The Basics of the Bayh-Dole Act

WATCH: The Bayh-Dole Coalition released a 2-minute explainer video capturing the basics of the Bayh-Dole Act, including its bipartisan creation, the numerous technological advancements it's facilitated and the intention behind its once-obscure march-in provision. With federal bureaucrats currently seeking to twist the meaning of this historic law and bring an end to the innovation it's fostered across all sectors of innovation, this video is an important educational resource that will help spread awareness of Bayh-Dole's tremendous benefits.

BioNJ has organized information about an opportunity to comment on the Biden administration’s proposed use of march-in rights. BioNJ encourages companies to submit comments underscoring the potential unintended consequences of the framework and its potential impacts on Patient access and medical innovation.

• WHO: National Institute of Standards and Technology (NIST)
• WHAT: Request for Information (RFI) seeking comments on the draft guidance framework, which reviews the factors that an agency may consider when deciding whether to exercise march-in rights.
• WHEN: Comments must be submitted before 5:00pm ET on February 6, 2024.
• WHERE: Electronic comments in response to the NIST RFI can be submitted by electronic submission via the Federal eRulemaking Portal with the docket number NIST–2023–0008 or HERE.

A Small Fix to the IRA Will Give Hope to Patients With Rare Diseases

For the roughly 30 million Americans living with a rare disease, the chances of finding an effective treatment are tragically slim. Our health care system defines a rare condition as one affecting fewer than 200,000 patients around the country. Such small patient populations create enormous financial and practical barriers to developing cures and therapeutics. Unfortunately, one element of last year's Inflation Reduction Act (IRA) is contributing to the challenge. As written, the law's provisions strongly discourage research into treatments for rare conditions – and also discourage making the most out of the few treatments that do emerge from our labs. The good news is that Congress can undo this unintended consequence by passing the ORPHAN Cures Act, bipartisan legislation introduced in the House and the Senate. The legislation would remove an unnecessary barrier to medical progress that Congress probably never intended to erect in the first place.

The Inflation Reduction Act’s Medicare Budget Implications: Results for States and Regions

The Inflation Reduction Act (IRA) has two primary policy initiatives: reforms to Medicare prescription drug policies and large-scale subsidies to clean (non-fossil) energy. In discussing the IRA, advocates typically keep the two separate, giving the impression that Medicare drug policy will yield savings for the Medicare program while clean energy subsidies will speed the transition to a new energy portfolio. But in fact, the two are linked by the unified federal budget. Previous American Action Forum research makes clear that some Medicare budget savings will be spent to subsidize clean energy. Thus, some beneficiaries may benefit from lower drug prices and lower corresponding out-of-pocket costs. But the possibility of additional Medicare benefits such as lower premiums or broader options from the $266 billion in budget savings used to subsidize clean energy will not be realized. New Jersey is among the states losing most from the Inflation Reduction Act’s misleading #Medicare savings. 

Government Grab for Rebates Makes Cheaper Asthma Inhaler Unaffordable

A new Biden administration rule is making life-saving medicines for kids unaffordable. Incredibly, under the Inflation Reduction Act, companies that introduce lower-cost generic versions of their medicines are less likely to be covered. That’s what happened when Glaxo Smith Kline replaced Flovent's branded asthma medication with a cheaper "authorized generic." Health insurers promptly stopped paying for Flovent in favor of similar medicines with higher list prices. You might wonder how that is possible. The short answer is health plans – and the federal government – make more money from higher-priced drugs. Pharmacy benefit managers, companies that negotiate with pharmaceutical companies on behalf of insurers, have one overarching goal: Generate as much revenue as they can in the form of cash rebates off of the list price of medicines. Therapies that pony up the biggest rebates are more likely to be covered by the PBM.

White House’s Drug Patent Plan Undercuts Research and Innovation

On Dec. 7, the White House announced a plan it claims will lower prescription drug costs. It centers on using a 43-year-old law—the Bayh-Dole Act—to let government officials force patent owners to cancel existing licenses, and instead license their patents to generic companies so they can make and sell cheaper copies. That amounts to seizing private patent rights. The proposal is legally unsupportable. Nowhere does the Bayh-Dole Act permit so-called march-in rights for price control. And from a policy standpoint, the proposed rule is ill-conceived.

The Impact of The House-Proposed IRA Expansion on the US Biopharma Ecosystem

Further expansion of the Inflation Reduction Act’s (IRA) government-mandated drug pricing policies would translate to a loss of 1.2 million U.S. jobs over the next decade and threaten billions in medical research funding for treatments in many areas of unmet need, according to a new study published today. Since 2021, venture capital investments in biopharma have dropped by 50% and IPOs for biopharma firms by 70% – with an outsized impact on investments targeting cancer treatments. A new study from research firm Vital Transformation warns of further declines in new treatments for patients – particularly seniors – if lawmakers act on plans to expand government price controls.

Despite Lawsuits, NJ Drugmakers take Part in Medicare Negotiations

Despite suing the Biden administration over a controversial new government program aimed at reducing the cost of prescription drugs for older Americans, New Jersey’s biggest pharmaceutical companies are taking part in price-setting negotiations. Designed to address rising health care costs, the Medicare Drug Price Negotiation Program is part of President Joe Biden’s signature Inflation Reduction Act. While the administration argues that the price adjustments will save taxpayers $160 billion by reducing how much Medicare pays for drugs through negotiation and inflation rebates, the pharmaceutical industry maintains the program will curtail profits and ultimately compel drugmakers to scale back development of groundbreaking new treatments.

Since CMS announced the inaugural round of drugs selected for talks, Debbie Hart, President and CEO of BioNJ, said “the unfolding of this process has proven to be less straightforward than anticipated. The selection of therapeutics for the initial round of price-setting revealed an element of unpredictability in the process. Additionally, CMS introduced ‘listening sessions’ for each selected therapeutic, aiming to gather input from representatives spanning the health care spectrum. Unfortunately, feedback from patient advocacy groups indicates that the incorporation of patients’ voices into the ultimate decisions has been insufficient. Moreover, a lack of clarity surrounds how patient input is factored into decision-making. This uncertainty about which therapeutics will be subject to IRA pricing provisions, coupled with ambiguity in the decision-making process, has already begun to impact development across the health care ecosystem. It is our hope that policymakers will address the concerns voiced by patient advocacy groups and the broader ecosystem as we move forward.”

Liberty Science Center Embarks on Next Chapter of SciTech Scity

The long-anticipated SciTech Scity project, a “Science City of Tomorrow” at the Liberty Science Center in Jersey City, marked some major milestones in 2023. The development will feature a 30-acre innovation campus devoted to using science and technology to address the most serious health care issues — most recently adding a biopharmaceutical component to the project. When completed, the complex will boast $450 million of new construction that includes Edge Works – an eight-story business creation center with laboratories, R&D spaces and more; Scholars Village – 500 apartments for innovators, scientists, entrepreneurs and other tech-forward individuals and families; Liberty Science Center High School – a new public magnet STEM high school; and Public Commons – 3 acres of outdoor space for art installations, food trucks, performances, famers markets, festivals fairs and more. Further evidence of LSC’s forward momentum also came last month when BioNJ announced it moved the location of its 14th Annual BioPartnering Conference, set for May 2024, to Liberty Science Center. The annual event brings together life sciences executives, investors, academic collaborators, business development professionals, and other stakeholders and leaders from around the world with a goal of fostering productive partnerships and facilitating investment opportunities.

TIVDAK® (tisotumab vedotin-tftv) Supplemental Biologics License Application Accepted for Priority Review by U.S. Food and Drug Administration for Patients With Recurrent or Metastatic Cervical Cancer

Princeton-Based BioNJ Member Genmab and BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of May 9, 2024. The sBLA is supported by efficacy and safety data from the global, randomized Phase 3 innovaTV 301 trial (NCT04697628), in which tisotumab vedotin-tftv demonstrated superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR), as assessed by the investigator, in patients with recurrent or metastatic cervical cancer compared to chemotherapy.

European Commission Approves Pfizer’s TALZENNA® in Combination With XTANDI® for Adult Patients With Metastatic Castration-Resistant Prostate Cancer

BioNJ Member Pfizer, with a site in Peapack, announced that the European Commission (EC) has approved TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. With this approval, TALZENNA is now the first and only PARP inhibitor licensed in the European Union for use with XTANDI for patients with mCRPC, with or without gene mutations. This approval by the European Commission of TALZENNA in combination with XTANDI for the mCRPC indication is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway.

The approval is based on data from the Phase 3 TALAPRO-2 trial, a multicenter, randomized, double-blind, placebo-controlled study, evaluating two mCRPC patient cohorts: Cohort 1 (all-comers [n=805]) and Cohort 2 (those with HRR gene mutations [HRRm; n=399]). 

Tevogen Bio Inc. and Semper Paratus Acquisition Corporation Announce Effectiveness of Registration Statement for Business Combination

Warren-based BioNJ Member Tevogen Bio Inc. announced that the Securities and Exchange Commission has declared effective the registration statement on Form S-4 filed by Semper Paratus in connection with Tevogen Bio and Semper Paratus' previously announced proposed business combination (the “Business Combination” or the “Transaction”). Upon closing of the Business Combination, the post-closing combined company will be renamed Tevogen Bio Holdings Inc. Ryan Saadi, CEO of Tevogen Bio, commented, “We believe Tevogen’s patient-centric approach, which merges a focus on affordability with advanced science, is a blueprint for sustainable success in the current era of healthcare. I am pleased that, upon the closure of this transaction, investors will have the opportunity to participate in Tevogen’s mission to become the very first life science company offering commercially attractive and affordable personalized T cell therapies for large patient populations in virology, oncology, and neurology.”

EmphyCorp Latest Publication in the European Journal of Respiratory Medicine "Reduces Lung Inflammation and Fibrosis"

Flemington-based BioNJ Member EmphyCorp Inc. announced its publication in the European Journal of Respiratory Medicine. A peer review of "Inhaled Sodium Pyruvate Reduces Lung Inflammation and Fibrosis in a Bleomycin Rat Model with N115" was published on January 9, 2024. The Patented N115 Technology Platform has demonstrated efficacy, with no known side effects, in 23 human clinical studies for all lung and sinus diseases tested including COPD, Interstitial Lung Disease (Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis), Long COVID, Allergic Rhinitis, Chronic Rhinitis and Sinusitis. In each Clinical Trial, N115 produced statistically significant increases in all lung functions with the reduction in nasal and respiratory inflammation, a reduction in oxygen radicals, congestion, coughing, fatigue and a reduction of inflammatory cytokines including IL-6, a cause of the cytokine storm in COVID-19 patients.

FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

Princeton-based BioNJ Member Soligenix announced that its SGX945 (dusquetide) development program for the treatment of oral lesions of Behçet's Disease has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). "We are very pleased to have SGX945 in Behçet's Disease granted fast track designation from the FDA," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "As demonstrated by the granting of the designation, our previous studies with dusquetide in oral mucositis have clearly validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation. Behçet's disease is an unmet medical need in which the underlying vasculitis leads to ulceration of the mucous membranes and skin, with up to 18,000 people in the U.S. and as many as one million people worldwide affected by this incurable disease."

COMBINE 3 Phase 3a Trial Successfully Completed With Once-Weekly IcoSema Demonstrating Non-Inferior Reduction in HbA1c Versus Daily Basal-Bolus Treatment (insulin glargine U100 and insulin aspart) in People With Type 2 Diabetes

Plainsboro-based BioNJ Member Novo Nordisk announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and semaglutide. COMBINE 3 was a 52-week, open-label treat-to-target trial comparing the efficacy and safety of once-weekly IcoSema vs once-daily insulin glargine U100 and insulin aspart (injected 2-4 times a day during mealtimes), dosed with or without oral glucose-lowering medications, in 679 people with type 2 diabetes inadequately controlled on daily basal insulin. The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with once-weekly IcoSema compared with insulin glargine U100 and insulin aspart. From an overall baseline HbA1c of 8.30%, once-weekly IcoSema achieved an estimated reduction in HbA1c of -1.47 percentage points compared with -1.40 percentage points for insulin glargine U100 and insulin aspart (estimated treatment difference: –0.06 percentage points).

SENVELGO® Wins Best New Product for Companion Animals Award​

S&P Global has recognized SENVELGO®, BioNJ Member Boehringer Ingelheim, with a site North Brunswick, in groundbreaking feline diabetes innovation, with the Animal Health Award 2023 in the category “Best New Product for Companion Animals”. A group of independent judges chose SENVELGO® because of its indication in a new product category (SGLT2 inhibitors), its milestone approvals in the US, Canada and Europe this year, and because it was designed specifically for cats. “The overwhelming excitement for SENVELGO® from our customer veterinarians was a first indication of the value this product brings and the impact on the lives of cats and their owners. We are honored to now receive this award for the Best New Product for Companion Animals,” shares Jean-Luc Michel, Head of Global Strategic Marketing Animal Health at Boehringer Ingelheim.

Boehringer Ingelheim and Click Therapeutics Receive FDA Breakthrough Device Designation for Schizophrenia Prescription Digital Therapeutic

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, and Click Therapeutics have received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for CT-155, an investigational prescription digital therapeutic (PDT) designed to treat negative symptoms of schizophrenia. The novel software accessible on mobile devices is one of multiple digital therapeutics under joint development by the companies for the treatment of schizophrenia. Christine Sakdalan, U.S. Head, Mental Health franchise, Boehringer Ingelheim: 

“The FDA Breakthrough Device designation is an important milestone towards our goal of addressing the unmet medical needs in mental health and providing an innovative, future treatment option to enable people with schizophrenia to thrive.” 

Boehringer Ingelheim Enters 2024 on a High Note: Announcing Five New R&D Partnerships

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, has kicked off 2024 on a high note by announcing that the company is entering five new R&D partnerships. Through these strategic partnerships, Boehringer is building on past years successes, including 2023 where the company entered into more than 100 new R&D partnerships. The five partnerships just unveiled focus on addressing high unmet patient needs across three leading of Boehringer’s focus areas: Oncology, cardio-renal-metabolic and fibro-inflammatory diseases. “With these partnerships we are not only bolstering our R&D portfolio, but also our ability to further accelerate the growth of our highly innovative pipeline by combining the novelty power of our partners with our internal translation expertise and capabilities for scaling,” said Detlev Mennerich, Global Head of Business Development & Licensing, Boehringer Ingelheim.

Nucala (mepolizumab) Approved in China for Use in Severe Asthma With an Eosinophilic Phenotype

Warren-based BioNJ Member GSK announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved for use in China for adult and adolescent patients with this condition. Kaivan Khavandi, Senior Vice President, Global Head, Respiratory and Immunology, R&D, said, “We are delighted with this approval, supported by evidence in a Chinese population. Millions of people in China with severe eosinophilic asthma can now potentially benefit from the advance in management that Nucala could offer – a testament to GSK’s ongoing commitment to redefine respiratory disease management globally.”

GSK Enters Agreement to Acquire Aiolos Bio

Warren-based BioNJ Member GSK and Aiolos Bio, Inc. announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments. The acquisition provides GSK with access to Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps. AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer

New Brunswick-based BioNJ Member Johnson & Johnson announced it has entered into a definitive agreement to acquire Ambrx Biopharma, Inc. in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired. Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety of its candidate therapeutics in multiple cancer indications, including ARX517, its proprietary ADC targeting PSMA for metastatic castration-resistant prostate cancer (mCRPC); ARX788, its proprietary ADC targeting human epidermal growth factor receptor 2 (HER2) for metastatic HER2+ breast cancer; and ARX305, its proprietary ADC targeting CD-70 for renal cell carcinoma.

Crohn’s & Colitis Foundation and Evotec Enter Agreement to Advance Drug Discovery for Novel IBD Therapies

The Crohn’s & Colitis Foundation has joined forces with Princeton-based BioNJ Member Evotec to help advance drug discovery for two innovative drug targets stemming from cutting-edge academic research for inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. The agreement will help translate the academic findings into drug discovery activities to identify novel therapies addressing the unmet needs of IBD patients through the IBD Therapeutics Incubator. The Incubator is part of the Foundation’s IBD Ventures program and is a groundbreaking initiative intended to revolutionize the landscape of drug discovery for IBD. While potential new drug targets can be discovered in academic labs, most of them never advance since academic researchers typically lack the resources and expertise to create a drug around an identified target.

Evotec Advances Strategic Neuroscience Partnership With Bristol Myers Squibb

Princeton-based BioNJ Member Evotec announced progress within the company’s strategic partnership with BioNJ Member Bristol Myers Squibb, further bolstering the joint pipeline of advanced neuroscience programmes. Evotec receives a US$ 25 m payment to progress further research. Evotec and Bristol Myers Squibb entered their strategic neuroscience collaboration in December 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases where there remains a significant unmet medical need for therapies that slow down or reverse disease progression. The partnership has generated a promising pipeline of discovery to clinical-stage programs. A first program, EVT8683, was in-licensed by Bristol Myers Squibb in September 2021 as BMS-986419. Following a successful Phase I study Bristol Myers Squibb announced that a Phase II study for BMS-986419 is scheduled to commence in 2024.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Repotrectinib for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer and NTRK-Positive Solid Tumors

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with ROS1-positiveNSCLCor NTRK-positivesolid tumors) and CARE study (pediatric patients with NTRK-positive solid tumors). Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

Dupixent® (dupilumab) U.S. Label Updated With Data Further Supporting Use in Atopic Dermatitis With Moderate-to-Severe Hand and Foot Involvement

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries. The label update is based on data from the Phase 3 LIBERTY-AD-HAFT trial. In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66). 

Merck Announces Phase 3 Trial Initiations for Four Investigational Candidates from its Promising Hematology and Oncology Pipeline

Rahway-based BioNJ Member Merck & Co. announced the initiation of pivotal Phase 3 trials for four of its investigational candidates from its diverse pipeline in hematologic malignancies and solid tumors. These Phase 3 trial initiations for four of our investigational candidates represent a critical step forward in our efforts to advance potential treatment options for people with solid tumors and hematologic neoplasms and malignancies,” said Dr. Marjorie Green, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “We have a proud legacy of turning breakthrough science into medicines that save and improve lives around the world, and we are dedicated to continuing research to expand our broad portfolio of oncology therapeutics to continue to address unmet needs in cancer care.”

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. The approval is based on data from the Phase 3 KEYNOTE-A18 trial, in which KEYTRUDA plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group. This approval marks the third indication for KEYTRUDA in cervical cancer and the 39th indication for KEYTRUDA in the U.S.

Merck to Acquire Harpoon Therapeutics, Further Diversifying Oncology Pipeline

Rahway-based BioNJ Member Merck & Co. and Harpoon Therapeutics, Inc. announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Harpoon for $23.00 per share in cash for an approximate total equity value of $680 million. “At Merck, we continue to enhance our oncology pipeline through strategic acquisitions that complement our current portfolio and advance breakthrough science to help address the needs of people with cancer worldwide,” said Dr. Dean Y. Li, President, Merck Research Laboratories. “This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon. We look forward to further evaluating HPN328 in innovative combinations with other pipeline candidates.”

Lutikizumab Showed Positive Results in a Phase 2 Trial of Adults With Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase 3

BioNJ Member AbbVie, with a site in Madison, announced Phase 2 results showing adults with moderate to severe hidradenitis suppurativa (HS) who had previously failed anti-TNF therapy who received lutikizumab (ABT-981) 300 mg every other week or 300 mg weekly achieved higher response rates (59.5 percent, nominal p=0.027 and 48.7 percent, nominal p=0.197, respectively) than placebo (35.0 percent) in the primary endpoint of achieving HS Clinical Response (HiSCR 50) at week 16. Based on these data, AbbVie will advance its clinical program of lutikizumab in HS to Phase 3. Lutikizumab is AbbVie's investigational, dual-variable-domain interleukin (IL) 1α/1β antagonist. Studies have shown IL 1α and 1β are elevated in HS lesions.

AbbVie and Umoja Biopharma Announce Strategic Collaboration to Develop Novel In-Situ CAR-T Cell Therapies

BioNJ Member AbbVie, with a site in Madison, and Umoja Biopharma announced two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology using Umoja's proprietary VivoVec^TM platform. The first agreement provides AbbVie an exclusive option to license Umoja's CD19 directed in-situ generated CAR-T cell therapy candidates. This includes UB-VV111, Umoja's lead clinical program for hematologic malignancies currently at the IND-enabling phase. Under the terms of the second agreement, AbbVie and Umoja will develop up to four additional in-situ generated CAR-T cell therapy candidates for discovery targets selected by AbbVie. "As we continue to strengthen our oncology portfolio, we believe that in-situ CAR-T cell therapy represents a paradigm shift utilizing genetic medicine concepts," said Jonathon Sedgwick, Ph.D., Vice President and Global Head of Discovery Research at AbbVie.

AbbVie Launches PRODUODOPA® (foslevodopa/foscarbidopa) for People Living With Advanced Parkinson's Disease in the European Union

BioNJ Member AbbVie, with a site in Madison, announced the launch of PRODUODOPA® (foslevodopa/foscarbidopa) in the European Union for the treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement), and when available combinations of Parkinson's medicinal products have not given satisfactory results. PRODUODOPA is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations in people living with advanced Parkinson's disease whose symptoms are inadequately controlled by other therapies. The continuous delivery of PRODUODOPA provides levodopa 24-hours a day which may help patients by extending the period when symptoms are well-controlled, often referred to as "On" time.

Bausch + Lomb Receives FDA Approval for TENEO™ Excimer Laser Platform for Myopia and Myopic Astigmatism LASIK Vision Correction Surgery

Bausch + Lomb Corporation, with a site in Bridgewater, announced the U.S. Food and Drug Administration (FDA) has approved the TENEO Excimer Laser Platform for laser-assisted in situ keratomileusis (LASIK) vision correction surgery for myopia and myopic astigmatism (nearsightedness and nearsightedness with astigmatism)*. “TENEO has been well received and is widely adopted in more than 50 countries around the world, and now U.S. ophthalmologists will benefit from this versatile laser," said Luc Bonnefoy, President, Global Surgical, Bausch + Lomb. “The precise engineering of this platform delivers a fast, small, technologically advanced machine that provides an exceptional experience for both surgeons and patients.” The advanced eye-tracker operates at 1,740Hz, which is more than three times the speed of the laser’s repetition.

LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in China

Nutley-based Eisai and BioNJ Member Biogen Inc. announced that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: generic name: lecanemab-irmb) has been approved in China as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. Preparations for launch within the second quarter of Eisai’s FY 2024 (July 1 – September 30, 2024) are underway. LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils*), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.

EDA to Support AI Hub in Princeton With $250K from Strategic Innovation Center Initiative

The State’s support of a hub for artificial intelligence research at Princeton University comes with more than just enthusiasm, it comes with $250,000. The New Jersey Economic Development Authority announced that the initial development of the Princeton AI hub will be supported with $250,000 in planning funds from the EDA’s Strategic Innovation Center initiative. The hub, announced last month with much fanfare by Gov. Phil Murphy and Princeton President Chris Eisgruber, will bring together AI researchers, industry leaders, start-up companies and other collaborators to advance research and development. It also will house dedicated accelerator space, advance the use of ethical AI for positive societal impact and promote workforce development to support new technology development.

NJBIZ Conversations: NJII President Michael Johnson

Since its inception in 2014, the Newark-based New Jersey Innovation Institute, a nonprofit organization owned by the New Jersey Institute of Technology, has combined the school’s resources with industry and government partners to “turn ideas into workable solutions” in five core areas: health care, entrepreneurship, defense and homeland security, and professional and corporate education. According to NJII, the organization acts as a “conduit that connects NJIT to the outside world and to be a significant economic driver in New Jersey.” That role will only become larger and more important as the global economy adopts new technology and the state government attempts to put New Jersey at the forefront of that move. Michael Johnson, who took over as President of NJII last October, will be at the center of the action.

Brian Foard Appointed Head of Specialty Care Global Business Unit, Member of Sanofi Executive Committee

Bridgewater-based BioNJ Member Sanofi announced Brian Foard, a healthcare industry veteran and Sanofi leader in the U.S., has been named Head of the company’s Specialty Care Global Business Unit (GBU). With this appointment, Mr. Foard becomes a member of Sanofi’s Executive Committee. Mr. Foard has been interim Head of the GBU since September 2023 while also serving as Head of Specialty Care North America and U.S. Country Lead. Mr. Foard, who has more than 20 years of specialty biopharma experience, has been at the helm of the successful launch of Dupixent® in more than 50 countries across multiple indications and age groups prior to his current role. He joined Sanofi in March 2017 as the Global Head of Dermatology and Respiratory, and held roles of increasing responsibility, including as Head of Global Immunology for Sanofi.

CitiusTech Adds Digital Expert as New COO

Nine months after naming a new CEO, Princeton-based CitiusTech added another executive to its leadership team. The health care technology company announced it appointed Sudhir Kesavan as Chief Operating Officer. As COO, Mr. Kesavan is responsible for leading the company’s global delivery organization, including enhancing practice capability, service delivery maturity and market innovation. Mr. Kesavan joins CitiusTech from PwC India, where he served as partner, Advisory – Cloud Transformation, and was responsible for that company’s cloud business. He has also held executive and management positions with Wipro, ValueLabs and Tata Consultancy Services. Mr. Kesavan has extensive experience facilitating “inside-out and outside-in transformations, optimizing technology operations and promoting customer-driven business models for clients.” 

Calliditas Therapeutics Appoints Maria Törnsén as President North America

Calliditas Therapeutics, with a site in Hoboken, announced that Maria Törnsén has been appointed to the position of President North America. Ms. Törnsén will be responsible for all U.S.-based operations and will report to the CEO. Ms. Törnsén has broad commercial leadership experience, having spent more than 20 years in the biopharma industry in senior commercial roles. Most recently, Ms. Törnsén held the position of Chief Commercial Officer at Passage Bio, prior to which she was Senior Vice President, General Manager U.S. at Sarepta Therapeutics. Prior to joining Sarepta, she served as Vice President, Global Therapeutic Area Head at Sanofi Genzyme and held several senior commercial roles at Shire, including Vice President, Head of U.S. Sales. Ms. Törnsén will replace Mr. Andrew Udell, who has held the position since 2020. 

10 Companies, Up to $3.6M in Grants: Meet Inaugural N.J. Innovation Fellows

Ten New Jersey businesses — made up of 30 entrepreneurs — will receive a total of $3.6 million in income replacement grants, as well as mentorship and training, as part of the New Jersey Innovation Fellows program, a first-of-its-kind initiative from the New Jersey Economic Development Authority. The inaugural cohort of companies are another example of Gov. Phil Murphy’s perpetual push to create a more innovative economy in the state as it aims to not only foster innovation, but support business ventures in their critical early stages. The program’s innovative approach of providing income replacement grants to diverse teams ensures entrepreneurs of all backgrounds can fully dedicate themselves to growing their ventures without the financial strain typically associated with the early stages of business development.

National Security Commission of Emerging Biotechnology December 2023 Interim Report

For over 50 years, the United States has spearheaded biotechnology innovation, with pivotal moments like Genentech's 1978 breakthrough in synthetic human insulin. Despite ongoing global leadership, challenges from countries like China threaten our position. Biotech's current contributions, spanning medicines, food and materials, are just the tip of the iceberg. As the pace of innovation accelerates, the U.S. faces a critical juncture — biotechnology's potential for both benefit and harm surpasses past technologies. To fortify American leadership, unity across government, industry, academia and global allies is essential. Our Commission aims to bolster this leadership through actionable policy recommendations, unlocking biotech's potential in defense and beyond. We welcome engagement from all, including academia, private companies, government agencies, and more, to shape a future aligned with our values.

NJEDA Support Advances Growth of Artificial Intelligence Industry Companies in New Jersey

Following last month’s announcement by Governor Phil Murphy and Princeton University President Christopher Eisgruber that the New Jersey Economic Development Authority (NJEDA) will collaborate with Princeton University to establish a hub for Artificial Intelligence (AI), the AI industry continues to gain momentum in New Jersey heading into 2024. “The AI hub announced in December by Governor Murphy and President Eisgruber will build on New Jersey’s legacy in innovation and continue to drive the state’s leadership in the rapidly-growing AI industry,” said Tim Sullivan, CEO of the New Jersey Economic Development Authority. “The opportunity presented by AI aligns with Governor Murphy’s vision for cultivating high-growth sectors, with the goal of creating family-sustaining career opportunities. Showcasing New Jersey’s bustling innovation community, talent pool, and robust resources will help AI companies recognize the state’s value proposition for growing innovative companies of the future.”

Eisai Listed as a Global 100 Most Sustainable Corporation for the Eighth Time

Eisai Co., Ltd. announced that it has been listed in the 2024 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc. This marks Eisai’s eighth inclusion on the list. Ranked 35th, Eisai is the highest ranking company among global pharmaceutical companies. The Global 100 evaluates the sustainability of more than 6,700 of the world’s major corporations based on various corporate initiatives in areas such as ESG (environment, society and governance).

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.