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July 28, 2023

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

We would like to congratulate Health Commissioner Judith Persichilli on her upcoming retirement. In 2022, BioNJ had the honor of presenting Commissioner Persichilli with the Dr. Sol J. Barer Award for Vision, Innovation and Leadership for her tireless work on behalf of Patients and her unwavering dedication as she led the State’s response to the COVID-19 pandemic. A longtime nurse and hospital executive, Ms. Persichilli proved time and time again her unwavering commitment to the residents of New Jersey by diligently working to protect our communities and improve New Jersey’s health care system. We would like to thank the Health Commissioner for all that she has done for the State and wish her a wonderful and joyful retirement.

Similarly, BioNJ would like to congratulate Dr. Kaitlan Baston of Cooper University Health Care, nominated earlier this week by Governor Murphy to succeed Commissioner Persichilli. Dr. Baston's impressive background makes her an exceptional choice to serve as Commissioner at the Department of Health. We wish Dr. Baston the best of luck in her new post and look forward to working with her as she applies her wealth of experience to ensure a healthy and equitable State for all.

Because Patients Can't Wait®,

Debbie Hart

President and CEO


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September 7, 2023

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September 13, 2023

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October 6, 2023

Putting Patients First:

The Value of Medical Innovation -

Recent Stories in the News


How to Lower Insulin Prices? Focus on the Middleman.

Millions of Americans depend on insulin. And due to price hikes, over 1 million of them have had to ration the drug. That's an outrage. Fortunately, we're beginning to understand the root causes of these increases — and lawmakers in Washington are investigating the problem. The Senate's Health, Education, Labor and Pensions Committee recently held a hearing on rising insulin costs — and focused on the cost-inflating role of pharmacy benefit managers. PBMs serve as the intermediary between employers and insurance plans that pay for drugs and biotech companies that manufacture them. PBMs determine which drugs insurers cover — and use this leverage to negotiate discounts from drug companies. 

IRA's Potential Impact on the U.S. Biopharma Ecosystem

In this Vital Health Podcast, Amitabh Chandra, Director, Health Policy Research, Harvard Kennedy School of Government, and a Professor of Business Administration at Harvard Business School, highlights the enormous disincentives for small molecules created by the IRA, as companies will receive four fewer years of revenue when compared to large molecules. He also touches on the challenges of PBM rebates due to their lack of transparency, and how this is creating political issues for the biopharma sector.

New Studies Add to Body of Evidence Questioning 340B Efficacy

Recent studies add to the growing body of evidence questioning the value of the current 340B program and whether it’s benefiting patients as Congress intended. The first recent study shows that while nonprofit hospitals saw substantial growth in profits between 2012 and 2019, there were no corresponding increases in their level of charity care. The majority of these hospitals participate in the 340B program, which was designed to help provide low-income and vulnerable patients with access to affordable medicines. The study’s conclusion is not surprising given nonprofit hospitals’ track record of exploiting the 340B program to rake in profits without using the money to help lower patient out-of-pocket costs for medicines. Some hospital chains take this a step further — instituting explicit policies to deny patients access to care despite bringing in record profits and avoiding millions in taxes due to their nonprofit status. Just last month, the New York Times reported a nonprofit hospital withheld care from patients with unpaid medical bills.

New Report Shows High-Impact R&D Happens After Cancer Medicines Are First Approved

A new report showcasing nine critical oncology treatments, highlights the vital role of post-approval research and development (R&D) in advancing cancer treatment options and delivering unprecedented progress in the fight against cancer over the past 10 years. The report builds off previous research that shows for certain cancer medicines, most of the high-impact clinical research happens after a medicine is initially approved. More than 60% of oncology medicines approved a decade ago received additional indications, with most being received seven or more years after initial approval. That suggests policies that discourage post-approval R&D could severely limit progress and patient benefit.

How Misguided Drug Pricing Policies Worsen Drug Shortages

More than 300 medicines are in short supply across the United States. Shortages can be a matter of life and death. Generic chemotherapy drugs that treat ovarian, breast and bladder cancer are currently in scant supply, leading doctors to ration them. Occasional shortages in all kinds of industries are inevitable, but these are different. For one, U.S. drug scarcity has grown steadily worse for five years. Ironically, a root cause of the current crisis is a "shortage" of drug buyers, rather than suppliers. Just three drug purchasing intermediaries known as pharmacy benefit managers (PBMs) control 80% of drug transactions, extracting enormous discounts and rebates from manufacturers. 

Three Things to Know from the Latest Patient Experience Survey

Most insured Americans believe insurance should provide affordable access to health care (93%), but only a third (34%) say it does, according to the fourth installment of the Patient Experience Survey (PES). The survey — based on interviews with 5,000 Americans — explores this disconnect, detailing the challenges insured Americans face affording care and how practices by health insurers and middlemen put patient lifelines to access at risk. This article highlights the three things you should know from the latest Patient Experience Survey.

BioNJ in the News


The Market Response to the TRIPS Waiver

In June 2022, World Trade Organization (WTO) members agreed to waive certain patent obligations on COVID vaccines. It is called a “TRIPS waiver” because it refers to rights under the WTO’s Trade-Related Aspects of Intellectual Property (TRIPS) Agreement. The waiver originally included COVID diagnostics and therapies, but they were removed from the text to gain political support. WTO members had planned to review this decision last December, but the Biden administration said it needed more time. The USITC has until October 17 to make sense of the matter. The mere prospect of an expanded exemption has taken a toll on U.S. biopharmaceutical innovation. There is mounting evidence that U.S. biopharmaceutical innovation has already been “chilled” by the TRIPS waiver. Debbie Hart, President and CEO of BioNJ, told the United States International Trade Commission (USITC) that since February 2021, companies making COVID-related drugs and diagnostics saw their stock prices fall 73% more than companies focused on different therapeutic areas.

Location, Infrastructure Boost NJ’s Biotech, Life Sciences Industries

Insiders say it’s no surprise that life sciences and biotech companies are attracted to New Jersey. For more than a century, the Garden State has had a history of developing lifesaving medicine, according to Choose New Jersey, a nonprofit economic development organization. “From incubators to stand alone laboratory space at research parks and hubs, you’ll find the support you need here, along with world-class research universities, medical schools and some of the best hospitals in the country,” the organization notes.” It’s an exciting time for research and development, according to Debbie Hart, President and CEO of the life sciences trade association BioNJ. “Biopharmaceutical innovation is ushering in the next generation of advanced medicines,” she explained. “We are on the brink of scientific breakthroughs, including gene editing and RNA-sequencing. Cell and gene therapies fight diseases at their source – the cellular or genetic level – through one-time administration, resulting in long-term, potentially curative benefits. These transformational therapies are revolutionizing health care and treatments for patients.”

Despite Challenges, ‘Capital is Always Available for Good Ideas’

Continued turbulence in the financial markets and headwinds from legislation aimed at capping drug costs, like the federal Inflation Reduction Act (IRA), as well as other issues have buffeted life sciences companies. But that hasn’t dampened spirits at some New Jersey enterprises. In October 2022, publicly held global biotech and BioNJ Member Insmed Inc. of Bridgewater – which focuses on serious and rare diseases – closed on a $275 million stock offering, secured a $350 million term loan and entered into a $150 million secured royalty financing agreement. Other life sciences companies in the State are also upbeat about long-term prospects, although they acknowledge the current market upheavals. In May, Princeton-based BioNJ Member Soligenix Inc. – a Nasdaq Stock Market-listed late clinical-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need – closed on an $8.5 million public offering.

NJAMHAA Celebrates Members and Other Partners Celebrating Milestone Anniversaries

NJAMHAA congratulates the members and other partners who reached significant anniversaries this year and is pleased to share highlights of their organizations’ achievements and impact. Soon after founding an association management company in 1992, Debbie Hart was approached by New Jersey’s biotechnology industry leaders to establish BioNJ, which her company still manages and for which she has served as the Founding President and CEO since 1994. BioNJ’s mission is to “help companies help patients by driving capital formation and fostering entrepreneurship, advocating for public policies that advance medical innovation, providing access to talent and education, and offering a cost-saving array of critical commercial resources.”

NJ Company News


CHMP Recommends Evrysdi® for Babies Under Two Months Old with Spinal Muscular Atrophy

South Plainfield-based BioNJ Member PTC Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Evrysdi® (risdiplam) marketing authorization to include infants under two months of age in the European Union (EU). A final decision regarding the approval is expected from the European Commission later this year. The CHMP opinion is based on the RAINBOWFISH interim analysis (n=18), which included six babies with two or three copies of the SMN2 gene who completed at least one year of study assessments. Of these, 100% (6/6) were able to sit after one year of treatment with Evrysdi, 67% (4/6) could stand and 50% (3/6) could walk independently. All infants were alive at 12 months without permanent ventilation.

Melinta Therapeutics Partners With BARDA to Advance Two FDA-Approved Antibiotics for Use in Pediatric Patients, and for Use Against Biothreat Pathogens

Parsippany-based BioNJ Member Melinta Therapeutics, LLC announced a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA® (delafloxacin) and VABOMERE® (meropenem and vaborbactam), for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications.

Hillstream BioPharma Announces Strategic Reprioritization of Pipeline to Targeting HER2/HER3 Solid Tumors via Bispecific and ADC Antibodies and Biologics

Bridgewater-based BioNJ Member Hillstream BioPharma announced a strategic reprioritization of its pipeline and provided a corporate update. The strategic assessment took into account, the pipeline’s near-term value creation opportunity and other factors. Hillstream will focus its pipeline on advancing novel oncology assets with the greatest potential and strong competitive profiles to address unmet needs across multiple solid tumors, such as bispecific antibodies and ADCs targeting novel conformational epitopes on high value validated targets, HER2 and HER3, with a more potent Bystander Effect. Hillstream’s lead asset, HSB-3215 is designed as a bispecific humanized immunoglobulin containing two arms targeting the extracellular domains of HER2 and HER3. 

Soligenix Announces Expansion of SGX302 (Synthetic Hypericin) Phase 2a Study in Mild-to-Moderate Psoriasis

Princeton-based BioNJ Member Soligenix announced the expansion of its Phase 2a trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis after demonstration of biological effect in the initial five subjects. The study is expected to enroll at least an additional five subjects, exploring the use of SGX302 in the standard of care psoriasis setting, prior to undertaking the larger phase of the study. Evaluation of the initial five subjects enrolled demonstrated a clear biological signal, with the majority of patients recording an improvement in the PASI (psoriasis area and severity index) score. Enrolling additional patients will enable Soligenix to evaluate the use of SGX302 in the context of accelerated light treatment and additional adjunct treatment.

Celldex Announces Completion of Enrollment in Phase 2 Study of Barzolvolimab in Patients With Chronic Spontaneous Urticaria

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced that patient enrollment has been completed in the company’s Phase 2 clinical study of barzolvolimab for the treatment of chronic spontaneous urticaria (CSU). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who do not respond to omalizumab.

ADMA BioCenters Receives FDA Approval for its Ninth Plasma Collection Center, Located in Dallas, GA

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that it has received U.S. Food and Drug Administration (“FDA”) approval for its ninth ADMA BioCenters plasma collection facility located in Dallas, GA. This plasma collection facility commenced operations and initiated source plasma collection in the third quarter of 2022. With the announcement of FDA approval, this facility is now licensed to collect, and introduce into interstate commerce, human source plasma for further manufacturing in the U.S. “With nine FDA-licensed plasma collection centers, we are well on our way to achieving our stated corporate objective of having a total of ten FDA-approved plasma collection centers, collecting normal source plasma and hyperimmune plasma, by year-end 2023,” said Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager, ADMA BioCenters.

Celularity and Verséa Ophthalmics Announce Exclusive U.S. Commercialization Agreement to Distribute Biovance® and Biovance® 3L Ocular for Ophthalmic Applications

Florham Park-based BioNJ Member Celularity Inc. and Verséa Ophthalmics, LLC announced that the companies have entered into an exclusive U.S. commercialization agreement in which Verséa Ophthalmics will distribute Celularity’s BIOVANCE® and BIOVANCE® 3L Ocular products to support the treatment of ocular surface disease and ocular surgical applications.

BIOVANCE® and BIOVANCE® 3L Ocular, which are single-layer and three-layer (3L) allografts, respectively, are intended for use as a biological membrane covering that provides an extracellular matrix. BIOVANCE® 3L Ocular is acellular and consists of three layers of an amniotic membrane that supports treatment of advanced ocular surface disease. As a barrier membrane, BIOVANCE® 3L Ocular is intended to protect the underlying tissue and preserve tissue plane boundaries. 

U.S. FDA Approves Expanded Indication for Novartis Leqvio® (inclisiran) to Include Treatment of Adults With High LDL-C and Who are at Increased Risk of Heart Disease

East Hanover-based BioNJ Member Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio® (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy. This patient population includes those who have comorbidities such as hypertension and diabetes and have not yet had a first cardiovascular event. Initially approved by the FDA in December 2021, Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. The updated indication for primary hyperlipidemia allows for the expanded use of Leqvio as an adjunct to diet and statin therapy beyond the previously approved atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH) patient populations.

Novartis Strengthens Commitment to Beacon of Hope Initiative, Engages New Collaborators to Support Clinical Trial Diversity, Break Down Economic and Education Barriers

East Hanover-based BioNJ Member Novartis and the Novartis U.S. Foundation proudly announce the significant expansion of Beacon of Hope, our 10-year commitment to co-create programs that address health and education inequities and create greater diversity, equity, inclusion and trust across the research and development ecosystem. The six new organizations joining Beacon of Hope were selected to provide tools and expertise to enable the Historically Black Medical School Centers of Excellence to accelerate progress on increasing diversity, equity, and inclusion in clinical trials, support new research into healthcare disparities, as well as help break down economic and education barriers that often stand in the way of promising career opportunities for students of color.

Medicines and Healthcare Products Regulatory Agency Authorises GSK’s Arexvy, the First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults

Warren-based BioNJ Member GSK announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been authorized for use in Great Britain by the MHRA. The authorization is supported by data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase III vaccine efficacy trial, published in the New England Journal of Medicine. In this trial, there was high overall vaccine efficacy against RSV-LRTD, including in participants with certain underlying medical conditions.

BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication

BioNJ Member BeiGene, with a site in Hopewell, announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) in combination with obinutuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior lines of therapy. BRUKINSA was previously granted Fast Track and Orphan designation for this indication. The FDA has assigned a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act. The sNDA filing in FL is based on results from the Phase 2 ROSEWOOD study (NCT03332017) that included 217 patients with pre-treated R/R non-Hodgkin FL (145 receiving BRUKINSA plus obinutuzumab and 72 patients receiving obinutuzumab monotherapy).

BeiGene and DualityBio Announce Partnership to Advance Differentiated Antibody Drug Conjugate (ADC) Therapy for Solid Tumors

BioNJ Member BeiGene, with a site in Hopewell, announced an agreement for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical ADC therapy for patients with select solid tumors. “With one of the industry’s leading global oncology research teams, we are investing in highly impactful therapeutic modalities such as ADCs that complement our dynamic and growing pipeline in solid tumors,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “Through this strategic partnership with DualityBio, we are well positioned to advance this asset globally alongside our initial internally discovered ADC assets with our end-to-end ADC manufacturing capabilities.”

BeiGene Announces Positive CHMP Opinion for Tislelizumab as a Treatment for Advanced or Metastatic ESCC

BioNJ Member BeiGene, with a site in Hopewell, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. The Marketing Authorization Application (MAA) for ESCC is based on results from BeiGene’s RATIONALE 302, a global, randomized, open-label, Phase 3 study (NCT03430843) to investigate the efficacy and safety of tislelizumab when compared with investigator’s choice chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC. The study enrolled 513 patients from 132 research sites in 11 countries in Asia, Europe and North America.

Evotec and Bristol Myers Squibb Enter License Agreement Within Neuroscience Partnership

Princeton-Based BioNJ Member Evotec announced that BioNJ Member Bristol Myers Squibb Company has exercised its option to enter into an exclusive global license agreement. The license covers selected late-stage discovery programs that were developed and progressed within the collaboration. Evotec and Bristol Myers Squibb originally entered their neurodegeneration partnership in 2016. The initial partnership proved highly productive in generating a promising pipeline of discovery to clinical-stage programs. Based on this success, Bristol Myers Squibb and Evotec have extended and expanded the partnership for an additional 8 years in March to further broaden and deepen the strategic alliance. Under the license agreement, Bristol Myers Squibb has selected an undisclosed number of programs that were rapidly developed and progressed using Evotec’s precision medicine platforms for further development within the expanded collaboration. 

Bristol Myers Squibb Launches Supporting You With UC, With Women’s World Cup Commentator, Former Professional Soccer Player and Ulcerative Colitis Patient, Rosie White

Princeton-based BioNJ Member Bristol Myers Squibb has launched Supporting You with UC, an ulcerative colitis (UC) educational campaign with patient ambassador Rosie White. The Supporting You with UC website includes White’s personal UC diagnosis and treatment journey, along with a collection of practical resources for people living with the disease to help manage symptoms on the go and in their everyday lives. White is using her platform as a TV sports commentator, former professional soccer player, coach, public speaker and person living with moderate to severe UC to empower others to speak up about their experiences. “By getting involved in Supporting You with UC, I hope to motivate others to find the courage to have a voice and have those difficult conversations sooner than I did,” said White.

Opdivo (nivolumab) in Combination With Cisplatin-Based Chemotherapy Shows Overall Survival and Progression-Free Survival Benefit for Cisplatin-Eligible Patients With Unresectable or Metastatic Urothelial Carcinoma in the Phase 3 CheckMate -901 Trial

Princeton-based BioNJ Member Bristol Myers Squibb announced that the sub-study of the Phase 3 CheckMate -901 trial met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at final analysis. Results of the sub-study showed that Opdivo (nivolumab) in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in OS and PFS compared to standard-of-care cisplatin-based combinations as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy. The combination of Opdivo with cisplatin-based chemotherapy in first-line urothelial carcinoma had a tolerable safety profile consistent with the known safety profiles of the individual components of the regimen. No new safety concerns have been identified.

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) as an Adjuvant Treatment for Patients With Completely Resected Stage IIB or IIC Melanoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage IIB or IIC melanoma. If approved, Opdivo would become the only PD-1 inhibitor that – between two approvals – is indicated as an adjuvant treatment for patients within stages IIB, IIC, III, as well as stage IV resected melanoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

FDA Approves Beyfortus™ (nirsevimab-alip) to Protect Infants Against RSV Disease

The U.S. Food and Drug Administration (FDA) has approved Bridgewater-based BioNJ Member Sanofi and AstraZeneca’s Beyfortus™ (nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The companies plan to make Beyfortus available in the U.S. ahead of the upcoming 2023-2024 RSV season. RSV is the leading cause of hospitalization for infants under the age of one in the U.S., averaging 16 times higher than the annual rate for influenza. Each year, an estimated 590,000 RSV disease cases in infants under one require medical care, including physician office, urgent care, emergency room visits and hospitalizations.

Treatment With RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients With Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced positive topline results from the Phase 3 PAPILLON study evaluating RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) in patients with newly diagnosed advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The Phase 3 PAPILLON study, the first late-stage clinical program for RYBREVANT®, is a confirmatory study supporting the approved use for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy and is the first randomized study evaluating patients with newly diagnosed NSCLC with EGFR exon 20 insertion mutations to demonstrate clinically meaningful results.

Janssen Receives Positive CHMP Opinions for Novel Bispecific Antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) for the Treatment of Patients With Relapsed and Refractory Multiple Myeloma

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorization (CMA) for TALVEY® (talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who 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. Talquetamab is a subcutaneous bispecific antibody that binds G protein-coupled receptor class C group 5 member D (GPRC5D), a novel target on multiple myeloma cells, and CD3, on T-cells.

Merck Announces Phase 3 KEYNOTE-756 Trial Met Primary Endpoint of Pathological Complete Response (pCR) Rate in Patients With High-Risk, Early-Stage ER+/HER2- Breast Cancer

Rahway-based BioNJ Member Merck & Co. announced that the pivotal Phase 3 KEYNOTE-756 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of pathological complete response (pCR) rate following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with high-risk, early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. At a prespecified interim analysis conducted by an independent Data Monitoring Committee (DMC), the KEYTRUDA-based regimen demonstrated a statistically significant improvement in pCR rate compared to neoadjuvant placebo plus chemotherapy.

Merck Announces Phase 3 KEYNOTE-A18 Trial Met Primary Endpoint of Progression-Free Survival (PFS) in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer

Rahway-based BioNJ Member Merck & Co. announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) met one of its primary endpoints of progression-free survival (PFS) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer. At a prespecified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with concurrent chemoradiotherapy showed a statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy as First-Line Treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)

Rahway-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The recommendation is based on interim results from the Phase 3 KEYNOTE-811 trial, in which the KEYTRUDA regimen demonstrated a statistically significant improvement in progression-free survival (PFS) and objective response rate (ORR) compared to trastuzumab and chemotherapy alone in patients whose tumors expressed PD-L1 (CPS ≥1).

Merck Receives Positive European Union CHMP Opinion for Gefapixant

Rahway-based BioNJ Member Merck & Co. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough. The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU) and a final decision is expected later this year. The CHMP’s positive opinion is based on results from the COUGH-1 and COUGH-2 clinical trials, which are the first companion Phase 3 studies ever completed in patients with refractory or unexplained chronic cough, a cough that persists despite appropriate treatment of underlying conditions or for which the underlying cause cannot be identified despite a thorough evaluation. 

Merck and Moderna Initiate Phase 3 Study Evaluating V940 (mRNA-4157) in Combination With KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients With Resected High-Risk(Stage IIB-IV) Melanoma

Rahway-based BioNJ Member Merck & Co. and Moderna, Inc., announced the initiation of the pivotal Phase 3 randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma. Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia. V940-001 is a Phase 3 global, randomized, double-blind, placebo- and active-comparator-controlled study designed to evaluate the safety and efficacy of V940 (mRNA-4157) in combination with KEYTRUDA in people with resected high-risk (Stage IIB-IV) melanoma compared to KEYTRUDA alone.

Merck Announces V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Met Key Immunogenicity and Safety Endpoints in Two Phase 3 Trials

Rahway-based BioNJ Member Merck & Co. announced positive topline results from two Phase 3 trials evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine in vaccine-naïve and previously vaccinated individuals. If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults. Results from the STRIDE-3 trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults for serotypes common to both vaccines as assessed by serotype-specific opsonophagocytic activity (OPA) 30 days post-vaccination. Positive immune responses were also observed for serotypes unique to V116. Additionally, results from STRIDE-6 demonstrated that V116 was immunogenic for all 21 pneumococcal serotypes in the vaccine among adults who previously received a pneumococcal vaccine at least one year prior to the study.

Pfizer Announces New England Journal of Medicine Publication on Group B Streptococcus (GBS) Maternal Vaccine Candidate

BioNJ Member Pfizer, with a site in Peapack, announced data from a Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6, being developed for maternal administration to protect infants against invasive GBS disease. In stage two of the three-part study, which enrolled 360 healthy pregnant individuals, GBS6 generated robust maternal antibody responses against the six GBS CPS serotypes included in the vaccine, and these antibodies were efficiently transferred to infants at ratios of ~0.4-1.3 depending on GBS6 group. Based on a parallel natural history study conducted in South Africa, the Phase 2 study immunogenicity data suggest that GBS6 may offer meaningful protection against invasive GBS disease in newborns and young infants. 

FDA Approves Veklury® (Remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. More than 1 in 7 (37 million) people in the U.S. are estimated to have chronic kidney disease (CKD) and are at increased risk of COVID-19 related morbidity and mortality. The U.S. approval comes on the heels of the European Commission decision to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis, which was adopted on June 26, 2023.

Gilead Partners With CHAI and Penta to Improve Treatment and Adherence Rates Among Children With HIV in Low and Middle Income Countries

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced two public-private partnerships. The first will accelerate the development of an investigational dispersible pediatric formulation containing emtricitabine and tenofovir alafenamide (F/TAF). The second aims to develop investigational pediatric formulations of TAF and sofosbuvir (SOF) designed to eliminate bitterness. For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, and cure research. Gilead is partnering with the Clinton Health Access Initiative (CHAI) and the Penta ID network, a scientific organization dedicated to child health research, to accelerate the development, regulatory approval and commercialization of a dispersible, fixed-dose combination treatment for the treatment of children with HIV who weigh at least 3 kg and live in low- and middle-income countries (LMICs). 

Twice-Yearly Lenacapavir Demonstrates Sustained Impact on Health-Related Quality of Life in People With HIV

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase 2/3 CAPELLA trial. These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical care. Using five validated scoring instruments measuring health-related quality of life components including physical and mental health, CAPELLA participants (n=64/72) reported favorable scores at Week 52 and with relative consistency over the time period. These reflect values that are similar to that of the general U.S. population. 

New Biktarvy® Data Presented at IAS 2023 Further Demonstrate Safety and Efficacy Profile in a Broad Range of People and Communities Affected by the Global HIV Epidemic

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced results from multiple studies reinforcing Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a treatment option for a broad range of people with HIV. The latest findings include key insights into the treatment of virologically suppressed pregnant women and children two years of age or older (weighing at least 14 kg to less than 25 kg) and positive Week 96 data from the ALLIANCE trial in adults with HIV/hepatitis B (HBV) coinfection who were initiating therapy. 

Gilead Sciences Announces Its Largest Commitment to Health Equity for Australian and Canadian Indigenous Communities

BioNJ Member Gilead Sciences, Inc., with a site in Morris Plains, announced its largest commitment to health equity for Australian and Canadian Indigenous communities. The initiative will support programs addressing societal barriers to care that persistently contribute to the transmission of HIV and viral hepatitis within Indigenous communities. Gilead is in discussions with two Indigenous-led organizations, the Lowitja Institute in Australia and CAAN Communities, Alliances & Networks in Canada, to create the new $6 million USD grant program, with funding divided equally between the two countries and invested over three years. The grant program will provide financial support to frontline organizations and initiatives.

Teva Pharmaceuticals and Alvotech Provide Update on Strategic Biosimilars Partnership

Parsippany-based BioNJ Member Teva Pharmaceuticals announced that they have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech. The partners continue working closely on matters concerning pending approval in the U.S. for AVT02, an interchangeable high-concentration biosimilar candidate for Humira® (adalimumab). The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Stelara® (ustekinumab), which is currently pending U.S. Food and Drug Administration (FDA) approval. “Teva remains fully committed to its leadership in biosimilars and the partnership with Alvotech,” said Sven Dethlefs, Executive Vice President, North America Commercial. “We remain optimistic about additional compounds in the pipeline and continued progress with AVT02 and ATV04.”

AbbVie Advances Immunology Pipeline With First Patient Dosed in Global Phase 3 Trial of Upadacitinib (RINVOQ®) in Hidradenitis Suppurativa

BioNJ Member AbbVie, with a site in Princeton, announced that the first patient has been dosed in the Phase 3 Step-Up HS study evaluating upadacitinib (RINVOQ®) in adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have failed anti-tumor necrosis factor (TNF) therapy and/or one approved non-anti-TNF inhibitor therapy for HS.1 "Hidradenitis suppurativa is a chronic, inflammatory disease that often leads to irreversible skin damage and extreme pain for patients," said Roopal Thakkar, M.D., Senior Vice President, Development and Regulatory Affairs and Chief Medical Officer, AbbVie. "Leveraging our proven expertise in immunology and experience in HS, we continue to drive innovation and pursue advancement of care in patient populations with difficult-to-treat immune-mediated diseases that have limited therapeutic options."

AbbVie and Calibr Expand Strategic Collaboration to Advance Several Preclinical and Early Stage Clinical Assets

BioNJ Member AbbVie, with a site in Princeton, and Calibr announced an expanded strategic collaboration to advance several innovative preclinical and early stage clinical assets across AbbVie's core therapeutic growth areas, including immunology, oncology, neuroscience and other areas of interest. This partnership is an expansion of the collaboration AbbVie and Scripps Research formed in 2019 to develop a broad range of potential new and novel therapeutics. In addition to programs initially named in the collaboration from preclinical to IND stages of development, Calibr will present to AbbVie a certain number of new discovery targets and preclinical assets of mutual interest for option considerations.

SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study

BioNJ Member AbbVie, with a site in Princeton, announced the British Journal of Dermatology published results from the head-to-head Phase 4 IMMpulse study that evaluated the efficacy and safety of SKYRIZI® (risankizumab) compared to Otezla® (apremilast) among adult patients with moderate plaque psoriasis eligible for systemic therapy. This study achieved all primary and ranked secondary endpoints with no new safety signals identified. The safety profile for risankizumab in this study was consistent with previously reported studies; it was well-tolerated with no new safety signals identified. The most frequent adverse events (reported in ≥5%) in risankizumab-treated patients were COVID-19, nasopharyngitis and upper respiratory tract infection.1 Diarrhea, nausea and headache were most frequent among apremilast-treated patients.

Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases

BioNJ Member Eli Lilly and Company, with a site in Branchburg, and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical company focused on the development of new medicines for the treatment of cardiometabolic diseases. Versanis' lead asset is bimagrumab, a monoclonal antibody that binds activin type II A and B receptors to block activin and myostatin signaling. Bimagrumab is currently being assessed in the BELIEVE Phase 2b study alone and in combination with semaglutide in adults who are overweight or obese. Combining incretins with bimagrumab has the potential to further reduce fat mass while preserving muscle mass and may lead to better outcomes for people living with obesity and obesity-related complications.

Results from Lilly's Landmark Phase 3 Trial of Donanemab Presented at Alzheimer's Association Conference and Published in JAMA

BioNJ Member Eli Lilly and Company, with a site in Branchburg, presented full results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease (AD). The data were published in the Journal of the American Medical Association (JAMA). Lilly previously announced that donanemab met the primary and all cognitive and functional secondary endpoints in the Phase 3 study. Submission to the U.S. FDA for traditional approval was completed last quarter with regulatory action expected by the end of the year. Submissions to other global regulators are currently underway, and the majority will be completed by year end.

Tirzepatide Demonstrated Significant and Superior Weight Loss Compared to Placebo in Two Pivotal Studies

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced results of two Phase 3 tirzepatide studies in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. SURMOUNT-3 and SURMOUNT-4 met all primary and key secondary objectives for tirzepatide compared to placebo. Across SURMOUNT-3 and SURMOUNT-4, participants on tirzepatide following intensive lifestyle intervention or with continued tirzepatide treatment, achieved up to 26.6% mean weight loss, for the efficacy estimand. The overall safety profile of tirzepatide in both studies was similar to previously reported SURMOUNT and SURPASS trials and to that of incretin-based therapies approved for the treatment of obesity and overweight. The most commonly reported adverse events in both trials were gastrointestinal-related and generally mild to moderate in severity.

Kyowa Kirin Completes New North American Headquarters in Princeton

BioNJ Member Kyowa Kirin, Inc., has completed its new 80,000-square-foot North America headquarters at 510 Carnegie Center in Princeton. The new space will host over 300 employees – across various functions that support all phases of the product life cycle including development, commercial and corporate functions – combining teams that used to be split across two New Jersey locations into one space. A company with a 70-year history, Kyowa Kirin has been steadily growing its market presence in North America since 2018 when it received approval from the U.S. Federal Drug Administration for the first of three first-in-class medicines it now markets in the US. North America is the company’s fastest-growing region in terms of revenue, contributing more than a quarter of Kyowa Kirin’s global revenues in 2022, up from 13% in 2019. 

Astellas Pharma Closes $5.9B Acquisition of Iveric Bio

Astellas Pharma Inc. announced that it completed its previously announced $5.9 billion acquisition of BioNJ Member Iveric Bio Inc., an early stage biopharmaceutical company based in Parsippany. As part of the deal through Astellas subsidiary Berry Merger Sub Inc., Iveric Bio has become a wholly owned subsidiary of Astellas, as of July 11. The close of the acquisition followed the satisfaction of all regulatory requirements, including approval by Iveric Bio’s shareholders during a special July 6 meeting. Iveric Bio’s common stock shares have been delisted from the Nasdaq Stock Market. In welcoming the Parsippany team to the company, Astellas President and CEO Naoki Okamura said in a statement, “By combining the capabilities of Astellas and Iveric Bio, we will potentially contribute to millions of patients around the world who are suffering from ophthalmologic diseases with fear of vision loss.” 

Eisai Presents Latest Analysis of Lecanemab’s Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer’s Association International Conference (AAIC) 2023

Nutley-based Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that the results of a detailed analysis of the Phase 3 Clarity AD study demonstrated that lecanemab-irmb (generic name, U.S. brand name: LEQEMBI®) treatment showed reductions in amyloid-beta (Aβ) pathology and downstream biomarker changes. This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023. The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer’s disease (AD). Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897). 

Nevakar Injectables Announces FDA Approval of Cyclophosphamide RTD Solution

Bridgewater-based Nevakar Injectables Inc. announced that the U.S. Food and Drug Administration has approved its new drug application for Cyclophosphamide Injection, 200mg/mL vials for use in combination therapy for various types of cancers, including malignant lymphoma, multiple myeloma and various types of leukemia. “We are delighted to receive FDA approval and believe that cyclophosphamide ready-to-dilute multi dose injection serves a very important need in oncology therapy. The product is available in two configurations, 500 mg / 2.5 mL and 1 gram / 5 mL vials to provide the health care providers with flexibility to use based on patient needs. Our simple and elegant formulation contains no unnecessary additives and benefits both providers and patients, as it minimizes waste, is easy to prepare and reduces the risk of dosing error and product exposure,” stated Sriram Ramanathan, MS, MBA, CEO, Nevakar Injectables. 

Calliditas Announces Supportive Interim Data from Phase 2 Head and Neck Cancer Trial With Lead NOX Inhibitor Candidate, Setanaxib

Hoboken-based Calliditas Therapeutics announced interim data from the proof-of-concept Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with its lead NOX 1 and 4 inhibitor product candidate, setanaxib. The analysis reflects encouraging early clinical progression-free survival (PFS) results and is supportive of the presumed anti fibrotic mode of action of setanaxib. The basis for the analysis consisted of a data set of 20 patients with recurrent or metastatic SCCHN, out of which 16 patients had evaluable tumor size and PFS related results. Twelve (12) patients had tumor biopsies before and after treatment that were evaluable for the biomarker analysis, which included transcriptomic analysis and also evaluated pathology markers such as SMA, Foxp3 regulatory T cells and PDL-1 CPS. 

SCYNEXIS and Hansoh Pharma Announce NMPA Acceptance of the New Drug Application for Ibrexafungerp in China

Jersey City-based SCYNEXIS, Inc. announced that China’s National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) in the Chinese mainland. The application was submitted by partner Hansoh Pharmaceutical Group Company Limited (3692.HK), one of the leading biopharmaceutical companies in China, and is based on positive results from Phase 3 studies in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints. In February 2021, SCYNEXIS entered into an agreement for the development and commercialization rights for oral ibrexafungerp in the greater China region with Hansoh Pharma. 

Bausch + Lomb Expands OTC Product Line With $106.5M Acquisition of Blink Eye Drops from J&J

Bausch + Lomb Corp. of Bridgewater recently said it purchased the Blink product line of eye and contact lens drops from BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson Vision for $106.5 million. The acquisition is the latest example of the company’s commitment to increasing over-the-counter consumer convenience in eye care. “There’s a growing need for relieving the symptoms of dry eyes and dry contact lenses, and OTC products are often the first option consumers choose,” John Ferris, Executive Vice President, Consumer, Bausch + Lomb, said. “The addition of Blink expands our robust portfolio of OTC eye care brands, enabling us to provide more choices for consumers and eye care professionals.”

Photocure Partner Asieris Announces Completion of Enrollment for Hexvix Phase III Clinical Trial in China

Princeton based Photocure announced that its partner Asieris Pharmaceuticals has communicated that it has completed patient enrollment for the Hexvix® Phase III bridging trial. The objective of the multicenter Phase III trial is to support regulatory approval of Hexvix in Mainland China. The bridging trial is intended to confirm results from prior clinical trials regarding the safety and detection benefits of blue light cystoscopy (BLC®) with Hexvix compared to white light cystoscopy in the diagnosis of non-muscle invasive bladder cancer (NMIBC) in a Chinese population. The clinical trial follows the same protocols for registration studies in countries where Hexvix already has market authorization.

ENHERTU® Approved in China as the First HER2 Directed Therapy for Patients With HER2 Low Metastatic Breast Cancer

Basking Ridge-based Daiichi Sankyo and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been approved in China as a monotherapy indicated for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval by China’s National Medical Products Administration (NMPA) is based on the results of the DESTINY-Breast04 Phase 3 trial. It follows the approval granted by China’s NMPA in Feburary 2023 for ENHERTU in patients with previously treated unresectable or metastatic HER2 positive breast cancer.

VANFLYTA® First FLT3 Inhibitor Approved in the U.S. Specifically for Patients With Newly Diagnosed FLT3-ITD Positive AML

Basking Ridge-based Daiichi Sankyo announced that VANFLYTA® (quizartinib) has been approved by the U.S. Food and Drug Administration (FDA) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test. VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated. AML is one of the most common forms of leukemia in adults and an estimated 20,380 new cases will be diagnosed in the U.S. in 2023. 

Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted for Review by USFDA, EMA and MHRA

Princeton-based Dr. Reddy’s Laboratories Ltd. announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration. In January 2023, Dr. Reddy’s had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets, such as the United States, European Union, and other regions. The submission of its dossier in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU and U.S. reference products.

Quest Diagnostics Unveils Consumer, Clinical Tests

Secaucus-based Quest Diagnostics announced two new product offerings: one for at-home consumer use and another for physicians. The consumer product, Genetic Insights, helps people understand their potential risk of developing certain inheritable health conditions, while the clinical offering is a novel prostate cancer biomarker test. The first consumer genetic health test under the Quest brand, Genetic Insights uses a saliva sample to analyze 36 genes to identify potential risk of several inheritable conditions. For physicians, Quest Diagnostics’ new novel prostate cancer biomarker test was launched through its subspecialty pathology business, AmeriPath, in collaboration with Australian-based Envision Sciences. The tissue-based test service aims to help clinicians identify and differentiate potentially aggressive cases of prostate cancer, one of the most prevalent and deadly cancers affecting men.

Avantor to Relocate to New and Expanded Bridgewater Innovation Center

Avantor, a global provider of mission-critical products and services to customers in the life sciences sector, announced it will relocate to a new facility plus double the size of its lab and pilot space at its Bridgewater Innovation Center. The Bridgewater Innovation Center opened in 2017 and serves as a technology-driven research and collaboration environment where Avantor works with customers to develop and enhance their offerings. Avantor says the expanded Innovation Center will open in August 2024 and will serve as its collaborative hub for supporting customers’ bioprocessing and the growing demands for gene therapy and mRNA workflows, facilitate pipeline project execution and enable quicker production scale-up.


NJEDA Approves Four Additional Qualified Venture Capital Firms for the New Jersey Innovation Evergreen Fund

The New Jersey Economic Development Authority (NJEDA) Board approved adding four venture capital firms to the growing list of Qualified Venture Firms (QVFs) that can access funding from the New Jersey Innovation Evergreen Fund (NJIEF). These QVFs, as well as the three approved by the NJEDA Board in May, are eligible to access up to $12.5 million annually per investor from the NJIEF to co-invest in innovative, high-growth New Jersey-based businesses. the NJIEF allows the State to become an equity investor in innovative early stage businesses based in New Jersey, investing up to $300 million in New Jersey companies alongside approved QVFs for a total of $600 million. The capital raised from the sale of tax credits auctioned off to eight corporations in December 2022 are expected to result in the funding of initial investments into high-growth businesses in New Jersey.

Mission BioCapital Platinum Program 2023

In partnership with BioLabs, Mission BioCapital (MBC) is excited to provide entrepreneurs with the chance to realize their ventures! The Platinum Program was designed to meet all these needs! Together with Eli Lilly and Company, MBC will award 4-6 Platinum Tickets to high-potential early stage companies with: A guaranteed lab bench in one of Mission BioCapital’s affiliated incubators located in 13 cities in the U.S. and Europe (including Princeton Innovation Center BioLabs and other BioLabs sites), $500,000 of seed capital per awardee and Strategic scientific and business development mentorship from experts across MBC’s corporate network, including Founding Sponsor Eli Lilly and Company. Applications for the Mission BioCapital Platinum Program 2023 are open until August 15, 2023. Platinum Tickets will be awarded to up to six companies in Fall 2023.



Podcast: Process Automation, "Platformization; and Supporting Academia Biotech Banter

This podcast features Dr. David Smith, Vice President of Development at BioCentriq, and Dr. Qasim Rafiq, an Associate Professor in Cell and Gene Therapy Bioprocess Engineering at University College London. Together, they discuss the realities of manufacturing, including automated processes, the benefits and possibilities around “platformization,” the challenges associated with moving early stage companies into a commercialization structure and how we in the industry can support the academics developing these processes.

Wei Appointed as Vice President for Research at Rowan

In preparation for exponential growth in its research profile, Rowan University said it appointed Mei Wei as Vice President for Research. Dr. Wei joined Rowan from Ohio University, an R1 public research institution, where she served as associate vice president for research and creative activity. Dr. Wei’s professional appointments have included interdisciplinary work in materials science and engineering, and biomedical engineering. An expert in biomaterials, Dr. Wei is also an entrepreneur who co-founded a biomedical device startup company specializing in products for improved bone repair and regeneration. She holds six patents and has published more than 200 refereed journal articles and conference proceedings.

Valley-Mount Sinai Welcomes 1st Patient for ICE COMPRESS Clinical Trial

Valley-Mount Sinai Comprehensive Cancer Care recently welcomed its first patient in the ICE COMPRESS clinical trial that is comparing the effectiveness of three approaches in the prevention of chemotherapy-induced peripheral neuropathy. At this time, Valley is the only site in New Jersey participating in the trial. The clinical trial is sponsored by SWOG Cancer Research Network in collaboration with the National Cancer Institute. Taxane chemotherapy drugs — medications that stop cancer cells from replicating — such as paclitaxel or docetaxel can cause a nerve disorder called peripheral neuropathy, which can cause numbness, tingling or pain in the arms and legs. Cooling and compression of the arms and legs may help to reduce the risk of peripheral neuropathy.

CNJ’s Efforts to Educate Next Generation of Health Care Workforce Get $33M Boost from N.J.

The College of New Jersey’s “Educating New Jersey’s Next Generation Health Workforce” plan got a major boost recently when it was awarded $33 million in capital facilities grants by the Office of the Secretary of Higher Education. TCNJ officials said the grant will be used for a number of items, including reimagining and renovating instructional and academic support space in Forcina Hall. Among the transformations will be the creation of a new home for the Department of Nursing, Department of Public Health and the School of Nursing and Health Sciences offices. The plan also will refurbish academic support spaces in Roscoe West Hall and enhance network services, connectivity and access across the campus, while securing equipment to support state-of-the-art pedagogy and research across a number of TCNJ’s academic programs.

3 Camden Organizations Pledge $30M to Create ‘One-of-a-Kind’ Cancer Center

Three Camden-based organizations have formed a “historic partnership” to further cancer research in South Jersey with the hopes of improving care worldwide. With an initial joint pledge of $30 million over several years, Coriell Institute for Medical Research, Cooper University Health Care and Cooper Medical School of Rowan University launched the Camden Cancer Research Center. The new cancer center – which will be housed at the Coriell Institute, will include scientists from all three organizations. It will encompass all of Coriell’s cancer research efforts, including eight scientists responsible for $5 million in annual federal research funding. The center will connect scientists conducting basic cancer research with clinical care, with the hopes of translating the findings into new treatments and improved care.  

People in the News

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Choose New Jersey Announces New Hires and Promotions, Expanding the Business Development Team

Choose New Jersey, New Jersey’s leading nonprofit economic development organization, announced two new hires and four internal promotions within its business development team. The team attracts businesses to the State by offering free, confidential, personalized services, including site selection assistance, market intelligence and customized RFI responses. The business development team also represents New Jersey at industry trade shows and Choose New Jersey-led trade missions.

Pfizer Announces Executive Leadership to Advance Oncology Research and Development Strategy

BioNJ Member Pfizer, with a site in Peapack, announced Chris Boshoff, M.D., PhD, will join Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President. Under his leadership, Pfizer will continue to invest in its fight against cancer and Dr. Boshoff will be the single point of accountability for the entire oncology pipeline – from discovery to early and late-phase clinical development. Mikael Dolsten, M.D., PhD, currently Chief Scientific Officer & President, Pfizer Worldwide Research, Development and Medical, will now expand his role to lead all discovery, early and late-stage clinical development, for all non-oncology therapeutic areas as Chief Scientific Officer, President, Pfizer Research & Development.

Tevogen Bio Welcomes Renowned Global Safety Management Expert

BioNJ Member Tevogen Bio Inc. announced it appointed safety management expert Victor Sordillo to its Board of Directors. Mr. Sordillo joins the Wayne-based pharmaceutical’s board alongside existing members Curtis Patton, Susan Podlogar, Jeffrey Feike, Lindee Goh and CEO Dr. Ryan Saadi. With over 35 years of experience in risk engineering, Mr. Sordillo currently serves as Executive Vice President, Director of Risk Control Services, at Sompo International, leading a global team of experienced risk control professionals who specialize in residential, commercial and industrial accounts. He previously was the Senior Vice President of risk solutions for QBE North America, as well as the global technical services manager for Chubb.

PTC Therapeutics Appoints Experienced Healthcare Finance Strategist Pierre Gravier as Chief Financial Officer

South Plainfield-based BioNJ Member PTC Therapeutics announced the appointment of Pierre Gravier to the role of Chief Financial Officer. Mr. Gravier brings more than 17 years of experience as an investment banker, venture capitalist and scientist to PTC. Most recently, Mr. Gravier was a Managing Director in the healthcare group of Perella Weinberg Partners. At Perella Weinberg, he focused on advising companies in the biopharmaceutical and pharmaceutical sectors on finance strategy and corporate development. “Mr. Gravier’s extensive global experience in finance and healthcare advisory will be incredibly helpful as we continue to build the PTC of tomorrow. Having known Pierre over the past several years, I am confident his knowledge, experience and passion to help patients make him a great addition to the PTC family,” said Matthew B. Klein, M.D., CEO, PTC Therapeutics.

PTC Therapeutics Co-Founder Allan Jacobson, Ph.D., Awarded 2023 Gruber Genetics Prize

South Plainfield-based BioNJ Member PTC Therapeutics announced that Allan Jacobson, Ph.D., co-founder of PTC and member of the Board of Directors, was presented the 2023 Gruber Genetics Prize for his work in identifying and describing the mechanism of nonsense-mediated mRNA decay. The Gruber International Prize Program honors individuals in the fields of Cosmology, Genetics and Neuroscience, whose groundbreaking work provides new models that inspire and enable fundamental shifts in knowledge and culture. "Allan's incredibly important work has led to meaningful advances in the treatment of rare diseases including Translarna which was foundational in the success of PTC." said Matthew B. Klein, M.D., CEO, PTC Therapeutics.

Zoetis Appoints Former Bristol Myers Squibb Exec as New President of U.S. Operations

Parsippany-based Zoetis announced that Ester Banque has joined the team as Executive Vice President and President, U.S. Operations. In connection with Ms. Banque’s appointment, William “Chip” Dorsey, interim head of U.S. Operations since February 2023, will continue in his finance leadership role and be a resource to Ms. Banque as she onboards. Ms. Banque is an accomplished global senior executive with over 30 years of experience in health sciences with top tier pharmaceutical companies and will report to CEO Kristin Peck. “We were impressed by Ester’s diverse, global experience, leadership of high-performing teams and above-market growth achievements. She is a passionate, purpose-driven leader who brings diverse experience and an impressive track record of driving results, which will promote Zoetis’ long-term sustainable growth,” said Ms. Peck.

BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer

BrainStorm Cell Therapeutics Inc., with a site in Hackensack, announced the appointment of Bob Dagher, M.D., as Executive Vice President and Chief Development Officer. Dr. Dagher will serve on BrainStorm's executive leadership team reporting to Stacy Lindborg, Ph.D., co-CEO of BrainStorm. He will be responsible for the portfolio strategy and advancement of clinical development plans towards regulatory approval, including the expansion of NurOwn into new diseases and the translation of pre-clinical research into first-in-human trials. "Bob’s background, which includes experience in neurology, psychiatry and rare diseases, provides a high level of scientific credibility and expertise in clinical management and corporate leadership. His personal integrity makes him a perfect cultural fit for our already strong team," said Chaim Lebovits, President and CEO of BrainStorm.

ESG Best Practices: Tools to Learn From

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Amicus Therapeutics Environmental, Social and Governance Report 2023

Our dedication to patients goes hand in hand with our commitment to our environmental, social and governance (ESG) program. Building strong ESG practices and oversight into our scientific and business activities creates a culture of integrity at every level of the organization, while safely and effectively delivering on our founding

beliefs – be at the forefront of therapies for rare and orphan diseases, create long-term value for our stakeholders, and foster teamwork and respect for individual contributions.

Industry Events


Healthcare Propelus I-Corps Info Session

Hosted by NSF I-Corps Hub: Northeast Region

August 3, 2023

Take your novel ideas to the next level by understanding how your health-related research discovery or Medtech innovation can create value for potential customers and improve patient outcomes. Learn about the people who could benefit from the commercialization of your technology and deepen your connections to the market ecosystem. Develop your skills for innovation, entrepreneurship, and technology commercialization through experiential learning. For scientific researchers, innovators and tech-entrepreneurs, I-Corps has become the standard for commercializing research discoveries and technological innovations across the country!

Innovating Together With Small Business Development Centers

Hosted by NSF I-Corps Hub: Northeast Region

August 7, 2023

For researchers exploring commercialization pathways and funding for their research or innovations, students and post-docs interested in learning more about innovation and entrepreneurship and community start-ups looking to connect with our community, join us for the next special event in the Innovating Together Series hosted by the Northeast I-Corps Hub! Come learn about how NSF I-Corps and the Small Business Development Centers mobilize resources, expertise and programs to accelerate technology commercialization and support tech start-ups!

Life Sciences Palooza 2023

Hosted by RLDatix Life Sciences

September 25-27, 2023

Gain the insight and inspiration you need to take your initiatives to the next level. Taking place from the afternoon of September 25 through 27 at the Hard Rock Hotel in Atlantic City, we will provide a robust schedule of thought-provoking keynotes, immersive hands-on discussion points, lively evening networking activities and so much more. 

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming and networking, with global deal making opportunities.

The TiE Women Global Pitch Competition

Hosted by TiE-NJ

November 2023

Calling all women entrepreneurs! Apply now for TIE Women Global Pitch Competition 2023.

The TiE Women Global Pitch Competition is a prestigious event that provides a platform for women entrepreneurs to pitch their innovative ideas and gain recognition and support. This is a great opportunity for women entrepreneurs in New Jersey to gain visibility and access to a Global network, in addition to mentorship and support from the local chapter. More about TiE Women here:

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