Proud producer of the 2019 BioNJ Dr. Sol J. Barer Award video featuring industry leader Dr. William Hait.
Welcome to the latest edition of the  BioLines Weekender

The industry came out to honor New Jersey's innovative life sciences companies and leaders, as well as the Patients who inspire them, last Thursday night at BioNJ's 26th Annual Dinner Meeting and Innovation Celebration. From an opening address by Governor Phil Murphy and the presentation of the 2019 Dr. Sol J. Barer Award to Dr. William Hait by Dr. Barer himself to the presentation of the Heart of BioNJ Award to Jayne Gershkowitz and Max Schill, as well as a salute to BioNJ's 17 Innovator Award honorees by New York City performers The Water Coolers, we hope that each of our 700 attendees left feeling proud of the important work they do -- offering hope for a longer, better life to Patients around the world.  


Please click here to enjoy our photo gallery.
 
Visit www.BioNJ.org  for our 2019 calendar of events and to register for BioNJ's Ninth Annual BioPartnering Conference  in concert with J.P. Morgan and Johnson & Johnson Innovation. Apply today to be a company presenter and showcase your innovations to investors and business development professionals looking for new collaborations and partnerships. Click here for details.

Because Patients Can't Wait®,
The BioNJ Team

P.S. Learn about BioNJ's Members-Only Health Benefits Plan during our free Webinar next Wednesday, February 20, at 10 a.m. Click here to register.

Blue Divider
BioNJ Meeting Published in Orphanet Journal of Rare Diseases

In a BioNJ first, we are proud to announce that paper, entitled " Regulatory Strategies for Rare Diseases Under Current Global Regulatory Statutes: A Discussion with Stakeholders ," has been published in the peer-reviewed  Orphanet Journal of Rare Diseases ! The paper is a report out of a meeting that BioNJ held last spring on rare disease regulatory hurdles in partnership with Dr. Andrew Mulberg, Senior Vice President, Global Regulatory Affairs at Amicus Therapeutics. Click here  to read.

The second iteration of that meeting, entitled "Scientific and Ethical Underpinnings of Gene Transfer/Therapy in Vulnerable Populations: Considerations Supporting Novel Treatments," will be held in concert with Amicus Therapeutics and PTC Therapeutics at Amicus on March 7, 2019 from 8:00 a.m.-4:15 p.m. Please click here to review the agenda and to register.
Job Opportunities at BioNJ


 
BioNJ, the largest life sciences trade association in NJ, is looking for a dynamic, high-energy Alliance Manager. The work of the Alliance Manager will support BioNJ's face-to-face engagement with stakeholders, such as employers, Patient advocacy groups, hospital groups, healthcare providers, payers and others. Responsibilities will include steering the BioNJ Patient Advocacy Committee, and support of BioNJ's efforts in Trenton and Washington to ensure that a unified, pro-Patient voice is heard by key constituencies. Contact Donna Gibbons at DGibbons@hq4u.com to learn more.

BioNJ Calendar

BioNJ Health Benefits Plan
Webinar
February 20, 2019
Scientific and Ethical Underpinnings of Gene Transfer/Therapy in Vulnerable Populations:  Considerations Supporting Novel Treatments
Amicus Therapeutics, Cranbury, NJ
March 7 , 2019
BioNJ BioPartnering Conference
Co-Sponsored by J.P. Morgan and Johnson & Johnson Innovation
The Palace at Somerset Park, Somerset, NJ 08873
May 8, 2019
Register now!

Putting Patients First: The Value of Medical Innovation
Brought to You by Celgene Corporation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of healthcare. Share with our community how your medical innovation is improving lives and impacting healthcare 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.


 
At Celgene, we believe that cancer treatment should be available to patients no matter who they are or where they live. That is why Celgene recently supported expanded care capacity in resource-constrained countries through $1 million in grants as part of the Celgene Cancer Care Links™ program.



 
Bridgewater-based BioNJ Member  Sanofi  and  Regeneron Pharmaceuticals  announced Praluent (alirocumab) will be made available at a new U.S. list price of $5,850 annually, a 60 percent reduction from the original price, for both the 75 mg and 150 mg doses, beginning in early March.  In a press release, Sanofi said that this is the latest step by the companies to help make Praluent more accessible and affordable for appropriate patients.


 
One part of President Trump's State of the Union address that received bipartisan cheers was the call to lower prescription drug prices. A "next major priority for me, and for all of us,"  said Trump, "should be to lower the cost of health care and prescription drugs -- and to protect patients with pre-existing conditions."  Trump's Department of Health and Human Services quietly  proposed  a new rule to fundamentally reform the biggest driver of rising prescription drug prices: the " Kabuki " drug rebate pricing system. The regulation would essentially eliminate the middlemen between government health insurers and drug manufacturers known as pharmacy benefit managers (PBMs).

Showing Our New Jersey Pride


 
Governor Phil Murphy appointed Gunjan Doshi as the Chair of the New Jersey Commission on Science, Innovation and Technology. The Commission was re-established by Governor Murphy and the Legislature in August 2018, with a new mission of researching technology partnerships between private industry and New Jersey's leading public and private research institutions. The Governor also appointed Debbie Hart, Beth Noveck and David Pascrell to serve on the commission. 


 
Increased investment and employment in the life sciences sector has driven life sciences related real estate to new heights, according to  Cushman & Wakefield's new report, Life Science: Great Promise & Rapid Growth"New Jersey historically has been a life science hub, and the industry continues to play a major role in the State's economy," noted Cushman & Wakefield's Jason Price, Director, Tri-State Suburbs Research. "The Garden State is in an ideal location for many life sciences companies due to its proximity to New York City and central location in the heart of the nation's Northeast Corridor, connecting Boston and Washington, D.C. via I-95." 

BioNJ in the News


As Featured in NJBIZ
  
A who's who of New Jersey pharmaceutical leaders touted their accomplishments and honored their innovators at the  BioNJ  2019 Annual Dinner Meeting & Innovation Celebration in New Brunswick.  Debbie Hart, President and CEO of BioNJ, said that the meeting was a celebration of innovation in New Jersey.  "We had more than 35 percent of all new FDA drug approvals in 2018 come from companies with a footprint here and we celebrated them tonight," Hart told NJBIZ. During the evening, Hart also announced that Johnson & Johnson Innovation is joining J.P. Morgan as a headliner sponsor of BioNJ's BioPartnering event.


As Featured in New Jersey Business Magazine
  
Governor Phil Murphy reminded an audience of approximately 700 people at BioNJ's 2019 Annual Dinner Meeting & Innovation Celebration, held at the Hilton East Brunswick, that pharmaceutical giant Johnson & Johnson's co-founder Robert Wood Johnson once walked down a New Brunswick street to have lunch with none other than Thomas Edison himself. Of such high-powered collaboration, Murphy said, "In a nutshell, this is the type of synergy we are seeking to create, once again, in New Jersey."  Overall, Gov. Murphy said, "If you are in the life sciences and pharmaceutical fields, there are few places on the planet, quite literally, that provide the tools for success that we do here in New Jersey."

NJ Company News

Ever proud of our ecosystem, we are pleased to share our New Jersey Company News. Be sure to click on the article titles below to read the full release.

 
Princeton-based BioNJ Member Soligenix, Inc. announced the allowance of a new United States (US) patent protecting its ricin toxin vaccine, RiVax®. The patent, titled "Multivalent Stable Vaccine Composition and Methods of making same", supports combination vaccines protecting against ricin intoxication as well as other toxins, such as those associated with anthrax.


 
Princeton-based BioNJ Member Soligenix, Inc. announced publication of a scientific article demonstrating the successful thermostabilization of an Ebola subunit vaccine candidate.  The article titled, "Thermostable Ebola virus vaccine formulations lyophilized in the presence of aluminum hydroxide", is published in the European Journal of Pharmaceutics and Biopharmaceutics.


 
East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Egaten® (triclabendazole) for the treatment of fascioliasis in patients six years of age and older. This makes Egaten the only FDA-approved drug for people with this disease and is expected to facilitate broader access to this important drug not only in the U.S., but also in affected countries worldwide.


 
BioNJ Member Advanced Accelerator Applications S.A., a Novartis company, announced that Health Canada has approved Lutathera™ (lutetium (177Lu) oxodotreotide) for the treatment of unresectable (not removable by surgery) or metastatic, well-differentiated, somatostatin receptor-positive (expressing the somatostatin receptor) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults with progressive disease.


 
Princeton-based  Sandoz , a division of BioNJ Member Novartis, announced that it has been certified Global Top Employer 2019 for its exceptional employee offerings globally. The certification is based on annual international research undertaken by the Top Employers Institute, an organization based in the Netherlands that recognizes leading employers around the world and their excellence in employee environment.



 
Cranbury-based BioNJ Member Amicus Therapeutics  announced additional positive results from a global Phase 1/2 clinical study (ATB200-02) to investigate AT-GAA in patients with Pompe disease, an inherited lysosomal storage disorder caused by an enzyme deficiency that leads to accumulation of glycogen (disease substrate) in cells. Patients treated with AT-GAA for up to 24 months showed improvements in six-minute walk test (6MWT) distance and other measures of motor function and muscle strength, stability or increases in forced vital capacity (FVC), and durable reductions in biomarkers of muscle damage and disease substrate.


 
The first data readout from a Phase 3 trial of Jersey City-based BioNJ Member Scynexis' ibrexafungerp has come in, and at first glance looks very positive for the first-in-class antifungal. The results come from the first 20 of a planned 60 patients in the FURI trial, which is focusing on invasive yeast infections caused by Candida species in patients that have failed multiple antifungal therapies and are at high risk of dying. 


 
Newark-based BioNJ Member Rafael Pharmaceuticals, Inc. announced that devimistat will be investigated in a new combination for the treatment of T-Cell Lymphoma under the 'Tailoring CAR-based immunotherapy strategies to T-Cell Lymphoma' project as a part of Stand Up To Cancer's T-Cell Lymphoma Dream Team Research Grant.


 
Princeton-based BioNJ Member  Agile Therapeutics, Inc. a nnounced topline results from a comparative wear study testing the adhesion of Twirla® compared to that of Xulane® (the "comparative wear study"), the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the  U.S. Food and Drug Administration  ("FDA") considers to have acceptable adhesion.  


 
Morristown-based BioNJ Member BioAegis Therapeutics Inc. announced that patient enrollment is underway in a Phase 1b/2a study of recombinant plasma gelsolin (rhu-pGSN) in Community-Acquired Pneumonia (CAP) in the Republic of Georgia. The clinical-stage company is focused on a novel approach to address infectious, inflammatory and degenerative diseases through a portfolio built around the supplementation of plasma gelsolin levels. 


 
South Plainfield-based BioNJ Member PTC Therapeutics, Inc.  announced the launch of the fifth annual STRIVE grant award program for Duchenne Muscular Dystrophy. The STRIVE Awards provide funds to patient advocacy organizations around the world to develop unique and collaborative programs that make meaningful contributions to the rare disease community.


 
Bridgewater-based BioNJ Member  Eli Lilly and Company  and Boehringer Ingelheim announced CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) met its primary endpoint, defined as non-inferiority for Tradjenta® (linagliptin) versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE). CAROLINA is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. 


 
Bridgewater-based BioNJ Member Eli Lilly and Company  announced that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis (AD). In both investigational trials, compared to patients treated with placebo, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint at Week 16 defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear (IGA 0,1). 



 
Princeton-based BioNJ Member  Bristol-Myers Squibb Company  announced that the European Commission (EC) has approved Sprycel  (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The approval includes both the tablet form of Sprycel and, in a first for pediatric patients with ALL in Europe, the powder for oral suspension (PFOS) formulation of Sprycel.


 
Princeton-based BioNJ Member Evotec AG and Galapagos NV announced a global collaboration focused on a novel target for fibrosis and other indications. The collaboration concerns a small molecule programme, currently in pre-clinical development for the treatment of fibrotic diseases of the liver and other organs. The target has been identified and validated using Evotec's proprietary platforms for fibrotic diseases and NASH. 


 
Princeton-based BioNJ Member Advaxis, Inc. announced it has initiated its Phase 1/2 clinical trial to evaluate ADXS-503, part of the company's ADXS-HOT program, in the treatment of non-small cell lung cancer (NSCLC) and has enrolled the first patient in the trial. ADXS-HOT is a cancer-type specific immunotherapy program which leverages Advaxis' proprietary Lmtechnology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens. 


 
BioNJ Member  Pfizer Inc., with offices in Madison,  and Astellas Pharma Inc. announced results from the Phase 3 ARCHES trial in men with metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is considered metastatic once the cancer has spread outside of the prostate gland to other parts of the body.  Men are considered hormone (or castration) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels.


 
BioNJ Member  Pfizer Inc., with offices in Madison,  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.


 
BioNJ Member  Pfizer Inc., with offices in Madison, and EMD Serono announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO®  (avelumab) in combination with INLYTA®  (axitinib) for patients with advanced renal cell carcinoma (RCC). The application has been given a target action date in June 2019.


 
Kenilworth-based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). 


 
Kenilworth-based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). 


 
Kenilworth-based BioNJ Member  Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending KEYTRUDA, Merck's anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adults. 




 
Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced the unblinding of the Phase 3 TITAN  study  evaluating ERLEADA ®  (apalutamide) plus androgen deprivation therapy (ADT) in the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The decision resulted from an Independent Data Monitoring Committee (IDMC) recommendation coinciding with a pre-planned analysis that showed the dual primary endpoints were both achieved, significantly improving radiographic progression-free survival (rPFS) and overall survival (OS). 


 
Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced a worldwide collaboration and license agreement with MeiraGTx Holdings plc , a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia (ACHM) caused by mutations in either CNGB3 or CNGA3, and X-linked retinitis pigmentosa (XLRP).


 
New Brunswick-based BioNJ Member Johnson & Johnson announced that  Ethicon Inc. , a subsidiary of Johnson & Johnson, has entered into a definitive agreement to acquire  Auris Health Inc.  in a deal worth $3.4 billion. "In this new era of health care, we're aiming to simplify surgery, drive efficiency, reduce complications and improve outcomes for patients, ultimately making surgery safer," said Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson.



Parsippany -based BioNJ Member  Teva Pharmaceutical Industries Ltd. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorization for AJOVY® (fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. 



Parsippany -based BioNJ Member  Teva Pharmaceutical Industries Ltd., announced the launch of ALYQ™, a generic version of ADCIRCA ®  (tadalafil) tablets, 20 mg in the U.S. ALYQ™ is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. PAH is high blood pressure in the blood vessels of the lungs.



Parsippany -based BioNJ Member  Teva Pharmaceutical Industries Ltd. announced the launch of a generic version of Sabril® (vigabatrin) tablets, 500 mg in the U.S. Vigabatrin oral tablets are indicated as adjunctive therapy for adults and children (10 years of age or older) with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. 


 
Cranbury-based BioNJ Member  Outlook Therapeutics, Inc.  announced that it closed on the final tranche (of four) of its  $20.0 million  private placement of common stock to  BioLexis Pte. Limited  (BioLexis), the company's strategic business partner and largest investor, receiving  $4.0 million  of cash proceeds in exchange for the issuance of 4,288,624 shares of common stock at  $0.9327  per share. 


 
Rutherford-based BioNJ Member Cancer Genetics, Inc. announced the closing and funding of its previously announced public offering of 15,217,392 shares of its common stock ("Common Stock") at a public offering price of $0.23 per share. The company's Chairman, John Pappajohn; board director, Ted Cannon; Chief Financial Officer, Glenn Miles; and President and Chief Executive Officer, John A. Roberts, each purchased shares in the offering. 


 
Ramsey-based BioNJ Member ADMA Biologics, Inc. announces that it has entered into a senior secured term loan facility with Perceptive Advisors ("Perceptive") for up to $72.5 million under two funding tranches. The first loan facility tranche from Perceptive of $45 million was used to prepay ADMA's former senior secured credit facility of $30 million in full plus associated costs and fees.


 
ADC Therapeutics, with offices in Murray Hill, announced that the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-402 (loncastuximab tesirine) plus AstraZeneca's IMFINZI® (durvalumab) in patients with advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).


 
Fair Lawn-based SK Life Science, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for cenobamate. Cenobamate, an investigational antiepileptic drug for the potential treatment of partial-onset seizures in adult patients, is the first molecule discovered and developed from inception through to the submission of an NDA without partnering or out-licensing from a Korean pharmaceutical company.


 
Takeda Pharmaceutical Company Limited, with offices in East Windsor, announced that the European Commission (EC) extended the current marketing authorization of ADCETRIS (brentuximab vedotin) to include treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine). ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. 


 
Takeda Pharmaceutical Company Limited, with offices in East Windsor, announced results from its Phase IIIb/IV clinical trial for ADYNOVATE. The PROPEL study is a PROspective, randomized, multi-center study comparing the safety and efficacy of ADYNOVATE following PK-guided prophylaxis targeting two different Factor Eight (FVIII) trough Levels in subjects with severe hemophilia A.


 
Freehold-based Avalon GloboCare Corp. announced that its ongoing co-development program with Weill Cornell Medicine, led by Yen-Michael Hsu, M.D., Ph.D., Director of cGMP Cellular Therapy Facility and Laboratory for Advanced Cellular Engineering, has identified novel human angiogenic exosomes/extracellular cellular vesicles (EV) derived from endothelial cells. 


 
Glenmark Pharmaceuticals Ltd. announced that it will spin off its innovation business as a new, U.S.-based company.  The new company will be a wholly owned subsidiary of Glenmark, with its own independent board and CEO. The company's research and development center in Paramus will become part of the new business, along with the innovative molecules in Glenmark's pipeline -- eight in total -- plus R&D centers in Switzerland and India related to the innovation business, and a Swiss biologics manufacturing facility. Innovative R&D employees will also be transferred to the new company.



Warren-based GlaxoSmithKline plc and Merck KGaA, Darmstadt, Germany announced that they have entered into a global strategic alliance to jointly develop and commercialize M7824 (bintrafusp alfa). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers. 


 
Woodcliff Lake-based Eisai Co., Ltd. announced that it has submitted an application to the European Medicines Agency (EMA) for its in-house discovered antiepileptic drug (AED) Fycompa® (perampanel) seeking approval for use in pediatric patients with epilepsy. This application aims to expand the indication for Fycompa, which is already approved for adjunctive use in patients aged 12 years and older with partial-onset seizures (with or without secondarily generalized seizures) or primarily generalized tonic-clonic seizures, to cover pediatric patients as well.


 
Woodcliff Lake-based Eisai Co., Ltd. and Purdue Pharma L.P., with offices in Ewing, announced six-month results from SUNRISE 2, a long-term Phase 3 clinical study evaluating the efficacy and safety of lemborexant, an investigational agent being developed for the treatment of insomnia, a sleep-wake disorder. SUNRISE 2 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 adult patients with insomnia disorder. 


 
Princeton-based ReGenTree, LLC announced that it has executed an agreement with Ora, Inc., located in Andover, Massachusetts, for the initiation of ARISE-3 to study the Company's new drug RGN-259 for the treatment of dry eye syndrome. ARISE-3 is a randomized, double masked, placebo controlled phase 3 clinical trial which is based entirely on the results of the company's previous clinical trials, ARISE-1 and ARISE-2.


 
Princeton-based  Navitas Life Sciences announced it plans to acquire  DataCeutics, a life sciences service provider.  The acquisition will spearhead Navitas' clinical business by using DataCeutics' capabilities with Navitas' AI-driven clinical platform.  "We are delighted to begin 2019 on a high note with this key acquisition. DataCeutics strengthens our capabilities in Data Sciences and FSP/BPO services and widens our therapeutic expertise in cardiology, oncology, pulmonology, CNS, infectious diseases, etc. The addition of these competencies translates to business expansion in North American, European and Asian marketings," Dr. Krishnan  Rajagopalan , Chief Growth Officer, Navitas Life Sciences.


 
Cedar Knolls-based Moberg Pharma has entered into a license agreement granting the Consumer Health division of Whippany-based Bayer exclusive European rights to MOB-015, a new topical treatment of onychomycosis based on Moberg's patented proprietary formulation of terbinafine. Bayer will be marketing, distributing and selling MOB-015 in Europe upon completion of Phase III clinical development and registration.



People in the News



 
Somerset-based Catalent has promoted Senior Vice President, Global Operations Alessandro Maselli to President and Chief Operating Officer, the Somerset-based pharmaceutical and biotechnology company announced. Mr.  Maselli will report to Chair and Chief Executive Officer John Chiminski. The new role has Mr. Maselli focusing on growing existing business, integrating the company's offerings and improving drug development and supply


 
Whippany-based Bayer U.S. announced that Raymond F. Kerins Jr., Senior Vice President of Corporate Affairs, has been named the chairman of the  U.S. Chamber of Commerce's  Global Innovation Policy CenterIn this role, Mr. Kerins will oversee the group and use insights to help shape the chamber's policies on intellectual property-led innovation and creativity.


 
Princeton-based Dr. Reddy's Laboratories Ltd. has named a new CEO for North American generics.  Marc Kikuchi will be based out of Princeton, where he will oversee the business unit as part of the India-based company's senior leadership team . Mr. Kikuchi has more than 20 years of experience in the pharmaceutical industry, most recently serving as CEO for the Americas at Zydus Pharmaceuticals Inc. He has also worked in leadership roles at AmerisourceBergen Corp., Johnson & Johnson and others.


Institution and Education News


 
Christopher J. Molloy  was appointed chancellor of Rutgers University-New Brunswick  after having served since July as interim chancellor. "Dr. Molloy is a strong and steady leader who brings a deep understanding of the institution to every discussion about its future," said University President Robert L. Barchi. "He has embraced the challenges of the chancellorship and has expressed a forward-looking vision that will, among other things, increase Rutgers-New Brunswick's public prominence, provide a clear financial plan and expand internships and related opportunities for students."


 
Scientists at  Rutgers University  have revealed the structure of a virus infecting bacteria that thrive in 160-degree hot springs in places like Yellowstone National Park in Wyoming. According to a recent study by Rutgers and other scientists in the Proceedings of the National Academy of Sciences, the discovery could enhance targeted drug delivery and new DNA sequencing technology.


 
Joseph E. Nyre has been named the new President at Seton Hall University. Nyre, currently the P resident at  Iona College , will start Aug. 1 "The board is overwhelmingly enthusiastic in its selection of Dr. Nyre as Seton Hall's next President," said Patrick Murray, Chair of the Seton Hall University Board of Regents"As a highly regarded educator, psychologist and health care innovator, Dr. Nyre is the perfect choice to lead Seton Hall into the highest echelon of American Catholic universities."


 
The community of startups that has emerged at Rowan University's Technology Business Incubator at the South Jersey Technology Park (SJTP) in Mullica Hill is a microcosm for New Jersey's innovation ecosystem. Entrepreneurs from a variety of technology and life sciences sectors-including health technology, information technology, medical devices makers, and defense companies-work side-by-side as they advance their businesses. Many of the incubator's tenant companies hire Rowan University students and graduates to fill jobs and internships.


 
Montclair State University  has earned the designation of R2 -- doctoral university high research activity -- in the latest reclassification of the Carnegie Classification of Institutions of Higher Education.  The accomplishment comes three years after Montclair State earned an initial Research Doctoral University designation, and signifies a continued expansion of its research portfolio and doctoral program offerings.

Funding News

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 to 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. 
Special Programs from Our Partners for BioNJ Members


February 19, 2019 | Newark
February 26, 2019 | East Hanover

The mission of Students 2 Science is to "inspire, motivate, and educate elementary, middle and high school students to pursue careers in science, technology, engineering and math (STEM subjects)." This social and open house will be held on Tuesday, Feb.19, from 3-6 p.m. in the Newark Technology Center, 765 Broad St., Newark, 07102 and on Tuesday, Feb. 26, from 3-6 p.m. in the East Hanover Technology Center, 66 Deforest Ave., East Hanover, 07936. It is a "free, fun and casual event" open to anyone 21 and older who would like to learn more about the organization and how to get involved. RSVP to Cyndi Mayer, Director of Volunteer Recruitment and Corporate Relations, 862-777-4237.


February 20, 2019 | Newark, DE

The Science & Technology Career Fair connects employers with exemplary candidates in search of new career opportunities. Organizations looking to fill full-time, part-time and internship roles are encouraged to exhibit. This event traditionally attracts over 350 scientists and technologists with a broad range of educational and technical expertise. For more information, visit https://delawarebio.org/events/career-fair/.


March 6, 2019 | West Windsor

NJBIA and Mercer County Community College have partnered together to explore the synergies between business and higher education, and how public-private partnerships can help build a skilled workforce ready for 21st-century jobs. Speakers include Debbie Hart, President & CEO, BioNJ; Dr. Jianping Wang, President, Mercer County Community College; Rashaad Bajwa, President & CEO, Domain Computer Services, Inc.;  
Judy Savage, Executive Director, NJ Council of County Vocational-Technical  Schools and Dr. Mark Harris, Vice President, Finance and Administration, Mercer County Community College.  For more information and to register, please visit  www.njbia.org .


March 11, 2019 | Trenton
New Jersey State Museum, Main Room, 205 W State Street, Trenton, NJ

Industry representatives, Patients, families, caregivers, medical professionals and elected officials and their staff are invited to join us for Rare Disease Day 2019. Learn about real-world advocacy from New Jersey legislators, hear about the Patient journey from those who live it and enjoy a Keynote by First Lady Tammy Murphy.   Click here to register.


June 3-6, 2019 | Philadelphia Convention Center

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. The key benefits of attending the 2019 BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry thought leaders with over 500 education sessions at your fingertips and unparalleled networking opportunities with 16,000+ attendees from 67 countries. 


June 9-14, 2019 | Drew University | Madison

NJ ResMed is a week-long graduate/professional-level course providing an accelerated program for medicinal chemists, biologists and other industrial and academic scientists who wish to broaden their knowledge of the drug discovery and development process. The course concentrates on the fundamentals of drug discovery spanning initial target validation through clinical development. More information and registration can be found at www.drew.edu/resmed.