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October 22, 2021

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

Thank you to everyone who joined us last Friday for BioNJ's 9th Annual C-Suite Summit. From Dr. Peter Marks of the FDA to Dr. Michael Ku of Pfizer, we were excited to have assembled a roster of world-class leaders to consider this past year's successes and challenges, the next wave of innovation across the value chain and how the industry might deepen and scale its commitment to delivering a positive impact for society.

The Summit brought together life sciences executives representing a wide breadth of companies from early to late stage, public and private and revenue and pre-revenue — all working toward the same goal of bringing much-needed treatments to Patients around the world.


Meanwhile, we saw history in the making last week with the groundbreaking of the New Jersey Innovation and Technology Hub, a 550,000 square foot development that will be a center of innovation, research and medical education in downtown New Brunswick. The Hub will bring together our best and brightest to further medical research and innovation while offering a nurturing environment for collaboration and entrepreneurship.

Lastly, BioNJ had the honor of celebrating with PTC Therapeutics at the ribbon cutting ceremony of its new gene therapy manufacturing facility in Hopewell Township. Congratulations to BioNJ Board Member and former BioNJ Chair and PTC Therapeutics CEO Dr. Stuart Peltz, as well as the entire PTC Team, on this exciting milestone.

Because Patients Can' Wait®,

The BioNJ Team


New Member Gennao Bio

Learn more at

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Upcoming BioNJ Events


Membership Webinar

Mark Your Calendar!

November 16, 2021

IT/Cyber/Finance Briefing: Topics in ESG and Beyond: Cyber, IT, Tax and More

Register Today!

November 17, 2021

A Pandemic Update: The Virus, the Vaccine, the Variants & the Legal Landscape

Register Today!

November 18, 2021

Inspiring Women in STEM Conference 

Mark Your Calendar!

December 3, 2021

Patient Advocacy Summit

Open exclusively to Patient advocacy groups and R&D company Patient advocacy and government affairs professionals.

Register Today!

December 9, 2021

Putting Patients First:

The Value of Medical Innovation

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3 Truths About the Cost of Prescription Drugs

The cost of prescription drugs grows more slowly than other health care costs, employers are eager to give pre-deductible coverage to pay for drugs, and the cost of drugs can triple if they are administered in a hospital, three studies find. Three recent reports give a clearer picture of the cost of prescription drugs — and show that a blunt instrument like price controls is not the best way to help patients pay for medicine. Drug prices are relatively stable — and average around 15% of health costs, even as the use of pharmaceuticals has increased, says a study of 11 countries by health care researcher IQVIA. U.S. spending on drugs was a below average 14%, the report found.

ICYMI: New Study Confirms Policies Like H.R. 3 Could Significantly Reduce Drug Development

A new study from economists at the University of Chicago examined the impact that government price-setting policies for medicines, like those in H.R. 3, could have if implemented. The economists found that a policy like H.R. 3 could reduce investment in the research and development (R&D) of new medicines by up to 60% between 2021 and 2039. The results reinforce why so many Americans have raised concerns over price-setting policies. To put a finer point on it, policies like H.R. 3 could result in as many as 342 fewer medicines coming to market during that same time. Those lost medicines could include critical future treatments and cures that would never make it to patients, impacting life expectancy as a result. In fact, the economists at the University of Chicago concluded that the loss of life over 10 years if policies like H.R. 3 are implemented could be as much as 20 times larger than the loss from COVID-19 to date in the United States.

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PTC Officially Opens Gene Therapy Manufacturing Facility

South Plainfield-based BioNJ Member PTC Therapeutics cut the ribbon on its new gene therapy manufacturing facility in Hopewell Township. PTC’s ribbon cutting ceremony occurred the same day that ground was broken for The Hub in New Brunswick. Debbie Hart, President and CEO of BioNJ, said of the PTC and Hub events: “This is an auspicious day in the New Jersey life sciences ecosystem. We witnessed landscape-altering history in the making when ground was broken on The Hub this morning … and here we are at PTC Therapeutics to celebrate an important milestone in the life of this flagship New Jersey company. PTC Therapeutics and BioNJ grew up together. We watched as PTC went through the roller coaster ride that is biotech for so many years, and we are here now to mark the opening of its very own gene manufacturing facility.”

Murphy on The Hub: ‘We Will Put on Clear Display and Under One Roof Everything that N.J. has to Offer’

Governor Phil Murphy tried to put the significance of the $665 million being invested in The Hub in New Brunswick in perspective — and do it in a way that goes beyond the talking points of simply the biggest investment by the State in innovation, translational research and medical education in history. Speaking at the groundbreaking before an all-star cast of leaders from government, life sciences, health care and higher education, Murphy offered this: “It is here at The Hub where we will leverage and put on clear display and under one roof everything New Jersey offers — our world-leading institutions of higher education; and our world-class health networks; our access to global markets and venture capital; and our diverse, highly educated and highly skilled workforce,” he said.

BioNJ in the News


ROI-NJ Presents the ROI Influencers: Health Care 2021

The global pandemic has brought more than just an appreciation for health care around the world: It has brought an appreciation for the people who provide us with health care. Simply put, our perception of the sector has changed. Years ago, the health care sector would say it was one-sixth of the economy in an effort to show its significance. Since the pandemic started, we’ve come to learn that the sector is 100% of our daily concern — and will be for the foreseeable future. It’s for this reason that we took special care to deliver the 2021 ROI Influencers: Health Care list. It’s a mix of those leading some of the world’s most important companies and those running some of the State’s most important hospitals and health systems. Congratulations to BioNJ’s President and CEO, Debbie Hart, and these BioNJ Members for making the list: Robert Davis & Ken Frazier, Merck & Co.; Joaquin Duato and Alex Gorsky, Johnson & Johnson; Scott Kobler, McCarter & English; Steve Libutti and Brian Strom, Rutgers; Thomas Polen, Becton, Dickinson; and Regina Foley, Bob Garrett, Nicole Harris-Hollingsworth, Don Parker, Mark Sparta, Bonita Stanton, Mark Stauder, Dan Varga, Hackensack Meridian.

NJ Company News


Oyster Point Pharma Announces FDA Approval of TYRVAYA™ (Varenicline Solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease

Princeton-based BioNJ Member Oyster Point Pharma announced that the U.S. Food and Drug Administration (FDA) has approved TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. TYRVAYA Nasal Spray is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases.

Tegsedi® Receives Innovative Drug Category Pricing in Brazil

South Plainfield-based BioNJ Member PTC Therapeutics announced that Tegsedi® (inotersen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. Category 1 classification is given to innovative treatments that provide greater efficacy than current standards of care. Category 1 allows for pricing in line with international markets. Tegsedi has been approved by the Brazilian regulatory agency ANVISA (Agência Nacional de Vigilância Sanitária) for the treatment of Stage 1 or 2 polyneuropathy (nerve damage) in adult patients with hereditary transthyretin-mediated (hATTR) amyloidosis to delay disease progression and improve quality of life. 

Phathom Pharmaceuticals Announces Positive Topline Results from PHALCON-EE Pivotal Phase 3 Erosive Esophagitis Trial

Florham Park-based BioNJ Member Phathom Pharma announced that vonoprazan successfully met its primary endpoints and key secondary superiority endpoints in PHALCON-EE, a pivotal Phase 3 trial evaluating vonoprazan versus lansoprazole for the treatment of erosive esophagitis. Based on the positive PHALCON-EE data, Phathom plans to submit an NDA to the U.S. Food and Drug Administration seeking the following indications: healing of all grades of EE and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. PHALCON-EE was a trial with two phases. In the first phase, vonoprazan 20 mg was compared to lansoprazole 30 mg in the healing of EE after up to 8 weeks of treatment (Healing Phase). In the Healing Phase, patients were assessed via endoscopy to determine complete healing following 2 weeks of treatment and, if complete healing was not achieved, a second endoscopy occurred at 8 weeks of treatment.

Antios Therapeutics and Assembly Biosciences Announce Clinical Collaboration Agreement to Evaluate the Combination of ATI-2173 and Vebicorvir in Patients with Chronic Hepatitis B Virus Infection

Mendham-based BioNJ Member Antios Therapeutics and Assembly Biosciences announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination treatment in patients with chronic hepatitis B virus (HBV) infection. A single cohort in the ongoing Antios Phase 2a ANTT201 clinical trial will evaluate ATI-2173, Antios' investigational proprietary active site polymerase inhibitor nucleotide (ASPIN), vebicorvir (VBR), Assembly Bio's investigational lead core inhibitor candidate, and tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor. The multi-center, double-blinded, placebo-controlled cohort will evaluate the safety, pharmacokinetics and antiviral activity of this all-oral triple combination. 

Masori Therapeutics and Vyant Bio, Inc. Announce New Partnership

Cherry Hill-based BioNJ Member Vyant Bio and Masori Therapeutics announced they entered into an agreement to pursue co-development and out-licensing partnerships with pharmaceutical and biotechnology companies. The Masori Therapeutics team has decades of experience in all areas of drug discovery and development, including building biopharmaceutical commercial infrastructures and partnerships from concept to consummation. Masori Therapeutics’ work with Vyant Bio will initially focus in Japan and will center on providing key insights into the application and intersection of their technologies to accelerate partnership-based therapeutic discovery and development.

SCYNEXIS Announces Preclinical Data at the 10th Trends in Medical Mycology Meeting Supporting Potential of Ibrexafungerp to Treat Mucormycosis

Jersey City-based BioNJ Member SCYNEXIS announced preclinical data supporting the potential of its broad-spectrum antifungal, ibrexafungerp, to treat mucormycosis. The study, conducted at The Lundquist Institute at Harbor-University of California at Los Angeles (UCLA) Medical Center, evaluated in a mouse model the potential of ibrexafungerp for the treatment of mucormycosis caused by Rhizopus delemar (the most common cause of mucormycosis) and found that ibrexafungerp monotherapy demonstrated survival benefits equivalent to current standard of care treatments, including liposomal amphotericin B and Posaconazole.

Otsuka and Lundbeck Announce FDA Acceptance of Supplemental New Drug Application; Receive Priority Review for Treatment of Schizophrenia in Adolescents

Princeton-based BioNJ Member Otsuka and Lundbeck report that the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for the treatment of schizophrenia in adolescents with Rexulti® (brexpiprazole) and has granted Otsuka and Lundbeck Priority Review. Up to one-third of patients with schizophrenia develop the disease during adolescence. Currently, Rexulti is approved in the U.S. for treatment of schizophrenia in adults and adjunctive treatment of major depressive disorder in adults. The submission has been completed one year earlier than planned, with the hope of benefitting adolescent patients with schizophrenia who need more treatment options.

FDA Approves Verzenio® (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved Bridgewater-based BioNJ Member Eli Lilly and Company's Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.

Lilly Announces Updated Verzenio® (abemaciclib) Phase 3 monarchE Trial Data Presented at ESMO Virtual Plenary and Simultaneously Published in the Annals of Oncology

Bridgewater-based BioNJ Member Eli Lilly and Company announced updated data from the positive Phase 3 monarchE trial evaluating the investigational use of Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC). MonarchE met its primary endpoint of a statistically significant improvement in invasive disease-free survival (IDFS) in the intent-to-treat (ITT) population for patients treated with adjuvant Verzenio plus ET compared to those treated with ET alone.

Tirzepatide Results Published in The Lancet Show Superior A1C and Body Weight Reductions Compared to Insulin Glargine in Adults With Type 2 Diabetes With Increased Cardiovascular Risk

Adults with type 2 diabetes with increased cardiovascular (CV) risk experienced superior A1C and body weight reductions from baseline across all three doses of tirzepatide compared to titrated insulin glargine in detailed results from Bridgewater-based BioNJ Member Eli Lilly and Company's SURPASS-4 clinical trial, which were published in The Lancet. SURPASS-4 is the largest and longest clinical trial completed to date of the Phase 3 program studying tirzepatide as a potential treatment for type 2 diabetes. The primary endpoint was measured at 52 weeks, with participants continuing treatment up to 104 weeks or until study completion.

AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults With Active Psoriatic Arthritis in the European Union (EU)

Madison-based BioNJ Member AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (SKYRIZI®, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. This CHMP positive opinion was supported by data from two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2.

Helsinn and Fosun Pharma Sign Exclusive License and Distribution Agreements for Aloxi®, Akynzeo® Oral, NEPA IV and Anamorelin in Mainland China, Hong Kong SAR and Macau SAR

Iselin-based BioNJ Member Helsinn and Fosun Pharma announced the signing of exclusive license and distribution agreements in the territory of Mainland China for Aloxi®, Akynzeo® and anamorelin. Helsinn will also grant Fosun Pharmaceutical A.G. an exclusive license for the said products in Hong Kong SAR and Macau SAR. In addition, Helsinn’s Chinese subsidiary, Helsinn Pharmaceuticals Beijing Co. Ltd. (HPC) will provide Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., a subsidiary company of Fosun Pharma with certain medical, marketing and commercial services, including co-promotion services in Shanghai, China, in support to the commercialization of the products in Mainland China, Hong Kong SAR and Macau SAR. 

U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices Votes Unanimously to Recommend Shingrix for Immunocompromised Adults Aged 19 and Up

Warren-based BioNJ Member GlaxoSmithKline plc announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend two doses of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) and its complications in adults 19 years of age and older who are or will be immunodeficient or immunosuppressed due to disease or therapy. The vote means that millions of adults in the U.S. aged 19 years and older who are at increased risk of shingles due to immunodeficiency or immunosuppression are now recommended to receive Shingrix.

Sandoz Completes Acquisition of GSK’s Cephalosporin Business, Reinforcing Leading Global Position in Antibiotics

Sandoz, a division of East Hanover-based BioNJ Member Novartis, has successfully completed the acquisition of GSK’s cephalosporin antibiotics business. Through this transaction, Sandoz has acquired rights to three established brands (Zinnat, Zinacef and Fortum)) in more than 100 markets, further reinforcing its leading global position in antibiotics. In 2020, the three brands had combined sales of approximately USD 140 million in the relevant markets. “Antibiotics are the backbone of modern healthcare systems and a central pillar of our worldwide Sandoz patient offering”, said Sandoz CEO Richard Saynor. “The successful and timely closing of this important transaction is further proof of our commitment at Sandoz to be a leading global supplier of these essential medicines.”

Novartis Announces FDA And EMA Filing Acceptances of Beovu® for Patients With Diabetic Macular Edema

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and that the European Medicines Agency (EMA) has validated the type-II variation application for Beovu®(brolucizumab) 6 mg for the treatment of diabetic macular edema (DME). Additionally, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) accepted an application for Beovu in the treatment of DME. Regulatory decisions for Beovu in DME are expected in mid-2022 for the US and Europe. If approved, DME would be the second indication for Beovu following its approval for wet age-related macular degeneration in October 2019 (FDA) and February 2020 (European Commission.)

Kesimpta® (Ofatumumab) Data at ECTRIMS Highlights Preservation of Igg Levels and Safety Experience Over Extended Exposure (~3.5 Years) in People Living With Relapsing Multiple Sclerosis

East Hanover-based BioNJ Member Novartis announced data demonstrating the safety of Kesimpta® (ofatumumab) over extended exposure (~3.5 years) in patients with relapsing forms of multiple sclerosis (RMS). These data further support Kesimpta as a potential first-choice treatment option for adults with active RMS, including newly diagnosed patients. These data build on previous efficacy and safety findings including the Phase III ASCLEPIOS I and II studies, in which Kesimpta demonstrated superiority versus teriflunomide in significantly reducing the annualized relapse rate (ARR, primary endpoint), 3-month confirmed disability progression (CDP), and the number of gadolinium-enhancing (Gd+) T1 and new or enlarging T2 lesions.

Pfizer’s Abrocitinib Receives Positive Chmp Opinion for the Treatment of Adults With Moderate to Severe Atopic Dermatitis

BioNJ Member Pfizer, with offices in Peapack, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. The CHMP also adopted a positive opinion recommending an extension to the existing indications for XELJANZ® (tofacitinib) for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Pfizer and Myovant Sciences Present Data on Relugolix Combination Therapy from Studies in Uterine Fibroids and Endometriosis at The American Society for Reproductive Medicine Congress

BioNJ Member Pfizer, with offices in Peapack, and Myovant Sciences announced the presentation of new data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in premenopausal women with uterine fibroids and in women with endometriosis pain (an investigational use). “These studies provide important new data for relugolix combination therapy, including detailed two-year efficacy and safety data in women with heavy menstrual bleeding associated with uterine fibroids from the Phase 3 LIBERTY studies,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “They also provide additional insight into the potential effect of relugolix combination therapy in women with pain associated with endometriosis.” 

Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older. In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.

Bristol Myers Squibb Announces Up to Five Years of Data from Long-Term DAYBREAK Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients With Relapsing Forms of Multiple Sclerosis

Princeton-based BioNJ Member Bristol Myers Squibb announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). In the DAYBREAK extension study, safety was consistent with prior findings and no new safety signals emerged during the reporting period with long-term use of Zeposia. Treatment with Zeposia demonstrated a low annualized relapse rate (ARR) of 0.103.

Bristol Myers Squibb Receives Positive CHMP Opinion for Zeposia (ozanimod) as a Treatment for Adult Patients With Moderately to Severely Active Ulcerative Colitis

Princeton-based BioNJ Member Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Zeposia(ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Zeposia, an oral medication taken once daily,is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

The Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program Announces First Group of Physicians to be Trained

Princeton-based BioNJ Member Bristol Myers Squibb together with its partners, National Medical Fellowships (NMF) and the American Association for Cancer Research (AACR), announced the first group of 52 physicians selected for its Diversity in Clinical Trials Career Development Program (BMSF DCTCDP). The 52 early stage investigators are the first of 250 community-oriented clinical trialists who will be trained through the program by 2027. The 52 physicians selected by an independent selection committee are an accomplished group working at a broad range of health care institutions in 22 states across the U.S.

Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

Titusville-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA). The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases. Data extrapolation is the process of estimating response, trends or effects based on previous observations from patients with closely related conditions.

U.S. CDC Advisory Committee Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster for All Eligible Individuals Who Receive Authorized COVID-19 Vaccines

New Brunswick-based BioNJ Member Johnson & Johnson announced announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), has recommended its COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine. The Johnson & Johnson COVID-19 vaccine was recommended as a booster for adults aged 18 and older who received the Johnson & Johnson single-shot vaccine at least two months earlier. A booster dose of the Johnson & Johnson COVID-19 vaccine was also recommended for eligible adults at least six months following the second dose of an authorized mRNA vaccine. The ACIP recommendation has been forwarded to the Director of the CDC and the U.S. Department of Health and Human Services (HHS) for review and adoption.

17 Million Doses of Johnson & Johnson COVID-19 Vaccine to be Donated to African Union Countries

New Brunswick-based BioNJ Member Johnson & Johnson welcomes the U.S. government’s decision to donate 17 million doses of the Johnson & Johnson COVID-19 single-shot vaccine to countries in the African Union (AU). The United States is providing these doses through COVAX, committed to the AU, under an agreement signed recently by the U.S. government, Johnson & Johnson, and Gavi, the Vaccine Alliance. A total of nearly 50 million doses of the Company’s vaccine have now been committed for donation by the U.S. government to approximately 40 countries across four continents via COVAX. To date, roughly half of these doses have been shipped.

New Long-Term Data Reinforcing Promising Safety and Efficacy Profile of Brain-Penetrant Tolebrutinib Presented at ECTRIMS 2021

Bridgewater-based BioNJ Member Sanofi’s investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, demonstrated favorable one-year tolerability in a Phase 2b long-term extension study (LTS) in patients with relapsing forms of multiple sclerosis (RMS). The results showed that after 48 weeks of treatment, tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by magnetic resonance imaging (MRI). “Understanding the ability of a brain-penetrant therapy to slow disability accumulation has the potential to bring new hope to people suffering from difficult-to-treat MS. For nearly two decades, Sanofi has been unwavering in its efforts to accelerate research and treatment options for these patients,” says Erik Wallström, M.D., Ph.D., Therapeutic Area Head, Neurology Development at Sanofi.

Agile Therapeutics Announces Pricing of $22,666,650 Underwritten Public Offering of Common Stock and Warrants

Princeton-based BioNJ Member Agile Therapeutics announced the pricing of its underwritten public offering of 26,666,648 shares of its common stock and warrants to purchase 13,333,324 shares of its common stock at a combined offering price to the public of $0.85 per one share of common stock and one-half of a warrant to purchase one share of common stock. The warrants have an exercise price of $0.85 per share of common stock, are exercisable immediately, and will expire five years from the date of issuance. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Agile Therapeutics, are expected to be approximately $22,666,650. All securities in the offering will be sold by Agile Therapeutics. 

U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy® for Treatment of HIV-1 in Pediatric Populations

Morris Plains-based BioNJ Member Gilead Sciences announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Certain Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Kenilworth-based BioNJ Member Merck & Co. that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease. Triple-negative breast cancer is an aggressive type of breast cancer. This represents KEYTRUDA’s first approval in Europe in a breast cancer setting. 

Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in at Risk Adults

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced that Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test. The approval is based on the Phase 3 KEYNOTE-826 trial evaluating KEYTRUDA plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab.

Merck Receives Positive CHMP Opinion for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Individuals 18 Years of Age and Older

Kenilworth-based BioNJ Member Merck & Co. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected by the end of the year. The CHMP opinion was based on data from seven randomized, double-blind clinical studies evaluating VAXNEUVANCE in 7,438 individuals from a variety of adult populations and clinical circumstances.

CDC ACIP Unanimously Votes to Provisionally Recommend Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in Series With PNEUMOVAX ® 23 (Pneumococcal Vaccine Polyvalent) as an Option for Pneumococcal Vaccination in Appropriate Adults

Kenilworth-based BioNJ Member Merck & Co. announced the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) unanimously voted in favor of updates to pneumococcal vaccination recommendations for adults 65 years and older, and for adults ages 19 to 64 with certain underlying medical conditions (e.g., chronic conditions such as diabetes, chronic heart disease, chronic lung disease, or chronic liver disease, as well as HIV, an immunocompromising condition) or other disease risk factors (e.g., smoking, alcoholism). In both groups, the ACIP voted to provisionally recommend vaccination either with a sequential regimen of VAXNEUVANCE followed by PNEUMOVAX23, or with a single dose of 20-valent pneumococcal conjugate vaccine.

Merck and Eisai Receive Positive EU CHMP Opinions for KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Two Different Types of Cancer

Kenilworth-based BioNJ Member Merck and Eisai announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinions recommending approval of the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA (marketed as KISPLYX® in the European Union [EU] for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for two different indications. One positive opinion is for the first-line treatment of adult patients with advanced RCC, and the other is for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.

Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS

BioNJ Member Biogen Inc., with offices in Princeton, announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). While tofersen did not meet the primary endpoint of change from baseline to week 28 in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R), trends favoring tofersen were seen across multiple secondary and exploratory measures of biologic activity and clinical function. In addition, a pre-specified integration of data from VALOR and its ongoing open-label extension study (OLE) reinforced these findings and showed that early tofersen initiation led to less decline across multiple measures of motor function, respiratory function, muscle strength, and quality of life in people with SOD1-ALS.

ADMA Biologics Announces Proposed Public Offering of Common Stock

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that it intends to offer shares of its common stock for sale in an underwritten public offering. The company intends to grant the underwriters of the offering a 30-day option to purchase up to an additional 15 percent of the number of shares of common stock sold in connection with the offering. ADMA intends to use the net proceeds from this offering (i) to advance the commercial sales of its U.S. Food and Drug Administration (FDA)-approved products through the procurement of raw materials for the manufacturing of BIVIGAM® and ASCENIV™; (ii) to expand its plasma collection facility network; (iii) to scale up the manufacturing capacity of its Boca Raton facility and to make continuous improvements in order to adhere to current Good Manufacturing Practice (cGMP) compliance; (iv) to explore business development opportunities; and (v) for general corporate purposes and other capital expenditures.

Genmab Announces that Janssen has Received Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients With Advanced Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations, After Failure of Platinum-based Therapy

Princeton-based BioNJ Member Genmab A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended the granting of a conditional marketing authorization in Europe for Janssen’s amivantamab, a fully human bispecific antibody, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy. In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. This is the first CHMP opinion for a product that was created using Genmab’s proprietary DuoBody technology platform.

BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients With Mantle Cell Lymphoma

Ridgefield Park-based BeiGene announced that BRUKINSA® (zanubrutinib) has been approved in Australia for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BRUKINSA received its initial approval in Australia for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy. Following registration of BRUKINSA with the Therapeutic Goods Administration (TGA) in both approved indications, these patients will have immediate access to BRUKINSA through the BeiGene sponsored post-approval, pre-reimbursement access program.

BeiGene and Nanolek Announce Approval in Russia for BRUKINSA® (Zanubrutinib) for Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma

Ridgefield Park-based BeiGene and Nanolek announced that BRUKINSA® (zanubrutinib) has received approval from the Russia Ministry of Health for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BeiGene and Nanolek entered into an exclusive distribution agreement for Nanolek to commercialize BRUKINSA in the Russian Federation. “The registration of BRUKINSA (zanubrutinib), a next-generation BTK inhibitor that demonstrated improved clinical benefit while reducing the frequency of certain off-target side effects in MCL, will give physicians and patients another treatment option. BRUKINSA has the potential to give those impacted by MCL in Russia an improved prognosis and a more tolerable therapeutic option,” siad Irina Vladimirovna Poddubnaya, Professor, Academician of Russian Academy of Sciences(RAS), and Head of Oncology Department at the Russian Medical Academy of Postgraduate Education.

FDA Accepts Regen-Cov® (Casirivimab and Imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19

Basking Ridge-based Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for REGEN-COV® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The BLA is supported by two positive Phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts).

Aerie Pharmaceuticals Announces Positive Phase 3 Topline Results for Netarsudil Ophthalmic Solution 0.02% Clinical Trial in Japan

Bedminster-based Aerie Pharmaceuticals reported positive topline results for the company’s Phase 3 clinical trial in Japan evaluating netarsudil ophthalmic solution 0.02% (“netarsudil 0.02%”) versus ripasudil hydrochloride hydrate ophthalmic solution 0.4% (“ripasudil 0.4%”). The results showed that netarsudil 0.02% once daily was superior to ripasudil 0.4% twice daily in lowering intraocular pressure (“IOP”) at week four (p<0.0001), the primary endpoint for the study. Both netarsudil 0.02% and ripasudil 0.4% are Rho kinase (ROCK) inhibitors. They are designed to treat open-angle glaucoma and elevated IOP by increasing outflow of aqueous humor through the trabecular outflow pathway, the drainage pathway responsible for maintaining normal IOP in the eye.

Ascendis Pharma A/S Announces U.S. Commercial Launch of SKYTROFA® (Lonapegsomatropin-tcgd), the First and Only FDA Approved Once-Weekly Treatment for Pediatric Growth Hormone Deficiency

Ascendis Pharma, with offices in Princeton, announced the U.S. commercial launch of SKYTROFA (lonapegsomatropin-tcgd), its once-weekly treatment for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone (GH). SKYTROFA (lonapegsomatropin-tcgd) is available by prescription and distributed through a network of specialty pharmacies across the United States. “SKYTROFA offers patients, caregivers and physicians the potential to replace daily somatropin injections that have been the standard of care for more than 30 years,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.

Phase 2 Clinical Trial Data of NurOwn® in Progressive MS Will Be Presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

Paramus-based BrainStorm Cell Therapeutics will present findings from a multicenter, open label clinical trial of NurOwn® in progressive multiple sclerosis. The Phase 2 clinical trial was designed to evaluate intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive MS. The study achieved the primary endpoint of safety and tolerability. It demonstrated a reduction of neuroinflammatory biomarkers and an increase in neuroprotective biomarkers in the cerebrospinal fluid (CSF) and consistent improvement across MS functional outcome measures, including measures of walking, upper extremity function, vision and cognition.

Pacira Biosciences to Acquire Flexion Therapeutics Further Expanding Leadership Position in Non-Opioid Pain Management

Parsippany-based Pacira BioSciences announced a definitive agreement pursuant to which Pacira will acquire Flexion for $8.50 per share in cash, plus one non-tradeable contingent value right (CVR) worth up to $8.00 per share in cash. The CVR is payable (subject to certain terms and conditions) in the event certain sales and/or regulatory milestones are achieved, as set forth in more detail below. Flexion is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, local non-opioid therapies for the treatment of patients with musculoskeletal conditions, including osteoarthritis (OA), postsurgical pain and low back pain. Approved in 2017, Flexion’s lead product, ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) is the first and only FDA-approved treatment for OA knee pain utilizing extended-release microsphere technology.

Antares Pharma Enters into Exclusive License Agreement With Lipocine for Tlando® in U.S.

Ewing-based Antares Pharna announced that it entered into an exclusive license agreement with Lipocine Inc. for TLANDO® (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”) in the United States. TLANDO® was granted tentative approval from the U.S. Food and Drug Administration (“FDA”) as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO® met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022.

Boehringer Ingelheim and Partners to Accelerate Development of First-In-Class Gene Therapy for Patients With Cystic Fibrosis

Boehringer Ingelheim, with offices in North Brunswick, announced that it has exercised its options on intellectual property and know-how from the partners to progress and further accelerate the development of a potential, new treatment option for patients with CF. In the partnership, IP Group, acting on behalf of the three GTC host Universities, is granting exclusive global rights to develop, manufacture, register and commercialize this lentiviral vector-based gene therapy for the treatment of cystic fibrosis. The GTC is additionally contributing its knowledge in pre-clinical research and clinical gene therapy development. OXB is adding its leading competence in manufacturing lentiviral vector-based therapies to Boehringer Ingelheim’s expertise in the development of novel breakthrough therapies for respiratory diseases.

CDMO Announces Opening of New Springfield Facility

Springfield-based Evergreen Theragnostics, a radiopharmaceutical contract development and manufacturing organization, has opened a new facility in Springfield. Evergreen Theragnostics Inc. celebrated the grand opening of its new 14,000-square-foot building in September, from which it will serve the manufacturing needs of companies developing radiopharmaceutical products. “We set out to build a world-class facility, and we think we’ve achieved that,” said CEO James Cook. “The facility provides high capacity, flexibility, efficient workflows and even great aesthetics. We are pleased to have opened just two years after initiating the project, and we can’t wait to begin manufacturing for our customers and delivering for our patients.”

Quest Diagnostics Unveils Giant Testing Lab at ON3 in Clifton

Quest Diagnostics announced they have completed the consolidations of its Northeast regional operations into its new, 250,000-square-foot facility at ON3 in Clifton. The lab will serve more than 40 million people per year in seven states, increasing productivity and capacity. It is capable of more than 300,000 tests per day thanks to extensive automation. The lab represents a $250 million commitment to customers and quality and will employ more than 1,000 people. “New Jersey is proud to be the home of Quest Diagnostics and this magnificent new laboratory,” said Governor Phil Murphy.

Eisai Lease at ON3 Wins Office Deal of the Year at NAIOP N.J. Gala

Woodcliff Lake-based Eisai Co., Ltd. announced it was able to relocate its entire team to one spot, the 116-acre ON3 campus that straddles Nutley and Clifton. Eisai, which focuses on oncology and neurology, will transfer up to 1,200 corporate and research staff from Woodcliff Lake to 300,000 square feet at 200 Metro Blvd., the campus’ 15-story flagship LEED Gold-certified office tower. “This ON3 Eisai workplace will bring the Eisai community together in one place and drive a culture of new scientific horizons and entrepreneurial innovation,” Tatsuyuki Yasuno, president of Eisai Inc., said at the time. “We draw inspiration from our patients and passion from our people. We break barriers every day. Our workplace will, too.”

Indian Pharmaceutical Giant Alembic has Leased its First U.S. Office Space in New Jersey

Indian pharmaceutical giant Alembic Pharmaceuticals will occupy about 7,300 s/f of space at the property located at 550 Hills Drive in Bedminster, New Jersey. Moving into the new space will help the century-old global pharmaceutical company prepare for further expansion across the United States. “We are pleased to welcome Alembic Pharmaceuticals to the building and include them among our roster of leading companies that call The Offices at Bedminster home,” said Joel Kiss, CEO of Northeast Capital Group.

BD Launches ‘Together We Advance’ Environmental, Social and Governance Strategy

Franklin Lakes-based BD announced new strategies to advance environmental, social and governance initiatives, as well as a suite of goals for 2030 and beyond that focus on enhancing stewardship of the company, the planet, community and human health. BD officials are calling their ESG strategy “Together We Advance.” They said the new approach builds on BD’s core purpose — advancing the world of health — and focuses on making meaningful impacts across four key pillars: Company health: Building a strong business foundation through good governance and transparent reporting; Planet health: Implementing sustainable solutions to reduce the company’s environmental footprint; Community health: Collaborating with communities and investing company resources to do what is right; Human health: Empowering employees to innovate new products and solutions to deliver what’s next in health care.

People in the News


ADMA Biologics Strengthens its Board of Directors With the Appointment of Young T. Kwon, Ph.D.

Ramsey-based BioNJ Member ADMA Biologics announced the appointment of Young T. Kwon, Ph.D., to its Board of Directors. Dr. Kwon is a highly accomplished corporate executive in the life sciences and biotechnology space. He brings over a decade of expertise in strategic advising, corporate finance and business development transactions to ADMA’s Board. “Young is a recognized leader in the health care sector and his deep strategic and financial experience will offer invaluable perspectives as ADMA continues to increase revenues for its commercial immunoglobulin (“IG”) product portfolio,” said Steven Elms, Chairman of ADMA’s Board of Directors. 

Agile Therapeutics Appoints Josephine Torrente to its Board of Directors

Princeton-based BioNJ Member Agile Therapeutics announced that Josephine Torrente has been appointed to the company’s Board of Directors, as a Class II Director. Ms. Torrente will serve on Agile’s Science and Technology Committee and Nominating and Corporate Governance Committee. Ms. Torrente has more than 30 years of experience in the pharmaceutical industry, and is currently a Director at Hyman, Phelps & McNamara PC, a law firm focused on advising clients on FDA matters, where she has practiced since 1998. In addition to her time at Hyman, Phelps & McNamara, Ms. Torrente has worked at Sprout Pharmaceuticals and Wyeth-Ayerst Research. 

J&J’s Chief Scientific Officer Announces His Retirement

Dr. Paul Stoffels, the Chief Scientific Officer of New Brunswick-based BioNJ Member Johnson & Johnson, will retire at the end of the year. Dr. Stoffels, who is also Vice Chairman of the Executive Committee, has led the company’s research and product pipeline in discovering and developing health care solutions. During his time at J&J, he has also served as Worldwide Chairman, Pharmaceuticals, leading the transformation of the pharma research and development pipeline for Janssen Pharmaceutical Cos. Among his accomplishments, Dr. Stoffels established Johnson & Johnson Innovation.

Johnson & Johnson Announces Jessica Moore as Vice President of Investor Relations

New Brunswick-based BioNJ Member Johnson & Johnson announced the appointment of Jessica Moore to Vice President of Investor Relations for Johnson & Johnson, effective November 1, 2021. Ms. Moore brings 20 years of strong, diverse and international financial experience spanning across sales operations, corporate and regional positions. Most recently, Ms. Moore served as the Vice President and Chief Financial Officer for the Janssen Pharmaceutical business in the EMEA Region where she played a critical role in the analysis of financial performance, assessment of risks and opportunities and maintenance of a strong compliant environment.

Zoetis Names New Head of R&D, as Current Leader Announces Retirement

Animal health company Parsippany-based Zoetis announced it is promoting an executive to President of Research & Development, as its current R&D head retires. Robert J. Polzer, currently Senior Vice President of Global Therapeutics for the Parsippany-based company, will become an Executive Vice President as well as President of R&D, effective Jan. 1. In his new role, Dr. Polzer will oversee the company’s global R&D organization and regulatory affairs, including its discovery and development pipeline. He will become a member of the executive team and report to CEO Kristin Peck.

Certara Promotes Exec to President of Integrated Drug Development

Princeton-based Certara Inc. has named a new President of Integrated Drug Development. In his new role, Dr. Patrick F. Smith will lead the company’s global drug development services team, which serves clients across the entire drug development life cycle with biosimulation and quantitative approaches. Dr. Smith succeeds Craig R. Rayner, who will be appointed Certara’s distinguished scientist. He will report to CEO William F. Feehery. Dr. Smith joined Certara in 2016 after the company’s acquisition of d3 Medicine, which he founded.

Neumentum’s Taggart McGurrin Awarded Rising Star in Accounting and Finance by Life Sciences Leaders and Stars

Morristown-based Neumentum Inc. is pleased to announce that Taggart McGurrin, Neumentum’s Chief Business Officer, has won the Rising Star Award from the Life Sciences Leaders & Stars Awards by Informa Connect. This award recognizes and celebrates achievement across three key categories within the life sciences accounting and finance community – Innovation, Achievement and Leadership. Mr. McGurrin was chosen and recognized as a forward-thinking industry leader who is moving the needle and driving progress within the broader life sciences community.


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NJEDA Reminds Investor Community of Upcoming Angel Investor Tax Credit Program Application Deadline

The New Jersey Economic Development Authority (NJEDA) reminded the investor community that applications for the New Jersey Angel Investor Tax Credit Program must be submitted by 11:59 p.m. on November 1 to be considered for the 2021 program year. Applications received after this time will be considered for the 2022 program. The program, which is open to both in-state and out-of-state investors, is designed to encourage and incentivize investment into emerging New Jersey technology businesses. Through the Angel Investor Tax Credit Program, an investor can receive a refundable tax credit equal to a percentage of their qualified investment made in a New Jersey early stage company. 



SciTech Scity, Game-Changing Innovation Campus, Breaks Ground

Liberty Science Center’s transformational “City of Tomorrow” will take a step closer to reality. SciTech Scity, a long-planned -- and hoped for -- 30-acre innovation campus that aims to launch and grow world-changing science and technology companies and reimagine public school science education, held a groundbreaking in Jersey City. “SciTech Scity is unique,” said Liberty Science Center CEO Paul Hoffman. “It’s what we’re calling a business optimizer, a new breed of innovation center that maximizes commercial success and social impact. “Our goal is to convene experts from multiple disciplines and harness science and technology to solve social problems and turn leading-edge ideas into a reality that makes the world a radically better place.”

Terumo Blood and Cell Technologies is Collaborating With Biocentriq to Provide Technologies and Expertise to Automate Cell and Gene Therapy Manufacturing

Newark-based BioCentriq and Terumo Blood and Cell Technologies announced the formation of a strategic collaboration designed to accelerate the adoption of automated manufacturing to bring novel cell and gene therapies (CGT) to patients more quickly and cost effectively. As part of the agreement, the BioCentriq laboratories will be equipped with Terumo's technologies, including Quantum®Cell Expansion System and Finia® Fill and Finish System. Quantum is a functionally closed, automated cell expansion system that enables process control for a variety of adherent cells, suspension cells, viral vectors and exosomes. The Finia System, made available to the market in 2020, provides automation for the final steps of cell and gene manufacturing.

Adaptation, Thriving and Scientific Innovation During the Pandemic

If there is one thing the pandemic has taught us all, it is the importance of adaptation. Regardless of the line of work, people around the world have had to adapt to major changes in both their businesses and day-to-day lives. At Princeton Innovation Center BioLabs (PICB) in Plainsboro, the premiere co-working space for science start-ups in New Jersey, start-ups adapted and made many major leaps forward. PICB is currently home to 17 start-ups, aligned with its intent to support commercialization of transformative technology to create societal benefits. 

‘Great Fun’: Manabe Wins Nobel Prize in Physics for Modeling Climate Change

“I was really happy and surprised,” said Syukuro “Suki” Manabe, a Senior Meteorologist at Princeton University who is a pioneer in the field of climate change research. “I never dreamed I would win the Nobel physics prize. If you look at the list of past winners, they are amazing people who have done marvelous work. In contrast, what I have been doing looks trivial to me. But I’m not going to complain!” Dr. Manabe had won “for the physical modeling of Earth’s climate, quantifying variability and reliably predicting global warming.” 

Kean University Installs President Lamont O. Repollet as 18th Leader

Kean University President Lamont O. Repollet, Ed.D., was installed as the 18th leader of the University in a campus-wide ceremony. In his inaugural address, the Kean alumnus, former Kean trustee and the University’s first Black president shared his vision for the University’s future. A former New Jersey Education Commissioner, school superintendent, principal and teacher, Mr. Repollet was named Kean President in 2020, but the pandemic delayed his formal installation. Since taking office, he has focused on safety, academic excellence and equity, including health and safety measures to curtail the spread of COVID-19. 

Rowan University Hosts National Science Foundation Research Program for Undergrads

When Brady Moore, a biomedical engineering senior, first began his journey into the scientific world as a high school student, he could not have predicted the path he would take over the next four years. His biology teacher recommended a summer research internship at Rowan University that he eagerly pursued. He chose to attend Rowan as a freshman the following year. This summer, Moore took part in another hands-on program directed by Rowan’s Department of Biomedical Engineering, called Research Experience for Undergraduates (REU). The 10-week program hosted 12 undergraduate students from eight states: Michigan, Minnesota, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania and Texas. 

Rowan University Expands Paid Research Opportunities for Undergrads

Rowan University has extended its paid summer research opportunities for underrepresented students pursuing degrees in science, technology, engineering and math. Twelve students matched this summer with faculty mentors for five- and 10-week internships in the College of Education, the Henry M. Rowan College of Engineering, the Rohrer College of Business and the College of Science & Mathematics. Funded by Rowan University’s Division of Diversity, Equity & Inclusion, the Office of the Provost and the Division of University Research, the DEI STEM experiential learning program prioritized underrepresented students without prior research experience and those interested in graduate studies. 

CMSRU Faculty Member R. Phillip Dellinger, MD, Honored With NJHA Lifetime Achievement Award

R. Phillip Dellinger, M.D., Professor of Medicine and Distinguished Scholar at Cooper Medical School of Rowan University (CMSRU), Senior Critical Care Attending at Cooper University Health Care and Director of the Cooper Research Institute, was honored with the New Jersey Hospital Association’s Lifetime Achievement, Clinical Excellence Award. He was among 14 individuals and organizations honored for exemplary service to the people of New Jersey during the COVID-19. “Dr. Dellinger is an outstanding physician, researcher and educator, and I couldn’t be prouder that he is a member of our faculty,” said Annette C. Reboli, M.D., Dean of CMSRU.

Study: Seton Hall has $1.6B Economic Impact on N.J., Supports Nearly 10,000 Jobs

Seton Hall University has an economic impact of $1.6 billion on New Jersey, directly supports nearly 10,000 jobs and has an impact of $64 million on state taxes. The economic statistics come from a study by Econsult Solutions Inc. that was commissioned by the university in a first-of-its-kind effort by Seton Hall to quantify the impact the school has on its local community. Seton Hall President Joseph Nyre said the study shows the complete impact a university can have. “Since 1856, Seton Hall has been dedicated to being a home for the mind, the heart and the spirit,” he said. “We are also pleased to be an externally-looking, active and engaged citizen of the region, state and nation.”

John Theurer Cancer Center Ranked Among Best Specialized Hospitals

Hackensack Meridian’s Hackensack University Medical Center and its John Theurer Cancer Center has again ranked among the top hospitals in the Newsweek‘s 2022 World’s Best Specialized Hospitals list. The ranking features the top 250 hospitals for oncology. John Theurer Cancer Center at Hackensack University Medical Center, which is a part of Georgetown Lombardi Comprehensive Cancer Center, is the largest and most comprehensive center in New Jersey dedicated to diagnosis, treatment, research, screening and preventive care as well as survivorship of patients with all types of cancers.

Lab-Ready Life Sciences Facility in Jersey City Gets New Tenant in RWJBH

The lab-ready life sciences property in Jersey City, 95 Greene, has a new tenant, as RWJBarnabas Health and its Jersey City Medical Center signed a long-term lease. RWJBH signed for 11,235 square feet of ground-floor retail space with a dedicated entrance.



Engage 2021 Conference

December 1-2, 2021

Organized by the Princeton University Office of Corporate Engagement and Foundation Relations for Princeton Innovation, Engage 2021 is virtual, free and open to all. We'll zero in on connections and skills to accelerate the impact of research and innovation on complex problems, practical information and specific resources and opportunities you can use to advance your work. We'll also step back and explore the big picture: How can Princeton and partners propel the development of a robust and inclusive innovation ecosystem.

2021 Patient & Health Advocacy Digital Summit

October 27-28, 2021

Now in it's 10th year, the 2021 BIO Patient & Health Advocacy Summit is a two-day virtual event that will bring together patient advocacy organizations, academia, regulators, biotechnology industry and other stakeholders for two days of robust programming to discuss timely policy issues and share best practices. We invite you to attend for invaluable networking opportunities to advance partnership among stakeholders in the health care ecosystem.

BioNJ Member Services Provider Directory


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


Please contact BioNJ with any questions.  | 609-890-3185 |

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