BioNJ and the Affiliated Physicians and Employers Master Trust ("APEMT") announced that they have reached a definitive agreement to allow BioNJ to become a sponsor in the APEMT Health Plan to benefit member companies of BioNJ. The new partnership will enable BioNJ to provide high-quality, affordable group health benefits to its member companies and their employees. The BioNJ sponsorship in the APEMT is subject to state regulatory approval and is expected to be operational as of January 1, 2019. APEMT Health Plan is an existing Self-Insured Multiple Employer Welfare Arrangement ("MEWA") registered with the New Jersey Department of Banking and Insurance as well as the New Jersey Department of Labor and Workforce Development which provides coverage to members of participating Associations throughout New Jersey.

Jersey City-based BioNJ Member   SCYNEXIS, Inc. announced the dosing of the first patient with a  Candida auris  infection, an emerging life-threatening and multidrug-resistant fungal pathogen, in a Phase 3 open-label study evaluating oral ibrexafungerp (formerly SCY-078) in patients with candidiasis caused by C. auris  (the CARES Study). Ibrexafungerp, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections.

Princeton-based BioNJ Member  Soligenix, Inc. announced it has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue enrolling into the company's Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL).  Following its unblinded interim analysis with data from approximately 100 subjects, including assessment of the study's primary efficacy endpoint, the DMC recommended that approximately 40 additional subjects be randomized into the trial to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint.  

Princeton-based BioNJ Member Ophthotech Corporation announced completion of patient recruitment for its Phase 2b clinical trial of Zimura® (avacincaptad pegol), the Company's complement factor C5 inhibitor, monotherapy in patients with geographic atrophy secondary to dry age-related macular degeneration (AMD). Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD.

In mid-November 2017, the U.S. Food and Drug Administration (FDA) approved what is perhaps the boldest use of digital technology in healthcare: a pill -- developed by Princeton-based BioNJ Member Otsuka Pharmaceutical Co., Ltd. -- that is integrated with an ingestible sensor that captures information about whether the patient has complied with her medication regimen. A patient ingests the pill and it sends the data to a patch worn on her torso, which adds various physiologic measures. 

Princeton-based BioNJ Member Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health (Proteus) announce the signing of an expanded global collaboration agreement that will strengthen the relationship between the two companies for the further development and commercialization of a portfolio of medicines including the ABILIFY MYCITE® (aripiprazole tablets with sensor) offering, which received NDA approval from the U.S. Food and Drug Administration in November 2017. 

Ramsey-based BioNJ Member  ADMA Biologics, Inc. announces that the U.S. Food and Drug Administration ("FDA") has acknowledged the receipt of ADMA's September 28, 2018 BLA resubmission for RI-002. The FDA stated that it considers the RI-002 BLA resubmission 'a complete, Class 2 response' and has established an action due date of April 2, 2019, under the Prescription Drug User Fee Act ("PDUFA"). 

Pennington-based BioNJ Member  OncoSec Medical Incorporated announced that it has initiated KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck's KEYTRUDA (pembrolizumab).  The initiation of KEYNOTE-890 marks the second Phase 2 trial for OncoSec involving a combination of TAVO and KEYTRUDA®.  

Pennington-based BioNJ Member  OncoSec Medical Incorporated announced that Dr.  Alain Algazi , Associate Professor of Medicine at UCSF, will present data from OncoSec's OMS-100 study of TAVO (intratumoral tavokinogene telseplasmid) as a monotherapy treatment for metastatic melanoma during the Melanoma Bridge Conference .  The presentation will describe the OMS-100 Phase 2 multicenter, single-group study which evaluated the efficacy and safety observed after repeat dosing and different intervals between TAVO cycles. 

Company President and CEO of Pennington-based BioNJ Member  OncoSec Immunotherapies , Dan O'Connor, discussed the company's late-stage studies to treat and potentially cure advanced melanoma and triple negative breast cancers. Their technology turns cold tumors hot which then allows combo therapy to attack and destroy cancer cells from inside the body. Early bench studies show very positive results.

Positive results from a feasibility study investigating Princeton-based BioNJ Member Photocure's Hexvix® with flexible cystoscopy in the outpatient (office) setting have been published in Research and Reports in Urology . The investigators concluded that routine outpatient management of patients with Blue Light Cystoscopy (BLC™) with a flexible scope for early identification of recurrent lesions using on-site biopsy, is feasible in patients with non-muscle invasive bladder cancer (NMIBC). 

Two pivotal Phase 3 placebo-controlled trials evaluating Bridgewater-based BioNJ Member Sanofi's Dupixent® (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps ("CRSwNP") met all primary and secondary endpoints. CRSwNP is a chronic disease in which Type 2 or allergic inflammation causes polyps that obstruct the sinus and nasal passages, leading to severe congestion, nasal discharge, facial pain or pressure, and reduced sense of smell and taste. 

Princeton-based BioNJ Member  Agile Therapeutics, Inc.  announced that it has received a response from FDA's  Office of New Drugs  ("OND") concerning the company's formal dispute resolution request. The company had appealed the decision by the FDA's  Division of Bone , Reproductive and Urological Products ("DBRUP") that concerns surrounding the in vivo adhesion properties of Twirla prevent its approval. While OND has formally denied the company's appeal, OND provided a path forward without the need to reformulate Twirla or conduct a bioequivalence study between formulations, as previously suggested by DBRUP. 

Bridgewater-based BioNJ Member   Allergan plc  announced the completion of two positive safety and tolerability studies of ubrogepant for the acute treatment of migraine. The first study (UBR-MD-04) evaluated the long-term safety and tolerability of ubrogepant (50 mg and 100 mg) compared to usual care for the acute treatment of migraine in adults for one year.The second study (3110-105-002) evaluated the hepatic safety and tolerability of ubrogepant 100 mg compared to placebo in healthy study participants over eight weeks. 

Bridgewater-based BioNJ Member   Allergan  and Medicines360 announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for  Liletta  (levonorgestrel-releasing intrauterine system) 52mg to prevent pregnancy for up to 5 years. Previously, Liletta was indicated for use up to 4 years. The expanded approval was supported by safety and efficacy data from the Phase 3 ACCESS IUS trial (N=1751) in women receiving Liletta.

East Hanover-based BioNJ Member   Novartis announced that it has entered into an agreement and plan of merger with Endocyte, a U.S.-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. Under the terms of the agreement, Novartis would acquire all outstanding shares of Endocyte common stock for USD 24 per share. This offer values Endocyte's equity at USD 2.1 billion.

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved XARELTO® (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). XARELTO® is now the first and only Factor Xa inhibitor approved for patients living with these conditions.

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for esketamine nasal spray, a glutamate receptor modulator, for treatment-resistant depression (TRD) in adults with Major Depressive Disorder (MDD) who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data showing treatment with a single intravenous (IV) dose of STELARA® (ustekinumab) induces clinical remission and response in adults with moderate to severe ulcerative colitis (UC) who previously experienced an inadequate response or intolerance to conventional or biologic therapies. 

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Janssen Pharmaceuticals, Inc. has entered into an agreement with Arrowhead Pharmaceuticals, Inc. for an exclusive, worldwide license to develop and commercialize ARO-HBV, a Phase 1/2 subcutaneous, ribonucleic acid interference (RNAi) therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

The  U.S. Department of Health and Human Services'  Office of the Assistant Secretary for Preparedness and Response announced that it will expand a strategic partnership with BioNJ Member  Johnson & Johnson .The expansion will focus on the development of innovative products to combat the potentially deadly health effects of chemical, biological, radiation and nuclear threats, emerging infectious diseases and antimicrobial resistant infections.

Summit-based BioNJ  Celgene Corporation announced the results of two post hoc analyses of data from the Phase 3 SUNBEAM™ and RADIANCE™ Part B trials, which evaluated the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P 1 ) and 5 (S1P 5 ) receptor modulator, versus a first-line treatment, Avonex ®  (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). 

Rutherfors-based BioNJ Member   Cancer Genetics, Inc. announced that it has signed an exclusive distribution agreement with Genecast Biotechnology to market, distribute and sell the Tissue of Origin® (TOO) Test in China. TOO is a microarray-based gene expression test that analyzes a tumor's genomic information to help identify its origin, which is valuable in classifying metastatic, poorly differentiated or undifferentiated cancers. 

Bridgewater-based BioNJ Member  Insmed Incorporated announced that the company presented data at IDWeek 2018 and at the CHEST Annual Meeting that provide additional insight into Mycobacterium avium complex (MAC) lung disease, a chronic and debilitating condition that can significantly increase patient morbidity and mortality. The company also presented additional data from clinical trials of ARIKAYCE® (amikacin liposome inhalation suspension), the first and only therapy approved in the U.S. for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients who have limited or no alternative treatment options. 

Woodcliff Lake-based Eisai Co., Ltd. and Purdue Pharma L.P. announced positive topline results from SUNRISE 2, a long-term Phase 3 efficacy and safety evaluation of lemborexant, an investigational agent for sleep-wake regulation currently being studied for the potential treatment of multiple sleep-wake disorders. Topline results reported today are the primary and key secondary outcomes of the study from the six-month, placebo-controlled treatment period; the study is ongoing to 12 months. 

Woodcliff Lake-based Eisai Co., Ltd. has announced that the National Medical Products Administration of China has accepted for review a New Drug Application for Eisai's antiepileptic drug (AED) perampanel (generic name, product name: Fycompa®) as an adjunctive treatment for partial onset seizures in epilepsy patients 12 years of age and older. This NDA is the first to be submitted for perampanel in China.

Basking Ridge-based Daiichi Sankyo Company announced that it has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). The submission to Japan MHLW is based on the results of the pivotal randomized Phase 3 QuANTUM-R study in the U.S., EU and Asia excluding Japan, and an open-label Phase 2 study of quizartinib in Japan in patients with relapsed/refractory FLT3-ITD AML.

Basking Ridge-based Daiichi Sankyo Company announced that axicabtagene ciloleucel (formerly KTE-C19) has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL) and transformed follicular lymphoma (TFL), which are aggressive forms of non-Hodgkin lymphoma (NHL).

Mitsubishi Tanabe Pharma Corporation, Daiichi Sankyo Company, Limited and Astellas Pharma Inc. announced that the companies will jointly conduct a program called "JOINUS" (Joint Open INnovation of drUg repoSitioning) to discover new therapeutic drugs using drug-repositioning compound libraries. The JOINUS program will be carried out as a part of the companies' open innovation activities.

Lexicon Pharmaceuticals, Inc., with offices in Basking Ridge, and Ipsen Biopharmaceuticals Canada Inc. announced that Health Canada has approved XERMELO® (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of refractory carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in patients inadequately controlled by SSA therapy alone. This approval allows for the marketing of XERMELO by Lexicon's collaborator, Ipsen, in the above indication in Canada.

Warren-based Bellerophon Therapeutics, Inc.  provided an update on the Company's ongoing Phase 2b randomized, double-blind, placebo-controlled clinical study (iNO-PF) evaluating INOpulse® in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), as well as updated interim results from the Pulmonary Arterial Hypertension (PAH) Phase 3 trial, INOvation-1. 

Takeda Pharmaceuticals U.S.A., Inc. announced the presentation of new long-term efficacy real-world data analyses for Entyvio®  (vedolizumab) at ACG 2018. Studies of note include a retrospective multicentre cohort study of biologic-naïve adults with ulcerative colitis (UC) and Crohn's disease (CD), two systematic reviews and meta-analyses of real-world treatment persistence and mucosal healing and a time-trend analysis of Entyvio utilization and outcomes across the United States (U.S.). 

Parsippany-based  Teva Pharmaceutical Industries Ltd.  announced safety and tolerability results representing 25 years of data from the open-label extension study of the original U.S. pivotal trial of COPAXONE®  (glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (RMS). The extension study initially examined the safety of COPAXONE®  20 mg/mL daily and then also the 40 mg/mL three times weekly formulation when it became available approximately 20 years later. 

Bedminster-based BioNJ Member  Matinas BioPharma Holdings, Inc.  announced that it has appointed industry and drug development veteran Theresa Matkovits, Ph.D. as Chief Development Officer. The company also announced that it has strengthened its manufacturing, supply chain and clinical development teams with the appointments of Frank Calamusa, CSCP and Jenel Cobb, Ph.D., PMP. 

 

 

Gov. Phil Murphy met with 25 technology and business officials and leaders from around the State at a roundtable in Newark to discuss the innovation economy. The governor spent time discussing his economic vision for the State, and the proposed venture fund -- the New Jersey Innovation Evergreen Fund -- that would raise $250 million from auctioning State tax credits, as well as another $250 million from venture capital firms, for start-ups in the State.

Nearly $50 million in financing has been provided to small and medium-sized business in 2018 through the New Jersey Economic Development Authority, leveraging more than $100 million in additional investments and 785 new full-time jobs. Click here for infographic.