BioNJ Member Edge Therapeutics and  PDS Biotechnology announced they are planning to merge.  The merger between Berkeley Heights-based Edge Therapeutics Inc. and North Brunswick-based PDS Biotechnology Corp. will create a new clinical-stage cancer immunotherapy company. Under terms of the deal, all of PDS's outstanding shares of common stock will be converted into Edge's common stock. Immediately following the completed merger, former PDS security holders will own 70 percent of the combined company and existing Edge security holders will own 30 percent.

 A new Expert Consensus Decision Pathway issued by the  American College of Cardiology  (ACC) recommends Jardiance® (empagliflozin) -- marketed by Bridgewater-based BioNJ Member Eli Lilly and Company and Boehringer Ingelheim -- as the preferred SGLT2 inhibitor for its proven benefit in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The recommendation is part of the ACC's first Expert Consensus Decision Pathway on novel therapies for cardiovascular risk reduction in adults with type 2 diabetes and atherosclerotic cardiovascular disease. 

BrainStorm Cell Therapeutics Inc., with offices in  Hackensack,  announced that it has submitted an Investigational New Drug (IND) application with the  U.S. Food and Drug Administration  ( FDA ) to initiate a Phase 2 study of NurOwn ®  in patients with progressive multiple sclerosis (MS). "This important step toward the development of NurOwn® in progressive MS confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease," said Chaim Lebovits , President and CEO of BrainStorm. 

Jersey City-based Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced that Mitsubishi Tanabe Pharma group companies will present pharmacokinetic (PK) data on an investigational oral suspension formulation of edaravone for the treatment of amyotrophic lateral sclerosis (ALS) at the 29th International Symposium on ALS/MND. The Phase 1 study showed oral edaravone is expected to have similar PK parameters to the current intravenous infusion.

Boehringer Ingelheim, with offices in North Brunswick, and Epizyme, Inc. announced a new global collaboration focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer. Specifically, these targets are enzymes within the helicase and histone acetyltransferase (HAT) families that when dysregulated have been linked to the development of cancers that currently lack therapeutic options. 

BeiGene, Ltd., with offices in Ridgefield Park, announced that Center for Drug Evaluation of China's National Medical Product Administration (NMPA, formerly known as CFDA) has granted priority review status to the New Drug Applications (NDAs) for the company's investigational BTK inhibitor zanubrutinib in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and for its investigational anti-PD-1 antibody tislelizumab in patients with R/R classical Hodgkin's lymphoma (cHL).

BeiGene, Ltd., with offices in Ridgefield Park, announced the presentation of preliminary clinical data from an ongoing Phase 1/2 trial of its investigational PARP inhibitor, pamiparib, in combination with radiation therapy (RT) and/or temozolomide (TMZ) in patients with newly diagnosed or recurrent/refractory (R/R) glioblastoma multiforme (GBM). Discovered by  BeiGene  scientists in  Beijing , pamiparib is currently in Phase 3 trials globally and in  China  as a monotherapy and in Phase 1/2 trials in combination with chemotherapy or immunotherapy for a variety of solid tumors.

BeiGene, Ltd., with offices in Ridgefield Park, and Zymeworks Inc. announced that the two companies have entered into a strategic collaboration for the clinical development and commercialization of Zymeworks' investigational ZW25 and ZW49 HER2-targeted bispecific antibodies. In addition, Zymeworks granted BeiGene a license to Zymeworks' proprietary Azymetric™ and EFECT™ platforms to develop and commercialize globally up to three other bispecific antibodies using the platforms.

Franklin Lakes-based  BD (Becton, Dickinson and Company) announced the U.S. Food and Drug Administration 510(k) clearance of the BD Phoenix ™  CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections.

Eatontown-based  Eagle Pharmaceuticals, Inc. announced positive results of a proof-of-concept (POC) study in a Total-Body Radiation Animal Model. The objective of the study was to evaluate the efficacy of intravenous administration of RYANODEX® to prevent or mitigate Acute Radiation Syndrome (ARS) in a total body irradiated C57BL/6 male mouse hematopoietic model.

Eatontown-based  Hikma Pharmaceuticals PLC announced a five-year licensing and supply agreement with Hansoh Pharmaceutical Group Co., Ltd., one of the few research and development-driven Chinese pharmaceutical companies with leading franchises in multiple large and fast-growing therapeutic areas. The agreement provides Hikma with exclusive rights to market a suite of Hansoh's injectable oncology medicines within the US for the next five years. Hansoh expects to file these products for approval with the FDA within the next 12 months. 

Woodcliff Lake-based  Eisai Co., Ltd. announced that based on topline results, the primary efficacy endpoint was met in a Phase III clinical study (Study 342) conducted for submission in Japan, which evaluated its in-house discovered antiepileptic drug (AED) Fycompa ® (perampanel) as monotherapy for partial-onset seizures. Based on the results of this study, Eisai plans to file an application seeking approval of Fycompa as monotherapy for partial onset seizures in Japan during fiscal 2018.

Takeda Pharmaceutical Company Limited, with offices in East Windsor,  announced that the European Commission (EC) granted marketing authorization for ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 20, 2018.

Cherry Hill-based  Adaptive Clinical Systems , a provider of cloud-based services that provides interoperability and data integration, has partnered with  Medidata , an eClinical software service company that develops solutions for research collaboration in clinical trials.  Adaptive Clinical Systems helps pharmaceutical and biotechnology companies, hospitals and academic research centers with integration of clinical study data from multiple systems and platforms.

Oldwick-based Provention Bio, Inc. announced that the company has joined the Critical Path Institute's Type 1 Diabetes (T1D) Consortium. Founded in March 2017 by the Critical Path Institute (C-Path), C-Path's T1D Consortium is focused on understanding the scientific and regulatory expectations associated with the application of biomarkers used to optimize clinical trial designs in this disease. Currently, the T1D Consortium is actively engaged in the regulatory qualification of islet autoantibodies as susceptibility/risk biomarkers to be used as enrichment criteria in the development of therapies for the treatment, and ultimately the prevention, of T1D.

East Rutherford-based Cambrex Corp., a life sciences company that provides products and services for small molecule therapeutics and generic active pharmaceutical ingredients, entered into a definitive agreement to acquire Avista Pharma Solutions, a contract development, manufacturing and testing organization, for about $252 million.  In a statement, Cambrex said that with the acquisition, Cambrex will enter the large and growing market for early stage small-molecule development and testing services.

Bridgewater-based Valeritas Holdings Inc. announced a pricing of $36 million for its underwritten public offering, expected to close Nov. 20, subject to customary conditions.  At a public offering price of $0.48 per share, the offering includes 75 million shares of its common stock; series A warrants for 75 million shares of common stock with an exercise price of $0.60 per share, immediately exercisable and set to expire on the fifth anniversary of the date of issuance; and series B warrants to purchase 75 million shares of common stock, with an exercise price of $0.48 per share, also immediately exercisable, and set to expire on the nine-month anniversary of issuance.

CarePoint Health , based in Jersey City, and digital health startup  Onduo  have agreed to develop a partnership designed to bring a diabetes management system to the health system's patients.  Onduo is a virtual diabetes program that provides tools, coaching and access to specialty doctors.

The Coriell Institute for Medical Research, Cooper University Health Care and Cooper Medical School of Rowan University (CMSRU) are launching the Camden Opioid Research Initiative (CORI), a first-of-its-kind undertaking to investigate the genetic and biological factors that contribute to the development of opioid use disorder. CORI will capitalize on Coriell's expertise in genomics, biobanking and personalized medicine, Cooper University Health Care's clinical infrastructure and expertise in treating opioid use disorder (OUD) patients, and Cooper Medical School of Rowan University's reputation for scientific excellence in genetics, the neurosciences and addiction research.

Princeton University has teamed up with Microsoft to collaborate on the leading edge of microbiology and computational modelling research.  In this project, Microsoft is helping Princeton to better understand the mechanisms of biofilm formation by providing advanced technology that will greatly extend the type of research analysis capable today. Biofilms -- surface-associated communities of bacteria -- are the leading cause of microbial infection worldwide and kill as many people as cancer does. They are also a leading cause of antibiotic resistance, a problem highlighted by the World Health Organization as "a global crisis that we cannot ignore." 

A five-year, $2,074,932 grant from the  National Cancer Institute was awarded to Sharon Manne,  Rutgers Cancer Institute of New Jersey's Associate Director for Cancer Prevention, control and population research.  The grant will support the expansion of behavioral intervention delivered through social media, via Facebook. The aim is to improve skin exams and sun protective behaviors among young melanoma survivors and their families.

Four schools from New Jersey made the list: Seton Hall (No. 41), Rutgers-Newark (No. 38), Stevens Institute of Technology (No. 12) and New Jersey Institute of Technology (No. 9).

The previously unheralded Missouri University of Science & Technology in Rolla, Missouri, took the top spot.

The New Jersey Economic Development Authority (NJEDA) is now accepting applications for a new round of funding for municipalities and counties to develop plans to build or augment their local innovation ecosystems. This second round of the Innovation Challenge follows an impressive response to round one of the Challenge, under which nine New Jersey communities were each awarded $100,000 to advance their planning projects in partnership with higher education institutions and other strategic partners.