Bedminster-based BioNJ Member Tyme Technologies, Inc. announced the results of a health economic outcomes study demonstrating that the therapeutic benefit of increasing the use of novel medicines is so great that it is driving a decrease in the actual total cost of healthcare. Health technology assessment programs are increasingly using real-world, longitudinal patient data to assess the effect of new medicines on total cost of care. This study analyzed such data to measure the impact of new pancreatic cancer therapies on other, non-drug medical expenditures.

Princeton-based BioNJ Member  Advaxis, Inc.  announced updated clinical and biomarker results from the monotherapy and combination arms of the Company's ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC). The trial is evaluating ADXS-503, alone and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. ADXS-503 is part of the Company's ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

East Hanover-based BioNJ Member AveXis, a Novartis company, announced the European Commission (EC) granted conditional approval for Zolgensma® (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene. The approval covers babies and young children with SMA up to 21 kg according to the approved dosing guidance.

Bridgewater-based BioNJ Member Amarin Corporation plc announced that data from the REDUCE-IT® study showed that administration of 4 g/day of VASCEPA® (icosapent ethyl) resulted in a significant 34% reduction in first coronary revascularizations versus placebo (p<0.0001). Similar reductions of 36% were observed in total, or first and subsequent, revascularizations (p<0.0001). Coronary revascularization procedures are invasive, carry multiple risks, and can have significant direct and indirect costs.

Parsippany-based BioNJ Member Ferring Pharmaceuticals welcomes the Swissmedic approval of Carbetocin Ferring, a heat-stable formulation of carbetocin, for the prevention of excessive bleeding after childbirth following all births, both vaginal and caesarean section. Every year, 14 million women experience excessive bleeding after birth, also known as postpartum haemorrhage (PPH),2 which leads to approximately 70,000 deaths per year. Although most deaths are preventable, PPH is the leading direct cause of maternal death worldwide, 99% of which occur in low- and lower-middle income countries.

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced  it has commenced the collection of convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia Inc., from individuals who have recovered from COVID-19.  ADMA is seeking U.S. citizens who have recovered from coronavirus (SARS-CoV-2) or COVID-19, to donate plasma, which can be used to produce an immune globulin to potentially help infected patients with COVID-19. People who have recovered from COVID-19 can have antibodies in their plasma that may be helpful in treating the virus. Immune globulin is a plasma-derived medicine that is comprised of polyclonal antibodies and is routinely used for the prevention and treatment of certain infectious diseases. 

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced The CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration recently established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19, is rapidly building momentum. Its membership has expanded globally to include 10 plasma companies, and now also includes global organizations from outside the plasma industry who are providing vital support to encourage more people to donate plasma.

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced that it has completed the submission of a Phase 1 data memo and the Phase 2a protocol to the FDA, and intends to commence its Phase 2a clinical trial of CRV431 for the treatment of NASH fibrosis in June. The randomized, single-blind, placebo-controlled, multi-center study, entitled "AMBITION: A Phase 2a, Multi-center, Single-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of CRV431 Dosed Once Daily in NASH induced F2 and F3 Subjects," will enroll 18 adults with presumed NASH F2 or F3 fibrosis. 

Basking Ridge-based BioNJ Member  Caladrius Biosciences along with researchers from Cedars-Sinai (Los Angeles), Mayo Clinic (Rochester, Minn.) and The Christ Hospital (Cincinnati), today presented full data results from the ESCaPE-CMD trial of Caladrius's autologous CD34+ cell therapy, CLBS16. Data showed highly statistically significant improvement in coronary flow reserve ("CFR") correlating with symptom relief for patients with coronary microvascular dysfunction ("CMD") after a single intracoronary injection of CLBS16.

Basking Ridge-based BioNJ Member Ipsen announced that data from the matching-adjusted indirect comparison (MAIC) of Cabometyx® (cabozantinib) versus Stivarga® (regorafenib) for the second-line (2L) treatment of patients with advanced hepatocellular carcinoma (aHCC) who received sorafenib as the only prior systemic therapy were published in Advances in Therapy. The MAIC represents the first published analysis of the comparative efficacy and safety of two key 2L treatments for aHCC.

Plainsboro-based BioNJ Member Novo Nordisk announced headline results from STEP 4, the first completed phase 3a trial in the STEP program. STEP 4 is a randomized, double-blind, multicentre, placebo-controlled, withdrawal trial exploring sustained weight management with semaglutide vs placebo. The 68-week trial investigated the effect of once-weekly subcutaneous (sc) semaglutide 2.4 mg on body weight in 902 people with obesity or overweight with comorbidities. 

Princeton-based BioNJ Member  Oyster Point Pharma, Inc. announced the pricing of its underwritten public offering of 3,750,000 shares of its common stock at a price to the public of $28.00 per share. All of the shares are being offered by Oyster Point Pharma.  The gross proceeds to Oyster Point Pharma from the offering, before deducting underwriting discounts and commissions and estimated offering expenses to be payable by Oyster Point Pharma, are expected to be $105.0 million.

BioNJ Member Pfizer Inc., with offices in Peapack, announced updated Phase 1b clinical data on PF-06939926, an investigational gene therapy being developed to treat Duchenne muscular dystrophy (DMD). The preliminary data from 9 ambulatory boys with DMD, aged 6 to 12 (mean age: 8 years) indicate that the intravenous administration of PF-06939926 was well-tolerated during the infusion period, with encouraging efficacy and manageable safety events, even when considering those adverse events that were more severe in nature. 

BioNJ Member Pfizer Inc., with offices in Peapack, announced top-line results from a second Phase 3 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) candidate in adults 18 through 49 years of age not previously vaccinated against pneumococcal disease. Responses elicited by 20vPnC for all 20 serotypes were equivalent across all three lots, meeting the primary immunogenicity objective of the study. 

Bridgewater-based BioNJ Member  Eli Lilly and Company  announced baseline results from the GERAS-US Study examining the societal costs associated with mild cognitive impairment (MCI), mild dementia (MILD), and caring for someone with Alzheimer's disease (AD). The study, published in  The Journal of Alzheimer's  Disease , is the first of its kind to show how early stages of cognitive decline economically impact both patients and caregivers. Alzheimer's is a relentless, fatal disease creating a health crisis for patients, families and society. Out of the top six diseases affecting Americans, AD is the only one with no treatment to prevent, cure or slow the disease.

Bridgewater-based BioNJ Member  Eli Lilly and Company announced that the  U.S. Food and Drug Administration  (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET -mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET  fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Princeton-based BioNJ Member  Bristol Myers Squibb  announced  the FDA granted accelerated approval to pomalidomide for treatment of two forms of Kaposi sarcoma.  The approval applies to use of pomalidomide (Pomalyst, Bristol-Myers Squibb) by patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or by  patients with Kaposi sarcoma  who are HIV-negative. Pomalidomide -- a thalidomide analogue already approved for use with dexamethasone for treatment of certain patients with multiple myeloma -- is the first new treatment option for Kaposi sarcoma in more than 20 years.

Princeton-based BioNJ Member  Bristol Myers Squibb announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Princeton-based BioNJ Member  Bristol Myers Squibb announced the first presentation of results from the Phase 3 CheckMate -9LA trial, which demonstrated a statistically significant and clinically meaningful survival benefit with Opdivo (nivolumab) plus Yervoy (ipilimumab), given concomitantly with two cycles of chemotherapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC). The study met both its primary and key secondary endpoints, demonstrating superior overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) for the dual immunotherapy plus chemotherapy combination versus chemotherapy alone.

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ-4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma. 

New Brunswick-based BioNJ Member Johnson & Johnson has formed a collaboration with Lava Therapeutics to develop gamma-delta T-cell engagers. The agreement moves J&J into an emerging corner of the immuno-oncology sector that has attracted the interest of companies including Pfizer Ventures and Takeda. Gamma-delta T cells are lymphocytes that play a role in natural and induced immunity to cancer.

Kenilworth-based BioNJ Member  Merck & Co. and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Kenilworth-based BioNJ Member  Merck & Co. announced positive results from the Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (mTNBC). In patients whose tumors expressed PD-L1 with Combined Positive Score (CPS) ≥10, KEYTRUDA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 35% (HR = 0.65 [95% CI, 0.49-0.86], p=0.0012) and improving PFS to a median of 9.7 months compared to 5.6 months for those receiving chemotherapy alone. 

Kenilworth-based BioNJ Member  Merck & Co. announced the first presentation of results from KEYNOTE-204, a Phase 3 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). In this pivotal study, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the dual primary endpoints. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p=0.00271]) and showed a median PFS of 13.2 months compared with 8.3 months for patients treated with brentuximab vedotin (BV), a current standard of care in this patient population. 

Kenilworth-based BioNJ Member  Merck & Co. announced first-time results from a Phase 2 trial evaluating the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck's oncology pipeline, for the treatment of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC). In the trial, MK-6482 demonstrated durable responses with a confirmed objective response rate (ORR) of 27.9% (n=17/61) (95% CI: 17.1-40.8), and the median duration of response (DOR) was not yet reached (range: 9.1-39.0 weeks).

Kenilworth-based BioNJ Member  Merck & Co. announced positive results from two studies from the company's leading lung cancer research program. Initial results from the Phase 2 KEYNOTE-799 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus concurrent chemoradiation therapy (CCRT) demonstrated an objective response rate (ORR) of 67.0% in Cohort A (squamous and nonsquamous non-small cell lung cancer [NSCLC] patients who received paclitaxel plus carboplatin) and 56.6% in Cohort B (nonsquamous NSCLC patients who received cisplatin plus pemetrexed) in untreated patients with unresectable, locally advanced stage III NSCLC. 

Kenilworth-based BioNJ Member  Merck & Co. announced results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase 3 clinical trial evaluating RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), the active comparator, in the primary and key secondary endpoints of the study, 28-day all-cause mortality and clinical response, respectively.

Kenilworth-based BioNJ Member  Merck & Co.  announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck's anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy and the relationship of exposure to safety. 

Kenilworth-based BioNJ Member  Merck & Co. announced it will acquire the U.S. rights to two Sentinel brands in the companion animal segment. For $400 million, Merck said it acquired Sentinel's Flavor Tabs and Spectrum Chews to enhance its offerings in canine parasite protection.  The deal is expected to close by mid-year 2020.  Merck Animal Health's Scott Bormann, senior vice president, North America commercial operations, said the product acquisition is anticipated to provide veterinarians with a comprehensive and continuous parasite protection for dogs in easy to use and eat formulas.

Kenilworth-based BioNJ Member  Merck & Co. announced that Infectious Disease Connect Inc., a UPMC-backed company offering telemedicine-enabled solutions to hospitals for treatment of infectious diseases, has combined with Merck's ILÚM Health Solutions, a provider of technology and services to support infectious disease management, clinical decision-support and precision antibiotic therapy.

Princeton-based ReGenTree, LLC  announced the results of a randomized, double masked, placebo-controlled Phase 3 clinical trial (SEER-1) using RGN-259 for the treatment of neurotrophic keratopathy (NK). The study originally planned to recruit 46 patients using RGN-259, the same eye drop formulation used in the dry eye trials. However, because of slow patient recruitment and future pricing strategy for NK as a rare disease, the trial was closed early and 18 patients were analyzed.

Warren-based  Bellerophon Therapeutics, Inc.  said the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application, allowing it to initiate a Phase 3 study of INOpulse® inhaled nitric oxide (iNO) therapy in up to 500 patients infected with COVID-19. The IND acceptance follows an agreement by the FDA earlier this year to allow investigational treatment with INOpulse for COVID-19 patients under emergency expanded access. To date, over 50 patients with COVID-19 have received treatment with INOpulse under the care and supervision of their physicians.

Warren-based  Bellerophon Therapeutics, Inc.  announced the pricing of offerings for an aggregate of 3,076,923 shares of its common stock at a public offering price of  $13.00  per share. The Offerings consisted of an underwritten public offering of 1,923,077 shares and a registered direct offering of 1,153,846 shares to an institutional investor affiliated with a member of the company's board of directors. 

Neurotrope Inc. and Freehold-based Metuchen Pharmaceuticals LLC revealed the two merged to become Petros Pharmaceuticals Inc., a company expected to become a Nasdaq traded company focused that is solely on men's health conditions.  Petros' cornerstone product would be Metuchen's Stendra (avanafil) for erectile dysfunction (ED), and its pipeline would include Metuchen's recently in-licensed product H-100 for Peyronie's disease. Petros will include a business development program exploring various men's health products, including endothelial dysfunction, prostate cancer, psychosexual and psychosocial ailments, hormone health and substance use disorders.

Lipocine Inc., with offices in Lawrence Township, announced the results of a pre-clinical study of LPCN 1144. LPCN 1144 is an oral prodrug of bioidentical testosterone ("testosterone undecanoate" or "TU"). The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet ("HFD")-induced, rabbit animal model of NASH and hepatic fibrosis. In the pre-clinical study, the HFD induced histological NASH features with fibrosis, altered key biomarkers and lowered serum testosterone levels. 

Princeton-based Neurotrope, Inc. and Freehold-based Metuchen Pharmaceuticals, L.L.C., announced that the two companies have entered into a definitive merger agreement under which Metuchen and Neurotrope, Inc. will merge in an all-stock transaction resulting in a newly formed holding company to be renamed Petros Pharmaceuticals, Inc. Petros is expected to become a Nasdaq traded company focused solely on men's health conditions. Petros' cornerstone product would be Metuchen's Stendra ® (avanafil) for erectile dysfunction.

Ridgefield Park-based  BeiGene, Ltd.  and Medison Pharma Ltd.  announced an exclusive distribution agreement for Medison to commercialize BeiGene's BTK inhibitor BRUKINSA™ (zanubrutinib) in Israel and the acceptance of a new drug application (NDA) in Israel for BRUKINSA for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Princeton-based  Certara® and DMTC have entered into a research collaboration to evaluate the preventative use of chloroquine in health care workers at risk of infection from the novel coronavirus strain that causes COVID-19. Certara will support the DMTC-led clinical trial by analyzing study data to develop mathematical models to understand the viral time course and factors impacting drug exposure and prophylactic response in health care workers. 

Woodcliff Lake-based Timber Pharmaceuticals said that the company closed its merger with BioPharmX Corp. and that the combined entity had completed a private placement financing valued at $25 million.  The biopharmaceutical company, which is focused on developing and commercializing treatments for orphan dermatologic diseases, will operate under the Timber Pharmaceuticals name and trade on the small-cap NYSE American Market. 

Thorofare-based Akers Biosciences, Inc. announced the closing of its previously announced registered direct offering of an aggregate of 1,366,856 shares of the company's common stock, at a purchase price of $3.53 per share priced at-the-market under Nasdaq rules. The gross proceeds to the company from this offering was approximately $4.8 million, before deducting the placement agent's fees and other offering expenses payable by the company.

Cranford-based  Citius Pharmaceuticals Inc. announced the closing of the previously announced registered direct offering priced at-the-market under Nasdaq rules.  In the offering, Citius sold 7,058,824 shares of its common stock, at a purchase price per share of $1.0625. Additionally, Citius issued to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock. 

Kenilworth-based BioNJ Member  Merck & Co. announced the appointment of Matthew Walsh and Rachel Stahler as Chief Financial Officer and Chief Information Officer, respectively, for Organon & Co., its intended spinoff of its women's health, legacy brands and biosimilars businesses. In his new role, Mr. Walsh will be responsible for the development and execution of the company's overall financial strategy. Ms. Stahler will be responsible for all information technology strategy, infrastructure, operations and delivery for Organon. 

Nancy Wysenski has been appointed to Oldwick-based Provention's board of directors. Ms. Wysenski, the former Chief Commercial Officer of Vertex Pharmaceuticals, brings over 30 years of leadership in biotechnology and pharmaceuticals, and a proven track record in innovative therapeutic launches and corporate value creation, including rare life-impacting diseases with high unmet need.

Montclair-based  Theranica USA  announced the appointment of two senior executives amid growing demand for the company's prescription migraine treatment device  Nerivio® .  Dave Duff , formerly of Sunovion Pharmaceuticals, joins Theranica as Head of Marketing and Training, and  Jennifer Stanton  from pharmaceutical company Zogenix joins as Head of Market Access to lead all reimbursement and access initiatives for Nerivio.

Englewood-based  Enzychem Lifesciences  announced that Dr.  Cameron Robert Wolfe , Associate Professor of Medicine at  Duke University  School of Medicine, an internationally renowned specialist in infectious diseases, has been appointed to lead the company's U.S COVID-19 efforts of the development of EC-18 as a COVID-19 therapeutic drug. Dr. Wolfe has been leading Duke University Medical School's Coronavirus Task Force, where he has been on the frontlines treating COVID-19 patients.

Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, announced that Rutgers Cancer Institute of  New Jersey  has become the 37 th  member of its Caris Precision Oncology Alliance™. The Alliance is a collaborative network of leading cancer centers that demonstrate a commitment to precision medicine. These centers work together to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology through conducting research studies focused on predictive and prognostic markers that advance the clinical outcomes of patients with cancer.

Aiming to identify new therapeutic strategies for the aggressive hematological disease T-cell acute lymphoblastic leukemia (T-ALL), Rutgers Cancer Institute of New Jersey resident researcher  Daniel Herranz Benito, Ph.D. , along with collaborators from Princeton University, found a new drug that has therapeutic effect against T-ALL by inhibiting SHMT and is complementary to standard-of-care treatment.

Hackensack Meridian Health invested in regenerative medicine company EpiBone Inc.