Welcome to the latest edition of the
BioLines
Weekender...
We hope this letter finds you
safe and well.
During these sad and uncertain time
s,
we continue to find hope in the tireless work being done by New Jersey's life sciences ecosystem to bring forward antiviral therapies and vaccines to combat the virus. We thank our Members for
your commitment to Patients around the world.
We are saddened by the loss of colleagues and friends due to COVID-19, including the passing of industry and academic legend Dr. Arnold (Arny) Demain, world-renowned microbiologist, research fellow of the Research Institute for Scientists Emeriti (RISE) program at Drew University and founder of the department of fermentation microbiology at Merck & Co, Inc. Dr. Demain's legacy lives on in his daughter, former BioNJ board member Pam Demain. We invite BioNJ Members to s
hare the names of those who have also passed due to the Coronavirus so that we can remember them to
BioNJ@BioNJ.org
.
Yesterday, BioNJ hosted its first program in our newly announced series, "Business UnUsual: A Webinar Series in the Age of COVID-19". Covering topics affecting our Members during this unprecedented time, yesterday's webinar, entitled "Labor & Workforce Management: Legal and Tax Implications for Life Sciences Companies", featured
New Jersey Department of Labor and Workforce Development Commissioner Robert Asaro-Angelo, along with experts from Faegre Drinker and RSM US LLP.
They engaged in an
informative discussion on topics including contingency planning, paid leave, immigration policies and tax implications. Click here for a recording of the webinar and see below for a listing of next week's
webinars on finance and cybersecurity.
Wishing everyone the very best of health.
Please reach out if we can assist you in any way.
Because Patients Can't Wait®,
The BioNJ Team
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In Memoriam:
BioNJ remembers our Members who have lost their fight to COVID-19
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Dr.
Arnold Demain, Research Fellow, Research Institute for Scientists Emeriti, Drew University
Steven Peltier, Vice President, Regulatory Affairs and Quality Compliance, Recordati
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BioNJ Calendar |
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NEW! BioNJ's Business UnUsual Webinar Series:
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Finance in the Age of COVID-19
Federal Relief Packages: Deciphering Your Options
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April 15, 2020
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IT/Cybersecurity in the Age of COVID-19 Webinar:
The Do's and Don'ts of Working from Home
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April 16, 2020
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Health Coverage in the Age of COVID-19
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April 23, 2020
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DATE CHANGED TO OCTOBER 6, 2020!
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BioNJ's 10th Annual BioPartnering Conference
Somerset, NJ
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October 6, 2020
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BioNJ's C-Suite Summit
Bridgewater, NJ
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October 30, 2020
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BioNJ's Manufacturing Briefing
New Jersey Innovation Institute
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Save the date!
November 12, 2020
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Putting Patients First: The Value of Medical Innovation
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Medical innovation enables longer and better quality lives and, in turn, reduces the costs of health care. Share with our community how your medical innovation is improving lives and impacting health care costs. Send us your Patient and related stories to BioNJ@BioNJ.org. Plus, click here for valuable tools and resources on the Value of Medical Innovation.
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In COVID-19 hot spots around the country, state health authorities are distributing rationing plans, anticipating too many patients and not enough critical care equipment. Alabama's plan would restrict children and adults with intellectual and cognitive disabilities from getting ventilators. The Washington State Health Department suggests transferring patients out of the hospital or to palliative care if their baseline functioning is marked by "loss of reserves in energy, physical ability, cognition and general health." This pick-and-choose approach to health care isn't unique to Coronavirus. It's been playing out for years in our health care system. Most people have never heard of the Institute for Clinical and Economic Review (ICER), but it plays a central role in deciding access to doctor-prescribed treatments.
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BioNJ in the News |
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No 6: Debbie Hart
Hart is the founding president and CEO of BioNJ, a network of 400 research-based life science and pharmaceutical companies working to expand what Gov. Phil Murphy has called New Jersey's "innovation economy." In the long run, that could mean more effective and cheaper health care technology, whether procedures or medications, or treatments or cures, in a state often called the "medicine chest of the world." The effort will resonate nationally, as public officials and the health care industry scramble for ways to test, treat and even cure COVID-19.
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BIO hosted a productive virtual summit intended to foster collaboration among key government agencies and biopharmaceutical innovators with one goal: eradicating COVID-19. The virtual event helped companies working on treatments, diagnostics and vaccines come together to discuss challenges and opportunities with government officials and other stakeholders.
According to Debbie Hart, President and CEO of BioNJ, "BIO's forum will be meaningful in accelerating this research and seeding possible collaborations that might otherwise not have happened.
It has been extraordinary to witness the number of companies that have switched or added gears to find a way to focus on this critical and crushing new need."
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NJ Company News |
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North Brunswick-based BioNJ Member Chromocell Corporation announced that it is making its proprietary Chromovert® Technology available to help accelerate research related to COVID-19 treatment and prevention. Chromovert is a technology that accelerates drug discovery against hard-to-express biological targets. Chromovert has been successfully used to identify a novel, non-addictive pain blocker that is in clinical development. The company is now making its technology available to the scientific community to shorten timelines for the discovery of new COVID-19 treatments.
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Pennington-based BioNJ Member OncoSec Medical Incorporated announced that Providence Cancer Institute, a part of Providence St. Joseph Health, is pursuing a first-in-human Phase 1 clinical trial of OncoSec's novel DNA-encodable, investigational vaccine, CORVax12, which is designed to act as a prophylactic vaccine to prevent COVID-19. CORVax12 consists of OncoSec's existing product candidate, TAVO™ (interleukin-12 or "IL-12" plasmid), in combination with an immunogenic component of the SARS-CoV-2 virus recently developed by researchers at NIH's National Institute of Allergy and Infectious Diseases and licensed to OncoSec on a non-exclusive basis.
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Princeton-based BioNJ Member Soligenix, Inc. announced that the European patent office has granted the divisional patent application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 2932973). The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of cutaneous T-cell lymphoma (CTCL). This new patent expands on Soligenix's comprehensive patent estate, which includes protection on the composition of the purified synthetic hypericin, methods of synthesis and therapeutic methods of use in both CTCL and psoriasis, and is being pursued worldwide.
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Warren-based BioNJ Member Celularity Inc. announced the expansion of its existing collaborative license agreement with United Therapeutics Corporation's wholly-owned subsidiary, Lung Biotechnology PBC, to include the treatment of COVID-19 and Acute Respiratory Distress Syndrome (ARDS). This announcement builds on recent pioneering work by Celularity for the use of its proprietary CYNK-001 for the treatment of the SARS-CoV-2 virus that causes the Coronavirus disease, COVID-19, and extends this application of the technology to ARDS.
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South Plainfield-based BioNJ Member
PTC Therapeutics, Inc.
announced that the
U.S. Food and Drug Administration
(FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam to
August 24, 2020
. Roche recently submitted additional data including comprehensive data from SUNFISH part 2 to help provide access to risdiplam for a broad range of people living with spinal muscular atrophy (SMA), triggering this extension.
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North Brunswick-based BioNJ Member BioAegis has been studying a therapy for pneumonia patients that they say can help treat people with severe cases of COVID-19. It's a protein called gelsolin. Now they're trying to get it through the FDA approval process. Carol MacKenzie spoke with the Chief Medical Officer at BioAegis Therapeutics, Dr. Mark DiNubile, to find out what he's working on and why he thinks it can help COVID-19 patients.
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Morris Plains-based BioNJ Member Immunomedics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting, including patients who are platinum ineligible and have previously received a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
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Morris Plains-based BioNJ Member Immunomedics, Inc. announced that its Phase 3 confirmatory ASCENT study will be halted due to compelling evidence of efficacy. This decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC), during its recent routine review of the ASCENT study. ASCENT is a Phase 3 confirmatory study designed to validate the promising safety and efficacy data of sacituzumab govitecan observed in a Phase 2 study of heavily pretreated patients with metastatic TNBC (mTNBC).
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Plainsboro-based BioNJ Member Novo Nordisk announced that the European Commission (EC) has granted marketing authorization for Rybelsus® (oral semaglutide), for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycemic control as an adjunct to diet and exercise. The marketing authorization applies to all 27 European Union member states and the United Kingdom. Rybelsus® is the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist.
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New Brunswick-based BioNJ Member Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since
January 2020
; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of
Johnson & Johnson
and the
Biomedical Advanced Research and Development Authority
(BARDA); and the rapid scaling of the company's manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine.
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Fate Therapeutics Inc. inked a multi-year, global collaboration worth up to $3 billion with Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson, which calls for the latter to contribute antigen binding domains for up to four tumor-associated targets. Fate receives $50 million in cash and another $50 million from the purchase by Johnson & Johnson Innovation - JJDC Inc. of newly issued shares of Fate's common stock at $31 per share. Janssen also is to reimburse Fate for all collaboration activities.
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Bridgewater-based BioNJ Member Sanofi announced the first patient outside of the U.S. has been treated as part of a global clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States -- all countries that have been impacted by COVID-19. This is the second multi-center, double-blind, Phase 2/3 trial as part of the Kevzara COVID-19 program, and the companies are continuing to work with health authorities around the world to secure initiation at additional sites.
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Bridgewater-based BioNJ Member Sanofi
has finalized the planned restructuring related to Praluent
®
(alirocumab) with Regeneron Pharmaceuticals, Inc.
As of April 1, 2020, Sanofi has sole responsibility for Praluent outside the U.S. Regeneron has sole responsibility for Praluent in the U.S. The restructuring simplifies the antibody collaboration between the companies, increases efficiency, and streamlines operations for Praluent
. Although each company will have responsibility for supplying Praluent in its respective territory, the companies have entered into agreements to support manufacturing needs in the near term.
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Bridgewater-based BioNJ Member Sanofi announced pivotal Phase 3 clinical trial results that show Dupixent ® (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged 6-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life. Sanofi and Regeneron previously announced topline positive results of this trial in August 2019.
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Princeton-based BioNJ Member Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt), the first and only erythroid maturation agent (EMA), for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
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Princeton-based BioNJ Member Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab), administered concomitantly with a limited course of chemotherapy, for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
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Princeton-based BioNJ Member Bristol-Myers Squibb announced an expansion of its existing patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. The expanded program offers access to any branded Bristol Myers Squibb medicine for free, including some of its most widely prescribed products, as well as those prescribed via telehealth services.
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Princeton-based BioNJ Member Bristol-Myers Squibb announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for idecabtagene vicleucel (ide-cel; bb2121), the companies' lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
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Princeton-based BioNJ Member Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for ZEPOSIA® (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. ZEPOSIA is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).
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East Hanover-based BioNJ Member Novartis announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19. The proposed trial will assess Jakavi in combination with standard of care (SoC) therapy, compared to SoC therapy alone, in patients with severe COVID-19 pneumonia as a result of SARS-CoV-2 infection.
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In response to the Coronavirus outbreak currently afflicting the United States, East Hanover-based BioNJ Member
Novartis
and its foundation arm announced they have established a
U.S. COVID-19 Community Response Fund
.
The fund will provide cash and in-kind donations totaling $5 million for immediate response to the pandemic. "COVID-19 has profoundly impacted the lives of Americans in many unprecedented ways. As a leading medicines company, we understand the public health implications of this pandemic and must do our part to support organizations that are in the best position to provide services to people in need," Tom Kendris, U.S. Country President, Novartis Corp. and Chairman, Board of Trustees, Novartis US Foundation, said.
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East Hanover-based BioNJ Member
Novartis
announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class investigational treatment for hyperlipidemia in adults. The pooled analysis of the ORION-9, -10 and -11 Phase III trials showed a durable and potent reduction in LDL-C of 51% when used in addition to other lipid-lowering therapies (LLT) over 17 months of treatment. The prespecified analysis of pooled data is consistent with the efficacy and safety findings of the individual Phase III trial results recently published in The New England Journal of Medicine.
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Kenilworth-based BioNJ Member
Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) ≥10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options.
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Kenilworth-based BioNJ Member
Merck & Co. announced top-line efficacy results from two ongoing pivotal Phase 3 trials (COUGH-1 and COUGH-2) evaluating the efficacy and safety of gefapixant (MK-7264), an investigational, orally administered, selective P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough. In these studies, the primary efficacy endpoints were met for the gefapixant 45 mg twice daily treatment arms - demonstrating a statistically significant decrease in 24-hour coughs per hour (average hourly cough frequency based on 24-hour sound recordings) versus placebo at 12 (COUGH-1) and 24 weeks (COUGH-2).
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Kenilworth-based BioNJ Member
Merck & Co. announced the presentation of results from the VICTORIA trial, a Phase 3 study evaluating the efficacy and safety of its investigational drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator being developed to treat patients with heart failure with reduced ejection fraction and following a worsening event. VICTORIA is the first contemporary outcomes study focused exclusively on symptomatic chronic heart failure patients (ejection fraction <45%) following a worsening event.
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Kenilworth-based BioNJ Member
Merck
announced a $3 million commitment to help strengthen the health systems affected by the COVID-19 pandemic.
Through the company's global initiative Merck for Mothers, Merck said it will donate funds to health systems to better meet the needs of pregnant women before, during and after labor. "Our goal in establishing Merck for Mothers in 2011 was to advance the quality of maternal health care and improve access to care during one of the most critical moments in a woman's life," Kenneth C. Frazier, Chairman and CEO, Merck, said. "That call to action for us is even stronger in the midst of the pandemic."
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BioNJ Members
Merck & Co., Inc., Pfizer Inc. and Eli Lilly and Company announced medical service volunteer programs to enable employees who are licensed medical professionals to aid in the fight against COVID-19 while maintaining their base pay. This new effort is one of the many ways that America's biopharmaceutical companies are coming together to fight COVID-19. Together, these three major biopharmaceutical companies employ thousands of doctors, nurses, pharmacists, medical laboratory technicians and other medical professionals whose services are in high demand during the COVID-19 pandemic.
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BioNJ Member Pfizer Inc., with offices in Peapack, announced important advances in the battle against the global COVID-19 pandemic. As outlined in Pfizer's five-point plan, the company has been collaborating across the health care innovation ecosystem ranging from large pharmaceutical companies to the smallest of biotech companies, from government agencies to academic institutions to address the COVID-19 global health care crisis. Researchers and scientists have been relentlessly working to develop an investigational antiviral compound to treat SARS-CoV-2, which causes the current pandemic of Coronavirus infections (COVID-19), a vaccine to prevent infection as well as evaluating other therapies that have scientific potential to help infected patients fight the viru
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BioNJ Member Pfizer Inc., with offices in Peapack, and
BioNTech SE disclosed additional details of their collaboration to advance candidates from BioNTech's mRNA vaccine program, previously announced on March 17, 2020. The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech's proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. The collaboration will leverage Pfizer's broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.
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BioNJ Member Pfizer Inc., with offices in Peapack, announced that the European Commission (EC) has approved RUXIENCE™ (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera® (rituximab), for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and pemphigus vulgaris (PV). The EC approval is based on a comprehensive data package which demonstrated biosimilarity of RUXIENCE to the reference product.
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Bridgewater-based BioNJ Member
Eli Lilly and Company
is introducing the
Lilly
Insulin Value Program, allowing anyone with commercial insurance and those without insurance at all to fill their monthly prescription of
Lilly
insulin for
$35
. The program covers most
Lilly
insulins including all Humalog
®
(insulin lispro injection 100 units/mL) formulations. "Too many people in the
U.S.
have lost their jobs because of the COVID-19 crisis, and we want to make sure no one goes without their
Lilly
insulin," said
Mike Mason
, President,
Lilly
Diabetes.
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Bridgewater-based BioNJ Member
Eli Lilly and Company
announced an exclusive global licensing and research collaboration with Sitryx, a biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation. The collaboration will study up to four novel preclinical targets identified by Sitryx that could lead to potential new medicines for autoimmune diseases.
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Franklin Lakes-based BD and BioGX Inc.
said the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for a new diagnostic test that will enable hospitals to screen for COVID-19 on site and get results in under three hours.
Earlier
in March, the companies submitted
EUA requests to the FDA for tests that would increase the potential capacity to screen for COVID-19 by thousands of tests per day. The test will be run on the BD MAX System, a molecular diagnostic platform already in use at hundreds of laboratories in nearly every state across the country.
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Paramus-based
Polaryx Therapeutics announced that the company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients. JNCL or CLN3 is a rare and fatal genetic lysosomal storage disorder caused by a Cln3 gene mutation. It is the most prevalent among the NCL diseases occurring in 3 out of 100,000 births.
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South Plainfield-based
Accurate Diagnostic Laboratories (ADL) and
Rutgers University
Cell & DNA Repository (RUCDR), through its Clinical Genomics Laboratory, are pleased to announce a joint mission aligning their efforts around improving testing capacity and service for the hospital inpatient population, health care providers and workers, first responders and patients. The relationship will facilitate providing high through-put and industry-leading turnaround time for COVID-19 testing, also capitalizing on new methods to test.
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Raritan-based Ortho Clinical Diagnostics said it is launching to market its COVID-19 antibody test.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack testing kits are expected to be available in a few weeks. "The unprecedented nature of this rapidly spreading virus required an immediate response from the diagnostics industry, and Ortho followed through on its commitment to help develop better ways to treat patients and provide robust data to help manage COVID-19," said Chris Smith, CEO.
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Bedminster-based
Mallinckrodt plc
and announced that
Stratatech
, a Mallinckrodt company, has initiated the rolling submission of a Biologics License Application (BLA) to the
U.S. Food and Drug Administration
(FDA) seeking approval to market StrataGraft®, a regenerative skin tissue therapy, for the treatment of adult patients with deep partial-thickness thermal burns. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.
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Bedminster-based
Mallinckrodt plc
and
Novoteris, LLC
announced that the
Therapeutic Products Directorate of Health Canada
has cleared the company's joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and
Viral Lung
(COVID-19) Infections" application to investigate the use of Thiolanox®, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at
Vancouver Coastal Health Authority
facilities.
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Thorofare-based
Akers Biosciences, Inc. announced that its collaboration with Premas Biotech has successfully completed the milestone of obtaining clones of all three coronavirus antigens, Spike (S), Envelope (E) and Membrane (M) that they have selected for their vaccine candidate. The clone development process has four primary steps including first, the design and synthesis of the genes; second, the selection of the right host; third, the insertion of the gene into the host; and fourth, the verification that the clone has the right gene, and all characteristics are correct.
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Basking Ridge-based
Daiichi Sankyo Company, Limited announced that it has entered into a strategic partnership with Ultragenyx Pharmaceutical Inc. for the non-exclusive use of Ultragenyx's proprietary adeno associated virus (AAV) based gene therapy manufacturing technology. In the research and development of gene therapy drugs, gene transfer methods to target cells are critical, and the method with the highest expectations is the AAV vector, which can be used to transfer genes into various human tissues.
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Basking Ridge-based
Daiichi Sankyo Company, Limited
announced that it has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for chimeric antigen receptor (CAR) T cell therapy axicabtagene ciloleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma and related lymphomas. The Japan NDA submission is based on previous pivotal trial data conducted globally by Kite for axicabtagene ciloleucel in addition to results from a phase 2 bridging study conducted by Daiichi Sankyo in Japan.
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Bridgewater-based
Menlo Therapeutics Inc.
announced top line results from two Phase 3 clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis (PN), studies MTI-105 and MTI-106. Study MTI-105 enrolled 285 patients in the US and study MTI-106 enrolled a total of 295 patients from
Germany
,
Poland
and
Austria
. Patients were randomized 1:1 to either serlopitant 5mg or placebo treatment.
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Woodcliff Lake-based Timber Pharmaceuticals LLC, said that the company was awarded the second tranche of $500,000 of a $1.5 million grant from the U.S. Food & Drug Administration (FDA) Office of Orphan Products Development (OOPD) Orphan Products Clinical Trials Grants Program after reaching certain clinical milestones in the development of TMB-001 (topical isotretinoin).
Timber Pharmaceuticals
is developing TMB-001 for the treatment of congenital ichthyosis (CI), a rare genetic keratinization disorder that leads to dry, thickened and scaling skin.
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Warren-based Bellerophon Therapeutics, Inc.
closed its previously announced registered direct offering of 1,275,000 shares of its common stock at a purchase price of
$12.00
per share for total gross proceeds of
$15.3 million
, before deducting placement agent fees and offering expenses. Bellerophon currently intends to use the net proceeds from this offering for working capital, general corporate purposes and other research and development efforts.
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People in the News |
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Bridgewater-based BioNJ Member
Eli Lilly and Company
announced that
Kathryn Beiser
joined the company as Vice President, Global Communications. In this role, Ms. Beiser will oversee all aspects of the company's corporate communications strategy, including internal and external corporate communications, media relations, crisis management, executive communications, digital and social media and corporate brand and reputation management. Ms. Beiser brings a strong background in health care communications to
Lilly
, most recently serving as Senior Vice President and Chief Communications Officer for
Kaiser Permanente
.
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BioNJ Member Pfizer Inc., with offices in Peapack, announced the election of Dr. Susan Desmond-Hellmann to its Board of Directors. Dr. Desmond-Hellmann was also appointed to the Governance & Sustainability Committee and the Science and Technology Committee of Pfizer's Board. Dr. Desmond-Hellmann served as Chief Executive Officer of the Bill & Melinda Gates Foundation from 2014 until 2020, where she oversaw the creation of the Gates Medical Research Institute-the world's first nonprofit biotech organization-as well as the launch of the Economic Mobility and Opportunity investment strategy in the U.S.
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AzurRx BioPharma, Inc. announced the appointment of Gregory Oakes to the Board of Directors effective April 13, 2020.
"Greg is a strong and welcomed addition to our board," said James Sapirstein, CEO of AzurRx BioPharma. "His broad experience in pharmaceutical commercialization and acquisitions will help AzurRx as we advance MS1819 through two Phase 2 clinical studies in 2020 and intensify our partnering discussions."
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Paramus-based
BrainStorm Cell Therapeutics, Inc
. announced that David Setboun, Pharm.D., MBA, has been appointed Executive Vice President and Chief Operating Officer. International pharmaceutical executive Dr. Setboun, has directed commercial development, business strategy, and product launches for 2 decades at 3 major biopharmaceutical companies. Most recently, Dr. Setboun served as Vice President Corporate Development, Strategy & Business at Life Biosciences.
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Institution and Education News |
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The
Rutgers COVID Response Pandemic Preparedness Center, which is coordinating the university's research, public health and outreach efforts to combat the pandemic, named Henry Raymond as its Associate Director for Public Health. Dr.
Raymond, an associate professor in the department of biostatistics and epidemiology at the Rutgers School of Public Health, will lead the center's public health initiatives, including coordinating public health-related COVID-19 research at Rutgers and collaborations between the university and external partners.
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We are pleased to announce that Dr. Haro Hartounian has been appointed Affiliated Faculty in the Department of Chemistry and Environmental Science.
Dr. Hartounian is responsible for leading the Biopharma Division at the New Jersey Innovation Institute (NJII). He works with colleagues in industry and academia to help biopharmaceutical companies improve their speed in transforming discovery into commercial production. He engineered the launch of NJIT's Cell and Gene Therapy Development Center, the only facility of its kind in Newark, NJ and the first such center on a university campus anywhere in the United States. He also partnered with Kevin Belfield and CES in the creation of NJIT's new Professional Master's Degree Program in Cell and Gene Therapy Sciences and associated graduate certificate.
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Joel Bloom jokes that an aerial view of
New Jersey Institute of Technology -- taken from a drone you'd figure one of the country's leading STEM universities would have -- would show that the Newark campus was like a ghost town in a movie. Dr.
Bloom, the school's longtime President, said the campus is 99% empty.
Those who remain, however, are doing exactly what you'd figure they would be doing -- using technology to help the State battle the COVID-19 outbreak. In its MakerSpace building, NJIT students and faculty are making face shields that health care workers on the front line so desperately need.
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To accommodate the dramatic increase in COVID-19 patients in North Jersey, Hackensack University Medical Center (HUMC) said it expanded overall capacity 23 percent by redesigning unused patient care areas, including the cafeteria which opened this weekend as a 74-bed specialized care unit for patients affected by the outbreak.
HUMC, Hackensack Meridian Health's academic flagship, has grown from 771 beds to nearly 950 to accommodate an increase in patients suffering from serious symptoms of COVID-19, which include high fever and respiratory distress.
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Promising treatments for COVID-19 are being made available through an expanded access program at Prime Healthcare's Saint Michael's Medical Center in Newark.
Remdesivir, considered by the World Health Organization to be one of the most promising drugs to treat COVID-19, was developed to treat Ebola. The antiviral drug is effective against two other Coronaviruses that cause deadly respiratory diseases -- SARS and MERS -- and is in five large clinical trials for the treatment of COVID-19
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University Hospital announced it has appointed three new members to its executive leadership team.
The Newark-based health system said Robert Iannaccone has been appointed to Executive Vice President, William Holubek to Chief Medical Officer and Tomas Gregorio to Chief Innovation and Technology Officer, all effective April 13. "These three health care executives will bring fresh ideas and new enthusiasm to University Hospital as we look to a new era of serving our community. Robert and Tomas have first-hand experience with New Jersey's health care environment, while William brings a great perspective on urban health care," said Shereef Elnahal, CEO and President of University Hospital.
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TCNJ's President Kathryn Foster announced the appointment of Jeffrey Osborn to the position of Provost and Vice President for Academic Affairs. Mr. Osborn will assume his post on July 1, 2020.
"Please join me in heartily congratulating Jeff Osborn on this career milestone and welcoming him to his new role at TCNJ," said Ms. Foster." As Dean of the TCNJ School of Science, Jeff has been at the helm for significant achievement in science education and research, student achievement, equity and inclusion and grant activity."
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Funding News |
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The New Jersey Economic Development Authority (NJEDA) will launch the application for its Small Business Emergency Assistance Loan Program on Monday, April 13, 2020 at 9:00 a.m. To provide business owners the opportunity to prepare to apply for the loan, a .pdf version of the application is now available. The loan program is part of a package of initiatives announced to support businesses and workers facing economic hardship due to the outbreak of the novel Coronavirus COVID-19. Click here for application and details.
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The New Jersey Economic Development Authority announced it has partnered with four organizations to offer support services to small businesses that have been impacted by the Coronavirus pandemic.
The organizations will help small business owners
file applications
through the Small Business Administration Economic Injury Loan program to receive up to $2 million of working capital loans to help survive the crisis. They will also help prepare financial information, package application documents and complete and submit the application.
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Special Programs from Our Partners for BioNJ Members |
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April 29-30, 2020 | Virtual
RESI
is planning its first ever, dedicated, digital partnering event on April 29-30th
with over 200 investors participating!
We're offering a special opportunity to our tech hubs to help your companies continue their business development in these difficult times
. To receive a a special
50% discount code
, good until April 17th, use special discount code RESITH50
. That means the registration for 2 full days of partnering will cost less than $300!
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June 8-12, 2020 | Virtual
For 2020, the BIO International Convention will transition to a new, virtual event format, BIO Digital. This virtual gathering of the global biotech industry will provide access to key partners via BIO One-on-One Partnering, educational resources to help drive your business, and the insights you need to continue critical research and development.
Join us, June 8-12, from wherever you are in the world, for BIO Digital 2020.
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June 16, 2020 | Morristown
Students 2 Science is delighted to invite you to S2S: The Salon, a community gathering in celebration of S2S' 10-year anniversary. It will be a wonderful event with key influencers in the State of New Jersey representing both public and private sectors, including corporate leaders, educators, administrators and policy officials.
A panel discussion, led by BioNJ President and CEO Debbie Hart will engage participants in a dialogue on the urgent and important topics of equity and diversity in STEM education: "How Do We Encourage a Ready and Diversified Workforce in STEM?" For more information on tickets and sponsorship contact S2S@students2science.org.
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BioNJ Member Services Provider Directory |
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BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations.
To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:
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 The NJBAC is a state agency offering free and confidential assistance to help your business grow. As a "one-stop shop," NJBAC can help businesses of all sizes and types manage the state's regulatory processes, boost exports, gain access to financial resources where applicable and tackle other obstacles along the way. You can download the NJBAC guide by clicking here or contact their business advocates at 1-800 JERSEY 7. |
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