The cost of this innovation is significant and depends on public funding for success, according to BioNJ, the trade association for life sciences research; in fact, the 3,200 life-sciences organizations in New Jersey depend heavily on this funding for early research. For each novel therapy approved it requires an investment of at least $2 billion on average and a decade of work, the group said.

  Berkeley Heights-based BioNJ Member  Cyclacel Pharmaceuticals, Inc. and the University of Texas MD Anderson Cancer Center announced a three-year strategic alliance agreement that will enable clinical evaluation for safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and other advanced leukemias.

Bridgewater-based BioNJ Member

Insmed Inc. gained an FDA accelerated approval for Arikayce (amikacin liposome inhalation suspension), a new treatment for nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults who don't respond to conventional treatment. It's the first and only therapy in the U.S. specifically approved for the indication, a rare and often chronic infection that can cause irreversible lung damage. 

Ramsey-based BioNJ Member  ADMA Biologics, Inc. announces that the company's wholly-owned subsidiary, ADMA BioCenters, has received U.S. Food and Drug Administration ("FDA") approval for its third plasma collection center, located at 166 Ernest W Barrett Parkway, NW, Marietta, Georgia. The facility commenced operations and initiated source plasma collection in December 2017, and is now FDA licensed to collect and enter into interstate commerce to sell and use the human source plasma for further manufacturing in the U.S.

Ramsey-based BioNJ Member  ADMA Biologics, Inc. announced that it has successfully resubmitted a Biologics License Application ("BLA") for lead candidate RI-002, a polyclonal intravenous immunoglobulin (IVIG) product for the treatment of primary immunodeficiency disorder (PIDD). ADMA previously reported positive results from a pivotal study that demonstrated efficacy of RI-002 in preventing serious bacterial infection (SBI) in 59 patients with PIDD. Treatment with RI-002 was further shown to decrease subsequent need for antibiotic therapy while producing positive effects on quality-of-life measures such as low rates of unscheduled medical visits and days lost from work or school. 

Parsippany-based BioNJ Member  The Medicines Company announced that the Independent Data Monitoring Committee (IDMC) for the ongoing inclisiran Phase III trials has recommended that the trials continue as designed and conducted, without modification. The IDMC's recommendation was based on its planned review of unblinded safety and efficacy data from the trials.

Plainsboro-based BioNJ Member Novo Nordisk  announced plans to make the durable, connected insulin pens NovoPen® 6 and NovoPen Echo® Plus commercially available across key markets commencing in early 2019. In parallel, to support the future integration of its connected pens with broader digital health solutions, Novo Nordisk has signed new partnership agreements with leading diabetes technology companies that share Novo Nordisk's vision to improve the lives of people with diabetes: Dexcom, Glooko and Roche.

Plainsboro-based BioNJ Member Novo Nordisk's Somapacitan, a novel growth hormone derivative in development for once-weekly administration of growth hormone, matched the therapeutic benefits of once-daily Norditropin®(somatropin) in a Phase 2 trial in children with growth hormone deficiency. There are currently no approved once-weekly treatments for growth hormone deficiency. 

East Hanover-based BioNJ Member Novartis announced results from a Phase III study of Lucentis® (ranibizumab) versus laser surgery (the current standard of care) in premature infants with retinopathy of prematurity (ROP), a rare disease but a leading cause of childhood blindness. Unlike laser surgery, which damages eye tissue and can be associated with significant complications such as high myopia, Lucentis pharmacologically targets and reduces the elevated intraocular level of vascular endothelial growth factor (VEGF), which is the underlying cause of the condition.

East Hanover-based BioNJ Member Novartis announced the winners of the 2018 eXcellence in Ophthalmology Vision Award (XOVA) for nonprofit eye health initiatives at EURETINA 2018. The 2018 XOVA winners will help create sustainable eye clinics, train healthcare professionals, fight childhood blindness and increase eye health awareness in rural populations.

Two letters sent to the Pentagon tested positive for ricin according to several reports. Investigators are still determining the origins of the letters; meanwhile, the mail delivery area of the Pentagon remains under quarantine. This could all be avoided if the heat-stable ricin vaccine, RiVax, from Princeton-based BioNJ Member Soligenix, was approved. The vaccine has been in the works since 2006, and has been awarded up to $24.7 million from the National Institute of Allergy and Infectious Diseases.

Princeton-based BioNJ Member  Soligenix, Inc. announced that it has been invited to present results from two of its development programs at National Organization for Rare Disorders' (NORD's) Rare Diseases and Orphan Products Breakthrough Summit. RiVax® is the company's proprietary vaccine candidate for the prevention of death following exposure to ricin toxin using a unique antigen that is completely devoid of the toxic activity of ricin.  RiVax® has demonstrated significantly enhanced thermostability and up to 100% protection in preclinical ricin aerosol challenge models.

Bridgewater-based BioNJ Member  Allergan plc  announced that the  U.S. Food and Drug Administration  ( FDA ) has accepted for review the company's supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine), seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults in the current product label.

Parsippany-based BioNJ Member  Taiho Oncology, Inc. announced real-world adherence data for patients with metastatic colorectal cancer (mCRC) who were treated with LONSURF® (trifluridine and tipiracil) or Stivarga® (regorafenib). In this retrospective study, medication adherence was assessed among adult patients with mCRC receiving LONSURF (469) or regorafenib (311). Treatment with LONSURF was associated with significantly higher medication adherence and longer time to discontinuation compared to treatment with regorafenib. 

Princeton-based BioNJ Member  Kyowa Hakko Kirin Co., Ltd., announced that the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency's (EMA) scientific committee, has adopted a Positive Opinion recommending approval of the marketing authorisation of mogamulizumab, a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

BioNJ Member  Ovid Therapeutics Inc.  announced initiations of the Phase 2 ELEKTRA and ARCADE trials for OV935/TAK-935 in pediatric patients with rare epilepsies. The company reports that the first patient has been randomized to receive either OV935 or placebo in the ELEKTRA trial and that patient screening is underway for the ARCADE trial. These trials are being conducted together with Ovid's collaboration partner  Takeda Pharmaceutical Company Limited .

BioNJ Member  AzurRx BioPharma, Inc. announced, in partnership with Mayoly Spindler, a European pharmaceutical company, that it achieved, in pre-planned analyses, both its primary and secondary endpoints with a statistically significant (p=0.002) improvement in the coefficient of fat absorption (CFA) of 21.8% (Per Protocol analysis), in its recent Phase IIa trial of MS1819-SD, a recombinant lipase, for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis. 

Bedminster-based BioNJ Member  Amarin Corporation  plc announced topline results from the Vascepa® cardiovascular (CV) outcomes trial, REDUCE-IT™, a global study of 8,179 statin-treated adults with elevated CV risk. REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance (p<0.001), in major adverse CV events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo.  

Woodcliff Lake-based BioNJ Member  Patagonia is excited to announce that we have been awarded a grant of $1.5MM over three years through FDA's Orphan Products Clinical Trials Grants Program! This non-dilutive funding will help support our clinical development of PAT-001, a proprietary topical formulation of isotretinoin in development for Congenital Ichthyosis. This is a highly competitive grant, generally awarded to less than 20% of applicants.  

Woodcliff Lake-based Eisai Co., Ltd. announced that it received approval from the U.S. Food and Drug Administration (FDA) for an indication expansion for Eisai's antiepileptic drug (AED) Fycompa (perampanel) to cover partial-onset seizures in pediatric patients with epilepsy 4 years of age and older. Fycompa was designated for Priority Review by the FDA, and was approved approximately six months after submission.

Ewing-based Antares Pharma, Inc. announced the approval of XYOSTED™ (testosterone enanthate) injection by the U.S. Food and Drug Administration (FDA). XYOSTED™ is the first FDA approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot® auto injector. XYOSTED™ has been approved in three dosage strengths, 50 mg, 75 mg and 100 mg and is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone

Princeton-based Luye Pharma Group has announced that the company's new drug candidate for the treatment of schizophrenia and schizoaffective disorders, Paliperidone Palmitate Injectable Suspension for Intramuscular Use (LY03010), has obtained approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. The FDA has confirmed acceptable demonstration of stable bioequivalence after multiple doses, satisfying the 505(b)(2) NDA submission requirements for LY03010 in the Pre-IND meeting minutes.

Parsippany-based GlaxoSmithKline  and Innoviva, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion supporting the use of Trelegy Ellipta (fluticasone furoate/ umeclidinium/vilanterol 'FF/UMEC/VI') in a broader group of patients with moderate to severe chronic obstructive pulmonary disease (COPD) and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD.

Parsippany-based GlaxoSmithKline and Aeras reported that GSK's M72/AS01E  candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection  in an ongoing Phase IIb clinical trial testing. These primary results published in the  New England Journal of Medicine  after two years of trial demonstrate an overall vaccine efficacy of 54%, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile.

Basking Ridge-based Daiichi Sankyo Company announced that it has entered into a clinical trial collaboration agreement with a subsidiary of BioNJ Member Merck & Co., Inc., to evaluate the combination of Daiichi Sankyo's investigational HER2 targeting antibody drug conjugate DS-8201 and KEYTRUDA ®  (pembrolizumab) in HER2 expressing advanced/metastatic breast and HER2 expressing or HER2 mutant non-small cell lung cancers (NSCLC).

Basking Ridge-based Daiichi Sankyo Company announced that the first patients have been dosed in DESTINY-Breast03 and DESTINY-Breast02, two global Phase 3 studies evaluating the safety and efficacy of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), in patients with previously-treated HER2 positive unresectable and/or metastatic breast cancer. 

Basking Ridge-based Daiichi Sankyo Company announced that updated phase 1 safety and efficacy data for [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), were presented for a subgroup of patients with heavily pretreated HER2 mutated or HER2 expressing non-small cell lung cancer (NSCLC) during an Oral Session at the IASLC 19th World Conference on Lung Cancer (#WCLC2018) hosted by the International Association for the Study of Lung Cancer in Toronto, Canada.

 

The New Jersey Innovation Institute, (NJII) an NJIT Corporation, recently conducted a cell and gene therapy manufacturing roundtable to launch its Cell and Gene Therapy Development Center at NJIT and address key industry manufacturing challenges. Roundtable participants included some of the world's leading pharmaceutical, pharma equipment and consulting companies including Novartis, Celgene, Merck, J&J, ThermoFisher Scientific, GE Healthcare, Pall Corporation,  Legend Biotech, Panasonic Healthcare, Sartorius Stedem and McKinsey & Company along with NJIT faculty.  

A new  Rutgers New Jersey Medical School  study shows that most people at high risk for tuberculosis (TB) relapse can be identified by testing the  Mycobacterium tuberculosis  bacteria that causes TB before the patient begins treatment. The study, led by Roberto Colangeli, assistant professor in the Department of Medicine, and David Alland, professor and chief of infectious disease in the Department of Medicine, appears in the New England Journal of Medicine.

In a new study published in the Journal of Internal Medicine, a Rutgers New Jersey Medical School (NJMS) faculty researcher and colleagues found that individuals with high levels of urinary Hcy-thiolactone, a chemically-reactive and toxic homocysteine metabolite, experienced 58% more heart attacks than individuals with low Hcy-thiolactone. To read the full study, visit the Journal of Internal Medicine website via the following link: b it.ly/wenbit92018.

Read the latest news on research, treatment, prevention and education from the State's National Cancer Institute-designated Comprehensive Cancer Center in Cancer Connection Monthly. 

 

Hackensack Meridian Health announced a new organizational structure, splitting the large health system into three regions: North, Central and South.  The regionalized strategy is not new in the country, or in the State --  RWJBarnabas Health  has already been using it - but Hackensack Meridian has added another component.  There will also be care transformation leaders, which will include  Carrier Clinic  CEO Don Parker if its merger with Hackensack is finalized, for behavioral health and mental health services.

Hackensack Meridian Health  has named Mark Sparta as President of  Hackensack University Medical Center . Dr.  Sparta will continue in his current role as the Executive Vice President of Population Health for Hackensack Meridian Health network. "I want to congratulate Dr. Sparta on his new executive leadership position. I am confident that his expertise and vision will best serve our patients, their families and our team members as Hackensack University Medical Center looks toward a promising future," said Robert C. Garrett, co-CEO of HMH.

Hackensack Meridian  Health  Hackensack University Medical Center is among the first hospitals in the world to acquire the innovative da Vinci single port (SP) system, a cutting-edge robotic-assisted technology used by surgeons to perform complex urological procedures. Hackensack University Medical Center, a center for excellence in advanced robotic surgery, is the first and only hospital in New Jersey to have access to this groundbreaking technology.

The new campus sits on 17-acres in Clifton and Nutley and houses Seton Hall's College of Nursing, School of Health and Medical Science and of course the brand-new medical school with Hackensack Meridian Health. It's one of few in the nation to cross health care disciplines in an academic setting. That means students from all three schools will get to use the shiny, new labs and latest technology. 

HealthStartNJ, established by Princeton-based BioNJ Member New Jersey Health Foundation, made a financial investment of  $50,000  in Paracelsus Neuroscience I, LLC ., , a startup company founded by Roland G.W. Staal, Ph.D. that focuses on the study and therapeutics of neuropathic pain. "Neuropathic pain is chronic, pathological pain caused by a lesion of the nervous system resulting in a significant decrease in the quality of life of an affected individual. Recent studies suggest that central and peripheral immune cells may play a significant role in its development and chronicity," explained Dr. Staal.