The Impact on R&D Investment of the CMS Draft National Coverage Determination for Amyloid-directed Monoclonal Antibodies in Alzheimer’s Disease

Recent research published by the healthcare consultancy Vital Transformation shows that the proposed draft decision by CMS to only cover newly approved FDA monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD), under Coverage with Evidence Development (CED) exclusively for patients enrolled in CMS approved randomized controlled trials, could add three or more years to the process of approving new Alzheimer’s therapies for coverage. This delay was found to have a profound impact on the financial viability of developing and commercializing those treatments successfully. According to this model, a three-year delay has the potential to reduce the number of therapies that will provide a return-on-investment by more than 80%.

Biopharmaceutical Industry Drives Economic Growth in All 50 States

The innovative biopharmaceutical industry has long been a significant driver of the nation’s economic growth and a key contributor to state and regional economies. A new report from TEConomy Partners highlights industry’s impact and reach across the country. While the industry is a driver for the national U.S. economy, research shows that biopharmaceutical companies and their supply chains play key roles in supporting local economies and a wide range of jobs in every state across the country. In fact, nearly every state is involved in the manufacturing of FDA-approved medicines, and the biopharmaceutical industry directly employed more than 900,000 workers across the United States in 2020.

Price Transparency Healthcare Policies Reduce Out-Of-Pocket Costs

Price transparency enables patients to shop for the most effective and inexpensive healthcare available and is vital as patient out-of-pocket healthcare costs continue to skyrocket year-over-year. A 2021 Kalorama Information analysis found that patient out-of-pocket costs are up 10% since 2020, with the net total of patient financial responsibility nearly $491 billion in 2021. The analysis also estimated a 9.9% increase in out-of-pocket healthcare spending through 2026, amounting to roughly $800 billion in patient spending. Various health benefit designs that include high deductibles, coinsurance, co-pay accumulators, and step therapy are barriers in patient care. These roadblocks often stand in the way of high-value care for the chronic conditions that drive most health spending. 

Why N.J. Can be ‘Medicine Chest’ — And Home to Innovative Companies of the Future

An Op-ed by BioNJ President and CEO, Debbie Hart

It was asked at a recent New Jersey Chamber of Commerce meeting whether New Jersey was losing its edge as the “Medicine Chest of the World,” as it’s making way for more innovative early stage companies and a fresh new moniker as the “Innovation State.” My response: Why not both? I would like to suggest that New Jersey can walk and chew gum at the same time.

New Jersey has maintained its well-deserved reputation as the “Medicine Chest of the World,” as evidenced by 70 new FDA drug approvals in the last two years, representing nearly 40% of all FDA drug approvals during that period. In addition, of the nearly 1,000 COVID-19 programs initiated since the onset of the pandemic, nearly 100 came from New Jersey-based companies — including the first COVID-19 vaccines (Pfizer and Johnson & Johnson) and therapeutics (Merck, Pfizer, Lilly, Gilead, GSK) … and the first saliva COVID-19 test from Rutgers University. Layer that on top of increased entrepreneurship and early stage company creation and spinouts from our academic institutions and, clearly, New Jersey remains the state for leading life sciences.

GBR Connect Series – An Interview With Debbie Hart - USA Life Sciences

With nearly 40% of all new FDA approvals over the last two years coming from companies with a footprint in New Jersey, our State continues to lead the way in bringing new therapies and cures to patients. The ecosystem continues to flourish...In 2021, we were thrilled to see Governor Phil Murphy break ground on “The Hub” in New Brunswick, which will bring together industry, academia, government and investors in a physical space. And, equally exciting is “The Cove” which is an even larger physical space with everything from housing, grocery shopping, industry, academia, government and investors – all in a walkable and waterfront complex.

BioNJ's Annual Dinner Meeting & Innovation Celebration to Honor New Jersey's Innovators, COVID-19 Heroes and the Patients Who Inspire Them

Considered the meeting place for the life sciences industry in New Jersey, BioNJ's 29th Annual Dinner Meeting & Innovation Celebration will take place on Thursday, June 9, 2022 at the Hilton East Brunswick. Hundreds of biotechnology and pharmaceutical professionals, academic leaders, Patients, advocates, service providers and government officials will come together to honor the groundbreaking medical innovation coming from the Garden State. "Because Patients Can't Wait®, we are so proud of our Members who are helping Patients live longer, better lives. And, we are pleased to celebrate their important work and dedication during BioNJ's Annual Dinner Meeting & Innovation Celebration," said BioNJ President and CEO Debbie Hart.

Biopharma Giant Gilead Planning Major Expansion in N.J.

Morris Plains-based BioNJ Member Gilead Sciences is looking to greatly expand its presence in New Jersey, where it intends to create an East Coast hub that eventually will employ 500 people. Gilead, which came to Morris Plains in the fall of 2020 — when it purchased Immunomedics in a $21 billion cash deal — is reworking its workforce in the State, according to Joydeep Ganguly, the Senior Vice President for Corporate Operations. Mr. Ganguly added the company has been impressed by the level of talent available in the state during its time in New Jersey — and is eager to tap into it. “Our commitment to Jersey is solid,” Ganguly said. “When we go into an acquisition, we don’t just acquire infrastructure, we also look at the people. And we recognized we wanted to really continue to invest in New Jersey as a location because it has phenomenal talent.”

ADMA Biologics Announces FDA Approval of Extended Shelf Life for ASCENIV™ & BIVIGAM® from 24 to 36 Months

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced the United States Food and Drug Administration’s (“FDA”) approval to extend the expiration dating from 24 to 36 months for both its ASCENIV and BIVIGAM immune globulin (“IG”) drug product stored at 2-8°C. The expiration date extension applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM in all vial sizes, production scales as well as internal and external fill-finished drug product. The newly approved 36-month dating for ASCENIV and BIVIGAM is immediately effective and product is available to U.S. healthcare providers and patients. At the present time, ADMA expects continuous and increasing supply across its IG product suite going forward. 

Soligenix COVID-19 Vaccine, CiVax™, Boosts Neutralizing Activity against SARS-CoV-2, including Delta and Omicron

Princeton-based BioNJ Member Soligenix announced the results of a booster vaccination study using CiVax™ (heat stable COVID-19 subunit vaccine program) in non-human primates (NHPs) demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. The NHPs had been double vaccinated with an adenovirus vaccine for COVID-19 seven months previously. Prior to administration of the booster vaccine, neutralizing antibody levels against the original and Delta strains of SARS-CoV-2 were low, but detectable, and were undetectable for the Omicron strain. Within one week of receiving booster, neutralizing antibody levels increased as much as 27-fold against the original and Delta strains. By three weeks this increased up to 243-fold. Protective neutralizing antibody levels were also rapidly raised against Omicron by one-week post-vaccination. 

Chris Schaber is Focused on Rare and Orphan Diseases With High Unmet Medical Need

OncologyTube recently spoke to Dr. Chris Schaber, President & CEO, of Princeton-based BioNJ Member Soligenix, Inc. Dr. Schaber is extremely optimistic about the future of medicine and the progress he and his team are making with the Soligenix drug pipeline – especially their lead product called HyBryte™ for a devastating blood and skin cancer. HyBryte™ is a unique drug that is activated by exposure to light (photodynamic therapy) for the treatment of early stages of a rare skin cancer called cutaneous T-cell lymphoma. Soligenix has completed all the necessary phases of clinical research for HyBryte™ and is now in the final stages preparing to file the drug with the Food and Drug Administration for review.

Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis

Florham Park-based BioNJ Member Phathom Pharmaceuticals announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of vonoprazan as a treatment for adults for the healing of all grades of erosive esophagitis (EE) and relief of heartburn, and maintenance of healing of all grades of EE and relief of heartburn. Erosive esophagitis, a major type of gastroesophageal reflux disease (GERD), affects approximately 20 million people in the U.S. In addition to experiencing troubling heartburn symptoms, patients with inadequately treated EE may progress to more severe diseases including Barrett’s esophagus, a condition in which esophageal tissue changes can progress to cancer.

Latest Analysis Shows Vascepa® (Icosapent Ethyl) Significantly Lowered the Risk of Potentially Fatal Cardiovascular Events in Patients With Prior Percutaneous Coronary Intervention

Bridgewater-based BioNJ Member Amarin Corporation announced the publication of new REDUCE-IT data analysis that helps support the clinical benefits of icosapent ethyl (IPE) for patients who have received a percutaneous coronary intervention (PCI) and are at high risk for experiencing a stroke, heart attack, or fatal cardiovascular (CV) event. Percutaneous coronary interventions (also known as coronary angioplasty, which can include stent insertion) are medical procedures used to open coronary arteries, the main blood vessels supplying the heart, that are narrowed or blocked by a build-up of atherosclerotic plaque. The heart needs a constant supply of oxygenated blood to function effectively; if the coronary arteries become narrowed and restricted, this can lead to serious heart health complications such as angina or a heart attack.

HMP Partners Invests in Tevogen Bio™

Warren-based BioNJ Member Tevogen Bio announced it has completed a strategic investment by HMP Partners of New Jersey, a life sciences investment firm managed by medical doctors. Tevogen’s next generation precision T cell platform is designed to provide increased target specificity to eliminate malignant and viral infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming mutational capacity of cancer cells and viruses. The potentially disruptive technology is designed to allow development of unmodified T cell therapeutics from a single donor to treat hundreds of patients sharing the same human leukocyte antigen (HLA) type, without the need for specialized medical facilities.

BioAegis Therapeutics Completes $22 Million Institutional Sale of Equity in a Non-Brokered Transaction

North Brunswick-based BioNJ Member BioAegis Therapaeutics announces the completion of a $22 million sale of equity in a non-brokered transaction. Gelsolin is a highly conserved abundant human protein in healthy individuals. As a master regulator of immune function, its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens. Normal levels are rapidly depleted by diverse inflammatory conditions. Supplementing gelsolin levels with the human recombinant form rebalances this defense system to restore the ability of immune cells to fight infection and to counter systemic inflammation that can damage otherwise healthy organs.

Agile Therapeutics Announces Closing of $4.85 Million Registered Direct Offering

Princeton-based BioNJ Member Agile Therapeutics announced that it has closed its previously announced registered direct offering with a single healthcare-focused institutional investor to sell 2,425 shares of Series A convertible preferred stock and 2,425 shares of Series B convertible preferred stock and Series A warrants to purchase up to an aggregate of 24,250,000 shares of common stock and Series B warrants to purchase up to an aggregate of 24,250,000 shares of common stock. Each share of Series A and Series B preferred stock has a stated value of $1,000 per share and a conversion price of $0.20 per share. 

Evotec Receives € 3 m Milestone Payment for Bayer Starting Phase II Clinical Development of DNP Program

Princeton-based BioNJ Member Evotec announced that the company received a € 3 m milestone payment from Bayer AG as a result of another promising small molecule from the Evotec-Bayer multi-target research alliance advancing into Phase II clinical development as a potential treatment for diabetic neuropathic pain ("DNP"). DNP is a common chronic condition associated with nerve damage caused by high blood sugar levels in diabetic patients. DNP may be triggered through the slightest touch upon which the body sends unprompted pain signals to the brain. Thus, DNP can drastically impair the quality of life for people living with this condition.

Jardiance® Phase III EMPA-KIDNEY Trial Will Stop Early Due to Clear Positive Efficacy in People With Chronic Kidney Disease

The EMPA-KIDNEY trial, evaluating the effect of Jardiance® (empagliflozin) in adults with chronic kidney disease, will stop early based on a recommendation from the trial's Independent Data Monitoring Committee. This follows a formal interim assessment that met prespecified criteria for positive efficacy, announced Bridgewater-based BioNJ Member Eli Lilly and Company, North Brunswick-based BioNJ Member Boehringer Ingelheim and the Medical Research Council Population Health Research Unit at the University of Oxford. As the largest SGLT2 inhibitor trial in CKD to date, EMPA-KIDNEY is evaluating the efficacy and safety of Jardiance in adults with CKD who are frequently seen in clinical practice but who have been under-represented in previous SGLT2 inhibitor trials, therefore addressing a critical unmet need. 

Sanofi and Seagen Announce Collaboration to Develop and Commercialize Multiple Novel Antibody-Drug Conjugates

Bridgewater-based BioNJ Member Sanofi and Seagen announced an exclusive collaboration agreement to design, develop and commercialize antibody-drug conjugates (ADCs) for up to three cancer targets. The collaboration will utilize Sanofi’s proprietary monoclonal antibody (mAb) technology and Seagen’s proprietary ADC technology. ADCs are antibodies engineered to deliver potent anti-cancer drugs to tumor cells expressing a specific protein and Sanofi currently has one ADC in development. Under the terms of the collaboration, Seagen and Sanofi will co-fund global development activities and share equally in any future profits. In addition, Sanofi will make an undisclosed payment to Seagen for each of the three targets as they are selected. 

Sanofi Announces €300 Million Collaboration With Blackstone Life Sciences to Advance an Innovative Treatment for Multiple Myeloma

Bridgewater-based BioNJ Member Sanofi and Blackstone Life Sciences announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences (BXLS) will contribute up to €300 million to accelerate the global pivotal studies and the clinical development program for the subcutaneous formulation and delivery of the anti-CD38 antibody Sarclisa®, to treat patients with multiple myeloma (MM). If successful, BXLS will be eligible to receive royalties on future subcutaneous sales. For the Sarclisa® subcutaneous formulation delivery, Sanofi has partnered with drug delivery technology innovator company Enable Injections, Inc. to advance the development of a subcutaneous delivery for Sarclisa® with the goal of offering a unique patient-centric treatment experience.

U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients With Unresectable or Metastatic Melanoma

Princeton-based BioNJ Member Bristol Myers Squibb announced that Opdualag^TM, a new, first-in-class,fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag to nivolumab alone. The trial met its primary endpoint, progression-free survival (PFS), and Opdualag more than doubled the median PFS when compared to nivolumabmonotherapy, 10.1 months (95% Confidence Interval [CI]: 6.4 to 15.7) versus 4.6 months (95% CI: 3.4 to 5.6); (Hazard Ratio [HR] 0.75; 95% CI: 0.62 to 0.92, P=0.0055).

Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults

BioNJ Member Pfizer, with offices in Peapack, announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older. The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age. In September 2021, Pfizer announced the initiation of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease), a Phase 3 clinical trial (NCT05035212) evaluating the efficacy, immunogenicity, and safety of a single dose of RSVpreF, in adults ages 60 years or older. 

Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients

BioNJ Member Pfizer, with offices in Peapack, announced positive topline results from a Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC). In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. Statistically significant improvements were achieved in all key secondary endpoints in the trial as well. The safety profile was consistent with previous Phase 2 studies. The global Phase 3 multi-center, randomized, double-blind, placebo-controlled study, also known as ELEVATE 12, enrolled 354 UC patients who had previously failed or were intolerant to at least one conventional, biologic, or JAK therapy. Participants received etrasimod 2mg once daily.

Pfizer to Supply UNICEF up to 4 Million Treatment Courses of Novel COVID-19 Oral Treatment for Low- and Middle-Income Countries

BioNJ Member Pfizer, with offices in Peapack, announced today an agreement with UNICEF to supply up to 4 million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), to 95 low- and middle-income countries, pending authorization or approval. This includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the last five years, accounting for approximately 53% of the world’s population. Pfizer expects supply to be available to support orders in April 2022, and supply will continue throughout 2022, pending regulatory authorization or approval and according to country needs. 

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults

BioNJ Member Pfizer, with offices in Peapack, and BioNTech SE announced the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. The submission is based on two real-world data sets from Israel analyzed at a time when the Omicron variant was widely circulating. These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness. 

U.S. FDA Approves Streamlined Process for Initiating HIV Therapy with CABENUVA (cabotegravir and rilpivirine), the First and Only Complete Long-Acting Injectable HIV Treatment

Titusville-based BioNJ Member the Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a label update for CABENUVA (cabotegravir and rilpivirine), giving healthcare professionals and people living with human immunodeficiency virus (HIV-1) in the U.S. the option to start this once-monthly or every-two-month injectable treatment without the need for the oral lead-in phase (daily cabotegravir and rilpivirine tablets, taken for one month prior to initiation of cabotegravir and rilpivirine injections). Clinical data demonstrated the regimen displays a similar safety and efficacy profile both with and without an oral lead-in period. CABENUVA was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s decades-long commitment to combatting HIV.

South Africa Health Products Regulatory Authority Approves Dapivirine Ring Developed by the International Partnership for Microbicides

New Brunswick-based BioNJ Member Johnson & Johnson welcomes the approval from the South African Health Products Regulatory Authority (SAHPRA) of the once-monthly dapivirine vaginal ring, developed by the not-for-profit International Partnership for Microbicides, Inc. (IPM), for use by women ages 18 and older to help reduce their risk of contracting HIV. The dapivirine ring, which is the first discreet, long-acting HIV prevention method designed exclusively for women, offers women a new option when deciding which method best meets their individual needs. The approval of the dapivirine ring in South Africa is an important step in the decades-long fight against HIV, which is one of the most significant challenges in global health.

Sandoz Targets Growth Opportunities in Respiratory and Complex Generics Through Acquisition of Respiratory Device Company Coalesce

Princeton-based BioNJ Member Sandoz, a Novartis division, announced that it has successfully acquired the UK-based medical and drug delivery device development company, Coalesce Product Development Limited. Through this deal, Sandoz has acquired the significant capabilities and assets of Coalesce, which will help it build on its existing portfolio of respiratory medicines and further improve patient access to these high-quality, complex therapies. With an existing portfolio of six in market-products and nearly twice as many more in the pipeline, Sandoz sees respiratory as a key pillar of its ambitious long-term growth strategy and intends to actively explore further opportunities both in-house and externally. More generally, Sandoz is determined to grow its portfolio in the complex generics space, including complex injectables.

Novartis Pluvicto™ Approved by FDA as First Targeted Radioligand Therapy for Treatment of Progressive, PSMA Positive Metastatic Castration-Resistant Prostate Cancer

East Hanover-based BioNJ Member Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body (metastatic). These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy). Pluvicto is the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). Pluvicto is expected to be available to physicians and patients within weeks.

Novartis Data Again Demonstrate Age-Appropriate Development When Zolgensma is Used Presymptomatically, and Post-Hoc Data Reveal SMA Type 1 Patients Could Speak, Swallow and Maintain Airway Protection

East Hanover-based BioNJ Member Novartis announced new data that reinforce the transformational benefit of Zolgensma® (onasemnogene abeparvovec), an essential one-time treatment for spinal muscular atrophy (SMA). The completed Phase 3 SPR1NT study demonstrated that children with three copies of the SMN2 back-up gene who were treated presymptomatically achieved age-appropriate motor milestones, including standing and walking. In addition, a descriptive post-hoc analyses of START, STR1VE-EU and STR1VE-US (n=65) indicated children with SMA Type 1 achieved or maintained important measures of bulbar function following treatment with Zolgensma, including ability to speak; swallow and meet nutritional needs; and maintain airway protection. 

New Peer-Reviewed Research Shows No Increased Risk of Serious COVID-19 Infections in Kesimpta® (Ofatumumab)-Treated Adults With Multiple Sclerosis

East Hanover-based BioNJ Member Novartis announced that the peer-reviewed journal Neurology and Therapy has published new data on COVID-19 infections in people living with relapsing multiple sclerosis (RMS) treated with Kesimpta® (ofatumumab). This data was compiled from the ongoing, open-label, long-term extension phase 3b ALITHIOS study and from post-marketing reports submitted through the Novartis Global Safety Database. Of the 1703 participants in ALITHIOS, 245 (14.3%) reported COVID-19, most cases were mild (44.1%) or moderate (46.5%) and the vast majority of patients recovered (98.4%). The overall fatal outcome (0.8%) and hospitalization rates (9.4%) due to COVID-19 in Kesimpta-treated patients were lower than the rates reported in the overall MS population (1.97% fatal outcome and 15.5%-21.5% hospitalization). Breakthrough COVID-19 infections occurred in 1.5% of fully vaccinated participants (n = 7/476), from which all recovered.

AbbVie and Scripps Research Announce Collaboration to Develop Antiviral Treatments for COVID-19

Madison-based BioNJ Member AbbVie and Scripps Research announced a global collaboration to develop potential novel, direct-acting antiviral treatments for COVID-19. The initial SARS-CoV-2 research program at Calibr, the drug discovery and development division of Scripps Research, was supported by funding from the Bill & Melinda Gates Foundation. "We believe our SARS-CoV-2 research program has the potential to impact significantly the ongoing gaps in patient needs to move from pandemic to endemic COVID-19," said Peter Schultz, Ph.D., President and Chief Executive Officer, Scripps Research. "We are excited to partner with AbbVie who brings both the scientific expertise and the manufacturing capabilities to accelerate the development of this program." 

RINVOQ® (upadacitinib) Receives FDA Approval for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis

Madison-based BioNJ Member AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for RINVOQ in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies. The two induction studies (U-ACHIEVE and U-ACCOMPLISH) utilized RINVOQ 45 mg once daily for 8 weeks, and then 15 mg or 30 mg once daily for the maintenance study (U-ACHIEVE maintenance) through 52 weeks.

FDA Approves LYNPARZA® (olaparib) as Adjuvant Treatment for Patients With Germline BRCA-Mutated (gBRCAm), HER2-Negative High-Risk Early Breast Cancer Who Have Been Treated With Neoadjuvant or Adjuvant Chemotherapy

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that LYNPARZA has been approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. The approval was based on results from the Phase 3 OlympiA trial, including data for the trial’s primary endpoint of invasive disease-free survival (IDFS).

LYNPARZA® (olaparib) Reduced Risk of Death by 32% in Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer in Phase 3 OlympiA Trial

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced additional positive results from the Phase 3 OlympiA trial. In OlympiA, LYNPARZA demonstrated a statistically significant improvement in overall survival (OS) versus placebo for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. The OlympiA trial is led by the Breast International Group (BIG) in partnership with the Frontier Science & Technology Research Foundation, NRG Oncology, AstraZeneca and Merck. In the key secondary endpoint of OS, LYNPARZA reduced the risk of death by 32% (HR=0.68 [98.5% CI, 0.47-0.97]; p=0.009) versus placebo. The three-year survival rate was 92.8% (95% CI, 90.8-94.4) versus 89.1% (95% CI, 86.7-91) for those on placebo.

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Disease-Free Survival (DFS) Versus Placebo as Adjuvant Therapy in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) Regardless of PD-L1 Expression

Kenilworth-based BioNJ Member Merck & Co., the European Organization for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. The study found that adjuvant treatment with KEYTRUDA significantly improved disease-free survival (DFS), one of the dual primary endpoints, reducing the risk of disease recurrence or death by 24% compared to placebo (hazard ratio [HR]=0.76 [95% CI, 0.63-0.91]; p=0.0014) in patients with stage IB (≥4 centimeters) to IIIA non-small cell lung cancer (NSCLC) following surgical resection regardless of PD-L1 expression. Median DFS was 53.6 months for KEYTRUDA versus 42.0 months for placebo, an improvement of nearly one year.

Glenmark Pharmaceuticals Receives ANDA Approval for Lacosamide Tablets USP, 50 Mg, 100 Mg, 150 Mg and 200 Mg

Mahwah-based Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Tablets 1 USP, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat®2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc. The company plans to launch the product immediately. Commenting on the development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals Ltd, said, “The FDA approval for generic Lacosamide Tablets USP reiterates our ongoing commitment to make treatment options more accessible for patients. We look forward to quickly launching this product in the U.S. market.”

ROI Influencers: Women in Business 2022

We’re tired of hearing from people who say they can’t find women to run their company, sit on their board, take a top leadership role or even simply be on a panel of thought leaders. It’s shameful. And once again, with the release of the 2022 ROI Influencers: Women in Business, we’re proving that the State is overflowing with qualified female leaders who are ready, willing and eager to do all of the above. Congratulations to BioNJ President and CEO Debbie Hart for making the list along with these BioNJ Members: Linda Bennet, Lowenstein Sandler; Kathleen Boozang, Seton Hall Law School; Chrissy Buteas, NJ Business & Industry Association; Nancy Cantor, Rutgers University; Jennifer Colapietro, PricewaterhouseCoopers, Tara Colton, NJEDA; Tai Cooper, NJEDA; Sonia Delgado, PPAG; Amanda DeMartino, The College of New Jersey; Alma DeMetroplolis, JP Morgan Chase; Regina Foley, Hackensack Meridian Health; Kate Foster, The College of New Jersey; Barbara George Johnson, Kean University; Nicole Harris-Hollingsworth, Hackensack Meridian Health; Lisa Kaplowitz, Rutgers Business School; Jaynee LaVecchia, McCarter English; Sarah Lechner, Hackensack Meridian Health; Lei Lei, Rutgers University; Lori Matheus, NJEDA; Linda McHugh, Hackensack Meridian Health; Michelle Mendelsohn, Hackensack Meridian Health; Kimberly Mutcherson, Rutgers University; Katia Passerini, Seton Hall University; Deborah Prentice, Princeton University; Dana Redd, Rowan University; Zsia Rosmarin, Withum; Michele Siekerka, NJ Business & Industry Association; Vonu Thakuriah, Rutgers Unievrsity; Oya Tukel, NJIT; Diane Wasser, EisnerAmper; and Monika Williams Shealey, Rowan University.

Genmab Announces the Nomination of a New Member of the Company’s Board of Directors

Princeton-based BioNJ Member Genmab announced that the company’s Board of Directors nominates Elizabeth O’Farrell for election as a new member of the Board of Directors. During her 24-year career at Eli Lilly, Ms. O’Farrell served as CFO of some of the company’s largest businesses including as Head of Global Finance Operations. She has solid financial experience including strategic, operational and financial decision-making and reporting across the value chain as well as expertise in driving global change initiatives. Ms. O’Farrell led cross-functional teams and drove paradigm changing contributions within finance and across Eli Lilly through collaboration, relationship and persuasive influence in addition to championing transformative business and culture changes. Most recently she served as Chief Procurement Officer and Global Head of Shared Services at Eli Lilly.

Phathom Pharmaceuticals Appoints New Chief Financial and Business Officer

Florham Park-based BioNJ Member Phathom Pharmaceuticals announced Molly Henderson will be its new Chief Financial and Business Officer. Most recently serving as CFO of UroGen Pharma, Ms. Henderson brings over two decades of global finance expertise and has extensive experience in financial planning and analysis, investor relations and capital raising. Ms. Henderson has extensive experience in the pharmaceutical industry and currently serves as a Member of the Board of Directors and Chair of the Audit Committee of Calliditas Therapeutics A.B. She was previously the Executive Vice President and CFO of Advaxis Inc., CFO of Iovance Biotherapeutics Inc. and, prior to then, the Chief Business and Financial Officer and Senior Vice President of VirtualScopics, Inc.

Merck Announces Retirement of Dr. Roy D. Baynes; Dr. Eliav Barr Appointed Head of Global Clinical Development and Chief Medical Officer

Kenilworth-based BioNJ Member Merck announced that Dr. Roy D. Baynes, Head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck. Dr. Baynes will continue to report to Dr. Dean Y. Li, president, Merck Research Laboratories, until his retirement. Dr. Baynes joined Merck in 2013. Under his leadership, Merck has become a leading oncology company and achieved more than 140 medicine and vaccine approvals globally across numerous therapeutic areas. Dr. Baynes will be succeeded by Dr. Eliav Barr, Senior Vice President, Global Clinical Development. During his more than two decades at Merck, Dr. Barr has held positions of increasing responsibility including leadership roles in oncology and infectious diseases clinical development.

GSK Announces Appointments to Designate Haleon Board

Warren-based BioNJ Member GlaxoSmithKline announced the appointment of six directors to the designate Board of Haleon, the new independent company to be formed following the demerger of the GSK Consumer Healthcare business. Haleon will be a new global-leading company in Consumer Health, and is strongly positioned to deliver better everyday health, sustainable above-market growth and attractive returns to shareholders. The new Board appointments follow the appointment of Sir Dave Lewis as Chair Designate and represent further progress to create a new, qualified Board for Haleon with the appropriate mix of skills, experience, diversity and continuity. The appointments include the transition of two GSK Non-Executive Directors and three new external appointees. In addition, it is also confirmed that Tobias Hestler, CFO Designate, Haleon, will join Brian McNamara, CEO Designate, Haleon, on the Board as an Executive Director.  

Berkeley Heights Biopharma Company Names CEO

Biopharmaceutical company CorMedix Inc. has appointed Joseph Todisco as its CEO. CorMedix recently resubmitted its DefenCath NDA to the Food & Drug Administration. The investigational drug product is a novel antibacterial and antifungal solution being developed for the prevention of catheter-related bloodstream infections. The company’s team has been active on all fronts as it has worked through manufacturing challenges and continued to build its understanding of the commercial opportunity for DefenCath. The board said it believes Todisco is the right person to lead CorMedix as it continues to advance DefenCath and aims to build a successful commercial franchise around its lead product. Mr. Todisco is an experienced pharmaceutical industry leader with a track record of building businesses globally and providing commercial leadership over the last 20 years.

Catalent Appoints Cedrone as Vice President, Corporate Innovation

Somerset-based Catalent announced the appointment of Frederic Cedrone as Vice President, Corporate Innovation. Dr. Cedrone will collaborate closely with Catalent’s scientific teams and external partners to leverage innovative technologies in the development of emerging therapeutic modalities. Dr. Cedrone brings with him more than 25 years of experience in biologic drug development, including cell and gene therapies, and joins Catalent from Lysogene S.A. in Paris, where he held the role of Vice President, Alliances & Business Development. Prior to Lysogene, Dr. Cedrone worked at Cellectis S.A., where he held a number of senior roles, both as a scientist and in business development, as well as partnering in the field of novel therapeutic modalities.

Aerie Pharmaceuticals Appoints Peter Lang as Chief Financial Officer

Bedminster-based Aerie Pharmaceuticals announced that Peter F. Lang will join the company as Chief Financial Officer. He will report to Raj Kannan, Chief Executive Officer of Aerie Pharmaceuticals and become a member of the Aerie Executive Committee. Mr. Lang comes to Aerie with over 25 years of experience delivering financial, strategic and operational solutions, with deep expertise in healthcare and a particular focus on the biopharma sector. He has held leadership roles at well-recognized global and boutique investment banks. In addition, Mr. Lang has a long track record of working with management teams and boards to optimize companies’ growth plans, capital structures and return on capital. 

Epygenix Names Landis as CF

Paramus-based Epygenix Therapeutics appointed G. Michael Landis as chief financial officer. Mr. Landis brings more than 25 years of experience in public company expertise, capital market transactions, investor relations and financial reporting. Mr. Landis was most recently the chief financial officer at Avisa Diagnostics Inc. Before that, he served as principal accounting officer and treasurer at Lannett Co. Inc. He was also actively involved in the initial public offering process in previous financial leadership roles at companies including Akrion Inc. and AlliedBarton Security Services LLC. Epygenix Therapeutics is a medicine-based biopharmaceutical company focused on discovering and developing drugs to treat rare and intractable forms of genetic epilepsy in childhood, such as Dravet Syndrome.

$3.5 Million NIH Grant will Help Harness Worldwide Big Data to Enhance Decision Support in Hodgkin Lymphoma

With the aid of a recently awarded $3.5 million, five-year National Cancer Institute grant (R01CA262265), Rutgers Cancer Institute of New Jersey, New Jersey’s only NCI-designated Comprehensive Cancer Center, and Tufts Medical Center in Boston are collaborating on groundbreaking work that is unifying global multi-source big data in order to enhance clinical decision support for improved acute and long-term outcomes for Hodgkin lymphoma patients around the world. This current project will leverage the global HoLISTIC (Hodgkin Lymphoma International Study for Individual Care) consortium created in 2018 that is comprised of diverse, multidisciplinary experts who study aspects of Hodgkin lymphoma epidemiology, biology, prognosis, treatment, survivorship, and health outcomes across all age groups. 

A STEM Powerhouse, NJIT Makes Partnerships Industry Standard

A regional coalition led by Newark and Newark-based BioNJ Member the New Jersey Institute of Technology is among 60 projects selected as finalists for funding from the U.S. Economic Development Administration’s $1 billion Build Back Better Regional Challenge. Over 500 applicants submitted proposals for the regional challenge that aims to boost economic pandemic recovery and rebuild American communities. The regional challenge provides transformative investments — up to $100 million per grantee — to develop and strengthen regional industry clusters across the country, all while embracing economic equity, creating good-paying jobs and enhancing U.S. competitiveness globally.

Panel Discussion: Raising a Series A Round

March 29, 2022

Raising a Series A round is a major milestone for a high-growth startup. To get there, you need to convince investors that you have a viable business model with strong growth potential. Join us on Tuesday, March 29, from 12–1:30 p.m. EDT via Zoom. Our panel of experts will discuss what it takes to raise a successful Series A round, including how to know when it’s time to raise your first round, implications of raising capital, how long the process takes, and much more. This event is hosted by Princeton Innovation Center BioLabs and the Princeton Entrepreneurship Council.

NJIT Start-up Job Fair 2022

April 1, 2022

Join NJIT's Entrepreneurship Society for its first-ever start-up-only job fair. If you are looking for co-founders, teammates, interns or anything in-between this is the perfect event for you. Connect and network with talented college students, start-ups and soon-to-be alumni. Partners participating in the event are looking to hire across all disciplines. Ticket prices are subsidized to support earlier-stage start-ups. And all ticket proceeds go to support the NJIT Student Entrepreneur Society.

Health Equity, and Diversity Leadership Impact Virtual Series

April 6, 2022

This 4-part series, Health Equity, and Diversity Leadership Impact Virtual Summit is paramount to addressing the issues faced in communities of color but more importantly was experienced during the pandemic. The inequities in healthcare were amplified that negatively impact people of color daily. The summit will explore ways to achieve health equity and the value of diverse participation to impact population health outcomes. It is our goal to feature experts who have dedicated their professional careers to advocating in these spaces for equity in healthcare.

NYC Tiger Entrepreneurs Conference

April 7-8, 2022

Princeton Entrepreneurship Council (PEC) is excited to invite you to join fellow alumni, students and faculty at the 2nd NYC Tiger Entrepreneurs Conference. The conference will kick off with a virtual Start-up Showcase featuring several exceptional alumni and faculty founders, to be held on Thursday evening, April 7. The following day, Friday, April 8, the conference will be an in-person event in midtown Manhattan featuring panel discussions, fireside chats, workshops and a closing reception. The 2022 NYC Tiger Entrepreneurs Conference will celebrate both Princeton entrepreneurship and Princeton's contribution to the vibrant NYC start-up scene.  

2022 AIChE Mid-Atlantic Student Conference

April 8-9, 2022

The 2022 AIChE Mid-Atlantic Student Conference will be held in-person on April 8-9. Hosted by AIChE and NJIT's Otto H. York Department of Chemical and Materials Engineering, this Career Fair is a rare opportunity for companies from the greater NJ & NYC greater area to connect with some of the brightest and most motivated undergraduates from the AIChE’s Mid-Atlantic region schools.

I-Corps Northeast Hub: New Training Program

April and May 2022

Researchers in the Northeast: Explore ways that your discovery can meet the needs of people and industries. Teams are eligible for grants of up to $3,000. The Hub emphasizes inclusive innovation and our programs are open to researchers at universities, colleges and research institutions throughout the Northeast. Our next training program for researchers will be held Tuesday, April 12, and Thursdays April 14, April 21 and May 5, from 1-4 p.m. ET online. Learn more and apply for the program at icorpsnortheasthub.org.

BIO 2022 in San Diego

June 13-16, 2022

BIO is thrilled to be back in person for the 2022 International Convention happening in San Diego, CA June 13-16, 2022. The Convention theme ‘LIMITLESS’ is BIO's commitment to unlocking possibilities for attendees while paving the path to the future of our industry. The BIO International Convention attracts 15,000+ biotechnology and pharma leaders who come together for one week of intensive networking to discover new opportunities and promising partnerships. BIO brings together a wide spectrum of life sciences and application, including drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy. Reach out to RBRomberg@BioNJ.org if you are interested in being part of the New Jersey Pavilion at BIO.

BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations. To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:



• Accounting Services
• Biobanking/Bioprocessing
• Clinical Research Centers
• Communications / Marketing / PR / IR
• Contract Manufacturing / Supply Chain & Logistics Management
• Contract Research Organizations & Consulting Services
• Digital Health & Life Sciences IT/Data Science Technologies
• Financial / Investment / Funding Sources and Services
• HR / Talent Acquisition / Professional Development
• Insurance Services
• IT/Data Management and Software Platform Technologies/Cybersecurity
• Laboratory Services
• Legal Services
• Other Services
• Publications
• Real Estate / Engineering and Construction / Property Development
• Supplies - Laboratory / Environmental / Research Instrumentation & Other