From Legislation to Innovation: Joe Allen and the Birth of the Bayh-Dole Act

In the 1970s, Joe Allen was a congressional staffer when an issue walked into his office that would shape his career for decades. As a staffer in Senator Birch Bayh’s office, he played a pivotal role in developing the Bayh-Dole Act, also known as the Patent and Trademark Law Amendments Act. Passed in 1980, this law enables businesses, universities and nonprofits to own inventions created through federally funded research. Now, 44 years later, Joe continues to defend the Bayh-Dole Act as the executive director of the Bayh-Dole Coalition. In this episode of The Transfer Files, Joe gives a firsthand account of how the legislation made it through Congress, the opposition it has faced and the impact this policy has on technology transfer and the U.S. economy.

#SaveBayhDole: The White House "March-In" Framework Explained

Visit http://SaveBayhDole.org to contact your congressional representatives and urge them to oppose the White House's proposed March-In framework.

Legislation Introduced to Increase New Jerseyans’ Access to Biomarker Testing, the Key to Precision Medicine

Legislation that seeks to improve New Jerseyans’ access to biomarker testing was introduced in the Legislature. Biomarker testing helps connect cancer patients to the right treatment at the right time, often resulting in improved outcomes and quality of life. In some cases, biomarker testing may provide information that enables patients to forgo ineffective treatments and eliminate the potentially harmful, life-altering side effects of those treatments, which could also result in reduced health care costs. S3098/A4163 is a priority bill for the American Cancer Society Cancer Action Network (ACS CAN), which, last month as a part of their annual Cancer Action Week, dispatched its volunteers to connect with their lawmakers on the potential of this legislation.

The EU General Pharmaceutical Legislation & Clawbacks: Calculated Impacts – Both Designed and Unintended

The European Commission has proposed that the revised General Pharmaceutical Legislation will replace the current base of 10-years of regulatory data protection with a base of 8-years. The General Pharmaceutical Legislation then provides for a series of carrots and sticks to gain back those lost years of regulatory data protection. As well, under some scenarios, innovators may have the ability to extend regulatory data protections to 12 years. The challenge for investors and drug developers regarding the potential risks created by two years of lost regulatory data protection is that there is never a 100% certainty that patent protection alone will satisfy the length of time to develop a drug. Shortening RDP will increase risks on the investments required to bring a drug to market, and further exacerbate the competitive disequilibria currently seen between the U.S. and EU biopharmaceutical innovative sectors.

IRA is Already Negatively Impacting Access to Medicines in Part D

Medicare Part D provides prescription drug coverage for our nation’s seniors and Americans with disabilities. As a result of Part D, nearly 90% of Medicare beneficiaries have comprehensive drug coverage, amounting to more than 50 million beneficiaries in 2023, and year after year, seniors have reiterated their satisfaction with the program. Unfortunately, price setting measures like in the Inflation Reduction Act (IRA), coupled with structural changes to the program, have put much of what has worked for patients in Part D at risk.

Indications are Going to be Deeply Affected by the IRA

Douglas Holtz-Eakin was formerly a professor of economics at Syracuse University and served as the director of the Congressional Budget Office from 2003 – 2005. He is currently President of the American Action Forum, a highly respected think tank in Washington, DC.While heading the CBO, Douglas played a pivotal role in designing and implementing the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, aka the Medicare Part D prescription drug benefit. Given his experience, in this podcast, we reflect upon how that legislation led to the rapid expansion of the U.S. innovative biopharma sector and the material risks posed by the Inflation Reduction Act.

BioNJ Unveils BioPartnering Conference Lineup

BioNJ is out with new details regarding the upcoming 14th Annual BioPartnering Conference. On May 14, for the first time, the event will take place at Liberty Science Center in Jersey City. The annual BioPartnering Conference is sponsored by J.P. Morgan, Johnson & Johnson and Morgan Lewis. Jersey City Economic Development Corp. is hosting. The event brings together life science executives, investors, strategists, academic collaborators and business development professionals. It offers one-on-one partnering, “Industry Connections,” exhibits, company pitch presentations, plenary sessions and lots of networking — including a closing reception.

Op-Ed: We Need a Deeper Conversation About Drug Prices

We should pursue proven policies that work, not ones that won’t make a difference for patients and risk serious harm to jobs and the economy. Any debate over prescription drug prices should begin with pointing out the facts that address several misconceptions. Among these facts are the great cost and long timelines required to develop innovative new medicines, how drug middlemen — known as pharmacy benefit managers (PBMs) — keep both drug prices and patient out-of-pocket costs artificially high, while according to the Drug Channels Institute net prices received by biopharmaceutical companies decline year after year, and a recent study by the Berkeley Research Group found that less than half the money spent on prescription drugs actually goes to the companies that discover, develop and manufacture them.

Forbes Names 19 NJ Firms to Best Employers for Diversity List

Forbes is highlighting 500 companies from around the nation that are prioritizing diversity, equity and inclusion initiatives, with 19 from New Jersey making the publication’s 2024 list. Forbes’ seventh annual America’s Best Employers for Diversity ranking was created in partnership with market research firm Statista. Among those honored in New Jersey were BioNJ Members Johnson & Johnson, New Brunswick (#24); Merck & Co., Rahway (#70); Sanofi, Bridgewater (#143); Inspira Health Network, Mullica Hill (#206); Novo Nordisk, Plainsboro (#329) and Novartis, East Hanover (#332).

Acadia Pharmaceuticals Announces Trofinetide New Drug Submission for Treatment of Rett Syndrome Has Been Accepted for Filing and Priority Review by Health Canada

BioNJ Member Acadia Pharmaceuticals Inc., with a site in Princeton, announced that Health Canada has accepted its New Drug Submission (NDS) for trofinetide for the treatment of Rett syndrome, a rare neurodevelopmental disorder. Health Canada has granted Priority Review for Acadia’s submission. The Health Canada filing is supported by results from the positive pivotal Phase 3 LAVENDER™ study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young women with Rett syndrome. The co-primary endpoints were changed from baseline in the Rett Syndrome Behaviour Questionnaire (RSBQ) total score, a caregiver assessment, and Clinical Global Impression–Improvement (CGI-I) scale score, clinician perspective, at week 12; both were statistically significant. The key secondary endpoint measuring improvements in communication was also statistically significant.

Soligenix Extends Patent Protection for its Filovirus Vaccine Platform to the United Kingdom and South Africa

Princeton-based BioNJ Member Soligenix announced that it has received notice of intent to grant additional patents based on its patent application titled "Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines" in the United Kingdom and South Africa, with other international jurisdictions pending. The company has previously announced multiple issued patents within the same patent family in the United States. The allowed claims are directed to unique, proprietary compositions and methods related to combinations of glycoprotein antigens with nanoemulsion adjuvants comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully applied to mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg marburgvirus, including monovalent vaccines SuVax™ (targeting Sudan ebolavirus) and MarVax™ (targeting Marburg marburgvirus).

Rilzabrutinib LUNA 3 Phase 3 Study Met Primary Endpoint in Immune Thrombocytopenia

Bridgewater-based BioNJ Member Sanofi announced positive results from the LUNA 3 Phase 3 study demonstrated that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia (ITP). The safety profile of rilzabrutinib was consistent with that reported in previous studies. LUNA 3 study met its primary endpoint demonstrating a significantly higher proportion of patients receiving rilzabrutinib achieved the primary endpoint of durable platelet response versus placebo. This clinically and statistically significant result was achieved in a population of patients with primary ITP that had been refractory to prior therapy. Overall, study participants had a median of four prior ITP therapies and a median baseline platelet count of 15,000/μL (normal platelet count levels typically range from 150,000-450,000/μL). 

U.S. FDA Accepts for Priority Review GSK’s Application for an Expanded Indication of Jemperli (dostarlimab) Plus Chemotherapy to Include all Adult Patients With Primary Advanced or Recurrent Endometrial Cancer

Warren-based BioNJ Member GSK announced the US Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer. This would include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumours. Currently, Jemperli is FDA-approved in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 August 2024.

Novartis Radioligand Therapy Lutathera® FDA Approved as First Medicine Specifically for Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors

East Hanover-based BioNJ Member Novartis announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs."Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer," said Tina Deignan, Therapeutic Area Head, Oncology U.S. "Radioligand therapies have extraordinary potential to shape the future of cancer care. With this approval, we have taken another vital step toward fulfilling that vision, strengthening our commitment to researching and developing the RLT platform across multiple cancer types and treatment settings." 

CARVYKTI® (ciltacabtagene autoleucel) Approved by the European Commission for Second-line Treatment of Patients With Relapsed and Refractory Multiple Myeloma

Piscataway-based BioNJ Member Legend Biotech Corporation announced that the European Commission (EC) has granted approval of CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), have demonstrated disease progression on the last therapy and are refractory to lenalidomide. The European approval is based on positive results from the CARTITUDE-4 study, which demonstrated that CARVYKTI® resulted in statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens, pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd), in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

U.S. FDA Approves Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults With Hemophilia B

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. BEQVEZ is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month.

FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer

BioNJ Member Pfizer, with a site in Peapack, and Princeton-Based BioNJ Member Genmab announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. "Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer. “Today’s full approval by the FDA reinforces the important role of TIVDAK for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.” 

European Commission Approves Pfizer’s EMBLAVEO® for Patients With Multidrug-Resistant Infections and Limited Treatment Options

BioNJ Member Pfizer, with a site in Peapack, announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. It is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. “For healthcare teams treating patients with serious Gram-negative bacterial infections, the prospect of running out of effective treatment options is a daunting but very real threat,” said Yehuda Carmeli, Head, National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center, Israel, and an investigator in the REVISIT study. 

Sandoz Confirms European Commission Approval of Pyzchiva® (ustekinumab), Further Strengthening Immunology Offering

Princeton-based BioNJ Member Sandoz announced that the European Commission (EC) has granted marketing authorization for Pyzchiva®* (biosimilar ustekinumab), developed and registered by Samsung Bioepis. Pyzchiva® is a key biosimilar value driver for the company over the mid-term and this approval is a major step in advancing Sandoz growth strategy. Pyzchiva® is approved as a biologic therapy within gastroenterology, dermatology, and rheumatology. Rebecca Guntern, President Sandoz Europe, said, "Chronic inflammatory diseases affect millions of people around the world and can have a profoundly negative impact on their quality of life. This approval is a crucial step towards offering European patients an additional safe and effective treatment option and further demonstrates our commitment to pioneer access to potentially life-changing medicines."

CHMP Adopts Positive Opinion Recommending Approval of Bristol Myers Squibb’s Opdivo® (nivolumab) in Combination With Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients With Unresectable or Metastatic Urothelial Carcinoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC decision is expected in June 2024. CheckMate -901 is the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit compared to standard-of-care chemotherapy alone in the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

Bristol Myers Squibb and Cellares Announce a $380M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster

Princeton-based BioNJ Member Bristol Myers Squibb and Bridgewater-based BioNJ Member Cellares announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M in upfront and milestone payments. As part of the agreement, Cellares will optimize, automate, and tech-transfer select Bristol Myers Squibb CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle™. Cellares will dedicate multiple Cell Shuttle and Cell Q™ systems with fully automated, high-throughput quality control for Bristol Myers Squibb’s exclusive use. The Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories in the U.S., EU and Japan. 

Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

Rahway-based BioNJ Member Merck & Co. announced results from STRIDE-10, a Phase 3 trial evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine. The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine. “Invasive pneumococcal disease and pneumococcal pneumonia represent significant public health challenges, particularly among older adult populations and those with risk conditions,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee. “These positive results show that V116 has the potential to help prevent invasive pneumococcal disease among adult populations.”

Merck Announces Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of Overall Survival (OS) as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Rahway-based BioNJ Member Merck & Co. announced that the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy met its dual primary endpoint of overall survival (OS) for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Based on results from KEYNOTE-811, KEYTRUDA is approved in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. 

Johnson & Johnson Receives Positive CHMP Opinion for RYBREVANT®▼ (amivantamab) in Combination With Chemotherapy for the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer With Activating EGFR Exon 20 Insertion Mutations

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of RYBREVANT®▼ (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations. “The PAPILLON study results represent an important advancement in the EGFR exon 20 insertion NSCLC treatment landscape, demonstrating significantly improved progression-free survival with first-line amivantamab plus chemotherapy, versus chemotherapy alone,” said trial investigator Professor Nicolas Girard, Head of Medical Oncology, Institut Curie, and Professor of Thoracic Oncology and Respiratory Medicine at the Paris Saclay University, France.

Johnson & Johnson Receives Positive CHMP Opinion Recommending Full Approval for SIRTURO® (bedaquiline) for Treatment of Multidrug-Resistant Tuberculosis

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for SIRTURO® (bedaquiline) and the conversion of the medicine’s Conditional Marketing Authorisation into a standard Marketing Authorisation. SIRTURO® is currently indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR TB) in adult and pediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. The approved indication may vary per country. 

Johnson & Johnson Submits Regulatory Applications to European Medicines Agency for TREMFYA® (guselkumab) for Treatment of Patients With Ulcerative Colitis and Crohn’s Disease

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced it has submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease. The submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI program in Crohn’s disease. In the Phase 3 QUASAR induction and maintenance studies, guselkumab achieved each primary endpoint and showed statistically significant and clinically meaningful improvements relative to placebo in symptoms, measures of disease activity including stringent endpoints such as endoscopic normalization and histo-endoscopic mucosal healing, and patient-reported outcomes such as fatigue. 

CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) is the First BCMA-Targeted Treatment Approved by the European Commission for Patients With Relapsed and Refractory Multiple Myeloma who have Received at Least one Prior Line of Therapy

New Brunswick-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has approved a Type II variation for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel). This latest approval is for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least one prior therapy, including an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI), have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. Cilta-cel is an innovative chimeric antigen receptor T-cell (CAR-T) therapy directed against B-cell maturation antigen (BCMA), a protein that is highly expressed on myeloma cells. With this approval, cilta-cel becomes the first BCMA CAR-T therapy approved in Europe for the treatment of eligible patients as early as first relapse.

New Data Show RINVOQ® (upadacitinib) Demonstrated Superiority Versus DUPIXENT® (dupilumab) Across Primary and All Secondary Endpoints in an Open-Label Head-to-Head Atopic Dermatitis Study

BioNJ Member AbbVie, with a site in Madison, announced positive topline results from LEVEL UP, an open-label, efficacy assessor-blinded head-to-head Phase 3b/4 study that evaluated the efficacy and safety of upadacitinib (RINVOQ®, 15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (DUPIXENT®, per its labeled dose) in adults and adolescents (≥12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable. In the LEVEL UP study, upadacitinib showed superior efficacy versus dupilumab in the primary endpoint, demonstrating that a significantly higher proportion of patients simultaneously achieved both a 90% or greater reduction in Eczema Area and Severity Index (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 [(19.9% vs 8.9% for upadacitinib and dupilumab respectively, p<0.0001)].

FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV

BioNJ Member Gilead Sciences, with a site in Morris Plains, announced the U.S. Food and Drug Administration (FDA) approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat pregnant people with HIV-1 (PWH) with suppressed viral loads. These additional data stem from Study 5310, which evaluated the pharmacokinetics, safety and efficacy of Biktarvy in pregnant PWH who have suppressed viral loads and no known resistance to any components of Biktarvy in their second and third trimesters and through a median of 16 weeks postpartum. This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.

Research on Treatments for Alzheimer’s Disease Based on its Pathological Mechanisms Receives Award for Science and Technology (Research Cstegory), as a Part of FY2024 Commendation for Science and Technology by MEXT

Nutley-based BioNJ Member Eisai announced that “The Research on Treatments for Alzheimer’s Disease Based on its Pathological Mechanisms” has received the Award for Science and Technology (Research Category) as a part of the FY2024 Commendation for Science and Technology by the Minister of Education, Culture, Sports, Science and Technology. The Ministry of Education, Culture, Sports, Science and Technology (MEXT) grants this award to individuals who have made remarkable achievements regarding research, development, and knowledge enhancement in the field of science and technology, with the aim of encouraging those who engage in the field and raising the standard of Japanese science and technology. This award is presented to individuals who have completed original research and development projects with high potential to contribute to the advancement of science and technology in Japan.

Evotec and Bayer Collaborate to Advance Precision Cardiology

Princeton-based BioNJ Member Evotec and Whippany-based Bayer announced that they have updated the focus of their strategic collaboration to developing innovative precision treatments for cardiovascular diseases (CVDs). The collaboration aims to identify and validate novel targets, with the goal of building a portfolio of precision cardiology therapeutics by leveraging Evotec's disease modelling capabilities using human induced pluripotent stem cells (iPSCs). iPSCs provide unique opportunities to identify new disease mechanisms and pathways for novel treatments. Under the terms of the agreement, both companies will contribute drug targets and a comprehensive set of high-quality technology platforms for the development of innovative treatment options.

U.S. FDA Approves High-Concentration, Citrate-Free Formulation of Cyltezo® (adalimumab-adbm) Injection, Boehringer Ingelheim’s Interchangeable Biosimilar to Humira®

BioNJ Member Boehringer Ingelheim, with a site in North Brunswick, announced that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm), the company’s interchangeable* biosimilar to Humira® (adalimumab), to treat multiple chronic inflammatory diseases. The high-concentration formulation (100 mg/mL), which is now available as a pre-filled syringe or pre-filled autoinjector, is priced at a 5% discount to Humira under the brand name Cyltezo® and at an 81% discount to Humira as the unbranded product Adalimumab-adbm. The low-concentration (50 mg/mL), citrate-free formulation of Cyltezo has been commercially available since July 2023. “This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” said Steven Taylor, President & CEO of the Arthritis Foundation.

Calliditas Announces Positive NefIgArd Open Label Extension Results

Hoboken-based Calliditas Therapeutics announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including those who had previously received Nefecon in the NefIgArd study. NefIgArd was a global, Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of Nefecon 16 mg once daily vs placebo in adult patients with primary IgAN as an addition to optimized RASi therapy. Patients were randomized 1:1 to receive 16 mg/day of Nefecon or matching placebo for 9 months, followed by a 15-month observational follow-up period without the study drug.

Palisades Therapeutics Announces Possible Breakthrough Treatment for Parkinson's Disease

Cliffside Park-based Pop Test Oncology/Palisades Therapeutics' collaborators at Colorado State University led by Ronald Tjalkens, Ph.D. and Richard Slayden, Ph.D., share a pre-print of the latest study results on BioRxIV. Results indicate that treatment with the clinical stage GR-antagonist PT150 reduced both loss of DAn and microgliosis in the nigrostriatal pathway in one of the most important animal models for the human disease. Although morphologic features of astrogliosis were not attenuated, PT150 treatment promoted potentially neuroprotective activity in these cells, including increased phagocytosis of hyperphosphorylated α-syn. Ultimately, PT150 treatment reduced the loss of DAn cell bodies in the SN, but not the striatum, and prohibited intra-neuronal accumulation of α-syn. Together, these data indicate that PT150 effectively reduced SN pathology in the rotenone mouse model of PD.

Zoetis to Sell Medicated Feed Additive Portfolio to Phibro Animal Health

Parsippany-based Zoetis Inc. and Teaneck-based Phibro Animal Health Corporation announced that they have entered into a definitive agreement where Phibro Animal Health will acquire Zoetis’ medicated feed additive (MFA) product portfolio, certain water soluble products and related assets for $350 million, subject to customary closing adjustments. This transaction is expected to be complete in the second half of calendar year 2024. Both Zoetis and Phibro Animal Health have a longstanding commitment to the production animal health sector. The acquired product portfolio, which generated approximately $400 million in revenue in 2023, is comprised of more than 37 product lines that are sold in approximately 80 countries. Also included in the agreement are six manufacturing sites, four in the U.S., one in Italy and one in China. 

Kenvue Breaks Ground in Summit: Big Win for Science — and Huge Hold for New Jersey

As much as it was billed as a ground-breaking for the new global headquarters of the new company — and there was plenty of construction equipment and a shovel ceremony to attest to that — Kenvue’s big event in Summit was more about the State holding onto its past in a way that bodes well for its future. Kenvue, the multibillion-dollar consumer health care spinoff of BioNJ Member Johnson & Johnson, said it proudly retains its 135-year history in the State. CEO Thibaut Mongon said New Jersey’s life sciences attributes were so strong that going elsewhere didn’t make sense.

BAP Pharma U.S. Opens State-of-the-Art Headquarters in Somerset

First setting up U.S. operations in Landing, New Jersey in 2016, BAP Pharma experienced extraordinary success and growth fueled by new customer acquisition, diversification, and expansion into new markets. This resulted in the formation of two new divisions to complement the original Comparator Sourcing business – Clinical Secondary Packaging and Labelling and Medicines Access – and necessitated the move to a much larger facility with a broader range of capabilities. BAB Pharma’s new US headquarters are in a modern, state-of-the-art 28,000 sq. ft. facility in Somerset, NJ. Fully licensed by the New Jersey State Department of Health, some of the capabilities include a 24-hour temperature-controlled and monitored warehouse with ambient (+15°C to +25°C), cold (+2°C to +8°C), and freezer (-20°C) storage facilities. 

NJEDA Innovation Office Hours

The Innovation Programs Department now offers Office Hours where companies and professionals can come together to learn more about the various NJEDA programs developed to support the technology and biotechnology start-up ecosystem. At each Office Hours event, there will be a brief presentation and time for networking. Additionally, the NJEDA will offer one-on-one meetings after the presentations to facilitate private discussion on specific program questions related directly to your business situation.

NJ Small Business Manual

NJ small businesses can now receive a small business manual to get information and guidance on establishing, maintaining and expanding a small business. The manual is available through the New Jersey Business Action Center, which is housed in the Department of State. Many thanks to the New Jersey Office of Innovation, which provides the website, www.business.nj.gov, where this information can also be found.  

NJEDA to Open Applications for 2024 NOL Program

The New Jersey Economic Development Authority (NJEDA) has opened applications for the 2024 Technology Business Tax Certificate Transfer Program, commonly known as the Net Operating Loss (NOL) program. The NOL program allows early stage technology and life sciences companies in New Jersey to sell a percentage of their net operating losses and unused research and development (R&D) tax credits to unrelated profitable corporations for cash. 

NJEDA Awards First $2M Under Angel Match Program to Support Early Stage Technology Companies

The New Jersey Economic Development Authority (NJEDA) has closed its first four approvals under the Angel Match Program, awarding a total of $2 million to support early stage technology companies. With a funding pool of $20 million from the federal State Small Business Credit Initiative (SSBCI), the Angel Match Program was launched last year and continues to gain traction in the market. Under the Angel Match Program, the NJEDA is the first entity to commit capital to a technology company, leading to other investors who provide matching funds.

Cellares Unveils First-of-its-kind Cell Therapy Manufacturing Tool

Earlier this year, NJBIZ was on hand as Cellares cut the ribbon on its new Smart Factory in Bridgewater. The site is the world’s first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing. When fully operational, it will be capable of producing more than 40,000 cell therapy batches a year utilizing the Cell Shuttles, a state-of-the-art modular platform for industrial scale cell therapy manufacturing.

Ipsen and Skyhawk Therapeutics Announce RNA Targeting Research Collaboration in Rare Neurological Diseases

Ipsen, with a site in Basking Ridge, and Skyhawk Therapeutics announced the signing of an exclusive worldwide collaboration to discover and develop novel small molecules that modulate RNA for rare neurological diseases. The agreement includes an option pursuant to which Ipsen would acquire an exclusive license for the worldwide rights to develop successful development candidates (DC). Following successful DC nomination, Ipsen will be responsible for all activities. Skyhawk’s unique platform accelerates building RNA-targeting small molecules across several therapeutic areas, including rare neurological diseases. “Our focus and expertise in movement disorders, and across our portfolio, is bringing best and first-in-class treatments to those with the highest unmet needs, now further fueled by this novel platform at the cutting-edge of research,” said Steve Glyman, Sr. Vice President and Head of Neuroscience, Research & Development at Ipsen.

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Where the Ocean Meets the Shore: Navigating Alzheimer’s Together

Navigating the complexities of Alzheimer’s disease and explaining those complexities to children can be a daunting task for caregivers. As the number of individuals diagnosed with this condition rises, the need for effective communication becomes even more important. This short film aims to be a valuable resource for caregivers, offering a unique approach to addressing Alzheimer’s with children. At Otsuka, we are committed to uplifting caregivers through awareness and support. Discover more resources and support on our website: https://www.otsuka-us.com/valued-mind.  

Governor Murphy Cuts the Ribbon at HAX Flagship U.S. HQ in Newark

Governor Phil Murphy, Newark Mayor Ras Baraka and the New Jersey Economic Development Authority (NJEDA) joined company leaders to cut the ribbon on HAX, LLC’s newly constructed United States flagship headquarters located at 707 Broad Street in Newark. HAX, a start-up development program for pre-seed hard tech companies, with offices across the world, supports startups and entrepreneurs through investment capital, mentorship and collaboration. HAX provides support for emerging companies, including a $250,000 initial investment in each participating company, 180 days of hands-on collaboration and a global community for early stage founders building hard tech start-ups.

Kean Awarded $800K NSF Grant to Study Ways to Increase Attraction/Retention of Diversity Students in STEM Fields

Kean University announced it was awarded an $800,000 grant for research from the NSF to study the impact of the use of instruction through more inclusive software design. According to professor Patricia Morreale, the principal investigator on the grant who is also chair of the Department of Computer Science and Technology at Kean, students will learn to design software accessible to more people. As part of their classroom work, students will design software for target users from one of several “personas,” each with a mix of different facets, including learning styles, access to reliable technology, risk tolerance and computer ability. The goals of the NSF-funded research are both to improve equity and inclusivity in computer science and information technology education and retain diverse students once they are enrolled.

EY Names 26 Finalists for 2024 NJ Entrepreneur of the Year Award

Founded in 1986 by the global tax and advisory services firm, the recognition is considered one of the preeminent competitive business awards for entrepreneurs and leaders of high-growth companies. It has celebrated more than 11,000 professionals who lead successful, dynamic businesses in the U.S. and nearly 60 countries around the world. Twenty-six business leaders from New Jersey are regional finalists for Ernst & Young’s Entrepreneur of the Year award. Among those honored are BioNJ Members Leonard Mazur, Chairman and CEO, Citius Pharma; Nina Tandon, Co-founder and CEO, EpiBone Inc.; and Dr. Emer Leahy, President and CEO, PsychoGenics Inc.

Evotec SE Appoints Dr. Christian Wojczewski as Chief Executive Officer

The Supervisory Board of Princeton-based BioNJ Member Evotec has appointed Dr. Christian Wojczewski as the company’s new Chief Executive Officer, effective 01 July 2024. The election was unanimous and is the result of an extensive selection process that began in January. Dr. Mario Polywka, who has led Evotec as Interim CEO since 03 January 2024, will retire from his position at the end of June and will also not seek re-election for his dormant Supervisory Board mandate, which expires with the 2024 Annual General Meeting. Dr. Christian Wojczewski holds a degree in chemistry and has over 20 years of experience in various management positions, most recently as CEO of Mediq and at Linde Healthcare. With his appointment, Evotec gains an experienced CEO from the healthcare industry with extraordinary success in the transformation of companies.

Jim Bartel Named CEO of Vantage MedTech

Moonachie-based Vantage MedTech announced it appointed Jim Bartel as CEO. Mr. Bartel brings over 25 years of leadership experience within medical device and contract manufacturing organizations, including roles leading marketing, business development and sales teams. With a passion for services and manufacturing, Mr. Bartel has a deep understanding of product development and building high-performing teams that share common values to accelerate growth. Mr. Bartel most recently served as CEO and a board member of Waltek Inc., and President of Spectralytics Inc., a medical device contract manufacturing organization, in addition to being Chief Operating Officer and board member of Precision ADM, a 3D metal contract manufacturing company.

BeiGene Demonstrates Global Progress in 2023 Responsible Business & Sustainability Report

BeiGene released its 2023 Responsible Business & Sustainability Report highlighting the company’s strategy, the progress it has made towards existing goals and how it intends to achieve its bold new targets. This report comes at a time of tremendous growth for BeiGene. In 2023, the company achieved the milestone of more than 1 million patients who were treated worldwide with BTK inhibitor BRUKINSA® and anti-PD-1 antibody TEVIMBRA®.

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. 

Propelus I-Corps Regional Program

May 31 & June 14 – Princeton University

The NSF I-Corps Hub Northeast Hub is accepting applications for a two-day, in-person educational program for tech-based entrepreneurs. The two-day intensive educational program, to be held May 31 and June 14 at Princeton University, is aimed at helping entrepreneurs gain a better understanding of the startup process. It is intended to help researchers develop early stage innovations into real-world products and services through training, funding, resources and follow-on opportunities.

Deal Making and Structuring Early Stage Technology and Life Sciences Deals

June 12 – LES NY/NJ Chapter

A panel discussion on the challenges and opportunities associated with technology transfer and licensing from universities to corporates and between emerging companies and more established companies. This program is for University tech transfer professionals, early stage Life science and technology companies, late-stage companies that recently acquired or in licensed IP originated at early stage companies.