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.

Cranbury-based BioNJ Member  Amicus Therapeutics  announced that the  U.S. Food and Drug Administration  ( FDA ) has granted to Amicus a  Breakthrough Therapy Designation  to  AT-GAA  for the treatment of late onset  Pompe disease , an inherited lysosomal storage disorder caused by the deficiency of an enzyme known as acid alpha-glucosidase (GAA).  AT-GAA  is the first ever investigational product for Pompe disease to receive BTD. 

Princeton-based BioNJ Member Genmab A/S announced topline results from the Phase III COLUMBA study (MMY3012) of subcutaneous (SC) versus intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma. The results showed that SC administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 is non-inferior to IV administration of daratumumab with regard to the co-primary end points of overall response rate (ORR) and Maximum Trough concentration (Ctrough ) of daratumumab on day 1 of the third treatment cycle.

Morris Plains-based BioNJ Member Immunomedics, Inc. announced that updated data from the Phase 2 study of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (mTNBC) were published in the New England Journal of Medicine (NEJM). We are committed to becoming a leading ADC company and this publication in NEJM is a validation of our unique ADC platform," remarked Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. 

Plainsboro-based BioNJ Member  Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for ESPEROCT® for the treatment of adults and children with haemophilia A. ESPEROCT® is the brand name for turoctocog alfa pegol, N8-GP. ESPEROCT® is indicated for use in adults and children with haemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding.

Plainsboro-based BioNJ Member  Novo Nordisk and Abbott announced a non-exclusive partnership that will integrate insulin dose data from Novo Nordisk pre-filled and durable connected pens directly into the digital health tools compatible with the FreeStyle Libre system.  The partnership reflects both companies' commitment to make diabetes management easier by connecting key technologies such as continuous glucose monitoring (CGM) and connected insulin pens. 

BioNJ Member  Pfizer Inc., with offices in Madison, announced the European Commission (EC) has approved ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.

Bridgewater-based BioNJ Member Eli Lilly and Company and BioNJ Member Pfizer, with offices in Madison,  announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain (CLBP). In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo.

BioNJ Member  Pfizer Inc., with offices in Madison, and  Ochsner Health System have entered into a multi-year strategic alliance to develop innovative models for clinical trials. Through this partnership, Pfizer and Ochsner -- through its innovation lab, innovationOchsner (iO), in partnership with Ochsner Research -- will explore ways to enhance the clinical trial experience and ease participation in clinical research for both patients and healthcare professionals.

Bridgewater-based BioNJ Member Sanofi etailed results were presented from two Phase 3 trials in patients with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids. These trials, known as SINUS-24 and SINUS-52, demonstrated that Dupixent® (dupilumab), when added to the standard of care corticosteroid nasal spray,  improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes.

Princeton-based BioNJ Member Evotec AG and the Helmholtz Centre for Infection Research ("HZI") announced a collaboration with the goal to address a major global health threat by developing novel antibiotics that overcome drug-resistant bacterial pathogens. Research activities will initially be focused on the optimisation of cystobactamids, a family of natural antibacterial products with innovative chemical scaffolds that are active against the most dangerous Gram-negative pathogens on the WHO priority list.

Kenilworth-based BioNJ Member  Merck & Co. and  AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of LYNPARZA tablets, as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations (BRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

Kenilworth-based BioNJ Member  Merck & Co. and  AstraZeneca announced positive results from the Phase 3 POLO trial.  Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with LYNPARZA versus placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials.

POLO is a randomized, double-blinded, placebo-controlled trial exploring the efficacy of LYNPARZA tablets as first-line maintenance monotherapy in patients with germline  BRCA-mutated (g BRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease has not progressed on platinum-based chemotherapy.

Kenilworth-based BioNJ Member  Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from the EORTC1325/KEYNOTE-054 trial. This pivotal Phase 3 trial demonstrated that KEYTRUDA significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 43 percent compared to placebo in patients with resected, high-risk stage III melanoma (HR=0.57 [95% CI, 0.46, 0.70]; p<0.001). 

Kenilworth-based BioNJ Member  Merck & Co. announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell carcinoma (RCC) at the 2019 Genitourinary Cancers Symposium. This is the first combination regimen to significantly improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib.

Kenilworth-based BioNJ Member  Merck & Co. and Immune Design announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Immune Design for $5.85 per share in cash for an approximate value of $300 million. "Scientists at Immune Design have established a unique portfolio of approaches to cancer immunization and adjuvant systems designed to enhance the ability of a vaccine to protect against infection, which could meaningfully improve vaccine development," said Dr. Roger M. Perlmutter, President, Merck Research Laboratories.

East Hanover-based BioNJ Member  Novartis announced that it is exercising its option to license the rights to develop and commercialize TQJ230, an investigational agent previously known as AKCEA-APO(a)-LRx, from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, for targeted cardiovascular therapy. TQJ230 was discovered by Ionis and has been co-developed to date by Akcea and Ionis. Novartis is now responsible for worldwide development and commercialization of this asset.

Basking Ridge-based BioNJ Member Ipsen  has  struck  a $1.3 billion (€1.1 billion) deal to buy Clementia Pharmaceuticals for its late-phase rare disease drug palovarotene. The transaction will see Ipsen hand over $1 billion upfront to acquire the retinoic acid receptor gamma agonist ahead of a filing for FDA approval.  Canada's Clementia picked up the worldwide rights to palovarotene from Roche in 2013. 

Iselin-based BioNJ Member Helsinn announces that Helsinn Investment Fund S.A. has made a €1 Million investment in Gain Therapeutics SA. Gain Therapeutics SA is a private company, based in Lugano and with a branch in Barcelona, that exclusively licensed an advanced computational technology, Site-directed Enzyme Enhancement Therapy, (SEE-Tx®) used to identify next generation non-competitive pharmacological chaperones, under the scientific management of its inventor, Prof. Xavier Barril.

Princeton-based BioNJ Member Oyster Point Pharma, Inc., a privately held clinical-stage pharmaceutical company with an initial focus on developing novel therapies to treat Dry Eye Disease, announced a $93 million Series B financing. The round was co-led by Invus Opportunities and Flying L Partners in collaboration with Falcon Vision. Existing investors New Enterprise Associates (NEA) and Versant Ventures, as well as new investor Vida Ventures, participated significantly in the round.

Princeton-based BioNJ Member Taiho Oncology, Inc., in partnership with leading advocacy groups including Colorectal Cancer Alliance, Fight Colorectal Cancer and COLONTOWN®,  announced its support of a number of prevention and awareness initiatives during National Colorectal Cancer Awareness Month. Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer and the second leading cause of cancer death in the United States, with an estimated 140,250 new cases and 50,630 deaths in 2018.

Princeton-based BioNJ Member  Bristol-Myers Squibb Company announced that it has filed an amended registration statement on Form S-4 with the Securities and Exchange Commission ("SEC") in connection with Bristol-Myers Squibb's proposed acquisition of Celgene. The special meetings of stockholders of both Bristol-Myers Squibb and Celgene are currently scheduled for April 12, 2019, and the record dates for stockholders of both companies eligible to vote at the respective special meetings is taking place today, Friday, March 1, 2019. 

TheWell Bioscience  was recently welcomed as the newest tenant at  the Commercialization Center for Innovative Technologies (CCIT) in North Brunswick , a life sciences incubator owned by the New Jersey Economic Development Authority (NJEDA). From its new location at CCIT, the biotech company will further develop and scale its advanced 3D cell culture hydrogel system for drug screening, tissue engineering, and pre-clinical applications.

Bedminster-based Tyme Technologies, Inc. announced that it received design guidance for a registrational trial from the U.S. Food and Drug Administration (FDA) on a drug development pathway for SM-88 in third-line pancreatic cancer during a recent Type C meeting. The planned trial is intended to be a pivotal trial in the third-line setting to support a submission for FDA approval upon achievement of the trial endpoints and satisfaction of customary regulatory requirements.

Woodcliff Lake-based Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) to potentially update the label for BELVIQ® (lorcaserin HCl) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCl) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM).

Lawrence-based Lipocine Inc. announced that the U.S. Food & Drug Administration indicated that the Phase 2 clinical study of LPCN 1144 in non-alcoholic steatohepatitis ("NASH") with biopsy confirmed NASH subjects may proceed in response to the company's Investigational New Drug ("IND") application. Lipocine's planned Phase 2 clinical study is a prospective, multi-center, randomized, placebo-controlled multiple-arm study in male hypogonadal biopsy-confirmed NASH subjects with grade F2/F3 fibrosis with an expected 36-week treatment period. 

Bedminster-based  Mallinckrodt Pharmaceuticals  announced interim analysis results of its company-sponsored, Phase 3, single-arm, open-label, multi-center study assessing the efficacy of treating steroid-refractory, acute Graft-versus-Host Disease (aGvHD) pediatric patients with UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX® Photopheresis system. Given the overall response rate exceeded the specified target at the study midpoint, the company is electing not to proceed with further enrollment of additional patients in the clinical trial.

Bedminster-based Mallinckrodt Pharmaceuticals announced it has entered into a research collaboration agreement with Transimmune AG, a company developing novel immunotherapies based on its unique understanding of the physiologic processes underlying the activation of antigen-presenting cells. THERAKOS UVAR XTS®/CELLEX® Photopheresis is a medical procedure that is administered using U.S. FDA-approved UVADEX® (methoxsalen) Sterile Solution for the palliative treatment of skin manifestations associated with Cutaneous T-Cell Lymphoma (CTCL) in patients who are unresponsive to other forms of treatment.

Kyowa Kirin International PLC, with offices in Princeton, and Ultragenyx Pharmaceutical Inc. announced positive results of a 64-week efficacy and safety analysis of the randomized active-controlled Phase 3 study of Crysvita® (burosumab) in children with X-linked hypophosphatemia (XLH) compared with oral phosphate and active vitamin D (current conventional therapy). The new results showed that Crysvita was superior to conventional therapy for all key efficacy endpoints, showing a meaningful improvement in rickets severity, lower limb deformity, growth and physical functioning as demonstrated by increases in distance walked.

Glen Rock-based RespireRx Pharmaceuticals Inc. announced that it has entered into a nonbinding memorandum of understanding ("MOU") and exclusivity agreement with Impression Healthcare Limited for the purpose of negotiating terms by which the parties would enter in an arrangement, such as a license, joint venture or partner agreement, so as to commercialize dronabinol for the treatment of OSA in Australia, New Zealand and Southeast Asia.

Fair Lawn-based SK Biopharmaceuticals and Arvelle Therapeutics GmbH announced that they have entered into an exclusive licensing agreement for Arvelle to develop and commercialize cenobamate in Europe. Cenobamate is a novel, small molecule investigational antiepileptic drug for the potential treatment of partial-onset seizures in adult patients. "We are very pleased to enter into this licensing agreement with Arvelle, as it provides important validation of the global potential for cenobamate as a new treatment option for adults with partial-onset seizures," said Dr. Jeong Woo Cho, President and CEO of SK Biopharmaceuticals.

Whippany-based  Bayer has exercised its option, under a change-in-control clause in the collaboration agreement with Loxo Oncology, to obtain the exclusive licensing rights for the global development and commercialization, for Vitrakvi® (larotrectinib) and BAY 2731954 (LOXO-195). Both compounds are being developed globally for the treatment of adult and pediatric patients with advanced solid tumors harboring NTRK gene fusions. 

The New Jersey Economic Development Authority (NJEDA) announced that PrimeWork and Incutate have been approved as the latest collaborative workspaces that can offer rent support to start-ups through NJ Ignite. NJ Ignite supports technology and life sciences startups moving to a collaborative workspace by providing rent support which makes the lab and office space more affordable, providing the startup with greater access to environments where they can work alongside other growing companies.