Where Science is Supported/Companies are Created/Drugs are Developed/Patients are Paramount
BioLines Weekender
Welcome to an early edition of BioLines Weekender as this Friday, the BioNJ Team is headed to   BioNJ's CEO Summit  at the Bridgewater Marriott. An industry trademark event, the CEO Summit will bring together nearly 300 biotech/pharma C-Suite leaders and their teams, investors, entrepreneurs, academics and other members of the diverse life sciences community to share their knowledge, experiences and views on the status and future of today's evolving market access and commercialization environment.

It's not too late to register and join us, along with Celgene CEO Mark Alles; Deiter Weinand, President Pharmaceuticals Chairman of the Board of Management, Bayer Pharma AG; Daniel O'Connor, President, CEO and Director, Advaxis; Robert Ward, President and CEO, Radius Health; Dr. Geert Cauwenbergh, President and CEO, RWi Pharmaceuticals; Jesper Hoiland, Executive Vice President, U.S., Novo Nordisk; and other members of the life sciences industry at BioNJ's CEO Summit!

Because Patients Can't Wait SM ,
The BioNJ Team 
Blue Divider
 
Tune in to Caucus: New Jersey  on NJTV at 12:00 p.m. on October 1  for an interview with the Officers of Opportunity New Jersey  (ONJ)  focused on "New Jersey's Business Climate." From left to right: Debbie Hart ( ONJ  Secretary), President and CEO, BioNJ; Michele Siekerka ( ONJ Co- Chair ), CEO, NJBIA; Steve Adubato, Host, Caucus: New Jersey; Ralph Thomas ( ONJ  Treasurer), CEO, New Jersey Society of CPAS; and Tom Bracken ( ONJ Co- Chair ), CEO, New Jersey Chamber of Commerce.



BioNJ Calendar 
BioNJ 4th Annual 
CEO Summit

THIS FRIDAY!

September 23, 2016
Bridgewater Marriott
Bridgewater, NJ

BioHUB Networking Mixer

October 17, 2016
Rider University
Lawrence Township, NJ


BioNJ HR Forum: 
Hot Topics in Industry Compensation
featuring Radford

October 20, 2016
The Center of Excellence
Bridgewater, NJ


BioNJ Patient Advocacy Summit*

November 4, 2016
Celgene
Summit, NJ


*Registration is open to patient advocacy groups, patient advocacy professionals in BioNJ Member companies and Sponsors only.
Save the Date
Inspiring Women in STEM Conference

December 2, 2016
Sanofi US
Bridgewater, NJ

Registration will be open shortly.

Save the Date
Beyond Value Frameworks: 
Measuring Health Benefits from a Patient's 
Point of View*

December 8, 2016

*An invitation only event for BioNJ Innovation Members and Sponsors. Limited seating is available.
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 [email protected].  
Accelerating MS Research Through Teamwork, New Approaches
 
Discovering a new therapy is no easy task, and Esther Martinborough, Associate Director of Research at Celgene, knows this firsthand. In 2008, she saw Receptos' two therapeutic candidates for cancer fail before her team rallied to identify a potential new treatment option for multiple sclerosis. Aided by the 2015 acquisition of Receptos by Celgene, her team is committed to bringing this potential new treatment option to MS patients.
 
Please click here to read the full press release.

More African Americans Needed in Myeloma Studies
 
When recruiting patients for a clinical trial, it is important that researchers select the right mixture of people -- in terms of age, gender and ethnicity -- who they're seeking to treat with a new therapy or treatment intervention. This variety is critical for researchers to understand how treatments impact patients differently. Unfortunately, achieving diversity in clinical trials continues to be a challenge. While African Americans make up over 20 percent of newly diagnosed multiple myeloma cases in the United States, they represent only 8 percent of cancer clinical trial participants. When it comes to multiple myeloma, a cancer of a type of white blood cells called plasma cells, African Americans are twice as likely to be diagnosed with the disease, which makes it even more important that they are better represented in myeloma clinical trials.
 
Please click here to read the full article.
BioNJ Talent Services
Job Seekers: Find Your Next Career Opportunity Here
Click here to see the list of available positions with companies such as Amicus Therapeutics, Churchill Pharmaceuticals, Ferring Pharmaceuticals, Inflamax Research Inc., Insmed, Kashiv Pharma, Regeneron and Soligenix.  

Employers: Connect With Top New Jersey Talent
Finding strong candidates is made easy with BioNJ's robust network of industry professionals and our top notch sourcing service. Post your job openings on the BioNJ Job Board and grab the attention of qualified industry candidates. Contact Vicki Gaddy at  [email protected]  to learn more.
Save Money With BioNJ's Purchasing Consortium
BioNJ's Purchasing Consortium: Enhanced Member Benefits, Saving Money and Time, Helping You Help Patients

Through  BioNJ's Purchasing Consortium, our Members have access to programs and services negotiated by BioNJ and BIO and offered at favorable rates and terms to save your company money. As the sole BIO affiliate in New Jersey, BioNJ is part of the largest cost savings program for the life sciences industry with the purchasing power of over 2,800 biotech companies. Our group discounts are for Members only and your Membership is the gateway to this purchasing power to save your company critical resources. 

From lab supplies to insurance and office supplies to shipping, take a fresh look at your savings and the current suppliers in BioNJ's Purchasing Consortium, including  Fisher ScientificUPS, AirgasCSS Building ServicesDynamic Strategies, BioPharm InsightBusiness WireChubb Group of Insurance CompaniesClean HarborsFemto ScientificHumboldt Moving, NikonNJBIZ, Springer NatureOffice Depot and  Tech Depot.

For more information on how you can take advantage of these Member discounts and save your working capital, contact Edie Esposito at  [email protected].
Economic Developments
The expansion of New Jersey's robust life sciences community. 
Advaxis Unveils State-of-the-Art Manufacturing Facility, Laboratory to Produce and Develop Novel Immuno-Oncology Therapeutics
 
Princeton-based BioNJ Member  Advaxis, Inc.  built out a 30,000-square-foot expansion at its College Road East headquarters to include a clean-room manufacturing and laboratory facility to develop and manufacture clinical-grade products to support Advaxis' clinical trials and future commercialization of its immuno-oncology therapeutics. Advaxis President and CEO Daniel O'Connor welcomed New Jersey Governor Christopher J. Christie and BioNJ President and Chief Executive Officer Debbie Hart to celebrate the completion of its new facility and laboratory with a ribbon-cutting event.
 
Please click here to read the full press release.

EDA Support Enables Nationally-Recognized Admera Health to Expand Patient Care
 
As an advanced molecular diagnostic company focused on personalized medicine and non-invasive cancer testing, South Plainfield-based BioNJ Member  Admera Health  is dedicated to developing cutting-edge diagnostics that span the continuum of care. With support from the New Jersey Economic Development Authority, the company plans to expand its product portfolio and grow its workforce by over 50 percent. Admera was formed in 2012 as a spinout from GENEWIZ, a global leader in research and development genomic services and one of the first graduates of the EDA's Commercialization Center for Innovative Technologies in North Brunswick.
 
Please click here to read the full press release.
NJ Company News
ContraVir Reports New CRV431 Data Highlighting Synergistic Activity With CMX157 Against Hepatitis B
 
Edison-based BioNJ Member ContraVir Pharmaceuticals, Inc. announced that it has taken a major step forward in its pursuit of a potentially curative combination therapy for chronic hepatitis B. The company presented new preclinical data profiling the robust anti-HBV activity of its potentially best-in-class cyclophilin inhibitor CRV431, including evidence of synergy with CMX157, ContraVir's highly potent prodrug of tenofovir, when the two drugs are used together. CMX157 is currently in Phase 2 clinical trials in  Thailand .
 
Please click here to read the full press release.

Elusys Therapeutics Announces Publication of Results from Five Clinical Trials With its Inhalational Anthrax Antitoxin, ANTHIM® (OBILTOXAXIMAB) Injection

Pine Brook-based BioNJ Member  Elusys Therapeutics, Inc.  announced that the company published data on over 450 healthy adult subjects from five clinical trials used to support recent U.S. Food and Drug Administration marketing approval of  ANTHIM® (obiltoxaximab) Injection, its treatment for inhalation anthrax ANTHIM received FDA marketing approval in March 2016. ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to  Bacillus anthracis  in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
 
Please click here to read the full press release.

Results from a Large German Study Show that BLC With HEXVIX® Significantly Improves Detection of NMIBC
 
Princeton-based BioNJ Member Photocure ASA announced that data from the OPTIC III study: Optimized photodynamic diagnosis for transurethral resection of the bladder tumor in German clinical practice, is now available online in the World Journal of Urology The results of this large 30 center study demonstrate that Blue Light Cystoscopy with Hexvix significantly improves the detection of NMIBC versus the standard procedure of white light alone in routine clinical practice in Germany.
 
Please click here to read the full press release.

Soligenix and SciClone Establish Regional Licensing Agreement for SGX942, a Novel Product Candidate for Oral Mucositis
 
Princeton-based BioNJ Member  Soligenix, Inc. and SciClone Pharmaceuticals, Inc. announced that the companies have entered into an exclusive license agreement granting rights to SciClone to develop, promote, market, distribute and sell SGX942 (dusquetide), a novel, first-in-class therapy being developed for the treatment of oral mucositis in patients with head and neck cancer. 
 
Please click here to read the full press release.

Amarin's REDUCE-IT Cardiovascular Outcomes Study of Vascepa to Continue as Planned at Recommendation of Independent Data Monitoring Committee
 
Bedminster-based BioNJ Member  Amarin Corporation plc  announced that, as expected, the independent data monitoring committee has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa®  (icosapent ethyl) reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
 
Please click here to read the full press release.

Caladrius Subsidiary, PCT, Announces Five-Year Strategic Manufacturing Services Agreement With Adaptimmune
 
Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider (PCT, LLC, A Caladrius Company or "PCT") with a select therapeutic development pipeline, announced a new five-year strategic manufacturing services agreement under which PCT will produce SPEAR® T-cell therapies for Adaptimmune Therapeutics plc. 
 
Please click here to read the full press release.

Caladrius Biosciences, Inc. Enters Into Agreements to Raise $25 Million in Common Equity Priced at Market Without Warrants
 
Basking Ridge-based BioNJ Member Caladrius Biosciences, Inc. announced that it entered into Securities Purchase Agreements with several accredited investors for the sale of 4,449,153 shares of its common stock in private placements of $21 million. Caladrius has a pre-existing relationship with each of these investors, including its now largest institutional shareholder and its strategic collaborator, Sanford Health, one of the largest health systems in the United States. 
 
Please click here to read the full press release.

Important New Analysis Shows that Novartis' Entresto® is Associated With Higher Relative Health-related Quality of Life Scores Among HFrEF Patients
 
East Hanover-based BioNJ Member Novartis announced a new post-hoc analysis demonstrates that the decline in health-related quality of life scores associated with a heart failure hospitalization among patients taking Novartis' Entresto® (sacubitril/valsartan) was lower -- approximately 50% less of a decline -- compared to those taking ACE inhibitor enalapril. A second post-hoc analysis in the overall study population shows an association between decline in HRQL score and increased risk of cardiovascular death and HF hospitalization. 
 
Please click here to read the full press release.

Novartis Presents New Positive Data Showing AMG 334 Significantly Reduces Monthly Migraine Days in Chronic Migraine
 
East Hanover-based BioNJ Member Novartis announced detailed Phase II results showing the fully human monoclonal antibody AMG 334 (erenumab) demonstrated a statistically significant reduction in monthly migraine days compared with placebo in patients with chronic migraine. Significantly more patients receiving monthly subcutaneous AMG 334 70mg or 140mg experienced a 50% or more reduction in the number of monthly migraine days compared with placebo (40%, 41% and 24%, respectively).
 
Please click here to read the full press release.

Johnson & Johnson Advances through PhII With a Promising Hep C Triple and 100% Cure Rate
 
Curing Hepatitis C is a done deal now. But New Brunswick-based BioNJ Member Johnson & Johnson is stepping through the clinic with a new combo that the pharma giant hopes will prove it can do it all faster, and presumably cheaper, than what's available now. In a new batch of data put out by J&J partner Achillion, J&J's team scored a 100% cure rate in three cohorts of patients getting a triple combination of odalasvir, AL-335 and Olysio (simeprevir). A fourth cohort that excluded simeprevir achieved a 90% cure rate at SVR12, 12 weeks after treatment. And one of the triplet cohorts achieved 100% cure for 20 patients after just 6 weeks of treatment.
 
Please click here to read the full article.

Johnson & Johnson Announces World Health Organization will Review Ebola Vaccine Regimen for Emergency Use Assessment and Listing (EUAL)
 
New Brunswick -based  BioNJ Member Johnson & Johnson announced that Janssen Vaccines & Prevention B.V. has completed a submission to the World Health Organization for Emergency Use Assessment and Listing for its investigational preventive Ebola prime-boost vaccine regimen. The EUAL is a special procedure that can be implemented when there is an outbreak of a disease with high rates of morbidity or mortality and a lack of treatment or prevention options.
 
Please click here to read the full press release.

Johnson & Johnson Makes $4.3B Acquisition to Enter Cataract Surgery Market
 
New Brunswick -based  BioNJ Member Johnson & Johnson  has agreed to pay $4.325 billion in cash for Abbott Laboratories' ophthalmic unit.  J&J said it has a definitive agreement to buy the Abbott Medical Optics business, which is known for its cataract surgery lenses, among other ophthalmic and laser vision surgery and eye health products. 

Please click here to read the full press release.

Oral Ozanimod Efficacy and Safety Results at 2 Years from Phase 2 RADIANCE Trial of Patients With Relapsing Multiple Sclerosis
 
Summit-based BioNJ Member Celgene Corporation  announced results from the 96-week blinded extension period (for a total of up to 120 weeks of exposure on treatment) of the RADIANCE phase 2 trial of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis.
 
Please click here to read the full press release.

Celgene Announces Interim Topline Data from Trial of Investigational Oral GED-0301 in Patients With Active Crohn's Disease
 
Summit-based BioNJ Member Celgene Corporation  announced interim topline data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn's disease.
 
Please click here to read the full press release.

European Medicines Agency Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) in Advanced Form of Bladder Cancer 
 
Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that the European Medicines Agency validated its type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. Validation of the application confirms the submission is complete and begins the EMA's centralized review process. 
 
Please click here to read the full press release.

Results from 1,000-Patient, Global Real-World Patient-Reported Outcomes Study of Sanofi Genzyme's Aubagio® (teriflunomide) in Patients With Relapsing Multiple Sclerosis Demonstrate High Levels of Treatment Satisfaction
 
Sanofi Genzyme, the specialty care global business unit of Bridgewater-based BioNJ Member Sanofi, announced positive new real-world data from the Phase 4 Teri-PRO (Patient Reported Outcomes) study of Aubagio ® (teriflunomide), a once-daily, oral treatment for relapsing forms of multiple sclerosis. 
 
Please click here to read the full press release.

Sanofi's Fixed-Ratio Combination Helps More Patients Reach Mealtime Blood Sugar Target than Insulin Glargine Alone
 
Bridgewater-based BioNJ Member Sanofi announced that iGlarLixi, the investigational, titratable fixed-ratio combination of insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide*, offers greater control of mealtime blood sugar (post-prandial glucose, PPG) in adults living with type 2 diabetes compared to insulin glargine 100 Units/mL alone. A new post-hoc analysis of data from the LixiLan-L pivotal Phase III clinical trial found more patients who received the fixed-ratio combination reached their daily PPG target than those who received only insulin glargine 100 Units/mL. 
 
Please click here to read the full press release.

Aerie Pharmaceuticals Reports Positive Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 Topline Efficacy Results
 
Bedminster-based BioNJ Member Aerie Pharmaceuticals, Inc.  reported the successful 90-day primary efficacy results of its 12-month Phase 3 "Mercury 1" clinical trial for its fixed-dose combination product candidate, Roclatan™ . The study achieved its primary efficacy endpoint demonstrating statistical superiority over each of its components, including Aerie product candidate Rhopressa (netarsudil ophthalmic solution) 0.02% and market leading prostaglandin analogue atanoprost, all of which were dosed once daily in the evening. 
 
Please click here to read the full press release.

Aerie Shares Rocket Up as Glaucoma Combo Drug Scores Positive Data
 
Shares of Bedminster-based BioNJ Member Aerie Pharmaceuticals  skyrocketed on promising data for a combination glaucoma drug that bested its own late-stage drug Rhopressa by adding a well known and widely prescribed generic treatment that  significantly improves its effect .
 
Please click here to read the full article.

Aerie Pharmaceuticals Raises $125 Million in Public Offerings
 
Bedminster-based BioNJ Member Aerie Pharmaceuticals, Inc.  announced the pricing of a registered underwritten public offering of  $75 million  of shares of its common stock at a price to the public of  $29.50  per share, before deducting underwriting discounts and commissions and other estimated offering expenses. The offering was upsized by  $25 million  over the offering amount anticipated to be sold as previously announced. 
 
Please click here to read the full press release.

Merck, Pfizer Tout PhIII Diabetes Data as Ertuglifozin Heads to the FDA
 
Kenilworth-based BioNJ Member Merck and BioNJ Member Pfizer, with locations in Madison, rolled out positive  Phase III data for their SGLT2 diabetes drug ertugliflozin.  The data, with two doses of their drug added to Januvia and metformin slicing A1c levels by an extra 0.69 percent and 0.76 percent, will be added to their regulatory filings for this drug, now slated to land at the FDA before the end of this year with Europe and other markets to follow in 2017.

Please click here to read the full article.

Allergan Acquires Akarna Therapeutics Adding to its Strong Development Program and Commitment to Innovation in NASH
 
Jersey City-based BioNJ Member Allergan plc  announced that the company has acquired Akarna Therapeutics Ltd. , a privately held biopharmaceutical company focused on developing novel small molecule therapeutics that target inflammatory and fibrotic diseases, for an up-front payment of $50 million , subject to certain adjustments, as well as potential clinical, regulatory and commercial milestone payments related to its lead development compound, AKN-083. 
 
Please click here to read the full press release.

Allergan to Acquire Vitae Pharmaceuticals Adding Innovative Development Programs for Dermatologic Conditions
 
Jersey City-based BioNJ Member Allergan plc  and  Vitae Pharmaceuticals, Inc.  announced that they have entered into a definitive agreement under which  Allergan  will acquire Vitae for  $21.00  per share, in cash, for a total transaction value of approximately  $639 million
 
Please click here to read the full press release.

Cancer Genetics, Inc. Announces a Global Partnership With BARC Global Central Laboratory to Offer Comprehensive Clinical Trial and Companion Diagnostic Solutions for the Oncology Industry 
 
Rutherford-based BioNJ Member Cancer Genetics, a leader in enabling precision medicine for oncology through molecular markers and diagnostics, announced that it has entered into a partnership with the Bio Analytical Research Corporation, a global central laboratory supporting clinical trials and serving large pharmaceutical and biotech companies globally, including in Europe, Africa, China, Australia and the USA.
 
Please click here to read the full press release.

Matinas BioPharma Completes Private Placement of $8.0 Million
 
Bedminster-based BioNJ Member  Matinas BioPharma Holdings, Inc.  announced the final closing of an $8.0 million private placement equity financing, which represents the full amount of the offering. The company sold to accredited investors an aggregate of 1,600,000 Series A Preferred Shares at a purchase price of $5.00 per share.
 
Please click here to read the full press release.

Lexicon Reports Positive Top-Line Results in Pivitol Phase 3 Study for Otagliflozin in Patients With Type 1 Diabetes
 
Basking Ridge-based Lexicon Pharmaceuticals , Inc. announced that the pivotal in Tandem1 Phase 3 clinical trial of sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin. 
 
Please click here to read the full press release.

FDA Extends PDUFA Date for TELOTRISTAT ETIPRATE for the Treatment of Carcinoid Syndrome 
 
Basking Ridge-based Lexicon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration will require additional time to complete its review of the New Drug Application for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome. In a notice received from the FDA, the Prescription Drug User Fee Act date for its Priority Review of telotristat etiprate has been extended by three months, from November 30, 2016 to February 28, 2017. 
 
Please click here to read the full press release.

Celsion Corporation Announces Independent NIH Analysis Showing Treatment With ThermoDox® Plus RFA May Significantly Improve Overall Survival of Patients With Primary Liver Cancer
 
Lawrenceville-based Celsion Corporation  announced that the  National Institutes of Health  has conducted an independent retrospective analysis of data from the intent-to-treat population of the company's HEAT Study, a 701-patient study investigating ThermoDox®,  Celsion's  proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation in primary liver cancer, also known as hepatocellular carcinoma. 
 
Please click here to read the full press release.

Celsion Corporation Announces Positive DSMB Review of Phase 1b OVATION Study in Ovarian Cancer
 
Lawrenceville-based Celsion Corporation announced that the independent Data Safety Monitoring Board has completed its safety review of data from the first three patient cohorts in the ongoing Phase Ib OVATION Study. Based on the DSMB's recommendation, the study will continue as planned and the company will proceed with dosing in its fourth and final patient cohort at an escalated dose. 
 
Please click here to read the full press release.

GSK Announces EU Regulatory Submission for Sirukumab in Rheumatoid Arthritis
 
GlaxoSmithKline plc announced the regulatory submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of subcutaneous formulation of sirukumab, a human anti-interleukin (IL)-6 monoclonal antibody, for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 
 
Please click here to read the full press release.

Victoza® Lowered the Progression of Kidney Damage in Adults With Type 2 Diabetes at High CV Risk
 
Princeton-based Novo Nordisk announced that the progression of kidney damage was significantly lower with Victoza ®  treatment vs. placebo, as measured by urinary albumin creatinine ratio, both added to standard of care in 9,340 adults with type 2 diabetes at high cardiovascular risk. Similar significant results were observed between Victoza ®  and placebo across subgroups (with no, mild or moderate renal impairment).  
 
Please click here to read the full press release.

Semaglutide Reduced Major Cardiovascular Events by 26% in Adults With Type 2 Diabetes at High Cardiovascular Risk

Princeton-based Novo Nordisk announced that semaglutide, an investigational glucagon-like peptide-1 analogue administered once-weekly, significantly reduced the risk of the primary composite endpoint of time to first occurrence of either cardiovascular death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 26% vs placebo, when added to standard of care in 3,297 adults with type 2 diabetes at high CV risk.  
 
Please click here to read the full press release.

NovoRapid® Receives Positive CHMP Opinion for Extended Use in Children as Young as One Year Old
 
Princeton-based Novo Nordisk  announced that the Committee for Medicinal Products for Human Use, CHMP, has adopted a positive opinion to extend the use of NovoRapid ®  (insulin aspart) in the European Union for children with diabetes from as young as one year old.
 
Please click here to read the full press release.

FDA Approves Bayer's New IUD
 
Whippany-based Bayer, whose Essure device has been struggling for years with safety complaints and lawsuits, is introducing a new IUD. The FDA approved its new intrauterine system for the prevention of pregnancy for up for 5 years.  The Kyleena IUS contains 19.5 mg of the progestin hormone levonorgestrel. It is inserted by a healthcare provider and will be available by prescription next month The device demonstrated its contraceptive efficacy in a randomized, open-label study conducted in 11 countries in Europe and the Americas.
 
Please click here to read the full press release.

Regeneron and Teva Announce Global Collaboration to Develop and Commercialize Fasinumab, an Investigational NGF Antibody for Chronic Pain
 
Basking Ridge-based Regeneron Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd.  announced a global agreement to develop and commercialize fasinumab, Regeneron's investigational NGF antibody in Phase 3 clinical development for osteoarthritis pain and in Phase 2 development for chronic low back pain. 
 
Please click here to read the full press release.

Adgero Biopharmaceuticals Completes $9.7 Million Equity Financing
 
Princeton-based Adgero Biopharmaceuticals Holdings, Inc., a privately-held biopharmaceutical company leveraging its late stage photodynamic therapy platform for the treatment of serious oncology indications, announced the final closing of $9.7 million in private placement equity financing. The net proceeds of the private placements will be used to fund the advancement of the company's REM-001 Therapy clinical program in CMBC. 
 
Please click here to read the full press release.

Drug Delivery Solutions Company Catalent Makes an Acquisition
 
Drug delivery solutions company Catalent Inc. is acquiring Pharmatek Laboratories Inc., a San Diego-based specialist in drug development and clinical manufacturing.  The deal will be conducted through Catalent Pharma Solutions Inc., a subsidiary of Catalent, which is based in Somerset. 

Please click here to read the full article.
Institution and Education News
Two Startups Based on Rutgers Inventions Chosen as Best University Startups
 
Two new companies built on Rutgers inventions presented this week at University Startup Demo Day, an event in the U.S. Capitol Building for members of Congress and staff, as well as venture capitalists, angel investors and corporate representatives.  The two Rutgers spinouts are  Celvive Inc. , which is refining a stem-cell technology for regenerative medicine applications, such as helping patients recover from spinal cord injury, and  XPEED Turbine Technology LLC , which is developing aerodynamic technology that could reduce the cost of wind energy by improving wind turbine efficiency and increasing annual energy production.  
 
Please click here to read the full article.

HackensackUMC and John Theurer Cancer Center Named National Pancreas Foundation Center
 
BioNJ Member Hackensack University Medical Center, a member of Hackensack Meridian Health, and John Theurer Cancer Center have been designated a National Pancreas Foundation Center for the treatment and care of patients with pancreatic cancer by the National Pancreas Foundation, a nonprofit organization that provides hope for those suffering from pancreatitis and pancreatic cancer. 
 
Please click here to read the full article.

Robert Wood Johnson Foundation's CEO is Stepping Down
 
Dr. Risa Lavizzo-Mourey is stepping down as CEO and President of the $10 billion Robert Wood Johnson Foundation. Dr.  Lavizzo-Mourey, the first woman and first African-American to lead the foundation, has spent nearly 14 years at the helm of the nation's largest philanthropy devoted to health.  She will serve until a successor is in place. 
 
Please click here to read the full article.
People in the News
Renowned Endocrinologist, Dr. Stan Schwartz, Regulatory Strategies Expert Dr. Nancy Motola and Formulations Expert, Dr. Hemant Joshi Join ARKAY Therapeutics' Scientific Advisory Board
 
East Windsor-based BioNJ Member ARKAY Therapeutics, LLC announced the appointment of Dr. Stanley Schwartz, a renowned diabetes expert and key opinion leader, Dr. Nancy Motola, a regulatory strategies veteran and Dr. Hemant Joshi, formulations development expert to ARKAY Therapeutics' scientific advisory board. "We are delighted to have these exceptional individuals join ARKAY's team. We are confident that with these new additions to our existing scientific advisory board and the current members of the board, ARKAY has assembled the team it needs to advance its innovative pancreatic beta-cell centric combination product, RK-01 to the clinic and to the market by the year 2020" said Ravi Kumar, Ph.D., President and CEO of ARKAY Therapeutics. 
 
Please click here to read the full press release.

Symphogen Names New Chief Financial Officer
 
Somerville-based BioNJ Member  Symphogen announced that Jesper Bramming has joined Symphogen as its new Chief Financial Officer, filling the position vacated by Martin Olin, M.Sc., EMBA, who was promoted to Chief Executive Officer and member of the Board of Directors. 
 
Please click here to read the full press release.

Levi Garraway, M.D., Ph.D., to Become Senior Vice President of Global Oncology at Lilly, Succeeding Richard Gaynor, M.D., Who is Retiring After a Distinguished Career
 
Bridgewater-based BioNJ Member Eli Lilly and Company  announced that  Levi Garraway , M.D., Ph.D., a world leader in the analysis of cancer genomics and resistance to targeted therapies, will join Lilly as Senior Vice President,  Global Development & Medical Affairs , for Lilly's Oncology business on  January 1, 2017 .  He will succeed  Richard Gaynor , M.D., who will retire after a distinguished career at Lilly.
 
Please click here to read the full press release.

Amneal Pharma Appoints General Counsel
 
Amneal Pharmaceuticals LLC announced that it has appointed Sheldon Hirt its new Senior Vice President and General Counsel. Mr.  Hirt, according to the Bridgewater-based generics pharmaceutical manufacturer, will succeed Robert Loewenstein, is retiring.
 
Please click here to read the full article.

Catalent Appoints Two to Executive Leadership Team
 
Somerset-based Catalent Pharma Solutions announced it has appointed two new executives to its leadership team.  Alessandro Maselli has been appointed Senior Vice President of Global Operations and Christine Dolan has been appointed Senior Vice President of Global Product Development.
 
Please click here to read the full article.
Upcoming Programs from Our Partners for BioNJ Members
The Future is Now: Dealing in a Transformed Healthcare Environment
September 27, 2016, Dolce Basking Ridge, 300 North Maple Ave., Basking Ridge

Network with other business development professionals and hear Ed Saltzman, the 2016 Frank Barnes' nominee, present an overview of the current deal making trends in BioPharma. This meeting is dedicated to Tom Picone, who worked over 30 years in the pharmaceutical industry, starting in R&D and then moving to business development and licensing. Click here for more information. You don't need to be an LES member to participate.

What Have I Gotten Myself Into?... The Good, the Bad and the Ugly Aspects of Taking Other People's Money
September 28, 2016, Office of Edison Partners, Princeton

Investors are like in-laws: Once you sign up, you can't fire them. What can you do to benefit from your investor's experience, and avoid the investor/management disputes that have torpedoed many promising businesses? How do you make sure you and your investor have the same vision and goals? Click here for more information.

NIH & NSF SBIR Programs and One-to-One Appointments
September 30, 2016, NJEDA Commercialization Center, North Brunswick

This seminar is intended to provide participants with an overview of the SBIR and STTR programs with a focus on the National Institutes of Health and the National Science Foundation. It will feature participation by NIH's 2 largest Institutes, the National Cancer Institute and the National Institute of Allergy and Infectious Diseases & NSF's Smart Health and Biomedical Technologies program. The seminar will also include instruction on topic searching and an introduction to proposal writing followed by a networking lunch and 1-to-1 conversations with the NIH and NSF representatives in the afternoon.  Click here for more information and to register.

1st Pitch Life Science  -- 
"Eavesdropping on Investors' Closed Door Discussions"
October 6, 2016,   Medidata Solutions, Inc. New York, NY  

Come to our new, special location to hear what happens AFTER a start-up company presents to an investor group. Usually after the company representatives leave the room, the investors have a private discussion to decide whether the opportunity merits further investigation and possible investment. 1st Pitch Life Science offers presenters and audience members the chance to hear what happens in those closed-door discussions and to learn what really matters to investors.  Click here to register.

Live2Lead
October 7, 2016, Bridgewater Marriott, Bridgewater

Live2Lead is a half-day, leader development experience designed to equip attendees with new perspectives, practical tools and key takeaways. You will learn from world-class leadership experts, be prepared to implement a new action plan, and start leading when they get back to the office with renewed passion and commitment.  Click here to register.

Life Sciences Forum: Costa Rica
October 9-11, 2016, San Jose, Costa Rica

Join the most unique and specialized forum for the life sciences sector in Latin America. The  Life Sciences Forum , now in its 3rd edition, gathers key representatives from leading manufacturing firms, researchers from the global academia, consultants and top government representatives for a 3-day agenda where exciting, innovative discussions take place around the latest advances and most important achievements in the industry. Click here to register.

Save the Date -- Second Annual Innovation Summit 
November 2, 2016, Princeton Plasma Physics Laboratory 

The half-day event will bring together thought leaders and feature speakers ranging from successful venture capitalists to internationally recognized CEOs. The Summit will also highlight the different resources around our State as well as provide insights and networking opportunities with some of the top academic and industry leaders in the defense, life sciences and the technology industries. More details regarding registration and partnership opportunities are forthcoming. Click here for the Save the Date announcement.

NDRI 2016 Scientific Symposium & NDRI 2016 Service to Science Awards Dinner
November 18, 2106, The Logan Philadelphia, Logan Square, Philadelphia, PA

Join NDRI for their Scientific Symposium and Service to Science Awards Dinner, featuring the real-life doctor who was first to discover and identify Chronic Traumatic Encephalopathy as portrayed by Will Smith in the film, Concussion. Click here to learn more and to register.  

Genesis 2016 -- The Science, Technology and Business of 21st Century Biomedical Innovation
November 30, 2016, Canada House, Trafalgar Square, London SW1Y 5BJ

Genesis 2016 will build on the previous 15 years of experience in assembling a forum where industry executives, investors, academic researchers, policymakers and the expert advisers can exchange and debate their collective insight in order to provide true thought leadership for the sector, themselves and their stakeholders. The overall theme of Genesis 2016 is "The Science, Technology and Business of 21st Century Biomedical Innovation" Click here for more information and to register.
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or  609-890-3185 with any questions.