Welcome New Members

• Acadia Pharmaceuticals
• Chartwell Partners
• Lachman Consultant Services, Inc.
• Ubuntu Research

 Learn more at www.BioNJ.org/Membership.

Brand-Name Drug Prices Fell for the Fifth Consecutive Year — And Plummeted After Adjusting for Inflation

Time for the Drug Channels annual reality check on drug pricing. The data once again tell a different story than you might read in your favorite politician’s Twitter feed or misleading news reports. For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%. The factors behind declining drug prices will remain in the coming years — and become even stronger due to forthcoming changes in Medicare and Medicaid. Employers, health plans and PBMs will determine whether patients will share in this ongoing deflation.

WTAS: Inflation Reduction Act Already Impacting R&D Decisions

The Inflation Reduction Act’s (IRA’s) drug price setting provisions, as predicted, are already impacting biopharmaceutical R&D decisions. Whether you are looking at estimates of how many fewer medicines or indications will be developed, or noting shifts away from areas of unmet patient need because the law is signaling those innovations are not valued, the IRA’s price setting provisions are a loss for patients everywhere. In late 2022, PhRMA commissioned a survey of its member companies on the impacts they expect the law to have on their R&D. As you might expect, companies are concerned with how price setting undermines current incentives for many advances critical to patients. As one company expert explained, the price setting provisions of the IRA “are likely to fundamentally change the economics of the pharma industry and disincentivize the industry from placing big bets on diseases with large unmet burdens.” 

The White House's Nonsensical Cancer Policies

With considerable fanfare this past February, the White House announced it was “reigniting” one of then-Vice President Joe Biden’s signature issues: the so-called cancer moonshot, which is supposed to “end cancer as we know it.” Six short months later, the President signed the Inflation Reduction Act (IRA), a law that will discourage cancer research more than any other federal law ever enacted. The IRA allows the federal government to set prices for the 60 top-selling drugs in the Medicare program for the first time. As most economists understand, price controls create scarcity, so the overall impact of the law will be fewer new drugs, including cancer drugs.

Inflation Reduction Act: Discussion About the Mixed Effect on Costs for Drugs With Amitabh Chandra and Craig Burton

The Inflation Reduction Act (IRA) will affect the cost of medicines in Medicare. Since making drugs less expensive is an objective of the law, the author spoke with two experts in drug costs about it: AEI’s Amitabh Chandra and Craig Burton of the Association for Accessible Medicines. The article concentrates on how the IRA will affect the availability and cost of generics and biosimilars, drug prices and patient out-of-pocket costs more broadly. Four IRA provisions focus on Medicare drug costs. The federal government can set the price for medicines that have the biggest sales in the program. Drug companies must pay penalties to the government if their prices outpace consumer inflation. There is a limit on the amount of beneficiaries’ out-of-pocket costs. Cost risk is transferred to drug companies and insurers for high-cost beneficiaries. 

Excluding Drugs from Coverage Helps PBMs Keep Profits Higher

When the largest private insurance companies use their leverage to save on the cost of prescription drugs, they make it harder for patients to obtain the medications they need, experts say. Pharmaceutical benefit managers (PBMs), which play a major role in determining the price of prescription drugs, also decide what medicines will be covered by private insurers. If medicines are not covered, patients cannot access them, and the number of drugs that are not being covered has been increasing, meaning patients are unable to afford medicine they need, according to experts.

Branded Drug Report 2023: John O’Brien, NPC

A contentious midterm election is behind us, and while pundits and other experts argue about what the results mean, those of us who deeply care about sound health care policy can hope for a new year where solid evidence and the quest for transparent information matters at least as much as political rhetoric. We’ve come off a year where that was largely not the case. I’m always an optimist, though, and the issues that are most prominent for this coming year offer at least the chance that policy makers may actually dig into data about what’s working and what’s not in our drug pricing system.

Novel Medicines Approved in 2022 Offer Increased Treatment Options for Patients

2022 marked another year of significant progress by biopharmaceutical research companies conducting lifesaving research and development for innovative medicines with a total of 45 new medicine approvals by the U.S. Food and Drug Administration (FDA). According to a new report released by the FDA’s Center for Drug Evaluation and Research (CDER), 37 novel medicines were approved by CDER last year. The Center for Biologics Evaluation and Research (CBER) also approved 8 new medicines in 2022 — including several gene therapies treating two rare blood disorders and a devastating neurodegenerative disease impacting young boys.

CSIT Awards $1.275 Million to 17 New Jersey Start-ups Focused on Supporting Maternal & Infant Health

The Commission on Science, Innovation and Technology (CSIT) Board awarded a combined $1.275 million in grants to 17 startups to accelerate the development of technologies, products and services that support maternal and child wellbeing. The grants were awarded through CSIT’s Maternal and Infant Health Research & Development (R&D) Grant Program, which launched last June. Through the Maternal and Infant Health R&D Seed Grant Program, CSIT will advance the innovation economy through the development of critically necessary research, products and services designed to support maternal and infant health. “We applaud those innovators who are creating solutions where they are so desperately needed, as well as the First Lady for her foresight and commitment to this important work. We are grateful to have the opportunity to partner in this way and that babies and their families will benefit in meaningful ways,” said CSIT Chair Debbie Hart. 

BRUKINSA^® Approved in the U.S. for Chronic Lymphocytic Leukemia

BioNJ Member BeiGene, with a site under development in Hopewell, announced that the U.S. Food and Drug Administration (FDA) has approved its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). “With four U.S. approvals in just over three years and demonstrated superiority versus ibrutinib in the final progression-free survival (PFS) analysis of the ALPINE trial, we believe BRUKINSA is well-positioned to become the BTKi of choice across multiple indications,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. “We’re grateful to the patients who participated in the ALPINE and SEQUOIA studies; and with this new approval, we’re excited to expand our impact to even more patients.” 

BRUKINSA® (zanubrutinib) Receives Marketing Authorization for Chronic Lymphocytic Leukemia (CLL) and Marginal Zone Lymphoma (MZL) in Great Britain by MHRA

BioNJ Member BeiGene, with a site under development in Hopewell, announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for BRUKINSA (zanubrutinib) in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia (CLL) and the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The MHRA authorization for CLL is based on two global Phase 3 clinical trials: SEQUOIA (NCT03336333), comparing BRUKINSA against bendamustine plus rituximab (BR) in patients with previously untreated CLL, and ALPINE (NCT03734016), comparing BRUKINSA® against IMBRUVICA® (ibrutinib) in patients with relapsed/refractory (R/R) CLL. 

Melinta Therapeutics and Cidara Therapeutics Announce FDA Advisory Committee Recommends Approval of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

Parsippany-based BioNJ Member Melinta Therapeutics, LLC and Cidara Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application (NDA), provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. The Committee’s positive vote was based on clinical data from the Cidara’s global ReSTORE Phase 3 and supported by the STRIVE Phase 2 clinical trials and extensive non-clinical development program. Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily, meeting the primary endpoints for both the FDA and the European Medicines Agency (EMA).

BioAegis Therapeutics Announces FDA Clearance of IND for its ‘Inflammation Regulator Protein,’ Gelsolin, for the Treatment of ARDS

North Brunswick-based BioNJ Member BioAegis Therapeutics, Inc., a clinical-stage company developing therapies for inflammatory diseases through a portfolio built around plasma gelsolin, a highly conserved and abundant endogenous human immune regulatory protein, announces that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for recombinant plasma gelsolin to proceed for the treatment of acute respiratory distress syndrome (ARDS). ARDS is a serious inflammatory condition for which there are severe consequences with no current therapies other than supportive care. Its genesis can be from various etiologies, with severe infection being a frequent cause. It is estimated that in the U.S. alone, ARDS affects over 700,000 patients per year or roughly 10% of all ICU admissions and these patients exhibit a mortality rate of ~40%.

NICE Recommends Reimbursement for Translarna™

South Plainfield-based BioNJ Member PTC Therapeutics announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Evaluation Document recommending Translarna™ (ataluren) for reimbursement and use across the National Health Service (NHS) in England and Wales. Translarna is the only approved treatment for patients with nonsense mutation Duchenne muscular dystrophy aged 2 years and older who can walk. Duchenne is a severe progressive disease that leads to rapidly worsening muscle function with children often using a wheelchair by early adolescence and eventually requiring artificial ventilation to breathe. The NICE recommendation was based on data from clinical trials and real-world evidence demonstrating Translarna's potential to slow disease progression and improve patient outcomes.

PTC Therapeutics Launches 9th Annual STRIVE™ Awards Program to Fund Initiatives Benefitting the Duchenne Muscular Dystrophy Community

South Plainfield-based BioNJ Member PTC Therapeutics announced the launch of the ninth annual STRIVE™ awards program. Through this program, PTC awards grants to patient advocacy organizations who are committed to developing initiatives that address the needs of the Duchenne Muscular Dystrophy (Duchenne) community. Organizations may submit entries to fund 2023 projects focused on one of two categories: Innovation or Transition to Adulthood. "For 25 years, we have remained committed to supporting the Duchenne community," said Mary Frances Harmon, Senior Vice President, Corporate Relations, PTC Therapeutics. "We created STRIVE in 2015 to encourage and reward innovation by patient advocacy organizations by supporting their unique ideas and programs that help to address the needs of people living with Duchenne around the world. We are excited to see the 2023 submissions."

First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio

BioNJ Member First Wave BioPharma, Inc., with a site in Roseland, announced the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase’s delayed release profile. This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase. Expansion of the adrulipase patent estate follows the recent submission of an Investigational New Drug (IND) amendment seeking authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial evaluating an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). 

Tevogen Bio Announces Positive Proof-of-Concept Clinical Trial Results of Its Off-The-Shelf, Allogeneic Cytotoxic CD8+ T Cell Therapy for Treatment of Acute High-Risk COVID Patients, First Clinical Product of Company’s Precision Cell Therapy Platform

Warren-based BioNJ Member Tevogen Bio announced positive topline results from its Proof-of-Concept (POC) clinical trial designed to evaluate the safety and feasibility of TVGN 489, the company’s first clinical product of its precision T Cell therapy platform, for the treatment of acute high-risk COVID-19 patients. TVGN 489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with precise targets across the SARS-CoV-2 genome, not just the Spike protein. To date, TVGN 489 targets, identified early in the pandemic, persist in the most recent SARS-CoV-2 variants. The open label comparative trial was conducted at Thomas Jefferson University Hospital to assess the safety and feasibility of TVGN 489 when given at one of four escalating doses.

Advaxis Updates on the Phase 1 Clinical Trial of ADXS-504 for the Treatment of Early Prostate Cancer

Monmouth Junction-based BioNJ Member Advaxis Inc. announced an update on the Phase 1 clinical study evaluating ADXS-504, the company’s off-the-shelf neoantigen drug candidate, in patients with biochemically recurrent (early) prostate cancer that is being conducted at Columbia University Irving Medical Center. The study design of this Phase 1 open-label dose escalation study for patients in both dose cohorts was presented at ASCO. The clinical assessment of three patients at the first dose level (1e7 CFU) and three at the second dose level (1e8 CFU) has shown that ADXS-504 monotherapy is safe and well-tolerated. In this study, ADXS-504 is being administered via infusion every four weeks for a total of six doses, followed by four additional maintenance doses every twelve weeks, in patients with biochemically recurrent prostate cancer.

Advaxis Completes Merger to Become Ayala Pharmaceuticals

Monmouth Junction-based BioNJ Member Advaxis Inc. announced it closed its previously announced merger with Ayala Pharmaceuticals Inc., a clinical-stage oncology company headquartered in Delaware. The stock will continue to trade on the OTC market under the symbol ADXS, but the newly combined company will operate under the name Ayala Pharmaceuticals. The merged company will focus primarily on the development and commercialization of Ayala’s lead program, AL102, for the treatment of desmoid tumors. Even before the merger, Ayala’s focus was on developing and commercializing small-molecule therapeutics for patients suffering from rare tumors and aggressive cancers. 

Helsinn and Immedica Enter Exclusive Partnership for Commercialisation of Cancer Supportive Care Products in Core European Markets

BioNJ Member Helsinn Group, with a site in Iselin, and Immedica Pharma AB announced that the companies have entered an exclusive long-term license and distribution agreement for the commercialization of two cancer supportive care products indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) in core European markets: AKYNZEO® (Netupitant-Palonosetron fixed combination) and ALOXI® (Palonosetron). Under the licence and distribution agreement Immedica will commercialize AKYNZEO® in Portugal, Spain, France, Switzerland, the Netherlands, Belgium, Luxembourg and Liechtenstein, ALOXI® in Switzerland, Belgium, Liechtenstein. Dr. Melanie Rolli, Helsinn Group CEO, commented: “This partnership will provide important treatment options for CINV across Europe. We look forward to working closely with Immedica in the months and years ahead to ensure more and more patients can access these important supportive care products.”

Sandoz Announces Agreement to Acquire Leading Antifungal Agent Mycamine^® from Astellas, Reinforcing Hospital Offering and Leading Anti-Infectives Portfolio

Princeton-based BioNJ Member Sandoz, a Novartis division, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine^® (micafungin sodium, Funguard^® in Japan) from Astellas. Closing is anticipated in the course of H1, 2023, subject to standard conditions and regulatory approvals. Astellas reported Mycamine® sales of JPY 18.9 billion (USD 135 million) for the year ending March 31, 2022. The announcement comes after Sandoz successfully completed the acquisition of GSK’s global cephalosporins portfolio in October 2021. Sandoz CEO Richard Saynor said: “Acquiring this leading and respected global brand will significantly reinforce the Sandoz global hospital offering, as well as complement our existing global leadership position in generic antibiotics.”

Pfizer Expands ‘An Accord for a Healthier World’ Product Offering to Include Full Portfolio for Greater Benefit to 1.2 Billion People in 45 Lower-Income Countries

BioNJ Member Pfizer, with a site in Peapack, announced that it has significantly expanded its commitment to 'An Accord for a Healthier World' to offer the full portfolio of medicines and vaccines for which it has global rights on a not-for-profit basis to enable greater health for 1.2 billion people living in 45 lower-income countries. The Accord, a transformative initiative focused on greatly reducing health inequities that exist between many lower-income countries and the rest of the world, initially included a commitment from Pfizer for access to all its patented medicines and vaccines available in the U.S. or European Union on a not-for-profit basis to 45 lower-income countries. However, to better align with disease burden and unmet patient needs in these countries, Pfizer will now expand its offering under the Accord to include off-patent products. 

U.S. FDA Accepts Supplemental New Drug Application for Jardiance® for Adults With Chronic Kidney Disease

BioNJ Members Eli Lilly and Company, with a site in Branchburg, and Boehringer Ingelheim, with a site in North Brunswick, announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which is being investigated as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD), "There is a significant need for additional therapies that reduce the risk of kidney disease progression and hospitalizations in adults with CKD," said Mohamed Eid, M.D., M.P.H., M.H.A., Vice President, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "This application acceptance is an important step forward for the approximately 37 million people in the U.S. living with CKD."

Lilly Supports Direct Relief's Efforts to Expand Access to Medicines by Improving Cold Chain Capacity

BioNJ Members Eli Lilly and Company, with a site in Branchburg, aand Direct Relief announced a new initiative to expand access to medicines in low- and middle-income countries by boosting cold chain capacity in 17 countries. Supported by $1.15M in funding from Lilly, Direct Relief will purchase and install an estimated 150 medical-grade refrigeration units at 25 Life for a Child partner facilities in Africa, Latin America, the Caribbean and Southeast Asia. Cold chain – the transportation and storage of temperature-controlled medications – is a vital component of medical logistics, especially as the global pharmaceutical industry shifts towards the production of biologics and other temperature-sensitive molecules. The World Health Organization's Global Diabetes Compact calls on the private sector to do more to support capacity building in supply chain management, including cold storage.

Evotec Announces Agreement With Janssen to Develop Immune-Based Therapies

Princeton-based BioNJ Member Evotec SE announced that the company has entered into a strategic collaboration and license agreement with BioNJ Member Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration focuses on the development of first-in-class targeted immune-based therapies for oncology, which will ultimately be commercialized by Janssen. The agreement was facilitated by Johnson & Johnson Innovation. The collaboration leverages Evotec’s integrated discovery and development capabilities and manufacturing optimization processes, including an option for the GMP manufacture of the immune-based therapies. Evotec will collaborate closely with Janssen during the pre-clinical R&D phase while Janssen will assume full responsibility for the clinical development and commercialization. 

Merck Named One of America’s Most JUST Companies by JUST Capital and CNBC, Industry Leader in Pharmaceuticals and Biotech

Kenilworth-based BioNJ Member Merck & Co. announced they have been named one of America’s Most JUST Companies, making this the sixth consecutive year that Merck has been recognized for its commitment to serving its workers, customers, communities, the environment, and shareholders. Merck ranked No. 26 overall and ranked No. 1 in the pharmaceuticals and biotech industry for the third straight year, notably also ranking as the top company for communities and customers in the industry. For the annual Rankings, JUST Capital collects and analyzes corporate data to evaluate the 1,000 largest public U.S. companies across 20 Issues identified through comprehensive, ongoing public opinion research on Americans’ attitudes toward responsible corporate behavior. JUST Capital has engaged more than 160,000 participants, on a fully representative basis, since 2015.

FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters [cm]), II, or IIIA non-small cell lung cancer (NSCLC).

The approval is based on data from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. The major efficacy outcome measure was investigator-assessed disease-free survival (DFS). In patients who received adjuvant platinum-based chemotherapy following surgical resection, KEYTRUDA reduced the risk of disease recurrence or death by 27% (hazard ratio [HR]=0.73 [95% CI, 0.60-0.89]) versus placebo regardless of PD-L1 expression.

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy in First-Line Advanced or Unresectable Biliary Tract Cancer in KEYNOTE-966 Trial

Kenilworth-based BioNJ Member Merck & Co. announced positive results from the Phase 3 KEYNOTE-966 trial. In the final analysis of this trial, KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be submitted to regulatory authorities. Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal, pancreatic and colorectal cancers.

FDA Grants Priority Review to Efanesoctocog Alfa for People With Hemophilia A

The U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder. The target action date for the FDA decision is February 28, 2023. Bridgewater-based BioNJ Member Sanofi and Sobi® collaborate on the development and commercialization of efanesoctocog alfa. The BLA is supported by data from the pivotal XTEND-1 Phase 3 study. Results were recently presented at the 30th International Society of Thrombosis and Haemostasis Congress. The data demonstrate a clinically meaningful prevention of bleeds and superiority to prior factor prophylaxis based on an intra-patient comparison.

Sun Pharma Launches SEZABY™ (phenobarbital sodium) in the U.S. for Treatment of Neonatal Seizures

Sun Pharmaceutical Industries, with a site in Princeton, announced the launch of SEZABY™ (phenobarbital sodium) in the U.S. for the treatment of neonatal seizures. SEZABY is the first and only product approved by the U.S. Food and Drug Administration for the treatment of neonatal seizures in term and preterm infants. SEZABY is a benzyl alcohol-free and propylene glycol-free formulation of phenobarbital sodium powder for injection. It was granted orphan drug designation by the U.S. FDA for the treatment of neonatal seizures. “As the first and only FDA-approved product for the treatment of seizures in term and preterm infants, SEZABY has the potential to make a meaningful difference in the lives of patients and their families,” said Abhay Gandhi, CEO North America, Sun Pharma.

Sun Pharma to Acquire Concert Pharmaceuticals, Advancing the Potential Treatment of Alopecia Areata

Sun Pharmaceutical Industries Limited, with a site in Princeton, and Concert Pharmaceuticals, Inc. announced that they have executed a definitive agreement under which Sun Pharma will acquire all outstanding shares of Concert through a tender offer. Concert is a late-stage biotechnology company pioneering the use of deuterium in medicinal chemistry. Concert has an extensive patent portfolio, including its lead product candidate deuruxolitinib – an oral inhibitor of Janus kinases JAK1 and JAK2 for the treatment of Alopecia Areata, an autoimmune dermatological disease – which is in late-stage development. Concert has completed the evaluation of the efficacy and safety of deuruxolitinib in adult patients with moderate to severe Alopecia Areata in its THRIVE-AA Phase 3 clinical program and two open label, long-term extension studies are ongoing in Page 2 North America and Europe. 

Sun Pharma Launches Palbociclib, a Novel Targeted Therapy for Advanced Breast Cancer With a Unique Patient Assistance Program

Sun Pharmaceutical Industries, with a site in Princeton, announced that one of its wholly-owned subsidiaries has launched a novel anti-cancer drug, Palbociclib in India for patients who have advanced breast cancer, the most common cancer among women in the country. The company will make the drug available under the brand name, PALENO™ (Palbociclib) 75 mg, 100 mg, 125 mg. Kirti Ganorkar, CEO – India Business, Sun Pharma, said "We are introducing Palbociclib at an affordable price which will help improve patient access. PALENO™ will address the treatment need of several advanced breast cancer patients in India. For the first time, we are introducing a unique patient assistance program that will improve patient compliance and accessibility."

Bellerophon Therapeutics Announces Completion of Enrollment in Phase 3 REBUILD Study for INOpulse® in Fibrotic Interstitial Lung Disease

Warren-based Bellerophon Therapeutics, Inc. announced that the last patient has been enrolled in the ongoing Phase 3 REBUILD study of INOpulse®, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic interstitial lung disease (fILD). The company now expects to report pivotal top-line results in mid- 2023. “We are pleased to have completed enrollment in this important study sooner than previously anticipated, which represents a significant milestone for Bellerophon, our INOpulse clinical development program, and the fILD patient community. Based on the earlier than expected enrollment completion, we now expect to report top-line results from REBUILD in mid-2023,” said Naseem Amin, M.D., Chair of Bellerophon’s Board of Directors.

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody LECANEMAB for Early Alzheimer’s Disease in Japan

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 mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA). This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.  

Eisai Aims to Advance Gastrointestinal Cancer Treatment With Research Across Multiple Tumor Types at ASCO GI 2023

Nutley-based Eisai Co., Ltd. announced the presentation of research across various types of gastrointestinal cancers during the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. Notable data include an update from the dose-escalation part of a Phase 1 Study evaluating E7386, a CREB-binding protein (CBP) / β-catenin interaction inhibitor, in patients with advanced solid tumors including colorectal cancer. Based on these additional analyses, further investigation of safety, preliminary efficacy, pharmacokinetics and biomarker analyses of E7386 is ongoing using two dose levels in the expansion part. “Our findings across colorectal, esophageal, gastric and liver cancer illustrate Eisai’s commitment to further oncology research for people living with gastrointestinal cancers, who account for over one quarter of the global cancer incidence,” said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. 

embecta Opens New Global HQ Parsippany

embecta Corp., one of the largest pure-play diabetes care companies in the world following its April 1, 2022, spinoff from Becton, Dickinson and Company (“BD”), yesterday held a grand opening ceremony at its new global headquarters office at 300 Kimball Drive, Suite 300, in Parsippany. The site will be home to members of the company’s leadership team, global support functions and the North America commercial organization. embecta has approximately 2,000 employees worldwide. “We are a new company, but our roots in New Jersey go back nearly 100 years when, as part of BD, we developed the first dedicated insulin syringe in 1924. We’re looking forward to advancing that legacy as we continue to develop and provide solutions that make life better for people living with diabetes,” said Devdatt Kurdikar, President and CEO, embecta.

Outcomes Matter Innovations of Jersey City Names Founder Pecora its Chairman, CEO

Outcomes Matter Innovations announced that Dr. Andrew Pecora has been named Chair and CEO of OMI, and Benjamin Schoen has been named Executive Vice President and Chief Business Officer. Dr. Pecora, a BioNJ Board Member, an nationally recognized leader in health care innovation and the founder of the Jersey City-based firm, has been instrumental in the growth and success of the company since inception. Under Pecora’s leadership, OMI has developed and launched value-based care programs in ophthalmology, pulmonology and breast cancer, which have proven to maintain or improve clinical outcomes for patients and reduce the total cost of care for health plans and government payers. Mr. Schoen has 20 years of senior management experience in health care, most recently as the Managing Director, Network, and Senior Vice President at One Call Care Management.  

Catalent Appoints Experienced Pharma Leader as North American Biologics Operations Exec

Somerset-based Catalent announced it has appointed Ricardo Zayas as Senior Vice President, Operations, Biologics North America. Mr. Zayas will be responsible for all of the company’s North American biologics operations. He will serve on the Executive Leadership Team, reporting directly to Catalent CEO and President Alessandro Maselli. Mr. Zayas’ experience includes more than 30 years working in pharmaceutical manufacturing and operations leadership. He joins Catalent from Ocyonbio, a biosimilars, cell and gene and viral vector development and manufacturing company, where he was Chief Operating Officer. Prior to that, as executive Vice President and Head of Operations for Romark Pharmaceuticals, Mr. Zayas led the development and buildout of Romark’s new manufacturing facility in Puerto Rico. His career also includes seven years at Bristol Myers Squibb.

NJEDA to Host Information Session for Next Phase of the New Jersey Innovation Evergreen Fund

The New Jersey Economic Development Authority (NJEDA) will hold a virtual information session to provide venture capitalists, private equity investors and New Jersey startups with information on how they can access capital from the New Jersey Innovation Evergreen Fund (NJIEF). Established by Governor Phil Murphy’s New Jersey Economic Recovery Act of 2020, the NJIEF is a ground-breaking tool designed to grow the state’s innovation economy by catalyzing up to $600 million to support early stage innovation-focused businesses in New Jersey, while creating mentoring, networking and educational opportunities to help position these companies for success. An information session was held on January 26. A recorded version can be viewed at http://www.njeda.com/evergreen.  

BioCentriq Announces Successful Tech Transfer from Avenge Bio for Manufacturing of Drug Product AVB-001 Resulting in Dosing of First Patient in Phase 1/2 Clinical Trial

Newark-based BioCentriq announced that they have successfully completed tech transfer of AVB-001 from client Avenge Bio and initiated manufacturing of clinical grade material, which will support Avenge Bio’s ongoing phase 1/2 clinical trial. Additionally, Avenge Bio announced that they successfully dosed the first patient in a First-in-Human Phase 1/2 clinical trial evaluating AVB-001 in relapsed refractory ovarian cancer. AVB-001, developed in the LOCOcyte™ platform, consists of proprietary engineered allogeneic human cells. “We’re very enthusiastic about the advances our client has made in the development of their novel allogeneic cell therapy. Our goal now is to continue offering strong support and process development and manufacturing expertise as Avenge advances through their program,” said BioCentriq CEO Haro Hartounian, Ph.D.  

BioCentriq Releases Results of Study Designed to Test Transfection of T-cells Using Kytopen's Flowfect® Technology

Newark-based BioCentriq, Inc. announced that it has completed a study designed to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post transfection growth using Kytopen's Flowfect® technology. The results are published in a white paper, entitled "Efficient, Large-Scale Transfection of T-Cells Using Flowfect® Technology." The study and white paper were at the heart of the partnership formed between BioCentriq and Kytopen in 2021 with the stated goal of determining if simple and efficient non-viral manufacturing of cell therapies could be successfully executed in days versus weeks. During the study, which was conducted at BioCentriq by their process development team, cells were transfected with mRNA encoding for GFP, which was analyzed using flow cytometry as a measure of transfection efficiency.

NJIT Receives $1.3M in Federal Funding for Engineering, Manufacturing Initiatives

New Jersey Institute of Technology announced that on they will receive $1.3 million for new initiatives that will bolster engineering education, as well as manufacturing and mechatronics apprenticeship training under the federal spending bill signed by President Joe Biden. The two new NJIT initiatives include the community college pre-engineering network initiative, which will develop community college-serving programs to strengthen the pathway and readiness for traditionally underserved students to pursue a science, technology, engineering and mathematics degree. Also included is the advanced manufacturing and mechatronics workforce development initiative, which will provide upskilling to individuals from underserved and economically disadvantaged communities for in-demand jobs and will advance manufacturing capabilities throughout the State.

Rutgers M.D.-Ph.D. Student Wins National Research Competition

A one-size-fits-all approach to health care – especially when it comes to infertility – didn’t sit well with Leelabati “Leela” Biswas. So, the aspiring physician-scientist sought answers in a genetics lab at Rutgers University, New Brunswick. All those hours on Busch Campus paid off big time for Biswas: She’s the 2022 winner of the American Medical Association (AMA) Research Challenge. Biswas, who is pursuing a dual doctoral degree in medicine and microbiology and molecular genetics (M.D.-Ph.D.) from Rutgers Robert Wood Johnson Medical School, earned a grand prize of $10,000 for her research, “Decoding Pregnancy Loss, Validating a Novel Genetic Biomarker of Poor Egg Quality.”

Stevens, Rutgers, NJIT, Rowan Top N.J. Schools in U.S. News’ Best Online Programs Rankings

U.S. News & World Report released its 2023 Best Online Programs rankings. The rankings evaluate online bachelor’s and master’s degree programs at regionally accredited institutions. This year’s edition resulted in the largest number of programs ever included, at 1,832. The Best Online Programs include rankings of bachelor’s programs as well as the following master’s-level disciplines: MBA, business (non-MBA), computer science information technology (including computer science), criminal justice/criminology, education, engineering and nursing.

U.S. News said that, while the methodologies are different for each discipline, they all incorporate metrics specific to online learning. Take a look at how New Jersey schools ranked by clicking here.

Merck Digital Sciences Studio Announces the Launch of its First Cohort

Merck announced the launch of their first biopharmaceutical cohort through the Merck Digital Sciences Studio (MDSS), a collaboration between Merck, Microsoft for Start-ups and the New Jersey Innovation Institute, a New Jersey Institute of Technology (NJIT) subsidiary. The 10-month start-up accelerator program with direct investments from Merck Global Health Innovation Fund, Northpond Ventures, and McKesson Ventures will empower members and enable the generation of innovative digital technologies for drug discovery and development through hands-on mentorship, connection opportunities with industry leading partners, and training in an active entrepreneurial setting. The program includes workshops, mentorship, coaching, subsidized office space, and access to Microsoft's Founders Hub resources, including Azure Cloud computing credits.

Acebo Named Interim President of NJCU

New Jersey City University announced that Andres Acebo has been named interim President of the university. Mr. Acebo, a Hudson County native who grew up in Union City, has been serving as Executive Vice President and University Counsel. He was elevated to those roles amid NJCU’s current financial emergence. He has also served as Secretary to the Board of Trustees and helped guide its government relations initiative. The appointment is for 24 months for Mr. Acebo, who will be only the second Hispanic to serve as the leader of a public institution in the State, and, at 37, will apparently be the youngest President to ever lead a public university in New Jersey.

Healthgrades Names 9 NJ Hospitals as Best in the U.S.

Nine Garden State hospitals landed on Healthgrades’ newly released 2023 America’s Best Hospitals lists – with three also cracking the top 100 and two making it onto the top 50 rankings. The Healthgrades lists recognize the national leaders in overall clinical care and the top-ranked hospitals for specialty care by state. These rankings represent the top 1%, 2% and 5% of hospitals in the U.S. Hospitals on the list include Morristown Medical Center, Overlook Medical Center, Valley Hospital, Chilton Medical Center, Cooperman Barnabas Medical Center, Hackensack Meridian Health Bayshore Medical Center, Hackensack Meridian Health Jersey Shore University Medical Center, Hackensack Meridian Health Hackensack University Medical Center, Princeton Medical Center and Valley Hospital.

JPMorgan Chase Survey: Most Businesses Expect Recession in 2023

A New Report by BioNJ Member JPMorgan Chase

The majority of small and mid-size U.S. business leaders anticipate a recession in 2023, according to JPMorgan Chase’s 2023 Annual Business Leaders Outlook survey. In total, 65% of midsize businesses and 61% of small businesses expect a recession in the year ahead. The heightened recession expectations come as businesses nationwide continue to combat inflation. Nearly all mid-size businesses (91%) are experiencing inflation challenges, while 45% of small businesses list inflation as a top challenge for the year ahead, up from 20% one year ago.

BIO 2023 International Convention

June 5-8, 2023, Boston Convention Center

It’s never been more important to stand up for science, for biotech, for innovation. Join us June 5-8, 2003, in Boston for four days to explore the hottest industry topics, a vibrant exhibit floor, networking, BIO One-on-One Partnering^TM, and much more.