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A new health pilot program to help cancer patients in New Jersey was announced through a partnership with Horizon Blue Cross Blue Shield of New Jersey and Nant Health.  Horizon is potentially investing a couple of million dollars into reimbursing the care for roughly 150 patients with previously untreated pancreatic cancer and metastatic breast cancer at Hackensack University Medical Center, Rutgers Cancer Institute, Regional Cancer Care Association and University of Pennsylvania Hospital.  The pilot program focuses on genomic testing to identify the best cancer treatment for patients with specific cancers.

So far, nothing has been able to stop past BioNJ Annual Dinner Meeting Speaker, Don Wright... Not even cancer.

Don was diagnosed with a terminal case of blood-based cancer in 2003 -- told by doctors that it  would kill him in three to five years.  He was horrified. He didn't know what to do. Don had just run his first marathon only a month before and had not intended to run anymore.  "Most of the way, I wondered why anyone would ever do this," he said.  But the cancer diagnosis made him rethink his priorities and seek out new challenges.  He began running and never stopped.  Don just completed his 99th marathon and has run marathons in all 50 states. Congratulations, Don, from your friends at BioNJ! 

Sometimes a health hurdle can actually be a stepping-stone towards a lifetime of victory. That's the case for two Cubs players who are also cancer survivors, and as their team wins the World Series, players and fans alike are flying hope like an iconic Clubs' W flag. 

Celgene and IBM are teaming up on a new patient safety monitoring platform to improve pharmacovigilance methods throughout the drug development process.  The platform, dubbed IBM Watson for Patient Safety, will combine Watson's cognitive computing chops with Celgene's extensive experience in drug safety and risk management. It will be an outcome- and evidence-based drug safety decision support system for life sciences companies.

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced that the company has entered into a definitive agreement to acquire Kolltan Pharmaceuticals, Inc., a privately held clinical-stage company focused on the discovery and development of novel, antibody-based drugs targeting receptor tyrosine kinases (RTKs). Focused primarily in oncology and backed by prominent thought leaders in RTK biology, Kolltan has reported clinical and preclinical data that its drug candidates can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies. 

Bedminster-based BioNJ Member  Aerie Pharmaceuticals, Inc. , a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, reported the successful 90-day topline efficacy results of its Rocket 4 Phase 3 clinical trial of product candidate Rhopressa ^TM, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. 

Hackensack-based BioNJ Member  BrainStorm Cell Therapeutics Inc. , a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that it has been granted United States Patent No. 9,474,787 titled "Mesenchymal Stem Cells for the Treatment of CNS Diseases."

Jersey City-based BioNJ Member and drug development company SCYNEXIS, Inc. announced the completion of two additional Drug-Drug Interaction (DDI) studies, further demonstrating the favorable safety profile of SCY-078.  An important milestone in drug development is to understand the potential impact of how two or more drugs interact with each other. Patients with invasive fungal infections are typically immuno-compromised and are commonly treated for long periods of time with multiple concomitant drugs for their underlying conditions.

Princeton-based BioNJ Member Advaxis, Inc., a clinical stage biotechnology company developing cancer immunotherapies, announced topline results from the early closure of stage 2 of the Phase 2 GOG-0265 trial, conducted by the Gynecologic Oncology Group (GOG, now part of NRG Oncology) and supported by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).  GOG-0265 is a single-arm, open-label Phase 2 multicenter study (NCT01266460) designed to evaluate the safety and activity of axalimogene filolisbac in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) in a standard Simon two-stage design.

Princeton-based BioNJ Member Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that it has been granted Small and Medium Enterprise (SME) designation by the European Medicines Agency (EMA). T he SME designation was established by EMA to promote innovation and the development of new medicinal products by smaller companies.

Bedminster-based BioNJ Member  Matinas Biopharma Holdings, Inc., a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective broad spectrum therapeutics for the treatment of serious and life-threatening infections, announced the presentation of positive preclinical data demonstrating its cochleate lipid-crystal nano-particle drug delivery technology significantly enhances the immune response of intranasally or orally administered influenza vaccine in murine models of influenza and provides a high level of protection from viral infection.

Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that the independent Data Safety Monitoring Board ("DSMB") for its Phase 2, The Sanford Project: T-Rex Study recommended that the trial proceed with the enrollment of the prescribed second cohort of subjects in the study to meet the target of 111 total participants. The company's decision to resume enrollment ahead of the original timeline represents an acceleration of the program. 

Plainsboro-based BioNJ Member Novo Nordisk announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation application to the European Medicines Agency (EMA) for including data from the LEADER cardiovascular outcomes trial in the product information of Victoza ® (liraglutide). In the LEADER trial, Victoza ®  statistically significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction (heart attack) and non-fatal stroke by 13% versus placebo, when added to standard of care.

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) accepted the company's New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib) as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole. The NDA is based on a comprehensive clinical package, including results of the Phase III MONALEESA-2 trial. 

Bridgewater-based BioNJ Member  Eli Lilly and Company  and Incyte Corporation  announced that new data from RA-BEACON -- a pivotal phase 3 study of baricitinib in the treatment of moderate-to-severe rheumatoid arthritis (RA) -- showed baricitinib demonstrated significant improvement in patient-reported outcomes and health-related quality of life (HRQOL) measures, fatigue and pain compared with placebo. The global trial is part of the ongoing study of baricitinib, a once-daily oral medication currently under regulatory review for the treatment of moderate-to-severe RA.

Jersey City-based BioNJ Member  Allergan plc  announced that it has successfully completed the acquisition of Tobira Therapeutics, Inc. , a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases. Allergan acquired Tobira for an upfront payment of $28.35 per share, in cash, and additional Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones.

Jersey City-based BioNJ Member  Allergan plc  announced that it has received approval from the U.S. Food and Drug Administration ( FDA ) for RESTASIS MULTIDOSE™ (Cyclosporine Ophthalmic Emulsion) 0.05%, a preservative-free, multi-dose bottle offering the same preservative-free formulation of RESTASIS since the launch in 2003. RESTASIS® is the one and only prescription treatment FDA approved to help patients with a type of Chronic Dry Eye make more of their own tears.

Jersey City-based BioNJ Member  Allergan plc  and Rhythm Holding Company, LLC , which owns Motus Therapeutics, Inc. a biopharmaceutical company developing peptide therapeutics for the treatment of gastrointestinal (GI) disorders, announced the top line results of a Phase 2b clinical trial assessing the efficacy and safety of relamorelin (RM-131) , Motus' ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Allergan also announced that it has exercised its option to acquire Motus Therapeutics.

Raritan-based BioNJ Member Janssen Research & Development, LLC announced the launch of ACCELERATE, a first-of-its-kind, patient-driven natural history registry dedicated to empowering patients with Castleman Disease (CD) to contribute their own personal medical information to advance the knowledge of the disease, including its diagnosis and treatment. CD is a rare immune system disorder, and there is poor understanding of its prognosis and treatment. Designed and led by the Castleman Disease Collaborative Network (CDCN) and The University of Pennsylvania (Penn), the patient registry is the result of an innovative collaborative research agreement among the scientific research and medical communities and patient advocacy and pharmaceutical industry thought-leaders.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced new results from CheckMate -205, a multi-cohort, single-arm, Phase 2 trial evaluating Opdivo (nivolumab) in patients with classical Hodgkin lymphoma (cHL). These results from cohort C (n=100) of the trial included patients with cHL who had received brentuximab vedotin before and/or after autologous hematopoietic stem cell transplantation (auto-HSCT).

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. The FDA granted the application priority review and previously granted Opdivo Breakthrough Therapy Designation for mUC in June 2016.

Kenilworth-based BioNJ Member Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company's anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. With this new indication, KEYTRUDA is now the only anti-PD-1 therapy to be approved in the first-line treatment setting for these patients.

Kenilworth-based BioNJ Member Merck announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL. Merck anticipates making ZINPLAVA available in first quarter 2017.  ZINPLAVA is indicated to reduce recurrence of Clostridium difficile  infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.

CytoSorbents, a Monmouth Junction medical device company focused on critical care immunotherapy, is commercializing a blood purification technology called CytoSorb® to reduce deadly inflammation common to many lethal conditions in the ICU such as sepsis and infection, trauma, liver failure and complications of open heart surgery. CytoSorb®, which is reported to have been used safely in more than 14,000 human treatments to date, is currently approved in the European Union, and is being distributed in 40 countries around the world.

Little Falls-based  Regenicin, Inc., a biotechnology company specializing in the development and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, announced that they have completed the Pre-IND (Investigational New Drug) Meeting via teleconference with members of the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) regarding its product NovaDerm®.

Woodcliff Lake-based  Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced th at enrollment has  commenced in  MISSION  AD ,  a  Phase III clinical  program  of the  b eta  secretase  c leaving  e nzyme (BACE)  inhibitor E2609 in patients with early Alzheimer's disease in the United States. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen Inc. as a potential Alzheimer's disease modifying treatment.

Basking Ridge-based Lexicon Pharmaceuticals, Inc. announced that the Phase 2 dose-ranging, inTandem4 clinical trial of dual SGLT1 and SGLT2 inhibitor sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 12 weeks in patients with type 1 diabetes.  The purposes of the Phase 2 inTandem4 study were to confirm the appropriateness of the doses selected for Lexicon's ongoing Phase 3 program in type 1 diabetes and to evaluate secondary endpoints relating to sotagliflozin's dual mechanism of action involving inhibition of SGLT1 in the gastrointestinal (GI) tract and SGLT2 in the kidney.

Parsippany-based GlaxoSmithKline Plc  announced that it has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, Shingrix^TM, to the United States Food and Drug Administration (FDA), seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over. The candidate vaccine is a non-live, recombinant vaccine to help prevent shingles and its complications. The Phase III clinical trial programme showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain associated with shingles.

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced initial results from the preclinical study conducted by Eagle at the National Institute on Drug Abuse ("NIDA")/National Institutes of Health ("NIH") exploring the use of Ryanodex® in the treatment of hyperthermia related to MDMA ("Ecstasy") intoxication. The study was conducted in the summer of 2016 utilizing a well-characterized animal model.

New Brunswick-based Hemispherx Biopharma announced that a retrospective analysis of the AMP-516 Phase III trial of Ampligen® in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), segmented primarily by disease duration, showed that 51% of Ampligen treated patients in a cohort with a disease duration of two to eight years vs. 18% of placebo patients demonstrated at least 25% improvement in placebo-adjusted exercise tolerance whereas the patient subset with less than two years or greater than eight years of disease duration failed to show a clinically-significant response. 

LEO Pharma, a global pharmaceutical company specializing in dermatology and critical care, has moved its U.S. headquarters to 7 Giralda Farms in Madison.  The company, which was previously headquartered in Parsippany, will occupy about half of the building's second floor.

Madison-based LEO Pharma announced that Enstilar® has been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis in adults 18 years of age and older. Enstilar® is a once-daily, alcohol free foam formulation in a pressurized spray can that allows application across large body areas of plaque psoriasis. In the pivotal Phase 3 clinical trial, over half of patients treated with Enstilar® were "Clear" or "Almost Clear" by Week 4 as assessed by the Investigator Global Assessment (IGA) score of disease severity.

Parsippany-based  Daiichi Sankyo Company and QuantumLeap Healthcare Collaborative announced that a new treatment arm of the I-SPY2 TRIAL will include patritumab, an investigational anti-HER3 monoclonal antibody. The I-SPY 2 TRIAL, sponsored by QuantumLeap Healthcare Collaborative (QLHC), is a standing Phase 2 randomized, controlled, multicenter study with an innovative adaptive design aimed to rapidly screen and identify promising new treatments in specific subgroups of women with newly-diagnosed, locally-advanced breast cancer (Stage II/III).

Novitium Pharmaceuticals has relocated to East Windsor from a small facility in South Plainfield. N ovitium Pharmaceuticals' decision to relocate and expand their company in East Windsor represents the attraction to East Windsor of yet another high-tech, high growth-potential company to our Einstein's Alley corridor. The startup pharmaceutical company, which employed 20 people at its previous location, moved to a 45,000-square-foot facility at 70 Lake Drive. The company now employs 46 employees and has plans to grow to 100 workers in 2017 and add another 100 in 2018.

Parsippany-based Castle Creek Pharmaceuticals has raised its first institutional round of $48 million entirely from active biotech crossover investor Fidelity Management and Research Company. Founded last year, the company has in-licensed a series of dermatology as well as ear, nose and throat (ENT) candidates specifically for rare diseases with limited therapeutic options.

Princeton-based Braeburn Pharmaceuticals and Camurus announced the expansion of their collaboration and license agreement from 2014 to include buprenorphine combination products. The first drug candidate within the expanded scope, (CAM2058), is an extended release injectable combination of buprenorphine and granisetron in the FluidCrystal® injection depot technology.