Myths v. Facts Can Bayh-Dole March-In Rights Lower Drug Costs?

In December 2023, the Biden administration proposed a new framework that would allow government agencies to disregard that long-standing interpretation of Bayh-Dole and grant March-In petitions on the basis of price as a means to lower drug costs. However, it would not achieve this goal — but instead would stunt research projects, start-up development and entrepreneurship across every U.S. industry. The Bayh-Dole Coalition debunks some common misconceptions about the government’s new March-In framework with this new infographic.

Preserving U.S. Leadership in Biopharmaceutical Innovation

U.S. leadership in advanced technology industries is never guaranteed. It takes ongoing stewardship from policymakers to ensure America provides the most globally competitive environment to support cutting-edge innovation. Unfortunately, policy lapses in recent decades have contributed to America losing its global competitiveness, market share, and high-skilled, high-value-added employment across a wide range of advanced technology industries, including semiconductors, telecommunications equipment, televisions, solar panels, and chemicals. Now we are at risk of compromising U.S. biopharmaceutical leadership, which has become increasingly imperiled by policies imposing price controls and weakening intellectual property rights (IPR), with measures such as COVID-19 waivers and proposals to expand Bayh-Dole March-In Rights.

Our Nation Must Reject Biden Administration Overreach on March-In Rights

The Biden administration recently unveiled a plan to impose price controls on products whose development can be traced in any way to a federal research grant, a cooperative research and development agreement (CRADA), or other federal funding. The proposal would cover all technologies and all agencies of the federal government. It reflects the fantasies of politicians and bureaucrats who dream of giving the government the power to control the prices of important goods and services, much as the Office of Price Administration did during WWII. It is critical that voters and rational politicians understand why the proposal has such sweeping coverage and what its long-term implications portend for national security and the well-being of Americans. Since the Biden administration has misleadingly described this proposal as focused only on "lowering drug prices," it has garnered tens of thousands of support letters.

ICYMI: Comer Speaks at Event on Bipartisan Action on PBM Accountability

House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) spoke at an event hosted by The Hill which focused on bipartisan efforts at reforming certain Pharmacy Benefit Manager (PBM) practices. In his remarks, Chairman Comer highlighted the House Committee on Oversight and Accountability’s work to bring accountability for harmful PBM practices which raise costs on American consumers and have a negative impact on independent pharmacies. “We’ve got a lot of problems with the way PBMs operate. In a bipartisan way, we believe that PBMs are operating in an anticompetitive manner. PBMs were created, like most entities, through legislation with good intentions, but overtime unintended consequences have happened."

John LaMattina – Drug Price Controls and IP Attacks Get Real

John LaMattina was President of Pfizer Global Research and Development and ran an international team of over 13,000 scientists and professionals. He has authored several books, including the highly acclaimed Pharma and Profits – Balancing Innovation, Medicine, and Drug Prices. He is also a senior partner at PureTech Health and a contributor to Forbes. John discusses how the IRA will impact the development of critically needed new therapies and provides his insights into the Biden Administration’s recent threats to use march-in rights to confiscate intellectual property as a way to control the price of drugs. 

Heart Disease Patients and the IRA’s Misguided Incentives

The Inflation Reduction Act (IRA) is expected to have broad negative impacts on patients, most notably through less access to future cures and treatments. The latest research shows that patients with heart disease may be especially affected, given the unique challenges surrounding cardiovascular treatments. What’s happening with the IRA and heart disease therapies? The IRA’s impact on heart disease therapies is likely to take two forms: 1) dampen investment in innovation, especially innovation that broadens the use of existing cardiovascular therapies and 2) Result in new access barriers and higher costs that fall disproportionately on patients with heart disease. The result will be fewer cardiovascular treatments.

Global Business Reports Interview With Debbie Hart, President of BioNJ

"The growth of New Jersey's ecosystem continues, marked by global companies expanding in the Garden State and concerted efforts to bolster the very earliest-stage companies. Notably, the New Jersey Commission on Science, Innovation and Technology's US$16 million investment in 274 startups over four years and the Innovation Evergreen Fund attracting fresh venture capital signal ample growth prospects," said Ms. Hart. "Moving ahead, we will see more partnerships between academia, industry and the public sector to ensure New Jersey remains a leader in life sciences and ultimately bring more drugs to market. Key innovation hubs like the HELIX in New Brunswick, NEST Center in Kenilworth, and SciTech Scity in Jersey City underscore the State's commitment to advancement."

PTC Announces Submission of Sepiapterin MAA for Treatment of PKU to EMA

South Plainfield-based BioNJ Member PTC Therapeutics announced the submission of the sepiapterin MAA to the European Medicines Agency. The MAA submission is for the treatment of pediatric and adult patients with PKU, including the full spectrum of disease subtypes. “This MAA submission is the first in a series of global submissions for sepiapterin as we move closer to bringing this therapy to children and adults with PKU worldwide," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "The strength of the sepiapterin data generated in clinical trials substantiate how differentiated sepiapterin is from currently available therapies and support how sepiapterin could address the significant unmet medical need for PKU patients."

Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “VOQUEZNA Can Kick Some Acid”

Florham Park-based BioNJ Member Phathom Pharmaceuticals, Inc. announced the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years. The multi-channel campaign delivers strong, compelling and motivating efficacy and safety information to educate consumers about this new treatment option.

SPEVIGO® Approved for Expanded Indications in China and the U.S.

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced that the U.S. Food and Drug Administration (FDA) has approved SPEVIGO® (spesolimab-sbzo) injection for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients aged 12 and above weighing ≥40 kg.5 This approval follows the Chinese National Medical Products Administration’s (NMPA) recent approval of SPEVIGO® for the reduction of occurrence of generalized pustular psoriasis (GPP) in adolescents from 12 years of age with a body weight ≥40 kg and adults. SPEVIGO® is a novel, humanized selective IgG1 antibody that binds to interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Hopewell-based BioNJ Member BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. TEVIMBRA will be available in the U.S. in the second half of 2024. The approval is based on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically significant and clinically meaningful survival benefit for TEVIMBRA compared with chemotherapy. In the ITT population, the median overall survival (OS) in the TEVIMBRA arm was 8.6 months (95% CI: 7.5, 10.4) compared to 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy arm (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]).

Tevogen Bio Reports Its Investigational SARS-CoV-2 Specific T Cell Therapy, TVGN-489, Retains Activity Against the Dominant JN.1 Variant

Warren-based BioNJ Member Tevogen announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated JN.1 strain based on a review of this variant’s protein sequences. TVGN 489 contains Cytotoxic T lymphocytes that recognize multiple SARS-CoV-2 proteins, or peptides. TVGN 489’s peptide targets have been preserved in all previously studied COVID strains. Continuing surveillance by Tevogen Bio of SARS-CoV-2 variants, including the currently dominant JN.1 strain and newer JN.1 strains, show that 96% of these CTLs remain active against the current circulating variants.

Mitsubishi Tanabe Pharma America Announces Publication of Positive Results from Phase 3 BouNDless Trial of Investigational ND0612 in People With Parkinson’s Disease Experiencing Motor Fluctuations

BioNJ Member Mitsubishi Tanabe Pharma America, with a site in Jersey City, announced the publication of results in The Lancet Neurology from the pivotal, Phase 3 BouNDless trial evaluating the efficacy, safety and tolerability of investigational ND0612 – a continuous, 24 hours/day subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) – in comparison to oral immediate-release (IR) LD/CD in people with Parkinson’s disease (PD) experiencing motor fluctuations. Results from the study, which met its primary endpoint and the first four secondary endpoints, showed ND0612 was superior at increasing “ON” time without troublesome dyskinesia and reducing “OFF” time, compared to oral IR-LD/CD after 12 weeks.

First Patient Enrolled in MTPA INSPIRE Study of Investigational Dersimelagon for EPP and XLP

BioNJ Member Mitsubishi Tanabe Pharma America, with a site in Jersey City, announced the first patient was enrolled in the INSPIRE (Increased Sun Exposure Without Pain In Research Subjects With EPP Or XLP) clinical study. INSPIRE is a phase 3 clinical study investigating the efficacy, safety, and tolerability of dersimelagon (MT-7117), in adults and adolescents with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). Dersimelagon is an investigational treatment under study for its potential to increase the time in sunlight before patients experience prodromal symptoms (i.e., the appearance of initial symptoms such as burning, tingling, itching, or stinging) or fully develop a phototoxic reaction associated with sunlight exposure.

Genmab to Broaden and Strengthen Oncology Portfolio With Acquisition of ProfoundBio

Princeton-based BioNJ Member Genmab A/S and ProfoundBio, Inc. announced that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction. ProfoundBio is a privately-owned clinical-stage biotechnology company developing next-generation ADCs and ADC technologies for the treatment of certain cancers, including ovarian cancer and other FRα-expressing solid tumors. Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses). The transaction will further broaden Genmab’s mid- to late-stage clinical pipeline and strengthen and complement Genmab’s already validated suite of proprietary technology platforms. The acquisition will give Genmab worldwide rights to ProfoundBio’s portfolio of next-generation ADCs, which consists of three clinical and multiple preclinical programs including Rina-S, a potential best-in-class, clinical-stage, FRα-targeted, Topo1 ADC, currently in Phase 2 of a Phase 1/2 clinical trial, for the treatment of ovarian cancer and other FRα-expressing solid tumors.

Soligenix Announces Agreement on the Design of a Second Confirmatory Placebo-Controlled Trial for HyBryte™ With the European Medicines Agency

Princeton-based BioNJ Member Soligenix, Inc. announced that it has received agreement from the European Medicines Agency (EMA) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early stage disease. This confirmatory 18-week study is expected to enroll approximately 80 patients in the United States and Europe and is targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026. The confirmatory study, called FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2), replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6 week double-blind, placebo-controlled treatment cycle (Cycle 1).

Positive RUBY Phase III Data Show Potential for Jemperli (dostarlimab) Combinations in More Patients With Primary Advanced or Recurrent Endometrial Cancer

Warren-based BioNJ Member GSK announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III trial in adult patients with primary advanced or recurrent endometrial cancer. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said “The positive data further show how dostarlimab-based regimens could benefit a broader set of patients with endometrial cancer. The results we’ve seen to date comprise the growing body of evidence supporting the role of dostarlimab as the backbone of our immuno-oncology development programme. Our goal is to continue to identify ways to use dostarlimab alone and in combination with other therapies to help improve outcomes for patients with limited treatment options.”

Awiqli® (once-weekly basal insulin icodec) Recommended for Approval for the Treatment of Diabetes by the European Regulatory Authorities

Plainsboro-based BioNJ Member Novo Nordisk announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization for Awiqli® (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults. The positive CHMP opinion is based on results from the ONWARDS Phase 3a clinical trial program. Once-weekly basal insulin icodec achieved superior blood sugar reduction (measured by a change in HbA1c) and superior Time in Range (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes. In people with type 2 diabetes who have not previously been treated with insulin, overall observed rates of clinically significant or severe hypoglycaemia were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators.

Novo Nordisk to Acquire Cardior Pharmaceuticals and Strengthen Pipeline in Cardiovascular Disease

Plainsboro-based BioNJ Member Novo Nordisk and Cardior Pharmaceuticals announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. Cardior is a leader in the discovery and development of therapies that target RNA as a means to prevent, repair and reverse diseases of the heart. The company’s therapeutic approach targets distinctive non-coding RNAs as a platform for addressing root causes of cardiac dysfunctions with an aim to achieve lasting patient impact. The agreement includes Cardior’s lead compound CDR132L, currently in Phase 2 clinical development for the treatment of heart failure.

First Wave BioPharma Announces Completion of Business Combination With ImmunogenX, Adding Phase 3-Ready Latiglutenase to its Late-Stage GI-Focused Clinical Pipeline

BioNJ Member First Wave BioPharma, Inc., announced it has acquired ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple, late-stage clinical assets, including latiglutenase, a potentially first-in-class, near Phase 3-ready, targeted, oral biotherapeutic for celiac disease. James Sapirstein will continue to serve as Chairman and Chief Executive Officer of First Wave BioPharma with Jack Syage, Ph.D., previously the Chief Executive Officer and Co-Founder of ImmunogenX, assuming the role of President and Chief Operating Officer of First Wave BioPharma. Dr. Syage and Dr. Chaitan Khosla will also join the board of directors of First Wave BioPharma.

European Commission Expands Approval of Bristol Myers Squibb’s Reblozyl® (luspatercept) to Include First-Line Treatment of Transfusion-Dependent Anemia in Adults With Lower-Risk Myelodysplastic Syndromes (LR-MDS)

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has expanded approval of Reblozyl^® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS). This approval of Reblozyl covers all EU member states. The approval is based on the pivotal Phase 3 COMMANDS study, in which Reblozyl demonstrated superior efficacy compared to epoetin alfa, an erythropoiesis stimulating agent, in the study’s primary endpoint of concurrent red blood cell transfusion independence and hemoglobin increase. Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population. Reblozyl is also approved in the U.S. and Japan for the first-line treatment of anemia associated with lower-risk MDS.

Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients With Pretreated KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung

Princeton-based BioNJ Member Bristol Myers Squibb announced that the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation, met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) as assessed by Blinded Independent Central Review (BICR) at final analysis for these endpoints. The study remains ongoing to assess the additional key secondary endpoint of overall survival. Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients. KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.

Bristol Myers Squibb Announces CheckMate -9DW Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) Meets Primary Endpoint of Overall Survival for the First-Line Treatment of Advanced Hepatocellular Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced the Phase 3 CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy met its primary endpoint of improved overall survival (OS) compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis.The dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in OS compared to investigator’s choice of sorafenib or lenvatinib. 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.

FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy

Princeton-based BioNJ Member Bristol Myers Squibb and 2seventy bio, Inc. announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival. The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population. The FDA has not yet assigned a new target action date for review of the sBLA.

Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) Becomes First CAR T Cell Therapy Approved in the European Union in Earlier Lines for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the European Commission (EC) has granted approval to Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. Abecma is the first chimeric antigen receptor (CAR) T cell immunotherapy approved in the European Union (EU) for use in earlier lines of therapy for relapsed and refractory multiple myeloma. This expanded approval of Abecma covers all EU member states. In the EU, Abecma has maintained its Orphan Designation for the treatment of multiple myeloma.

Bristol Myers Squibb Completes $14B Acquisition of Karuna Therapeutics

Princeton-based BioNJ Member Bristol Myers Squibb announced it completed the previously announced acquisition of Karuna Therapeutics for $330 per share, or a total equity value of approximately $14 billion. With the acquisition, BMS now gains full control of KarXT (xanomeline tartrate/trospium chloride), an antipsychotic drug that could become the first to reach the schizophrenia market with a completely new mechanism of action in more than 50 years. KarXT is also in registrational trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease, with potential to expand to additional indications, including Bipolar I disorder and Alzheimer’s disease agitation.

Eisai Completes Submission of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease to the U.S. FDA

Nutley-based BioNJ Member Eisai and BioNJ Member Biogen Inc. announced that Eisai submitted to the U.S. Food and Drug Administration (FDA) a Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD). As part of the monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, exact period under discussion with the FDA, would receive a monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic protofibrils which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain.

Chugai Obtains Regulatory Approval for Vabysmo, the Only Bispecific Antibody in the Ophthalmology Field, for Additional Indication of Macular Edema Associated with Retinal Vein Occlusion

BioNJ Member Chugai Pharmaceutical Co, with a site in Berkley Heights, announced that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo® Intravitreal Injection 120 mg/mL [generic name: faricimab (genetical recombination)], for an additional indication of the treatment of macular edema associated with retinal vein occlusion (RVO). Vabysmo is the first bispecific antibody in Japan for the treatment of this disease. “I’m very pleased to have obtained approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. Treatment with Vabysmo is expected to improve and maintain vision in patients with RVO, a disease that can severely affect vision and lead to blindness,” said Chugai’s President and CEO, Dr. Osamu Okuda.

Chugai Obtains Regulatory Approval for “Piasky 340mg” for Paroxysmal Nocturnal Hemoglobinuria in Japan

BioNJ Member Chugai Pharmaceutical Co, with a site in Berkley Heights, announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Piasky® for Injection 340 mg (generic name: crovalimab (genetical recombination)) (hereafter, Piasky), a pH-dependent binding humanized anti-complement (C5) monoclonal antibody for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Piasky was approved in China in February this year for the treatment of adults and adolescents (12 years of age and above) with PNH who have not been previously treated with complement inhibitors. Japan is the first country in the world to obtain approval without restrictions on switching from existing C5 inhibitors, and without restrictions of age in patients over body weight of 40kg.

Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile to Be Used as a Companion Diagnostic for the AKT Inhibitor, Capivasertib for Advanced HR-positive, HER2-negative Breast Cancer With PIK3CA, AKT1 or PTEN Alterations

BioNJ Member Chugai Pharmaceutical Co., with a site in Berkley Heights, announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW), for FoundationOne® CDx Cancer Genomic Profile to be used as a companion diagnostic to identify patients eligible for AstraZeneca K.K.’s AKT inhibitor, Truqap tablets (generic name: capivasertib), in combination with Faslodex (generic name: fulvestrant) for patients with advanced unresectable or recurrent HR-positive, HER2-negative breast cancer with specific PIK3CA, AKT1 or PTEN alterations, which was approved by the MHLW. This approval enables the detection of PIK3CA, AKT1 and PTEN alterations using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use capivasertib in combination with faslodex for advanced HR-positive, HER2-negative breast cancer patients with tumors harbouring these alterations.

U.S. FDA Approves EDURANT® PED (rilpivirine) for Certain Pediatric Patients Living With HIV-1

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved EDURANT® PED (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) at least 2 years of age and weighing at least 14 kg and less than 25 kg. This approval builds on Johnson & Johnson’s longstanding commitment to ensuring that people living with HIV, including children, have treatment options that may work for them. The FDA’s decision is based on results from the PAINT (NCT00799864) and PICTURE (NCT04012931) studies in pediatric subjects, which showed that rilpivirine, in combination with other ARVs, effectively suppresses the virus in treatment-naïve (with HIV-1 RNA <100,000 copies/mL) pediatric patients.

U.S. FDA Oncologic Drugs Advisory Committee Recommends CARVYKTI® (ciltacabtagene autoleucel) for the Earlier Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI® (11 to 0) finding the risk-benefit assessment of CARVYKTI® for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA.

Johnson & Johnson’s Nipocalimab Granted U.S. FDA Fast Track Designation to Reduce the Risk of Fetal Neonatal Alloimmune Thrombocytopenia (FNAIT) in Alloimmunized Pregnant Adults

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for nipocalimab to reduce the risk of FNAIT in alloimmunized pregnant adults during their current pregnancy. FNAIT is a rare and severe condition that occurs when the immune system of a pregnant person mistakenly attacks platelets in a developing fetus. This immune response can lead to impaired clotting ability and bleeding, posing a significant risk to the fetus or newborn. Nipocalimab, an investigational monoclonal antibody targeting FcRn, is the only investigational therapy currently reported to be in clinical development to address the needs of alloimmunized pregnant individuals at risk of FNAIT.

U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients With Pulmonary Arterial Hypertension (PAH)

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III. OPSYNVI® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. OPSYNVI® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.

FDA Expands Indication for Gilead's Vemlidy (Tenofovir Alafenamide) to Treat Chronic HBV Infection in Pediatric Patients as Young as Six

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. Vemlidy is a targeted prodrug of tenofovir that was approved by the FDA in 2016 as a once-daily treatment for adults with chronic HBV infection with compensated liver disease. In 2022, the FDA approved Vemlidy for the treatment of chronic HBV infection in pediatric patients 12 years of age and older with compensated liver disease.

Gilead and Xilio Announce Exclusive License Agreement for Tumor-Activated IL-12 Program

BioNJ Member Gilead Sciences, with a site in Morris Plains, and Xilio Therapeutics, Inc. announced an exclusive license agreement to develop and commercialize Xilio’s Phase 1 tumor-activated IL-12 program, XTX301. Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies. The company is using its proprietary tumor-activation platform to build a pipeline of novel, tumor-activated molecules, including antibodies, cytokines, bispecifics, and cell engagers, which are designed to optimize the therapeutic index and localize anti-tumor activity within the tumor microenvironment. XTX301 is currently being evaluated in a Phase 1 dose escalation trial in patients with advanced solid tumors.

U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients

BioNJ Member AbbVie, with a site in Madison, announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery, and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE. "The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy," said Roopal Thakkar, M.D., Senior Vice President, Chief Medical Officer, Global Therapeutics, AbbVie.

AbbVie to Acquire Landos Biopharma, Further Strengthening its Portfolio in Inflammatory and Autoimmune Diseases

BioNJ Member AbbVie, with a site in Madison, and Landos Biopharma, Inc. announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos' lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family) with a bimodal mechanism of action (MOA), which is anti-inflammatory and facilitates epithelial repair. "With this acquisition, we aim to advance the clinical development of NX-13, a differentiated, first-in-class, oral asset with the potential to make a difference in the lives of people living with ulcerative colitis and Crohn's disease," said Roopal Thakkar, M.D., Senior Vice President, Chief Medical Officer, Global Therapeutics, AbbVie.

Teva and mAbxience Announce Strategic Global Licensing Agreement for Oncology Biosimilar Candidate

Parsippany-based BioNJ Member Teva Pharmaceutical Industries Ltd. and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. Biosimilars show promising potential in providing more cost-effective alternatives to existing oncology therapies, thereby addressing a critical need in global oncology care. The licensing agreement covers multiple global markets, including in Europe and the United States, signaling a major step in mAbxience’s global expansion strategy, and supports a key element of Teva’s Pivot to Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships.

Clinical Collaboration Agreement Between Teva and Launch Therapeutics to Accelerate Development of Dual-Action Asthma Rescue Inhaler (ICS-SABA/TEV-’248) Respiratory Program; Teva and Abingworth Enter Strategic Development Funding Agreement

Parsippany-based BioNJ Member Teva Pharmaceutical Industries Ltd. and Launch Therapeutics, Inc. announced a clinical collaboration agreement to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-‘248). Teva and Abingworth, a leading international life sciences investment group, part of global investment firm Carlyle, also announced a strategic development funding agreement in which Abingworth provides Teva up to $150 million to offset Teva’s ICS/SABA (TEV-‘248) program costs. As part of the clinical collaboration agreement, Launch Therapeutics, a clinical development company backed by Abingworth and Carlyle, will have the lead role in the operational execution and management of the planned clinical trials, focused on accelerating Teva’s ICS-SABA (TEV-‘248) clinical research program. Teva will retain primary responsibility for manufacturing, regulatory interactions in the U.S. and commercialization.

Merck Initiates Phase 3 Clinical Trial of MK-1084, an Investigational Oral KRAS G12C Inhibitor, in Combination With KEYTRUDA® (pembrolizumab) for First-Line Treatment of Certain Patients With Metastatic Non-Small Cell Lung Cancer

Rahway-based BioNJ Member Merck & Co. announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1 (tumor proportion score [TPS] ≥50%). Merck has initiated a Phase 3, randomized, double-blind, multicenter clinical trial (NCT06345729) evaluating once daily MK-1084 in combination with KEYTRUDA administered once every three weeks compared with KEYTRUDA plus placebo in previously untreated patients with KRAS G12C-mutated metastatic NSCLC with a PD-L1 TPS ≥50%. The trial will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival, and key secondary endpoints include objective response rate and duration of response.

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for Resectable Non-Small Cell Lung Cancer (NSCLC) at High Risk of Recurrence in Adults

Rahway-based BioNJ Member Merck & Co. announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults. This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in February 2024 and was based on results from the Phase 3 KEYNOTE-671 trial. At a median follow-up of 29.8 months (range, 0.4 to 62.0 months), KEYTRUDA plus chemotherapy in the neoadjuvant setting followed by KEYTRUDA as monotherapy after surgical resection significantly improved overall survival (OS), reducing the risk of death by 28% (HR=0.72 [95% CI, 0.56-0.93]; one-sided p=0.00517) in patients with resectable stage II, IIIA or IIIB NSCLC versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection, regardless of PD-L1 expression.

FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in-Class Treatment for Adults With Pulmonary Arterial Hypertension (PAH, WHO* Group 1)

Rahway-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: WINREVAIR™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. WINREVAIR was previously granted Breakthrough Therapy Designation by the FDA. WINREVAIR is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.

Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Rahway-based BioNJ Member Merck & Co. announced positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine. Across the clinical studies presented, V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, including those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve), those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus (HIV). V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients With Platinum-Resistant Ovarian Cancer

Rahway-based BioNJ Member Merck & Co. and Basking Ridge-based Daiichi Sankyo announced that the first patient has been dosed in the REJOICE-Ovarian01 Phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. The Phase 2 portion of the trial will be conducted to identify the dose of raludotatug deruxtecan to be used in the Phase 3 part of the trial, which will evaluate raludotatug deruxtecan versus investigator’s choice of chemotherapy. Raludotatug deruxtecan is an investigational specifically engineered potential first-in-class CDH6 directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed with Merck. Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. 

Datopotamab Deruxtecan New Drug Application Submitted in Japan for Patients With Previously Treated Advanced HR Positive, HER2 Negative Breast Cancer

Basking Ridge-based Daiichi Sankyo has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. “Today’s submission for datopotamab deruxtecan in Japan is a significant step forward in our goal to create new standards of care globally with our pipeline of DXd antibody drug conjugates,” said Wataru Takasaki, Ph.D., Executive Officer, Head of R&D Division in Japan, Daiichi Sankyo. “We will work closely with the Japan Health Authority to bring this TROP2 directed antibody drug conjugate to patients with previously treated HR positive, HER2 negative metastatic breast cancer."

U.S. FDA Approves Idorsia’s Once-Daily TRYVIO (aprocitentan) – the First and Only Endothelin Receptor Antagonist for the Treatment of High Blood Pressure Not Adequately Controlled in Combination With Other Antihypertensives

Idorsia, with a site in Cherry Hill, announced that the U.S. Food and Drug Administration (FDA) has approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. TRYVIO (aprocitentan) is an endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors. The effects of ET-1 bear many similarities with the pathophysiology of hypertension, and ET-1 is a major driver of aldosterone production. Until the approval of TRYVIO, no systemic antihypertensive medications targeted the ET pathway, as approved antihypertensive therapies focus on the regulation of salt and water (diuretics), antagonism of the renin–angiotensin–aldosterone (RAAS) system, reduction of influx of extracellular calcium into the cell (calcium channel blockers), sympatholytic activity (beta blockers, central alpha-agonist agents), or non-selective vasodilatory effects.

Ipsen and Sutro Biopharma Announce Exclusive Global Licensing Agreement for an ADC Targeting Solid Tumors

Basking Ridge-based Ipsen and Sutro Biopharma announced an exclusive global licensing agreement for STRO-003. STRO-003, an antibody-drug conjugate (ADC) in the final stages of pre-clinical development, targets the ROR1 tumor antigen which is known to be overexpressed in many different cancer types including solid tumors and hematological malignancies. The agreement gives Ipsen exclusive worldwide rights to develop and commercialize STRO-003 and will be the first ADC candidate joining Ipsen’s expanding portfolio.“STRO-003 is a next-generation ROR1 ADC, leveraging Sutro’s site-specific technology to generate a highly stable conjugate, coupled with exatecan payloads, that have shown significant potential in solid tumors. This is our focus as we prepare to enter Phase I, harnessing Ipsen’s global expertise in oncology development, while also reinforcing our commitment to bringing new medicines to patients with few treatment options,” said Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen.

Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy

Florham Park-based Celularity Inc. announced that it has submitted a request to the U.S. Food and Drug Administration (FDA) for orphan drug designation for its off-the-shelf, placental-derived cell therapy, PDA-002, for treating Facioscapulohumeral Muscular Dystrophy (FSHD). Orphan drug designation is a status given to drugs that show the potential to treat, prevent or diagnose serious or life-threatening diseases that affect fewer than 200,000 people in the U.S. Earlier, Celularity received FDA Investigational New Drug Application clearance for PDA-002 in FSHD and plans to commence a phase 1/2 study in the second half of 2024. The trial serves as an important component for submitting a Biologics License Application (BLA) to the FDA in the future as a potential treatment for FSHD and other types of muscular dystrophy.

Dr. Reddy's Laboratories Launches Versavo® (bevacizumab) in the UK

Princeton-based Dr. Reddy’s Laboratories Ltd. announced the launch of Versavo® (bevacizumab) in the United Kingdom (UK). Dr. Reddy’s Versavo® is a (bevacizumab) biosimilar of Avastin® and indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer. Versavo® is the first Dr. Reddy’s biosimilar product to be approved and launched in the UK. It is available in strengths of 100mg and 400mg single use vials. Dr. Reddy’s launched Versavo® in India in 2019. Subsequently, Versavo® was introduced in other markets such as Thailand, Ukraine, Nepal and Jamaica under the same brand name.

Dr. Reddy's and Pharmazz, Inc. Enter into Licensing Agreement to Market First-in-Class Centhaquine (Lyfaquin®) for Hypovolemic Shock in India

Princeton-based Dr. Reddy’s Laboratories Ltd. has entered into a license agreement with Pharmazz, Inc. to commercialize the first-in-class innovative drug Centhaquine in India. Developed by Pharmazz, Centhaquine is a resuscitative agent presently indicated for the treatment of hypovolemic shock by the Drugs Controller General of India (DCGI). As per the agreement, Dr. Reddy's has received exclusive rights to market and distribute Centhaquine in India. Pharmazz will be entitled to upfront payments and royalties. Dr. Reddy’s will market the product under the brand name Lyfaquin®, which it shall own. In addition to India, Dr. Reddy’s also receives marketing rights for Lyfaquin® from Pharmazz for Nepal.

Integra LifeSciences Completes Acquisition of Acclarent

Integra LifeSciences Holdings Corp., a Princeton-based medical technology company, successfully completed its acquisition of Acclarent Inc. The addition of Acclarent, a subsidiary of Johnson & Johnson, expands the breadth of Integra’s market-leading brands and provides immediate scale and accretive growth via a dedicated sales channel. The acquisition adds $1 billion to the total addressable market of the company’s offerings, while providing unique market opportunities for access to the attractive ear, nose and throat device segment. “Acclarent’s strong commercial capabilities, R&D expertise, advanced portfolio and deep clinical knowledge will be important assets to Integra, enabling us to deliver transformative technologies to restore patients’ lives,” said Mike McBreen, Executive Vice President and President, Codman Specialty Surgical division.

8 from N.J. Among Most Innovative Companies, Fortune Says

Fortune has named America’s Most Innovative Companies for 2024, and eight companies from New Jersey made the 200-firm list. Among them were BioNJ Members Johnson & Johnson (16), ADP (80) and Bristol Myers Squibb (141). The list was compiled with the assistance of Statista Inc., a leading industry ranking and statistics company. Online surveys with employees and industry experts evaluated product innovation, process innovation and innovation culture.

HELIX Hits Another Homer: J&J to Take Space at Life Sciences Center

The HELIX, the life sciences innovation hub in New Brunswick that aims to be a leader of translational research in the State and throughout the East Coast, landed another world-class tenant, as BioNJ Member Johnson & Johnson announced it will take space at the complex. Johnson & Johnson’s global headquarters is within walking distance of the HELIX. The chance to be in the daily conversation with some of the leading companies in innovation in health care and other sectors was something J&J officials said the company wanted to be a part of. “At Johnson & Johnson, we know that a great idea can come from anywhere and welcome promising early innovations and partners that could benefit from our insight and collaboration,” a spokesperson said.

Seton Hall University Names Monsignor Joseph Reilly as its 22nd President

Seton Hall University named Monsignor Joseph Reilly as its 22nd President. Monsignor Reilly will assume the role July 1. This appointment marks the return of a priest-president to Seton Hall, which has been a hallmark of the university for 146 years of its 168-year history. Monsignor Reilly brings a deep knowledge of Catholic higher education, impressive administrative skills and personal experience as a Seton Hall student, alumnus, faculty member, administrator and priest. He takes over for Katia Passerini, who has served as interim president since July 2023. In 2012, Monsignor Reilly was named rector/dean of the Immaculate Conception Seminary School of Theology, where he served until 2022. During this period, he helped strengthen the university’s Catholic foundation as a member of the board of trustees. 

Presenting the 2024 NJBIZ Health Care Power 50

The power list is compiled by the NJBIZ editorial staff based on our reporting throughout the past year with input from experts in a variety of fields and recommendations from our readers. The staff looks for people who have gained public attention — and perhaps acclaim — for their professional accomplishments and public service. The list identifies individuals who, through their efforts, are helping to make New Jersey a better place to live, work and do business.

Congratulations to these BioNJ Members for making the list:

Kevin Ali, Organon; Thomas Cavalieri, Rowan University; Robert Davis, Merck & Co.; Amadou Diarra, Bristol Myers Squibb; Joaquin Duato, Johnson & Johnson; Matthew Edson, Rowan University; Robert Garrett, Hackensack Meridian Health; Andre Goy, Hackensack Meridian Health; Perry Halkitis, Rutgers University; Debbie Hart, BioNJ; Pavita Howe, BioNJ; Michael Johnson, New Jersey Institute of Technology; Robert Johnson, Rutgers New Jersey Medical School; Doug Langa, Novo Nordisk; William Lewis, Insmed; Steven Libutti, Rutgers Cancer Institute; Thibaut Mongon, Kenvue; Gary Small, Hackensack University Medical Center; Brian Strom, Rutgers Biomedical and Health Sciences; Debra Wentz, New Jersey Association of Mental Health and Addiction Agencies; and Tatsuyuki Yasuno, Eisai

Acadia Appoints Elizabeth H. Z. Thompson, Ph.D. as Executive Vice President, Head of Research and Development

Princeton-based BioNJ Member Acadia Pharmaceuticals Inc. announced the appointment of Dr. Elizabeth H. Z. Thompson as Executive Vice President, Head of Research and Development. Dr. Thompson will lead research and development at Acadia and serve as a member of the company’s Executive Leadership Team, reporting to Steve Davis, Chief Executive Officer of Acadia. Dr. Thompson most recently served as Executive Vice President, Research and Development (Rare Disease) at Amgen following its acquisition of Horizon Therapeutics plc. At Horizon, Dr. Thompson led the R&D organization and oversaw the rapid realization of the company’s goal to become a science-based biopharma. She joined Horizon in 2018 and served in roles of increasing responsibility that culminated at Executive Vice President, Research and Development. 

Tevogen Bio Appoints Former Citygroup and Morgan Stanley Exec as Head of Investor Relations and Corporate Development

Warren-based BioNJ Member Tevogen Bio Holdings Inc. announced it appointed Tapan Shah as Head of Investor Relations and Corporate Development. Mr. Shah, a Wall Street veteran with over 25 years of experience across key financial services industry verticals, brings broad leadership capabilities to the clinical biotech firm. In this new position, Mr. Shah will lead communications with all financial stakeholders, including shareholders, lenders, research analysts and investment bankers. He also will lead the mergers & acquisitions and capital raising functions at Tevogen Bio and be responsible for consolidating and analyzing inputs from key internal stakeholders to advise the executive leadership team on an appropriate course of action. Most recently, Mr. Shah was Director, Relationship Management, in Citigroup’s client organization, where he was also a member of the Executive Office.

Industry Veteran Joins Merck as New EVP, Chief HR Officer

Rahway-based BioNJ Member Merck appointed 20-year health care industry veteran Betty Larson as Executive Vice President and Chief Human Resources Officer. In her new position, Ms. Larson is responsible for global human resources and diversity, equity and inclusion for the company. She comes to Merck from GE HealthCare, where she served as Chief People Officer for the global medical technology, pharmaceutical diagnostics and digital solutions company. Before GE HealthCare, Ms. Larson held executive HR positions with Becton, Dickinson and Co. — which she joined through the acquisition of C.R. Bard Inc. — as well as with Baxter International.

NJAMHAA President/CEO and Members Receive New Jersey Social Innovation Awards

Debra L. Wentz, Ph.D., President and CEO of NJAMHAA, received the New Jersey Social Innovation Award for Legislative Impact, which recognizes “innovation through policy reform and improvements in financial models to improve service delivery and reduce barriers to care”, from the Social Innovations Journal. “I am filled with gratitude and humbled by this recognition. This is a team effort and I am so grateful for my staff — in particular, our advocacy team Shauna Moses, Mary Abrams and Rob DePlautt — our Partners in Advocacy, Board members, our members and the greater stakeholder community,” Dr. Wentz said.

Bayer Appoints Sue Ann Pentecost as Head of U.S. Pharmaceutical Communications

Sue Ann Pentecost has been named by Whippany-based Bayer as the new Vice President, Head of Pharmaceutical Communications in the U.S. Pentecost joined Bayer in 2022 as Head, External Communications, for U.S. Pharmaceuticals, responsible for above-brand efforts to support business priorities. Her role expanded to include U.S. Oncology communications, where she drove creative campaigns in the prostate cancer space. More recently, Ms. Pentecost has played an integral role on key corporate media relations initiatives to continue building Bayer’s reputation in the U.S. market. In her new role, Ms. Pentecost will be responsible for developing and executing fully integrated programs to advance the reputation of Bayer overall with an emphasis on the U.S. Pharmaceuticals business and brands.

Colliers Arranges Genmab’s 135K-Square-Foot Princeton Expansion

News that Genmab would expand its footprint in Princeton broke earlier this month, when it secured an award through the State’s Emerge tax incentive program. Genmab signed a 12-year lease that expands the international biotechnology company’s footprint by 135,000 square feet at 777 Scudders Mill Road. Altogether, Genmab will now occupy 270,000 square feet. Genmab’s U.S. headquarters already supports 660 employees. The larger footprint is expected to add another 300 jobs to the site. At the beginning of March, the New Jersey Economic Development Authority approved up to $8.4 million in tax credits through the Emerge Program to support Genmab’s expansion. The company will receive $1.2 million in tax credits each year for seven years.

Legend Biotech Announces Publication of Inaugural Environmental, Social and Governance (ESG) Report

Legend Biotech Corporation released its inaugural Environmental, Social & Governance (ESG) report. The inaugural report provides an overview of Legend Biotech’s ESG program and reporting in alignment with the Sustainable Accounting Standards Board (“SASB”) Biotechnology and Pharmaceutical sector standards, the company’s ESG data collection and disclosure roadmap, and future growth areas in its ESG journey.

Bayer's Expert Mondays 2024

Select Mondays in March – December 2024

Calling pre-seed and seed innovators and entrepreneurs in Oncology, Cell & Gene Therapy, Cardiovascular, Immunology, Radiology and Digital Health! Do you have disruptive science but struggle to bring it to life in the entrepreneurial world? Bayer's passion is to enable and support standout healthcare innovation! Take your innovation to new heights and join Bayer´s Expert Mondays 2024, a series of knowledge exchange sessions to supercharge your start-up’s growth. 

(CSIT) R&D Voucher Matching Event - Call for Projects

April 15 – The New Jersey Commission on Science, Innovation and Technology

The event will provide an opportunity for university, federal labs and non-profit core facility Partners to connect with New Jersey companies to discuss research projects that require the use of specialized core facility equipment. New Jersey companies with approved projects will have an opportunity to leverage the CSIT R&D Voucher Grant Program for up to $40,000 to support the cost of utilizing specialized equipment. For assistance understanding the Clean Tech and Catalyst R&D Voucher Grant Program requirements, please visit our website at www.njeda.gov/csit in the Grant Opportunities section. 

Annual Healthcare Symposium

April 18 – Rutgers Business School

The Inflation Reduction Act (IRA) of 2022 brought a tremendous change in the Medicare Part D Prescription Drug benefit operation and coverage. Academia and the industry has been analyzing the impact of the IRA on biopharma R&D, access to drugs by the elderly population in the USA, drugs approvals and employment. This will have a spillover effect on the prescription drugs in the private market. The symposium will bring together industry experts, academia and patient advocacy groups to discuss this important topic — giving our students and faculty the opportunity to interact with the experts in the form of a Q&A session. The free symposium is open to all students, faculty and industry executives.

2024 Tiger Entrepreneurs Conference

April 18 & 19 – Princeton Entrepreneurship Council

Join the Princeton Entrepreneurship Council at our upcoming 2024 Tiger Entrepreneurs Conference on April 18 and 19 on campus at Princeton University. Engage with brilliant innovators and entrepreneurs from the Princeton community, including faculty and alumni, founders and investors, on topics including artificial intelligence, biotechnology, quantum engineering, arts & humanities, climate tech and blockchain. The conference includes an alumni start-up showcase and numerous networking opportunities. Early bird pricing is available now! 

69th NJ Academy of Science Annual Meeting

April 20 – New Jersey Academy of Science

The NJAS Executive Board cordially invites you to join us in celebrating and fortifying the ongoing projects and collaborations among science, policy and communication. Our aim is to bolster the infusion of scientific and technical expertise into public discourse and collaborations. During this event, we will emphasize the significance of innovation, resilience and addressing health disparities challenges, while also marveling at the collective potential within our community to shape a brighter future for New Jersey. Planned activities include keynote addresses, scientific sessions featuring both junior and senior academy members, workshop sessions and a STEM showcase.

Panel Discussion: Tricks of the Trade — Partnering With Pharma Companies

April 30 – Princeton Innovation Center BioLabs

Panelists with expertise in pharma, biotech, diagnostics, venture and technical and laboratory services, will offer large and small company perspectives on working with value-added partners as well as buy-side and sell-side partnering approaches and business models. This is a great opportunity to interact with experts who have hands-on experience putting together collaborations and creating agreements to advance products and technologies, and secure capital. This program is co-sponsored by Princeton Innovation Center BioLabs, the NJEDA’s New Jersey Bioscience Center and BioNJ.