Correcting the Record: Putting Medicine Costs and Spending in Context

Too many Americans struggle to afford their medicines, but we must take a holistic approach to addressing the problem. Focusing solely on drug prices and relying on misleading claims will not fix the affordability challenges patients worry about most. Data from the Bureau of Labor Statistics (BLS) show that prices for prescription medicines are growing significantly more slowly than overall inflation (1.3% vs. 7.5%). Data from IQVIA confirms this is a trend, showing that brand medicine prices have grown in line with or below the rate of inflation for the past five years. Net prices for brand medicines declined 2.9%, on average, in 2020. The BLS data reflect undiscounted prices, not the amount manufacturers ultimately receive on the sale of medicines (the net price), which declined for brand products in 2020. Despite this, many continue to focus on the list prices of medicines, failing to account for the rebates, discounts and other payments manufacturers provide to health insurers, PBMs and other stakeholders.

Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA

Nutley-based BioNJ Member Y-mAbs Therapeutics announced that the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the company expects to publish later this year. Dr. Claus Moller, CEO, said, “We look forward to working with the FDA to bring omburtamab to the appropriate patients. This is a key milestone for families and patients facing CNS/leptomeningeal metastasis from neuroblastoma and for Y-mAbs.”

PTC Therapeutics Announces Initiation of PIVOT-HD Phase 2 Clinical Trial to Evaluate PTC518 in Patients With Huntington's Disease

South Plainfield-based BioNJ Member PTC Therapeutics announced the initiation of the PIVOT-HD Phase 2 clinical trial evaluating PTC518 in people with Huntington's disease (HD). PIVOT-HD is a global trial starting in the United States. PTC518 is an oral, small molecule splicing modifier that was specifically designed to selectively lower huntingtin mRNA and protein. There are no current treatments for the underlying cause of HD. The PIVOT-HD Phase 2 clinical trial is designed in two parts: an initial 12-week placebo-controlled phase focused on PTC518 pharmacology and pharmacodynamic effect, followed by a 9-month placebo-controlled phase focused on PTC518 biomarker effect.

Agile Therapeutics® Announces First Twirla® Commercial Targeting Gen Z

Princeton-based BioNJ Member Agile Therapeutics announced the launch of its first consumer commercial intended to increase awareness of the Twirla weekly birth control patch. The new ad launched on connected TV (CTV) will run during key months through the remainder of 2022. In contrast to the inefficient mass advertising approach of traditional cable TV, CTV allows brands to utilize internet-connected video streaming services to focus exposure on a custom target audience. Deployment of the commercial is focused on Twirla’s primary consumer target, 18- to 24-year-old women, and geotargeted in California, Florida, Illinois, New York and Texas, reaching 41%-45% of its primary consumer base in the country – equating to approximately 5.7 million women.

Regulatory Approval of DYSVAL capsules 40mg for Treatment of Tardive Dyskinesia in Japan

Jersey City-based BioNJ Member Mitsubishi Tanabe Pharma obtained the regulatory approval of the vesicular monoamine transporter type 2 (VMAT2) inhibitor, DYSVAL® capsules 40mg (DYSVAL, development code: MT-5199, generic name: valbenazine) for the treatment of tardive dyskinesia from the Ministry of Health, Labour and Welfare. As the first drug approved in Japan for the treatment of tardive dyskinesia, MTPC believes that DYSVAL offers a new treatment option for tardive dyskinesia. Tardive dyskinesia is a neurologic disorder characterized by involuntary movement. Symptoms include uncontrollable, abnormal and repetitive movements of the tongue, lips, jaw, face, the extremities and torso. 

Vyant Bio and Organotherapeutics Announce Strategic Collaboration to Discover Therapeutics to Treat Parkinson’s Disease

Cherry Hill-based BioNJ Member Vyant Bio and Organotherapeutics announced they have entered into a collaboration agreement to work toward accelerating the discovery of drugs for the treatment of Parkinson’s Disease. The collaboration brings together the respective teams’ expertise in drug discovery using human-derived cells, high-throughput biology and chemistry, and machine learning-based therapeutic design to identify potential PD drugs. Together, they will focus on the identification of drug candidates that rescue the PD phenotype through the development of disease-linked, clinically- translatable assays and biomarkers through multiple molecular, biochemical and cellular methods. This approach will integrate and leverage Organotherapeutic’s complex, patient-derived, 3D-organoid disease models derived from induced pluripotent stem cells (iPSCs), and Vyant Bio’s iPSC expertise and its AnalytiXTM machine learning technology.

New Spesolimab Data Show Clinically Significant Improvement in Patients With Generalized Pustular Psoriasis (GPP) Flares

North Brunswick-based BioNJ Member Boehringer Ingelheim announced new data from the pivotal Effisayil™ 1 trial. The Effisayil™ 1 trial, recently published in The New England Journal of Medicine, showed significant clearance of skin pustules in patients with GPP flares within the first week after treatment with a single intravenous dose of spesolimab versus placebo. This effect was sustained over 12 weeks, according to data presented at AAD, which found that 84.4% of patients had no visible pustules after the 12-week trial duration and 81.3% had clear/almost clear skin. Generalized pustular psoriasis is a rare, potentially life-threatening neutrophilic skin disease, which is distinct from plaque psoriasis. 

Boehringer Ingelheim Selects Veeva Development Cloud Worldwide to Bring Innovative Therapies to Patients Faster

North Brunswick-based BioNJ Member Boehringer Ingelheim and Veeva Systems announce Boehringer Ingelheim’s selection of Veeva Development Cloud to drive end-to-end processes and seamless information sharing enterprise wide for greater speed in the delivery of innovative therapies. Boehringer Ingelheim, a leading research-driven biopharmaceutical company, is working on breakthrough therapies that improve the lives of humans and animals and creating value through innovation in areas of high unmet medical need. By bringing together data and processes across clinical, regulatory and quality on a single cloud platform for the enterprise, Boehringer Ingelheim will establish a connected technology landscape for agile collaboration that can accelerate the development of novel medicines.

Taiho Pharmaceutical Obtains Approval to Manufacture and Market NK1 Receptor Antagonist Arokaris® I.V. Infusion 235mg in Japan

Iselin-based BioNJ Member Helsinn Therapeutics, Inc. and Taiho Pharmaceuticals announced that Taiho has been granted approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market the NK receptor antagonist antiemetic drug “Arokaris® I.V. Infusion 235mg” (generic name: fosnetupitant chloride hydrochloride) for gastrointestinal symptoms (nausea and vomiting, including delayed phase) associated with cancer chemotherapy (cisplatin, etc.). Arokaris® is an NK receptor antagonist antiemetic drug and is a phosphorylated pro-drug preparation (injection) which is converted to netupitant, the active component. Chemotherapy-induced nausea and vomiting can have deleterious effects on patients’ quality-of-life, and may also interfere with chemotherapy administration, therefore guidelines recommend adequate prophylaxis.

Eicosapentaenoic Acid (Epa) Combined With Widely Used Statins Significantly Reduced Lipid Oxidation in Model Membranes

Bridgewater-based BioNJ Member Amarin Corporation announced in vitro research results suggesting that Eicosapentaenoic Acid (EPA), in combination with widely prescribed statins, contributed to a reduction in lipid oxidation in membranes in a manner that may be enhanced with the use of these statins. Amarin’s VASCEPA®/VAZKEPA® (icosapent ethyl) is the highly purified, prescription form of the ethyl ester of EPA. The oxidation of lipids in vascular cell membranes can be an important factor in heart disease and risk of an adverse cardiovascular event, as it contributes to inflammation, endothelial dysfunction, and cholesterol domain and foam cell formation during atherogenesis, as well as to circulating levels of oxidized LDL, which correlate with acute coronary syndromes and increased risk for ischemic events and metabolic disease.

Majority of Patients Treated With Lebrikizumab Achieved Skin Clearance in Lilly's Pivotal Phase 3 Atopic Dermatitis

More than 50 percent of patients with moderate-to-severe atopic dermatitis (AD) experienced at least 75 percent reduction in disease severity (EASI-75) at 16 weeks when receiving lebrikizumab monotherapy in the ADvocate program, Bridgewater-based BioNJ Member Eli Lilly and Company announced. Lebrikizumab, an investigational IL-13 inhibitor, also led to clinically meaningful improvements in itch and other important patient-reported outcomes compared to placebo. Lebrikizumab is a monoclonal antibody (mAb) that binds to the interleukin 13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13Rα1/IL-4Rα (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway.

Nearly 40% of Adults With Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly's Pivotal Phase 3 Studies

Adults with severe alopecia areata who took OLUMIANT® (baricitinib) achieved significant scalp, eyelash and eyebrow hair regrowth and nearly 75% of those who responded to OLUMIANT 4-mg achieved 90% scalp coverage at 52 weeks, Bridgewater-based BioNJ Member Eli Lilly and Company and Incyte announced. In February 2022, the U.S. Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. In the pooled 52-week analysis, patients at baseline had a mean Severity of Alopecia Tool (SALT) score of 85.5 (85.5% scalp hair loss, or 14.5% scalp hair coverage); severe AA is defined as having a SALT score ≥50 (≥50% scalp hair loss). 

Lilly Presents Updated Data on Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) at the 2022 European Lung Cancer Congress

Bridgewater-based BioNJ Member Eli Lilly and Company announced updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo® (selpercatinib 40 mg & 80 mg capsules) in patients with RET fusion-positive non-small cell lung cancer. Retevmo is a selective and potent RET kinase inhibitor that is approved in multiple countries including the United States for treatment of adult patients with metastatic rearranged during transfection fusion-positive NSCLC, and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.

Novo Nordisk Receives FDA Approval of Higher-Dose Ozempic® 2 Mg Providing Increased Glycemic Control for Adults With Type 2 Diabetes

Plainsboro-based BioNJ Member Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mg dose of Ozempic® (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease. Ozempic® is not a weight loss drug but may help people lose some weight. In the Ozempic® SUSTAIN phase 3 clinical trial program, up to 73% of people with type 2 diabetes treated with Ozempic® 1 mg lowered their blood sugar and reached the American Diabetes Association target of <7%.

Chugai Obtains Regulatory Approval for Vabysmo, the First Bispecific Antibody in Ophthalmology, for Neovascular Age-related Macular Degeneration and Diabetic Macular Edema

Berkeley Heights-based BioNJ Member Chugai Pharma announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Vabysmo® for Intravitreal Injection 120 mg/ mL (generic name: faricimab), an anti VEGF/anti Ang-2 bispecific antibody for the treatment of "age-related macular degeneration associated with subfoveal choroidal neovascularization" and "diabetic macular edema (DME)." Age-related macular degeneration associated with subfoveal choroidal neovascularization is generally known as neovascular age-related macular degeneration (nAMD). nAMD is a disease in which age-related choroidal neovascularization grows under the retina, causing leakage of fluid and blood, resulting in retinal edema and fluid retention that leads to visual impairment.

Maruho Obtained Regulatory Approval for Mitchga, the First Antibody Targeting IL-31 for Itching Associated With Atopic Dermatitis

Berkeley Heights-based BioNJ Member Chugai Pharma announced that Maruho Co., Ltd. obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-IL-31 receptor A humanized monoclonal antibody Mitchga® Subcutaneous Injection 60 mg Syringes [generic name: nemolizumab (genetical recombination)] for the treatment of itching associated with atopic dermatitis (only when existing treatment is insufficiently effective). The approval is based on the results from a Japanese phase III clinical study in patients with moderate to severe AD who are older than 13 years old and are tolerant to existing treatments.

Chugai Obtains Regulatory Approval for Perjeta and Herceptin for Additional Indication of HER2-Positive Colorectal Cancer

Berkeley Heights-based BioNJ Member Chugai Pharma announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare for the anti-HER2 humanized monoclonal antibodies, Perjeta® for intravenous infusion 420mg/14 mL and Herceptin® for intravenous infusion 60 and 150, for the additional indication of advanced or recurrent HER2-positive colon cancer or rectal cancer not amenable to curative resection that has progressed after cancer chemotherapy. The approval is based on the results of an investigator-initiated phase II clinical trial conducted in Japan that evaluated the efficacy and safety of the combination of Perjeta and Herceptin in 30 patients with HER2-positive, curatively unresectable advanced or recurrent colorectal cancer who had previously undergone chemotherapy.

Allergan, an AbbVie Company, Announces Positive Topline Phase 3 Results Evaluating Investigational Twice-Daily Administration of VUITY™ (pilocarpine HCI ophthalmic solution) 1.25% in Adults With Age-Related Blurry Near Vision (Presbyopia)

BioNJ Member Allergan, an AbbVie company, announced that the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia met its primary efficacy endpoint, improving near vision without compromising distance vision at Hour 9 (3 hours after the second drop) on Day 14. Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, VUITY is the first and only eye drop to treat age-related blurry near vision in adults.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)

Kenilworth-based BioNJ Member Merck & Co. announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab (the KEYTRUDA regimen), for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The recommendation is based on results from the Phase 3 KEYNOTE-826 trial, in which the KEYTRUDA regimen demonstrated a statistically significant improvement in overall survival (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy with or without bevacizumab (the chemotherapy regimen) in this patient population.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors in Five Different Types of Cancer

Kenilworth-based BioNJ Member Merck & Co. announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of the following microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy; advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine or biliary cancer who have disease progression on or following at least one prior therapy.

Merck and Ridgeback to Present Data Demonstrating That Treatment With LAGEVRIO™ (molnupiravir) Was Associated With More Rapid Elimination of Infectious SARS-CoV-2 Than Placebo

Kenilworth-based BioNJ Member Merck & Co. and Ridgeback Biotherapeutics announced that data evaluating LAGEVRIO™ (molnupiravir), an investigational oral antiviral COVID-19 medicine, will be presented at the 2022 European Congress of Clinical Microbiology & Infectious Diseases. The presentation includes final analyses evaluating virologic outcomes throughout and following a five-day course of LAGEVRIO as part of the Phase 3 MOVe-OUT trial, which studied LAGEVRIO versus placebo for the treatment of COVID-19 in non-hospitalized adults with mild to moderate COVID-19 who were at high risk for progressing to severe disease. Among study participants for whom samples were available, viral infectivity was assessed via a plaque-forming assay in Vero cells. 

Merck Provides Update on FDA Review of Supplemental Biologics License Application for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) for Use in Infants and Children

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental biologics license application (sBLA) for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) in infants and children. The FDA requested additional analyses of data from the pediatric studies, which Merck has submitted to the FDA. No new studies have been requested by the FDA. Merck previously announced that the FDA accepted the company’s application for VAXNEUVANCE for the prevention of invasive pneumococcal disease in children 6 weeks through 17 years of age and it was granted Priority Review.

Sanofi and IGM Biosciences Announce Collaboration Agreement for Oncology, Immunology and Inflammation Targets

Bridgewater-based BioNJ Member Sanofi and IGM Biosciences announced the signing of an exclusive worldwide collaboration agreement to create, develop, manufacture and commercialize IgM antibody agonists against three oncology targets and three immunology/inflammation targets. Engineered IgM antibodies represent a new class of potential therapeutics that combine the multi-valency of IgM antibodies possessing 10 binding sites compared to conventional IgG antibodies having only 2 target binding sites. Under the terms of the agreement, IGM will receive a $ 150 million upfront payment. Sanofi has also expressed an interest in purchasing up to $100M of IGM non-voting common stock in a public financing.

Xenpozyme® (Olipudase Alfa) Approved in Japan, First and Only Approved Therapy Indicated to Treat Acid Sphingomyelinase Deficiency

Bridgewater-based BioNJ Member Sanofi announced the Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Xenpozyme® (olipudase alfa) for the treatment of adult and pediatric patients with non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare, progressive, and potentially life-threatening genetic disease. Xenpozyme is currently the only approved treatment for ASMD and represents Sanofi’s first therapy to be approved under the SAKIGAKE (or “pioneer”) designation, which is the Japanese government’s regulatory fast-track pathway to promote research and development of innovative new medical products addressing urgent unmet medical needs.

FDA Accepts Dupixent® (Dupilumab) for Priority Review in Patients Aged 12 Years and Older With Eosinophilic Esophagitis

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow. The sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE, and data from an active long-term extension trial. 

Sanofi Launches First-in-Pharma Diversity, Equity & Inclusion Board

Bridgewater-based BioNJ Member Sanofi launched its Diversity, Equity & Inclusion (DE&I) Board, the first-of-its-kind in the pharmaceutical industry to feature outside advisors. Sanofi’s DE&I Board will include three of the most influential voices in the DE&I space as Board members appointed for 3 years: organizational psychologist and best-selling author John Amaechi, award-winning social entrepreneur Caroline Casey, and DE&I pioneer and renowned thought-leader Dr. Rohini Anand. Sanofi’s DE&I strategy was revamped with set objectives, built around three key pillars: building representative leadership, creating a work environment where employees can bring their whole selves and engaging with the company’s diverse communities.

Gilead Sciences Announces $24 Million in Grants to Help End the HIV Epidemic for Everyone, Everywhere

Morris Plains-based BioNJ Member Gilead Sciences announced $24 million in grants to help reduce health disparities, improve access to quality healthcare, advance medical education and support local communities most impacted by the HIV epidemic and COVID-19 pandemic. The Zeroing In: Ending the HIV Epidemic program, will support 116 organizations in 41 countries. The funding recipients will focus on advancing at least one of three focus areas: Comprehensive HIV Innovation, Digital Health Innovation and Community Outreach and Education. To build on progress in local communities, Zeroing In organizations will prioritize populations most affected by the HIV epidemic.

Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

Kite, a Morris Plains-based BioNJ Member Gilead Company, announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause. Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment, after their one-time infusion of Yescarta vs. SOC (16.3%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) With Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Medicines Agency has validated its type II variation application for Opdivo in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure. In the pivotal CheckMate -816 study, the first positive Phase 3 trial with an immunotherapy in the neoadjuvant setting of NSCLC, three cycles of Opdivo in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival and pathologic complete response (pCR) versus chemotherapy alone when given before surgery.

Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Certain Forms of Relapsed or Refractory Large B-cell Lymphoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has granted Marketing Authorization for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. The Marketing Authorization approves Breyanzi for use in all European Union (EU) member states. Breyanzi is delivered as a personalized treatment via a single infusion. Treatment with Breyanzi has demonstrated sustained complete responses in a high proportion of patients with R/R large B-cell lymphoma (LBCL) and a manageable and differentiated safety profile.

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Patients

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥ 1%. The EC’s decision is based on results from the Phase 3 CheckMate -648 trial, in which treatment with Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to fluoropyrimidine- and platinum-containing chemotherapy at the pre-specified interim analysis. The safety profile of Opdivo plus Yervoy was consistent with previously reported studies. 

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) as Adjuvant Treatment for Patients With Radically Resected, High-Risk Muscle-Invasive Urothelial Carcinoma With Tumor Cell PD-L1 Expression ≥1%

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection. With this EC decision, Opdivo becomes the first adjuvant immunotherapy option approved for patients in the European Union (EU) in this setting. In the Phase 3 CheckMate -274 trial, Opdivo demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared to placebo in both all-randomized patients and in patients whose tumor cells express PD-L1 ≥1%.

Viiv Healthcare Announces U.S. FDA Approval of Triumeq PD, the First Dispersible Single Tablet Regimen Containing Dolutegravir, a Once-Daily Treatment for Children Living With HIV

ViiV Healthcare, the global specialist HIV company majority-owned by Warren-based BioNJ Member GlaxoSmithKline plc, BioNJ Member Pfizer Inc., with offices in Peapack, and Shionogi B.V. as shareholders, has announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10kgs to <25 kgs with human immunodeficiency virus type 1 (HIV-1). In addition, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 (HIV-1) can be prescribed this medicine to 25kgs from 40kgs.

Antares Pharma Announces FDA Approval Of TLANDOTM, an Oral Treatment for Testosterone Replacement Therapy

Ewing-based Antares Pharma announced that the U.S. Food and Drug Administration granted final approval for TLANDOTM (testosterone undecanoate), an oral treatment for testosterone replacement therapy (“TRT”) indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, “The FDA approval of TLANDO brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of TLANDO.” 

BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients With ESCC and NSCLC

Ridgefield Park-based BeiGene announced that marketing authorization applications (MAA) for tislelizumab, submitted by BioNJ Member Novartis, the license holder in Europe, have been validated for regulatory review by the European Medicines Agency (EMA) for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy and for patients with non-small cell lung cancers (NSCLC). The MAA for tislelizumab in NSCLC is supported by clinical results from three BeiGene-sponsored trials (NCT03358875, NCT03594747, NCT03663205) of 1,499 patients, including the global randomized, open-label, Phase 3 RATIONALE 303 trial comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy. 

Announcement About an Approval for Additional Indication of Jyseleca®, JAK Inhibitor, for the Treatment of Moderate to Severe Ulcerative Colitis With Inadequate Response to Conventional Therapies

Nutley-based Eisai, Morris Plains-based BioNJ Member Gilead Sciences and EA Pharma announced that Gilead acquired an approval of additional indication of Jyseleca® (Generic name: Filgotinib, “Jyseleca”), Janus Kinase (JAK) inhibitor, for the treatment of patients with active moderate-to-severe ulcerative colitis in Japan. In September 2020, Jyseleca was approved for the treatment of patients with rheumatoid arthritis (including prevention of structural joint damage) who had an inadequate response to conventional therapies in Japan. The approval of the additional indication is based on the data from Phase IIb/III SELECTION trial evaluating the efficacy and safety of Jyseleca in the induction and maintenance treatment of biologic-naïve and biologic-experienced patients with moderately to severely active ulcerative colitis.

Tarlige® Tablets Approved in Japan for Treatment of Patients With Neuropathic Pain

Basking Ridge-based Daiichi Sankyo announced that it has obtained approval in Japan to change the indication of the analgesic “Tarlige® Tablets” (mirogabalin besilate) from “peripheral neuropathic pain” to “neuropathic pain.” Neuropathic pain is pain caused by lesions or diseases of the somatosensory nervous system and is classified into peripheral neuropathic pain and central neuropathic pain (CNP), according to the anatomical location of the nerve damage site that causes the pain. CNP is pain that arises from central nerve injury or impairment such as spinal cord injury and central post-stroke pain. In May 2021, Daiichi Sankyo submitted a supplemental new drug application (sNDA) for Tarlige® Tablets based on results from a Phase 3 trial in patients with CNP.

Sun Pharma Presents Phase 3 Data for WINLEVI® (clascoterone) Cream 1% for the Topical Treatment of Acne Vulgaris at the AAD Annual Meeting

Princeton-based Sun Pharmaceuticals announced that the company’s wholly owned U.S. subsidiary presented data from two pivotal Phase 3 clinical trials of WINLEVI (clascoterone) cream 1% for the topical treatment of acne vulgaris (acne). The results showed favorable safety and efficacy data in patients 12 years of age and older with acne. A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by the U.S. Food and Drug Administration for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years. 

Sotagliflozin Improved Outcomes in Patients With and Without Prior Cardiovascular Disease in New Analysis Presented at the American College of Cardiology's 71st Annual Scientific Session (ACC.22)

Basking Ridge-based Lexicon Pharmaceuticals announced results of a new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin. The SCORED clinical trial randomized 10,584 patients with type 2 diabetes and chronic kidney disease to sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, or placebo. Treatment with sotagliflozin resulted in a significant reduction in major adverse cardiovascular events (MACE) of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in the entire cohort as compared to placebo. This analysis also evaluated the effect of sotagliflozin on MACE in prespecified subgroups of patients with cardiovascular disease (CVD; n=5,144) and without CVD (n=5,440) at baseline. 

Cresskill Biopharma Company Closes on $25M in Private Financing

Cresskill-based Vascular Therapies announced it closed on $25 million in private financing from current and new investors, including a Fortune 100 global health care company. Vascular Therapies company plans to use the proceeds to further advance Sirogen, which has indicated encouraging arteriovenous fistula outcomes in trials in elderly end-stage renal disease patients. The proceeds are to fund ACCESS 2 — a randomized clinical trial evaluating Sirogen for improving hemodialysis AV fistula outcomes in high-risk patients with kidney disease. “With this financing completed, we are now focused on initiating enrollment of the ACCESS 2 clinical study, which we expect to start in the second quarter of 2022,” John McDermott, CEO of Vascular Therapies, said.

Infinity Biologix and Roylance Pharma Rebrand As "Sampled"

Piscataway-based Infinity Biologix and Roylance Pharma announced the rebrand of both organizations as "Sampled". Sampled is a next-generation laboratory that unlocks valuable data from any biological sample. By focusing on the genetic causes of common, complex diseases, Sampled aims to discover diagnoses, treatments and, eventually, cures. Through its integrated "SMART Labs" services, the company can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Since commercializing outside of Rutgers in 2020, the company has rapidly expanded its capabilities and partnerships, while launching several ground-breaking new products.

Eagle Pharmaceuticals Agrees to Terms to Acquire Acacia Pharma Group plc

Woodcliff Lake-based Eagle Pharmaceuticals announced it has reached agreement on the terms of a transfer of the entire issued and to be issued share capital of Acacia Pharma Group plc to Eagle by way of a scheme of arrangement under Part 26 of the United Kingdom’s Companies Act 2006. The terms of the proposed transaction value Acacia Pharma’s existing issued and to be issued share capital at approximately €94,700,000, or the equivalent of €0.90 per share. Each shareholder of Acacia Pharma would receive, as consideration for each share of Acacia Pharma held by such shareholder, €0.68 in cash and 0.0049 shares of common stock of Eagle. 

BD Announces Completion of Embecta Corp. Spinoff

Franklin Lakes-based Becton, Dickinson and Company announced that it has completed its spinoff of Embecta Corp. (embecta), which holds BD's former Diabetes Care business and is now one of the largest pure-play diabetes management companies in the world. The spinoff of embecta demonstrates BD's ongoing commitment to the company's BD 2025 strategy, which includes its three strategic pillars of Grow, Simplify and Empower. The strategic rationale for the spinoff was to create two, independent companies with attractive long-term value for BD shareholders and enhanced strategic, operational and financial characteristics. Each company will focus on its core business and product portfolios, with BD maintaining its category leadership positions across its BD Medical, BD Life Sciences and BD Interventional segments.

Presenting the 2022 NJBIZ Health Care Power 50

Last year, the pandemic was still a fact of life, though many experts and officials believed it would soon begin to fade. Still, it was a time to take stock and express gratitude to the professionals who met the unprecedented challenge posed by COVID-19. Congratulations to BioNJ President and CEO Debbie Hart for making the list, as well as these BioNJ Members: Diane Calello and Bruce Ruck, Rutgers New Jersey Medical School; Robert Davis, Merck & Co., Joaquin Duato, Johnson & Johnson; Matthew Edson, Rowan University; Robert Garrett, Hackensack Meridian Health; Andre Goy, Hackensack Meridian Health ; Thomas Kendris, Novartis; Scott Kobler, McCarter & English; Perry Halkitis, Rutgers School of Public Health; Robert Johnson, Rutgers New Jersey Medical School; Steven Libutti, Rutgers Cancer Institute of New Jersey; Scott McBride, Lowenstein Sandler; Jack and Sheryl Morris, Rutgers Cancer Institute of New Jersey; Donald Parker, Hackensack Meridian Health; Gary Small, Hackensack University Medical Center; Brian Strom, Rutgers School of Biomedical and Health Services; and Marco Taglietti, Scynexis.

Senate Approves Kathi Vidal for Patent and Trademark Office

Kathi Vidal, President Joe Biden’s pick to lead the U.S. Patent and Trademark Office, was confirmed by the Senate by voice vote. Ms. Vidal is the second woman to hold the dual roles of under Secretary of Commerce for Intellectual Property and USPTO Director. She brings experience as a litigator who’s been on both sides of patent disputes, most recently as managing partner of Winston & Strawn LLP. Attorneys and other legal observers previously have said that a review of the USPTO’s practice of discretionary denials at the PTAB is likely on Ms. Vidal’s agenda as the new Director. With a permanent leader, the PTO could also provide guidance on issues such as patent eligibility under Section 101 of the Patent Act and proposed policy changes on patents essential to industry standards.

Tevogen Bio Expands Executive Leadership Team to Accelerate Operational Growth and Commercial Readiness

Warren-based BioNJ Member Tevogen Bio announced the strategic expansion of its leadership team with two new executives to support the biotech’s rapid operational growth, manufacturing readiness and the continued development and utilization of its next generation precision T cell platform technology. Stephen Chen, MBA, has more than 18 years of biotech industry experience. He was most recently Chief Operating Officer and Chief Technical Officer at NKGen Biotech. Sadiq Khan, MBA, brings over 30 years of commercial leadership, operations, and alliance management experience. Most recently, he served as Executive Director of Operations & Business Planning at BioCentriq.

Legend Biotech Announces Appointment of Global Head of Research and Early Development

Somerset-based BioNJ Member Legend Biotech appointed Guowei Fang as Senior Vice President, Global Head of Research and Early Development. Dr. Fang will assume the responsibilities of Frank Fan, who resigned from the company. Dr. Fang, an accomplished scientist and pharmaceutical research and development leader, will be responsible for advancing the company’s multiple pipeline agents for hematologic and solid cancers and steering R&D in the U.S., Ireland and China. Dr. Fang comes to Legend Biotech from Zymeworks Inc., where he served as Senior Vice President of Research and oversaw the development of novel platforms and a portfolio of multifunctional biologics and antibody drug conjugates.

Laura Schumacher Announced as Recipient of ABA’s 2022 Margaret Brent Award

Madison-based BioNJ Member AbbVie is honored to announce that Laura Schumacher, Vice Chairman, External Affairs and Chief Legal Officer at AbbVie, has been selected by the American Bar Association (ABA) Commission on Women in the Profession as a winner of the 2022 Margaret Brent Award. Founded in 1991, the Margaret Brent Award recognizes outstanding female lawyers who have achieved professional excellence in their industry and have successfully advanced career opportunities for women in the legal field. Ms. Schumacher has spearheaded numerous initiatives driving a measurable impact on diversity, equity and inclusion at AbbVie. She is the architect of AbbVie’s Diversity in Law program, a distinguished AbbVie initiative to drive greater diversity and inclusion in the legal industry. 

TCNJ School of Science Names Former Rutgers Faculty Leader as its New Dean

The College of New Jersey‘s School of Science has found its new Dean after a national search. Sunita Gupta Kramer will join the Ewing-based college with her extensive experience in connecting disciplines, creating new programs, cultivating research development and fostering diversity, equity and inclusion. Dr. Kramer comes to TCNJ from Rutgers University, where she served 12 years on the faculty before taking on progressive leadership roles. Additionally, Dr. Kramer is the creator and current Director of Rutgers’ Innovation, Design & Entrepreneurship Academy; IDEA is a four-year program integrating research, design and entrepreneurial thinking into the undergraduate experience. 

Montclair State University and Bloomfield College Announce Efforts to Forge a Permanent Relationship

Montclair State University's Board of Trustees authorized the University to provide financial support to Bloomfield College, if needed, to ensure the College can remain open through the 2022-23 academic year while the two institutions work toward their goal of establishing a permanent relationship. As New Jersey's only four-year Predominantly Black Institution (PBI), as well as a Hispanic-Serving Institution (HSI) and Minority Serving Institution (MSI), Bloomfield College provides students from these underrepresented communities with the education they need for social and economic mobility. Recognized as one of the most diverse national liberal arts colleges in the United States by U.S. News & World Report, the College offers the lowest tuition among the private four-year institutions in New Jersey.

Seton Hall Law Ranked Best in N.J. by U.S. News

Seton Hall University was ranked as having the best law school in the state of New Jersey, according to the graduate school rankings released by U.S. News & World Report. Seton Hall was ranked in a tie for No. 70 overall. Rutgers University was ranked in a tie for No. 91 overall. New Jersey fared far better for part-time law studies, with Rutgers ranking in a tie for No. 14 and Seton Hall ranking in a tie for No. 17. The rankings measured 192 law schools that were fully accredited by the American Bar Association, or ABA.

7 in N.J. Recognized on Newsweek’s List of World’s Best Hospitals 2022

Seven of New Jersey’s hospitals have been recognized on Newsweek’s list of the World’s Best Hospitals 2022, presented by Newsweek and Statista Inc. Newsweek and Statista developed a complex methodology to ensure the quality and validity of the ranking, according to information released. This includes hospital recommendations from peers, with an international online survey sent to more than 80,000 doctors, hospital managers and health care professionals; patient experiences and surveys measuring patient satisfaction with hospitals; and medical key performance indicators, such as patient safety, hygiene measures and quality of treatment. The seven recognized New Jersey hospitals inclue Morristown Medical Center, Hackensack University Medical Center, Valley Hospital, Overlook Medical Center, Newark Beth Israel Medical Center, Englewood Hospital and Medical Center and Monmouth Medical Center.

Maplewood-based StationMD Receives $3.2M Investment

Adam Boehler, former director of the Center for Medicare & Medicaid Innovation, a department of the U.S. Department of Health & Human Services, said in just two years he has watched health care company StationMD expand from three states to 12, using telemedicine to help care for people with intellectual and developmental disabilities. Now, he — in partnership with venture capitalist firm Martin Ventures — has announced a $3.2 million investment in the Maplewood-based company to further that growth. The investment is part of a trend to back innovative home- and community-based care models that help patients avoid emergency room and hospital visits, while cutting costs and improving health outcomes.

Fibromyalgia Care Society of America Awarded $25,000 in Grant Funding

Fibromyalgia causes pain all over the body, sleep problems, fatigue and often emotional and mental distress. People with fibromyalgia may be more sensitive to pain than people without fibromyalgia, according to the Centers for Disease Control and Prevention. Yet, people with fibromyalgia often look well, and results from conventional tests typically come back normal, making the condition difficult to diagnose and treat. Fibromyalgia Care Society of America was recently awarded $25,000 in grant funding to assist in onboarding an additional 24 people living in Essex County with fibromyalgia for their virtual coordinated care program.

Health Care Veteran O’Loughlin to Lead Innovative Remote Patient Monitoring

Platform

Health Recovery Solutions announced that Kimberly O’Loughlin has joined the company as its CEO. A 30-plus-year veteran of the health care technology and communications industries, O’Loughlin has had a career focused on growing and scaling businesses, delighting customers and driving change and impact through innovation and operational transformation. Concurrent with O’Loughlin’s appointment as CEO, HRS’ co-founder Jarrett Bauer was appointed Chairman of the board. Ms. O’Loughlin has an impressive record of success in transformational leadership. Most recently, she served as CEO of Therapy Brands, a health care information technology and services company serving mental, behavioral and rehabilitative health providers with a comprehensive portfolio of software and services.

CytoSorbents Receives $740K from Tax Program

The State’s Technology Business Tax Certificate Transfer Program allows life sciences and tech companies to sell a percentage of their unused net operating loss and R&D tax credits to an unrelated profitable corporation in the State. Now, health technology company CytoSorbents Corp. has taken advantage of the opportunity. The firm — which has facilities in Monmouth Junction and Princeton — announced it has received approximately $740,000, net of transactions costs, in cash proceeds from the sale of its 2020 NOL and R&D tax credits from the program, which is sponsored by the New Jersey Economic Development Authority. “These funds will support our global clinical trial program, as well as manufacturing capacity expansion at our new Princeton, New Jersey facility as we pursue FDA marketing approval of our technology in the United States, among other investments,” said Kathleen Bloch, CFO, CytoSorbents.

Hybrid Workforce Strategy: How to Affirm and Operationalize Your Strategy

Learn how to create, affirm and operationalize a Hybrid Workforce Strategy that supports your employee and organizational needs. Developed by BioNJ Member Cresa, topics include determining the right blend for your organization, establishing criteria for a successful hybrid strategy and developing a successful roadmap for implementation. 

2022 AIChE Mid-Atlantic Student Conference

April 8-9, 2022

The 2022 AIChE Mid-Atlantic Student Conference will be held in-person on April 8-9. Hosted by AIChE and NJIT's Otto H. York Department of Chemical and Materials Engineering, this Career Fair is a rare opportunity for companies from the greater NJ & NYC greater area to connect with some of the brightest and most motivated undergraduates from the AIChE’s Mid-Atlantic region schools.

I-Corps Northeast Hub: New Training Program

April and May 2022

Researchers in the Northeast: Explore ways that your discovery can meet the needs of people and industries. Teams are eligible for grants of up to $3,000. The Hub emphasizes inclusive innovation and our programs are open to researchers at universities, colleges and research institutions throughout the Northeast. Our next training program for researchers will be held Tuesday, April 12, and Thursdays April 14, April 21 and May 5, from 1-4 p.m. ET online. Learn more and apply for the program at icorpsnortheasthub.org.

BIO 2022 in San Diego

June 13-16, 2022

BIO is thrilled to be back in person for the 2022 International Convention happening in San Diego, CA June 13-16, 2022. The Convention theme ‘LIMITLESS’ is BIO's commitment to unlocking possibilities for attendees while paving the path to the future of our industry. The BIO International Convention attracts 15,000+ biotechnology and pharma leaders who come together for one week of intensive networking to discover new opportunities and promising partnerships. BIO brings together a wide spectrum of life sciences and application, including drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy. Reach out to RBRomberg@BioNJ.org if you are interested in being part of the New Jersey Pavilion at BIO.