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US Copyright Office in spotlight as it plans to release three key reports in 2024 about its  copyright law and AI positions

—  The office is reviewing how centuries-old laws should apply to artificial intelligence technology, with both content creators and tech giants arguing their cases.

 

 

Cecilia Kang / New York Times:

 

For decades, the Copyright Office has been a small and sleepy office within the Library of Congress. Each year, the agency’s 450 employees register roughly half a million copyrights, the ownership rights for creative works, based on a two-centuries-old law.

 

In recent months, however, the office has suddenly found itself in the spotlight. Lobbyists for Microsoft, Google, and the music and news industries have asked to meet with Shira Perlmutter, the register of copyrights, and her staff. Thousands of artists, musicians and tech executives have written to the agency, and hundreds have asked to speak at listening sessions hosted by the office.

“We are now finding ourselves the subject of a lot of attention from the broader general public,” said Shira Perlmutter, the director of the Copyright Office. Credit — Jared Soares for The New York Times

 

The attention stems from a first-of-its-kind review of copyright law that the Copyright Office is conducting in the age of artificial intelligence. The technology — which feeds off creative content — has upended traditional norms around copyright, which gives owners of books, movies and music the exclusive ability to distribute and copy their works.

 

The agency plans to put out three reports this year revealing its position on copyright law in relation to A.I. The reports are set to be hugely consequential, weighing heavily in courts as well as with lawmakers and regulators.

 

“We are now finding ourselves the subject of a lot of attention from the broader general public, so it is a very exciting and challenging time,” Ms. Perlmutter said.

 

The Copyright Office’s review has thrust it into the middle of a high-stakes clash between the tech and media industries over the value of intellectual property to train new A.I. models that are likely to ingest copyrighted books, news articles, songs, art and essays to generate writing or images. Since the 1790s, copyright law has protected works so an author or artist “may reap the fruits of his or her intellectual creativity,” the Copyright Office declares on its website.

 

That law is now a topic of hot debate. Authors, artists, media companies and others say the A.I. models are infringing on their copyrights. Tech companies say that they aren’t replicating the materials and that they consume data that is publicly available on the internet, practices that are fair use and within the bounds of the law. The fight has led to lawsuits, including one by The New York Times against the ChatGPT creator OpenAI and Microsoft. And copyright owners are pushing for officials to rein in the tech companies.

 

“What the Copyright Office is doing is a big deal because there are important principles of law and lots and lots of money involved,” said Rebecca Tushnet, a professor of copyright and intellectual property law at Harvard Law School. “At the end of the day, the issue is not whether these models will exist. It’s who will get paid.”

The Copyright Office, part of the Library of Congress, has in the past weighed in on how copyright would apply to technological innovations like records, the internet and streaming music.  Credit — Jared Soares for The New York Times

 

Congress created the Copyright Office in 1870 to register licenses for books, maps, essays and other creative works and store those works for the use of lawmakers at the Library of Congress. The first registration was given to the “Philadelphia Spelling Book,” a children’s language book.

When Ms. Perlmutter, a veteran copyright official and former intellectual property lawyer for Time Warner, was appointed to lead the Copyright Office in late 2020, she promised to bring the office into the modern era by focusing on big tech trends. She took inspiration from previous leaders, who dealt with technological innovations including the camera, records, Xerox machines, the internet and streaming music, all of which required the office to weigh in on how copyright would apply and advise Congress on proposed updates to the law.

 

Right away, A.I. became a hot topic. Stephen Thaler, a computer scientist, tried to register an A.I.-generated art piece for a copyright by submitting an application on the Copyright Office’s website. In 2019, the office rejected his first attempt to register the piece, a pixelated scene of train tracks running through a tunnel overgrown with brush and flowers called “A Recent Entrance to Paradise.” In February 2022, Ms. Perlmutter declined his second attempt to register the piece on the same grounds: Copyrights were given only to original works created by humans.

 

The decision — a first on an A.I.-produced work — set an important precedent. Artists and lawmakers flooded Ms. Perlmutter’s office with emails and phone calls asking her to also intervene in the way A.I. companies were using copyrighted material to train their systems.

 

In August, she opened the formal review of A.I. and copyright law. The office said it would examine whether the use of intellectual property to train A.I. models violated the law and would look more deeply into whether machine-generated works could be eligible for copyright protections. The office said it would also review how A.I. tools were creating content that used the names, images and likenesses of individuals without their consent or compensation.

 

“The attention on A.I. is intense,” Ms. Perlmutter said in an interview. “The current generative A.I. systems raise a lot of complicated copyright issues — some have called them existential — that really require us to start grappling with fundamental questions about the nature and value of human creativity.”

 

The interest in the office’s review was overwhelming. The office solicited public comments on the topic and received more than 10,000 responses on a form on its website. A typical policy review gets no more than 20 comments, the office said.

 

Tech companies argued in comments on the website that the way their models ingested creative content was innovative and legal. The venture capital firm Andreessen Horowitz, which has several investments in A.I. start-ups, warned in its comments that any slowdown for A.I. companies in consuming content “would upset at least a decade’s worth of investment-backed expectations that were premised on the current understanding of the scope of copyright protection in this country.”

 

OpenAI, Microsoft, Meta (Facebook’s parent) and Google are currently relying on a 2015 court decision in a case filed by the Authors Guild.

 

The guild sued Google in 2005 for scanning books to use in excerpts in its search engine results and to share with libraries. A court ruled that Google had not violated copyright law. It said that the scanning of entire books was permissible because Google didn’t make the full book available and that it was “transformative” use of copyrighted material. Google relied on an exemption to copyright law known as “fair use” that allows limited replication of copyrighted material for things like criticism, parody or other transformational uses.

 

Google, Meta and the A.I. start-up Anthropic all echoed arguments from that case in their comments to the Copyright Office, including that A.I. copies the information to analyze data, not repurpose it for creative works.

 

Authors, musicians and the media industry argued that by taking their content without permission or licensing payments, the A.I. companies were robbing them of their livelihoods.

 

“The absence of consent and compensation in this process is theft,” Justine Bateman, the “Family Ties” actress and author, wrote in comments to the Copyright Office.

 

News Corp, which publishes The Wall Street Journal and The New York Post, implored the office to “not lose sight of this simple truth: Protecting content creators is one of copyright law’s core missions.” (The Times also submitted a comment).

 

Ms. Perlmutter said she and a staff of about two dozen copyright lawyers were going through each comment filed to the office.

 

Still, the office may not offer clear-cut views that will satisfy either the tech companies or creative people.

 

“As technology gets more and more sophisticated, the challenges are exponentially more difficult and the risks and rewards are exponentially greater,” Ms. Perlmutter said.

 

 

 

Read more

 

 

— Techmeme

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The AACCNJ plans to host a Town Hall Meeting to address  ‘The Fierce Urgency of Now’ — A Presentation on the State’s Disparity Study

TRENTON, N.J. —  “The African American Chamber of Commerce of New Jersey (AACCNJ) will host a town hall meeting topic: “The Fierce Urgency of Now” – A Presentation on the State’s newly released Disparity Study, conducted by Mason Tillman Associates, LTD.

 

The Town Hall Meeting will be held at The Crowne Plaza Princeton, N.J. on Feb. 6 from 3 to 5 p.m., and is a free event. The Presentation will be led by Dr. Denise Anderson, Founder & CEO, Denise Anderson & Associates (DA&A) LLC, moderated by John E. Harmon, Sr., IOM, Founder, President & CEO, AACCNJ, and will include a Q&A session with the audience.

 

“The Study, as expected, revealed that African American businesses received little of the $ 18.5 billion the Murphy administration spent on contracts for construction, professional services and goods and services from 2015 to 2020,” said John E. Harmon, Sr.

 

“While expecting the worst, little did we know that the Study would document African Americans received less than one (1) percent of the $18.5 billion dollars the State awarded to contractors. African American businesses received a pittance despite the fact that we represent, 14 percent of the population, and over 10 percent of the businesses in New Jersey willing and able to contract with the State.”

 

The Study also documented that all ethnic groups received fewer contracts than expected given the number of New Jersey businesses owned by people of color. More than 25 percent of the businesses the Study identified as willing and able to contract with the State were owned by African Americans, Asian Americans, Hispanic Americans, and Native Americans.

 

“Now that the State’s commissioned study has documented the institutional discrimination our members have long experienced, we must demand that the Murphy Administration immediately establish a race and gender-based program with minority and woman-owned business utilization goals to end the discriminatory practices in its award of contracts,” said Harmon.

 

“As we move forward, we ask the Governor and his administration to also hold a statewide meeting, to discuss the results of the disparity study,” said Harmon.

 

“We plan to work in partnership with the State to put forth best practices that will provide the constituency of the AACCNJ, and others, with consistent access to opportunities and resources that they can leverage to strengthen their enterprises and ideals while mitigating past underperformance,” said Harmon.

“Our mutual goal henceforth is to have a more equitable participation in every area of the public sector wherein economic opportunities exist.”

 

“These times remind me of words that were expressed by the late Dr. Martin Luther King, Jr.: “The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy,” said Harmon.

 

 

About the African American Chamber of Commerce of New Jersey

The AACCNJ performs an essential role in the economic viability of New Jersey. While providing a platform for New Jersey’s African American business leaders, to speak with a collective voice, the AACCNJ advocates and promotes economic diversity fostering a climate of business growth through major initiatives centering on education and public policy. The Chamber serves as a proactive advocacy group with a 501(c) 3 tax exemption, which is shared by the National Black Chamber of Commerce.

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The AACCNJ responds to the press announcement of the Murphy Administration’s Disparity Study

TRENTON, N.J. —  The African American Chamber of Commerce of New Jersey (AACCNJ) responds to the release of the Murphy Administration’s Disparity Study.

The Office of Diversity and Inclusion oversaw the effort, which was the first study of its kind to be commissioned by the State since 2003. It was conducted by Mason Tillman Associates, LTD.

Gov. Murphy recently signed a package of legislation into law in Trenton. (Rich Hundley III/ NJ Governors Office).

“On behalf of the 1.2 million black residents and over 88,000 black owned businesses in the state of New Jersey, the announcement of the completion of the disparity study, is the news that we have been patiently awaiting and have prepared our hearts and minds to receive,” said John E. Harmon, Sr., IOM., Founder, President & CEO, African American Chamber of Commerce of N.J. (AACCNJ).

“Acknowledgement is an essential step to establishing the proper pathway to a credible coexistence. Today’s announcement serves as confirmation of what we all knew, and we are eagerly looking forward to a focused strategic alignment with the Murphy Administration, said Harmon.”

“This study speaks to the intolerance for equitable participation in taxpayer funded opportunities resulting in wide social and economic disparities that cannot be glossed over. It is incumbent on this administration, and the legislature, to not try to appease Black and Brown People with well-crafted conciliatory statements given the magnitude of harm we have been dealt with over the years,” said John E. Harmon, Sr.

“As I read through the pages of the Disparity Study it is difficult for me to conclude that there was not a greater degree of awareness, which should have led our leaders to figure out how they could have procured more opportunities to make our state more equitable, while we awaited the completion of the Mason Tillman Study,” said Harmon.

“There were substantial gains for contract awardees and elected officials since 2015 and the economic benefits for Blacks and Brown people in our state have not been reciprocated. The Port Authority of New York and New Jersey completed its disparity study in 2017 with results that were almost identical. Herein, a lost opportunity to apply best practices to really produce a Stronger and Fairer Economy,” said Harmon.

“We just celebrated in the past week, what would have been the 95th birthday of Rev. Dr. Martin Luther King, Jr., his powerful words have even greater significance today,” said John E. Harmon, Sr.

“An individual has not started living fully until they can rise above the narrow confines of individualistic concerns to the broader concerns of humanity. Every person must decide, at some point, whether they will walk in the light of creative altruism, or in the darkness of destructive selfishness,” Dr. Martin Luther King Jr., Montgomery, AL. Aug. 11, 1957.

“As we move forward, we plan to work in partnership with the State to put forth best practices that will provide the constituency of the AACCNJ, and others, with consistent access to opportunities and resources that they can leverage to strengthen their enterprises and ideals while mitigating past underperformance,” said Harmon. “Our mutual goal henceforth is to have a more equitable participation in every area of the public sector wherein economic opportunities exist.”

“We put forth a call to action for your continued support of the AACCNJ, so that we may continue to advocate for a more equitable share of the state’s balance sheet, we have been a leading voice in the advocacy for the completion of this disparity study since our inception in 2007”, said Harmon. “We now claim a seat at the table to ensure that reciprocity, and recompense become a reality with what Dr. King called “the fierce urgency of Now,” on behalf of our constituents and the beloved community. Let us combat selfishness, which is self-destructive behavior, not providing opportunities for those with the capabilities to contribute to the success of the state; let us embark on a new chapter of authentic and transparent collective collaboration.

Background and timeline

Dec. 23, 2020 “The Department of the Treasury announced several key initiatives on Wednesday that will advance the Murphy Administration’s commitment to ensuring Minority-, Women-, and Veteran-Owned Businesses (MWVOB) can more fully participate in New Jersey’s multi-billion-dollar supply chain.1

“Chief among these initiatives is the commissioning of the first disparity study in 20 years to measure current spend data, which is viewed as key to identifying and opening up new opportunities for MWVOBs to contract with the State of New Jersey to provide goods and services. The disparity study has been a priority for the Murphy Administration from day one.”2

“This disparity study is not only long overdue, it is an integral part of our vision for a stronger, fairer, and more resilient, post-COVID economy that opens doors for diverse businesses to play a greater role in shaping our state’s future,” said Governor Phil Murphy. “This study will provide us with an opportunity to create a more equitable business environment, which is a win for us all.”3

“Recognizing how long it has been since the last study was conducted, we tried to ensure that this new study will capture as much data as possible, beyond just statistics that are available on our spend, but also including outreach to stakeholders and community groups as well,” said Treasurer Muoio. “This will give us the tools and the information necessary to determine where our strengths and weaknesses lie so we can implement more equitable procurement strategies moving forward. The state has a vast supply chain of goods, commodities, and professional and financial services and in a truly equitable society every qualified vendor in our state should have the opportunity to participate in the economy fueled by their tax dollars.”4

The goal, as laid out in the bid solicitation, is to research, structure, and conduct a comprehensive and legally defensible disparity study of the State’s contract awards in construction, goods, and services over a five year period (July 1, 2015 through June 30, 2020) to determine whether there is a disparity between the number of qualified minority, women, and veteran-owned businesses ready, willing, and able to perform services, and the number of vendors/contractors actually engaged to perform such services. The Disparity Study will include a review of contracts for construction, goods, commodities, and services and shall be appropriately structured so that the state may, if appropriate, use the information to fashion race- and/or gender-neutral, and if necessary, race- and gender-conscious methods of achieving those goals for state contracts and employment by state vendors.5

The State of New Jersey held a series of virtual business community meetings on Sept. 20, 21, and 22, 2021 regarding its disparity study. AACCNJ’s member organizations participated in the meetings conducted by Mason Tillman Associates.

Jan. 9, 2023. “In spite of so many challenges, black businesses continue as the fastest-growing business segment of our country, so we remain very hopeful. With 94% of the black vote going to Governor Murphy in his last statewide election, we look forward to learning more about the tangible actions he will take in the second half of his final term to help level the playing field for all of us, said John E. Harmon, Sr. “Notably, we eagerly anticipate the announcement and projected timeline on a statewide Disparity Study that will further identify barriers and inequalities within our communities and take them head on.”

“These times remind me of words that were expressed by the late Dr. Martin Luther King, Jr.: “The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy,” stated John E. Harmon, Sr. “We are now in those times once again and the optimal outcomes can be realized when the rules of engagement are clearly defined, and the playing field is available to all to compete effectively with value being the declared goal. In conclusion, the data in this study confirms that Black people are still at the bottom.”

 

1 https://www.nj.gov/treasury/news/2020/12232020.shtml

2 https://www.nj.gov/treasury/news/2020/12232020.shtml

3 https://www.nj.gov/treasury/news/2020/12232020.shtml

4 https://www.nj.gov/treasury/news/2020/12232020.shtml

 

About the African American Chamber of Commerce of New Jersey

The AACCNJ performs an essential role in the economic viability of New Jersey. While providing a platform for New Jersey’s African American business leaders, to speak with a collective voice, the AACCNJ advocates and promotes economic diversity fostering a climate of business growth through major initiatives centering on education and public policy. The Chamber serves as a proactive advocacy group with a 501(c) 3 tax exemption, which is shared by the National Black Chamber of Commerce.

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New Jersey Housing and Mortgage Finance Agency celebrates 40 years of service

TRENTON, N.J. — On Jan. 17, 2024, the New Jersey Housing and Mortgage Finance Agency (NJHMFA) celebrates its 40th anniversary.

Since its founding 40 years ago, NJHMFA’s programs have directly benefited hundreds of thousands of New Jersey residents by providing affordable housing options and vital mortgage assistance.

Through the Low-Income Housing Tax Credit program, NJHMFA has financed 70,000 apartments, over 66,000 of which are affordable to low- and moderate-income households. Another 112 new multifamily developments are underway, which together will bring online another 9,000 affordable units. NJHMFA has helped more than 10,000 families buy their first home, representing more than $2 billion in market value at the time of purchase and nearly the same again in wealth created through equity.

NJHMFA has also helped more than 56,000 families facing housing instability by providing counseling and financial assistance. Beyond the numbers, NJHMFA’s work has improved thousands of lives: families have found stable homes, neighborhoods have been revitalized, and individuals have found support in their time of greatest need. Against this backdrop, NJHMFA’s 40th anniversary commemorates not only the Agency’s work, but the substantial impact investment in New Jersey’s residents can have on our communities and our future.

“For 40 years, the New Jersey Housing and Mortgage Finance Agency has helped many thousands of New Jerseyans become new homeowners,” said Governor Murphy.

“Our Administration’s partnership with NJHMFA has been essential to creating access to more affordable housing throughout our state. As the agency reaches this incredible milestone of an anniversary, we recognize the many programs the agency has created to make the American dream attainable for so many in our state.”

“NJHMFA exists to make New Jersey housing affordable to all New Jerseyans, and for 40 years, it has delivered. We have deployed innovative programs, policies, and partnerships, becoming a nationally recognized leader in affordable housing development and producing numerous award-winning and landmark properties,” said Executive Director Melanie Walter.

“NJHMFA is proud of the positive impact that we have on the lives of all New Jerseyans, particularly those looking for apartments or first homes that are affordable to them in the communities where they want to live. We look forward to continuing to support community development and revitalization in the years ahead.”

“Congratulations to the New Jersey Housing and Mortgage Finance Agency (NJHMFA) on 40 years of progressive and innovative work making communities more diverse, and municipalities economically stronger,” said DCA Acting Commissioner Jacquelyn A. Suárez.

“Today, New Jersey families and individuals with specialized housing needs have more options when seeking safe, affordable, and stable rental housing and homeownership opportunities. Without a doubt, New Jerseyans will continue to benefit from NJHMFA’s transformative work in the future.”

NJHMFA was created by an act of the New Jersey legislature merging the New Jersey Housing Finance Agency (HFA) and the New Jersey Mortgage Finance Agency (MFA) into a single organization to house the state’s affordable housing production capacity for both multifamily and single-family housing. Today, NJHMFA oversees a multifamily production portfolio that has grown to exceed $1.3 billion each year, and an approximately $1 billion annual single-family mortgage program. Over the past 40 years, NJHMFA has become the New Jersey state allocator of the federal Low-Income Housing Tax Credit (LIHTC), the host of the state’s preeminent down payment assistance program for new homebuyers, and the administrator of federal assistance programs designed to protect homeowners against the impacts of economic downturns.

Through the LIHTC program, created in 1984, NJHMFA has financed the creation or preservation of over 75,000 affordable apartments across 1,010 properties, with 66,000 of these units already completed and another 9,000 units forthcoming. These projects have provided thousands of low- and moderate-income residents throughout the state with safe and high-quality homes, cumulatively generated billions of dollars in the direct and indirect economic impacts of new construction, supported thousands of jobs, and helped municipalities advance their community development goals.

At the same time, NJHMFA has consistently expanded homeownership opportunities for low- and moderate-income households. Since the 2017 expansion in single-family programs, NJHMFA has allocated over $100 million in down payment and closing cost assistance to approximately 10,000 first-time low-and moderate-income homebuyers. These borrowers were able to make home purchases cumulatively valued at over $2 billion. Despite the challenges of recent interest rate hikes, this initiative has continued to grow, assisting about 2,500 households in 2023 alone. That same year, NJHMFA created a program specifically tailored to the needs of first-generation homebuyers, making New Jersey one of only a handful of states to offer such assistance.

In addition to creating multifamily housing opportunities and offering access to homeownership opportunities, NJHMFA works to effectively protect quality of life throughout the state by preventing the loss of homeownership. When the housing market collapsed in 2008, NJHMFA provided more than $320 million to over 8,000 impacted homeowners, as well as housing counseling that helped struggling homeowners avoid foreclosure. More than 56,000 New Jersey families have benefitted from NJHMFA’s free housing counseling initiatives. When the COVID-19 pandemic struck, NJHMFA developed the federally funded ERMA program, which has distributed more than $150 million to help more than 5,000 homeowners avoid foreclosure so far.

As NJHMFA marks its 40th anniversary, it uses the lessons of the past to shape its clear vision for the future. The Agency seeks to expand its impact, leveraging data resources, technology, and state and federal resources to meet the many diverse housing needs in evidence across the state. It will continue building strong community and development partnerships, optimizing resources, and addressing emerging housing issues proactively. In these ways, NJHMFA will remain at the forefront of New Jersey affordability, accessibility, and sustainability, supporting NJ residents and fostering community well-being in the decades ahead.

About Us: The New Jersey Housing and Mortgage Finance Agency (NJHMFA) advances the quality of life for residents of and communities throughout New Jersey by investing in, financing, and facilitating access to affordable rental housing and homeownership opportunities for low and moderate-income families, older adults, and individuals with specialized housing needs. To learn more about NJHMFA, visit: https://NJHousing.gov/

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New Jersey American Water files rate request driven by over $1.3 billion in investment

Request reinforces company’s commitment to providing safe, clean reliable and affordable service

 

CAMDEN, N.J. — (BUSINESS WIRE) — New Jersey American Water filed a petition Monday with the New Jersey Board of Public Utilities (BPU) requesting new rates, driven by more than $1.3 billion in capital investments through December 2024, to continue providing safe and reliable service.

 

The company continues to make needed investments to replace aging infrastructure, meet water quality and environmental regulations, provide resiliency of operations, increase fire protection, and meet customers’ other water and wastewater service needs.

 

“Our approach to long-term, efficient and consistent investments in our water and wastewater systems helps us continue to deliver high-quality, reliable service and fire protection for the more than 2.8 million people in 18 counties we serve. As the state’s largest water and wastewater utility, we believe it is essential that the service we provide is safe, complies with state and federal water quality regulations; reliable, so that it is resilient in the face of floods, droughts, and other weather-related impacts; and affordable,” said Mark McDonough, president of New Jersey American Water.

 

“One of the steps we are taking to address affordability is proposing a universal affordability tariff to expand our customer assistance program.”

 

If the company’s proposed rates are approved as requested, the water bill for the average residential customer using 5,640 gallons per month would increase about $11.30 per month. The average monthly residential wastewater bill would increase about $6.16 per month. The new affordability tariff, if approved by the BPU, would provide a 20 to 80 percent monthly bill reduction for income-eligible customers.

 

New Jersey American Water’s investment in replacing or rehabilitating nearly 176 miles of aging water mains is included in this rate request. Additional critical infrastructure projects included in the rate request are improvements to the company’s seven surface water treatment plants serving nearly all customers statewide; investments in its treatment facilities to comply with regulations for PFAS; replacement of aging, critical, large-diameter transmission mains and several large-scale pipeline replacement projects throughout the state to improve system reliability; replacement of thousands of utility-owned lead and galvanized service lines statewide; additional advanced leak detection technology; replacement or upgrades to improve reliability and efficiency at dozens of wells, pumping stations and other critical facilities statewide; and sewer system upgrades to meet environmental regulations throughout the company’s service areas.

 

The company’s rate request undergoes extensive public scrutiny by the BPU, the New Jersey Division of Rate Counsel, and the Office of Administrative Law. This process includes numerous interrogatories, public hearings and evidentiary hearings and can take nine months or more. To increase transparency of the process, the company’s petition and its associated exhibits are being posted to the Company’s website, newjerseyamwater.com, under Customer Service & Billing, Your Water and Wastewater Rates.

 

New Jersey American Water is seeking a total annual revenue increase of approximately $161.7 million. The increased rates proposed in the petition are a request only. The BPU will make the final decision regarding the actual increase. Once a final decision has been made, customers will receive information on the new rates in the mail and on the company’s website.

 

About American Water

American Water (NYSE: AWK) is the largest regulated water and wastewater utility company in the United States. With a history dating back to 1886, We Keep Life Flowing® by providing safe, clean, reliable and affordable drinking water and wastewater services to more than 14 million people with regulated operations in 14 states and on 18 military installations. American Water’s 6,500 talented professionals leverage their significant expertise and the company’s national size and scale to achieve excellent outcomes for the benefit of customers, employees, investors and other stakeholders. For more information, visit amwater.com and join American Water on LinkedIn, Facebook, X (formerly Twitter) and Instagram.

 

About New Jersey American Water

New Jersey American Water, a subsidiary of American Water, is the largest investor-owned water utility in the state, providing high-quality and reliable water and wastewater services to approximately 2.8 million people. For more information, visit www.newjerseyamwater.com and follow New Jersey American Water on Facebook, X (formerly Twitter), Instagram, and LinkedIn.

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Contacts

Media Contact:
Denise Venuti Free

Senior Director of Communications & External Affairs

New Jersey American Water

Denise.Free@amwater.com

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Second TSMC factory for Arizona faces delays as US grants remain in flux

— The firm’s first fab in Arizona has been pushed back to 2025

— Biden White House has yet to hand out promised chip subsidies

 

Bloomberg:

 

Taiwan Semiconductor Manufacturing Co. announced another delay to its $40 billion site in Arizona, dealing a further blow to the Biden administration’s plans to boost manufacturing of critical components on U.S. soil.

Executives said their second plant in Arizona, whose shell is now being built, will start operations in 2027 or 2028, later than TSMC’s prior guidance of 2026. That’s after the company in July announced a delay to the first site, now due to start making 4-nanometer chips only in 2025, citing a lack of skilled labor and higher costs.

“Our overseas decisions are based on customer needs and the necessary level of government subsidy, or support,” Chairman Mark Liu said during TSMC’s earnings conference in Taipei on Thursday. The company’s upbeat outlook for the year drove a rally in chip stocks across Asia on Friday, with TSMC shares up as much as 6.3%.

Previously, TSMC had said it will make 3nm chips at the second factory, which is expected to be more advanced than the first in Arizona. But on Thursday, the company said that incentives from the U.S. government will help determine how advanced the tech inside will be, adding uncertainty to the project’s outcome.

Because of the setback with the first fab, TSMC has delayed its second factory too, according to Chief Financial Officer Wendell Huang. The Taiwanese chipmaker is in talks with the U.S. government about incentives and tax credits, Liu said. He also reiterated TSMC was working with the local union and trade partners in the state. The company has faced resistance to plans to bring in technicians from Taiwan for the construction project.

Pushing back the start of the second fab could mean a delay of as much as two years, time enough for semiconductor tech to advance by one generation.

More than a year after U.S. President Joe Biden signed the Chips and Science Act into law — which is supposed to provide tens of billions of dollars in subsidies to chipmakers expanding in the U.S. — the administration has yet to hand out any grants to major chipmakers like TSMC or Intel Corp. It has so far only provided some modest financial support to two minor industry players.

By contrast, TSMC publicized its plans for a more modest plant in Japan later than its Arizona project, but it has already received funds from the Japanese government. The facility is on track to start production in late 2024, according to the latest update the company provided.

 

— Techmeme

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The EU Council, Parliament reach a provisional deal on Anti-Money Laundering for crypto companies

—  Crypto firms have to do checks on transactions of 1,000 euro or more, and the framework adds measures to mitigate risks in transfers with self-hosted wallets

 

 

Sandali Handagama / CoinDesk:

 

 

Policymakers in the European Union on Wednesday reached a provisional deal on parts of a comprehensive regulatory package to combat money laundering that will force all crypto firms to run due diligence on their customers.

 

The Anti-Money Laundering Regulation (AMLR) is a broad-stroke effort to combat sanctions evasion and money laundering. It includes the creation of a single rulebook and sets up a supervisory authority that will also have purview over the crypto sector.

 

The European Parliament and Council (which gathers finance ministers from the bloc’s 27 member states) have agreed to measures, including for crypto firms to apply “customer due diligence measures when carrying out transactions amounting to €1,000 ($1,090) or more.”

 

The deal also adds measures to mitigate risks in relation to transactions with self-hosted wallets, Wednesday’s announcement said.

 

The EU last year finalized specific AML checks on crypto fund-transfers alongside its landmark Markets in Crypto Assets (MiCA) regulation. In December, the European Parliament and Council agreed on setting up the AML supervisory authority. Wednesday’s agreement specifically concerned the EU’s sixth money-laundering directive and the rulebook as part of the AMLR.

 

The package may have got tougher as it went through the EU’s complex legislative process in light of U.S. sanctions against crypto anonymizing tool Tornado Cash, as well as fears that crypto was being used to evade sanctions by Russia and even Hamas. A lawmaker leading the discussions on the package in Parliament last year assured the measures won’t seek to outlaw privacy-enhancing crypto.

 

Industry body, the EU Crypto Initiative, urged lawmakers in May 2023 to remove planned restrictions on privacy-preservation tools or, failing that, to include a “clear delineation between prohibited anonymous high-risk accounts and high-risk anonymizing instruments.”

 

“This agreement is part and parcel of the EU’s new anti-money laundering system. It will improve the way national systems against money laundering and terrorist financing are organized and work together. This will ensure that fraudsters, organized crime and terrorists will have no space left for legitimizing their proceeds through the financial system,” Belgian Minister of Finance, Vincent Van Peteghem, said in a press statement.

 

 

 

— Techmeme

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FDA approves Merck’s KEYTRUDA® (pembrolizumab) plus chemoradiotherapy as treatment for patients with FIGO 2014 Stage III-IVA cervical cancer

KEYTRUDA is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients

Approval marks third FDA-approved indication for KEYTRUDA in cervical cancer and 39th indication for KEYTRUDA in the US

 

 

RAHWAY, N.J. — (BUSINESS WIRE) — $MRK #MRK — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, on Monday announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

 

The approval is based on data from the Phase 3 KEYNOTE-A18 trial, in which KEYTRUDA plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group. This approval marks the third indication for KEYTRUDA in cervical cancer and the 39th indication for KEYTRUDA in the U.S.

 

“Today’s approval of KEYTRUDA plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer,” said Dr. Bradley Monk, oncologist and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine. “This KEYTRUDA-based regimen offers a new treatment option for these patients, so today’s approval has important implications for the way we treat them moving forward.”

 

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

 

“Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “This approval provides newly diagnosed patients with an anti-PD-1-based treatment option that has the potential to reduce the risk of disease progression or death compared to chemoradiotherapy alone.”

 

In the U.S., KEYTRUDA has two additional approved indications in cervical cancer: in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test; and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

 

Study design and additional data supporting the approval

KEYNOTE-A18, also known as ENGOT-cx11/GOG-3047, is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT04221945) sponsored by Merck and conducted in collaboration with the European Network for Gynaecological Oncological Trial (ENGOT) groups and the GOG Foundation, Inc. (GOG) investigating KEYTRUDA in combination with CRT (cisplatin and external beam radiotherapy [EBRT] followed by brachytherapy [BT]). The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer. There were 596 patients with FIGO 2014 Stage III-IVA cervical cancer (tumor involvement of the lower vagina with or without extension onto pelvic sidewall or hydronephrosis/non-functioning kidney or has spread to adjacent pelvic organs) with either node-positive or node-negative disease, and 462 patients with FIGO 2014 Stage IB2-IIB cervical cancer (tumor lesions >4 cm or clinically visible lesions that have spread beyond the uterus but have not extended onto the pelvic wall or to the lower third of vagina) with node-positive disease; two patients had FIGO 2014 Stage IVB disease. Patients were randomized (1:1) to receive either:

  • KEYTRUDA (200 mg intravenously [IV]) every three weeks (Q3W) for five cycles concurrent with cisplatin (40 mg/m2 IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by KEYTRUDA (400 mg IV) every six weeks (Q6W) for 15 cycles;
  • Placebo IV Q3W for five cycles concurrent with cisplatin (40 mg/m2 IV) weekly for five cycles (an optional sixth infusion could be administered per local practice) and radiotherapy (EBRT followed by BT), followed by placebo IV Q6W for 15 cycles.

 

Treatment continued until RECIST v.1.1-defined progression of disease as determined by investigator or unacceptable toxicity. Assessment of tumor status was performed every 12 weeks from completion of CRT for the first two years, followed by every 24 weeks in year three, and then annually. The major efficacy outcome measures were PFS as assessed by investigator according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, or histopathologic confirmation, and overall survival (OS).

 

The trial demonstrated a statistically significant improvement in PFS in the overall population. In an exploratory subgroup analysis for the 462 patients (44%) with FIGO 2014 Stage IB2-IIB disease, the PFS HR estimate was 0.91 (95% CI, 0.63-1.31), indicating that the PFS improvement in the overall population was primarily attributed to the results seen in the subgroup of patients with FIGO 2014 Stage III-IVA disease. Overall survival data were not mature at the time of PFS analysis, with 10% deaths in the overall population.

 

In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303). Median PFS was not reached in either arm. The 12-month PFS rate was 81% (95% CI, 75-85) for KEYTRUDA plus CRT versus 70% (95% CI, 64-76) for placebo plus CRT.

 

The median duration of exposure to KEYTRUDA was 12.1 months (range, 1 day to 27 months). Fatal adverse reactions occurred in 1.4% of 292 patients receiving KEYTRUDA in combination with chemoradiotherapy, including one case each (0.3%) of large intestinal perforation, urosepsis, sepsis, and vaginal hemorrhage. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with CRT. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with CRT. Serious adverse reactions occurring in ≥1% of patients included urinary tract infection (2.7%), urosepsis (1.4%), and sepsis (1%). KEYTRUDA was discontinued for adverse reactions in 7% of patients. The most common adverse reaction (≥1%) resulting in permanent discontinuation was diarrhea (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 43% of patients; the most common adverse reactions leading to interruption of KEYTRUDA (≥2%) were anemia (8%), COVID-19 (6%), SARS-CoV-2 test positive (3.1%), decreased neutrophil count (2.7%), diarrhea (2.7%), urinary tract infection (2.7%), and increased alanine aminotransferase (2.4%). The most common adverse reactions (≥10%) among patients receiving KEYTRUDA were nausea (56%), diarrhea (50%), vomiting (33%), urinary tract infection (32%), fatigue (26%), hypothyroidism (20%), constipation (18%), decreased appetite and weight loss (17% each), abdominal pain and pyrexia (12% each), hyperthyroidism, dysuria and rash (11% each), and pelvic pain (10%).

 

About cervical cancer

Cervical cancer forms in the cells lining the cervix, which is the lower part of the uterus. While screenings and prevention have resulted in declining cervical cancer rates, the disease continues to affect many people in the U.S. and around the world. Cervical cancer is the fourth most common cancer in women globally. In the U.S., it is estimated there were approximately 13,960 new cases of invasive cervical cancer and about 4,310 deaths from cervical cancer in 2023.

 

About KEYTRUDA® (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

 

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

 

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Cervical Cancer

KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer.

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.

Selected Important Safety Information for KEYTRUDA

 

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

 

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

 

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

 

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

 

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

 

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

 

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

 

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

 

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

 

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

 

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

 

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-M

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

John Infanti

(609) 500-4714

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

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AACCNJ welcomes new management for two of its boards in 2024

TRENTON, N.J. —  The AACCNJ announced that Gary Mann, CEO of Jasfel Analytics, and Viviana Lamm, CEO of Risk Strategies, will serve as Chairman and Chair of the AACCNJ Board of Directors and Foundation Board of Directors, respectively.

 

Tammeisha Smith, CEO, Dunbar Center will serve as Vice Chair of the Board of Directors. The appointments were effective Jan. 1, 2024.

 

“I am truly honored and humbled to step into the role of Chairman of the Board. Stan Prater has been an exemplary steward and leader, and I extend my sincere gratitude to him,” said Gary Mann, CEO, Jasfel Analytics.

 

“As I assume this responsibility, I am mindful of the extraordinary work of John Harmon, Founder and CEO. Standing on the shoulders of both Stan and John, I am committed to building on their incredible legacy. Together, with the continued guidance of John, we will further advance and expand revenue generating opportunities and strategic relationships for African American businesses in New Jersey and beyond,” said Viviana Lamm, CEO, Risk Strategies.

 

“I am beyond honored, grateful and inspired to be a part of a forward moving organization that is driven by the triumph of a collective team of individuals that recognize diversity and difference yet having the ability to bring people together and create bridges between them. I intend to ensure active participation, encourage and give back to meet the commitment and common goals of our organization. I look forward to learning from our directors and board members as we forge forward.”

 

“As we look ahead, I am inspired by the collective strength and diversity of talent within our membership. I firmly believe that our success is interlinked with the success of every member,” said Tammeisha Smith, CEO, Dunbar Center.

 

“Therefore, I encourage active participation, constructive feedback, and a shared commitment to our common goals. Together, we will chart a course that not only sustains our present momentum but also paves the way for a brighter, more prosperous future.”

 

“We are grateful to former Chairman Stan Prater for his leadership to excellence, growth and sustainability over his tenure, he definitely made an impact on our organization,” said John E. Harmon, Sr., IOM, Founder, President, & CEO, AACCNJ.

 

“And to our incoming Chairman, Gary Mann, and Foundation Board Chair Lamm, and Vice Chair Smith, there remains a tremendous amount of work to be done and each of you possess the commitment and unique skills necessary to get the job done with excellence. I look forward to working with each of you to design strategies that will derive value for our members and those that invest in the mission of AACCNJ while concurrently contributing to the competitiveness of New Jersey.”

 

The official Changing of the Guard ceremony/reception will take place on Jan. 18th from 6 p.m. to 8 p.m. at the Lobby Club in Trenton, N.J. Members only, may register at www.aaccnj.com.

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AACCNJ honors the legacy and memory of Rev. Dr. Martin Luther King, Jr.

Martin Luther King on Black Economic Empowerment
(Coca Cola Boycott 1968)

 

Martin Luther King, Jr., (January 15, 1929-April 4, 1968) was born Michael Luther King, Jr., but later had his name changed to Martin.

 

His grandfather began the family’s long tenure as pastors of the Ebenezer Baptist Church in Atlanta, serving from 1914 to 1931; his father has served from then until the present, and from 1960 until his death Martin Luther acted as co-pastor.

 

Martin Luther attended segregated public schools in Georgia, graduating from high school at the age of fifteen; he received the B. A. degree in 1948 from Morehouse College, a distinguished Negro institution of Atlanta from which both his father and grandfather had graduated.

 

After three years of theological study at Crozer Theological Seminary in Pennsylvania where he was elected president of a predominantly white senior class, he was awarded the B.D. in 1951. With a fellowship won at Crozer, he enrolled in graduate studies at Boston University, completing his residence for the doctorate in 1953 and receiving the degree in 1955. In Boston he met and married Coretta Scott, a young woman of uncommon intellectual and artistic attainments. Two sons and two daughters were born into the family.

 

On April 3, 1968 Dr. Martin Luther King, Jr. gave is final speech, “I’ve Been to the Mountain Top.” Dr. King gave what many feel is one of his most important speeches. In this speech Dr. King called for a major boycott of all local and national brands. Dr. King spoke of the importance of the Black Dollar and how it could be used to leverage the garnering of civil rights.

 

In 1954, Martin Luther King became pastor of the Dexter Avenue Baptist Church in Montgomery, Ala. Always a strong worker for civil rights for members of his race, King was, by this time, a member of the executive committee of the National Association for the Advancement of Colored People, the leading organization of its kind in the nation.
He was ready, then, early in December, 1955, to accept the leadership of the first great Negro nonviolent demonstration of contemporary times in the United States, the bus boycott described by Gunnar Jahn in his presentation speech in honor of the laureate. The boycott lasted 382 days.
On December 21, 1956, after the Supreme Court of the United States had declared unconstitutional the laws requiring segregation on buses, Negroes and whites rode the buses as equals. During these days of boycott, King was arrested, his home was bombed, he was subjected to personal abuse, but at the same time he emerged as a Negro leader of the first rank.
In 1957 he was elected president of the Southern Christian Leadership Conference, an organization formed to provide new leadership for the now burgeoning civil rights movement. The ideals for this organization he took from Christianity; its operational techniques from Gandhi. In the eleven-year period between 1957 and 1968, King traveled over six million miles and spoke over twenty-five hundred times, appearing wherever there was injustice, protest, and action; and meanwhile he wrote five books as well as numerous articles.
In these years, he led a massive protest in Birmingham, Alabama, that caught the attention of the entire world, providing what he called a coalition of conscience. and inspiring his “Letter from a Birmingham Jail”, a manifesto of the Negro revolution; he planned the drives in Alabama for the registration of Negroes as voters; he directed the peaceful march on Washington, D.C., of 250,000 people to whom he delivered his address, “l Have a Dream”, he conferred with President John F. Kennedy and campaigned for President Lyndon B. Johnson; he was arrested upwards of twenty times and assaulted at least four times; he was awarded five honorary degrees; was named Man of the Year by Time magazine in 1963; and became not only the symbolic leader of American blacks but also a world figure.
At the age of thirty-five, Martin Luther King, Jr., was the youngest man to have received the Nobel Peace Prize. When notified of his selection, he announced that he would turn over the prize money of $54,123 to the furtherance of the civil rights movement.
On the evening of April 4, 1968, while standing on the balcony of his motel room in Memphis, Tennessee, where he was to lead a protest march in sympathy with striking garbage workers of that city, he was assassinated.

The NJ Chamber office is closed Jan. 15

in observance of Martin Luther King Jr Day.