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IRA’s Impact on the U.S. Biopharma

Vital Transformation (VT) modeled and estimated the impacts of the Inflation Reduction Act’s (IRA) pricing provisions for a cohort of the top 200 Part B and D drugs by CMS spend, resulting in 92 drugs impacted by IRA in the next 10 years, which are produced, collectively, by 41 biopharmaceutical companies. Had the IRA been in place beginning in 2014, VT estimates the reductions in revenue on the impacted drugs to be up to 40%. Because of this, between 24 and 49 therapies currently available today would most likely not have come to market and therefore not available for patients and their providers.

Unscathed Middlemen Getting Away With Theft at the Pharmacy

An Op-Ed by BioNJ President & CEO, Debbie Hart

In the face of finger-pointing by elected officials in Washington, middlemen in our healthcare system continue to disrupt patient access. A case in point is the pharmacy benefit managers (PBMs) that manipulate health plan policies and systems meant to help patients with debilitating diseases afford their medications. As Washington seeks solutions to curb the high costs patients face at the pharmacy, some are passing blame to pharmaceutical manufacturers while failing to acknowledge the role of these middlemen within our healthcare system. The Senate HELP Committee, Senate Finance Committee and others are looking in the right direction by investigating PBMs because, without oversight, PBMs’ use of deceptive practices will only cause patients more health and financial harm.

Why N.J. Figures to Be a Main Attraction at BIO 2023

Entities from New Jersey have long had a major presence at the annual Bio International Convention. This year’s version taking place in Boston is no exception. But, this year is a bit different. While New Jersey has long been acknowledged as a national and global leader in life sciences, there is a feeling that New Jersey is hot again in the sector. And for good reason. Class A, state-of-the-art lab space is surging, thanks to the announcement of HELIX in New Brunswick and various other properties. Then there was the news that Kenvue, Johnson & Johnson’s multibillion-dollar spinoff, will make its headquarters at an Onyx Equities site in Summit — and that Onyx Equities had acquired and plans to upgrade the 108-acre Merck site in Kenilworth. Altogether, there is a 27% increase in lab space in the pipeline. And, as always, a workforce that includes the highest number of scientists and engineers, per square mile, in the country.

There is No Innovation in a Vacuum

Trade associations and public-sector agencies are the perfect partners for New Jersey’s high-tech entrepreneurs.

Innovation thrives in teamwork, whether it’s a group of researchers from the halls of academia or high-tech entrepreneurs working in a shared incubator space. It can even be a collaboration between both of these groups. On another level, teamwork in the innovative realm also comes from trade association and public-sector agency assistance. This help exists in many forms: access to grants, tax incentives and various other economic development programs; access to government leaders; workforce development initiatives; entrepreneurial start-up advice, and so much more. BioNJ is featured as one of the State’s top advocates for innovation —proving that New Jersey entrepreneurs are not alone in their pursuit of scientific greatness.

Celldex Announces First Patient Dosed in Phase 1 Study of CDX-585 in Patients With Advanced Malignancies

Hampton-based BioNJ Member Celldex Therapeutics, Inc. announced that the first patient has been dosed in a Phase 1 study of CDX-585. CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. Celldex plans to develop CDX-585 for the treatment of solid tumors either as monotherapy or in combination with other oncologic treatments. CDX-585 is the first compound from Celldex’s research and collaboration agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with Biosion’s PD-1 mAb. "Targeting both myeloid and T cell checkpoints with a bispecific is a novel approach that we believe could provide benefit for patients that are either refractory to or not likely to benefit from PD-1 blockade alone,” said Diane C. Young, M.D., Senior Vice President and Chief Medical Officer of Celldex Therapeutics.

Evotec Receives Grant from Open Philanthropy for Discovery of RNA-Targeting Henipavirus Therapeutics

Princeton-based BioNJ Member Evotec announced that the company has received a $ 1.7 m grant from Open Philanthropy, a philanthropic funder prioritizing global health and wellbeing. Under the grant, Evotec aims to discover and develop RNA-targeting small molecules as potential first-in-class therapeutics against Henipaviruses. Henipavirus is a genus of zoonotic viruses that can cause fatal encephalitis in humans. The genus comprises six different established species including Hendra virus and Nipah virus, from which it receives its name. The World Health Organization lists henipaviral agents as R&D Blueprint Priority Pathogens, indicating their pandemic potential. Currently there are no approved drugs or vaccines for neither Hendra nor Nipah virus infections available underlining an urgent need for accelerated research and development.

BRUKINSA® Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia

BioNJ Member BeiGene, with a site in Hopewell, announced that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL). “BRUKINSA now has four approved indications in Canada, demonstrating our commitment to bring this innovative BTKi treatment option to more patients across the world,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “Our bold development program for BRUKINSA in CLL provided evidence for superior efficacy in the first line and relapsed/refractory treatment settings, positioning BRUKINSA to become the BTKi of choice.” Typically diagnosed among individuals in their early 70s, CLL is a slow-growing, incurable blood cancer and is the most common leukemia in adults.

Sandoz Marketing Authorization Applications for Proposed Biosimilar Denosumab Accepted by EMA

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review. The two applications include all indications covered by the reference medicines Prolia® (denosumab) and Xgeva® (denosumab), respectively, for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone. “Sandoz is one of the first to have its applications for a proposed biosimilar denosumab accepted by the EMA. If approved, this has the potential to provide people living with osteoporosis and cancer of the bone or bone metastasis access to a cost-effective and high-quality treatment option,” said Florian Bieber, Development Platform Head Biopharmaceuticals and Chief Medical Officer, Sandoz. 

Novartis Kisqali® Significantly Reduced the Risk of Recurrence by 25% Across a Broad Population of Patients With Early Breast Cancer; Clinically Meaningful Benefit was Consistent Across Subgroups

East Hanover-based BioNJ Member Novartis announced positive primary endpoint data from the pivotal Phase III NATALEE trial. Data showed that Kisqali® (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (HR=0.748; 95% CI: 0.618, 0.906; p=0.0014) along with a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups. Kisqali data across all secondary efficacy endpoints was also consistent, including distant disease-free survival (DDFS) (26% risk reduction) and recurrence-free survival (RFS) (28% risk reduction), with a trend for improvement in overall survival (OS) (HR=0.759; 95% CI: 0.539, 1.068).

Positive Phase 2 Data of Novel Investigational Anti-CD40L Antibody Frexalimab Show Significantly Reduced Disease Activity in Relapsing Multiple Sclerosis

Bridgewater-based BioNJ Member Sanofi announced new data that demonstrates that frexalimab, Sanofi’s novel second-generation investigational anti-CD40L antibody, with a unique mechanism of action, significantly reduced disease activity in a Phase 2 trial of patients with relapsing multiple sclerosis (MS). Following 12 weeks of therapy, the number of new gadolinium-enhancing (GdE) T1-lesions was reduced by 89% and 79% in the higher- and lower-dose treatment arms, respectively, compared with placebo, meeting the study’s primary endpoint. A substantial unmet need remains in MS for highly effective and well-tolerated treatment options that provide sustainable control of disease activity and disability progression, while minimizing risks. As the first second-generation anti-CD40L antibody to show efficacy in MS, frexalimab is thought to block the costimulatory CD40/CD40L cellular pathway necessary for adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cell activation and function, without lymphocyte-depletion.

Four-Year Outcomes from Phase 3 CheckMate -9LA Trial Show Durable, Long-Term Survival With Opdivo (nivolumab) Plus Yervoy (ipilimumab) With Two Cycles of Chemotherapy for Patients With Metastatic Non-Small Cell Lung Cancer

Princeton-based BioNJ Member Bristol Myers Squibb announced four-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrating durable, long-term survival benefits with Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer (NSCLC). With a minimum follow-up of 47.9 months, the dual immunotherapy-based combination continued to enhance overall survival (OS), the trial’s primary endpoint, with 21% of patients treated with Opdivo plus Yervoy with two cycles of chemotherapy alive compared to 16% of patients treated with chemotherapy alone at four years (Hazard Ratio [HR] 0.74; 95% Confidence Interval [CI]: 0.63 to 0.87). 

Bristol Myers Squibb to Present First Results at ASCO and EHA from Phase 3 COMMANDS Study of Reblozyl® (luspatercept-aamt) in First-Line Treatment of Anemia in Adults With Lower-Risk Myelodysplastic Syndromes (MDS)

Princeton-based BioNJ Member Bristol Myers Squibb announced first results from the Phase 3 COMMANDS study, an open-label, randomized trial evaluating Reblozyl® (luspatercept-aamt) versus epoetin alfa, an erythropoiesis-stimulating agent (ESA), for the treatment of anemia in adult patients with very low-, low- or intermediate-risk myelodysplastic syndromes (MDS) who require red blood cell (RBC) transfusions and are ESA-naïve. The primary endpoint evaluated in the COMMANDS study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin increase of ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions. 

Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) is First and Only CAR T to Deliver Deep and Durable Efficacy in Pivotal Multicenter Trial in Relapsed or Refractory Chronic Lymphocytic Leukemia, Based on Data Presented at ASCO 2023

Princeton-based BioNJ Member Bristol Myers Squibb announced the first disclosure of results from the primary analysis of the pivotal TRANSCEND CLL 004 study, a Phase 1/2, open-label, single-arm multicenter study evaluating Breyanzi (lisocabtagene maraleucel, liso-cel) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). At a median follow-up of 21.1 months, results show that Breyanzi delivered statistically significant complete response (CR) rates, the study’s primary endpoint, in 18.4% of patients in the primary efficacy analysis set (95% CI: 8.8-32; p=0.0006). Among patients who achieved a CR, no disease progression or deaths were observed, with median duration of response not reached. 

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) With Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients With Tumor Cell PD-L1

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 platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The positive opinion is based on results from the CheckMate -816 trial, which demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) with three cycles of Opdivo in combination with chemotherapy compared to chemotherapy alone when given before surgery. 

Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients With Systemic Lupus Erythematosus

BioNJ Member AbbVie, with a site in Madison, announced the results of the Phase 2 SLEek study evaluating upadacitinib (RINVOQ® 30 mg) alone and in combination [ABBV-599 high dose (elsubrutinib 60 mg and upadacitinib 30 mg)] in adults with moderately to severely active systemic lupus erythematosus (SLE) who continued to receive standard lupus therapies. In the Phase 2 SLEek study, a greater proportion of patients receiving upadacitinib 30 mg or ABBV-599 high dose achieved the primary endpoint, SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24, compared to placebo (54.8 percent; p=0.028 and 48.5 percent; p=0.081* versus 37.3 percent, respectively). SRI-4 and steroid dose less than or equal to 10 mg prednisone equivalent per day assess reductions in disease activity and glucocorticoid use, respectively.

U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults

BioNJ Member Pfizer, with a site in Peapack, announced that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective. The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.

Phase 3 Studies of Pfizer’s Novel Antibiotic Combination Offer New Treatment Hope for Patients With Multidrug-Resistant Infections and Limited Treatment Options

BioNJ Member Pfizer, with a site in Peapack, announced positive results from the Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and tolerability of the novel investigational antibiotic combination aztreonam-avibactam (ATM-AVI) in treating serious bacterial infections due to Gram-negative bacteria, including metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens for which there are limited or no treatment options. Data support that ATM-AVI is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone.

Pfizer Announces Positive Marstacimab Results from Pivotal Phase 3 Hemophilia A and B Trial

BioNJ Member Pfizer, with a site in Peapack, announced that the pivotal Phase 3 BASIS clinical trial evaluating marstacimab has met its primary endpoints, having demonstrated statically significant and clinically meaningful effects. Marstacimab, a novel, investigational anti-tissue factor pathway inhibitor (anti-TFPI) being studied for the treatment of hemophilia A or B for people without inhibitors to Factor VIII (FVIII) or Factor IX (FIX), was administered weekly with flat (not weight-based) dosing in the trial as a subcutaneous 300 mg loading dose followed by 150 mg once weekly. Pfizer currently has three Phase 3 programs investigating novel treatment options for people living with hemophilia. In addition to the BASIS study, fidanacogene elaparvovec and giroctocogene fitelparvovec are investigational gene therapy treatments being studied for the treatment of adults living with hemophilia B and hemophilia A, respectively.

Novo Nordisk A/S: Once-Weekly Sogroya® (somapacitan) Receives CHMP Positive Opinion for Expanded Use in Children and Adolescents With Growth Hormone Deficiency

Plainsboro-based BioNJ Member Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending once-weekly Sogroya® (somapacitan) for replacement of endogenous growth hormone (GH) in children aged three years and above, and adolescents with growth failure due to growth hormone deficiency. Symptoms of growth hormone deficiency in children often start early in life, leading to short stature as well as other growth-related health problems. Current treatment for growth hormone deficiency typically requires daily injections of growth hormone. However, frequent injections can be burdensome, disrupting daily life, reducing adherence and thereby affecting clinical outcomes – particularly in children.

Novo Nordisk Enters Exclusive Negotiations to Acquire a Controlling Stake in BIOCORP, to be Followed by a Tender Offer on all Remaining Shares

Plainsboro-based BioNJ Member Novo Nordisk and BIOCORP Production SA announced that Novo Nordisk has entered into exclusive negotiations for a controlling stake in BIOCORP, which would be followed by a mandatory simplified tender offer on all remaining outstanding shares in BIOCORP at a price of 35.00 Euros per share in cash, representing a total equity value of approximately 154 million Euros. BIOCORP is a French company specialized in the design, development and manufacturing of delivery systems and innovative medical devices, including Mallya, a Bluetooth enabled smart add-on device for pen injectors. Since 2021 the companies have been collaborating on the development and commercialization of a Mallya add-on device for the Novo Nordisk FlexTouch pen used by people with diabetes.

Legend Biotech Announces Submission to the European Medicines Agency for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel)

Somerset-based BioNJ Member Legend Biotech Corporation headquartered in Somerset announced that a Type II variation application was submitted to the European Medicines Agency (EMA) for CARVYKTI® based on data from the CARTITUDE-4 study, which investigates the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. The submission was filed to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend Biotech’s collaborator for the development and commercialization of cilta-cel. “We are committed to investigating the full potential of CARVYKTI® across patient populations, including in earlier lines of treatment,” said Ying Huang, Ph.D., CEO of Legend Biotech. “I am proud of the efforts that Legend Biotech and our collaborator, Janssen, continue to make to potentially bring CARVYKTI® to a broader range of patients.”

Legend Biotech Announces Submission of Supplemental Application to the U.S. FDA for Expanded Use of CARVYKTI® (ciltacabtagene autoleucel)

Somerset-based BioNJ Member Legend Biotech Corporation announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The sBLA seeks to expand the label for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The submission is supported by data from the CARTITUDE-4 study (NCT04181827), the first international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus standard of care (SOC) regimens in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. SOC in the protocol included pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab and pomalidomide and dexamethasone (DPd).

European Commission Authorizes GSK’s Arexvy, the First Respiratory Syncytial Virus (RSV) Vaccine for Older Adults

Warren-based BioNJ Member GSK plc announced that the European Commission has authorized Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. The first launches are planned ahead of the 2023/2024 RSV season which typically starts in the autumn. The authorization is based on GSK’s landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase III trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs 40 of 12,494) against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint.

GSK Receives U.S. FDA File Acceptance for Jemperli (dostarlimab) Plus Chemotherapy for the Treatment of dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

Warren-based BioNJ Member GSK plc announced the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. If approved in this patient population, dostarlimab plus chemotherapy could represent the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer. The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 September 2023. Dostarlimab also was recently granted Breakthrough Therapy designation for this potential new indication.

GSK Announces the COiMMUNITY Initiative to Help Achieve Higher Adult Vaccination Rates in the US

Warren-based BioNJ Member GSK plc announced the launch of the COiMMUNITY Initiative to help reduce health inequities and set a new precedent for adult immunization rates in the US, which continue to remain below pre-pandemic levels[i]. The initiative is a multipronged effort to address long-standing barriers to adult immunization in the US with funding, increased data transparency through enhanced Vaccine Track capabilities and collaborations, and resource-sharing opportunities. Judy Stewart, Senior Vice President, Head of U.S. Vaccines, GSK said “This is a critical moment for public health. While there is a heightened level of awareness of the importance of vaccines to prevent infectious diseases, too often, adults miss the opportunity to prioritize vaccination, despite being increasingly susceptible to immune decline and infectious diseases. Our industry can do more by investing in local interventions to help create healthier communities and sustain best practices from the pandemic. We believe this initiative will contribute to a more equitable and resilient public health infrastructure and bolster existing partner efforts—leading to more vaccinated adults.”  

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia program is unrivaled as the most comprehensive FXIa clinical development program to date and will provide extensive data from nearly 50,000 patients. All three indications being studied in the Phase 3 Librexia program were granted Fast Track Designation from the FDA. 

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients With Pulmonary Arterial Hypertension (PAH)

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of an investigational single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients with WHO functional class (FC) II-III. The application is based on positive data from the Phase 3 A DUE study, which met its primary endpoint and demonstrated that M/T STCT significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) versus macitentan and tadalafil monotherapies in this PAH patient population.

Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Raritan-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for 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, an immunomodulatory agent, and are refractory to lenalidomide. The application is supported by data from the CARTITUDE-4 study (NCT04181827), the first randomized Phase 3 study evaluating the efficacy and safety of CARVYKTI® versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed or lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients With Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the pivotal Phase 1/2 MonumenTAL-1 study of the investigational bispecific antibody talquetamab in the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Data from the MonumenTAL-1 study highlight safety and efficacy results and an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab. Patients in the Phase 1/2 MonumenTAL-1 study (n=339) were treated with subcutaneous (SC) talquetamab at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) or 0.4 mg/kg weekly (QW) with step-up doses. The overall response rate (ORR) to talquetamab was similar across both doses.

CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced that results from the Phase 3 CARTITUDE-4 study showed CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) reduced the risk of disease progression or death by 74 percent compared to two standard of care treatment (SOC) 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. The CARTITUDE-4 study is the first randomized study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma. The Phase 3 CARTITUDE-4 study included patients (n=419) who received one to three prior lines of therapy, including a proteasome inhibitor (PI) and immunomodulatory agent (IMiD), and were lenalidomide-refractory.

TREMFYA® (guselkumab) Provides Sustained Improvements Across All Minimal Disease Activity Domains for Adults Living With Active Psoriatic Arthritis in Phase 3b Trial

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the Phase 3b COSMOS clinical trial showing that treatment with TREMFYA® (guselkumab) provided sustainable improvements in all minimal disease activity (MDA) domains through week 48 in adults living with active psoriatic arthritis (PsA) who previously had an inadequate response to one to two tumor necrosis factor inhibitors (TNFi-IR). In a separate post-hoc analysis of the Phase 3 DISCOVER-1 and DISCOVER-2 clinical trial findings, TREMFYA was shown to be associated with prompt and sustained improvements in all identified determinants. This analysis also identified factors that influenced disagreement between patient and physician global assessments (GA), such as patient-reported pain, physical aspects of health-related quality of life and fatigue. 

New Long-Term Data from the CHRYSALIS Study Show Median Progression-Free Survival Not Reached after 33.6 Months of Follow-Up With First-Line Use of RYBREVANT® (amivantamab-vmjw) and Lazertinib Combination Therapy in Patients With Treatment-Naïve EGFR-Mutated Advanced Non-Small Cell Lung Cancer

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced long-term results from the CHRYSALIS study, which showed the combination of RYBREVANT® (amivantamab-vmjw) and lazertinib*, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), was associated with sustained antitumor activity as a first-line treatment in patients with EGFR-mutated non-small cell lung cancer (NSCLC). Patients enrolled in the treatment-naïve cohort from the ongoing CHRYSALIS (NCT02609776) study had NSCLC characterized by either an EGFR exon 19 deletion (ex19del) (n=11) or L858R mutation (n=9).1,4 After a median follow-up of nearly three years (33.6 months), the median duration of response (DOR), median progression-free survival (PFS) and overall survival (OS) were not yet reached. The estimated PFS rate was 85 percent after one year, 65 percent at two years and 51 percent at three years. 

Janssen Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients With Relapsed or Refractory Multiple Myeloma

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson announced long-term data from the pivotal Phase 1/2 MajesTEC-1 study showing the sustained efficacy and safety of TECVAYLI® (teclistamab-cqyv) in the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed and previously received treatment with three or more prior lines of therapy. These results showed that nearly half of patients achieved a complete response (CR) or better which underscore the continued durable responses seen in this patient population.¹ Extended follow-up data from the pivotal Phase 1/2 MajesTEC-1 study of TECVAYLI® demonstrate an overall response rate (ORR) of 63 percent, with responses that continued to deepen over time. More than 45 percent of patients have now achieved a CR or better, and median time to CR or better was 4.6 months (range, 1.6-18.5).

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer

Rahway-based BioNJ Member Merck & Co. announced the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone. Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers, which includes KEYNOTE-937 in earlier-stage hepatocellular carcinoma (HCC), and in combination with LENVIMA® (lenvatinib, in collaboration with Eisai) and transarterial chemoembolization (TACE) in the LEAP-012 study.

Merck and Moderna Announce mRNA-4157 (V940) in Combination With KEYTRUDA® (pembrolizumab) Demonstrated a Statistically Significant and Clinically Meaningful Improvement in Distant Metastasis-Free Survival (DMFS) in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA

Rahway-based BioNJ Member Merck & Co. and Moderna, Inc. announced distant metastasis-free survival (DMFS) results from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV). In the overall intention-to-treat (ITT) population, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DMFS, a key secondary endpoint of the study, compared with KEYTRUDA alone and reduced the risk of developing distant metastasis or death by 65% (HR=0.347 [95% CI, 0.145-0.828]); one-sided p value=0.0063). 

FDA Approves LYNPARZA® (olaparib)Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Rahway-based BioNJ Member Merck & Co. and AstraZeneca announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59]) versus abi/pred alone in patients with BRCAm mCRPC.

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as a Single Agent After Surgery Reduced the Risk of Event-Free Survival Events by 42% Versus Pre-Operative Chemotherapy in Resectable Stage II, IIIA or IIIB NSCLC

Rahway-based BioNJ Member Merck & Co. announced positive results from the pivotal Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). After a median follow-up of 25.2 months, neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant single-agent KEYTRUDA significantly improved EFS, reducing the risk of disease recurrence, progression or death by 42% (HR=0.58 [95% CI, 0.46-0.72]; p<0.00001) for patients with resectable stage II, IIIA or IIIB NSCLC versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo. For patients who received the KEYTRUDA-based regimen, median EFS was not reached (95% CI, 34.1-NR) versus 17 months (95% CI, 14.3-22) for patients who received chemotherapy alone.

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Unresectable Advanced Pleural Mesothelioma

Rahway-based BioNJ Member Merck & Co. and the Canadian Cancer Trials Group (CCTG) announced results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma. At the final analysis of the study, KEYTRUDA plus chemotherapy significantly improved overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. “These results support the potential of KEYTRUDA plus chemotherapy as a new first-line option for patients with advanced pleural mesothelioma, who currently have limited treatment options,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. 

LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Rahway-based BioNJ Member Merck & Co. and Nutley-based Eisai Co., Ltd. announced data from the final pre-specified overall survival (OS) analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial investigating LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, Merck’s anti-PD-1 therapy, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). The 24- and 36-month estimated OS rates were 80.4% and 66.4% for LENVIMA plus KEYTRUDA versus 69.6% and 60.2% for sunitinib, respectively. Results from the final pre-specified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial.

Eisai Files Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in South Korea

Nutley-based Eisai Co., Ltd. and BioNJ Member Biogen Inc. announced that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI®), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain, to the Ministry of Food and Drug Safety (MFDS) in South Korea. This application is the first application for lecanemab in Asia outside of Japan and China. Eisai plans to submit additional applications in other Asian countries. The application is based on the results of the confirmatory Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. 

Eisai’s Initiatives for Developing New Medicines for Neglected Tropical Diseases and Malaria and Commitment for Funding to the 3rd Phase of Global Health Innovative Technology Fund Activities

Nutley-based Eisai Co., Ltd. announced that it will grant a total of 625 million yen to the Global Health Innovative Technology Fund (“GHIT Fund”) to fund the third phase of its activities, which will take place in the five-year period from FY2023 to FY2027. The GHIT Fund is a public-private partnership, co-established in April 2013 by partners such as Japanese pharmaceutical companies (including Eisai), the Japanese government, and the Bill & Melinda Gates Foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in Japan and overseas. Eisai has provided a total of 1 billion yen to the first phase (FY2013 – FY2017) and the second phase (FY2018 – FY2022) of the GHIT Fund.

Vyluma Announces FDA Acceptance of New Drug Application for NVK002, its Novel Investigational Treatment for Pediatric Myopia

Bridgewater-based Vyluma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead compound, NVK002 (low dose atropine 0.01%) as a potential treatment for myopia in children. NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for patients ages 3 to 17. A Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2024 has been assigned by FDA. “FDA acceptance of our NDA is a major milestone for Vyluma and brings us one step closer to advancing NVK002 as a new, first-in-class treatment option for children with myopia,” stated Founder & Chairman, Navneet Puri Ph.D. 

Lexicon Announces FDA Approval of INPEFA™ (Sotagliflozin) for Treatment of Heart Failure

Lexicon Pharmaceuticals, Inc., with a site in Bridgewater, announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The broad label encompasses heart failure patients across the full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes. “We expect this important innovation to be commercially available in the U.S. market by the end of June 2023,” said Lonnel Coats, Lexicon’s Chief Executive Officer.

VANFLYTA® First FLT3 Inhibitor Approved in Japan for Patients With Newly Diagnosed FLT3-ITD Positive AML

Basking Ridge-based Daiichi Sankyo announced that VANFLYTA® (quizartinib) has

been approved in Japan for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD mutation positive. VANFLYTA is now approved to treat patients with newly diagnosed FLT3-ITD positive AML in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy, making it the first and only FLT3 inhibitor in Japan approved for newly diagnosed AML treatment. VANFLYTA was first approved in 2019 as a monotherapy in the relapsed/refractory setting. AML is one of the most common leukemias in adults. Approximately 7,000 new cases of AML are diagnosed each year in Japan where the five-year survival rate has been reported at 21.1% for adult patients.

Datopotamab Deruxtecan Combinations Showed Encouraging Tumor Responses in Patients With Advanced Non-Small Cell Lung Cancer in TROPION-Lung02 Phase 1b Trial

Updated results from the TROPION-Lung02 Phase 1b trial showed that with additional enrollment and follow-up from the initial presentation datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum-based chemotherapy demonstrated promising clinical activity and no new safety signals in both previously untreated or pretreated patients with advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGAs). Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Basking Ridge-based Daiichi Sankyo and AstraZeneca. More than one million people are diagnosed with NSCLC at an advanced stage each year. While first-line treatment with immune checkpoint inhibitors with or without chemotherapy has improved outcomes for patients with NSCLC without AGAs, like EGFR or ALK, most patients eventually experience disease progression.

ENHERTU® Demonstrated Clinically Meaningful and Durable Responses in Patients Across Multiple HER2 Expressing Advanced Solid Tumors

Positive results from an interim analysis of the ongoing DESTINY-PanTumor02 Phase 2 trial showed that ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful and durable responses across a broad range of HER2 expressing advanced solid tumors in previously treated patients. ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Basking Ridge-based Daiichi Sankyo and AstraZeneca. In the trial, previously treated patients (n=267) with HER2 expressing advanced solid tumors including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancers or other tumors were treated with ENHERTU. The results showed a confirmed objective response rate (ORR) of 37.1% as assessed by investigator at an interim analysis. Complete response (CR) was achieved in 5.6% (n=15) of patients, 31.5% (n=84) achieved a partial response (PR) and 46.1% (n=123) had stable disease.

Catalent Expands OneBio Suite for Integrated Development, Manufacturing and Supply

Somerset-based Catalent announced it expanded its integrated development, manufacturing and supply solution, OneBio, across a range of biologic modalities, including antibody and recombinant proteins, cell and gene therapies and mRNA. Originally launched in 2019 for early phase protein therapy development, the OneBio suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. Under the newly expanded OneBio offering, customers will continue to benefit from an integrated contract and proposal, harmonized project management, a global development and manufacturing network and diverse expertise, now across biologic modalities and service offerings.

Agile Therapeutics Announces Closing of $7.5 Million Public Offering

Princeton-based Agile Therapeutics, Inc. announced the closing of its previously announced public offering of an aggregate of 1,896,286 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock warrants, at a public offering price of $3.9551 per share (or pre-funded warrant) and accompanying warrants. Each share of common stock (or pre-funded warrant) was sold in the offering together with a Series C-1 warrant to purchase one share of common stock at an exercise price of $3.69 per share and a Series C-2 warrant to purchase one share of common stock at an exercise price of $3.69 per share. Total gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, were approximately $7.5 million. The company intends to use the net proceeds from this offering for working capital, business development activities and other general corporate purposes. 

Organon Partners With Latin American Development Bank to Increase Sustainable Financing in Women’s Health

Jersey City-based Organon and CAF, the Latin American development bank, on Wednesday announced the launch of a first-of-its-kind partnership to prioritize the design, financial structuring and implementation of sustainable women’s health programs in Latin America and the Caribbean.

This agreement is part of a transformative model (created by Organon) that convenes governments, global development banks and other multilateral agencies to use results-based financing to improve the lives of women. According to a signed Memorandum of Understanding, Organon and CAF will contribute to the United Nations Sustainable Development Goals through the design, structure and implementation of programs that promote and improve equity, health and autonomy of girls and women in Latin America and the Caribbean.

Pharm Tech Giant Croda Announces Two Partnerships That Will Help Drive Sustainable Delivery Systems

Princeton-based Croda, Inc., the company that uses smart science to create high-performance ingredients and solutions that improve lives, has announced two new partnerships that will help the biopharmaceutical industry move towards a more sustainable supply chain. The first partnership is an exclusive license agreement with Amyris, a leading synthetic biology company, for the supply of a biotechnology-derived, pharmaceutical grade ingredient used in vaccines to boost immune responses. The second partnership is with Botanical Solutions to produce a sustainable pharmaceutical grade vaccine adjuvant (an ingredient of a vaccine that boosts immune response).

Life Sciences Firm Accurant Biotech Expanding to 27K Square Feet in Princeton

Princeton has attracted another life sciences firm to the market, with Accurant Biotech Inc. signing on for 26,566 feet of office space, which the company will use to expand from East Windsor. The full-service contract research organization signed a 10-year lease at 500 College Road E. in the Mercer County municipality with move-in slated for August. According to Accurant Biotech co-founder and U.S. Site Head Dongbei Li, the relocation offers an opportunity to expand and modernize operations in addition to attracting and retaining talent.

CBRE Analysis: New Jersey Remains Among Top Markets for Life Sciences Research Talent

The greater New Jersey market ranked fourth in the nation for life sciences research talent, according to a recent analysis conducted by CBRE, with a score of 126.8. The market’s robust performance is supported by a workforce of 38,700 life sciences professionals — the largest in the country — and 9,500 annual relevant degree completions at area universities — also the largest in the country. Nationally, the growth of U.S. life sciences researchers remains resilient in the face of economic concerns, with the number of life sciences researchers in the U.S. increasing by 87% over the past 20 years, compared with 14% for all U.S. occupations. Research jobs have not fallen across those 20 years, through three recessions and amid the tight labor market of recent years. CBRE evaluated each of the largest 74 U.S. life sciences labor markets against multiple criteria, including the number and concentration of life sciences researchers, number of new graduates with life sciences degrees and specifically with doctorate degrees in life sciences, concentration of all doctorate degree holders and concentration of jobs in the broader professional, scientific and technical services professions.

BioLabs Announces the Launch of Two New Network-Wide Partnerships and Affiliated Golden Ticket Programs 

Otsuka Pharmaceutical Company, Ltd., has become a network-wide sponsor of BioLabs in the US. The company has signed a three-year agreement with BioLabs to provide funding which will support BioLabs and their resident companies (US only). As part of their sponsorship, Otsuka can award up to two Golden Tickets per year. Each Golden Ticket provides one year of fully paid individual bench space and membership at Princeton Innovation Center BioLabs (or other BioLabs US sites), a fully equipped laboratory designed to accelerate early stage startups working on research and development in novel platform technologies for discovery of novel targets, improved drug discovery, tissue tropism, delivery of large molecules, or new pharmaceutical-based therapeutic interventions. Therapeutic areas of strategic focus include, psychiatry, neurology, cardio-renal and immunology. 

BioCentriq™ and Kytopen® Expand Partnership to Expedite Impact of Transformative Gene-Editing Technology on Cell Therapy Manufacturing

BioCentriq® announced that it has expanded its partnership with Kytopen, a start-up spun out of Massachusetts Institute of Technology (MIT). The partnership was originally announced in March of 2021. In the initial phase of the collaboration, the Kytopen and BioCentriq teams worked together to test transfection of T-cells using Kytopen’s Flowfect® technology and the potential impact to both autologous and allogeneic cell therapies of integrating this novel transfection technology with other steps in the manufacturing process. The extension of the partnership with BioCentriq will expand therapeutic developers’ access to a leading non-viral cell engineering method by combining BioCentriq’s process development expertise with Kytopen’s Flowfect Discover™ platform.

Bpeace Pharma Maximizer Program Participants from El Salvador Visit BioCentriq for Insights and Networking

BioCentriq hosted a group of 10 Salvadoran business leaders representing Laboratorios Suizos, Laboratorios Hifar, SYM Lab, Meditech Laboratories, and Laboratorios Rodim as part of an exclusive visit organized for the Bpeace Pharma Maximizer Program. The visit aimed to foster knowledge sharing between BioCentriq and the participants, offering valuable insights into the company’s cutting-edge research and development efforts. The Bpeace Pharma Maximizer Program, in partnership with and with funding from the USAID Economic Competitiveness Project, supports the growth of Salvadoran pharmaceutical manufacturers in the Association of Pharmaceutical Laboratories of El Salvador (ALFA). By connecting Salvadoran business leaders with industry experts and innovative companies like BioCentriq, the program provides them with valuable opportunities to expand their knowledge and improve how they operate, as a catalyst for growth and job creation.

Teva’s 2022 Impact: A Closer Look

Each year, Teva publishes an Environmental, Social and Governance (ESG) Progress Report, which shares how we are managing topics important to our business and making a positive impact on people and the planet. ESG is an integral part of our company, guided by a robust strategy, priority topics, dedicated governance structure and ambitious targets. Our focus on ESG supports us in creating long-term value and ensuring the sustainability of our company — allowing us to continue improving the lives of patients. Our 2022 report offers a closer look at our latest progress, including how we’re delivering against our targets — reducing greenhouse gas emissions, increasing access to medicines, strengthening our culture of compliance and more.

ON Helix

Hosted by One Nucleus

July 6, 2023

This one-day conference will address key bio innovation trends, from developments in life sciences and technology research to their translation into new diagnostics, prevention tools or treatments. Delegates and Supporters will connect with the One Nucleus network to explore New Horizons for Bio Innovation. BioNJ Members enjoy a 10% discount. Contact RBromberg@BioNJ.org for the discount code.

2023 SAPA Healthcare Investment Forum & Roadshow

Hosted by Sino-American Pharmaceutical Professionals Association (SAPA)

July 8, 2023

As a global organization for pharmaceutical professionals, Sino-American Pharmaceutical Professionals Association (SAPA) 6th SAPA Investment Forum & Roadshow is an organizational flagship event, aiming to provide a premium platform for connecting investors and entrepreneurs and offer effective solutions and support to emerging enterprises in the healthcare industry. This in-person only event will include plenary sessions, fireside chats, healthcare innovation roadshow presentations, networking, one-to-one private partnership meetings and other development opportunities. 

Winds of Change: Dealmaking Trends in the Evolving Innovation Economy

Hosted by LES USA & Canada

October 15-18, 2023

Under the theme of Winds of Change: Dealmaking Trends in the Evolving Innovation Economy, our dynamic international IP community will meet in Chicago for two action-packed days of education, outstanding programming and networking, with global deal making opportunities.