The  House of Representatives passed H.R. 3 in a nearly straight party-line vote last week. While prescription drug pricing reforms are needed, the legislation would unravel many of the market incentives that have made America the undisputed leader bringing new medicines -- and new hope -- to people facing devastating diagnoses.  Bipartisan legislation crafted by the  Senate Finance Committee , and supported by the White House, is the last opportunity Congress has to strike a sensible bargain that lowers drug costs for patients while sustaining America's leadership in this vital field.

The Senate confirmed Dr. Stephen Hahn as the next Food and Drug (FDA) Commissioner yesterday in a 72-18 vote.  Dr. Hahn is leaving his post as Chief Medical Executive at Houston's MD Anderson Medical Center. He is taking over from Dr. Ned Sharpless, who has served as acting commissioner after Dr. Scott Gottlieb resigned earlier this year. Dr. Sharpless will return to his job leading the National Cancer Institute. 

Improving affordability for prescription drugs, especially for seniors, has remained a key priority in Washington for the past year, both on Capitol Hill and with the administration. High out-of-pocket (OOP) exposure for Patients, particularly for those with chronic conditions, can threaten access and adherence and may lead to worsened Patient outcomes. PCSK9 inhibitors, a relatively new class of drugs designed to lower cholesterol levels and reduce the risk of heart attacks and strokes, have encountered challenges with uptake. 

The U.S. House Ways and Means Committee, which oversees the Medicare program, voted in favor of  House Resolution 3, the Elijah E. Cummings Lower Drug Costs Now Act.  This bill establishes several programs and requirements relating to the prices of prescription drugs. In particular, the bill requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain drugs -- current law prohibits the CMS from doing so. BioNJ President and CEO Debbie Hart said: "Today marks a very disappointing step in the fight to ensure that American patients have the greatest access in the world to lifesaving prescription drugs and biologics. H.R. 3 would decimate investment in the biopharmaceutical industry, reduce Patient access to lifesaving cures and disrupt the wildly successful Medicare Part D program."

For Debbie Hart, President and CEO of  BioNJ, the issues around including more women in STEM can be simplified.  "If one subscribes to the 'We can't be what we can't see' theory, then the opposite is true when BioNJ can help show women at all points in their professional development the pathways and people who can help them discover their potential," she said. Hart was speaking in reference to BioNJ's fifth annual Inspiring Women in STEM Conference, held at Sanofi U.S. headquarters in Bridgewater. More than 100 women with careers in all aspects of science, technology, engineering and mathematics attended.

Dr. Gaurang Daftary, Senior Director of Medical Affairs, Reproductive Medicine and Maternal Health at  Ferring Pharmaceuticals , said it was important for all the women attending  BioNJ 's Inspiring Women in STEM conference to understand how they themselves have been affected by systemic limitations in women's health care. "Women respond differently to diseases and diseases are differently manifested in women -- yet much of the research for available treatments have been based on male models," he said. "We still need more female models in all sorts of clinical trials."

The NJBIZ Manufacturing Power 50 represent  the men and women who have been, and will continue to be, responsible for maintaining and expanding the skilled workforce necessary for a strong Garden State manufacturing sector. In addition to BioNJ President and CEO Debbie Hart, these BioNJ Members made the list:

• Giovanni Caforio, Bristol-Myers Squibb
• Frank Danieli, Choose New Jersey
• Kenneth Frazier, Merck & Co.
• Julia Lopez, Reed Smith LLP
• Richard McCardle, Rutgers Food Innovation Center 
• Brian Sabina, NJEDA
• Marco Taglietti, SCYNEXIS, Inc.
• Michael Tardugno, Celsion Corp. 

Basking Ridge-based BioNJ Member  Amgen  announced that the  U.S. Food and Drug Administration  ( FDA ) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

Basking Ridge-based BioNJ Member  Amgen  announced additional results from the primary analysis of the Phase 3 CANDOR study evaluating KYPROLIS ®  (carfilzomib) in combination with dexamethasone and DARZALEX ®  (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma. At a median follow up of 17 months, the study met its primary endpoint of progression-free survival (PFS), resulting in a 37% reduction in the risk of disease progression or death in patients receiving KdD (HR=0.63; 95% CI: 0.464, 0.854; p=0.0014). Median PFS was not reached for the KdD arm versus 15.8 months for the Kd arm.

OncoSec Presents Interim Data of 28.5% Objective Response Rate (ORR) from Ongoing KEYNOTE-890 Study Evaluating TAVO™ in Combination With KEYTRUDA® for Heavily Pretreated, Late-Stage, Metastatic Triple Negative Breast Cancer (mTNBC) at the 2019 San Antonio Breast Cancer Symposium 

Berkeley Heights-based BioNJ Member Chugai Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for nemolizumab, an anti-interleukin-31 (IL-31) receptor A humanized monoclonal antibody created by Chugai, for the treatment of pruritus associated with prurigo nodularis. The designation was received by Galderma, a global leader in skin health, with whom Chugai made a license agreement for the development and marketing of nemolizumab worldwide with the exception of Japan and Taiwan.

Princeton-based BioNJ Member  Soligenix, Inc. announced that it has opened the study titled "A Phase 1C, Double-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety of RiVax®, a Lyophilized Ricin Toxin A-Chain Subunit Vaccine with Alum-Adjuvant, in Healthy, Normal Adults." Preliminary safety results from the trial are expected in the second quarter of 2020 with longer-term safety and immunogenicity results from throughout the 6-month follow-up period expected in the fourth quarter of 2020.

Berkeley Heights-based BioNJ-Member  Cyclacel Pharmaceuticals, Inc.  announced study design and preliminary data from two of the company's Phase 1 studies evaluating a combination of CYC065, a CDK2/9 inhibitor, with venetoclax, a BCL2 inhibitor, to treat patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) and chronic lymphocytic leukemia (CLL) respectively. The CYC065-venetoclax combination was well tolerated and no dose-limiting toxicities have been reported. No tumor lysis syndrome was observed. 

Warren -based BioNJ-Member  Celularity, Inc. announced data introducing an extensive platform in genetically-modified NK- and T cell-based programs, and highlighting long-term safety and efficacy results from the Phase 1 study of PNK-007 in patients with multiple myeloma (MM). In pre-clinical studies, Celularity's allogeneic, placental-derived CD19 CAR T cell-based product candidate demonstrated in vivo anti-tumor efficacy in a lymphoma tumor model. 

Parsippany-based BioNJ Member Ferring Pharmaceuticals announced positive results from the pivotal Phase 3 clinical trial evaluating nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy, for the treatment of high-grade, Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). FKD Therapies Oy (FKD) has led the development and regulatory filing of nadofaragene firadenovec, which has been studied in 33 centers across the U.S. in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). 

BioNJ-Member  Pfizer, with offices in Peapack, and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). In 2019, it is estimated that just over 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.

BioNJ-Member  Pfizer, with offices in Peapack, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VYNDAQEL® (tafamidis), a once-daily 61 mg oral capsule, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). ATTR-CM is a rare, life-threatening disease characterized by the buildup of abnormal deposits of misfolded protein called amyloid in the heart and is defined by restrictive cardiomyopathy and progressive heart failure.

BioNJ-Member  Pfizer, with offices in Peapack, announced updated follow-up results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy in patients with severe hemophilia A. The data showed that SB-525 was generally well tolerated and demonstrated sustained increased Factor VIII (FVIII) levels following treatment with SB-525 through to 44 weeks, the extent of follow-up for the longest treated patient in the 3e13 vg/kg dose cohort. 

East Hanover -based BioNJ-Member  Novartis announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E (IgE). The FDA is expected to make a decision on approval for this indication by Q3 2020.

MONALEESA-3 data published in The New England Journal of Medicine shows  East Hanover -based BioNJ-Member  Novartis Kisqali® (ribociclib) plus fulvestrant demonstrated a statistically significant improvement in overall survival, with an almost 30% reduction in risk of death compared to fulvestrant alone, in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. 

Princeton-based BioNJ-Member  Genmab A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX® (daratumumab) in the European Union. The recommendation is for the use of DARZALEX in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 ALCYONE study, which showed the addition of DARZALEX® (daratumumab) to bortezomib, melphalan and prednisone (D-VMP) improved OS in patients with newly diagnosed, transplant-ineligible multiple myeloma, with a 40 percent reduction in the risk of death compared to VMP alone. These updated data from the ALCYONE study also demonstrated that the addition of DARZALEX® to VMP resulted in higher rates of minimal residual disease (MRD) negativity.

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the Phase 3 CANDOR study showing the addition of DARZALEX® (daratumumab) to carfilzomib (Kyprolis®) and dexamethasone (DKd), compared to carfilzomib and dexamethasone (Kd) alone, significantly improved progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma, resulting in a 37 percent reduction in the risk of progression or death (HR, 0.63; 95 percent CI, 0.46-0.85; P=0.0014).

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-68284528 (JNJ-4528), an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in previously treated patients with multiple myeloma. Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.

Titusville-based BioNJ Member Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, announced that it has entered a definitive agreement to acquire all rights to the investigational compound bermekimab from XBiotech Inc. Bermekimab is an anti-IL-1alpha monoclonal antibody (mAb) in Phase 2 development for the treatment of atopic dermatitis and hidradenitis suppurativa. It is the only antibody targeting IL-1a currently in clinical development and has the potential for superior efficacy and safety compared to the current standard of care.

New Brunswick-based BioNJ Member Johnson & Johnson announced that its Janssen Pharmaceutical Companies will provide up to 200,000 Ebola vaccine regimens to the Republic of Rwanda. This commitment will support a new immunization program led by the Rwanda Government that aims to help protect the country's citizens from the Ebola outbreak in neighboring Democratic Republic of the Congo (DRC). The first batches of Janssen vaccine have been delivered to the country, and further shipments are being organized.

Princeton -based BioNJ Member  Bristol-Myers Squibb Company  announced clinical results from the QUAZAR AML-001 study, evaluating investigational agent CC-486 as maintenance therapy in a broad population of patients with front-line, newly diagnosed acute myeloid leukemia (AML) who have achieved remission with intensive induction chemotherapy. In the QUAZAR AML-001 study, treatment with CC-486 in the maintenance setting provided patients a statistically significant and clinically meaningful improvement in overall survival (OS) and relapse-free survival (RFS), as compared to those patients treated with placebo.

Princeton -based BioNJ Member  Bristol-Myers Squibb Company  and Acceleron Pharma announced data evaluating the erythroid maturation agent (EMA) Reblozyl ® (luspatercept-aamt) in patients with anemia associated with a range of serious and rare blood diseases. "The data presented at ASH this year underscore the role that Reblozyl, the first and only erythroid maturation agent, plays for patients with beta thalassemia-associated anemia and may serve in further investigational uses in myelofibrosis and MDS," said Samit Hirawat, M.D., Chief Medical Officer of Bristol-Myers Squibb.

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

Merck's KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients With High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Data from Exploratory Analysis Show Merck's KEYTRUDA® (pembrolizumab) Improved Overall Survival as Monotherapy for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer Regardless of KRAS Mutational Status

Merck to Acquire ArQule, Advancing Leadership in Oncology

Princeton -based BioNJ-Member  PDS Biotechnology Corporation   announced that Dr. Jared Weiss , an internationally recognized expert in the field of thoracic and head and neck cancers and faculty at the  University of North Carolina at Chapel Hill  School of Medicine and  Lineberger Comprehensive Cancer Center , will be the Principal Investigator for the Company's Phase 2 VERSATILE-002 study in collaboration with BioNJ Member  Merck & Co . The combination study will evaluate the efficacy and safety of PDS Biotech's lead Versamune®-based immunotherapy, PDS0101, in combination with  Merck's  anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in the first-line treatment of patients with recurrent or metastatic human papillomavirus-16 (HPV16) positive head and neck cancer. 

Bridgewater-based BioNJ-Member  Eli Lilly and Company  announced the launch of TRIUMPH, a long-term, real-world evidence study of Emgality ®  (galcanezumab-gnlm). The objective of the TRIUMPH study (Preventive Tr eatment of Mi graine: Ou tcom es for P atients in Real-World H ealthcare Systems) is to evaluate the real-world effectiveness of Emgality, in comparison to other preventive treatments for migraine, among people receiving routine medical care who are switching or beginning a new prescription treatment for migraine prevention.

Bridgewater-based BioNJ-Member  Eli Lilly and Company  has announced a global commercialization agreement to integrate  DexCom, Inc.  products into Lilly's personalized diabetes management system, currently in development to advance the treatment of diabetes. Under the terms of the non-exclusive agreement, Lilly will use Dexcom's continuous glucose  monitoring (CGM) devices in both the pen- and pump-based platforms of the system being designed to help improve diabetes management.

Bridgewater-based BioNJ-Member  Eli Lilly and Company  announced that the  European Medicines Agency's  (EMA)  Committee for Medicinal Products for Human Use  (CHMP) issued a positive opinion recommending a new indication and associated label update for CYRAMZA ®  (ramucirumab). The Committee agreed that the label should include an indication for CYRAMZA in combination with erlotinib for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. 

Bridgewater-based BioNJ-Member  Eli Lilly and Company  announced the opening of the LIBRETTO-431 clinical trial [NCT04194944] for selpercatinib, also known as LOXO-292, for treatment-naïve RET  fusion-positive non-small cell lung cancer (NSCLC) patients. Enrolled trial participants will be randomized to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET  fusion-positive NSCLC.

Bridgewater-based BioNJ-Member  Eli Lilly and Company  announced interim clinical data from the LOXO-305 global Phase 1/2 BRUIN dose escalation trial. LOXO-305 is an investigational, highly selective, non-covalent Bruton's tyrosine kinase (BTK) inhibitor. At all doses studied, LOXO-305 delivered objective responses in patients who had received diverse prior therapies and had exhibited varied molecular mechanisms of acquired resistance.

Madison-based BioNJ-Member  Allergan plc  announced that positive results from ACHIEVE I (UBR-MD-01), a robust Phase 3 clinical trial evaluating the efficacy, safety and tolerability of ubrogepant, have been published in The New England Journal of Medicine. The data from this second published pivotal trial reinforced that the acute treatment of migraine with ubrogepant, compared with placebo, led to significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours with both the 50 mg and 100 mg doses.

Morristown-based BioNJ-Member  BioAegis Therapeutics, Inc. announces publication of new research findings with recombinant human plasma gelsolin in influenza. The research demonstrates that recombinant human plasma gelsolin therapy dramatically improves survival in a highly lethal influenza animal model. Seasonal influenza continues to be a cause of substantial morbidity and mortality. The U.S. Center for Disease Control and Prevention (CDC) documented that seasonal influenza was responsible for close to 57,000 deaths during the 2018-2019 season.

The New Jersey  Commission on Science, Innovation and Technology (CSIT)  announced that it has named Judith A. Sheft as its Executive Director. Sheft, who has an extensive background in fostering opportunities for early-stage New Jersey companies and for the next generation of New Jersey entrepreneurs, will officially take the helm of the CSIT beginning January 13, 2020. In August 2018, Governor Murphy signed legislation re-establishing the former New Jersey Commission on Science and Technology as the CSIT. Comprised of representatives from the public and private sectors, as well as academia, the Commission is tasked with leading the way in promoting the State as a home for academic and technological research, development, and commercialization.

Princeton -based BioNJ Member SCYNEXIS, Inc. announced the appointment of accomplished business development executive Philippe Tinmouth to its Board of Directors. Mr. Tinmouth brings over 20 years of experience across multiple business development and alliance management roles, and is retiring as Vice President and Head of Business Development at Vertex Pharmaceuticals Incorporated, a role he has held since 2013.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that John Elicker, Executive Vice President, Corporate Affairs and Investor Relations, will retire from the company March 31, 2020. Kathryn Metcalfe, currently Chief Communications Officer of CVS Health, has been appointed Executive Vice President, Corporate Affairs, effective January 6, 2020. Tim Power has been appointed Vice President and Head of Investor Relations, effective March 31, 2020 upon Mr. Elicker's retirement.

Paramus -based Ichnos Sciences Inc. is pleased to announce two important additions to its leadership team. Patrick E. Flanigan III has assumed the role of Chief Financial Officer and Martin L. Wilson will start as General Counsel (GC) effective January 7, 2020. Mr. Flanigan is a finance leader with over 20 years of experience in the biotechnology industry. Prior to joining Ichnos Sciences, he served as Senior Vice President of Investor Relations & Treasury for Celgene Corporation. Mr. Wilson is joining Ichnos Sciences from Teligent, Inc., where he served as GC from 2017-2019. He has more than 15 years of experience in the pharmaceutical industry.

NJIT to Launch New Programs in Cell and Gene Therapy

Representative Pallone Recognized as 2019 'Champion of Science'

Novel Cell-Based Therapy Induces Cell Death in Sensitive and Resistant Non-Hodgkin Lymphoma Models

Rutgers Cancer Institute IDs Gene With Ovarian Cancer Prognosis Potential

Rutgers University, Microsoft Launch App to Fight SIDS

Stevens Institute of Technology Opens $68M Gateway Academic Center

Soligenix to Receive $850,000 in Non-Dilutive Funding Through New Jersey Technology Business Tax Certificate Transfer Program 

OncoSec to Receive Approximately $885,000 Through New Jersey Technology Business Tax (NOL) Program 

Celsion Receives $2.0 Million Allocation Through the New Jersey Technology Business Tax Certificate Transfer (NOL) Program

46 Approved for EDA's Tech, Life Science Business Tax Credit