the Medicare program,” the report found. The investigation suggests that the high cost of prescription drugs is driven by market distortions in the private insurance system. The findings indicate that the new “Inflation Reduction Act,” which seeks to reduce drug prices by allowing Medicare to force manufacturers to agree to lower prices, is missing the mark. Apparently, lowering the cost of drugs, for both patients and taxpayers, requires reforms of the current system in which insurer’s pharmacy benefit managers (PBMs) take rebates from drug manufacturers in exchange for including their products in the formulary of drugs covered by insurers.

From Meat to Insulin, How the Middlemen Economy Makes Everything More Expensive

The Federal Trade Commission recently launched an inquiry into the practices of pharmacy benefit managers, known in the industry as PBMs. PBMs are the hidden middlemen who were supposed to make drug distribution more efficient. Yet over time, they have grown in size and power, and research suggests they have contributed to the rapidly rising costs of prescription drugs, while taking home a growing chunk of those ballooning prices. The way that their growth and growing profits puts critical drugs out of reach for many, contributing to avoidable deaths and disease, may be extreme but it’s not an aberration. It is instead reflective of the way the growing size and power of middlemen is undermining the health of the economy and the real people the economy is supposed to help serve.

Inflation Reduction Act Breaks the Prescription-Drug Pipeline

The pharmaceutical-innovation pipeline, which recently delivered the life-saving COVID-19 vaccines in record time, may be irrevocably broken. The so-called Inflation Reduction Act allows the government for the first time to enact price controls on some prescription drugs in Medicare. Artificially lowering prescription drug prices by government fiat will reduce the revenues needed to fund the next generation of cures. The dynamic U.S. prescription drug industry has helped Americans live longer and healthier lives. New medications are responsible for around half the increase in U.S. life expectancy over the past 30 years. The IRA’s price controls threaten this progress. They effectively transfer nearly $300 billion from the productive pharmaceutical industry to the unproductive green energy complex. This wealth transfer will meaningfully reduce the nearly $100 billion, or about 28% of revenues, drug makers spend yearly on research and development.

An Oversimplified Drug Price Policy That Misses the Point

Anyone who understands the true challenges of the prescription drug supply chain in the United States has sufficient reason to be, at the least, annoyed with the Inflation Reduction Act. The bill offers the simple-sounding solution of drug price controls, but it utterly fails to solve the true long-term problem of higher costs for everyone who shows up at the pharmacy counter. It is well-documented that people are paying more and more out of their own pocket for medicines, even when they have “good” health insurance from their employer. The Inflation Reduction Act does nothing to change this. So, unless you are in Medicare Part D – which this measure thankfully updates with a $2,000 cap on out-of-pocket drug costs – the Inflation Reduction Act won’t help you.

New Survey: Voters Seriously Concerned About Fine Print in Reconciliation Bill

A new Morning Consult survey explores what Inflation Reduction Act actually does – and does not do – and finds that voters are skeptical of its impact on inflation, worried about the consequences of Medicare “negotiation” and concerned the bill doesn’t do enough to help make medicines affordable for patients. Here are three takeaways from a new PhRMA/Morning Consult survey of 2,005 registered voters.

Democrats Are On a Dangerous Path With Drug Pricing

The passage of Democrats’ sweeping economic package, which is designed to combat climate change, address health care costs and reduce the deficit by raising taxes on corporations, is a major win for President Biden’s agenda. Democrats’ final legislation extends expanded subsidies under the Affordable Care Act and realizes the party’s long-sought goal of allowing Medicare to “negotiate” prescription drug prices directly with pharmaceutical companies. Proponents claim that enabling Medicare to negotiate prices will lower the cost of prescription drugs for the nearly 64 million Americans who are currently on Medicare, and more specifically for the 1.4 million beneficiaries who spend more than $2,000 per year on their medications. Regrettably, this is a misguided assessment that fails to consider how this policy will actually decrease both the affordability and accessibility of prescription drugs in the long run.

ICYMI: New Research Builds Upon Growing Body of Evidence On Value of COVID-19 Treatments and Vaccines

Innovative biopharmaceutical research companies have been dedicated to fighting COVID-19 for over two years. Since the start of the pandemic, America’s biopharmaceutical companies have worked around the clock to research, develop and manufacture treatments and vaccines to fight COVID-19. We’ve made unprecedented progress in a short time thanks to decades of experience having produced over 14 billion vaccines globally to date. What’s more, lessons learned during the pandemic are already informing the future of fighting disease. In new research released by the University of Chicago, data demonstrates what a growing body of evidence has noted: COVID-19 vaccines and treatments helped save millions of lives and billions of dollars in the U.S.

BioNJ in the News


NJBIZ Conversations: Debbie Hart

The life sciences industry is crucial to New Jersey’s economic health and the physical health of individuals around the world. It’s a pretty big deal. Keeping the business healthy, then, is an important task – one BioNJ has been tackling since 1994. The organization advocates for its membership in Trenton and Washington, pursuing policies that will nurture and expand the industry in the State. In addition, BioNJ provides education and networking opportunities, fosters collaboration where appropriate and offers a variety of business assistance. In this edition of NJBIZ Conversations, Debbie Hart, BioNJ’s President and founding CEO, discusses the state of the life sciences industry in New Jersey, the outlook for the next year and the organization’s priorities in the post-COVID era.

NJ Company News


LYNPARZA® (olaparib) Approved in Japan as Adjuvant Treatment for Patients With BRCA-Mutated, HER2-Negative High Recurrent Risk Breast Cancer

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that LYNPARZA has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the adjuvant treatment for patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high recurrent risk breast cancer. This approval was based on results from the Phase 3 OlympiA trial published in The New England Journal of Medicine in June 2021. In the trial, LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p<0.0001) versus placebo.

FDA Accepts Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone for Patients With Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review

Kenilworth-based BioNJ Member Merck & Co. announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). In the U.S., prostate cancer is the second most common cancer in male patients. Approximately 10-20% of male patients with advanced prostate cancer are estimated to develop castration resistant prostate cancer (CRPC) within five years, and at least 84% of these men may develop metastases at the time of CRPC diagnosis. 

Merck and Orna Therapeutics Collaborate to Advance Orna’s Next Generation of RNA Technology

Kenilworth-based BioNJ Member Merck & Co. and Orna Therapeutics announced a collaboration agreement to discover, develop and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology. Orna’s proprietary oRNA technology creates circular RNAs (oRNAs) from linear RNAs by self-circularization. oRNA molecules have been shown to have greater stability in vivo than linear mRNA and have the potential to produce larger quantities of therapeutic proteins inside the body. Newly synthesized oRNA molecules are more compactly packaged into custom lipid nanoparticles (LNPs), which Orna has engineered to target key tissues in the body. Preclinical data have demonstrated the potential of oRNA expression and delivery as an approach for further development in multiple areas, including vaccines and oncology therapeutics. 

Merck Receives Fast Track Designation from the U.S. FDA for MK-2060, an Investigational Anticoagulant Therapy

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck’s investigational anticoagulant therapy MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. MK-2060 is an investigational monoclonal antibody designed to inhibit Factor XI and its ability to activate downstream proteins involved in the blood coagulation cascade. MK-2060 is currently being evaluated in a Phase 2 study for the treatment of patients with ESRD receiving hemodialysis. 

Bristol Myers Squibb and 2seventy bio Announce Topline Results from KarMMa-3 Trial Showing Abecma (idecabtagene vicleucel) Significantly Improves Progression-Free Survival Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma

Princeton-based BioNJ Member Bristol Myers Squibb and 2seventy bio, Inc. announced positive topline results from KarMMa-3, a Phase 3, global, randomized, multicenter, open-label study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory after two to four prior lines of therapy and refractory to the last regimen. KarMMa-3 is the first randomized clinical trial to evaluate a CAR T cell therapy in multiple myeloma. Results of a pre-specified interim analysis conducted through an independent review committee showed that KarMMa-3 met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens. 

Bristol Myers Squibb Completes Acquisition of Turning Point Therapeutics, Expanding Precision Oncology Portfolio

Princeton-based BioNJ Member Bristol Myers Squibb announced that it has successfully completed its acquisition of Turning Point Therapeutics, Inc. Through the transaction, Bristol Myers Squibb gains a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis, including repotrectinib. Repotrectinib is a next-generation, potential best-in-class tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors. In the Phase 1/2 TRIDENT-1 clinical trial, longer duration of response has been observed in the landmark analysis with repotrectinib than with existing ROS1 agents in first-line NSCLC. The asset has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration. 

Kyowa Kirin Receives European Commission Approval for Use of CRYSVITA®▼(burosumab) for the Treatment of Tumor-Induced Osteomalacia (TIO)

BioNJ Member Kyowa Kirin Co., Ltd., with a site in Bedminster, announced that the European Commission (EC) approved CRYSVITA® (burosumab) for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localized in children and adolescents aged 1 to 17 years and in adults.1 CRYSVITA is also already licensed in the EU for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.2 “The approval by the European Commission is a very welcome milestone for those living with TIO that cannot be cured by complete surgical resection,” said Professor Ralf Oheim, Department of Osteology and Biomechanics, University Medical Center Hamburg. 

Guess Which Jersey Company Topped 2022 Inc. 5000 List of Fastest-Growing Private Companies

According to Inc., the companies on the 2022 Inc. 5000 have not only been successful, but have also demonstrated resilience amid supply chain woes, labor shortages and the ongoing impact of COVID-19. Among the Top 500, the average median three-year revenue growth rate soared to 2,144%. Together, those companies added more than 68,394 jobs over the past three years. Specifically in New Jersey, companies that placed on the list were responsible for $4.6 billion in total revenue and 11,256 jobs. Congratulations to BioNJ Member for making the list!

U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients With Chronic Graft-Versus-Host Disease

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced  that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. This milestone marks the first pediatric indication for IMBRUVICA® and the introduction of a new oral suspension formulation for patients ages one to less than 12. IMBRUVICA® is now the first FDA-approved therapy for these younger patients who previously had no approved treatment options for this life-threatening disease.

8 N.J.-Based Companies Rank on Forbes Best-in-State Employers 2022 List

Forbes Magazine released its annual rankings for its America’s Best Employers by State with insurance, health care and higher education organizations ranking highest on the New Jersey List. The list, compiled by market research company Statista, anonymously surveyed 70,000 Americans working for businesses with at least 500 employees to come up with the state-by-state rankings. The employees were asked to rate their company’s handling of such things as safety of work environment, competitiveness of compensation, opportunities for advancement and openness to telecommuting. Congratulations to BioNJ Members Johnson & Johnson and Princeton University for making the list. 

Janssen Marks First Approval Worldwide for TECVAYLI® (teclistamab) With EC Authorization of First-in-Class Bispecific Antibody for the Treatment of Patients With Multiple Myeloma

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted conditional marketing authorization (CMA) of TECVAYLI® (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. This milestone marks the first approval worldwide for teclistamab, a first-in-class bispecific antibody that redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumor cells.

PAN-TB Collaboration to Advance Investigational Tuberculosis Drug Regimens to Phase 2 Clinical Trials

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration announced the execution of a joint development agreement (JDA) supporting the progression of two investigational tuberculosis (TB) combination treatment regimens into Phase 2 clinical development. The collaboration will evaluate whether the novel regimens, which combine registered products and new chemical entities (NCEs), can effectively treat all forms of active pulmonary TB using substantially shorter treatment durations than existing drug regimens, with the goal of identifying a regimen suitable for phase 3 development. Recognizing that no single organization produces the full range of drugs needed to respond to TB, the PAN-TB collaboration brings together philanthropic, non-profit and private sector organizations to accelerate the development of novel, shorter drug regimens to treat all forms of TB. 

Chugai Obtains Regulatory Approval for POLIVY for Additional Indication of Previously Untreated Diffuse Large B-cell Lymphoma

BioNJ Member, Chugai Pharmaceutical Co., Ltd., with a site in Berkeley Heights, announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy® intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Polivy is an antibody-drug conjugate, which is a combination of an antibody and a small molecule compound. This approval is based on the global Phase III clinical study (POLARIX study) in patients with previously untreated DLBCL.

Chugai Obtains Regulatory Approval for Osteoporosis Treatment Edirol Tablet

BioNJ Member, Chugai Pharmaceutical Co., Ltd., with a site in Berkeley Heights, announced they have obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for an osteoporosis treatment Edirol® Tablets 0.5 µg/0.75 µg (generic name: eldecalcitol, hereafter, Edirol Tablet). Edirol is an active vitamin D3 derivative created based on Chugai’s long-standing vitamin D research. The drug was launched in 2011 in a soft capsule formulation as Edirol Capsule and has been used as a base drug for the treatment of osteoporosis. Chugai developed an alternative tablet formulation for Edirol that is easier to handle and identify. The regulatory approval for Edirol Tablet is based on the results of a bioequivalence study comparing the soft capsule and the tablet in 49 healthy adult volunteers.

Anti-C5 Recycling Antibody Crovalimab Obtains Priority Review in China for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

BioNJ Member, Chugai Pharmaceutical Co., Ltd., with a site in Berkeley Heights, announced that the National Medical Products Administration (NMPA) of People’s Republic of China accepted an application for regulatory approval of crovalimab (development code: SKY59/RG6107) for paroxysmal nocturnal hemoglobinuria (PNH) and granted priority review. Crovalimab is a humanized complement inhibitor C5 monoclonal antibody discovered by Chugai. As F. Hoffmann-La Roche Ltd. (hereafter “Roche”) is responsible for the development of crovalimab outside Japan and Taiwan, the regulatory application was filed by a China affiliate of Roche. In China, crovalimab was designated as a Breakthrough Therapy for PNH in July 2021.

Chugai and Noile-Immune Biotech Enter into a License Agreement for Noile-Immune’s PRIME CAR-T Technology

BioNJ Member Chugai Pharmaceutical Co., Ltd,. with a site in Berkeley Heights, and Noile-Immune Biotech Inc. announced that the companies entered into a license agreement for Noile-Immune’s proprietary PRIME (Proliferation-Inducing and Migration-Enhancing) CAR-T technology. Chimeric antigen receptor T cell (CAR-T cell) therapy is a type of cancer immunotherapy, in which a patient’s immune cells (T cells) are collected, transfected with a gene for an artificial chimeric antigen receptor (CAR), which recognizes a cancer antigen, expanded in large numbers and returned to the patient’s body. The therapy is currently used as a new treatment for hematologic cancers. Noile-Immune’s PRIME technology is expected to open the possibility of CAR-T cell therapy not only for hematologic cancers but also for solid tumors. 

Pfizer Announces Positive Top-Line Data from Phase 3 Trial of Older Adults for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate

BioNJ Member Pfizer, with a site in Peapack, announced positive top-line data from the Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease) investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older. The bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains.

RSV disease is characterized by several respiratory symptoms varying from mild to more severe disease, with more severe disease having more symptoms. A pre-planned, interim analysis of Pfizer’s RSVpreF efficacy conducted by an independent, external Data Monitoring Committee (DMC) to assess protection against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms demonstrated vaccine efficacy: 66.7% (96.66% CI: 28.8%, 85.8%). 

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine

BioNJ Member Pfizer, with a site in Peapack, and BioNTech SE announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older. The application follows guidance from the FDA to include clinical data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately. 

Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children 6 Months Through 4 Years of Age

BioNJ Member Pfizer, with a site in Peapack, and BioNTech SE announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022. Emergency Use Authorization (EUA) of this vaccine was granted by the U.S. Food and Drug Administration (FDA) for this age group and an application for conditional Marketing Authorization in this age group is under review by the European Medicines Agency (EMA). Pfizer and BioNTech submitted safety and immunogenicity data to the EMA requesting an update to the Conditional Marketing Authorization (CMA) in the European Union (EU) to include children ages 6 months through 4 years. 

Pfizer Announces Positive Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Infants

BioNJ Member Pfizer, with a site in Peapack, announced positive top-line results from its pivotal U.S. Phase 3 study (NCT04382326) in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population. The study had two co-primary objectives, associated with immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series, respectively: non-inferiority (NI) of the percentage of participants with predefined serotype-specific immunoglobin G (IgG) concentrations after Dose 3 and NI of IgG geometric mean concentrations (GMCs) after Dose 4. 

Trodelvy® Significantly Improves Overall Survival in Pre-Treated HR+/HER2- Metastatic Breast Cancer Patients in the TROPiCS-02 Study

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase 3 TROPiCS-02 study evaluating Trodelvy® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Detailed OS results will be presented at an upcoming medical conference. The safety profile for Trodelvy was consistent with prior studies, and no new safety signals emerged in this patient population. Gilead has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA). 

Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced that the European Commission (EC) has granted Marketing Authorization for Sunlenca® (lenacapavir) injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. Lenacapavir is a first-in-class capsid inhibitor with a multi-stage mechanism of action and has no known cross resistance to other existing drug classes, offering a new, every six-month treatment option for people with HIV whose virus no longer effectively responds to their current therapy. 

Gilead to Acquire Remaining Worldwide Rights of Trodelvy®

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced an agreement with Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy® (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. In China mainland and Singapore, Trodelvy is approved for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Gilead continues to work closely with regulatory bodies in Hong Kong, South Korea and Taiwan, where New Drug Applications, filed by Everest Medicines for metastatic TNBC, are currently under review. 

GSK Completes Acquisition of Affinivax, Inc.

Warren-based BioNJ Member GSK announced it has completed the acquisition of Affinivax, Inc., a clinical-stage biopharmaceutical company. The acquisition of Affinivax aligns with GSK’s strategy of building a strong portfolio of specialty medicines and vaccines. It includes a next-generation 24-valent pneumococcal vaccine candidate (AFX3772), currently in Phase II development, which is based on the highly innovative Multiple Antigen Presenting System (MAPSTM) platform technology. A 30-plus valent pneumococcal candidate vaccine is also in pre-clinical development. The MAPSTM technology supports higher valency than conventional conjugation technologies, potentially enabling broader coverage against prevalent pneumococcal serotypes and generating higher antibody responses against many individual serotypes than current pneumococcal vaccines.

ADC Therapeutics Announces $175 Million Senior Secured Term Loan from Owl Rock and Oaktree and Settlement of Existing Senior Secured Convertible Notes

BioNJ Member ADC Therapeutics, with a site in New Providence, announced that it has completed a series of strategic transactions in which it entered a new $175 million senior secured term loan with certain funds of Owl Rock and funds managed by Oaktree Capital Management, L.P. with an upfront tranche of $120 million received upon closing. Settled in full the $115 million aggregate principal amount of senior secured convertible notes held by Deerfield Management Company. "We are excited to partner with ADC Therapeutics as it continues to develop a pipeline of novel ADCs for hematologic malignancies and solid tumors,” said Aman Kumar, Co-Portfolio Manager of Life Sciences Lending at Oaktree. “This is an important time in the company’s development with its first product approval validating its first-in-class ADC platform.”

JLL: More Than One-Third of Leases Signed Thru Mid-2022 Involved Life Sciences Companies

Life sciences companies were active in the pursuit of Class A office space, research & development/lab and manufacturing facilities through mid-2022 — that’s according to a new report from JLL with a site in Parsippany. The latest figures show that more than one-third of leases signed in New Jersey during the first half of the year involved life sciences companies, which was the highest proportion among the various business sectors. Cell therapy and biomanufacturing tenants remain in expansion mode, while growing biotech companies are tapping the pool of skilled employees available following consolidations among the larger pharmaceutical players. Looking ahead, JLL’s report finds that accelerating demand from life sciences companies seeking modern, amenity-rich workspaces will foster the conversion of outdated office buildings with lab favorable infrastructures.

Eisai Inc. Opens New HQ in Nutley

Eisai Inc. held a grand opening for its new headquarters, the Eisai U.S. hhceco Center, in Nutley. This new facility, on the ON3 Campus, is strategically located to advance the company’s human health care (hhc) mission. The Eisai U.S. hhceco Center will expand the diverse and powerful life sciences community in New Jersey, and aim to address pressing medical challenges in cancer, Alzheimer’s disease and other neurological diseases. At the grand opening celebration, Eisai’s Global CEO, Haruo Naito, highlighted how the company is expanding its longstanding hhc mission to address health care’s most pressing challenges, based on the concept of an ecosystem model in which organizations share technologies, exchange values and grow together to deliver health-related solutions that matter to people and contribute to society – called hhceco.

BeiGene Announces Acceptance of 11th Regulatory Submission for PD-1 Inhibitor Tislelizumab in China

Hopewell-based BeiGene announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for tislelizumab in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). Esophageal cancers are classified based on the type of cells involved and ESCC is the most common subtype, accounting for more than 85% of esophageal cancers worldwide. In China, esophageal cancer is the fourth leading cause of death due to malignancy and remains a significant threat to public health with 246,000 new diagnoses reported in 2015. 

ENHERTU ® Significantly Delayed Disease Progression in DESTINY- Breast02 Phase 3 Trial Versus Physician’s Choice of Treatment in Patients With HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo, with a site in Basking Ridge, announced positive topline results from the DESTINY-Breast02 Phase 3 trial of ENHERTU® (trastuzumab deruxtecan) versus physician’s choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine (T-DM1). The trial also met the key secondary endpoint of improved overall survival. The trial evaluated a similar later-line patient population as the single-arm DESTINY-Breast01 Phase 2 trial, which is the basis for initial approvals in advanced HER2 positive metastatic breast cancer.

ENHERTU® Approved in the U.S. as the First HER2 Directed Therapy for Patients With Previously Treated HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Daiichi Sankyo, with a site in Basking Ridge, announced ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU is the first HER2 directed medicine to be approved for the treatment of patients with HER2 mutant metastatic NSCLC. This is the third tumor type approved by the FDA for ENHERTU in three years.

Princeton Pharma Partners With Provepharm on Injectable Product

Princeton-based Calyptus Pharmaceuticals Inc. announced that it entered into an agreement with Provepharm SAS to accelerate development of its complex injectable product used in acute care settings. Upon approval of the deal, Provepharm will acquire global rights to the product and will take on all development activities and commercial distribution. In other Calyptus news, the company also announced that the U.S. Food and Drug Administration granted its partner, Akorn Operating Co., approval of an abbreviated new drug application for a generic version of Cetrotide (cetrorelix acetate for injection). The approval, along with a competitive generic therapy (CGT) designation, makes the product eligible for 180 days of CGT market exclusivity. The injection is indicated for women undergoing controlled ovarian stimulation during infertility treatment.

BD Collaborates With Accelerate Diagnostics on Rapid Test Kits

BD (Becton, Dickinson and Co.) headquartered in Franklin Lakes, announced a commercial collaboration under which the company will offer Accelerate Diagnostics Inc.’s rapid tests through its global sales network. Accelerate, provides rapid in-vitro diagnostics in microbiology. The collaboration includes its rapid-testing solution for antibiotic resistance and susceptibility, which offers results in a few hours – as opposed to the one- or two-day turnaround of traditional lab methods. According to BD, the PhenoTest BC kit is the first test cleared by the U.S. Food and Drug Administration that can deliver both rapid identification and phenotypic antibiotic susceptibility results in hours from positive blood cultures.  

Catalent Acquires Metrics Contract Services for $475M

Catalent, headquartered in Somerset, continues its growth trajectory with the $475 million acquisition of Metrics Contract Services, a full-service specialty contract development and manufacturing organization (CDMO). The company announced the move just a few weeks after unveiling its new operating structure, not to mention a new CEO, Alessandro Maselli. Catalent said the acquisition from Mayne Pharma Group Ltd. will strengthen its capabilities in integrated oral solid formulation development, manufacturing and packaging, while also expanding its capacity to handle highly potent compounds. The facility’s estimated annual production capacity exceeds 1 billion oral solid dose units. 

GenScript USA Offers Monkeypox Test for Research

Elected officials and health care professionals are working diligently to curb the spread of monkeypox, which was declared a public health emergency earlier this month. GenScript USA Inc., located in Piscataway, announced the immediate availability of a monkeypox PCR test kit to help detect the virus. The firm said diagnostic labs and medical device distributors may now order the kit, which was developed in partnership with Anbio Biotechnology of China. The test kit has received the CE mark for IVD (in vitro diagnostics) use in the European Union; however, it is currently available only for research purposes in the U.S. and not for official diagnoses.  

Funding/Economic Development

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An Inside Look at the New Jersey Innovation Evergreen Fund Tax Credit Auction

The New Jersey Innovation Evergreen Fund (NJIEF) corporate tax credit auction is now open. The auction is an unprecedented opportunity for established corporate citizens in New Jersey to access a discount of up to 25% on their corporate business tax liability in the State and promote their strategic engagement and innovation objectives. Auction bids will be evaluated according to price and strategic commitment.


The funds raised from the auction will later be matched by professional venture capital firms and invested into high-growth, early stage start-up businesses across the Garden State. This novel platform is built to align important constituents operating in the State to create the conditions necessary to drive New Jersey towards the goal to become the most diverse, innovative ecosystem in the nation. 

Last week BioNJ hosted a webinar, led by our colleagues at the New Jersey Economic Development Authority, which highlighted the structure of the program, the benefits to corporations, the process to apply and post-approval compliance requirements.

Click here to view a recorded version and learn what you need to know to take advantage of this game-changing opportunity to build New Jersey's innovation economy! 

SBIR/STTR Federal Seed-Funding Programs Need Reauthorization

Two federal programs that have been driving innovation for 40 years by providing seed funding to entrepreneurs are in danger of running out of money – unless Congress acts by September 30, according to the USA’s Biotechnology Innovation Organization (BIO). The Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) programs typically give up to $250,000 for the first year of development of an idea and up to $750,000 more if the idea proves feasible. But reauthorization is delayed. The largest SBIR/STTR programs are run by the Department of Defense (DoD). While he is moving towards granting approval, Congress needs to act quickly to get the budget through a packed agenda in September.

People in the News


2022 NJBIZ Healthcare Heroes

Congratulations to BioNJ Members Rutgers, Cancer Institute of New Jersey, Hackensack Meridian Health, Rowan University and Princeton University for being recognized as NJBIZ's 2022 Healthcare Heroes. See the full list here.

Congratulations to the 2022 NJBIZ Forty Under 40 Honorees!

The Forty Under 40 program recognizes 40 business men and women under the age of 40 for their notable successes and demonstrations of strong leadership in the state. Congratulations to BioNJ Members Charles Brown, Rutgers Business School; Brad Caruso, WithumSmith+Brown; Austin Hagaman, Withum Wealth Management; and Ashley Koning, Rutgers, The State University of New Jersey for being recognized on the Forty Under 40 list.

Tevogen Bio Appoints 3 Prominent Health Care Leaders to Board

Warren-based BioNJ Member Tevogen Bio appointed three new members to its Board of Directors. The new health care leaders include Susan Podlogar, Jeffrey Feike and Lindee Goh. Ms. Podlogar is MetLife’s Chief Human Resources Officer. Mr. Feike is a public health servant-leader with 30-plus years of experience as CEO of multiple hospitals. Ms. Goh leads Tapestry Networks’ health care practice, working with public and private sector leaders to develop effective strategies to improve clinical outcomes while fostering sustainable health care innovation. “Susan, Jeffery and Lindee are wholly committed to our corporate culture of creativity, optimism, respect and equality and our aspiration to be the very first biopharma company to achieve commercial success while ensuring patient affordability,” said Tevogen CEO Dr. Ryan Saadi.

GSK Board Changes

Warren-based BioNJ Member GSK plc announced that Elizabeth McKee Anderson will join the Board of the Company as a Non-Executive Director with effect from 1 September 2022. Ms. McKee brings significant experience in commercial biopharmaceuticals and is a seasoned biotech board member. She previously served as Worldwide Vice President and commercial leader in infectious diseases and vaccines and also for immunology and oncology at Janssen Pharmaceuticals, and as Vice President and General Manager at Wyeth Vaccines. Ms. McKee is currently a Board member of BioMarin Pharmaceuticals, Revolution Medicines, Inc., Insmed, Inc. and Aro Biotherapeutics Company.

J&J Appoints Former CEO of CVS Health as Chair Designate of Planned Consumer Health Company

New Brunswick-based BioNJ Member Johnson & Johnson appointed Larry Merlo as non-executive Chair designate on the future, listed “New Consumer Health Company” Board of Directors. Mr. Merlo will formally assume the role upon completion of the planned separation, expected to occur in 2023. With over 30 years of purpose-driven and transformative health leadership, Mr. Merlo previously served as CEO and President of CVS Health from 2011 to 2021, overseeing a decade of purpose-driven transformation. Alex Gorsky, Executive Chairman of Johnson & Johnson, said “A purpose-driven leader, Larry’s experience in the fast-paced health retail sector will be a strong asset to the leadership team as they unlock value and deliver for consumers as a standalone company.”

Mallinckrodt Announces Appointment of Karen Ling to Its Board of Directors

Mallinckrodt, with a site in Hampton, announced that Karen Ling has been appointed to the company's Board of Directors. With the addition of Ms. Ling, the Mallinckrodt Board will expand to eight directors, seven of whom are independent. Ms. Ling has more than 25 years of experience in human resources leadership and has worked extensively in the pharmaceutical industry. She most recently served as Executive Vice President and Chief Human Resources Officer of American International Group, Inc. (AIG) from 2019 to 2021, leading the company's global human resources function. Ms. Ling serves on the boards of iRhythm Technologies and TherapeuticsMD, where she chairs the Compensation Committee. 

Integra LifeSciences Announces the Passing of Dr. Richard Caruso, Founder and Former Chairman and CEO

Princeton-based Integra LifeSciences announced that Dr. Richard Caruso, founder and former Chairman and CEO passed away. Dr. Caruso founded Integra LifeSciences in 1989 with a vision that the human body could be enabled to regenerate many of its own damaged or diseased tissues, paving the way for a new discipline back then known as regenerative medicine. Through his vision, Integra became the first company to develop and bring to market a tissue regeneration product, Integra Dermal Regeneration Template, which was approved by the FDA in 1996 as a skin replacement system with a claim for regeneration of dermal tissue for the treatment of life-threatening burns and repair of scar contractures. 



Nine from New Jersey Make Princeton Review’s 31st Annual Best Colleges 2023 List

The Princeton Review released its 31st annual Best Colleges 2023 ranking lists recently, with nine institutions from New Jersey making the grade. Listed alphabetically, the nine from the Garden State include: The College of New Jersey, Ewing; Drew University, Madison; Monmouth University, West Long Branch; New Jersey Institute of Technology, Newark; Princeton University, Princeton; Rider University, Lawrenceville; Rutgers University-New Brunswick; Seton Hall University, South Orange; Stevens Institute of Technology, Hoboken. The Princeton Review’s 85-question survey asks students to rate their professors, administrators, school services and other aspects of life at their colleges and to report on their campus and community experiences. 

Rutgers to Conduct Largest and Most Comprehensive Study on Type 1 Diabetes

Backed by a grant approaching $700,000 from JDRF, Rutgers University recently said it will conduct the largest and most comprehensive study of children at high risk of developing a life-threatening complication of type 1 diabetes. JDRF, the leading global type 1 diabetes research and advocacy non-profit, said that, together with Rutgers Center for Pharmacoepidemiology and Treatment Science, it aims to develop a tool to help clinicians identify children who are at high risk of developing diabetic ketoacidosis, which occurs when the body produces high levels of blood acid called ketones because it can’t produce enough insulin. 

Institute for Life Science Entrepreneurship Receives New Jersey Department of Labor Award to Create Life Science Apprenticeship Program

The Institute for Life Science Entrepreneurship (ILSE) at Kean University is launching an apprenticeship program to train workers for life science careers. The program received pilot funding under the Growing Apprenticeships in Nontraditional Sectors (GAINS) program from the New Jersey Department of Labor’s Office of Apprenticeship. ILSE will receive $187,600 in GAINS funding to train 20 new lab technicians and create a new lab technician Registered Apprenticeship Program with the U.S. Department of Labor. The one-year apprenticeship initiative will include both in-class learning and on-the-job training. Successful apprentices will work with sponsoring employers to gain valuable experience and learn critical skills to enter the life science industry.

Hackensack Meridian’s CDI Findings Could Improve Cancer Therapies, Vaccines

A new publication in a major journal by scientists from the Hackensack Meridian Center for Discovery and Innovation (CDI) could hold the key to better modulating the human immune system to fight cancer and produce vaccines of the future. The laboratory of Hai-Hui “Howard” Xue at the CDI published the findings of the complex and cascading molecular interactions modulating T-cell immunology in Nature Immunology. “This is our second Nature Immunology paper from the CDI this year. The initial observation was made eight years ago, and Drs. Qiang Shan (the first author) and Weiqun Peng (collaborators from George Washington University) have continuously pursued mechanistic insights since then,” said Xue, Ph.D., a member of the CDI.



Successfully Navigating the USPTO and FDA

September 8, 2022

Hear about the intricacies biotech/medtech independent inventors and startups face when securing Intellectual Property (IP) rights from the U.S. Patent and Trademark Office (USPTO) and/or seeking regulatory approval from the Food and Drug Administration (FDA). Government officials and industry professionals will join the discussion by offering their views on current hot topic issues while highlighting best practices to consider when filing with the USPTO or FDA.

SBIR/STTR Reauthorization Webinar

September 13, 2022

AdvaMed, BIO and CSBA is hosting a special briefing to discuss the success of SBIR/STTR programs, their economic impact and the important next steps to Federal reauthorization. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are highly competitive award-based programs that encourage domestic small businesses to engage in Federal Research/Research and Development with the potential for commercialization. Federal funding for the SBIR/STTR Program will expire on September 30, 2022, and we need your support to ensure timely reauthorization! Hear from successful SBIR/STTR grantees, program officers, and technical experts on these vital programs. After this webinar, you will be able to effectively advocate for Federal SBIR/STTR program reauthorization.

MDS-PAS 7th Annual Movement Disorders School for Neurology Residents

October 1, 2022

The Michael J. Fox Foundation, in partnership with the Edmond J. Safra Foundation, provides a free, two-day educational opportunity for neurology residents interested in learning about care, research and careers in Parkinson’s and other movement disorders. The course will take place October 1 and 2 in Northern New Jersey. The deadline to apply is September 5, 2022. Learn more and apply

Propelify Innovation Festival

October 6, 2022

For Those Who Propel Ideas Into Action! If you’re in the innovation community in the northeast you belong here. Learn from amazing speakers, connect with start-ups and investors, hire and be hired. Plus virtual reality, drones, music and a start-up competition. And lots more. BioNJ Members can attend for free. Contact for the code!

ISG TechXchange: Healthcare & Life Sciences

October 13, 2022

The ISG TechXchange: Healthcare & Life Sciences will explore the evolving healthcare and life-science ecosystems. Register today and embrace the digital transformation approaches organizations are taking to succeed in pushing the boundaries of innovation. Put interoperability at the heart of your organization. Utilize emerging innovations to rapidly respond to shifts in patient and payer expectations. Leverage the effects of pandemic-forced advancements to focus on innovation and diversification. Learn more and register here.

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