BioNJ's Manufacturing Briefing

Rutgers University, Piscataway, NJ

September 21, 2018

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Beyond Value Frameworks: Defining the Value of Medical Innovation Workshop

Amicus Therapeutics, Cranbury, NJ

October 11, 2018

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BioNJ's C-Suite Summit

Bridgewater Marriott, Bridgewater, NJ

October 25, 2018

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BioNJ's Patient Advocacy Summit

Celgene Corporation, 179 Passaic Ave, Summit, NJ

December 13, 2018

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Hackensack UMC, UHC Offer Bundled Payment Option for Joint, Spine Procedures

Hackensack Meridian Health's  Hackensack University Medical Center has teamed with  UnitedHealthcare to offer a bundled payment option to patients for knee, hip and spine procedures.  Under UHC's Spine and Joint Solution bundled payment program, patients covered by UHC undergoing these types of procedures can make an upfront payment -- covered by UnitedHealthcare -- and get coverage for the procedure as well as pre- and post-surgical care.

Doctors across the U.S. say the health care industry has made little progress toward creating fee-for-value medicine, or value-based care.  That's according to a new survey by Secaucus-based  Quest Diagnostics . Of 451 physicians, 67 percent said the U.S. generally has made little progress moving towards a value-based system. And 57 percent said they don't have the tools to implement a fee-for-value system, such as efficient billing systems and value-based payment models from insurance companies. Click here for the full study.

Governor Phil Murphy announced two important tools- - the Incubator and Collaborative Workspace Rent Initiative (ICWRI) and a modernized Research and Development (R&D) tax credit -- to support new and established high-tech companies in growing the Garden State's Innovation Economy. "Both of these initiatives will allow us to take full advantage of all New Jersey has to offer entrepreneurs and start-ups as well as our established innovation-driven companies," said Governor Phil Murphy. "We've led this sector before, and through these additional tools, New Jersey will reclaim our national and international prominence for innovation and discovery."

Entitled "Recent Advances in Laboratory and Innovation Space in New Jersey", the paper includes profiles of major biopharma incubators and innovation spaces in New Jersey and perspectives from leaders of successful industrial and academic incubators as well as the recognized biopharma industry organization, BioNJ, all who support prioritizing investment in infrastructure for biopharma start-ups.

When the budget deal was finally completed, many legislative and business leaders complained that changing the corporate business tax is so complicated it needed more than just a last-minute push to get it done.  What many don't know is that the fight is more than a decade old.  BioNJ President and CEO Debbie Hart told ROI-NJ,  "We are still parsing our way through the budget and determining where the challenges and opportunities lie for the industry for our members both large and small. Certainly one of the greatest opportunities for our economy is the biotechnology and life sciences industry and we look forward to working with the governor and his administration and the legislature to make the New Jersey life sciences industry as well as New Jersey's economy the strongest it can be." 

New Jersey has a lot going for it, from an enviable location to a well developed workforce to a transportation network that connects it with many key centers of commerce. But high taxes, regulatory burdens and other issues are hurting the State's ability to attract and retain businesses.  BioNJ's President and CEO  Debbie Hart commented  "New Jersey has an excellent educational  system and has established itself  as a biotechnology industry hub, which  makes it easier to attract these companies,  since they can find talent and collaborate  with other companies. New  Jersey also enjoys an excellent geographic  location, with access to transportation  that promotes participation  in the global economy. At the same  time, we're concerned about the tax  structure and affordability of doing  business here."

BioNJ is pleased to shine the spotlight on one of our Innovation Members each month featuring their progress and work on behalf of Patients and their impact on the New Jersey life sciences ecosystem. This month's Emerging Company in the Spotlight is Evotec. So many of our Members are making a dramatic impact on our State's innovation ecosystem. We celebrate you! Evotec is one such company.

Edison-based BioNJ Member  ContraVir Pharmaceuticals, Inc.  announced that it has completed dosing of the first cohort in Part 1 of the Phase 1/2A trial of CRV431. Preliminary data from the first completed cohort suggest that CRV431 is safe and well-tolerated. The pharmacokinetic (PK) profile following oral dosing indicates that systemic exposures of CRV431 are in-line with anticipated exposures from completed pre-clinical studies.

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced that it has entered into an agreement to acquire  Agilis Biotherapeutics, Inc. , a biotechnology company advancing an innovative gene therapy platform for rare monogenic diseases that affect the central nervous system (CNS). The transaction was approved by the Boards of both companies.

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc. a nnounced the publication of data in Muscle & Nerve  comparing the efficacy and safety of deflazacort and prednisone/prednisolone from the placebo arm of the ACT DMD study. The results demonstrated a clinically differentiated benefit of deflazacort over prednisone/prednisolone in slowing disease progression as measured using physical function endpoints and the time to delay loss of ambulation. 

Morris Plains-based Immunomedics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. 

Morris Plains-based Immunomedics, Inc. announced a clinical collaboration with AstraZeneca and its global biologics research and development arm, MedImmune, to evaluate the safety and efficacy of the combination of Imfinzi® (durvalumab), a human monoclonal antibody directed against PD-L1, and Immunomedics' lead antibody-drug conjugate (ADC) product candidate, sacituzumab govitecan, as a frontline treatment of patients with triple-negative breast cancer (TNBC) and urothelial cancer (UC).

Princeton-based BioNJ Member Photocure ASA announced that the Patient Reported Outcomes (PRO) with Blue Light Cystoscopy (BLC™) with Cysview® Study was published online, in the prestigious British Journal of Urology. The publication shows that patient anxiety levels decreased following flexible blue light cystoscopy with Cysview, and the vast majority of patients (94%) undergoing this procedure found it worthwhile and would do it again and recommend it to others (91%). 

Bedminster-based BioNJ Member  Advaxis, Inc.  announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company's Investigational New Drug (IND) application for its Phase 1/2 study of axalimogene filolisbac (AXAL) in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.

Pennington-based BioNJ Member OncoSec Medical Incorporated announced that Sharron Gargosky, PhD, Chief Clinical and Regulatory Officer, presented a clinical update of the Company's intratumoral therapy, ImmunoPulse™ tavokinogene telseplasmid (TAVO), as well as an overview of the ongoing and anticipated clinical programs involving TAVO in triple-negative breast cancer (TNBC). 

Princeton-based BioNJ Member Oyster Point Pharma announced results from the PEARL study, a Phase 2b clinical trial evaluating the company's novel therapy for the treatment of Dry Eye Disease (DED). The study met both sign and symptom primary endpoints by showing a statistically significant improvement in each compared to a vehicle control. The study evaluated OC-02, a nicotinic acetylcholine receptor (nAChR) agonist the company is developing to treat the signs and symptoms of DED. 

The Food and Drug Administration (FDA) has approved  Parsippany-based BioNJ Member Ferring Pharmaceuticals'   Zomacton  (somatropin;  Ferring ) for the treatment of pediatric patients with idiopathic short stature (ISS), short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by 2-4 years, and short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency. 

Berkeley Heights-based BioNJ Member CorMedix Inc. announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase 3 LOCK-IT-100 study for Neutrolin®. Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB  recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis. 

 

Ramsey-based BioNJ Member ADMA Biologics, Inc.announces that the Company has received formal notice from the U.S. Food and Drug Administration of the successful close-out for the April 2018 compliance inspection of the Boca Raton, FL production facility. This is the first EIR issued to the site since 2012. The EIR received by the company contains detailed information about the April 2018 FDA inspection, discussions had with the investigators, requests for clarification and information, as well as a summary of potential next steps for the review of the Prior Approval Supplement ("PAS") for BIVIGAM®. 

BioNJ MemberJazz Pharmaceuticals plc, with offices in Ewing, announced that the U.S. Food and Drug Administration accepted for priority review its supplemental new drug application (sNDA) seeking revised labeling for Xyrem® (sodium oxybate) oral solution, CIII, to include an indication to treat cataplexy and excessive daytime sleepiness ( EDS ) in pediatric narcolepsy patients. 

BioNJ Member  Jazz Pharmaceuticals plc, with offices in  Ewing,  announced that data from the pivotal Phase 3 study of Vyxeos® (daunorubicin and cytarabine) liposome for injection compared to standard of care cytarabine and daunorubicin (7+3) were published online in the  Journal of Clinical Oncology . The study met its primary endpoint as Vyxeos demonstrated a superior improvement in overall survival compared to the 7+3 treatment regimen. 

Lawrenceville-based BioNJ Member Bristol-Myers Squibb Company and Tsinghua University have entered into a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers. The collaboration brings together Bristol-Myers Squibb and Tsinghua University's respective scientific expertise and capabilities with a focus on validating new targets and generating early drug candidates for clinical development.

Bridgewater-based BioNJ Member  Allergan plc  announced the  U.S. Food and Drug Administration  has granted Fast Track  designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD). AGN-241751 is a novel, oral, rapid-acting anti-depressant that recently entered Phase 2 development. AGN-241751 is a novel, orally bioavailable, small molecule N-methyl-D-aspartate receptor (NMDAR) modulator.  

Bridgewater-based BioNJ Member  Allergan plc  and  Molecular Partners  announced the release of two positive clinical trials, SEQUOIA and  CEDAR for abicipar, demonstrating that both the 8-week and 12-week treatment regimens met the pre-specified primary endpoint of non-inferiority to ranibizumab. SEQUOIA and CEDAR are identical global phase 3 studies designed to assess the efficacy and safety of abicipar compared with ranibizumab in treatment-naïve patients with neovascular age-related macular degeneration (AMD).  

BioNJ Member Pfizer, with offices in Madison, announced that the United States Food and Drug Administration has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product."The FDA approval of NIVESTYM marks an important step in helping expand access to critical treatment options for patients with neutropenia, many of whom have cancer and can be hospitalized for potentially life-threatening side effects stemming from chemotherapy," said Berk Gurdogan, U.S. Institutions President, Pfizer Essential Health. 

BioNJ Member Pfizer, with offices in Madison, announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. 

BioNJ Member Pfizer, with offices in Madison, announced that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for those patients that enroll into the next part of the Phase 3 study, which will evaluate the investigational gene therapy fidanacogene elaparvovec for the treatment of hemophilia B. 

BioNJ Members Pfizer and Eli Lilly and Company announced that a 16-week Phase 3 study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. The study demonstrated that patients who received two doses of tanezumab separated by eight weeks experienced a statistically significant improvement in pain, physical function and the patients' overall assessment of their OA, compared to those receiving placebo. 

The U.S. label for  Bridgewater-based BioNJ Member Eli Lilly  and Company's  once-weekly Trulicity® (dulaglutide) is updated to show the medicine's safety and efficacy in people with type 2 diabetes who have moderate to severe chronic kidney disease (CKD). The label now includes data from the AWARD-7 clinical trial, which showed that people treated with Trulicity 1.5 mg or 0.75 mg in combination with mealtime insulin lispro achieved similar glycemic control with weight loss, compared to those treated with traditional basal-bolus insulin.

CARMELINA® met its primary endpoint, defined as time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3-point MACE), with Tradjenta® demonstrating similar cardiovascular safety compared with placebo. Bridgewater-based BioNJ Member Eli Lilly and Company and Boehringer Ingelheim announced the positive top-line results from the trial, which evaluated the impact of treatment with Tradjenta compared with placebo on cardiovascular safety on top of standard of care.

Bridgewater-based BioNJ Member  Eli Lilly and Company  and  Incyte Corporation  announced that results of a global systemic lupus erythematosus (SLE) Phase 2 study for baricitinib were published by The Lancet. The study, the first completed Phase 2 study of a JAK inhibitor in SLE, showed that a statistically significant proportion of patients treated with 4 mg of baricitinib achieved resolution of their SLE-related arthritis or rash compared to placebo at Week 24, the primary endpoint for the trial.

Bridgewater-based BioNJ Member  Eli Lilly and Company  partnered with Bernardsville-based Anima Biotech Inc. to discover and develop translation inhibitors against undisclosed targets chosen by Lilly using Anima's Translation Control Therapeutics platform. Anima will receive $30 million up front and $14 million in research funding. Anima will also be eligible for $1.1 billion in milestones, plus low to mid single-digit tiered royalties. The pharma will be responsible for clinical development and commercialization.

Kenilworth-based BioNJ Member Merck & Co. announced that KEYTRUDA®, Merck's anti-PD-1 therapy, has been approved by the China National Drug Administration (CNDA) for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first and only approval of an anti-PD-1 therapy for advanced melanoma in China. 

Kenilworth-based BioNJ Member Merck & Co. announced that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA®, Merck's anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed PD-L1 (Combined Proportion Score (CPS) ≥20).

Kenilworth-based BioNJ Member Merck & Co. announced Week 96 results from the Phase 3 DRIVE-FORWARD clinical trial evaluating the efficacy and safety of doravirine (DOR), the company's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history (treatment-naïve). 

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. SYMTUZA™ combines the proven high barrier to resistance of darunavir with a formulation designed for improved tolerability and the convenience of an STR. 

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for a supplemental New Drug Application (sNDA) for INVOKANA® (canagliflozin). The sNDA seeks a new indication for INVOKANA® to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) who have established cardiovascular (CV) disease or are at risk for CV disease. 

Summit -based BioNJ Member  Celgene Corporation  announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (PFS). This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast cancer (TNBC), a type of breast cancer with high unmet need.

Summit -based BioNJ Member  Celgene Corporation  announced results from a Phase III, randomized, double-blind, international clinical study (AUGMENT). REVLIMID® (lenalidomide) plus rituximab (R2) achieved a highly statistically significant improvement in the primary endpoint of progression-free survival (PFS), compared to rituximab plus placebo, in the final PFS analysis.

BeiGene announced that their PD-1 tislelizumab -- partnered with Summit-based BioNJ Member  Celgene Corporation  -- scored stellar data in a small Phase II trial for classical Hodgkin's lymphoma among patients who had either failed or couldn't take autologous stem cell transplantation. This is their first pivotal trial, and it underscores why Celgene inked a  $1.4 billion deal to buy into the drug -- which may end up as the 7th new checkpoint to hit the global market.

East Hanover -based BioNJ Member Novartis announced a new approval for Kisqali (ribociclib) from the U.S. Food and Drug Administration (FDA) for women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is now the only CDK4/6 inhibitor indicated for use with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women in the U.S., and also is indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women.

East Hanover -based BioNJ Member Novartis reaffirms its commitment to the fight against liver fluke (fascioliasis), signing a renewed memorandum of understanding with the World Health Organization (WHO) to extend its drug donation for Egaten®(triclabendazole) until 2022. Egaten is currently the only treatment for fascioliasis recommended by the WHO and is on the WHO Model List of Essential Medicines.

East Hanover -based BioNJ Member Novartis announced that it has entered into an exclusive license agreement with biotech companies Galapagos NV, Mechelen and MorphoSys AG, Planegg/Munich regarding their compound MOR106. Under the agreement, Novartis acquires the exclusive global development and marketing rights to MOR106 for atopic dermatitis and all other potential indications. Novartis will make an upfront payment of EUR 95 million to Galapagos and MorphoSys, and additional payments, royalties and fees pending achievement of agreed milestones.

Iselin -based BioNJ Member ThromboGenics NV reports Day 150 topline results from aPhase 1/2, single-masked, multicentre study (THR-317-001) evaluating the safety and efficacy of 2 dose levels (4 mg and 8 mg) of THR-317, administered by three monthly intravitreal injections with Day 90 and Day 150 follow-up, for the treatment of diabetic macular edema (NCT03071068). The THR-317-001 study enrolled a total of 49 patients and included anti-VEGF treatment naïve patients (N=40) and anti-VEGF sub-optimal responder patients (N=9). 

Genmab Enters Strategic Partnership With Immatics to Discover and Develop Next Generation Bispecific Cancer Immunotherapies

Princeton-based BioNJ Member Genmab A/S announced that it has entered into a research collaboration and exclusive license agreement with privately owned Immatics Biotechnologies GmbH (Immatics), to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. The deal strengthens Genmab's position in immuno-oncology by combining Genmab's proprietary technologies and antibody know-how with Immatics' XPRESIDENT® targets and T-cell receptor (TCR) capabilities.

BioNJ Member Evotec AG, with offices in Princeton, announced that its multi-target alliance with Bayer, with offices in Whippany, in the field of endometriosis has advanced a promising small molecule into Phase II clinical development for the treatment of chronic cough, resulting in a payment of € 4 m to Evotec. This new trial has been initiated following positive results from a Phase I study which is part of the ongoing Bayer-Evotec endometriosis alliance.

Rutherford-based BioNJ Member Cancer Genetics, Inc. announced the closing of a $2.625 million convertible note financing with a single institutional investor. John A. Roberts, Chief Executive Officer of Cancer Genetics, commented, "This capital raise helps the company continue to execute on our strategy of consolidating operations and expanding our biopharma business. We plan to utilize this capital to assist with funding our 2018 transformation and strategic plan to streamline our business and execute against a path to profitability with an emphasis on becoming a leader in oncology-focused testing, genomic services and biomarker insight capabilities."

BioNJ Member  Ovid Therapeutics Inc. and Takeda P harmaceutical Company Limited provided an overview o f their TAK-935/OV935 broad clinical development program. The companies plan to initiate three clinical trials: in pediatric patients with Dravet syndrome and Lennox-Gastaut syndrome, in pediatric patients with CDKL5 deficiency disorder (CDD) and Duplication 15q (Dup15q) syndrome, and an extension trial for patients with developmental and epileptic encephalopathies (DEEs) who participated in a previous TAK-935/OV935 clinical study.

Now that genomic analytics company  Health Interactive, Inc . has expanded into New Jersey, it is strategically positioned within the State's vast pharmaceutical and biotechnology research ecosystem. Health Interactive's research and development (R&D) focuses on developing capabilities in bioinformatic analysis and reporting of genetic sequencing data. Health Interactive was founded in Massachusetts in 2016 but quickly expanded its footprint into New Jersey in 2017, setting down roots at the New Jersey Economic Development Authority's (EDA's) Commercialization Center for Innovative Technologies (CCIT).

Eisai and Biogen Announce Detailed Results of Phase II Clinical Study of BAN2401 in Early Alzheimer's Disease

Woodcliff Lake-based Eisai Co., Ltd.  announced and Biogen Inc. announced detailed results from the Phase II study (Study 201) with BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, in 856 patients with early Alzheimer's disease. Study 201 is a placebo-controlled, double-blind, parallel-group, randomized Phase II clinical study in 856 patients with mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia with confirmed amyloid pathology in the brain.

Positive Topline Results Obtained from Large-Scale Cardiovascular Outcomes Trial of Anti-Obesity Agent BELVIQ®

Woodcliff Lake-based Eisai Co., Ltd.  announced that it has obtained the topline results of the ongoing Cardiovascular Outcomes Trial ("CAMELLIA-TIMI61") of lorcaserin hydrochloride (generic name, product name in the U.S.: BELVIQ®, "BELVIQ") in 12,000 patients as a post-marketing clinical trial evaluating safety as the primary objective. BELVIQ was approved in the United States in June 2012 by the U.S. Food and Drugs Administration (FDA) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients, and was launched in June 2013.

Glenmark Pharmaceuticals Announces Encouraging Phase 1 Results Supporting Biosimilarity Criteria for GBR 310 Compared to the Reference Product Omalizumab

Maywah-based Glenmark Pharmaceuticals announced results from a Phase 1 study that suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark's GBR 310 proposed biosimilar and reference product omalizumab, marketed in the U.S. under the brand name Xolair®. GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. 

Parsippany-based GlaxoSmithKline pc and Adaptimmune Therapeutics plc announced the transition of the development programme for GSK3377794 (GSK '794), an NY-ESO SPEAR T-cell therapy, to GSK.  GSK '794 is an engineered T-cell therapy, for which a patient's own cells have been genetically modified to express a T-cell receptor (TCR) recognising with high affinity the tumour-specific antigen, NY-ESO. 

Parsippany-based GlaxoSmithKline pc and Medicines for Malaria Venture (MMV) announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.

Parsippany-based GlaxoSmithKline pc and 23andMe unveiled an exclusive four-year collaboration that will focus on research and development of innovative new medicines and potential cures, using human genetics as the basis for discovery. The collaboration will combine 23andMe's large-scale genetic resources and advanced data science skills, with the scientific and medical knowledge and commercialisation expertise of GSK. 

Lawrenceville-based Asana BioSciences announced initiation of a Phase 2b study of ASN002, an oral JAK/SYK inhibitor, in patients with moderate-to-severe atopic dermatitis (AD). In the recently concluded Phase 1b study in patients with moderate-to-severe atopic dermatitis, ASN002, dosed at 40 and 80 mg once daily, was well tolerated and showed clear evidence of clinical efficacy per EASI score and rapid symptom improvement, with significant reduction in patient-reported itch as early as day 2. 

Freehold-based  Avalon GloboCare Corp. announced that the company has formed a new wholly owned U.S. subsidiary, Avactis Biosciences, Inc., which will be focused on accelerating commercial activities related to its proprietary Chimeric Antigen Receptor (CAR)-T technologies. The new subsidiary is designed to integrate and optimize the company's global scientific and clinical resources. 

Hackensack-based BrainStorm Cell Therapeutics Inc.  announced that the European Patent Office ("EPO") has granted an European-wide patent entitled 'Mesenchymal Stem Cells for the Treatment of CNS Diseases' for the treatment of Amyotrophic Lateral Sclerosis (ALS) with NurOwn®. This patent provides protection for NurOwn® in  Europe  until 2029. The allowed claims cover methods of treating amyotrophic lateral sclerosis (ALS) using mesenchymal stem cells that secrete neurotrophic factors, including Brain derived neurotrophic factor (BDNF).

Bedminster-based Aerie Pharmaceuticals, Inc. reported that it has received the "Day 74" notification from the U.S. Food and Drug Administration (FDA) earlier than scheduled, the FDA has completed its initial 60-day review of the NDA (new drug application) for Roclatan™ and the FDA has determined that the application is sufficiently complete to permit a substantive review.

Bedminster-based Aerie Pharmaceuticals, Inc. announced that the  $125 million  of senior secured convertible notes held by affiliates (the "holders") of  Deerfield Management Company L.P.  ("Deerfield") since  September 2014  have been fully converted into 5,040,323 shares of Aerie common stock in accordance with their terms, plus the issuance of 329,124 additional shares mutually agreed to with the holders in order to complete the conversion at this time, for a total of 5,369,447 shares.

East Rutherford-based  Cambrex Corporation announced it has entered into a definitive agreement to acquire Halo Pharma (Halo), a leading dosage form Contract Development and Manufacturing Organization (CDMO), majority owned by funds managed by the private investment firm SK Capital Partners, for approximately $425 million. With the acquisition of Halo, Cambrex will enter the large and growing finished dosage form CDMO market. 

Glen Rock-based RespireRx Pharmaceuticals Inc. announced that an article describing the company's translational research on the ability of its proprietary ampakines to stimulate neurotrophin expression has been published in Biomedical Pharmacotherapy. The paper demonstrates that low-impact ampakines, when administered to animals at therapeutically relevant doses for two weeks, enhance expression of the neurotrophic factors, brain derived neurotrophic factor (BDNF) and nerve growth factor (NGF). 

Warren-based Aquestive Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs, announced the pricing of its initial public offering of 4,500,000 shares of common stock at a public offering price of $15.00 per share for aggregate gross proceeds of $67,500,000 . All of the shares in the offering are being offered by Aquestive Therapeutics .

Teva Pharmaceuticals USA Inc. ,  which announced earlier this month  that it was moving its U.S. headquarters to Parsippany, has signed a lease at the MCCBLUE office complex in the township . The life sciences company signed a 12-year lease for 345,000 square feet at the site, a 541,000-square-foot Class A complex at 400 Interpace Parkway. The deal is the largest lease in New Jersey so far this year.

Two animal health compounding pharmacies, Swedesboro-based  Wedgewood Pharmacy and Scottsdale, Arizona-based  Diamondback Drugs, have merged.  The merger will increase medication availability and delivery, and enhance the service and quality available to the market, they said. Compounding pharmacies make customized medications for animals when commercial drugs cannot meet their needs.

Princeton-based BioNJ Member Soligenix, Inc. announced the appointment of Mark Pearson, Chief Executive Officer (CEO) of Altamont Pharmaceutical Holdings, LLC, to its Board of Directors. Mr. Pearson is an accomplished businessman, investor and philanthropist, with past and present managing partner roles in a number of successful ventures. He is the founder and serves as General Partner and CEO at Altamont Pharmaceutical Holdings, LLC with over $100 million invested in more than 20 life science companies.

Pennington-based BioNJ Member OncoSec Medical Incorporated  announced the appointment of Sara Bonstein as Chief Financial Officer and Chief Operating Officer.  In her new roles, Ms. Bonstein will lead financial and capital market activity and oversee G&A and technical operations for the biotechnology company which moved its executive offices from San Diego, California to Pennington  in May . 

Hamilton-based Genesis Drug Discovery & Development, the contract research organization of  Genesis Biotechnology Group , announced it has appointed Dr. Olesia Buiakova its new Chief Scientific Officer. Dr. Buiakova will be responsible for managing the company's entire portfolio of drug discovery services. She will also head development and management of new preclinical drug discovery platforms in oncology, immunology, metabolic and ocular diseases.

Princeton-based  Slayback Pharma LLC, a pharmaceutical research and development company, announced it has appointed Dr. Girish Jain as Senior Vice President and Head of Global R&D.  Prior to Slayback, Dr. Jain was President and Head of R&D at Alkem. Before that, he was at Wockhardt as Senior Vice President and Head of R&D.

With the success of the  VOICE Summit - nearly 3,000 attendees in one day versus an anticipated 1,500 -- in Newark, and the recent buzz around Propelify in Hoboken, the state appears ripe to push an innovation agenda. It's why New Jersey Innovation Institute President Donald Sebastian is bullish on New Jersey's ability to grow an innovation economy.

Celgene Donates $100K to Rutgers' TechAdvance Funding Program

Rutgers University's  TechAdvance Fund received $100,000 from Celgene Corp.  The fund was created through the university's Office of Research and Economic Development to advance early stage Rutgers technologies toward commercialization. "Celgene's donation to the Rutgers TechAdvance fund is consistent with Celgene's entrepreneurial vision to enable bold pursuits in science and to support the start-up ecosystem in N.J.," said Rupert Vessey, President of Research and Early Development, Celgene.

Traumatic Brain Injury: Discovery of Two Molecules Could Lead to New Drug Treatments

After 10 years of research, a Rutgers-led team of scientists has identified two molecules that protect nerve cells after a traumatic brain injury and could lead to new drug treatments.

The molecules promote full recovery after traumatic brain injury (TBI) in mice, according to the study published online in Neurobiology of Disease. Traumatic brain injury is the leading cause of death for people under 45 years old in the United States and is associated with disability, early-onset dementia, cognitive disorders, mental illness and epilepsy.

Rutgers, NJDOH Chosen to Participate in Prostate Cancer Study

The New Jersey Department of Health and Rutgers Cancer Institute have been chosen to participate in a $26.5 million, statewide cancer surveillance and population-based epidemiological cancer research study of prostate cancer among African-American men. The goal of the study is to determine social and biological factors that contribute to prostate cancer in African-American men in the state. According to Rutgers Cancer Institute, the incidence of prostate cancer among African-American men in New Jersey is 50 percent higher than Caucasian men. 

Ramapo Enters into Pharmacy School Agreement With N.Y.'s Touro College

Students in New Jersey looking to get a pharmacy degree just got another option.

Ramapo College in Mahwah has entered into an agreement with Touro College of Pharmacy in Harlem, creating a pre-pharmacy program that will allow qualified students to earn both bachelor's and Doctor of Pharmacy (PharmD) degrees in seven years, rather than the eight usually needed to complete both.  Interested students can apply to the program through Ramapo beginning Sept. 1.

Nokia officially launched the Nokia Open Innovation Challenge (NOIC), an annual global competition that seeks innovative technologies, products and solutions that can change the world. The focus of this year's competition is industrial automation and the industrial Internet of Things (IoT) domain, with prize money totaling $175,000 available to winning companies. The winners will also be given access to Nokia Bell Labs research & development resources, as well as opportunities to grow their businesses through joint partnerships with Nokia.

NJ Innovators Look to the Future

August 2, 2018 | Woodbridge

SBIR Road Tour -- Delaware

August 20, 2018 | 100 David Hollowell Dr., Newark, DE

The MedTech Conference

September 24-26, 2018 | Philadelphia