Pfizer CEO Blasts America's Drug Pricing System: 'We Have a Problem Here'

Prescription drug prices have become a key target of criticism by those calling for reforms to the U.S. health care system. Upon taking office, President Biden vowed to lower these prices. His plan called on Congress to allow Medicare to negotiate drug prices with manufacturers, allow prescription drugs to be imported from Canada, impose an out-of-pocket spending cap for those on Medicare and limit annual price increases. Unfortunately, the plan was dropped from the latest White House spending bill after key Democrats objected to it. And according to Pfizer CEO Albert Bourla, politicians are going at it from the wrong angle anyways. “The issue of drug pricing is a real issue in the U.S.,” Bourla said during Yahoo Finance's All Markets Summit. “But it is not the issue that some people think and present.” According to a January 2021 report from the RAND Corporation, “prescription drug prices in the United States are significantly higher than in other nations, with prices in the United States averaging 2.56 times those seen in 32 other nations.”

Why Congress Must Reject Drug Pricing Proposals That Are Dangerous for Patients Like Me: An Opinion Piece

As someone with a rare disease, I know how desperate patients and families are for medical breakthroughs. And as a leader of a company striving to answer that call, I also know how harmful current drug pricing proposals being offered up in the Build Back Better Act may be to foster innovation and deliver meaningful therapies to those in need. While the stated intent behind these proposals is to lower costs, they would instead likely damage the biotechnology industry’s critical research and development efforts over several decades, destroying hope for the patients who need innovation most and exerting government control over patient access to future therapies. For 10 years, I suffered with pain and inflammation, shuffling between more than 100 doctors, only to hear “you’re an interesting case.” Years later, I was finally diagnosed with a rare disease and an autoimmune disease before being prescribed medication that would allow me to live a better life. Unfortunately, the journey for many other patients to find effective treatment leads to a dead end. For me, and for patients who share my story, providing my perspective on the harmful proposals being put forward in Congress is personal.

The Patient Experience: Insurance Design Hurdles Lead to Access Issues for Too Many Americans, Including Communities of Color and the Chronically Ill

3 in 10 insured Americans still face a financial barrier to care and some of the most vulnerable patients are also those more likely to experience barriers in accessing their care, according to our inaugural Patient Experience Survey (PES). This is apparent when we look at the disproportionate application of insurer tools – including prior authorization and failing first – on patients with chronic illnesses and communities of color. Practices like prior authorization and failing first are designed to keep spending down for insurance companies, but for patients, these practices are roadblocks for receiving the care a patient’s doctor advises, including prescription medicines. If we want to improve health care in this country, insurance must first work like insurance – ensuring patients have access to the medicines and care they need. Here are three things you should know: 1) Americans face a variety of insurance coverage barriers, like prior authorization and failing first, that can impede access to the medicines they need. 2) Insurance coverage barriers disproportionately impact people with chronic diseases and communities of color. 3) Coverage barriers can contribute to patients not taking their medicines as prescribed by a doctor.

A Report: Drug Expenditure Dynamics 1995-2020: Understanding Medicine Spending in Context

While the level of drug expenditure is closely watched and often commented upon, the composition of that expenditure and its dynamics are not as well understood. Typically, official statistics of drug spending only include drugs dispensed in pharmacies and do not include drugs used in hospitals, an issue which raises questions about their representativeness of total drug spending. In this report, for the first time, we have included estimates of total drug spending, including hospitals and net of discounts and rebates. These estimates have been based on official statistics from government agencies in the countries where available, in some cases not previously published internationally. Some key messages in the report: While the level of drug expenditure is closely watched and often commented upon, the composition of that expenditure and its dynamics are not as well understood; the changes in drug spending over the past quarter century have been dramatic in terms of the types of medicine and the diseases they are used to treat; and drug spending as a share of health care spending has changed to a lesser degree and has represented greater stability than one might have expected. 

2021’s Top Employers Engage, Nurture, and Harness the Power of Scientists

Congratulations to BioNJ Chair and Chair and CEO of Bridgewater-based Insmed Incorporated, Will Lewis, as well as the entire Insmed Team, for ranking #1 on the Science 2021 Top Employers list. “Our culture is something our employees are exceptionally proud of,” says Nicole Schaeffer, Chief People Strategy Officer at Insmed. Walter Perkins, Chief Technology Officer, explains the origin of this tenet: “Our CEO said put the patient first, use that as your compass, and everything will take care of itself in the business.” To bring home this point, Insmed, like several top employers, regularly invites patients to speak directly with the employees, an effort that empowers its staff to more actively engage in furthering the company’s mission of developing life-saving interventions with patient outcomes in mind. “It is hard to understand how devastating these diseases are, so to hear [patients’] intimate stories of what they go through on a daily basis is striking,” says Perkins.

PTC Announces Expansion of Translarna™ Label to Include Ambulatory Patients as Young as 2 Years Old in Brazil

South Plainfield-based BioNJ Member PTC Therapeutics announced that the Brazilian National Health Surveillance Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved the expansion of the indication of Translarna™ (ataluren) to include ambulatory children aged 2 to 5 years old with nonsense mutation Duchenne muscular dystrophy (Duchenne). This broadens the use beyond the previous age range of 5 years and older. "Expanding access to Translarna to children with nonsense mutation Duchenne in Brazil is important to us," said Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics. "We know that with Duchenne, early diagnosis and treatment gives children the best chance of preserving muscle function and delaying the progression of the disease."

Thermostable Vaccine Technology Platform to be Presented at the 6th International Conference on Vaccines Research and Development

Princeton-based BioNJ Member Soligenix announced that Oreola Donini, Ph.D., Chief Scientific Officer, will be presenting key data from the company's thermostable vaccine technology platform, including results from the company's programs for ricin toxin vaccine (RiVax®), COVID-19 vaccine (CiVax™) and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses). The presentation will be given at the upcoming 6th International Conference on Vaccines Research and Development. Under the company's Public Health Solutions business segment, Soligenix is developing thermostabilized subunit vaccines. Thermostabilization is achieved by using a combination of Generally Recognized as Safe (GRAS) excipients and lyophilization (freeze-drying) to yield a single-vial presentation of vaccine that is stable at ambient and higher temperatures and that can be reconstituted with water for injection immediately prior to use. 

Soligenix Announces Publication Demonstrating Enduring Protection of its Thermostable RiVax® Vaccine

Princeton-based BioNJ Member Soligenix, Inc. announced publication of pre-clinical immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) demonstrating enduring protection for at least 12 months post-vaccination. The article titled "Durable Immunity to Ricin Toxin Elicited by a Thermostable, Lyophilized Subunit Vaccine" has been accepted for publication in the journal mSphere. The article results from collaborative work with the Wadsworth Center of the New York State Department of Health. Coupled with previous demonstration of efficacy in mice and non-human primates (NHPs) as well as long-term thermostability (at least 1 year at 40°C or 104°F), these results reinforce the practicality of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities that arise for vaccines that require stringent cold chain handling.

SCYNEXIS Pivotal Phase 3 VANISH-303 Trial Results Published in Clinical Infectious Diseases Demonstrate Significant Superiority of Ibrexafungerp Over Placebo for Treatment of Vaginal Yeast Infection

Jersey City-based BioNJ Member SCYNEXIS announced the peer-reviewed publication of results from its Phase 3 VANISH-303 and Phase 2 DOVE studies in Clinical Infectious Diseases. Findings from the pivotal Phase 3 VANISH-303 clinical trial led to the June approval by the U.S. Food and Drug Administration (FDA) of BREXAFEMME® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC), the first new antifungal class of therapy in more than 20 years. “We hope the publication of these important findings from the groundbreaking research of our VANISH-303 study will provide clinicians valuable insight regarding the efficacy and safety of ibrexafungerp for the treatment of vaginal yeast infections,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS.

Matinas BioPharma Initiates Dosing in Phase 1 Study of Potential First Oral Aminoglycoside Antibiotic Drug MAT2501

Bedminster-based BioNJ Member Matinas BioPharma announced that it has dosed the first patient in a Phase 1 single ascending dose (SAD) pharmacokinetic study in healthy volunteers with MAT2501. The company expects to complete enrollment of the Phase 1 SAD study in the first quarter of 2022, with data anticipated during the second quarter of 2022. Pending successful completion of the Phase 1 SAD study, the company expects to start a Phase 2 program in patients with nontuberculous mycobacterial (NTM) infections by the first quarter of 2023, following required longer-term preclinical toxicology studies to be conducted during 2022. MAT2501 is being developed to potentially become the first oral aminoglycoside, with the application of Matinas’ proprietary LNC platform technology to the broad-spectrum antibiotic drug amikacin. 

Rafael Pharmaceuticals Announces APOLLO613 Phase I/II Clinical Trial of CPI-613® (devimistat) in Combination With Hydroxychloroquine in Patients with Relapsed Clear Cell Sarcoma Begins Enrollment at City of Hope in Duarte, Calif.

Cranbury-based BioNJ Member Rafael Pharmaceuticals announced that the Phase 1 clinical trial of CPI-613® (devimistat) in combination with hydroxychloroquine in patients with clear cell sarcoma is open for enrollment. The clinical trial will begin enrolling patients at City of Hope in Duarte, California, with other sites across the country to quickly follow. “Clear cell sarcoma is truly one of the most challenging sarcomas to treat, as it often spreads quickly to other parts of the body and prognosis is generally poor,” said Sanjeev Luther, President and CEO of Rafael Pharmaceuticals. “The opening of this trial at City of Hope and several other sites across the country has the potential to grant a population with significant unmet medical needs a promising new treatment option.” 

Phathom Pharmaceuticals Announces New Data at ACG 2021 Annual Scientific Meeting

Florham Park-based BioNJ Member Phathom Pharmaceuticals announced data from the PHALCON-HP Phase 3 study, the largest U.S. registrational trial ever conducted for H. pylori. PHALCON-HP showed that both vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) demonstrated superior eradication rates in all patients compared to a current standard of care therapy consisting of the proton pump inhibitor (PPI), lansoprazole, in combination with amoxicillin and clarithromycin. In the primary endpoint analyses of the PHALCON-HP study comparing the non-inferiority of vonoprazan-based therapies to lansoprazole triple therapy in patients with H. pylori without strains resistant to antibiotics, eradication rates with vonoprazan triple therapy and vonoprazan dual therapy were 84.7% (p<0.0001) and 78.5% (p=0.0037), respectively, compared to 78.8% for lansoprazole triple therapy. 

ADMA Biologics Announces Closing of $57.5 Million Public Offering Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

Ramsey-based BioNJ Member ADMA Biologics announced underwritten public offering of 50 million shares of its common stock at a public offering price of $1.00 per share, in addition to the exercise in full of the underwriters’ option to purchase an additional 7.5 million shares of common stock. ADMA intends to use the net proceeds from this offering 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™; to expand its plasma collection facility network; 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; to explore business development opportunities; and for general corporate purposes and other capital expenditures.

Antios Therapeutics Raises $75 Million in a Series B-1 Funding to Advance Clinical Programs for HBV

Mendham-based BioNJ Member Antios Therapeutics announced the successful closing of a $75 million Series B-1 financing. The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios' lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development and has the potential, if approved, to become the cornerstone of a curative, once-daily HBV therapy. Pre-clinical data to date for ATI-2173, alone or combined with tenofovir disoproxil fumarate (TDF), indicate the potential for sustained HBV DNA suppression off treatment, unique among approved nucleosides and investigational anti-HBV therapies.

Leading Independent Proxy Advisory Firm ISS Recommends Advaxis Stockholders Vote “FOR” the Merger with Biosight

Monmouth Junction-based BioNJ Member Advaxis Inc. announced that leading proxy advisory firm Institutional Shareholder Services Inc. (“ISS”) issued a report recommending that Advaxis stockholders vote “FOR” the merger of the company with Biosight and recommends voting “FOR” all proposals, at the company’s Special Meeting scheduled for November 16, 2021. The ISS recommendation stated, “The board ran what appears to have been a thorough strategic review process, corresponding with over 200 potential counterparties on a broad variety of transaction types, and no competing offers have been publicly disclosed since the announcement. The strategic rationale also appears logical, as it will diversify the pipeline of product candidates, and is expected to result in a combined company with a more stable financial position. In light of these factors, support for the proposal is warranted.”

Additional Verzenio® (abemaciclib) Phase 3 monarchE Trial Data Published in the Annals of Oncology

Overall survival data from Bridgewater-based BioNJ Member Eli Lilly and Company’s Verzenio® (abemaciclib) Phase 3 monarchE study were published in a Letter to the Editor in the Annals of Oncology. These OS data, while immature, have been published to address questions regarding the recent approval by the U.S. Food and Drug Administration (FDA) in a subgroup of the population studied in the monarchE trial. Patients participating in monarchE continue to be followed over time while overall survival data mature. On October 12, the FDA approved Verzenio 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 at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test.

Lilly to Supply 614,000 Additional Doses of Bamlanivimab and Etesevimab to the U.S. Government for the Treatment or Post-Exposure Prevention of COVID-19

Bridgewater-based BioNJ Member Eli Lilly and Company announced an additional purchase by the U.S. government for bamlanivimab with etesevimab for administration together. This neutralizing antibody therapy is authorized for emergency use for the treatment of mild to moderate COVID-19 or for post-exposure prophylaxis of COVID-19 in certain individuals. As part of the agreement, Lilly will supply 614,000 doses of bamlanivimab with etesevimab no later than January 31, 2022 for a total of $1.29 billion. A minimum of 400,000 doses will be supplied no later than December 31, 2021. The estimated impact of the new purchase to the 2021 guidance provided in Lilly's earnings release dated October 26, 2021 is $840 million of additional revenue and approximately 25 cents of additional earnings per share. The expected impact in 2022 will be reflected in the company's financial guidance to be provided in December 2021.  

FDA Approves Novartis Scemblix® (Asciminib), With Novel Mechanism of Action for the Treatment of Chronic Myeloid Leukemia

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) approved Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response (MMR) rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation. In accordance with the Accelerated Approval Program, continued approval for the first indication may be contingent upon verification and description of clinical benefit from confirmatory evidence. Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies.

Novartis Receives Priority Review by U.S. FDA and Filing Acceptance by EMA for Kymriah® to Treat Patients With Relapsed or Refractory Follicular Lymphoma

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted the company’s Supplemental Biologics License Application (sBLA) and Type II Variation, respectively, for Kymriah® (tisagenlecleucel) in adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines of treatment. The FDA has also granted priority review to the company’s sBLA for Kymriah in adult patients with r/r FL. Kymriah was previously granted orphan medicinal product designation by the European Commission (EC) for FL. If approved in this potential third indication, Kymriah would have the opportunity to present an important treatment option for those patients with r/r FL in need of potentially definitive outcomes.

AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients With Advanced Parkinson's Disease

Madison-based BioNJ Member AbbVie announced that continuous 24 hours/day subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) was statistically superior to oral levodopa/carbidopa in reducing motor fluctuations in patients with advanced Parkinson's disease (PD) in a Phase 3, randomized, double-blind, double-dummy, active-controlled study. The study met its primary endpoint of increase from baseline in "On" time (hours) without troublesome dyskinesia (involuntary movements) after 12 weeks based on the Parkinson's Disease Diary (PD Diary). These results will be a key component of global regulatory submissions. The increase in "On" time at week 12 was 2.72 hours for ABBV-951 versus 0.97 hours for oral levodopa/carbidopa (LD/CD) (p= 0.0083). Improvements in "On" time were observed as early as the first week and persisted throughout the 12 weeks.

AbbVie's Cariprazine (VRAYLAR®) Met Primary Endpoint in Phase 3 Study as an Adjunctive Treatment for Major Depressive Disorder

Madison-based BioNJ Member AbbVie announced top-line results from two Phase 3 clinical trials, Study 3111-301-001 and Study 3111-302-001, evaluating the efficacy and safety of cariprazine (VRAYLAR®) as an adjunctive treatment for patients with major depressive disorder (MDD). In Study 3111-301-001, cariprazine showed a statistically significant change from baseline to week six in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. Patients treated with cariprazine at 1.5 mg/day achieved improved MADRS total score at week six compared to placebo (p-value=0.0050). Patients treated with cariprazine at 3.0 mg/day demonstrated improvement in MADRS total score at week six over placebo but did not meet statistical significance (p-value=0.0727). In Study 3111-302-001, cariprazine demonstrated numerical improvement in depressive symptoms from baseline to week six in MADRS total score compared with placebo but did not meet its primary endpoint for either the 1.5 mg/day or 3.0 mg/day dose.

U.S. Food and Drug Administration Approves VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%, the First and Only Eye Drop to Treat Presbyopia (Age-Related Blurry Near Vision)

Madison-based BioNJ Member AbbVie announced the U.S. Food and Drug Administration (FDA) approval of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population. VUITY is a daily, prescription eye drop that works in as early as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision. Specifically designed for presbyopia, VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, delivered with pHast™ technology. The proprietary pHast™ technology allows VUITY to rapidly adjust to the physiologic pH of the tear film.

Viiv Healthcare Presents Positive Interim Data Showing Vocabria (Cabotegravir) and Rekambys (Rilpivirine) Can be Implemented Successfully in a Variety of European Healthcare Settings

ViiV Healthcare, the global specialist HIV company majority owned by Warren-based BioNJ Member GlaxoSmithKline presented positive interim data from the CARISEL (Cabotegravir and Rilpivirine Implementation Study in European Locations) study, which was initiated and conducted during the COVID-19 pandemic. The study evaluated perspectives of health care teams and people living with HIV, through surveys and interviews, around the implementation of Vocabria (cabotegravir injection) and Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine long-acting injectable suspension) administered every 2-months, with data showing that implementation of the long-acting regimen is realistic and achievable in a variety of European health care settings. 

Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study

BioNJ Member Pfizer, with offices in Peapack, announced its investigational novel COVID-19 oral antiviral candidate,PAXLOVID™, significantly reduced hospitalization and death, based on an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness. The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID™ were hospitalized through Day 28 following randomization (3/389 hospitalized with no deaths), compared to 7.0% of patients who received placebo and were hospitalized or died (27/385 hospitalized with 7 subsequent deaths).

Pfizer and Biontech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age. “This is a day so many parents, eager to protect their young children from this virus, have been waiting for,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Over 6 million children in the U.S. have been diagnosed with COVID-19 since the start of this pandemic, and a high number of young people continue to be infected every week.”

Pfizer and BioNTech to Provide U.S. Government an Additional 50 Million Pediatric Doses of COVID-19 Vaccine to Support Further Preparedness for Future Needs

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced that the U.S. government has purchased 50 million more doses of the companies’ COVID-19 vaccine. The U.S. will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5 years of age, should they receive regulatory authorization. The companies expect to deliver all these doses by April 30, 2022. With this order, the U.S. government has exercised its final purchase option under its existing U.S. supply agreement with the companies, bringing the total number of Pfizer-BioNTech COVID-19 Vaccine doses secured under the agreement since the start of the pandemic to 600 million – spanning doses for adults and adolescents, and children. Separately, Pfizer and BioNTech have agreed to provide a total of 1 billion doses to the U.S. government at a not-for-profit price for donation to low- and lower-middle-income countries. 

Dupixent® (Dupilumab) is the First Biologic to Significantly Reduce Itch and Skin Lesions in Phase 3 Trial for Prurigo Nodularis, Demonstrating the Role of Type 2 Inflammation in this Disease

Bridgewater-based BioNJ Member Sanofi announced a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions, met its primary and all key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases with intense, chronic itch. “We are encouraged that patients in this trial experienced a significant reduction in itch and skin lesions, especially given that prior to enrollment nearly all patients had severe itch and nearly 40% had 100 or more nodules covering their body,” said John Reed, M.D., Ph.D., Global Head of Research and Development at Sanofi.

Second Dupixent® (Dupilumab) Phase 3 Eosinophilic Esophagitis Trial to Demonstrate Significant Disease Improvements, Underscoring Role of Type 2 Inflammation in this Complex Disease

Bridgewater-based BioNJ Member Sanofi announced results from a second Phase 3 trial assessing the investigational use of Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE) demonstrated that the trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. EoE is a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow. In September 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE.

Boehringer Ingelheim Announces European Medicines Agency’s Filing Acceptance and Validation of Marketing Authorization Application for Spesolimab in Generalized Pustular Psoriasis

North Brunswick-based BioNJ Member Boehringer Ingelheim announced that the company’s marketing authorization application (MAA) for the treatment of flares in generalized pustular psoriasis (GPP), has been validated and is now under evaluation with the European Medicines Agency (EMA). GPP is characterized by episodes of widespread eruptions of painful, sterile pustules (blisters of non-infectious pus). The inflammation can also affect other parts of the body and can lead to infections or other organ complications that may be life-threatening. There is a high unmet need for treatments that can rapidly and completely resolve the symptoms of GPP flares. Flares greatly affect a person’s quality of life and can lead to hospitalization with life-threatening complications, such as heart failure, renal failure, sepsis and even death.

New Phase 3 Data Presented at Psych Congress 2021 Showed TV-46000/mdc-IRM Significantly Prolonged Time to Impending Relapse Compared to Placebo in Patients With Schizophrenia

Parsippany-based BioNJ Member Teva Pharmaceuticals announced results from the pivotal Phase 3 Risperidone Subcutaneous Extended-release (RISE) study comparing TV-46000/mdc-IRM once monthly (q1m) and TV-46000/mdc-IRM once every two months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone. Results showed treatment with TV-46000 (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. The safety profile of TV-46000, as demonstrated in this study, is consistent with other formulations of risperidone. The most common adverse reactions (≥5% and greater than placebo) were nasopharyngitis, increased weight, and extrapyramidal disorder.

New Analyses Suggest Favorable Results for STELARA®(ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients With Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis

Titusville-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). In a modeled analysis focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely active UC relative to outcomes associated with second- or third-line use (P0540). Additionally, in a separate real-world claims analysis, a greater proportion of bio-naïve patients who started biologic therapy with STELARA (n=948) for moderately to severely active CD showed persistence at 12 months versus adalimumab (n=4,143) (P0525).

New Comprehensive Phase 3 Data Show First-in-Class TREMFYA® (guselkumab) Provided Durable Improvements in Measures of Psoriatic Arthritis (PsA) Disease Activity Through Two Years

Titusville-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced comprehensive efficacy and safety data from the DISCOVER–2 trial of TREMFYA® (guselkumab) were published in Arthritis & Rheumatology, representing the final results of the first two-year clinical trial investigating a selective interleukin (IL)-23 inhibitor therapy in active psoriatic arthritis (PsA). Results show a majority of TREMFYA-treated biologic-naïve adult patients with active PsA achieved improvements in joint signs and symptoms and complete skin clearance that were maintained or increased over time, suggesting continued TREMFYA treatment may lead to higher levels of symptom improvement. TREMFYA demonstrated low rates of radiographic progression, a key indicator of structural damage, which includes erosion and joint space narrowing, and provided substantial and durable improvements across multiple additional disease domains, including achievement of minimal disease activity (MDA) and normalized physical function.

Janssen Announces Extension of U.S. FDA BLA PDUFA Date for BCMA CAR-T Ciltacabtagene Autoleucel

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date to February 28, 2022 for the ciltacabtagene autoleucel (cilta-cel) Biologics License Application (BLA). Cilta-cel is a B-cell maturation antigen (BCMA) CAR-T therapy that is being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma. The FDA extended the PDUFA date to allow sufficient time to review information recently submitted by the company pertaining to an updated analytical method following an FDA information request. No additional clinical data have been requested. Janssen is committed to working with the FDA in its ongoing review of the BLA. Cilta-cel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.

Statement on Data Published in PLOS Medicine on Tolerability and Immune Response of Johnson & Johnson Ebola Vaccine Regimen in Adults Living With HIV

Data published in PLOS Medicine demonstrated that the New Brunswick-based BioNJ Member Johnson & Johnson Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), was well tolerated and induced a robust immune response in both healthy adults and adults living with HIV. These findings, alongside Phase 3 data recently published in The Lancet Infectious Diseases, support the potential prophylactic use of the vaccine regimen to protect people at risk of acquiring Ebola. The regimen was granted Marketing Authorization by the European Commission in July 2020 and Prequalification from the World Health Organization (WHO) in April 2021. The data is from the Phase 2 EBL2002 study, which was conducted in Burkina Faso, Cote d’Ivoire, Kenya and Uganda and enrolled 668 healthy adults and 142 adults living with HIV. There were no safety signals of concern.

Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults

Kenilworth-based BioNJ Member Merck & Co. and Morris Plains-based BioNJ Member Gilead Sciences announced the start of a Phase 2 clinical study evaluating an investigational once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy. “This innovative research collaboration builds on the efforts of both companies to help make the end of the epidemic a reality through continued scientific advances in HIV. Initiating the trial represents an important step forward toward our goal of offering long-acting options that can help address the differentiated needs and preferences of the diverse range of people living with HIV,” said Jared Baeten, M.D., Ph.D., Vice President, HIV Clinical Development, Gilead Sciences.

Merck and Ridgeback’s Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. In the U.K., LAGEVRIO® (lah-GEV-ree-oh) is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application.

Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. Merck plans to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. Merck has submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) and is actively working to submit applications to other regulatory agencies worldwide. “We believe that molnupiravir will be an important addition to the range of public health tools to fight COVID-19 – including the vaccines developed by the research-based pharmaceutical industry, which remain essential and are the first-line of defense against this pandemic,” said Dr. Dean Y. Li, Executive Vice President and President, Merck Research Laboratories.

The Medicines Patent Pool (MPP) and Merck Enter into License Agreement for Molnupiravir, an Investigational Oral Antiviral COVID-19 Medicine, to Increase Broad Access in Low- and Middle-Income Countries

Kenilworth-based BioNJ Member Merck & Co. and The Medicines Patent Pool announced the signing of a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 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. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following appropriate regulatory approvals. Merck and Ridgeback Biotherapeutics are jointly developing molnupiravir. Under the terms of the agreement, MPP, through the license granted by Merck, will be permitted to further license non-exclusive sublicenses to manufacturers and diversify the manufacturing base for the supply of quality-assured or WHO-prequalified molnupiravir to countries covered by the MPP License, subject to local regulatory authorization.

Merck Announces Positive Top-Line Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily Oral Fixed Dose Combination of Doravirine/Islatravir for the Treatment of People With HIV-1 Infection

Kenilworth-based BioNJ Member Merck & Co. announced positive top-line results from two pivotal Phase 3 trials of the investigational, once-daily oral fixed dose combination pill of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens (ART; ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF; ILLUMINATE SWITCH B). At 48 weeks, both trials met their primary efficacy endpoint of percentage of participants with HIV-1 RNA levels ≥50 copies/mL, demonstrating that antiviral efficacy was comparable between DOR/ISL and ART (ILLUMINATE SWITCH A) and between DOR/ISL and BIC/FTC/TAF (ILLUMINATE SWITCH B). The safety and tolerability profile of DOR/ISL during the trials to date are consistent with the previously reported Phase 2 studies.

Merck Presents New Data from Ongoing Phase 2b Clinical Trial Evaluating Efficacy and Safety of Investigational Islatravir in Combination With Doravirine Through 144 Weeks for HIV-1 Treatment at EACS 2021

Kenilworth-based BioNJ Member Merck & Co. announced Week 144 data from the Phase 2b dose-ranging study evaluating the antiretroviral activity, tolerability, and safety of islatravir in combination with doravirine compared to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) in antiretroviral treatment-naïve adults with HIV-1. Phase 2b data through 144 weeks demonstrated that islatravir combined with doravirine continued to maintain viral suppression, as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DOR/3TC/TDF. The data further characterized the tolerability and safety profile of islatravir in combination with doravirine. 

Second Clinical Trial Collaboration Initiated to Evaluate Datopotamab Deruxtecan in Combination With KEYTRUDA® (pembrolizumab) in Patients With Metastatic Non-Small Cell Lung Cancer

Basking Ridge-based Daiichi Sankyo and AstraZeneca announced that a second clinical trial collaboration and supply agreement has been entered with a subsidiary of BioNJ Member Merck & Co., Inc., Kenilworth, NJ., USA to evaluate the combination of datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC), and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab). Under the terms of the agreement between Daiichi Sankyo and Merck, Daiichi Sankyo will lead TROPION-Lung08, a global Phase 3 trial that will evaluate datopotamab deruxtecan in combination with KEYTRUDA compared to KEYTRUDA alone in treatment-naïve patients with PD-L1 high advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations, on behalf of the Daiichi Sankyo and AstraZeneca collaboration.

Daiichi Sankyo Launches DELYTACT® Oncolytic Virus G47∆ in Japan

Basking Ridge-based Daiichi Sankyo announced that it has launched DELYTACT® (teserpaturev/G47∆), an oncolytic virus developed by the company in collaboration with Professor Tomoki Todo of the Institute of Medical Science, The University of Tokyo. DELYTACT® received conditional and time-limited marketing approval in Japan as a regenerative medical product for treatment of malignant glioma in June 2021 based on results from a Japanese phase 2 clinical trial (investigator-initiated trial) in patients with glioblastoma (a type of malignant glioma) conducted by Dr. Todo. For the time being, DELYTACT® will be commercially available only at hospitals that served as trial sites. Daiichi Sankyo will establish a stable supply system of the medicine as soon as possible.

Mallinckrodt and Terumo Blood and Cell Technologies Announce Positive Recommendations in Australia for Public Funding of UVADEX® (methoxsalen) for ECP Administration With the THERAKOS® CELLEX® Photopheresis System for Chronic Graft Versus Host Disease (cGvHD) in Adults

Hampton-based Mallinckrodt Pharmaceuticals and Terumo Blood and Cell Technologies announced that both the Medical Services Advisory Committee (MSAC) and the Pharmaceutical Benefits Advisory Committee (PBAC) recently recommended that UVADEX® (methoxsalen) for extracorporeal administration with the THERAKOS® CELLEX® Photopheresis System be listed on the Pharmaceutical Benefits Scheme (PBS) in Australia for the treatment of steroid dependent, intolerant or resistant chronic graft versus host disease (cGvHD) in adults. In this two-part evaluation, the PBAC supported the cost-effectiveness of UVADEX, the pharmaceutical component of the treatment system; and the MSAC accepted the claim of superiority for safety and non-inferiority for efficacy between ECP with UVADEX and comparators. 

The CREB-Binding Protein (CBP)/Β-Catenin Inhibitor E7386, Co-Created by Eisai and PRISM Biolab, Achieved the Clinical POC (Proof of Concept)

Woodcliff Lake-based Eisai Co., Ltd. announced that the CREB-binding protein (CBP) / β-catenin inhibitor E7386, a medium-molecular weight compound created through collaboration research between Eisai and PRISM, has achieved the clinical POC (Proof of Concept). Eisai is conducting a Phase I clinical study of E7386 monotherapy for solid tumors, and a Phase Ib clinical trial of E7386 plus lenvatinib mesylate (product name: LENVIMA®, “lenvatinib”), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for solid tumors including hepatocellular carcinoma. The achievement of the POC, which is defined in a collaborative research agreement between Eisai and PRISM, was confirmed based on data such as antitumor activity and changes of biomarkers in these clinical trials.

GenScript Expands Commercial Production in U.S. With State-of-the-Art Gene Synthesis Center

Piscataway-based GenScript USA announced that it has opened a larger than 50,000-square-foot facility for highly automated gene synthesis and plasmid preparation services near its U.S. headquarters in Piscataway, New Jersey. The state-of-the-art site marks a significant expansion of the company's advanced gene synthesis services and is designed to mitigate U.S-based customers' supply chain risks with high quality, fast-turnaround on products required for new vaccines, therapeutics and innovations in synthetic biology. "GenScript is extremely committed to supporting our customers as they expand globally, and this specialized laboratory and manufacturing facility allows us to deliver reliable products to them faster than ever before," said Ray Chen, Ph.D., President, GenScript USA Life Science Group, Inc.

Certara’s Simcyp™ COVID-19 Vaccine Model Wins R&D 100 Award

Princeton-based Certara announced that its Simcyp COVID-19 Vaccine Model has won an R&D 100 Award, which recognizes the top 100 “R&D pioneers and their revolutionary ideas in science and technology” in the past year. The model, which is incorporated in Certara’s Vaccine Simulator, has been used by major pharmaceutical companies and allows researchers to study how a vaccine is handled by the human body in computer-generated, virtual populations. “Our COVID-19 Vaccine Model is being used to determine optimal vaccine doses and timing between doses, investigate differences in immune response with age and ethnicity, evaluate the duration of immune response after vaccination, and identify the best booster sequencing for COVID-19 vaccines. We are also now applying our Vaccine Simulator to develop vaccines for oncology and respiratory syncytial virus,” said Piet van der Graaf, PharmD, Ph.D., Senior Vice President, Quantitative Systems Pharmacology, Certara.

BD Begins Selling COVID-19 Test That Uses Smartphone Technology and Was Given EUA by FDA This Summer

Franklin Lakes-based BD has begun selling the first over-the-counter COVID-19 rapid antigen test that uses computer vision technology in a smartphone to interpret testing results. The company said the BD Veritor At-Home COVID-19 Test, which was given emergency use authorization by the FDA at the end of August, is now available for purchase by consumers online at Amazon. BD officials said the test also is available for businesses, governments and schools through traditional BD sales channels. Company officials feel the test is an option for businesses, enterprises and schools looking to provide a self-testing method for employees or students. BD officials said the test uses the Scanwell Health mobile app to interpret and provide a digital display of testing results in 15 minutes.

Bone Breakthrough: Onkos Surgical is Using 3D Medical Technology to Revolutionize How Oncologists Can Help Patients With Cancer

It’s a situation an orthopedic oncology surgeon faces every day: The patient, who already may be undergoing chemotherapy or other cancer treatments, has a diseased bone that must be removed. And removed as soon as possible. After removing a large part of the bone, the surgeon has two choices: Replace it with something that was not designed specifically for the patient — or perform an amputation. Onkos Surgical, a fast-growing, industry-changing medtech company based in Parsippany, is aiming to change that paradigm. The company, using advanced imaging analysis and 3D printing capability, is giving doctors the ability to remove the specific part of the bone that is diseased — and giving them the necessary tools to do so. And Onkos Surgical can provide its services in a matter of days in a niche sector of the bone replacement industry where most of its competitors require months.

Surgical Solution for CPAP? Saint Peter’s Offering Innovative Solution

More than 50% of patients who use a CPAP stop using the device because of discomfort — despite its potentially life-saving benefits. The Center for Sleep and Breathing Disorders at Saint Peter’s Healthcare System is trying to change that. Saint Peter’s University Hospital has introduced Inspire sleep therapy for patients suffering from obstructive sleep apnea — a surgical implant that serves as an innovative alternative to the traditional CPAP, which stands for continuous positive airway pressure therapy. Inspire, an FDA-approved implantable upper airway stimulation device, stabilizes a patient’s airway while they are sleeping to prevent obstruction. The device continuously monitors the patient’s breathing patterns and delivers mild stimulation to the airway muscles to keep the airway open during sleep.

Bristol-Myers Squibb Names Former J&J Diversity Head as Chief D&I Officer

Pamela Fisher was named Chief Diversity and Inclusion Officer for Princeton-based BioNJ Member Bristol-Myers Squibb. Ms. Fisher joins BMS from Johnson & Johnson, where she served as head of diversity, equity and inclusion global strategy and partnerships. Ms. Fisher will drive BMS’ Global Diversity & Inclusion business strategy, including advancing the company’s five core diversity commitments. She will be a member of CEO Giovanni Caforio’s leadership team. “As a science leader, we have seen firsthand how diversity of thought, experience and background drive innovation that transforms patients’ lives. Pam is joining our company as we make progress on our commitment to increase health equity, further strengthen our diversity and shape our culture of inclusion,” Caforio said.

Leaders at Janssen, Merck, Comcast to Get Highest Individual Honors at Edison Patent Awards

Janssen leaders Dr. Macaya Douoguih and Remo Colarusso, Merck & Co. Executive Chairman Kenneth Frazier and will be given the top individual awards at the 42nd annual Thomas Edison Patent Awards — the event by the Research & Development Council of New Jersey that honors the top leaders in innovation in our State. Congratulations to both BioNJ Members. Additionally, teams from BioNJ Members Celularity, Merck, Princeton and Rutgers University will be honored at a ceremony for their groundbreaking patents. Winners were selected by a team of R&D Council researchers who evaluated patents for the significance of the problem, utility/socio-economic value, novelty and commercial impact.

Vyant Bio Announces Robert T. Fremeau, Jr. Ph.D. as Chief Scientific Officer

Cherry Hill-based BioNJ Member Vyant Bio announced the appointment of Robert T. Fremeau Jr., Ph.D., as Chief Scientific Officer. Dr. Fremeau is an experienced R&D leader with over two decades of drug discovery experience in academia and industry advancing next-gen drug development for severe neurological disorders. He is an accomplished scientist and biotech entrepreneur with an established history of scientific innovation and program leadership at the intersection of target validation, translation and clinical development. As a Scientific Director at Amgen Inc., he led and contributed to multiple teams that advanced small molecules into clinical trials against innovative targets across neurological indications.

GSK Announces Dr. Harry (Hal) C. Dietz M.D. to Join the Board as Non-Executive Director

Warren-based BioNJ Member GlaxoSmithKline announced that Dr. Harry (Hal) C. Dietz M.D., Professor of Genetic Medicine at The Johns Hopkins University School of Medicine, will join the Board of the company as a Non-Executive Director. Dr. Dietz’s appointment further strengthens the Board’s scientific capabilities, in line with the commitment to increase biopharmaceutical and scientific expertise for new GSK through Non-Executive Director appointments prior to the demerger of the Consumer Healthcare business in mid-2022. On joining the Board, Dr. Dietz will become a member of the Science Committee which supports the Board in its oversight and scrutiny of the Company’s R&D strategy and annual performance targets. It also provides technical assurance, particularly in relation to potential R&D related transactions.

CitiusTech Names Bhaskar Sambasivan as CEO, Succeeding Co-Founder Rizwan Koita

Princeton-based CitiusTech announced that its Board of Directors has appointed Bhaskar Sambasivan as Chief Executive Officer. Mr. Sambasivan joined CitiusTech as President in May 2021, and has been working closely with Rizwan Koita, CEO, as part of a structured leadership transition process. Before joining CitiusTech, Mr. Sambasivan was President of Patient Services and Chief Strategy Officer of EVERSANA, a leading life sciences platform company. Prior to this, he spent close to 15 years at Cognizant as the Global Head of Life Sciences. Under his leadership, Cognizant’s Life Sciences business grew over thirty-fold in 15 years. Before Cognizant, he spent many years with Siebel/Oracle and PricewaterhouseCoopers in key leadership roles.

Integra LifeSciences Announces New CEO as Former Chief Leaves for Same Role at GE Healthcare

Princeton-based Integra LifeSciences named Jan De Witte as its new CEO and President. Mr. De Witte will succeed Peter Arduini, who previously announced he will step down as CEO to accept the role of President and CEO of GE Healthcare. A 30-year health care and technology veteran, Mr. De Witte has extensive global executive experience and diverse expertise in research & development, commercialization, product management, digital innovation and operations. He will join Integra prior to the end of the year, at which time he will also be appointed to its Board of Directors. “We are thrilled to have Jan join Integra at this exciting time in the company’s history. Jan is a proven global business leader with extensive C-level experience at internationally-recognized companies,” said Stuart Essig, Chairman of Integra’s Board of Directors.

Brainstorm Cell Therapeutics Announces Appointment of Menghis Bairu, MD, to Board of Directors

Paramus-based BrainStorm Cell Therapeutics announced the appointment of Menghis Bairu, M.D., to the company's Board of Directors. "I am pleased to welcome Menghis to our Board of Directors," said Chaim Lebovits, CEO, Brainstorm Cell Therapeutics. “Brainstorm will benefit greatly from his expertise and world view, and we look forward to his guidance as we approach a new phase of our mission." Dr. Bairu, a physician, entrepreneur, business executive, editor, author and philanthropist, is Founder, Chairman and CEO of Proxenia Venture Partners, which provides capital, talent management and access to a global network of experts to companies in late preclinical and early stage clinical development in biotechnology.

Cellectar Appoints Oncology Expert as Interim Chief Medical Officer

Florham Park-based Cellectar Biosciences announced Dr. Laurence Reilly will assume the role as interim Chief Medical Officer, succeeding Dr. John Friend. Dr. Reilly, who has a successful track record of developing and advancing oncology clinical programs through regulatory approval, will oversee the Florham Park-based company’s clinical development programs and report to CEO James Caruso. “We are delighted to welcome Laurence to our executive team and look forward to his leadership of our clinical development programs. His deep background in hematological oncology and experience leading global clinical development teams to successfully bring new therapies to patients will support Cellectar’s next phase of growth,” Mr. Caruso said.

NJIT to Launch $500,000 Innovation Venture Fund

The New Jersey Institute of Technology, through leaders at NJII and VentureLink, will introduce the NJIT Innovation Venture Fund, a $500,000 fund that will make one-time, $75,000 investments in early stage start-ups — including those still in the concept stage — by members of the NJIT community. The fund will be led by three leaders at NJII: CEO Simon Nynens, General Manager/Entrepreneurship Will Lutz and Director of Growth/Entrepreneurship Chelsea Samuelson. Fund’s leaders already are in talks with more than a half-dozen potential companies. NJIT President Joel Bloom told ROI-NJ that the fund is intended to give a start to those who otherwise are not in position to do so: Recent graduates who may not have access to personal fortunes that enable them to work on their projects without having employment — or faculty who may not have the business background necessary to transform an idea into a commercial entity.

START Exclusive Entrepreneurship: Princeton University

The START Entrepreneurs program is an integrated program that is part academic fellowship and part start-up accelerator. The goal of the program is to help aspiring commercial and social entrepreneurs translate academic scholarship into highly impactful new ventures. Princeton desires to help create a better future by ensuring that its innovations become available to the broader public. The University's initiative is especially important at this time in our history, as we confront multiple interwoven global challenges. Our faculty and professional research staff are increasingly involved in translating their scholarly research into creative solutions to address societal challenges. The program is fully funded and includes both salary and benefits for the entrepreneur as well as a stipend during the research phase. All start-ups that are approved to participate in the Accelerator phase also receive a substantial additional investment over the course of the Accelerator phase.

Rutgers Researchers Find Links to Genetic Disorders in Walking Patterns

Rutgers researchers have linked the genetic disorders Fragile X and SHANK3 deletion syndrome – both linked to autism and health problems – to walking patterns by examining the microscopic movements of those wearing motion-sensored sneakers. The method detects gait problems 15 to 20 years before their clinical diagnosis and could help advance intervention models to preserve brain structure and function. According to the National Fragile X Foundation, approximately 1 in 468 men and 1 in 151 women are carriers of the abnormal gene that causes Fragile X syndrome. In the study, researchers examined the walking movements that cannot be seen by the naked eye in 189 people to detect nervous system disorders.

Rowan Opens Center for Neurodiversity, First-of-its-Kind Expansion of Services for Neurodiverse Students

Rowan University established the first Center for Neurodiversity in New Jersey — an expansion of services for neurodiverse students that university officials said shows the commitment Rowan has to greater access and inclusion on its campus in Glassboro. Rowan President Ali Houshmand has long made neurodiversity inclusion a priority. In 2019, Rowan became the first college or university in New Jersey to launch a full division dedicated to diversity, equity and inclusion. “This is about human beings trying to be supportive of other human beings,” he said. “For me, the issue is not just working with neurodiverse students while they are students, because that we can do. For me, the bigger issue is what happens afterwards, when they graduate. I want to make sure they can function, run a business, create wealth and have a happy life.”

Kean Researchers Uncover Inconsistencies in COVID-19 Genetic Tests

Genetic tests aimed at determining a person’s risk of getting COVID-19 provide inconsistent results and aren’t based on established science, according to a new research study conducted by a team at Kean University. Faculty and graduate students from Kean’s Genetic Counseling graduate program launched the study after seeing ads for the genetic testing pop up on social media. The researchers submitted genetic data to five different direct-to-consumer tests and compared results. “Essentially, we learned there was really poor science, a lack of consistency in the different genes and variants the tests claimed to look at, and the risk information they presented was extremely variable and inconsistent,” said Assistant Professor Robert Pyatt, Ph.D., Director of Kean’s COVID-19 lab, who led the study.  

Kean University Named One of 25 Colleges Nationwide to Lead Economic Development Programs

Kean University said it is one of 25 colleges and universities nationwide selected for a U.S. University Center Program | U.S. Economic Development Administration grant to promote innovation and strengthen regional economies. Through the more than $1 million, five-year grant, Kean will create the Center for Business/Workforce Development, Innovation & Social Entrepreneurship, the first of its kind in the State. The center will work to strengthen regional economies statewide by providing support, expertise, applied research and technical assistance to identify and address the specific regional needs of urban centers. Kean will receive $101,000 each year for five years from the EDA and will provide matching funds. After the end of the grant period, Kean and the other EDA University Center institutions may reapply for an additional five-year grant.

NJIT-Led Team Wins a $1.25 Million Grant to Ensure Women Scholars Flourish as Inventors

Women’s ingenuity dots the human landscape, from the external fire escape, to the word processor, to the first dishwashing machine to replace scrubbers with water pressure, to Kevlar, the lightweight, but supremely strong fiber used in bulletproof vests. And yet statistics show that too few of their ideas successfully navigate the journey from concept to product. Indeed, some don’t make it over the early hurdles. Men with doctorates in STEM fields, for example, are nearly twice as likely to hold at least one patent as their female counterparts. Backed by a $1.25 million ADVANCE grant from the National Science Foundation (NSF), a team of NJIT-led New Jersey scholars has set out to identify and eliminate barriers on university campuses to technology commercialization, such as patenting, licensing and the formation of startup ventures. Treena Arinzeh, a distinguished professor of biomedical engineering at NJIT and the principal investigator (PI) for the grant, points to a recent study showing that 28.4% of men with a Ph.D. in STEM hold at least one patent, compared to 15% of women.

Why Montclair State’s New President (Koppell) Says School is Ready for New World of Higher Ed

Taking the reins of a university after a longtime leader — someone who rightly is credited with literally and figuratively building the school up to be one of the finest in the State — obviously is not an easy task. Doing it during a pandemic, which shook higher education as much as any sector in the economy, only adds to the challenge. Montclair State University President Jonathan Koppell sees it as an opportunity. A chance to add to the legacy created by Susan Cole. A chance to use the lessons learned during the pandemic to move the school — the second-largest in the state — to greater heights. “I think the philosophy at a lot of schools during the pandemic has been, ‘Make it go away,’ or ‘Is it the way it was again?’” he said. “That’s not the attitude here.

Navigating State Departments

November 9, 2021 • 11:00 a.m. • Virtual Workshop

The New Jersey Economic Development Authority (NJEDA) will host a virtual workshop to provide information on how to obtain and maintain the necessary documents from state departments. This is a great opportunity for New Jersey’s small businesses, startups, and nonprofits to learn how to properly navigate the numerous programs and services offered by State entities, such as how to properly register a business in New Jersey; how to obtain a tax clearance certificate; how to certify a business as women-, minority-, or veteran-owned; and ways to access free available technical assistance, federal resources, and mentorship opportunities, among other relevant topics.

Engage 2021 Conference

December 1-2, 2021 • Virtual

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 step back and explore the big picture: How can Princeton and partners propel the development of a robust and inclusive innovation ecosystem.

Princeton Start-up Bootcamp, Powered by VentureWell

Applications for the January 2022 cohort will open on November 1, 2021.

All graduate students and postdoctoral researchers who are interested in entrepreneurship are welcome to apply to attend the Princeton Start-up Bootcamp, Powered by VentureWell, an intensive program presented by VentureWell, a leading start-up accelerator. This program is designed for interdisciplinary collaboration and those curious about what it takes to bring an idea to market. If you already have an idea for a product, service or solution — that’s great, but not required! Team members are needed for a variety of roles including business strategy, marketing and communications, and financial modeling, among others.

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 KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:



• Accounting Services
• Biobanking/Bioprocessing
• Clinical Research Centers
• Communications / Marketing / PR / IR
• Contract Manufacturing / Supply Chain & Logistics Management
• Contract Research Organizations & Consulting Services
• Digital Health & Life Sciences IT/Data Science Technologies
• Financial / Investment / Funding Sources and Services
• HR / Talent Acquisition / Professional Development
• Insurance Services
• IT/Data Management and Software Platform Technologies/Cybersecurity
• Laboratory Services
• Legal Services
• Other Services
• Publications
• Real Estate / Engineering and Construction / Property Development
• Supplies - Laboratory / Environmental / Research Instrumentation & Other