Welcome to the latest edition of the BioLines Weekender...
As the country -- and the nation -- continue to navigate the new "norm" in the era of COVID-19, we, at BioNJ, are extremely proud of the unwavering commitment and tireless work being done by the life sciences industry here in New Jersey. The Garden State has gallantly led the way in research for testing, antivirals, therapeutics and vaccines against this devastating virus. 

So, when our friend, the legendary Fred Hassan asked us to share the following story, we said "yes" with great pride and respect for the industry that literally saved the world.  

Click here to read "Thank You: Honoring the CEOs and the System That Saved the World" published in Chief Executive

Separately, sadly, there are many who still have doubts about the COVID-19 vaccines...who are frightened by misinformation. Through BioNJ's #GETVACCINATED campaign, "The Truth About COVID-19 Vaccine Misconceptions," our goal is to improve COVID-19 vaccine literacy and increase public confidence in the COVID-19 vaccines. From clinical trial diversity and participation, the technologies used in the COVID-19 vaccines and protection against variants to getting free transportation to and from vaccination sites, our hope is that more New Jerseyians will get vaccinated as a result of our educational materials and resources. 

Our materials are intended to quell the fears by providing facts and figures and answers to those fallacies to encourage everyone to get the vaccine. Please consider sharing our materials with your community by following BioNJ on social media and share and like our #GETVACCINATED posts.
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  • Additionally, we have created a website for easy access to this important information.
Together, we can build public trust and increase vaccination rates! The COVID-19 vaccines are our opportunity to protect ourselves, our loved ones and our communities and allow us to return to normalcy. Thank you in advance for your help. 

Because Patients Can' Wait®,
The BioNJ Team

BioNJ Calendar

Manufacturing Briefing: Pandemic-Induced Innovation & Adaptation

September 29, 2021
C-Suite Summit: Transitioning to the "Next Norm" (BioNJ's First In-Person  Event!)
October 15, 2021
IT/Cyber Security Briefing

November 17, 2021
Membership Webinar
November 18, 2021
Inspiring Women in STEM Conference 
December 3, 2021
Patient Advocacy Summit
December 9, 2021
Be Part of the Solution to Stop COVID-19

Take Action to Stop COVID-19 and Save Lives! Visit and share BioNJ's COVID-19 Vaccine Toolbox for educational information.

View BioNJ's COVID-19 Toolbox

Putting Patients First: The Value of Medical Innovation

Some members of Congress are considering significant changes to Medicare that could have a devastating effect on millions of Americans. Proponents call these changes government "negotiation," but what they are actually proposing is anything but that. These politicians want to repeal a key provision of the Medicare Part D program that protects robust coverage and access to medicines for seniors and people with disabilities. Seniors and people with disabilities have robust access to medicines in Medicare Part D due in large part to a protection known as the "noninterference clause." The noninterference clause prohibits the Secretary of Health and Human Services from interfering in the private negotiations -- which already occur in Medicare Part D -- between pharmaceutical manufacturers and Part D insurance plans or pharmacy benefit managers (PBMs).

From new data released, in 2020 alone, PhRMA member companies invested $91.1 billion in R&D, the highest level of investment on record, according to the 2021 PhRMA member annual survey. The survey also found that in 2020, approximately one out of every five dollars of revenue was devoted to R&D -- among the highest R&D intensity ratios of all industries -- and that PhRMA member company R&D spending accounts for most of the estimated $102 billion spent by the entire U.S. biopharmaceutical industry on R&D in 2018, the latest figure available. Over the past two decades, member companies invested a grand total of more than $1 trillion in the research and development of new and better medicines. These biopharmaceutical companies are at the heart of a robust R&D ecosystem that has led to the development of innovative treatments and cures for patients, with more on the horizon.

BioNJ in the News

As Featured in the Washington Post

"We believe there are right and wrong ways to address drug pricing concerns. According to a recent report by Vital Transformation, 90% fewer drugs would have been brought to market had HR-3 been in place over the past 10-year period from 2010-2019 years. Patients cannot afford such proposals. Our own Senator Menendez has been a leader in finding solutions to address Patient out-of-pocket costs -- such as recent bipartisan legislation which he introduced with Senator Bill Cassidy to provide cost certainty to Medicare Part D beneficiaries," stated BioNJ President and CEO, Debbie Hart. "We look forward to working with Senator Menendez and our Congressional delegation to deliver both lower Patient costs and tomorrow's cures." 

NJ Company News

East Hanover-based BioNJ Member Novartis and its Novartis U.S. Foundation announced a planned 10-year collaboration to create programs addressing the root causes of systemic disparities in health outcomes, and to create greater diversity, equity and inclusion across the research & development ecosystem. Novartis is collaborating with Coursera, the National Medical Association, Thurgood Marshall College Fund, Morehouse School of Medicine and 26 other Historically Black Colleges, Universities and Medical Schools. Leaders from all of the organizations have signed a pledge to develop programs focused on building trust in the health care system with communities of color and making measurable progress toward health equity, according to a news release.

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that results from Part 2 of the FIREFISH pivotal study were published in the New England Journal of Medicine. This trial showed that symptomatic Type 1 spinal muscular atrophy (SMA) infants treated with Evrysdi™ (risdiplam) showed significant improvements in survival, motor milestones, and motor function compared to historical controls. "It is exciting to see such profound results in infants treated with Evrysdi," said  Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. "We are proud that such a significant treatment for SMA patients was developed from PTC's splicing platform. We believe that the splicing platform is a disruptive technology that will continue to drive the development of new therapies in diseases with no treatment options available."

Bedminster-based BioNJ Member Kyowa Kirin Co., Ltd and LEO Pharma K.K announced that a new product, Dovobet Foam, is launched. Dovobet Foam was approved for the treatment of psoriasis vulgaris as an additional dosage form of Dovobet by MHLW (Ministry of Health, Labour and Welfare) in Japan, January 6, 2021. Dovobet, a combined topical preparation containing calcipotriol hydrate as active vitamin D3 and betamethasone dipropionate as a steroid, was developed by LEO Pharma A/S, the parent company of LEO Pharma K.K. It was approved as an ointment for psoriasis vulgaris in Denmark in 2001 and approved as a gel in the U.S. in 2008. And it has been approved and used in more than 90 countries.

Bedminster-based BioNJ Member Kyowa Kirin Co., Ltd announced that Kyowa Kirin has submitted an NDA of bardoxolone methyl (RTA 402) for the treatment of Alport Syndrome. Bardoxolone methyl is a small-molecular compound licensed from Reata Pharmaceuticals, Inc., which was designated as an orphan drug for the indication of "improvement of renal function in Alport Syndrome" by the Ministry of Health, Labour and Welfare (MHLW). With the designation, it is eligible for priority review. This application is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial, which was conducted by Reata for patients with Alport Syndrome. 

Lawrenceville-based BioNJ Member Celsion announced that following a pre-planned interim safety review of 55 as treated patients randomized in the Phase I/II OVATION 2 Study with GEN-1 in advanced (Stage III/IV) ovarian cancer, the Data Safety Monitoring Board (DSMB) has unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit, and that patients tolerate up to 17 doses of GEN-1 during a course of treatment that lasts up to six months. No dose-limiting toxicities were reported. The OVATION 2 Study combines GEN-1, the company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer.

Bridgewater-based BioNJ Member Eli Lilly and Company and Incyte announced the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). The FDA based the decision on data from the Phase 3 COV-BARRIER study, announced April 8, 2021

Loxo Oncology at Lilly, a research and development group of Bridgewater-based BioNJ Member Eli Lilly and Company, and Kumquat Biosciences today announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses. Through the multi-year collaboration, Kumquat will utilize its small molecule immuno-oncology (IO) platform to discover novel clinical candidates and Lilly has the option to select a certain number of drug candidates for further development and commercialization worldwide, excluding Greater China. Kumquat has retained development and commercialization rights in Greater China for each of the drug candidates selected by Lilly, subject to Lilly's option to co-commercialize in Greater China.

Princeton-based BioNJ Member Bristol Myers Squibb announced an update on the Phase 3 CheckMate -651 trial comparing Opdivo (nivolumab) plus Yervoy (ipilimumab) to the EXTREME regimen (cetuximab, cisplatin/carboplatin and fluorouracil) as a first-line treatment in platinum-eligible patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Although Opdivo plus Yervoy showed a clear, positive trend towards overall survival (OS) in patients whose tumors express PD-L1 with a combined positive score (CPS) ≥ 20, the study did not meet its primary endpoints. The safety profile of Opdivo and Yervoy in this trial was consistent with previously reported studies in solid tumors.

The U.S. Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg. Fexinidazole was developed as part of an innovative partnership between the non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), which conducted the pivotal clinical trials for this treatment, in partnership with the National Sleeping Sickness Programs of the Democratic Republic of Congo (DRC) and Central African Republic (CAR), and Bridgewater-based BioNJ Member Sanofi. Through Sanofi's collaboration the number of sleeping sickness cases reported to the WHO has been reduced by ~97% between 2001 and 2020.

Bridgewater-based BioNJ Member Sanofi announced a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease, met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to those treated with antihistamines alone (placebo) in Study A (the first of two trials) of the LIBERTY CUPID clinical program. CSU is a chronic inflammatory skin disease characterized by the sudden onset of hives on the skin and/or swelling deep under the skin. 

Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced new results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir, the company's investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. The findings demonstrate that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression at Week 26 in people living with HIV whose virus was no longer effectively responding to therapy. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 26.

Madison-based BioNJ Member AbbVie announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. DALVANCE is the first single-dose option administered as a 30-minute intravenous (IV) infusion for the treatment of ABSSSI caused by designated susceptible Gram-positive bacteria in pediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). ABSSSI are bacterial infections of skin and associated tissues primarily caused by Gram-positive pathogens, including Staphylococcus aureus and Streptococcus pyogenes.

Madison-based BioNJ Member AbbVie announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation (BTD) to venetoclax (VENCLEXTA®) in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes (MDS) based on revised International Prognostic Scoring System (IPSS-R). A BTD is intended to expedite the development and review of medications to treat a serious medical condition and is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies.

Madison-based BioNJ Member AbbVie announced new data, including the full results from the Phase 3 GEMINI 1 clinical study, evaluating the efficacy, safety and tolerability of investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. Multiple data presentations demonstrated that AGN-190584 met both its primary and key secondary efficacy endpoints with patients achieving near and intermediate vision gains. In addition, AGN-190584 showed no loss of distance vision, a rapid onset of action and sustained vision gains of up to six hours. GEMINI 1 data, in combination with data from the GEMINI 2 study, formed the basis of the AGN-190584 New Drug Application (NDA) currently under review with the U.S. Food and Drug Administration, which the agency is expected to act on by the end of 2021. 

Madison-based BioNJ Member AbbVie and Calico Life Sciences today announced an extension of their leading-edge collaboration to discover, develop and bring to market new therapies for patients with age-related diseases, including neurodegeneration and cancer. 
Calico is a life sciences company founded by Alphabet together with Calico CEO Arthur D. Levinson, Ph.D., who previously led Genentech as Chairman and CEO. As part of the collaboration, working together with AbbVie, Calico pursues discovery-stage research and development utilizing state-of-the-art technology and advanced computing capabilities. AbbVie provides scientific and clinical development support and will lend its expertise to future commercialization activities. 

BioNJ Member Pfizer Inc., with offices in Peapack, and Valneva announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15. The trial builds on previous positive Phase 2 trials and includes both adult and pediatric participants with the aim to support acceleration of the vaccine candidate's pediatric program. A total of 625 participants, 5 to 65 years of age, have been randomized in the Phase 2 trial to receive VLA15 at Month 0-2-6 or Month 0-6 (200 volunteers each) or placebo at Month 0-2-6 (200 volunteers). The main safety and immunogenicity readout will be performed approximately one month after completion of the primary vaccination schedule (i.e. at Month 7).

BioNJ Member Pfizer Inc., with offices in Peapack, and Arvinas, Inc. announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The estrogen receptor is a well-known disease driver in most breast cancers. ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. Under the terms of the agreement, Pfizer will pay Arvinas $650 million upfront. Separately, Pfizer will make a $350 million equity investment in Arvinas.

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. Biovac will perform manufacturing and distribution activities within Pfizer's and BioNTech's global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities. To facilitate Biovac's involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately.

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million. In a separate, Pfizer and BioNTech shared plans to provide the U.S. government with 500 million doses of the companies' COVID-19 vaccine for donation to the world's poorest nations. The companies expect to deliver 110 million of the additional doses by December 31, 2021.

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, for the treatment of patients with high-risk early stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an increased risk for disease recurrence. With this approval, KEYTRUDA is now approved in the U.S. for 30 indications.

Kenilworth-based BioNJ Member Merck & Co. announced positive overall survival (OS) results from the pivotal Phase 3 KEYNOTE-355 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC). Findings from the final analysis show first-line treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in OS compared with chemotherapy alone in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10).

Kenilworth-based BioNJ Member Merck & Co. announced results from a Phase 2a clinical trial evaluating the safety, tolerability and pharmacokinetics (PK) of six monthly oral doses, over 24 weeks, of islatravir, the company's investigational nucleoside reverse transcriptase translocation inhibitor, versus placebo for pre-exposure prophylaxis (PrEP) of HIV-1 infection in adults at low-risk of contracting HIV-1. After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo. Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. The levels of islatravir in peripheral blood mononuclear cells (PBMCs) also remained above the pre-specified efficacy PK threshold for PrEP at both doses studied (60 mg and 120 mg) eight weeks after the last study dose.

Kenilworth-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. The approval follows the FDA's Priority Review of Merck's application. VAXNEUVANCE is contraindicated for individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid; see additional Select Safety Information below.

Kenilworth-based BioNJ Member Merck & Co. announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase 3 study KEYNOTE-522. The trial investigated neoadjuvant KEYTRUDA, Merck's anti-PD-1 therapy, plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early stage triple-negative breast cancer (TNBC). This is the first time an anti-PD-1/L1 therapy has demonstrated a statistically significant EFS result as combined neoadjuvant and adjuvant therapy for these patients.

Kenilworth-based BioNJ Member Merck & Co. announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO® (vericiguat). In the EU, VERQUVO (2.5 mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. VERQUVO is being jointly developed by Merck and Bayer AG. Merck has the commercial rights to VERQUVO in the United States and Bayer has the exclusive commercial rights in the rest of world.

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved the combination of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Biotechnology Innovation Organization (BIO) announced that Princeton-based Kayothera Inc. is the winner of the Start-up Stadium competition held during BIO Digital in June. Pre-recorded presentation videos submitted by 16 finalists were evaluated by expert judges with entrepreneurial, investment, start-up, economic development, capital formation, and academic backgrounds from both the public and private sectors. "The Start-up Stadium was a fantastic opportunity to craft Kayothera's narrative while reaching a broad audience of stakeholders in the cancer immunotherapy field," noted Mark Esposito, CEO of Kayothera Inc. "We made several high-value investor introductions through the Start-up Stadium that have led to fruitful discussions since the event."

Berkeley Heights-based BioNJ Member Amgen and Teneobio announced an agreement under which Amgen will acquire Teneobio, a privately held, clinical stage biotechnology company developing a new class of biologics called Human Heavy-Chain Antibodies.  The acquisition includes Teneobio's proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen's core therapeutic areas.

Ewing-based Antares Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug Application (IND) for ATRS-1902 for adrenal crisis rescue. The active IND enables Antares to initiate a Phase 1 clinical study for ATRS-1902 for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver hydrocortisone. Adrenal crisis is a potentially fatal condition associated mainly with an acute deficiency of cortisol, which is a hormone produced and released by the adrenal gland, and commonly occurs in patients with long-term adrenal insufficiency.

Tarrytown-based Regeneron Pharmaceuticals, Inc. and AstraZeneca announced that the companies have entered into a collaboration to research, develop and commercialize small molecule compounds directed against the GPR75 target with the potential to treat obesity and related co-morbidities. The collaboration builds on the recent discovery from the Regeneron Genetics Center® of rare genetic mutations in the GPR75 gene associated with protection against obesity and on early joint research initiated soon after discovery of the target so that potential treatments can be developed as quickly as possible. The companies will evenly split research and development costs and share equally in any future potential profits.

Warren-based GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. Immunocompromised individuals are at greater risk of shingles and associated complications than immunocompetent individuals. Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA in 2017 for the prevention of shingles in adults 50 years of age or older.

Warren-based GlaxoSmithKline and Vir Biotechnology, Inc. announced they have signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab, an investigational single dose SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.

Jersey City-based Heron Therapeutics, Inc. announced the online publication of new analysis evaluating the efficacy and safety of ZYNRELEF (bupivacaine and meloxicam) extended-release solution in adults aged 65 years and older undergoing bunionectomy and hernia repair from the Phase 3 EPOCH 1 and EPOCH 2 studies. The analysis, published in the peer-reviewed journal Pain Management, showed that 58% of bunionectomy and 87% of hernia repair patients aged 65 years and older receiving ZYNRELEF required no opioids to manage their postoperative pain through 72 hours following surgery. Further, throughout the 72-hour period, the mean pain intensity never rose above the mild range.

Ridgefield Park-based BeiGene, Ltd. announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. This is the second approval for BRUKINSA in Canada, following its initial approval for adult patients with Waldenström's macroglobulinemia (WM). The Health Canada approval for BRUKINSA in MCL is based on efficacy results from two single-arm clinical trials. Across both trials, as assessed by independent review committee (IRC) per 2014 Lugano Classification BRUKINSA achieved an overall response rate (ORR) of 84%, defined as the combined rate of complete responses (CRs) and partial responses (PRs).

Parsippany-based Daiichi Sankyo Company announced that Daiichi Sankyo Biotech Co., Ltd., a subsidiary of Daiichi Sankyo, has made its shipment of VAXZEVRIATM Intramuscular Injection, a vaccine against novel coronavirus developed by AstraZeneca K.K. This shipment of the COVID-19 vaccine is to be provided to Southeast Asian countries and other regions through the Japanese Government. Under the contract manufacture agreement of the COVID-19 vaccine that Daiichi Sankyo concluded with AstraZeneca in February 2021, Daiichi Sankyo Biotech has engaged in manufacturing the COVID-19 vaccine, including vial filling and packaging, since March of the same year.

Florham Park-based Shionogi & Co., Ltd announced they have entered into a license agreement for development of novel nasal vaccine candidates for COVID-19 using HanaVax's cationic nanogel delivery system (cCHP). cCHP is HanaVax's unique delivery technology using cationic cholesteryl group-bearing pullulan. When administered intranasally, it can effectively induce immunity in the respiratory mucosa, and the whole body, without the pain caused by conventional injections. In emerging countries where the medical environment is not well established, it may be difficult to administer vaccines by injection, and from the viewpoint of medical access, there is an increasing need for a nasal vaccine as an easy-to-use preparation globally.

Florham Park-based Shionogi & Co., Ltd announced that it has initiated a Japanese Phase 1 clinical trial of the therapeutic agent S-217622 as an orally administered antiviral drug for COVID-19, caused by the novel coronavirus (SARS-CoV-2) infection, and the first dose was administered successfully on July 22. No safety concerns have been identified after the first dose. S-217622 is a 3CL protease inhibitor discovered by Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the duplication of the virus. S-217622 suppresses the duplication of SARS-CoV-2 by selectively inhibiting 3CL protease. In non-clinical trials using SARS-CoV-2 infected animals, it has been confirmed that the viral load is rapidly and significantly reduced.

Franklin Lakes-based Becton, Dickinson and Company announced it has taken a large step forward in transforming the patient experience through a vision of a "One-Stick Hospital Stay," building on its history of innovation and leadership in blood collection and vascular access solutions. With the recent acquisition of Velano Vascular and its innovative, needle-free technology that enables high-quality blood draws from existing peripheral intravenous catheter (PIVC) lines, BD can now enable health care providers to help eliminate multiple needlesticks for blood sample collection, reducing the pain and discomfort from the process while delivering quality outcomes and increased patient satisfaction.

People in the News

The Tri-County Scholarship Fund (TCSF) will host its 40th Annual Awards Dinner honoring prominent New Jersey leaders, including Tewksbury residents Reema and Navneet Puri, founders of Bridgewater-based Nevakar Inc. TCSF's mission to provide scholarships for many of the State's most financially disadvantaged children, enabling them to attend accredited K-12 values-based, independent schools. The awards celebration is the largest fundraiser for the New Jersey non-profit which in the past 40 years, has provided more than $30 million for more than 33,000 scholarships for financially disadvantaged New Jersey children.

Imagine how much easier controlling the COVID-19 pandemic would be if public health officials could prevent infections without administering an injected vaccine - if individuals could take medication themselves. Jeffrey Nau is not only imagining it, he and his staff are making it happen. Mr. Nau is the President and CEO of Princeton-based Oyster Point Pharma, which is developing a nasal spray that recent trials have shown could be effective in blocking the virus that causes COVID-19. For this edition of NJBIZ Conversations, Editor Jeff Kanige spoke with Nau about the company, its lead product - a treatment for dry eye disease - and what the anti-COVID nasal spray would mean in the fight against the pandemic.

Featured in RRE Revolution Magazine's PEO Series

Jayne Gershkowitz has been with Amicus since 2006 and serves as their Chief Patient Advocate. In this interview, Jayne talks to RARE Revolution about how patient advocacy is embedded in their organization and about how heartened it makes her to see it being elevated to a key business function in many companies.

Bridgewater-based BioNJ Member Sanofi announced that Karen Linehan and Philippe Luscan, who have led Legal, Ethics & Business Integrity (LEBI) and Industrial Affairs at Sanofi for the last 14 and 13 years respectively have decided to retire. Sanofi has appointed Roy Papatheodorou and Brendan O'Callaghan as their respective replacements, joining the company's Executive Committee. Additionally, Viviane Monges will join EUROAPI, a future leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API), as an independent non-executive Chair of the Supervisory Board. 

Kenilworth-based BioNJ Member Merck & Co. announced that Cristal N. Downing has been appointed chief communications & public affairs officer, a newly created role, effective August 16, 2021. Ms. Downing will become a member of Merck's Executive Team and lead the development, advancement and execution of the company's communications and public affairs strategy. Most recently, Ms. Downing was Vice President, Communications & Public Affairs, Medical Devices, at Johnson & Johnson. Prior to that, she held the role of Vice President, Global Finance Communications at Johnson & Johnson, where she partnered with the Chief Financial Officer to develop, integrate and implement a broad range of public affairs and communications strategies that supported the CFO and CEO strategic platforms.

Parsippany-based BioNJ Member Teva Pharmaceutical Industries Ltd. announced changes to its leadership team. Sven Dethlefs, who currently serves as Teva's Executive Vice President, Global Marketing and Portfolio and International Markets Commercial has been appointed the new head of North America Commercial. Additionally, Mark Sabag has been appointed as Executive Vice President, International Markets Commercial; Galia Inbar will be promoted to Executive Vice President, Chief Human Resources Officer, and Global Communications, Brand and ESG; and Eli Shani will be promoted to Executive Vice President, Global Marketing and Portfolio.

For 35 years, EY's Entrepreneur of the Year® program has recognized the unstoppable entrepreneurs who test the limits of the possible and catapult us forward to what's next. Congratulations to these BioNJ Members for being honored: Davie Gockel, Langan Engineering & Environmental Services (Winner); Angelo Stracquatanio, Apprentice.io (Finalist); Susan Levinson, Bioaegis Therapeutics (Finalist); and Brian Leuthner, OncoSec Medical (Finalist).

In the best of times, doing business in New Jersey requires owners and executives to navigate a dense web of legal and regulatory issues and requirements. During a deadly global pandemic -- and in its aftermath -- that task is even more difficult. Even the most skilled leaders will need guidance, advice and sometimes representation. The individuals we recognize in this year have proven themselves up to the challenge. We congratulate these BioNJ Members for making the list: Audrey Murphy, Hackensack Meridian Health; Michael Ullmann, Johnson & Johnson; Matt Platkin, Chris Porrino and Gary Wingens, Lowenstein Sandler; and Joseph Boccassini, Scott Kobler, William Palatucci and Dave Sorin, McCarter & English.

The Board of Warren-based GSK announced that Brian McNamara, the CEO of GSK Consumer Healthcare (a Joint Venture between GSK and Pfizer) has been appointed as CEO Designate of the new, listed Consumer Healthcare company which will result from the proposed demerger of Consumer Healthcare from GSK. Mr. McNamara joined GSK from Novartis in 2015, where he was head of the Over the Counter (OTC) division. He has been a driving force behind two successful Joint Ventures, first between GSK and Novartis and more recently with Pfizer to create a new world-leading Consumer Healthcare business.


The New Jersey Economic Development Authority (NJEDA) opened pre-registration for Phase 2 of the Small Business Emergency Assistance Loan Program as part of Governor Phil Murphy's ongoing COVID-19 relief and recovery efforts. This loan program provides financing of up to $100,000 at 0% interest to eligible New Jersey small businesses and nonprofits. All entities must pre-register before 5:00 p.m. EDT TODAY, Friday, July 30, 2021, to be eligible to apply for the loan.

The New Jersey Economic Development Authority (NJEDA) Board recently approved rules to enact the creation of the Personal Protective Equipment (PPE) Manufacturing Tax Credit (PMTC) Program. Created under the New Jersey Economic Recovery Act of 2020 (ERA), the PMTC Program will provide tax credits to incentivize the development of PPE manufacturing in New Jersey. More information is available at https://www.njeda.com/ppe. The PMTC Program provides per-job tax credits to PPE manufacturing projects in New Jersey that have made or make investments in 2020, 2021, or 2022. Projects can receive up to a maximum of $500,000 in tax credits per year in which they make qualified investments.


Students 2 Science would like to announce two generous grants from Bayer Fund, in the amount of $125,000 and $25,000 respectively, to bring innovative STEM programs to Passaic Public Schools, NJ and Pittsburgh Public Schools, PA. These grants, as part of a long-standing partnership with Bayer Fund, ensure that students in these priority districts have access to hands-on, real-world, career-oriented experiences that empower them to succeed with STEM. "S2S is a convener between the public and the private sector, all with a shared vision to educate our future workforce by closing gaps in access to hands-on, rigorous STEM education and real-world experiences. With the support of partners such as Bayer Fund, we are confident we will be able to provide them with a world-class education and the skills they need to succeed in 21st Century careers," said Paul A. Winslow, Ph.D., President and Co-Founder of Students 2 Science.

Could a targeted therapy derived from a plant used medicinally in China for centuries offer the next breakthrough in cancer treatment? Dr. Gary Goldberg, Associate Professor in the Department of Molecular Biology at Rowan University School of Osteopathic Medicine (RowanSOM), is undertaking a human clinical trial to find out. Dr. Goldberg and his team are collaborating with a group at the Rutgers New Jersey Medical School headed by Dr. Mahnaz Fatazadeh, Professor at Rutgers School of Dental Medicine, to test a new drug candidate called MASL. This novel compound has been trademarked and licensed from Rowan University by Sentrimed, a company founded by Dr. Goldberg.

Elisa Charters, a stalwart for diversity, equity, inclusion and belonging (DEIB) and dedicated alumna of New Jersey Institute of Technology (NJIT), has been appointed to the NJIT Board of Trustees. Ms. Charters, a first-generation college student-athlete who attended NJIT with support from its Educational Opportunity Program, said, "I cannot express how extremely proud I am in this moment - as a daughter and first to attend college, as a mother of a daughter and son, as a wife of an NJIT alumnus (Brian Charters M.Eng. '93) and most especially as a Latina advocate and professional representing other multicultural women who led before me and those who will follow."

It's the result that was desired - and hoped for. Now, thanks to a Rutgers University study, it can be said that high school students who participated in summer programs about public health have increased interest in pursuing careers in science, technology, engineering and mathematics. The study, published in the journal Pedagogy in Health Promotion, explored whether increasing public health awareness would motivate high school students to pursue public health careers. Researchers found that the summer program, "Public Health: Outbreaks, Communities and Urban Studies" (called "PHocus"), which was offered in 2018 and 2019, increased the students' knowledge in public health, epidemiology, urban public health and global public health.

Salma Jabbour, M.D., Vice Chair of Clinical Research and Faculty Development at Rutgers Cancer Institute of New Jersey, and Clinical Chief of Radiation Oncology at Robert Wood Johnson University Hospital, an RWJBarnabas Health facility, has been named a Fellow of the American Society of Radiation Oncology (FASTRO). This distinction honors individuals who have made significant contributions to the society and to the field of radiation oncology through research, education, patient care and service to the field. In her roles at Rutgers Cancer Institute, Dr. Jabbour works closely with a multi-disciplinary team from the Thoracic Oncology and Gastrointestinal Oncology Programs to educate patients and help them make informed decisions about what treatment options are right for them.

Cardiac care is not likely the first thing on a patient's mind when fighting cancer, however, cancer and cardiovascular issues are closely linked. Cardio-oncology is an emerging medical specialty focused on cardiac complications that may arise from cancer treatment. Andrew M. Evens, DO, MSc, Associate Director for Clinical Services at Rutgers Cancer Institute of New Jersey and medical director of the Oncology Service Line at RWJBarnabas Health, is a participating physician in the Cardio-Oncology Program at Rutgers Cancer Institute of New Jersey in partnership with RWJBarnabas Health and shares more information.

Aiding in the longtime mission to increase investment in cancer research, Governor Phil Murphy recently signed the fiscal year 2022 State budget, which included a $10 million appropriation to support pediatric cancer research. This legislation, which was sponsored by Senate President Stephen M. Sweeney and Senator Anthony M. Bucco, will support the establishment of the Pediatric Cancer Center at Rutgers Cancer Institute of New Jersey, which in partnership with RWJBarnabas Health, is a leader in pediatric cancer research and care.

The way Dr. Achintya Moulick sees it, the future of health care innovation starts with collaboration. That's why Moulick, the CEO of CarePoint Health, was so delighted to hold a ribbon-cutting for CarePoint's Healthcare Innovation Center - what he is calling a groundbreaking initiative focused on bringing together clinicians and external thought leaders to collaborate and redesign health care. Working together to solve health care's hardest problems, the Innovation Center will partner with vendors, investors, startups and visionaries to apply clinical expertise and excellence while piloting novel applications, approaches and concepts to improve the patient experience.

The newest class members at the Hackensack Meridian School of Medicine launched their medical careers with a white coat ceremony at the school. The 161 students that make up the latest class at the school participated in the symbolic moment that marks the start of the journey to a medical degree. The school admitted its first class in 2018 with 60 students. Each year has brought an increasing number of students, leading to this fourth year of admissions. Students have the opportunity for a three-year path to residency, or an optional fourth year which offers combined master's degree or graduate certificate programs, intense clinical immersion or focused research.

Morristown Medical Center and Hackensack University Medical Center tied for the No. 1 spot in New Jersey in the prestigious U.S. News & World Report rankings -- and therefore share the title of Best Hospital in the State. It is perhaps fitting that the two hospitals share the top spot, as one or the other has been No. 1 for the past 10 years. Morristown was tops in 2018-20; Hackensack was No. 1 from 2012-2017. U.S. News compared more than 4,750 medical centers nationwide in 15 specialties and 17 procedures and conditions.

Scientists from the Hackensack Meridian Center for Discovery and Innovation (CDI) were awarded $6.4 million from the National Institutes of Health (NIH) to pursue an innovative new tuberculosis (TB) vaccine concept. The only TB vaccine available, Bacille Calmette-Guérin, or BCG, is very unreliable. The team proposes to improve BCG by engineering it to stimulate the development and communication of B cells, an important part of the immune system. With this strategy, the researchers hope to develop a second-generation TB vaccine which provides reliable protection from new infections and can even help to cure existing TB infections by complementing antibiotic therapy.

Thought Leadership from BioNJ Members

We invite our Innovation and Associate Members at the Executive, Preferred and Market Maker levels to submit their white papers for consideration for this new section of the Weekender. Please submit papers to [email protected].

Article by BioNJ Member Buchanan Ingersoll & Rooney

With the pandemic winding down and a new administration in Washington D.C., the U.S. Food and Drug Administration (FDA) and other enforcement agencies are starting to return to their pre-COVID-19 agendas by, among other things, targeting compliance violations in the life sciences industry. Based on Buchanan's careful and consistent monitoring of trends in the life sciences enforcement space before and after the outbreak of the pandemic, its decades of experience working with life sciences regulators, and its expertise in counseling life sciences companies on compliance best practices, there are certain areas in particular we expect enforcement agencies to examine closely in the near term. Click here for full article.

Partner Events

What is a Master Class? A Master Class is a class (often in music) given by renowned experts to highly talented students. Why do we want to host a masterclass for leadership? Leadership matters. And fortunately, leadership skills can be learned and acquired once appreciated and apprehended. It is also an art. Inspired by the notion of Master Class, we have invited distinguished and acclaimed leaders and veteran coaches to share with us their invaluable insights and experiences. BioNJ Members can attend for free. If interested, send an email to [email protected].

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 [email protected], or 609-890-3185. Find providers in these categories:

Please contact BioNJ at [email protected] 
or call 609-890-3185 with any questions.