Tales of the Unsurprised: Brand-Name Drug Prices Fell for the Fourth Consecutive Year

Reality has again failed to cooperate with the politically motivated cries of “skyrocketing drug prices” or anecdotes about companies “jacking up prices” (as President Biden recently claimed). Brand-name drug prices continue to decline, while the prices of other health care products and services continue to rise. For 2021, brand-name drugs’ net prices dropped for the fourth consecutive year. Meanwhile, brand-name drug list prices grew more slowly than overall inflation. What’s more, we project that the gross-to-net bubble for patent-protected brand-name drugs will exceed $200 billion in 2021. The factors that drive declining brand-name drug prices remain for 2022, suggesting that these trends will continue.

Dusquetide Demonstrates Positive Anti-Tumor Efficacy in Multiple Nonclinical Animal Studies

Princeton-based BioNJ Member Soligenix announced that dusquetide is effective at reducing tumor size in nonclinical xenograft models. Recent studies, recapitulating results from previously published studies, have confirmed the efficacy of dusquetide as a stand-alone and combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast cancer cell line. Dusquetide previously demonstrated benefits in reducing the duration of severe oral mucositis (SOM) in a Phase 2 clinical trial and reduction in SOM rates in the per protocol population in a Phase 3 study. In addition to the reduction of severe oral mucositis, an acceleration in the clearance of tumor response and an increase in overall survival were also observed in the Phase 2 clinical study as an ancillary benefit to treating oral mucositis in patients receiving chemo-radiation for their head and neck cancer.

Waylivra™ Receives Innovative Drug Category Pricing to Treat Familial Chylomicronemia Syndrome in Brazil

South Plainfield-based BioNJ Member PTC Therapeutics announced that Waylivra™ (volanesorsen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil. Waylivra is the only treatment for familial chylomicronemia syndrome (FCS) in Brazil. Category 1 classification is given to innovative treatments that provide greater efficacy than current standards of care, and it allows for pricing in line with international markets. In addition, PTC submitted an application to the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), for approval of Waylivra for the treatment of familial partial lipodystrophy (FPL).

Evotec Receives €7.5M Grant for Development of COVID-19 Therapeutic

Princeton-based BioNJ Member Evotec announced that the company has been selected by the German Federal Ministry of Education and Research (“BMBF”) to receive a grant for the development of EVT075, a potential first-in-class immunomodulatory therapy against COVID 19. Evotec is one of three companies receiving a highly competitive grant as part of a new initiative by the BMBF to support the clinical development of novel therapeutic candidates against COVID-19. Under the €7.5m grant, Evotec will use clinical material manufactured within its Just – Evotec Biologics manufacturing platform to initiate the clinical development of a potentially highly potent immunomodulatory molecule.

Celularity Receives Fast Track Designation from U.S. FDA for its NK Cell Therapy CYNK-001 in Development for the Treatment of AML

Florham Park-based BioNJ Member Celularity announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy, CYNK-001, in development for the treatment of acute myeloid leukemia (AML). Celularity’s lead therapeutic program based on its placental-derived unmodified NK cell type is CYNK-001, an allogeneic unmodified NK cell being developed as a treatment for hematologic malignancies, solid tumors, and infectious diseases. CYNK-001 is a cryopreserved allogeneic off-the-shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.

AbbVie Announces U.S. FDA Granted Breakthrough Therapy Designation (BTD) to Telisotuzumab Vedotin (Teliso-V) for Previously Treated Non-Small Cell Lung Cancer

Madison-based BioNJ Member AbbVie announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. The FDA's BTD program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicate that the investigational treatment may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Gilead Announces New England Journal of Medicine Publication of Data Demonstrating Veklury® (Remdesivir) Significantly Reduced Risk of Hospitalization in High-Risk Patients With COVID-19

Morris Plains-based BioNJ Member Gilead Sciences announced full results from a Phase 3 investigational study evaluating the efficacy and safety of a three-day course of Veklury® (remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. The results have been published in the New England Journal of Medicine (NEJM) and have been submitted to the Food and Drug Administration (FDA) for the potential use of Veklury in earlier stages of disease, including prior to hospitalization.

Helsinn Group Announces European Medicines Agency’s (EMA) Acceptance for Review of the Marketing Authorization Application (MAA) for Infigratinib for Patients With Cholangiocarcinoma With Fibroblast Growth Factor Receptor 2 Fusions or Rearrangements

Iselin-based BioNJ Member Helsinn Therapeutics announced that the European Medicines Agency (EMA) accepted for review the company’s Marketing Authorization Application (MAA) for infigratinib for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. The EMA’s acceptance for review of the MAA confirms that the submission is complete, and the formal review process can begin. In March 2021, Helsinn Group entered a strategic collaboration with QED Therapeutics, an affiliate company of BridgeBio Pharma, Inc. to co-develop and co-commercialize infigratinib in oncology indications worldwide except in China, Hong Kong and Macau.

Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 in the Treatment of Liver Cancer

Edison-based BioNJ Member Hepion Pharmaceuticals announced that the U.S. Food and Drug Administration (“FDA”) has accepted its investigational new drug (“IND”) application for CRV431, a liver-targeting, novel cyclophilin inhibitor, for the treatment of hepatocellular carcinoma (“HCC”). Hepion received FDA authorization of an IND to initiate the study of CRV431 for the treatment of NASH. To date, Hepion has completed Phase 1 studies in healthy volunteers and, more recently, announced positive data from its Phase 2a ‘AMBITION’ trial in subjects with presumed F2 and F3, where CRV431 was well tolerated, and all primary endpoints were met. A larger Phase 2b NASH study of over 300 subjects with paired liver biopsies, called ‘ASCEND-NASH’, is expected to be initiated in 2022.

Cyclacel Pharmaceuticals Reviews 2021 Achievements and Announces Key Business Objectives for 2022

Berkeley Heights-based BioNJ Member Cyclacel Pharmaceuticals, Inc. provided a business update reviewing 2021 achievements and outlining the company’s key business objectives for 2022. “This past year proved to be very productive for Cyclacel as we achieved our planned business objectives,” said Spiro Rombotis, President and Chief Executive Officer. “First and foremost, we initiated two registration-directed, Phase 1/2 trials for our lead candidate fadraciclib, an oral CDK2/9 inhibitor. These studies are assessing fadraciclib activity across a range of solid tumors and hematological malignancies. In the solid tumor study we are enrolling patients at the third dose level using a schedule of twice daily dosing for five days, for 3 out of 4 weeks. In the leukemia study we are enrolling patients at the initial dosing level. We have also completed FDA review of an Investigational New Drug Application (IND) of CYC140, a differentiated oral PLK1 inhibitor, and received clearance to proceed with a registration-directed Phase 1/2 study in solid tumors.”

Exscientia and Sanofi Establish Strategic Research Collaboration to Develop AI-Driven Pipeline of Precision-Engineered Medicines

Bridgewater-based BioNJ Member Sanofi and Exscientia announced a groundbreaking research collaboration and license agreement to develop up to 15 novel small molecule candidates across oncology and immunology, leveraging Exscientia’s end-to-end AI-driven platform utilizing actual patient samples. The companies have been working together since 2016 and in 2019, Sanofi in-licensed Exscientia’s novel bispecific small molecule candidate capable of targeting two distinct targets in inflammation and immunology. Exscientia and Sanofi will collaborate to identify and select target projects, leveraging Exscientia’s personalised medicine platform. The platform enables a “patient-first” approach through integrating primary human tissue samples into early target and drug discovery research.

Lilly and Entos Pharmaceuticals Enter into Research and Collaboration Agreement to Support the Development of Innovative Therapies in Multiple Neurologic Indications

Bridgewater-based BioNJ Member Eli Lilly and Company has acquired exclusive rights to Entos Pharmaceuticals' Fusogenix nucleic acid delivery technology to research, develop and commercialize nucleic acid products targeting the central and peripheral nervous system, the companies announced today. This technology provides an opportunity for Lilly to access a novel delivery platform technology with the potential to solve a key delivery challenge for many nucleic acid therapeutic modalities. Under the terms of the research and collaboration agreement, Lilly and Entos have agreed to multiple programs focused on the development of proteo-lipid vehicles (PLV) for delivery of therapeutic cargo supplied by Lilly to targets in the central and peripheral nervous systems. 

Pfizer and Biohaven Complete Collaboration Transaction for Commercialization of Rimegepant and Zavegepant Outside United States

BioNJ Member Pfizer, with offices in Peapack, and Biohaven announced that the parties have completed the collaboration transaction between the two companies. The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of required regulatory approvals and the satisfaction of other customary conditions, and BHVN shares have been issued to Pfizer. Biohaven will continue to lead research and development globally and retain rights to the U.S. market. Rimegepant is commercialized as Nurtec® ODT in the U.S. and is the only oral CGRP (calcitonin gene-related peptide) receptor antagonist approved for both the acute and preventive treatment of migraine in adults. An application for the approval of rimegepant is currently under review by the European Medicines Agency with a decision expected in the first half of 2022.

Pfizer and BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced a new research, development and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV), a debilitating, disfiguring and painful disease that impacts about one in three people in the United States during their lifetime. The collaboration builds on the companies’ success in developing the first approved and most widely used mRNA vaccine to help prevent COVID-19. This is the third collaboration between Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the COVID-19 vaccine collaboration initiated in 2020.

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength (30-µg) as the dose approved in the primary series. A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 16 years of age and older. The vaccine is also authorized for eligible individuals 18 and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Real world evidence from the Ministry of Health of Israel on the administration of over 4.1 million third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series revealed no new safety concerns in adolescents 12 through 17 years of age.

Pfizer to Provide U.S. Government With an Additional 10 Million Treatment Courses of its Oral Therapy to Help Combat COVID-19

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced that the U.S. government has committed to purchasing an additional 10 million treatment courses of its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). This commitment will supplement the 10 million treatment courses previously contracted by the U.S. Government, bringing the total amount of treatment courses to 20 million. Collectively, approximately 10 million PAXLOVID treatment courses have been accelerated for delivery by the end of June, with the remaining 10 million to follow by the end of September. PAXLOVID is also currently authorized for conditional or emergency use in several countries across the globe. Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies and anticipates further regulatory decisions to follow.

Sandoz Launches Authorized Generic of Narcan® (Naloxone Hydrochloride) Nasal Spray 4 Mg in U.S. to Help Reverse Opioid Overdose, Expanding Access During Surge in Overdose Deaths

Princeton-based BioNJ Member Sandoz announced the U.S. launch of its authorized generic of Narcan® (naloxone hydrochloride) Nasal Spray 4mg, which is used to reverse opioid overdose. It is immediately available to people in the U.S. via retail pharmacies and institutions, including hospitals. Approximately every 8 minutes in the U.S. a life is lost to an opioid overdose. Opioid dependency and accidental opioid overdoses are a serious national crisis affecting public health and social and economic welfare. Opioid overdose death rates have been continuously increasing in the U.S. for over two decades. Of the 49 million patients prescribed opioids in the U.S., more than 18 million are considered at-risk, but only five percent received a prescription for naloxone.

Novartis Announces Collaboration With Alnylam to Explore Targeted Therapy to Restore Liver Function

East Hanover-based BioNJ Member Novartis announced a collaboration with Alnylam to leverage Alnylam’s proven, proprietary siRNA technology to inhibit a target discovered at the Novartis Institutes for BioMedical Research, potentially leading to development of a treatment designed to promote the regrowth of functional liver cells and to provide an alternative to transplantation for patients with liver failure. End-stage liver disease (ESLD) is a progressive illness, most often resulting from cirrhosis, that is characterized by the destruction of healthy liver tissue and the loss of critical liver function. The disease has a profound impact on patients’ quality of life, and accounts for over one million deaths globally each year. 

FDA Approves Novartis Leqvio® (Inclisiran), First-in-Class Sirna to Lower Cholesterol and Keep it Low With Two Doses a Year

East Hanover-based BioNJ Member Novartis announced the U.S. Food and Drug Administration (FDA) approval of Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at three months. Leqvio is indicated in the United States as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C. The effect of Leqvio on cardiovascular morbidity and mortality is being explored in clinical trials currently underway.

Novartis Cosentyx® Receives FDA Approval for the Treatment of Children and Adolescents With Enthesitis-Related Arthritis and Psoriatic Arthritis

East Hanover-based BioNJ Member Novartis announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in four years and older, and active juvenile psoriatic arthritis (JPsA) in patients two years and older. Cosentyx is now the first biologic indicated for ERA, and the only biologic treatment approved for both ERA and PsA in pediatric patients in the U.S. These are the second and third approvals for Cosentyx in a pediatric population in the U.S., and Cosentyx now has a total of five indications across rheumatology and dermatology.

Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Raritan-based the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of teclistamab for the treatment of patients with relapsed or refractory (R/R) multiple myeloma. Teclistamab is an investigational, off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3. The BLA submission for teclistamab is supported by data from MajesTEC-1, an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with R/R multiple myeloma. In the study, investigators assessed efficacy outcomes, including overall response rate, very good partial response and complete response using International Myeloma Working Group (IMWG) criteria, as well as the safety profile of teclistamab.

Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant

New Brunswick-based BioNJ Member Johnson and Johnson announced new preliminary results from the South African Phase 3b Sisonke study which showed that a homologous (same vaccine) booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S) demonstrated 85 percent effectiveness against COVID-19-related hospitalization. The study, conducted by the South African Medical Research Council (SAMRC), showed that the Johnson & Johnson booster reduced the risk of hospitalization from COVID-19 among healthcare workers in South Africa after Omicron became the dominant variant. During the months studied, the frequency of Omicron increased from 82 to 98 percent of COVID-19 cases in South Africa as reported by GISAID, an initiative that provides COVID-19 data.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Approved in Japan for Patients With Unresectable, Advanced or Recurrent Endometrial Carcinoma That Progressed After Cancer Chemotherapy

Kenilworth-based BioNJ Member Merck & Co. and Eisai announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. This approval marks the first time the combination of KEYTRUDA plus LENVIMA has been approved in Japan. KEYTRUDA plus LENVIMA is now approved in Japan, the U.S. and Europe for certain types of advanced endometrial carcinoma.

LEO Pharma Announces FDA Approval of Adbry™ (Tralokinumab) as the First and Only Treatment Specifically Targeting IL-13 for Adults With Moderate-to-Severe Atopic Dermatitis

Madison-based LEO Pharma A/S announced that the U.S. Food and Drug Administration (FDA) has approved Adbry™ (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids. Adbry is the first and only FDA approved biologic that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. The approval of Adbry is based on safety and efficacy results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included nearly 2,000 adult patients with moderate-to-severe atopic dermatitis.

FDA Authorizes Further NurOwn® Dosing Under Expanded Access Program

Hackensack-based BrainStorm Cell Therapeutics announced plans for a dosing extension of NurOwn® for participants who completed the Expanded Access Protocol (EAP). The U.S. Food and Drug Administration (FDA) recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the original EAP protocol, participants who had completed the Phase 3 NurOwn trial and who met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the original EAP treatments informed the decision to move forward with additional doses for participants who completed it.

Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults With Type 2 Diabetes

Basking Ridge-based Lexicon Pharmaceuticals announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. The NDA submission is supported by the results from the Phase 3 SOLOIST clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease. 

Investigational Alzheimer’s Disease Therapy Lecanemab Granted FDA Fast Track Designation

Woodcliff Lake-based Eisai and BioNJ Member Biogen announced that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA.

Patritumab Deruxtecan Granted U.S. FDA Breakthrough Therapy Designation in Patients With Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

Basking Ridge-based Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to patritumab deruxtecan (HER3-DXd), a potential first-in-class HER3 directed antibody drug conjugate (ADC), for the treatment of patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC) with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor (TKI) and platinum-based therapies. Lung cancer is the second most common cancer and the leading cause of cancer-related mortality worldwide, with 80% to 85% classified as NSCLC.

DESTINY-Lung04 Phase 3 Trial of ENHERTU® Initiated in Patients With Previously Untreated HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Basking Ridge-based Daiichi Sankyo announced that the first patient was dosed in the global DESTINY-Lung04 phase 3 trial evaluating the efficacy and safety of ENHERTU® (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca, as a first-line treatment in patients with HER2 mutant unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). DESTINY-Lung04 is the first head-to-head trial in NSCLC evaluating ENHERTU as a first-line treatment compared to the standard of care (platinum-pemetrexed doublet chemotherapy in combination with pembrolizumab) in patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring a HER2 exon 19 or 20 mutation.

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients With HER2 Positive Metastatic Breast Cancer Treated With a Prior Anti-HER2-Based Regimen

Basking Ridge-based Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). This application is based on data from the DESTINY-Breast03 Phase 3 trial.

Daiichi Sankyo Obtains Supplemental New Drug Application Approval Submitted for Additional Indication and Dosage and Administration of Antiplatelet Agent “Efient® 3.75 mg Tablets” and “Efient® 2.5 mg Tablets” in Japan

Basking Ridge-based Daiichi Sankyo announced that it has obtained a supplemental new drug application approval for additional indication and dosage and administration of the antiplatelet agents “Efient® 3.75 mg Tablets” and “Efient® 2.5 mg Tablets” (generic name prasugrel hydrochloride, hereinafter “Efient® Tablets”) in Japan. This approval authorizes Efient® Tablets to be used for “Prevention of recurrence of ischemic cerebrovascular disease following the former appearance of ischemic cerebrovascular disease (associated with large-artery atherosclerosis or small-vessel occlusion) (restricted to cases with a high risk of ischemic stroke).” 

Valemetostat New Drug Application Submitted in Japan for Treatment of Patients With Adult T-Cell Leukemia/Lymphoma

Basking Ridge-based Daiichi Sankyo announced that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for valemetostat, a potential first-in-class dual inhibitor of EZH1 and EZH2, for the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma (ATL). ATL is a rare and aggressive type of peripheral T-cell lymphoma that occurs with greater frequency in parts of Japan and other regions. Patients with ATL face a poor prognosis with current therapies. Nearly 90% of patients relapse after completing intensive first-line treatment, at which point there are few options available. The Japan NDA submission of valemetostat is based on pivotal Phase 2 study results in Japanese patients with three aggressive subtypes of relapsed/refractory ATL.

Amneal Acquires Saol Therapeutics’ Baclofen Franchise

Amneal Pharmaceuticals Inc. in Bridgewater will acquire Georgia-based pharmaceutical company Saol Therapeutics’ Baclofen franchise, including Lioresal and LYVISPAH^TM, as well as a pipeline product under development for $83.5 million. Amneal said the acquisition expands its commercial institutional and specialty portfolio in neurology and adds commercial infrastructure in advance of its entry into the biosimilar institutional market. Under the terms of the transaction, Amneal will also pay certain royalties based on annual net sales for certain acquired products. The transaction is expected to close in the first quarter of 2022, subject to the satisfaction of customary closing conditions. Baclofen is a skeletal muscle relaxant used to treat muscle spasms caused by conditions including spinal cord injury and multiple sclerosis.

Quidel Buying Ortho Clinical Diagnostics in $6B Deal

Quidel Corp. said it agreed to acquire Raritan-based Ortho Clinical Diagnostics Holdings PLC for $24.68 per share of common stock in cash and newly issued shares in the combined company. The price amounts to a 25% premium over Ortho’s closing price Wednesday and an equity value of about $6 billion. The transaction is expected to close during the first half of fiscal year 2022, subject to customary closing conditions. The combined organization will unite world-class technologies and platforms to benefit customers with expanded access to clinical chemistry, immunoassay, molecular diagnostics, immunohematology, donor screening and point-of-care diagnostics offerings.

Wesley Mathews Named President and CEO of Choose New Jersey

Choose New Jersey announced that Wesley Mathews will serve as President and CEO beginning February 2022. He will succeed Jose Lozano, who has served as President and CEO of the organization since June 2018. A career diplomat, Mathews joined the U.S. Foreign Service in 2008 and served at American embassies and consulates in India, Germany, Saudi Arabia, Nigeria, and Pakistan, as well as in Washington, D.C. He most recently served at the U.S. embassy in Riyadh, Saudi Arabia as the deputy economic counselor managing bilateral economic and energy policy. On loan from the U.S. Department of State from 2018 to 2019, Mathews established the State of New Jersey’s Office of International Trade and Investment at the New Jersey Economic Development Authority, serving as its Director and Vice President.

Adare Pharma Solutions Announces Appointment of Tom Sellig as Chief Executive Officer

Lawrenceville-based BioNJ Member Adare Pharma Solutions announced the appointment of Tom Sellig as Chief Executive Officer. Mr. Sellig will lead the organization in supporting pharmaceutical companies in the development and manufacturing of transformative medicines that improve patient health and outcomes. Mr. Sellig brings 30 years of executive experience in life sciences, with a focus on CDMO. He served as Chief Executive Officer of LabConnect, a leading global provider of central laboratory and support services for the biopharmaceutical industry. Prior to LabConnect, Sellig was Chief Commercial Officer at ConnectiveRx, where he was responsible for all commercial and customer-facing activity at the patient-support and patient-access company. Before joining ConnectiveRx, he served as Senior Vice President of Global Sales at Patheon, where he played an integral role in the company’s sale to and integration with Thermo Fisher.

East Brunswick Veterinary Pharma Company Hires Animal Health Sales and Marketing Leader

East Brunswick-based Cronus Pharma announced that Todd Brodersen has joined as Senior Director of Sales and Marketing. Mr. Brodersen has 30 years of animal health industry experience. Prior to joining Cronus 13 years ago, he served as President and Founder of Same Page Consulting Inc., spearheading consulting, marketing and business development projects with many leading animal health manufacturers and distributors. He has extensive knowledge of the animal health market, including sales, marketing, data analytics, distribution channels, market penetration strategies and practice management. Mr. Brodersen has helped to brand, launch and grow both products and companies, including Animalytix, Avimark, Boehringer Ingelheim, Henry Schein (Covetrus), HorsePower Technologies, Impromed, Merck Animal Health, Pawdentify and Thomas Labs, among others.

Catalent Announces Succession Plan for New CEO

Somerset-based Catalent announced that, effective July 1, Alessandro Maselli will be the company’s next CEO and president, succeeding John Chiminski. Mr. Maselli will also join the company’s board of directors upon assuming his new role. Mr. Maselli, who has more than 11 years of experience at Catalent, is currently the President and Chief Operating Officer. Mr. Chiminski, currently Chair and CEO, will remain in his present role until July 1, when he will assume the position of Executive Chair of the board.

Institute for Life Science Entrepreneurship Launches Plumeria Therapeutics

The Institute for Life Science Entrepreneurship has launched Plumeria Therapeutics, Inc., a clinical stage developer of non- opioid treatments for pain. ILSE will support Plumeria’s business, scientific and technical development under the Biotech Launchpad program. With support from ILSE, Plumeria was recently awarded a $700,000 Phase 1 Small Business Innovation Research grant from The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM which supports a wide range of programs to develop new or improved prevention and treatment strategies for opioid addiction. Plumeria will be working in collaboration with an undisclosed pharmaceutical company on biological samples from a phase 2 clinical trial evaluating a compound that showed promise in various pain endpoints for painful diabetic neuropathy (PDN).

New Jersey Institute of Technology Names Dr. Teik C. Lim as University’s Ninth President

The Board of Trustees of New Jersey Institute of Technology (NJIT) is proud to announce the appointment of Dr. Teik C. Lim as NJIT’s ninth President following a national search and a unanimous vote of the Board on January 5, 2022. President-elect Lim, who also will be appointed as a Distinguished Professor of Mechanical Engineering, will begin his NJIT tenure on July 1, 2022. As noted by Cohen, Dr. Lim presently serves as the interim president of the University of Texas at Arlington (UTA), where he also holds the rank of Professor within the Department of Mechanical and Aerospace Engineering. Prior to assuming the interim presidency at UTA, Dr. Lim was the university’s Provost and Vice President for Academic Affairs from 2017 to 2020.

Rowan, Virtua Health Partner to Create New College of Medicine & Health Sciences

Virtua Health and Rowan University announced an agreement to create the Virtua Health College of Medicine & Health Sciences of Rowan University. With an $85 million investment to Rowan University, Virtua is establishing an endowment that will help support the partnership — fueling investments in faculty, educational programs and the construction of a state-of-the-art research facility. This partnership between the Top 100 public research university and the largest health system in southern New Jersey will further distinguish South Jersey as a regional hub for innovation, research and clinical discovery. The new college will encompass the State’s only osteopathic medical school, an expanded nursing and allied health professions school, a new school of translational biomedical engineering and sciences, multiple new research institutes and aligned clinical practices to improve patient care and train the workforce of the future.

I-Corps Info Session

January 14, 2022

Learn how the I-Corps Hub Northeast Regional Program can help you evaluate your research discovery or technology for its potential to benefit society as the basis of a startup or venture. I-Corps Lead Instructor Christina Pellicane, Assistant Director of Innovation at Princeton University, will provide an overview of the program and answer your questions. All researchers (faculty members, staff researchers, postdoctoral researchers, graduate students and undergraduates) are welcome to attend. 

De-Risking Biotech: Panel Discussion

January 25, 2022

Join the Princeton Innovation Center BioLabs and colleagues at BioLabs@NYU for a panel discussion about how startups can work with law firms to enhance success and de-risk endeavors at various stages of a start-up. Panelists will talk the tools and insights that law firms can provide on topics such as partnerships, resources and risk capital. 

2nd Annual Princeton Women Founders Start-Up Showcase

January 27, 2022

Presented by Princeton Entrepreneurship Council, this year’s event will feature six outstanding Princeton founders who represent faculty/postdoc, graduate alumna, and undergraduate alumnae across the Princeton entrepreneurial community. Each will present an overview of their start-up and then answer questions from the audience. At the conclusion of the presentations, each audience member will cast his/her vote for the “best of the best” start-up.

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. To show appreciation for BioNJ Members, BIO is pleased to offer you a $200 registration discount to attend the 2022 BIO International Convention. Request your discount code by February 1, 2022!

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