Myth vs. Fact: Polling and Medicare “Negotiation”

As some in Washington consider legislation related to prescription medicines and how to best help Americans manage health care costs, government “negotiation” of prescription medicines within Medicare continues to be debated. The concept of government-led negotiation is highly misleading – and there are other, more common-sense policy solutions that are in the better interest of patients. PhRMA digs into the top myths and facts surrounding Medicare negotiation.

PTC Therapeutics Announces Waylivra™ Approval in Brazil as First Treatment for Familial Chylomicronemia Syndrome

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced that the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved Waylivra™ (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS) in Brazil. FCS is a rare genetic disease which results in significant disease burden to patients including potentially fatal pancreatitis and chronic complications due to permanent organ damage. ANVISA's approval of Waylivra is based on results from the Phase 3 APPROACH study and the APPROACH Open-Label Extension study and is supported by results from the Phase 3 COMPASS study. 

Targeting the Putamen With Gene Therapy Leads to Sustained Improvements in Motor and Non-Motor Functions in Children With AADC Deficiency

South Plainfield-based BioNJ Member PTC Therapeutics, Inc. announced the publication of a manuscript, "Gene Therapy in the Putamen for Curing AADC Deficiency and Parkinson's Disease," in the European Molecular Biology Organization Journal. The paper describes a pioneering approach that delivers gene therapy to a specific part of the brain called the putamen, which is helping successfully treat a previously intractable, devastating disorder and transforming the lives of children born with AADC deficiency (AADC-d). Currently there are no approved disease-modifying therapies for treating AADC-d, and the success of symptomatic treatment using combinations of vitamin B6, dopamine (DA) agonists and monoamine oxidase inhibitors is very limited, especially in severe cases.

Rafael Pharmaceuticals Announces the Successful Completion of Phase 1b Clinical Trial and Initiates Phase 2 for CPI-613® (devimistat) in Combination With Gemcitabine and Cisplatin in Patients With Biliary Tract Cancer

Cranbury-based BioNJ Member Rafael Pharmaceuticals, Inc. announced the successful completion of a Phase 1b clinical trial of CPI-613® (devimistat) in combination with gemcitabine and cisplatin in patients with biliary tract cancer. In collaboration with Michigan Medicine, the Phase 1b study consisted of a multicenter trial of gemcitabine and cisplatin with devimistat as first-line therapy for patients with locally advanced unresectable or metastatic biliary tract cancer who have had no prior treatment.

Vyant Bio and Cyclica Announce a Strategic Collaboration to Identify Compounds to Treat Cdkl5 Deficiency Disorder

Cherry Hill-based BioNJ Member Vyant Bio and Cyclica, Inc., the partner of choice for data driven drug discovery, announced a non-exclusive strategic collaboration combining Vyant Bio’s patient-derived complex organoid biology alongside Cyclica’s proteome-wide, Artificial Intelligence (“AI”) enabled discovery platform to identify new treatments for CDKL5 Deficiency Disorder (“CDD”), a severe neurodevelopmental epilepsy disorder with no effective treatments or cure. Vyant Bio has deep experience in using human-based disease biology to ensure that early findings are directly related to the patients destined to receive treatments. 

Photocure Announces Regulatory Approval of Hexvix in Chile

Princeton-based BioNJ Member Photocure entered into an agreement with Genotests, a privately held company specializing in the marketing of genetic tests for cancer and targeting cancer specialists, to exclusively market and distribute Hexvix in Chile. Under the terms of the agreement, Genotests will fund all costs to secure regulatory approval and commercialize Hexvix in Chile. Photocure will manufacture the product and support Genotests with regulatory activities, training and promotional materials. “With Genotests’ dedication and strong execution on this initiative, we expect that Hexvix will become accessible to patients in Chile in the fourth quarter of this year,” said Dan Schneider, President and CEO of Photocure. 

Photocure Regains Rights to Cysview in Canada Further Consolidating its Bladder Cancer Franchise

Princeton-based BioNJ Member Photocure announces that it has reached agreement with BioSyent Pharma Inc. (“BioSyent”) to reacquire the marketing and distribution rights to Cysview® in Canada. The parties entered into a final agreement stipulating that commercial rights will transfer to Photocure on January 1, 2022. The reacquisition of marketing and distribution rights enables Photocure’s direct management of the Cysview brand in Canada and consolidates the territory into Photocure’s existing U.S. business to form its North America sales segment.

Soligenix Announces Publication Demonstrating Successful Formulation and Heat Stabilization of Filovirus Vaccine Platform for Ebola and Marburg Virus Diseases

Princeton-based BioNJ Member Soligenix, Inc. announced a publication describing the formulation of single-vial platform presentations of monovalent (single antigen), bivalent (two antigens) and trivalent (three antigens) combinations of filovirus vaccine candidates. In collaboration with University of Hawaiʻi at Mānoa (UHM) and University of Colorado (UC) co-authors, the manuscript entitled "Single-Vial Filovirus Glycoprotein Vaccines: Biophysical Characteristics and Immunogenicity after Co-lyophilization with Adjuvant", has been published in Vaccine.

Soligenix Announces Positive Preclinical Data With Multiple Heat Stable Filovirus Vaccine Candidates

Princeton-based BioNJ Member Soligenix, Inc. announced positive data demonstrating the efficacy of multiple filovirus vaccine candidates in NHPs, including thermostabilized multivalent vaccines in a single vial platform presentation. Collaborators at the at the University of Hawaiʻi at Mānoa (UHM) describe the potent efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from Ebola, Sudan and Marburg Viruses", published in Frontiers in Immunology. 

Soligenix Announces Publication Demonstrating Thermostabilization of Filovirus Vaccine Antigens

Princeton-based BioNJ Member Soligenix, Inc. announced publication of nonclinical results characterizing filovirus protein antigens (including for Ebola and Marburg viruses) and their thermostabilization. The article, authored by collaborators at the University of Colorado, University of Hawaiʻi at Mānoa (UHM) and Soligenix, is titled, "Preservation of Quaternary Structure in Thermostable, Lyophilized Filovirus Glycoprotein Vaccines: A Search for Stability-Indicating Assays" and has been accepted for publication in the Journal of Pharmaceutical Sciences.

MEI Pharma and Kyowa Kirin Announce First Patient Dosed in the Phase 3 COASTAL Study Evaluating Zandelisib Plus Rituximab in Relapsed or Refractory Indolent Non Hodgkin's B-cell Lymphoma

Princeton-based BioNJ Member Kyowa Kirin Co., Ltd. And MEI Pharma, Inc. announced the dosing of the first patient in a Phase 3 study of zandelisib known as COASTAL. COASTAL is evaluating zandelisib, a selective phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor, in combination with rituximab in patients with relapsed or refractory (r/r) follicular lymphoma (FL) or marginal zone lymphoma (MZL) who have received at least one prior line of therapy.

Agile Therapeutics Partners With Telehealth Service, Pandia Health, to Increase Women’s Access to Twirla® (Levonorgestrel and Ethinyl Estradiol) Transdermal System

Princeton-based BioNJ Member Agile Therapeutics, Inc. announced a partnership with Pandia Health, an online telehealth service, which will establish the first telehealth relationship for Agile and offer an additional point of access to Twirla® (levonorgestrel and ethinyl estradiol) transdermal system in a fast-growing channel. Pandia Health offers convenient prescription fulfillment for women with active birth control prescriptions, as well as access to expert birth control doctors who can provide prescriptions through asynchronous online visits. All patients receive free delivery of their birth control.

European Medicines Agency Validates Gilead’s Marketing Authorization Application for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

Morris Plains-based BioNJ Member Gilead Sciences, Inc. announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, has been fully validated and is now under evaluation with the European Medicines Agency (EMA). The proposed indication is for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multidrug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations.

Pfizer and BioNTech Announce Collaboration With Brazil’s Eurofarma to Manufacture COVID-19 Vaccine Doses for Latin America

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced the signing of a letter of intent with Eurofarma Laboratórios SA, a Brazilian biopharmaceutical company, to manufacture COMIRNATY^® (COVID-19 Vaccine, mRNA) for distribution within Latin America. Eurofarma will perform manufacturing activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span four continents and include more than 20 manufacturing facilities. To facilitate Eurofarma’s involvement in the process, technical transfer on-site development, and equipment installation activities will begin immediately. 

Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.

This press release features multimedia. The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020. The EUA permitted essential rollout of vaccine doses across the U.S. to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial.

Pfizer and BioNTech Announce Submission of Initial Data to U.S. FDA to Support Booster Dose of COVID-19 Vaccine

BioNJ Member Pfizer Inc., with offices in Peapack, and BioNTech SE announced that they have submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. These data also will be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks to address the evolving challenges of this pandemic. A third dose of the Pfizer-BioNTech vaccine is not currently authorized for broad use in the U.S. However, under the current amended Emergency Use Authorization, a third dose was authorized on August 12 for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. 

U.S. FDA Approves TICOVAC™, Pfizer’s Tick-Borne Encephalitis (TBE) Vaccine

BioNJ Member Pfizer Inc., with offices in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved TICOVAC™ (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. TICOVAC™ is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas. Following the FDA’s approval, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to discuss recommendations on the safe and appropriate use of TICOVAC™.

Pfizer to Acquire Trillium Therapeutics Inc.

BioNJ Member Pfizer Inc., with offices in Peapack, and Trillium Therapeutics Inc. announced that the companies have entered into a definitive agreement under which Pfizer will acquire Trillium, a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer. Under the terms of the agreement, Pfizer will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share, in cash. Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies.

XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis

BioNJ Member Pfizer Inc., with offices in Peapack, announced that the European Commission (EC) has approved XELJANZ® (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). Two formulations were approved, a tablet and a new oral solution (weight-based dosing). XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor.

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Type II Variation Marketing Authorization Applications (MAA) for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). Validation of these applications confirm that the submissions are complete and begins the EMA’s centralized review process.

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Orencia (abatacept) for the Prevention of Acute Graft Versus Host Disease (aGvHD)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 23, 2021. Stem cell transplants include infusion of donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders in the recipient’s body, including cancer cells. 

Johnson & Johnson Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine

New Brunswick-based BioNJ Member Johnson & Johnson announced data supporting the use of its COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine. In July, the company reported interim Phase 1/2a data published in the New England Journal of Medicine that demonstrated neutralizing antibody responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization.

Janssen Presents Phase 1 Results for RYBREVANT^TM (amivantamab-vmjw) in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer With MET Exon 14 Skipping Mutations

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT^TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. The initial data showed anti-tumor activity in patients with METex14 mutations and a safety profile consistent with reported experience at the approved CHRYSALIS Phase 2 dose (RYBREVANT^TM 1050 mg [<80 kg] / 1400 mg [≥80 kg]). 

KEYTRUDA Now Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer

Kenilworth-based BioNJ Member Merck & Co. announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has received two new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). KEYTRUDA is approved for the treatment of patients with PD-L1-positive, hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative, inoperable or recurrent breast cancer, based on the results of the Phase 3 KEYNOTE-355 trial. Additionally, KEYTRUDA as a monotherapy is approved for the treatment of patients with unresectable, advanced or recurrent high microsatellite instability (MSI-H) colorectal cancer, based on results of the Phase 3 KEYNOTE-177 trial.

Merck Announces VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) Met Key Immunogenicity and Safety Endpoints in Phase 3 Pivotal Trial Evaluating Use in Infants, PNEU-PED (V114-029)

Kenilworth-based BioNJ Member Merck & Co. announced topline results from the pivotal PNEU-PED (V114-029) study evaluating the immunogenicity, safety and tolerability of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in healthy infants enrolled between 42-90 days of age (n=1720). In the trial, infants were given a 4-dose regimen of either VAXNEUVANCE or the licensed 13-valent pneumococcal conjugate vaccine (PCV13) at 2, 4, 6, and 12-15 months of age. VAXNEUVANCE was generally well-tolerated with a safety profile generally comparable to PCV13 in healthy infants enrolled at 42-90 days of age (n=2409).

FDA Approves Merck’s Hypoxia-Inducible Factor-2 Alpha (HIF-2α) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. The recommended dose of WELIREG (40 mg tablets) is 120 mg once daily until disease progression or unacceptance toxicity. The approval is based on results from the open-label Study 004 trial (N=61), where the major efficacy endpoint was overall response rate (ORR) in patients with VHL-associated RCC.

GSK Receives FDA Accelerated Approval for JEMPERLI (Dostarlimab-Gxly) for Adult Patients With Mismatch Repair-Deficient (Dmmr) Recurrent or Advanced Solid Tumours

Warren-based BioNJ Member GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) approved a new indication for JEMPERLI (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody, for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication received accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

Warren-based BioNJ Member GlaxoSmithKline and CureVac N.V. announced the publication of preclinical data investigating immune responses as well as the protective efficacy of CureVac’s first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, against SARS-CoV-2 challenge in non-human primates. The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies, and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. 

Lilly and Lycia Therapeutics Enter into Strategic Collaboration to Discover and Develop Novel Lysosomal Targeting Chimera (LYTAC) Degraders

Bridgewater-based BioNJ Member Eli Lilly and Company and Lycia Therapeutics, Inc. announced a multi-year research collaboration and licensing agreement focused on the discovery, development and commercialization of novel targeted therapeutics using Lycia's proprietary lysosomal targeting chimera, or LYTAC, protein degradation technology.

Lycia uses its next-generation degradation approach to target the untapped extracellular proteome, including cell surface receptors and secreted proteins. The LYTAC platform may enable the development of several therapeutic modalities, including antibodies and small molecules, with the potential to inhibit many targets previously considered intractable across a spectrum of therapeutic areas and diseases.

Lilly's Lebrikizumab Significantly Improved Skin Clearance and Itch in People With Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials

Lebrikizumab led to significant improvements with at least 75 percent skin clearance in more than half of people with moderate-to-severe atopic dermatitis (AD), as measured by EASI, in Bridgewater-based BioNJ Member Eli Lilly and Company's ADvocate 1 and ADvocate 2 Phase 3 clinical trials. In the top-line results from these two studies of lebrikizumab as a monotherapy in AD, primary and all key secondary endpoints, including skin clearance and itch improvement, were met at Week 16. Lebrikizumab is a novel monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, has high bioavailability, a long half-life and blocks IL-13 signaling.

U.S. FDA Approves Jardiance® (empagliflozin) to Treat Adults Living With Heart Failure With Reduced Ejection Fraction

Jardiance® (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), Bridgewater-based BioNJ Member Eli Lilly and Company and Boehringer Ingelheim announced. Jardiance is not for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR <30 mL/min/1.73 m as it is likely to be ineffective in this setting based upon its mechanism of action.

Novartis Secures New Approval in China for Cosentyx® (Secukinumab) in Pediatric Psoriasis

East Hanover-based BioNJ Member Novartis announced that the China National Medical Products Administration (NMPA) has further approved Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in pediatric patients (six years and older with a body weight ≥50 kg) who are candidates for systemic therapy or phototherapy, making it the only interleukin inhibitor approved in China for these patients. Cosentyx is already approved in China for the treatment of moderate-to-severe plaque psoriasis in adults and adult ankylosing spondylitis. The approval is based on two Phase III international studies in pediatric patients aged 6 to < 18 years old, which showed that Cosentyx was as safe in children and adolescents as when used in adults.

Novartis Announces Positive Results from Phase III Trials of Beovu® in Diabetic Macular Edema, Including Dosing Intervals Up to 16 Weeks

East Hanover-based BioNJ Member Novartis announced positive results from two Phase III clinical trials assessing Beovu® (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). Year two of the pivotal KITE trial evaluated Beovu on up to 16-week dosing intervals, and the one-year KINGFISHER study evaluated Beovu dosed every four weeks. Both trials demonstrated an overall well-tolerated safety profile. Results from year two (week 100) of KITE demonstrated that a majority of patients who successfully completed an initial 12-week cycle following the loading phase were maintained on a 12- or 16-week dosing interval through the end of the study.

European Commission Approves RINVOQ® (upadacitinib) as First JAK Inhibitor in the European Union for the Treatment of Both Adults and Adolescents With Moderate to Severe Atopic Dermatitis

Madison-based BioNJ Member AbbVie announced the European Commission (EC) approved RINVOQ® (upadacitinib), an oral, selective and reversible JAK inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. The recommended dose of RINVOQ for atopic dermatitis in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents (12-17 years of age) and adults 65 years and older.1 RINVOQ can be used with or without topical corticosteroids (TCS).

BD Launches Fully Automated High-Throughput Molecular Diagnostic Platform for U.S. Laboratories

Franklin Lakes-based BioNJ Member BD (Becton, Dickinson and Company) announced that it has launched a new, fully automated high-throughput diagnostic system using robotics and sample management software algorithms to set a new standard in automation for infectious disease molecular testing in core laboratories and other centralized laboratories in the United States. The launch will make the BD Onclarity™ HPV Assay with extended genotyping for the BD COR™ System available to the high-throughput labs that process the majority of cervical cancer screening specimens in the U.S. Persistent infection with human papillomavirus (HPV) is one of the primary causes of cervical cancer. 

BD Receives Emergency Use Authorization for First At-Home COVID-19 Test to Use Smartphone to Interpret, Deliver Results

Franklin Lakes-based BioNJ Member BD (Becton, Dickinson and Company) announced the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BD Veritor™ At-Home COVID-19 Test — the first at-home COVID-19 rapid antigen test to use computer vision technology in a smartphone to interpret and provide a digital display of testing results. The test does not require a prescription, a laboratory or a long wait for results. The test will initially be made available to businesses, schools and governments looking to provide a self-testing option for employees or students.

ADC Therapeutics Enters Into a Financing Agreement with HealthCare Royalty for Up to $325 Million

New Providence-based BioNJ Member ADC Therapeutics SA announced it had entered into a royalty purchase agreement with HealthCare Royalty Partners (HealthCare Royalty). Under the terms of the $325 million financing agreement, ADC Therapeutics will receive $225 million upon closing, and is eligible to receive an additional $75 million upon the first commercial sale of ZYNLONTATM (loncastuximab tesirine) in Europe and an additional $25 million upon the achievement of a near-term commercial milestone for ZYNLONTA. “We are pleased to partner with ADC Therapeutics to reach their vision of developing and commercializing potent and targeted ADCs for patients with hematological malignancies and solid tumors,” said Clarke Futch, Chairman and Chief Executive Officer of HealthCare Royalty.

UK Authorizes Regeneron Antibody Cocktail to Prevent and Treat Acute COVID-19 Infection

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced that the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted Conditional Marketing Authorization (CMA) for the casirivimab and imdevimab antibody cocktail, known as REGEN-COV™ in the U.S. and Ronapreve® in the UK and other countries, to prevent and treat acute COVID-19 infection. In addition to the CMA, which affects people in England, Scotland and Wales, the MHRA has also authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection for people in Northern Ireland.

Regeneron Announces Encouraging Topline Phase 2 Data of High-Dose Aflibercept in Wet Age-Related Macular Degeneration

Basking Ridge-based Regeneron Pharmaceuticals, Inc. announced that an ongoing Phase 2 proof-of-concept trial evaluating an investigational 8 mg dose of aflibercept met its primary safety endpoint, with no new safety signals observed compared to the currently approved 2 mg dose of EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). In this small trial involving 106 patients, a higher proportion of patients in the aflibercept 8 mg group had no retinal fluid (43.4%, n=23/53) compared to patients treated with EYLEA 2 mg (26.4%, n=14/53) (p=0.067) at week 16, the primary efficacy endpoint.

Anticancer Agent “Tazverik® Tablets 200mg” (Tazemetostat Hydrobromide) Launched in Japan for Ezh2 Gene Mutation-Positive Follicular Lymphoma

Woodcliff Lake-based Eisai Co., Ltd. announced that it has launched the anticancer agent EZH2 inhibitor “Tazverik® Tablets 200 mg” (tazemetostat hydrobromide), in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable). Eisai obtained the manufacturing and marketing approval of “Tazverik” on June 23, 2021. “Tazverik” was included to Japan’s National Health Insurance Drug Price List on August 12, 2021.

Lexicon’s Sotagliflozin Demonstrates Additional Compelling Benefits in Reducing Cardiovascular Endpoints: Results from Soloist and Scored Trials

Lexicon Pharmaceuticals, Inc., with offices in Basking Ridge, presented additional analyses of sotagliflozin data from the SOLOIST and SCORED Phase 3 clinical trials. Sotagliflozin is a first-in-class, investigational dual SGLT1 and SGLT2 inhibitor that showed substantial reductions, compared to placebo, in the primary endpoint of total cardiovascular deaths, hospitalizations for heart failure and urgent visits for heart failure in both studies in patients with type 2 diabetes and worsening heart failure or chronic kidney disease. “Based on analyses of the SOLOIST and SCORED trials, sotagliflozin robustly and significantly reduced heart failure hospitalizations, myocardial infarction and stroke,” said Dr. Deepak L. Bhatt, M.D., M.P.H., Study Chair of the SOLOIST and SCORED clinical trials.

Valo Health Opens Office on Nassau Street in Princeton

Valo Health, an artificial intelligence-powered, early stage drug discovery company that announced it will go public this summer in a $2.8 billion SPAC deal, has opened an office in Princeton. The Princeton office is poised to become a major hub for the nearly 200-employee company. The Princeton office will be home to the company’s chief financial officer, Graeme Bell, its head of data science, key therapeutic leaders as well as employees from its finance, regulatory and therapeutic teams.

Enteris BioPharma Receives 2021 Best of Boonton Award

Boonton-based Enteris BioPharma announced that it has received the 2021 Best of Boonton Award in the Pharmaceutical Company category from the Boonton Award Program. This is Enteris' third consecutive Best of Boonton Award, given this year in recognition of the company's continued growth since 2013 from pharmaceutical industry start-up to the industry leader in enabling the oral delivery of peptide and small molecule therapeutics. As a three-time Best of Boonton Award recipient, Enteris has qualified for inclusion in the 2021 Boonton Business Hall of Fame.

N.J. Health Care Companies Dominate Forbes List of ‘Best Employers’ by State

The country was in the middle of the pandemic when Forbes began the process of making its third annual list of America’s Best Employers by State. So, perhaps it’s only fitting that, of the 30 companies selected to represent New Jersey, 15 of them were primarily based in health care, whether it was as a hospital system, pharmaceutical company or part of the medical testing community. Congratulations to these BioNJ Members for making the list: Becton, Dickinson and Company, Hackensack Meridian Health, Johnson & Johnson, Merck & Co., Novartis, Princeton University, Rutgers University and Sanofi.

Pfizer Announces New Chief Business Innovation Officer

BioNJ Member Pfizer Inc., with offices in Peapack, announced that Aamir Malik has joined the company as Executive Vice President and Chief Business Innovation Officer. Mr. Malik will be a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Albert Bourla. Mr. Malik joins Pfizer from McKinsey & Company, where he most recently served as the Managing Partner responsible for the firm’s U.S. operations. Previously, he led the firm’s Global Pharmaceuticals & Medical Products practice. At Pfizer, Mr. Malik will oversee the company’s strategy, business development, portfolio management, pipeline prioritization, and formation of new business ventures, as well as the advancement of innovative access partnerships with payers and governments around the world. 

Lilly Announces Leadership Changes and Formation of Neuroscience and Immunology Business Units

Bridgewater-based BioNJ Member Eli Lilly and Company announced executive leadership changes and the creation of neuroscience and immunology business units. These changes will increase Lilly's focus on introducing breakthrough new medicines to millions of people with unmet needs. Lilly Bio-Medicines will split into two business units: Lilly Neuroscience and Lilly Immunology. Anne White, currently Senior Vice President and President of Lilly Oncology, will lead Lilly Neuroscience as Senior Vice President and President. Patrik Jonsson will lead Lilly's launched products and Phase 3 portfolio of medicines in dermatology, gastroenterology and rheumatology as President, Lilly Immunology, in addition to his ongoing responsibilities as Senior Vice President and President, Lilly USA and Chief Customer Officer.  

OncoSec Provides Leadership Update

Pennington-based BioNJ Member OncoSec Medical Incorporated announced the establishment of a Leadership Committee consisting of three board members, Margaret Dalesandro, Ph.D., Herbert Kim Lyerly, M.D. and Yuhang Zhao, Ph.D., MBA, to lead all development efforts, with a focus on the company's lead asset, TAVO™. Effective immediately, OncoSec's interim CEO, Mr. Brian Leuthner, will be leaving the company. Dr. Dalesandro has three decades of experience in the pharmaceutical, biotechnology and diagnostics industries. Dr. Kim Lyerly, Duke University School of Medicine, is an internationally recognized expert in cancer therapy and interleukin-12. And, Dr. Zhao has previously held positions at PaineWebber, Deloitte and Bayer.  

Alex Gorsky to Serve as Executive Chairman and Transition Role of Chief Executive Officer of Johnson & Johnson to Joaquin Duato, Effective January 3, 2022

New Brunswick-based BioNJ Member Johnson & Johnson announced that Mr. Alex Gorsky, currently Chairman and Chief Executive Officer, will serve as Executive Chairman of Johnson & Johnson and transition the Chief Executive Officer role to Mr. Joaquin Duato, currently Vice Chairman of the Company’s Executive Committee, effective January 3, 2022. Following the transition of the Chief Executive Officer role, Mr. Duato will also be appointed as a member of the company’s Board of Directors. Mr. Gorsky has served as Chairman and Chief Executive Officer of Johnson & Johnson since 2012. During his tenure, Mr. Gorsky has overseen a more than 60% increase in R&D investments to $12 billion in 2020, making Johnson & Johnson one of the industry’s top investors in research and development.

Jubilant Therapeutics Strengthens Board of Directors With Addition of Leila Alland, M.D. and Announces Appointment of Jeremy Barton, M.D., as Strategic Advisor and Interim CMO

Bedminster-based Jubilant Therapeutics Inc. announced the appointments of Leila Alland, M.D. to its Board of Directors, and Jeremy Barton, M.D. as Strategic Advisor and Interim Chief Medical Officer. "Dr. Alland and Dr. Barton's combined experience in strategic oncology drug development will help propel the company towards our goal to bring innovative small molecule modulators to patients with cancer," said Syed Kazmi, Ph.D., President and Chief Executive Officer of Jubilant Therapeutics Inc. Dr. Alland currently serves as Chief Medical Officer of PMV Pharmaceuticals where she is responsible for leading the company's clinical stage precision anticancer therapies.

New Regional Princeton-led Innovation Hub to Accelerate Tech, Enhance Diversity in Entrepreneurship

The NSF Innovation Corps (I-Corps) Northeast Hub is one of five new hubs announced this week in a nationwide NSF-funded network of universities formed to accelerate the economic impact of federally funded research – delivering benefits in health care, energy and the environment, computing, artificial intelligence, robotics, advanced materials and other areas – while building skills and opportunities among researchers from all backgrounds. Princeton will be the principal institution in the new hub, with the University of Delaware and Rutgers University as partner institutions. The hub will include five initial affiliates: New Jersey Institute of Technology (NJIT) and Rowan University in New Jersey; Lehigh University and Temple University in Pennsylvania; and Delaware State University, an Historically Black College or University (HBCU).

Rowan Innovations: Moving Great Ideas from the Lab to the Marketplace

Rowan University researchers are developing promising ideas and new technology in their labs – the trick is getting their new inventions out into the marketplace. The National Science Foundation’s Innovation Corps (I-Corps) program accelerates the commercialization process.

Since 2018, Rowan researchers have earned 10 national I-Corps awards, plus another through the National Institutes of Health – more than any other R2 institution without a formal designation as an I-Corps site or node, noted Dr. Yatin Karpe, Director of the University’s Office of Technology Commercialization and Rowan Innovations.

ROI-NJ Presents the 2021 ROI Influencers: Higher Education

When the pandemic hit in the spring of 2020 and showed no signs of letting up, two things became clear when it came to higher education: Learning must continue and the way students learned would be far different than ever before. Institutions of higher education suddenly had to come up with new policies, procedures and programs in a matter of days and weeks. The 2021 ROI Influencers: Higher Education list is a way to recognize the schools, the presidents, the deans and directors, the doers and the donors that made higher education possible during the most uncertain of times. Click here for the full list of honorees, including BioNJ Member Dr. Joel Bloom of the New Jersey Institute of Technology for being named Valedictorian.

Rutgers Dean Receives Lifetime Achievement Award

Robert Johnson, Dean of Rutgers New Jersey Medical School and Interim Dean of Rutgers Robert Wood Johnson Medical School, recently received the NJBIZ Health Care Heroes Lifetime Achievement Award. The award recognizes professionals whose work demonstrates the highest level of dedication to improving the lives of New Jerseyans. NJBIZ noted Johnson’s distinction as the Dean of two medical schools, his work with adolescents and his role as a professor of pediatrics and Founder and Director of the Division of Adolescent and Young Adult Medicine at Rutgers New Jersey Medical School.

RWJBarnabas Health and Rutgers Cancer Institute of New Jersey Leader Selected to be Inducted as a Fellow of the American Academy of Nursing

Carolyn Hayes, Ph.D., RN, NEA-BC, Chief Nursing Officer for Oncology Services at RWJBarnabas Health and Rutgers Cancer Institute of New Jersey, has been selected by the American Academy of Nursing (AAN) as a 2021 Fellow. Induction into the Academy is a significant milestone in a nurse leader’s career in which their accomplishments are honored by their colleagues within and outside the profession. Fellows are selected based on their contributions and impact to advance the public’s health.

NJIT Names State Deputy Treasurer as University Sr. VP and CFO

New Jersey Institute of Technology (NJIT) has named Catherine Z. Brennan as the university’s Senior Vice President (SVP)/Chief Financial Officer (CFO). She will begin her NJIT tenure on September 20, 2021. As NJIT’s SVP and CFO, Ms. Brennan will maintain responsibility for the university’s financial management and accountability, and will lead the Offices of General Accounting, University Budgeting, Payroll, Procurement Services, Accounts Payable, Financial Systems and Innovation, Risk Management, Treasury and Bursar.

Intro to Design & Manufacturing of Viral Vectors in Gene Therapy

October 18 - 21, 2021

This online virtual training course will provide a detailed understanding in upstream and downstream processing of viral vectors used in cell and gene therapy. The course will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics. Program includes interactive learning and technical demonstrations. There are only 20 spots available. BioNJ Members receive a 10% discount. Contact RBromberg@BioNJ.org for the registration code.

US-TW Business Networking and InvesTaiwan Roadshow

September 15, 2021

This event aims to introduce Taiwan's business environment and investment opportunities especially in smart medicine and electric vehicles. The first hour is an in-person networking session between US and Taiwnaese business communities in New Jersey. The second hour focuses on Taiwan's industrial policies and investment incentives. US companies like Merck and IBM will share their successful stories in Taiwan. 

Parkinson’s Biological Research Funding Available

The Michael J. Fox Foundation has opened five funding programs supporting work across Parkinson’s biology, biomarkers and therapeutic development. Studies applying learnings or methodologies (e.g., targets, algorithms) from other disease areas are encouraged. All programs are open to academic and industry researchers. Pre-proposals are due September 28, 2021. Learn more and apply at www.michaeljfox.org/funding.

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