New Jersey Leads U.S. Biotech Innovation. We Can't Endanger that Economic Strength

New Jersey leads the nation when it comes to drug development — and it's not particularly close. We boast the highest concentration of scientists per square mile of any state. Fourteen of the top 20 American pharmaceutical companies have a presence in New Jersey, including Johnson & Johnson and Merck, which were instrumental in developing COVID-19 vaccines and therapies. All told, the life sciences sector generates over $33 billion of our state GDP. That's why no state would suffer as much damage as New Jersey if, in the coming weeks, the Biden administration decides to grant some developing countries' request to waive intellectual property protections for American-designed COVID-19 tests and treatments.

New March-In Guidelines Threaten U.S. Innovation

The Biden Administration unveiled its long awaited “guidelines” for agency use of the march-in- rights provision of the Bayh-Dole Act. With the unveiling of the Federal Register Notice, the White House bragged that it was unleashing a potent weapon to bring down drug costs. If that was the target, this is a swing and a miss. In reality, the threat of the government forcing a university to license competitors because someone doesn’t like a product’s price affects so few drugs that its impact is minimal. But what the White House apparently doesn’t realize is that this is a dagger over the heads of the innovative small companies which drive our economy by bringing high risk inventions to market.

Using March-In as a Price Control Mechanism Is a “Dangerous Precedent to Set”

The White House announced plans to use Bayh-Dole “march-in rights” to step in and license patent rights of drugs “developed with federal funding” to other manufacturers when the price of the drug is deemed too high. In response, BIO's Chief Advocacy Officer, Nick Shipley, made the following statement: "Using the Bayh-Dole Act’s march-in process as a mechanism to control prices is a dangerous precedent to set. The move would create yet another element of uncertainty within the biotech industry at a time when policy makers have been increasingly adding obstacles to innovation. This type of policy would discourage the exact type of private-public-sector partnerships that the Bayh-Dole Act was designed to encourage, and it would undermine a valuable piece of the drug discovery process..." Click here for full statement.  

Ranking Member Cassidy Rebukes Biden Admin Claiming Authority to Seize Drug Patents

U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement following reporting that “the Biden administration has determined that it has the authority to seize the patents of certain high-priced medicines.” In a Washington Post OpEd, former Senators Birch Bayh (D-IN) and Bob Dole (R-KS) made clear that the Bayh-Dole legislation, which the Biden administration is using to claim this authority, “did not intend that government set prices on resulting products. The law makes no reference to a reasonable price that should be dictated by the government.”

Matthews: When Government Goes Marching in, Innovation Marches Out

President Joe Biden's new provision to a 43-year-old law that has been debated and rejected numerous times doesn’t just target the pharmaceutical industry, it’s threatening any and every industry, academic institution and researcher that receives even a whiff of federal funding. The bipartisan Patent and Trademark Act Amendments of 1980, also known as Bayh-Dole, allows universities, medical schools and research institutions to use federal funds for research to develop innovative technology and products. These institutions and inventors can then file patent applications, license their discoveries and try to generate revenue that can help cover the costs of university programs. But creating something of value in a university lab isn’t the same as manufacturing a product, pricing it and marketing it to the public. That’s why Bayh-Dole allows universities and research institutions to license their innovations to businesses that have the capital, manufacturing plants and marketing expertise to bring an innovation to market.  

New BIO Poll Reveals Americans Strongly Support the Orphan Cures Act

The Biotechnology Innovation Organization released a poll that shows voters overwhelmingly support the ORPHAN Cures Act, a recently introduced bill that would incentivize rare disease drug development. The ORPHAN Cures Act would fix a provision in the Inflation Reduction Act that punishes biopharmaceutical companies for discovering multiple rare disease applications for the same medicine. Of the more than 280 orphan drugs approved since 2003, nearly a quarter were later approved to treat additional diseases. According to the survey, 94% of American voters think it's important for scientists to search for rare disease treatments, while 85% agree it is critical for the government to "expand incentives for rare disease drug development."

Without Comprehensive PBM Reform, Patient Health Outcomes Will Suffer

As patients faced both high rates of inflation and record high costs at the pharmacy counter, President Biden signed the Inflation Reduction Act (IRA) into law in August 2022. The IRA significantly impacts how patients can access their prescription medicines and how future innovations will be brought to market. While the law includes provisions that will help patients living with chronic conditions access the medications they need, the path remains for industry middlemen known as pharmacy benefit managers (PBMs) to use harmful and profit-seeking practices to hurt patients without consequence. Unless Congress takes action to pass comprehensive reforms around PBM practices, price “negotiation” policies for prescription medicines will fall short of lowering costs for patients.

BioPartnering Conference Moving to Liberty Science Center in 2024

The Liberty Science Center in Jersey City has long been viewed as an innovative center where science comes to life. Next May, it will be the place where some of the top life sciences executives, investors, academic collaborators and business professionals come together. On Wednesday, BioNJ announced it is moving its 14th annual BioNJ BioPartnering Conference to the Liberty Science Center on May 14, 2024. BioNJ CEO Debbie Hart said it’s a perfect match.

Insmed’s Lewis to Receive BioNJ’s 2024 Dr. Sol J. Barer Award

BioNJ has announced that William H. Lewis, J.D., MBA, Chair and CEO of Insmed, will receive the Dr. Sol J. Barer Award for Vision, Innovation and Leadership at the organization’s Annual Dinner Meeting and Innovation Celebration to be held Feb. 8 at the Hilton East Brunswick. Named for Dr. Sol J. Barer, founder and former chairman and CEO of Celgene Corporation and former BioNJ chairman, the Dr. Sol J. Barer Award recognizes outstanding researchers and business leaders who have made significant contributions to the growth and prosperity of the life sciences industry in New Jersey and throughout the world.

John Crowley, Legendary Biotech Executive in New Jersey, Named CEO of BIO

John Crowley, a pioneering biotech leader who used his family’s own struggles to start Princeton-based Amicus Therapeutics, a company that is developing needed cures and innovations, was named the new CEO of BIO, the national organization under which BioNJ is the New Jersey affiliate. The announcement is substantial to New Jersey for two reasons. At a time when New Jersey has tremendously upped its game as a center for life sciences innovation, having a Jersey resident as head of the national organization can only be helpful (Crowley is a former BioNJ board member). Crowley is an incredible thought leader in all things bio and life sciences, making his ascension good for the sector and society. That’s the way Debbie Hart, CEO of BioNJ, and many others see it. “We are ecstatic that John Crowley, Founder and Executive Chairman of New Jersey’s own Amicus Therapeutics, has been named the new President and CEO of the Biotechnology Innovation Organization,” she said.

ADMA Biologics Announces FDA Approval for BIVIGAM® in the Pediatric Patient Setting for Those 2 Years of Age and Older

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced the U.S. Food and Drug Administration has approved the company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM. The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of BIVIGAM’s prescribing information to expand the primary humoral immunodeficiency (“PI”) indication to pediatric patients 2 years of age and older. “This expanded label for BIVIGAM allows ADMA to actively address the treatment needs of younger PI patients earlier in their treatment journey. In the period ahead, we look forward to offering BIVIGAM as an FDA-approved treatment option for these pediatric PI patients,” said Adam Grossman, President and Chief Executive Officer of ADMA.

Phathom Pharmaceuticals Announces FDA Acceptance for Filing of VOQUEZNA® (vonoprazan) Tablets New Drug Application for the Treatment of Heartburn Associated With Non-Erosive GERD

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced the FDA has accepted for review the company’s NDA for VOQUEZNA (vonoprazan) as a daily treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adults. The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024. Non-Erosive GERD is the largest subcategory of GERD and is characterized by reflux-related symptoms in the absence of esophageal mucosal erosions. Phathom is also finalizing its plans to initiate an additional Phase 3 study in 2024 evaluating VOQUEZNA as an investigational As Needed treatment for episodic heartburn relief in adults with Non-Erosive GERD, a novel dosing treatment regimen for which proton pump inhibitors (PPIs) are not approved in the U.S.

"HyBryte™ Use in Early Stage Cutaneous T-Cell Lymphoma" Published in Frontiers in Drug Discovery

Princeton-based BioNJ Member Soligenix announced that an article describing the potential use of HyBryte™ in the treatment of cutaneous T-cell lymphoma (CTCL) has been published in Frontiers in Drug Discovery. The mini-review summarizes findings about the use, mechanism and effectiveness of HyBryte™ in the treatment of CTCL with a particular emphasis on the ability of HyBryte™ to address the unmet medical need in patients with early stage disease. "In treating CTCL, which is a chronic cancer with no cure, long-term safety is a strong driver of treatment choice. Most current treatment options for CTCL are associated with significant safety concerns, including black-box warnings. HyBryte™ treatment has demonstrated strong and rapid efficacy with a very benign safety profile," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. 

Ferring and PharmaBiome Enter into a New Microbiome R&D Collaboration and Exclusive Licensing Agreement

Parsippany-based BioNJ Member Ferring Pharmaceuticals and Zürich-based microbiome translation company PharmaBiome are announcing a research and development collaboration to drive forward new microbiome-based biotherapeutics in the field of gastroenterology. The deal provides Ferring with exclusive rights to develop, manufacture and commercialize next generation microbiome-based therapeutics within the field of gastroenterology arising out of the collaboration. Based on two core technologies, PharmaBiome has developed a unique technology platform to select bacterial strains for the design of bacterial consortia as live biotherapeutic products with defined activities – the NicheMapTM and a co-cultivation approach that enables fast and scalable production. PharmaBiome’s programmes aim at a next generation of products that are independent of donor material and deliver exactly the consortium of bacterial strains with the desired activity and therapeutic effect (“defined consortia”).

Novartis Receives FDA Approval for Fabhalta® (iptacopan), Offering Superior Hemoglobin Improvement in the Absence of Transfusions as the First Oral Monotherapy for Adults With PNH

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). In clinical trials, treatment with Fabhalta increased hemoglobin levels (≥ 2 g/dL from baseline in the absence of RBC transfusions) in the majority of patients and in APPLY-PNH nearly all patients treated with Fabhalta did not receive blood transfusions.

Latest Novartis Kisqali® NATALEE Analysis Reinforces 25% Reduction in Risk of Recurrence Across Broad Population of Patients With Early Breast Cancer; Supports Regulatory Submissions

East Hanover-based BioNJ Member Novartis announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients. Results reinforce the benefit seen at the earlier interim analysis, with a 25.1% (HR=0.749; 95% CI: 0.628, 0.892; p=0.0006) reduction in risk of disease recurrence in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with adjuvant Kisqali plus a non-steroidal aromatase inhibitor as standard endocrine therapy (ET) compared to ET alone.

Novartis Presents New 48-Week Results from Phase III APPLY-PNH Trial Showing Sustained Efficacy and Long-Term Safety of Fabhalta® (iptacopan) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)

East Hanover-based BioNJ Member Novartis announced results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) who had residual anemia (hemoglobin <10 g/dL) despite previous anti-C5 therapy. Continuous Fabhalta treatment (200 mg twice daily) for 48 weeks enabled sustained hemoglobin-level increases to near-normal (12 g/dL or more), blood transfusion avoidance, and reduced patient-reported fatigue in the majority of patients; comparable benefits emerged in those patients switching from anti-C5 therapy to Fabhalta in the extension. Patients completing the 24-week randomized treatment period of APPLY-PNH could elect to enter the extension, continuing Fabhalta (61/62 patients; one patient discontinued due to pregnancy) or switching from anti-C5s to Fabhalta (34/35 patients; one patient discontinued based on investigator decision) through week 48.

U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination With Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients With Unresectable or Metastatic Urothelial Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024. The filing was based on the results from the Phase 3 CheckMate -901 study, in which the combination showed statistically significant and clinically meaningful survival benefit over standard-of-care gemcitabine plus cisplatin in the treatment of this patient population. 

Bristol Myers Squibb's Abecma® Becomes First CAR T Approved for Use in Earlier Lines of Therapy for Patients With Relapsed or Refractory Multiple Myeloma in Japan

Princeton-based BioNJ Member Bristol Myers Squibb announced that the company has received manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma® (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for patients with relapsed or refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Abecma is the first-in-class BCMA-directed CAR T cell immunotherapy. Abecma recognizes and binds to BCMA on the surface of multiple myeloma cells, which leads to the proliferation of CAR T cells and cytokine release, resulting in the dissolution and death of BCMA-expressing cells.

Bristol Myers Squibb Announces Phase 3 CheckMate -8HW Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Compared to Chemotherapy in Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer Meets Primary Endpoints

Princeton-based BioNJ Member Bristol Myers Squibb announced the Phase 3 CheckMate -8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) met the dual primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at a pre-specified interim analysis. The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified.

Bristol Myers Squibb Presents Primary Efficacy and Safety Analysis of the Phase 3 COMMANDS Trial of Reblozyl for Treatment of Anemia in Erythropoiesis Stimulating Agent-Naïve Patients With Lower-Risk Myelodysplastic Syndromes at ASH 2023

Princeton-based BioNJ Member Bristol Myers Squibb announced updated results from the primary analysis of the Phase 3 COMMANDS trial, comparing Reblozyl®(luspatercept-aamt) versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes (MDS) who may require red blood cell (RBC) transfusions. Results from COMMANDS are under review with the European Commission and served as the basis of a priority review approval by the United States Food and Drug Administration in August 2023 for Reblozyl as a treatment for anemia in ESA-naïve adult patients with very low- to intermediate-risk MDS who may require regular RBC transfusions. Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021.

SystImmune and Bristol Myers Squibb Announce a Global Strategic Collaboration Agreement for the Development and Commercialization of BL-B01D1

Princeton-based BioNJ Member Bristol Myers Squibb and SystImmune announced an exclusive license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC). Under the terms of the agreement, the companies will jointly develop and commercialize BL-B01D1 in the United States. Through its affiliates, SystImmune will be solely responsible for development, commercialization, and manufacturing in Mainland China and will be responsible for manufacturing certain drug supplies for use outside of Mainland China. Bristol Myers Squibb will assume sole responsibility for development and commercialization in the rest of the world. Data from earlier clinical studies of BL-B01D1 demonstrate promising anti-tumor activity in patients with a range of solid tumors that had progressed after standard of care treatments, including NSCLC and breast cancer.

Evotec – Partner Jingxin Receives Approval for EVT201 in China

Princeton-based BioNJ Member Evotec announced that Zhejiang Jingxin Pharmaceutical Co., Ltd has received the approval from the Chinese National Medical Products Administration (“NMPA”) for the novel insomnia treatment EVT201, also known as Dimdazenil in China. From 2005 onwards, EVT201 was originally developed by Evotec as a treatment option for insomnia. The Company led clinical Phase II development for EVT201, yielding positive safety and efficacy results, before licensing the program out to Jingxin for further development and commercialization in China. After Jingxin reported positive results of its Phase III clinical trials for EVT201 in insomnia in 2021, the agreement was expanded to South Korea in 2022. Jingxin also retains an option to expand the license globally.

Japan’s Ministry of Health, Labour and Welfare Accepts Arexvy (RSV vaccine) Regulatory Application to Prevent RSV Disease in Adults Aged 50-59 at Increased Risk

Warren-based BioNJ Member GSK announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a regulatory application to extend the indication of GSK’s respiratory syncytial virus (RSV) vaccine (recombinant adjuvanted) for the prevention of RSV disease in adults aged 50-59 at increased risk. This regulatory submission follows Japan’s approval of GSK’s vaccine for the prevention of RSV disease in adults from the age of 60 years, and the recent announcement of the positive results of a Phase III trial [NCT05590403] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV lower respiratory tract disease (LRTD) due to certain underlying medical conditions.

GSK’s Jemperli (dostarlimab) Plus Chemotherapy Approved as the First and Only Frontline Immuno-Oncology Treatment in the European Union for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

Warren-based BioNJ Member GSK announced the European Commission (EC) has granted marketing authorisation for Jemperli (dostarlimab) in combination with carboplatin-paclitaxel (chemotherapy), for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy. Additionally, with the authorization in this indication, the EC’s conditional approval for Jemperli as a monotherapy for treating adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen is now converted to full approval. The EC authorization of Jemperli is based on interim analysis results from the dMMR/MSI-H population of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial, which reflected a robust median duration of follow-up of ≥ 25 months. 

Teva and Biolojic Design Announce Exclusive License Agreement for the Development of a Therapeutic Antibody for Atopic Dermatitis and Asthma

Parsippany-based BioNJ Member Teva Pharmaceutical and Biolojic Design Ltd., a biotechnology company that uses computational biology and artificial intelligence to transform antibodies into intelligent medicinal solutions, today announced an exclusive license agreement to develop a potential novel antibody-based therapy for the treatment of Atopic Dermatitis and Asthma. BD9 is a dual specific antibody that can block both TSLP (Thymic stromal lymphopoietin) and IL-13, and has the potential to deliver treatment across typically TH2-driven inflammatory diseases, such as atopic dermatitis and asthma. Existing drugs currently approved by health authorities focus on only one of these two drivers of inflammation, and do not respond to pathway dynamics.

New Post Hoc Phase 3 Data Analysis Shows AJOVY® (fremanezumab) Reduced Migraine Attacks in Adults With Migraine and Co-morbid Obesity

Parsippany-based BioNJ Member Teva Pharmaceutical announced that a post hoc analysis of two Phase 3 clinical studies has shown the effectiveness of the migraine prevention treatment AJOVY® (fremanezumab) in reducing migraine attacks in patients with migraine and co-morbid obesity. Migraine and obesity are both associated with high levels of disability and both conditions are more prevalent amongst females. It is estimated that 59% of people in Europe are either overweight or obese, with almost a quarter (23%) of adults living with obesity. A higher body mass index (BMI) is frequently associated with increased migraine prevalence and severity, and an increased number of adverse effects. As such, assessing the efficacy and safety of migraine preventative treatment in patients with obesity can help guide migraine management and treatment decisions.

New Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Shows Strong, Durable Treatment Response for Patients With Difficult-To-Treat Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

Princeton-based BioNJ Member Genmab and BioNJ Member AbbVie, with a site in Madison, announced that adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) previously treated with two or more prior therapies experienced strong and durable responses with high overall response (ORR) and complete response (CR) rates when treated with epcoritamab (DuoBody® CD3xCD20), an investigational, subcutaneously administered T-cell engaging bispecific antibody. "Further developing epcoritamab as a core therapy to help treat more patients with B-cell malignancies, including follicular lymphoma, is an important goal we share with our partner Genmab," said Mariana Cota Stirner, M.D., Ph.D., Vice President, Therapeutic Area Head for Hematology, AbbVie. "These data further build our confidence in epcoritamab's treatment potential as well as development for earlier patient treatment."

AbbVie and BigHat Biosciences Announce Research Collaboration to Leverage Artificial Intelligence and Machine Learning to Discover Next-Generation Therapeutic Antibodies

BioNJ Member AbbVie, with a site in Madison and BigHat Biosciences, announced a research collaboration to discover and develop next-generation therapeutic antibodies in oncology and neuroscience. Working closely with AbbVie, BigHat will utilize its Milliner™ platform, a suite of machine learning technologies integrated with a high-speed wet lab, to guide the design and selection for high quality antibodies for multiple therapeutic targets. "This collaboration further demonstrates our commitment to integrate AI/ML-based approaches in drug discovery and development, as we strive to accelerate our oncology and neuroscience pipeline, and deliver better medicines faster," said Jonathon Sedgwick, Ph.D., Vice President and Global Head of Discovery Research at AbbVie. "We look forward to working with BigHat's team to design novel antibody-based therapies that may help address persistent unmet needs faced by patients."

AbbVie to Acquire Cerevel Therapeutics in Transformative Transaction to Strengthen Neuroscience Pipeline

BioNJ Member AbbVie, with a site in Madison, and Cerevel Therapeutics announced a definitive agreement under which AbbVie will acquire Cerevel Therapeutics and its robust neuroscience pipeline of multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson's disease (PD), and mood disorders. The acquisition complements AbbVie's neuroscience portfolio, adding a wide range of potentially best-in-class assets that may transform standards of care across psychiatric and neurological disorders where significant unmet needs remain for patients. This transaction is expected to close in the middle of 2024, subject to Cerevel shareholder approval, regulatory approvals, and other customary closing conditions.  

Novo Nordisk Named ‘Company of the Year’ by Yahoo Finance

Plainsboro-based BioNJ Member Novo Nordisk was named Company of the Year by Yahoo Finance — an honor spurred by the success of Ozempic, the diabetes drug that has shown to have an amazing ability to spur weight loss. The diabetes drug Ozempic, along with its counterpart Wegovy, which is approved for obesity treatment, has had an unprecedented impact in the weight loss business. About 1.7% of people in the country have been prescribed a semaglutide, an active ingredient in Wegovy and Ozempic, in 2023, up 40-fold over the past five years, according to a recent report. Analysts predict weight loss drugs will have ripples across many industries, including food, clothing and airlines. It already is having an impact on Novo Nordisk’s stock price: It is up 45% year to date, outperforming the S&P 500’s 19% gain.

Sarclisa® (isatuximab) Plus KRd Significantly Improved Rate of Minimal Residual Disease Negativity in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma Versus KRd Alone

Bridgewater-based BioNJ Member Sanofi announced the Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM). MRD negativity is defined as the absence of myeloma cells in the bone marrow after treatment, as measured by diagnostic techniques that must have a sensitivity of at least 1 in 100,000 cells. In this trial, MRD negativity was detected with a sensitivity of 10-5 (no cancer cells detected within 100,000 bone marrow cells) and 10-6 (no cancer cells detected within 1,000,000 bone marrow cells).

Sarclisa® (isatuximab) Phase 3 Trial Met Primary Endpoint of Progression Free Survival in Patients With Newly Diagnosed Multiple Myeloma not Eligible for Transplant

Bridgewater-based BioNJ Member Sanofi announced the Phase 3 IMROZ trial evaluating the investigational use of Sarclisa® (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma (MM). This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care. The safety and tolerability of Sarclisa observed in this trial was consistent with the established safety profile of Sarclisa and VRd.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-Based Quadruplet Therapy Regimen Shows Significant Improvement in Outcomes for Patients With Transplant-eligible Newly Diagnosed Multiple Myeloma

New Brunswick-based BioNJ Member Johnson & Johnson announced the first data from the Phase 3 PERSEUS study highlighting significant clinical improvement with a DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet induction, consolidation regimen and doublet maintenance regimen in the treatment of transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM). The data, showing an unrivaled progression-free survival (PFS) in a Phase 3 study evaluating TE NDMM and clinically significant improvement of rates of overall complete response (CR) or better and minimal residual disease (MRD) negativity over the comparator arm, were published in The New England Journal of Medicine.

Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder). TAR-200 is a novel investigational targeted releasing system designed to provide sustained local release of gemcitabine into the bladder. Today’s BTD marks Johnson & Johnson’s 13th such designation in oncology. The BTD is supported by data from SunRISe-1 (NCT04640623), an open-label Phase 2b clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC carcinoma in situ (CIS) patients, who are ineligible for or elected not to undergo radical cystectomy.

Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced updated clinical data from the international Phase 1/2 BRUIN trial of pirtobrutinib, a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with a range of B-cell malignancies. These data continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL). "These data demonstrate the ability of pirtobrutinib to potentially lengthen the time patients may benefit from inhibiting BTK, a key target in these diseases. It is also encouraging to see the promising initial data for pirtobrutinib combined with venetoclax, which has the possibility to allow for a time-limited regimen for patients with CLL," said Matthew S. Davids, M.D., M.M.Sc., Dana-Farber Cancer Institute.

Jaypirca® (pirtobrutinib) Now Approved by U.S. FDA for the Treatment of Adult Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Received at Least Two Lines of Therapy, Including a BTK Inhibitor and a BCL-2 Inhibitor

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor. Jaypirca was approved under the FDA's Accelerated Approval pathway based on overall response rate (ORR) and duration of response (DOR) from the open-label, single-arm, multicohort, international, Phase 1/2 BRUIN trial.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Lilly to Present Final Overall Survival Analysis from the MONARCH 3 Study of Verzenio® (abemaciclib) and Additional Results from Its Breast Cancer Portfolio at the 2023 San Antonio Breast Cancer Symposium

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced results from the MONARCH 3 clinical trial. MONARCH 3 evaluated Verzenio® (abemaciclib) in combination with an aromatase inhibitor (AI) compared to an AI alone as initial endocrine-based therapy for post-menopausal patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer. At eight years of follow-up, MONARCH 3 showed women taking Verzenio and an AI had a median overall survival (OS) of more than 5.5 years – an increase of 13.1 months compared to the control arm in the intent-to-treat (ITT) population (66.8 vs 53.7 months), although statistical significance for the OS outcome was not reached (HR, 0.804; 95% CI, 0.637-1.015; p=0.0664).

Zepbound™ (tirzepatide) is Now Available in U.S. Pharmacies for Adults Living With Obesity

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced that Zepbound™ (tirzepatide) injection is now available. Zepbound is indicated for adults with obesity (with a BMI of 30 kg/m2 or greater), or those who are overweight (with a BMI of 27 kg/m2 or greater) and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease, to lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity. Zepbound should not be used with other tirzepatide-containing products or any GLP-1 (glucagon-like peptide-1) receptor agonist medicines, and it has not been studied in patients with a history of pancreatitis, or with severe gastrointestinal disease, including severe gastroparesis.

Lilly's Zepbound™ (tirzepatide) Achieved Additional 6.7% Weight Loss Following a 36-Week Open-Label Lead-in Period, for a Total Mean Weight Loss of 26.0% from Study Entry Over 88 Weeks

BioNJ Member Eli Lilly and Company, with a site in Branchburg, announced detailed results from SURMOUNT-4, which showed Zepbound™ (tirzepatide) injection achieved superior mean percent change in body weight compared to placebo in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. Zepbound met the primary endpoint of mean percent change in body weight, and all key secondary endpoints for both estimands, compared to placebo 52 weeks after randomization. SURMOUNT-4 utilized a maximum tolerated dose of 10 mg or 15 mg once-weekly. The starting dose of 2.5 mg Zepbound was increased by 2.5 mg every four weeks until maximum tolerated dose was achieved. Participants who tolerated 15 mg continued on 15 mg as their maximum tolerated dose.

Updated ODRONEXTAMAB Data from Relapsed/Refractory DIiffuse Large B-Cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and that Potential of CTDNA to Predict Long-Term Outcomes

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. “The primary analysis from the pivotal trial of odronextamab demonstrated impressive response rates, including in certain high-risk subgroups. Furthermore, these responses were durable and consistent with those seen in a Phase 1 trial in patients who had previously progressed on CAR-T therapy, a population with a very poor prognosis,” said Sabarish Ram Ayyappan, M.D., Medical Director of hematologic malignancies, City of Hope Atlanta, and a trial investigator.

Latest ODRONEXTAMAB Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced positive data for odronextamab in patients with relapsed/refractory (R/R) follicular lymphoma (FL) from a pivotal Phase 2 trial (ELM-2). Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. Odronextamab is currently under regulatory review for the treatment of R/R FL and diffuse large B-cell lymphoma (DLBCL) by the U.S. Food and Drug Administration, with a target action date of March 31, 2024, as well as by the European Medicines Agency (EMA). In the U.S., odronextamab has been granted Fast Track Designation by the FDA. In the European Union, odronextamab has been granted Orphan Drug Designation by the EMA.

Updated LINVOSELTAMAB Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients With Heavily Pre-Treated Multiple Myeloma

BioNJ Member Regeneron Pharmaceuticals, Inc., with a site in Basking Ridge, announced that the primary endpoint analysis from the pivotal trial (LINKER-MM1) investigating linvoseltamab demonstrated high rates of deep and durable responses in patients with relapsed/refractory (R/R) multiple myeloma (MM). These Phase 1/2 results are planned to be submitted to regulatory authorities, including to the U.S. Food and Drug Administration (FDA) this year. Linvoseltamab is an investigational BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Merck Animal Health Receives Positive CVMP Opinion for an Injectable Formulation of BRAVECTO® (Fluralaner) for Use in Dogs

Rahway-based BioNJ Member Merck Animal Health announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for BRAVECTO^® (fluralaner) 150 mg/ml powder and solvent for suspension for injection for dogs. The CVMP recommends the product for approval for the treatment and persistent killing of fleas (Ctenocephalidesfelis and Ctenocephalidescanis) and ticks (Rhipicephalussanguineus, Ixodesricinus, Ixodeshexagonusand Dermacentorreticulatus) for 12 months. If the European Commission (EC) adopts the recommendation, this injectable formulation of BRAVECTO can be used by or under the supervision of a veterinarian and for administration to dogs and puppies six months of age and older.

FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). The approval is based on statistically significant and clinically meaningful results from LITESPARK-005, which is the only trial in advanced RCC to specifically evaluate patients who have progressed following a PD-1 or PD-L1 inhibitor and a VEGF-TKI. In the trial, WELIREG demonstrated superior progression-free survival (PFS) (HR=0.75 [95% CI, 0.63-0.90]; p=0.0008) versus everolimus in advanced RCC following treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor targeted therapy, given in sequence or in combination. 

Moderna and Merck Announce mRNA-4157 (V940) in Combination With KEYTRUDA® (pembrolizumab) Demonstrated Continued Improvement in Recurrence-Free Survival and Distant Metastasis-Free Survival in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA at Three Years

Rahway-based BioNJ Member Merck & Co. and Moderna, Inc. announced follow-up data from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection. In this planned analysis occurring with a median follow-up of approximately three years, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA continued to demonstrate a clinically meaningful improvement in recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510 [95% CI, 0.288-0.906]; one-sided nominal p=0.0095) compared with KEYTRUDA alone. mRNA-4157 (V940) in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62% (HR=0.384 [95% CI, 0.172-0.858]; one-sided nominal p= 0.0077). 

Merck and Moderna Initiate INTerpath-002, a Phase 3 Study Evaluating V940 (mRNA-4157) in Combination With KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients With Certain Types of Resected Non-Small Cell Lung Cancer

Rahway-based BioNJ Member Merck & Co. and Moderna, Inc. announced the initiation of INTerpath-002, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia. As previously announced, in addition to INTerpath-002, the combination of V940 (mRNA-4157) plus KEYTRUDA is being investigated in INTerpath-001, formerly referred to as V940-001 (NCT05933577), a global, randomized, double-blind, placebo- and active-comparator-controlled Phase 3 trial evaluating approximately 1,089 patients with resected high-risk (Stage IIB-IV) melanoma.

Pfizer Completes Acquisition of Seagen

BioNJ Member Pfizer, with a site in Peapack, announced the successful completion of its acquisition of Seagen Inc., a global biotechnology company that discovers, develops and commercializes transformative cancer medicines. Pfizer completed its acquisition of all outstanding common stock of Seagen for $229 in cash per share, for a total enterprise value of approximately $43 billion. With the addition of Seagen, Pfizer’s Oncology pipeline has doubled in size with 60 programs spanning multiple modalities, including ADCs, small molecules, bispecifics and other immunotherapies. Moving forward, Pfizer will leverage its leading protein engineering and medicinal chemistry capabilities to advance Seagen’s ADC technology, unlocking potential novel combinations and next-generation biologics.

Pfizer Announces Topline Phase 2b Results of Oral GLP-1R Agonist, Danuglipron, in Adults With Obesity

BioNJ Member Pfizer, with a site in Peapack, announced topline data from the Phase 2b clinical trial investigating its oral Glucagon-like peptide-1 receptor agonist (GLP-1RA) candidate, danuglipron (PF-06882961), in adults with obesity and without type 2 diabetes. The study met its primary endpoint demonstrating statistically significant change in body weight from baseline. Twice-daily dosing of danuglipron showed statistically significant reductions from baseline in body weight for all doses, with mean reductions ranging from -6.9% to -11.7%, compared to +1.4% for placebo at 32 weeks, and -4.8% to -9.4%, compared to +0.17% for placebo at 26 weeks. Placebo-adjusted reductions in mean body weight ranged from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks. Depending on titration schedule, participants were at target dose levels for 6 to 24 weeks.

FDA and EMA Accept Marstacimab Regulatory Submissions for the Treatment of Hemophilia A and B

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). The European marketing authorization application (MAA) for marstacimab also passed validation and is currently under review by the European Medicines Agency (EMA). If approved in the U.S. and EU, marstacimab is expected to become the first once-weekly subcutaneous treatment for people living with hemophilia B and the first treatment administered as a flat dose for people living with hemophilia A or B.

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

BioNJ Member Pfizer, with a site in Peapack, announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab). ELREXFIO is a targeted immunotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. ELREXFIO is an off-the-shelf (ready-to-use) B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy that induces deep and durable responses, with a manageable tolerability profile as well as convenient subcutaneous dosing. The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.

Ipsen Confirms U.S. FDA Grants Priority Review for New Drug Application for Elafibranor for the Treatment of Rare Cholestatic Liver Disease, PBC

Ipsen, with a site in Berkeley Heights, and GENFIT announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade. The target FDA PDUFA date under priority review is June 10, 2024. The European Medicines Agency (EMA) has also validated Ipsen’s Marketing Authorization Application (MAA) for elafibranor and the review of the submission to the EMA’s Committee for Medicinal Products for Human Use (CHMP) began on 26 October 2023. Furthermore, a third simultaneous regulatory filing of elafibranor has been validated for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

“LEQEMBI® Intravenous Infusion” (Lecanemab) for the Treatment of Alzheimer’s Disease to be Launched in Japan on December 20

Nutley-based Eisai announced and BioNJ Member Biogen Inc. announced that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI® Intravenous Infusion” (200 mg, 500mg, lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) Drug Price List.

LEQEMBI received manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in Japan on September 25, 2023. The launch in Japan marks the second country to have LEQEMBI on the market, following the U.S. In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.

Mallinckrodt Announces FDA Clearance of the INOmax® EVOLVE™ DS Delivery System and Approval of the INOmax® (nitric oxide) Mini-Cylinder

Mallinckrodt, with a site in Bedminster, announced that the INOmax® EVOLVE™ DS delivery system has been cleared by the U.S. Food and Drug Administration (FDA) for the delivery of INOmax® (nitric oxide) gas, for inhalation. The INOmax EVOLVE DS delivers INOmax into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with the ventilators and respiratory care devices for which INOmax EVOLVE DS has been validated.

EZHARMIA® Showed Clinically Meaningful and Durable Responses in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma in VALENTINE-PTCL01 Phase 2 Trial

Results from the VALENTINE-PTCL01 Phase 2 trial of Basking Ridge-based Daiichi Sankyo EZHARMIA® (valemetostat tosilate) showed clinically meaningful and durable responses in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL is a group of rare and aggressive blood cancers, which represent about 10 to 15% of all non-Hodgkin lymphomas (NHL). A majority of patients with PTCL experience disease progression following initial treatment with a multi-drug chemotherapy-based regimen and median overall survival following relapse is approximately 5.8 months. An objective response rate (ORR) of 43.7% (95% CI: 34.6-53.1) was observed with EZHARMIA in 119 patients with relapsed or refractory PTCL as assessed by CT-based blinded independent central review (BICR). Seventeen complete responses (CRs) and 35 partial responses (PRs) were seen.

New Phase 3 Data With Aprocitentan for Patients With Resistant Hypertension has been Presented at the American Society of Nephrology Kidney Week 2023

Idorsia Ltd, with a site in Cherry Hill, announced that further data for aprocitentan, Idorsia’s investigational dual endothelin receptor antagonist for the treatment of patients with resistant hypertension, were presented at the American Society of Nephrology Kidney Week. The Phase 3 PRECISION study demonstrated both the safety and the efficacy of aprocitentan to significantly lower blood pressure (BP) in patients with resistant hypertension on top of at least three antihypertensive medications of different classes, including a diuretic. Patients with hypertension can often successfully control their blood pressure by combining a healthier lifestyle with effective medication. However, approximately 10% of patients have resistant hypertension where the blood pressure remains high despite receiving at least three antihypertensive medications of different pharmacological classes, including a diuretic, at optimal doses.

Agile Therapeutics Provides Update on Actions Being Taken to Strengthen the Affordable Care Act’s No-Cost Contraceptive Coverage Requirements

Princeton-based Agile Therapeutics, Inc. provided an update on the actions being taken to strengthen the Affordable Care Act’s (ACA) no-cost contraceptive coverage requirement. Following several months of focus by the Biden Administration and lawmakers on contraception and reproductive healthcare access barriers, the House Committee on Oversight and Accountability issued a new report addressing the topic: Revised Federal Guidance Regarding Contraceptive Coverage Could Benefit Millions of Women. The report highlights the continued barriers to contraceptive care and inequalities that continue to impact women’s freedom to access the contraceptive that is best for them. “We appreciate the continued hard work of the Administration to ensure all women have access to contraceptive care without barriers and cost-sharing,” said Agile Therapeutics Chairperson and Chief Executive Officer Al Altomari.

FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients With Hypoparathyroidism

Ascendis Pharma, with a site in Princeton, announced that the U.S. Food & Drug Administration has accepted for review the company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024. In the U.S., TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism. “We are pleased that the FDA can continue its review of TransCon PTH and look forward to working with the agency during its review,” said Jan Mikkelsen, President and CEO at Ascendis Pharma.

Integra LifeSciences to buy Acclarent from Johnson & Johnson for $275M

Princeton-based Integra LifeSciences Holdings Corp. on announced it agreed to buy ear, nose and throat procedures firm Acclarent from Ethicon, a unit of Johnson & Johnson, for $275 million in cash. Integra said the deal, which expands its portfolio of ear, nose and throat products and technologies, also includes an additional $5 million based on the achievement of certain regulatory milestones. “This acquisition presents Integra with a rare opportunity to become a key player in the ENT segment. Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives,” Jan De Witte, CEO and President of Integra LifeSciences, said.

Optimizing Gross-to-Net Calculations in Pharma: Challenges and Strategic Solutions

In the pharmaceutical industry, understanding the actual revenue earned from drug sales hinges on the concept of "Gross to Net" (GTN). This process, pivotal for financial analysis, pricing strategy, and regulatory compliance, can be one of the most complex in pharmaceutical accounting. It entails deducing the net revenue from initial gross sales, a task that involves handling various deductions and ensuring accuracy in financial reporting.

Click here for a helpful article written by BioNJ Member Archer Insights.

BMS Joins SciTech Scity as Healthcare Innovation Lead Partner

Liberty Science Center has announced that BioNJ Member Bristol Myers Squibb (BMS) is joining SciTech Scity’s Healthcare Innovation Engine effort as the Healthcare Innovation Lead Partner for the biopharmaceutical Industry. BMS will work with the SciTech Scity team to identify how digital health devices can work in tandem with traditional pharmaceutical products to offer a more holistic and personalized approach to patient care. Alongside other industry leaders and community representatives, this partnership is designed to better understand and address the structural barriers to digital health adoption and identify priority areas for innovation. This work will be done with startup companies to test and validate specific products and solutions and conduct joint research efforts with the SciTech Scity academic ecosystem to collect the data needed to support broader adoption.

Cooper University Health Care Receives $280K Grant from Bristol Myers Squibb Foundation

Cooper University Health Care, through its Urban Health Institute, has been awarded a two-year, $280,000 grant from the Bristol Myers Squibb Foundation to enhance screening for social determinants of health, drive connections to community-based organizations to increase the breadth and depth of resources available to patients, and provide workforce development around the care of marginalized individuals. This grant is part of an initiative known as the New Jersey Safety Net Innovation Program, or NJ SNIP. Through the grant, the UHI will be working in partnership with the Camden-based Center for Family Services, a leading nonprofit social services provider with a strong and innovative continuum of care to help individuals and families lead capable, responsible, fulfilled lives in strong and healthy communities.

Nokia Bell Labs is Moving to HELIX in New Brunswick

Nokia Bell Labs announced that it is moving to the HELIX innovation center in New Brunswick, where it will use one of the three buildings planned for the complex as its North American research and development center. The move is expected to bring approximately 1,000 jobs to the New Jersey Health + Life Science Exchange (better known as the HELIX), while affirming the complex as the leading center for research and innovation in the state. The new facility will be one of 10 R&D facilities that Nokia Bell Labs has around the world — but the only one located in North America. Nokia’s announcement is the crown jewel for a project that had a groundbreaking with much fanfare in the fall of 2021.

2 Rutgers Professors Named 2023 Fellows of National Academy of Inventors

Two Rutgers University professors were named 2023 fellows of the National Academy of Inventors, an honor recognizing individuals for their contributions to major advancements in science and consumer technologies. Fred Russell Kramer, professor of microbiology, biochemistry and molecular genetics and associate director of public health research for business development at Rutgers New Jersey Medical School, and Patrick Sinko, distinguished professor of pharmaceutics and Parke-Davis Endowed Chair in Pharmaceutics and Drug Delivery at Rutgers Ernest Mario School of Pharmacy, were among the 162 academic inventors in 35 states and 10 nations to receive the highest professional distinction awarded solely to inventors.

NJII Welcomes Michael Edmondson as VP for Continued Learning

The Newark-based New Jersey Innovation Institute announced it appointed Michael Edmondson as its Vice President for Continued Learning to oversee the Professional & Corporate Education division. Mr. Edmondson also serves as the Associate Provost for continued learning at New Jersey Institute of Technology. The Continued Learning operating unit is a joint venture between NJII and NJIT. Mr. Edmondson’s 30-year experience includes positions inside and outside of higher education, such as pharmaceutical market research and nonprofit management. Prior to joining NJIT and NJII, Edmondson managed the continued learning offices at both the community college and university levels.

MD Anderson at Cooper First in World to Enroll Patient in Promising Trial for Metastatic Melanoma

Researchers at MD Anderson Cancer Center at Cooper are leading the way in new approaches to treating advanced melanoma using tumor infiltrating lymphocyte therapy. Earlier this year, Camden-based MD Anderson at Cooper became the first site in the world to offer and enroll a patient in TILVANCE-301, a new randomized Phase III clinical trial evaluating the efficacy of “TIL” therapy as a first-line treatment versus pembrolizumab, the current standard of immunotherapy care, for advanced melanoma. This clinical trial is part of emerging cell therapy treatments for several types of solid tumor cancers, including non-small cell lung cancer, cervical cancer and head and neck cancers. Researchers at MD Anderson at Cooper are participating in clinical trials in these areas as well.

9 N.J. Hospitals Named ‘Top Teaching Hospitals’ by Leapfrog

Nine hospitals in the Garden State have been named to the Top Teaching Hospital list by the Leapfrog Group, a national watchdog organization dedicated to health care quality and safety. The Leapfrog Top Hospital award is widely acknowledged as one of the most competitive awards American hospitals can receive. More than 2,100 hospitals were considered for the award. The New Jersey facilities recognized among the Top Teaching Hospitals include Bergen New Bridge Medical Center, Deborah Heart and Lung Center, Englewood Hospital and Medical Center, Hackensack Meridian Jersey Shore University Medical Center, Inspira Medical Center Mullica Hill, Jefferson Cherry Hill Hospital, Morristown Medical Center, St. Luke’s Warren Campus and Virtua Voorhees Hospital.

Industry Leader and Globally Recognized Patient Advocate John F. Crowley Appointed to Lead BIO as President & CEO

The Biotechnology Innovation Organization (BIO) is proud to announce that industry leader and military veteran John F. Crowley will be its new President and CEO, effective March 4. Mr. Crowley is best known for his role as an entrepreneur in the biotechnology industry following the 1998 diagnosis of his two youngest children with Pompe disease, a rare and often fatal neuromuscular disorder. His children’s diagnosis inspired him to co-found a biotech company to develop a treatment that he credits with ultimately saving his children’s lives. In 2005, Crowley went on to help found Amicus Therapeutics, a now 500+ person global biotechnology company, where he served as Chairman and CEO from 2005-2022 and is presently the company’s Executive Chairman.

2024 Rutgers - New Brunswick Winter Career & Internship Mega Fair

Thursday, February 1, 2024 & Friday, February 2, 2024

Rutgers, New Brunswick is delighted to see your organization's interest in attending the 2024 Winter Career & Internship Mega Fair. Students and alumni from all Rutgers University campuses (New Brunswick, Camden, Newark and RBHS) from all majors are invited to attend. The event is scheduled to take place at the Jersey Mike's Arena from 11:30 a.m. to 3:30 p.m.

BIO International Convention 2024

Hosted by Biotechnology Innovation Organization

June 3-6, 2024

Taking place June 3-6,2024 at the San Diego Convention, the BIO International Convention is the largest gathering of the biotech community in the world. As a member of BioNJ, your organization is eligible for a $200 discount on Premier or General registration rates. And, if you redeem your code during Early Bird registration, your total savings may exceed $400! Contact Randi Bromberg at RBromberg@BioNJ.org for the BioNJ Member code. Deadline is Dec. 15!