Category: Regulations & Security

These stories, posts and articles include legal hearings, criminal procedures, governmental approvals, societal norms, and other universal orders…

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Reckitt/Mead Johnson Nutrition voluntarily recalls select batches of Nutramigen Hypoallergenic Infant Formula Powder because of possible health risk

  • All product tested by MJN was confirmed negative for contaminants.
  • No illnesses or adverse consumer reactions have been reported to date.
  • No Nutramigen liquid formulas or any other Reckitt nutrition products are impacted.

 

 

PARSIPPANY, N.J. — (BUSINESS WIRE) — Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced today that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria.


Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

 

Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023. Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed. There are no reports of illnesses or adverse events to date. The products were distributed through retail stores nationwide. The batches in question can be identified by the batch code on the bottom of the can.

 

The following recalled product batch codes and can size associated with each batch were distributed in the U.S.:

  • ZL3FHG (12.6 oz cans);
  • ZL3FMH (12.6 oz cans);
  • ZL3FPE (12.6 oz cans);
  • ZL3FQD (12.6 oz cans);
  • ZL3FRW (19.8 oz cans); and
  • ZL3FXJ (12.6 oz cans).

 

The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

 

No other U.S. distributed Nutramigen batches or other Reckitt products are impacted

Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products.

 

If parents have any questions, they should consult with their pediatrician or contact us at 866-534-9986 24/7 or by email at consumer.relations@rb.com

 

We are committed to the highest level of quality and safety and it is for this reason that we have taken this measure. Other testing of the batches in question tested negative for Cronobacter and other bacteria.

 

The health and safety of infants is our highest priority. All of our products undergo rigorous and industry-leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration. It is for this reason that we have confidence in the safety and quality of every infant formula we make.

 

What Consumers Should Do if They Purchased This Product

Consumers who purchased Nutramigen should check the bottom of the can to identify whether the batch number is affected. Product with the batch codes listed above should be disposed of, or contact us for a total refund. Please contact us at 866-534-9986 or by email at consumer.relations@rb.com and we will help verify if this product was impacted. If you have any concerns, contact your health care provider. For more information, please visit us at www.enfamil.com.

Contacts

Media Contact: US.CA.MEDIAandPR@reckitt.com

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Business Digital - AI & Apps Economics Lifestyle Regulations & Security Technology

Amazon Prime Video plans to start showing ads on Jan. 29, with option for customers to pay extra $2.99 per month for no ads

Movies and TV shows on Amazon’s streaming service will start getting broken up with ads in January — unless you’re willing to pony up an extra fee each month.

 

 

Chris Welch / The Verge:

 

 

—  Earlier this year, Amazon announced plans to start incorporating ads into movies and TV shows streamed from its Prime Video service, and now the company has revealed a specific date when you’ll start seeing them: it’s January 29th.

 

“This will allow us to continue investing in compelling content and keep increasing that investment over a long period of time,” the company said in an email to customers about the pending shift to “limited advertisements.”

 

“We aim to have meaningfully fewer ads than linear TV and other streaming TV providers. No action is required from you, and there is no change to the current price of your Prime membership,” the company wrote. Customers have the option of paying an additional $2.99 per month to keep avoiding advertisements.

 

The rest of the email summarizes the many benefits of a Prime subscription — no doubt an attempt to keep customers from canceling over this decision. Verge readers were none too pleased about the initial news back in September:

 

Amazon Prime currently costs $14.99 each month or $139 annually. (Prime Video can be subscribed to individually for $8.99/month.) The new charge for ad-free streaming would bring Prime to just under $18, and would push standalone Prime Video to just under $12.

 

Amazon also operates Freevee, a free, ad-sponsored streaming service. The company’s email notes that “live event content such as sports, and content offered through Amazon Freevee will continue to include advertising.”

 

The move comes as competing streaming services continue to raise subscription rates across the board and push ads upon customers on their cheapest monthly plans. Disney Plus, Hulu, Max, Netflix, and Paramount Plus all include ads on their most affordable tiers. The monthly cost of Amazon Prime itself isn’t changing, but if you want to preserve the same experience you have today starting on January 29th, you’ll end up paying more.

 

 

Read more:

Amazon Prime Video plans to start showing ads starting on January 29, with an option for customers to pay an additional $2.99 per month to avoid the ads

 

 

— Techmeme

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Business Culture Economics Government International & World Regulations & Security Technology

China struggles to contain a shadow market for business data, as most companies shun the 48 official gov. data exchanges

—  Dozens of marketplaces have sprung up since a 2020 initiative but most transactions still happen on the black market

 

 

Financial Times:

 

China is struggling to reduce the influence of a shadow market for business data, as companies shun the official exchanges that have been set up to tighten control over the sale of information.

 

Local governments across the country have established 48 exchanges, most of them coming after Beijing enshrined data as a national priority in 2020, making it a fifth pillar of production alongside land, labour, capital and entrepreneurship. Under regulatory supervision, government bodies, state-owned enterprises and private companies can buy and sell data on everything from weather patterns to city traffic flows.

 

However, industry insiders and experts say there is no clear incentive for companies to participate in these fledgling marketplaces and that most data sales are still happening off the exchanges.

 

“We are having difficulty attracting participants to enter the marketplace,” said an employee at a state-backed data exchange, adding that the majority of data sales occurred elsewhere.

 

A report published by the Shanghai Data Exchange last month forecast that by 2025, only 10 per cent of data sales would occur on exchanges.

 

The initiative has been part of broader reforms to increase authorities’ control over data after two decades when internet companies such as Tencent and Alibaba created economic fiefdoms powered by vast troves of consumer data. Since 2021, Big Tech has suffered fines for data violations and the Cyberspace Administration of China has been given stronger regulatory powers over how companies procure, manage and store data.

 

Since the 2020 move by the State Council, the country’s cabinet, to make data a factor of production, “the government has put data on a pedestal as something that can be traded”, said Xiang Li, an expert on data management in Hong Kong.

 

Beijing’s stated aim is to unleash productivity by giving more companies access to data that will enable them to deploy artificial intelligence in everything from smart manufacturing to autonomous driving. The value of data bought and sold in China is expected to increase from Rmb88bn ($12.3bn) last year to Rmb516bn ($72.5bn) by the end of the decade as the use of AI grows, according to the Shanghai Data Exchange report.

 

But experts say that the government faces an uphill battle in convincing private companies to sell their data on centralized exchanges rather than through a data broker.

 

The majority of existing data sold on these platforms comes from government bodies, including local transportation and weather bureaus, or from state-owned enterprises (SOEs), which are easier to cajole into handing over their data than private companies, said Kendra Schaefer, head of tech policy at the Beijing-based consultancy Trivium China.

 

According to a Financial Times analysis, the majority of data sold by the 700 merchants on the state-backed Guiyang Global Big Data Exchange, the country’s first such platform, are from state agencies and SOEs.

 

The government of Guizhou province in south-west China, where Guiyang is the capital, has also introduced draft regulations that compel local government bodies and SOEs to hand over their data to the exchange.

 

Companies such as China Southern Power Grid sell customers’ electricity consumption data on Guiyang’s exchange to credit agencies as a new tool to conduct credit checks, according to domestic media reports.

 

The official data exchanges are also designed to provide ways for companies, cash-strapped local governments, and state-owned enterprises to monetise data resources amid slowing economic growth.

 

The official exchanges in Guiyang, Shanghai and Beijing are offering subsidies to incentivise companies to participate.  Even with such incentives, companies are still showing reluctance owing to concerns about getting on the wrong side of data laws restricting the sale of consumer data, according to Trivium’s Schaefer.

 

“We’re at an interesting point in history. Companies are buying and selling this critical economic resource, but the laws surrounding how trading works for this resource don’t exist yet,” she said.

 

The employee at the state-backed exchange, who did not wish to be named, acknowledged that this legal uncertainty prevented it from onboarding new merchants.

“Current data laws are not specific about the legality of data exchanges,” they said.

 

The CAC did not respond to a request for comment.

 

While Beijing had hoped to court data hawkers with the promise of new revenue streams for their data, Schaefer said many companies were also deterred by the high expense of cleaning up their data in preparation for selling on a centralised exchange.

 

“Many companies have poor data management processes, so they need to clean it up before they sell it, which is costly,” she said.

 

“The state wanted companies to jump on board and say: ‘This is an amazing way to make additional revenue from a resource I generate already’,” said Schaefer.

 

“But the reality is that it’s risky and expensive for companies to stick their data on the platforms. The benefit for the companies is unclear.”

 

 

 

— Techmeme

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Business Culture Digital - AI & Apps Education Lifestyle Regulations & Security Science Technology

Hollywood unions against AI to recreate actors’ performances set precedent for future labor movements to prevent automation

—  The year was dominated by talk of what artificial intelligence could do — and what it could do better than most humans.

 

 

Angela Watercutter / Wired:

 

 

Revolt against the machines began at Swingers. And at Bob’s Big Boy, where for weeks Drew Carey picked up the tab. Members of the Writers Guild of America, (WGA), met at both Los Angeles-area diners frequently during their 148-day strike, which hinged on protecting Hollywood’s scribes from being overrun by the march of artificial intelligence.

 

Members of the WGA were just a small part of the resistance. There were others. The Screen Actors Guild—American Federation of Television and Radio Artists, or SAG-AFTRA, soon joined them on the picket lines, together forming a formidable uprising against the perceived threat of AI.

 

What each union was seeking was different. Writers wanted to make sure AI couldn’t be trained on their work or manipulate it without their say-so; actors wanted guardrails on how the technology could be used to recreate their performances. Both parties ended up setting a tone for how labor movements in the future could push back against encroaching automation.

“It is interesting that the Hollywood strikes became the highest-profile example of workers resisting AI in 2023,” says Brian Merchant, author of this year’s Blood in the Machine: The Origins of the Rebellion Against Big Tech, a book about the Luddite movement.

 

At the same time, he adds, the unions’ confrontations with studios came at a time when the boom in AI technology was causing a lot of folks to be critical of Silicon Valley and new tools primed to take their jobs. Originally, the WGA’s AI stipulations didn’t seem like they’d be hotly contested demands—then they became a central issue. “Workers and unions have been fighting automation and certain uses of AI in the workplace for years, of course, but the Writers Guild were among the first to do so after the rise of OpenAI and ChatGPT,” Merchant says. Ultimately, it was the first big face-off between humans and AI, he adds, and “the humans won.”

 

Their timing couldn’t have been better. Throughout 2023, many trades and professions, from painters to coders and beyond, found themselves vulnerable to being replaced by machine learning. IBM’s CEO estimated out loud that some 7,800 jobs at the company could be done by bots in the next five years. A Goldman Sachs report from late March estimated nearly 300,000 jobs globally could be affected by automation. Radiologists, journalists(gulp), tax preparers—everyone, it seemed, spent at least part of 2023 wondering if robots were coming for their jobs.

 

That, in turn, led to increased interest in what protections organized labor could provide workers, even as some unions, like the United Auto Workers and Teamsters, seemed to fall behind on addressing AI’s potential to encroach on jobs. In a recent piece for Harvard Business Review, MIT engineering professor Yossi Sheffi argued short-sightedness on these issues affects both workers and employers, since disengaged staffers could become part of a workforce that’s even less prepared if and when automation comes to their industry.

 

Sheffi wrote the piece in September, when both SAG and WGA were deep into their strikes. At the time, he noted that other industries should “take to heart” what was happening in Hollywood. “Resolving these issues [between the actors and writers and the studios] will take time, but at least in this case, the parties have started the process before AI has become an industry mainstay,” he wrote. “But other unions don’t seem to be facing up to the ways technological advances will change jobs.”

AS THE ADVANCE of AI marched on throughout 2023, it became clear that unions were only part of the resistance. Authors, worried that large language models had been trained using their books, filed a handful of lawsuits against OpenAI, Meta, Microsoft, and others. So did visual artists, against Stable Diffusion,

 

Midjourney, DeviantArt, and more. None of those suits has reached any kind of conclusion, and some argue copyright claims aren’t the way to stop the bots from absorbing creative work, but the suits did turn the courts into yet another battlefield, in addition to picket lines, on which humans pushed back against AI incursion.

 

By the end of 2023, governments entered the fray. In early November, US president Joe Biden signed an executive orderattempting, among other things, to curtail AI’s impact on human work and provide “federal support for workers facing labor disruptions, including from AI.” Unions, including SAG, praised the move, which came as world leaders were heading to the UK for the AI Safety Summit, where, as my colleague Will Knight wrote, they sought to contain the threats of machine learning while also harnessing its power.

 

That has always been the tricky part. From weavers to writers, lots of people use machines to improve their work. Automation helps! As AI boosters will tell you, the technology can cultivate new forms of creativity. People can write books alongside AI, create new styles of visual art, build infinite Seinfeld generators. Some Hollywood writers use the tools for basic brainstorming tasks. Fear comes in when brainstorming evolves into a studio head asking ChatGPT to write a new movie about a cat and a cop who are best friends. No scribes needed.

 

Currently, chatbots can’t whip up fully formed scripts, or novels, or Caravaggios, but the tech is evolving so quickly it feels all but imminent. When Sam Altman was briefly ousted from OpenAI in November, there was all kinds of speculation that the company was developing its tech too quickly, that its for-profit ambitions had overwhelmed its altruistic intentions. Altman is now back at the head of his company, but whether or not OpenAI is still evolving too quickly remains to be seen. But Microsoft does now have a nonvoting board seat.

 

Funny thing about that: Microsoft actually offered jobs to OpenAI staffers during that brief period when Altman was voted off the island. So did Salesforce. OpenAI employees all but told Salesforce CEO Marc Benioff to go screw, but the sentiment stood as a reminder that while AI is poised to take many jobs, it also creates jobs in AI. The “learn to code” crowd has all new ammo. Even Biden’s executive order was clear about the fact that the US government wanted to attract the best and brightest in the field.

 

But that’s job creation, not job displacement. New technologies create jobs all the time, but with AI, some of those jobs pay pennies. What’s more, AI can also ask you to train it to do your job before picking up your tools. Going forward, the likelihood that AI will displace many entry-level jobs while creating a few highly skilled gigs seems high. The biggest questions in AI right now nearly all revolve around what these machines are learning from people, whether it’s human skill or human bias.

 

 

 

— Techmeme

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Art & Life Education International & World Perspectives Regulations & Security Science Travel & Leisure

More than a century-old, buried documents throw doubt on fate of condemned man

NEW YORK — Patrick O’Donnell survived the seemingly unsurvivable — including the Great Hunger, the aptly nicknamed Coffin Ships and the infamous Typhoid Sheds — on his way to the hangman’s noose in December 1883.

 

Having traveled from Ireland to the United States in search of a better life, Patrick O’Donnell sealed his grim fate when he committed murder, but there is so much more to his life than was ever revealed — until now.

 

In his unforgettable new book, The Execution, Life and Times of Patrick O’Donnell, author Gavin O’Donnell uses an epistolary technique to reconstruct the story of Patrick’s remarkable life using a series of letters purportedly written by Patrick as he awaited the hangman’s noose — letters smuggled from his death cell in his wife Margaret’s petticoats and that have remained undiscovered for 133 years.

 

“There has in my family always been a belief that we are related to a man named Patrick O’Donnell,” Gavin O’Donnell explained in an interview. “There is some evidence to support this but it’s patchy and not strong. … but it is the reason I took an interest in the man.”

 

Gavin O’Donnell blends real world events, biographical information about Patrick and his own imagination to create a compelling narrative that follows Patrick’s path through the Great Hunger to the typhoid sheds of Quebec; from his service in the Confederate army and capture at Chattanooga in 1863 to the grisly O’Donnell massacre at Wiggan’s Patch, Pennsylvania; and ultimately to that fateful day off the coast of Port Elizabeth where Patrick put three bullets into James Carey, and in so doing sealed his own fate and his place in history — but for the wrong reasons.

 

“He was a real person, but how I draw him is how I imagine him to have been as he faced his lifelong challenges and as he sat in his death cell,” Gavin O’Donnell said.

 

Included are accounts of letters of clemency sent to Patrick’s trial and indeed to Queen Victoria herself by Victor Hugo, (the great author but also well-known campaigner against capital punishment), and from U.S. President Chester Arthur. Interventions which hint at an extraordinary life for an Irish peasant.

 

“History tells us that Patrick O’Donnell was hanged in Newgate Prison in December 1883 for the murder of James Carey,” Gavin O’Donnell added. “History, however, tells us almost nothing of his remarkable life. Was he a British agent, hero of Ireland or something else altogether?”

 

About the Author

Gavin O’Donnell grew up in Wales, Ireland, North Africa and England. A selective mute until age 5, he was unable to read properly at age 11 and was classified as “Educationally Sub Normal.” He studied Construction Management in Limerick, obtaining a degree, and later, at age 40, by way of distance learning, he obtained a Bachelor of Laws honors degree at Nottingham.

 

While vacationing in Bordeaux in 1990, he and his wife lost their daughter in a fire, and their son was badly injured. Later diagnosed with bipolar disorder and PTSD partly as a result of the trauma, he retired from his career in Project Management and concentrated on property development.

 

He and his wife, Linda, refurbished several cottages in Southern France and built up a small holiday business before selling up and returning to rural South Wales. They now reside in a self-built stone cottage along with three cats, Jess, Bob and Kpo; a few thousand bees, whom they have not named; and several chickens. Two grown children and one grandchild live nearby.

 

For more information, please visit https://www.patrickodonnell.uk or  https://www.facebook.com/executionpatrickodonnell

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Business Culture Digital - AI & Apps Lifestyle Perspectives Politics Regulations & Security Technology

Elon Musk is fielding complaints about Grok giving liberal responses on diversity, transgender rights, and inequality, despite promising an ‘anti-woke’ chatbot

—  Grok, launched this month on X, has angered conservatives by endorsing diversity.  Musk says he’s trying to fix it.

 

Will Oremus / Washington Post:

 

 

Decrying what he saw as the liberal bias of ChatGPT, Elon Musk earlier this year announced plans to create an artificial intelligence chatbot of his own.

 

In contrast to AI tools built by OpenAI, Microsoft and Google, which are trained to tread lightly around controversial topics, Musk’s would be edgy, unfiltered and anti-“woke,” meaning it wouldn’t hesitate to give politically incorrect responses.

 

That’s turning out to be trickier than he thought.

Two weeks after the Dec. 8 launch of Grok to paid subscribers of X, formerly Twitter, Musk is fielding complaints from the political right that the chatbot gives liberal responses to questions about diversity programs, transgender rights and inequality.

“I’ve been using Grok as well as ChatGPT a lot as research assistants,” posted Jordan Peterson, the socially conservative psychologist and YouTube personality, on Wednesday. The former is “near as woke as the latter,” he said.

The gripe drew a chagrined reply from Musk. “Unfortunately, the Internet (on which it is trained), is overrun with woke nonsense,” he responded. “Grok will get better. This is just the beta.”

Grok is the first commercial product from xAI, the AI company Musk founded in March. Like ChatGPT and other popular chatbots, it is based on a large language model that gleans patterns of word association from vast amounts of written text, much of it scraped from the internet.

Unlike others, Grok is programmed to give vulgar and sarcastic answers when asked, and it promises to “answer spicy questions that are rejected by most other AI systems.” It can also draw information from the latest posts on X to give up-to-date answers to questions about current events.

Artificial intelligence systems of all kinds are prone to biases ingrained in their design or the data they’ve learned from. In the past year, the rise of OpenAI’s ChatGPT and other AI chatbots and image generators has sparked debate over how they represent minority groups or respond to prompts about politics and culture-war issues such as race and gender identity. While many tech ethicists and AI experts warn that these systems can absorb and reinforce harmful stereotypes, efforts by tech firms to counter those tendencies have provoked a backlash from some on the right who see them as overly censorial.

Touting xAI to former Fox News host Tucker Carlson in April, Musk accused OpenAI’s programmers of “training the AI to lie” or to refrain from commenting when asked about sensitive issues. (OpenAI wrote in a February blog post that its goal is not for the AI to lie, but for it to avoid favoring any one political group or taking positions on controversial topics.) Musk said his AI, in contrast, would be “a maximum truth-seeking AI,” even if that meant offending people.

So far, however, the people most offended by Grok’s answers seem to be the people who were counting on it to readily disparage minorities, vaccines and President Biden.

Asked by a verified X user whether trans women are real women, Grok answered simply, “yes,” prompting the anonymous user to grumble that the chatbot “might need some tweaking.” Another widely followed account reposted the screenshot, asking, “Has Grok been captured by woke programmers? I am extremely concerned here.”

A prominent anti-vaccine influencer complained that when he asked Grok why vaccines cause autism, the chatbot responded, “Vaccines do not cause autism,” calling it “a myth that has been debunked by numerous scientific studies.” Other verified X accounts have reported with frustration about responses in which Grok endorses the value of diversity, equity and inclusion programs, which Musk has dismissed as “propaganda.”

The Washington Post’s own tests of the chatbot verified that, as of this week, Grok continues to give the responses illustrated in the screenshots.

David Rozado, an academic researcher from New Zealand who examines AI bias, gained attention for a paper published in March that found ChatGPT’s responses to political questions tended to lean moderately left and socially libertarian. Recently, he subjected Grok to some of the same tests and found that its answers to political orientation tests were broadly similar to those of ChatGPT.

“I think both ChatGPT and Grok have probably been trained on similar Internet-derived corpora, so the similarity of responses should perhaps not be too surprising,” Rozado told The Post via email.

Earlier this month, a post on X of a chart showing one of Rozado’s findings drew a response from Musk. While the chart “exaggerates the situation,” Musk said, “we are taking immediate action to shift Grok closer to politically neutral.” (Rozado agreed the chart in question shows Grok to be further left than the results of some other tests he has conducted.)

Other AI researchers argue that the sort of political orientation tests used by Rozado overlook ways in which chatbots, including ChatGPT, often exhibit negative stereotypes about marginalized groups.

A recent Securities and Exchange Commission filing showed that xAI is seeking to raise up to $1 billion in funding from investors, though Musk has said that the company isn’t raising money right now.

Musk and X did not respond to requests for comment as to what actions they’re taking to alter Grok’s politics, or whether that amounts to putting a thumb on the scale in much the same way Musk has accused OpenAI of doing with ChatGPT.

 

 

 

— Techmeme

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Business Culture Digital - AI & Apps Healthcare Lifestyle Perspectives Regulations & Security Science

HealthEC, LLC data event impacts companies nationwide, including Corewell Health

GRAND RAPIDS, Mich. — (BUSINESS WIRE) — Please replace the release with the following corrected version due to multiple revisions.

 

The updated release reads:

HEALTHEC, LLC DATA EVENT IMPACTS COMPANIES NATIONWIDE, INCLUDING COREWELL HEALTH

 

Population health management platform HealthEC, LLC, is notifying people nationwide of a data security event that happened earlier this year. For more information, please see HealthEC’s news release.

 

The company enables value-based health systems to identify high-risk patients, close gaps in care and recognize barriers to optimal care. HealthEC is a vendor for Corewell Health in Southeast Michigan.

 

The information of approximately 1 million patients of Corewell Health in Southeast Michigan could be impacted by the HealthEC data event. HealthEC is sending letters to every person who was impacted.

 

Not all individuals have the same data impacted, but the possible impacted data could include: Name; address; date of birth; Social Security number; medical record number; medical information like diagnosis, diagnosis code, mental/physical condition, prescription information, and provider’s name; health insurance information including beneficiary number, subscriber number, Medicaid and/or Medicare identification; billing and claims information including patient account number, patient identification number, treatment cost information. This event did not impact platforms such as Epic and MyChart and they are safe to use.

 

HealthEC is offering 12 months of credit monitoring and identity protection services through TransUnion. Instructions on how to activate these services is being sent to all impacted people.

 

Those seeking additional information can contact HealthEC toll-free at 1-833-466-9216 or visit the HealthEC website. People can also write to HealthEC at Attn: Compliance Officer, 343 Thornall St., Suite 630, Edison, NJ 08837.

Contacts

Ellen Bristol, Ellen.Bristol@corewellhealth.org

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Business Healthcare Lifestyle Perspectives Regulations & Security Science

Patritumab Deruxtecan granted Priority Review in the U.S. for certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer

  • Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients with advanced EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies
  • Application being evaluated under FDA Real-Time Oncology Review
  • If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients

 

 

BASKING RIDGE, N.J. & RAHWAY, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) and Merck (known as MSD outside of the United States and Canada) (NYSE: MRK) announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.

The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2021.

 

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The BLA is being reviewed under the Real-Time Oncology Review (RTOR) program, an initiative of the FDA which is designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application.

 

Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and Merck.

 

The BLA is based on the primary results from the HERTHENA-Lung01 pivotal phase 2 trial and data results presented at the IASLC 2023 World Conference on Lung Cancer (#WCLC23), which were simultaneously published in the Journal of Clinical Oncology.

 

In HERTHENA-Lung01, patritumab deruxtecan was studied in 225 patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy, which demonstrated an objective response rate (ORR) of 29.8% (95% CI: 23.9-36.2), including one complete response and 66 partial responses. The median duration of response was 6.4 months (95% CI: 4.9-7.8). The safety profile of patritumab deruxtecan observed in HERTHENA-Lung01 was consistent with previous phase 1 clinical trials in NSCLC with a treatment discontinuation rate of 7.1% due to treatment-emergent adverse events (TEAEs). Grade 3 or higher TEAEs occurred in 64.9% of patients. The most common (≥5%) grade 3 or higher TEAEs were thrombocytopenia (21%), neutropenia (19%), anemia (14%), leukopenia (10%), fatigue (6%), hypokalemia (5%) and asthenia (5%). Twelve patients (5.3%) had confirmed treatment-related interstitial lung disease (ILD) as determined by an independent adjudication committee. One grade 5 ILD event was observed.

 

“The FDA’s prioritization of the BLA submission reflects the strength of the data from HERTHENA-Lung01 and emphasizes the need to provide new options to patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “If approved, patritumab deruxtecan could become the first HER3 directed medicine approved in the US and the second DXd antibody drug conjugate approved from Daiichi Sankyo’s oncology pipeline.”

 

“The acceptance of the BLA submission of patritumab deruxtecan marks an important step in potentially bringing this new medicine to previously treated patients with EGFR-mutated non-small cell lung cancer who often experience recurrence and have few remaining treatment options,” said Marjorie Green, MD, Senior Vice President and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories. “Today is the first of many important milestones from our collaboration with Daiichi Sankyo, as we work together to bring new and potentially first-in-class antibody drug conjugates to people living with cancer.”

 

About HERTHENA-Lung01

HERTHENA-Lung01 is a global, multicenter, open-label, two-arm phase 2 trial evaluating the safety and efficacy of patritumab deruxtecan in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Patients were randomized 1:1 to receive 5.6 mg/kg (n=225) or an uptitration regimen (n=50). The uptitration arm was discontinued as the dose of 5.6 mg/kg of patritumab deruxtecan was selected following a risk-benefit analysis conducted from the phase 1 trial assessing the doses in a similar patient population.

 

The primary endpoint of HERTHENA-Lung01 was ORR as assessed by blinded independent central review (BICR). Secondary endpoints included duration of response, progression-free survival (PFS), disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, overall survival, safety and tolerability.

 

HERTHENA-Lung01 enrolled patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

 

About EGFR-Mutated Non-Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 NSCLC accounts for approximately 85% of all lung cancers – 55% having distant spread at diagnosis – with EGFR mutations occurring in 14% to 38% of all NSCLC tumors worldwide.2,3,4

 

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases.5 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment.6,7 There is currently no HER3 directed therapy approved for the treatment of any cancer.

 

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

 

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02, a phase 3 trial versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with advanced NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been completed.

 

About the Daiichi Sankyo and Merck Collaboration

Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply.

 

About the DXd ADC Portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of six ADCs in clinical development across multiple types of cancer. ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

 

Designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver a cytotoxic payload inside cancer cells that express a specific cell surface antigen, each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

 

Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan and DS-3939 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

 

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

 

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

 

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

 

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

 

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2022 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

References

1 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Accessed September 2023.

2 Economopoulou P, et al. Ann Transl Med. 2018; 6(8):138.

3 Chen R, et al. J Hematol Oncol. 2020; 13(1):58.

4 Zhang Y-L, et al. Oncotarget. 2016; 7(48):78985-78993.

5 Mishra R, et al. Onco Rev. 2018; 12(355):45-62.

6 Scharpenseel H, et al. Scientific Reports. 2019; 9:7406.

7 Yonesaka K, et al. Clin Cancer Res. 2022; 15:28(2):390-403.

Contacts

Daiichi Sankyo
Global/US Media:
Jennifer Brennan

Daiichi Sankyo, Inc.

jbrennan2@dsi.com
+1 908 900 3183 (mobile)

Japan Media:
Koji Ogiwara

Daiichi Sankyo Co., Ltd.

Ogiwara.koji.ay@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

Merck
Media:
Robert Josephson

+1 203 914 2372

robert.josephson@merck.com

Investors:
Peter Dannenbaum

+1 732 594 1579

peter.dannenbaum@merck.com

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Culture Environment Government Lifestyle Local News Regulations & Security Travel & Leisure

Mercer Park Commission receives approval for Community Based Deer Management

The Mercer County Park Commission has been approved for a Community Based Deer Management (CBDM) permit from the New Jersey Division of Fish and Wildlife.

The CBDM permit allows for additional opportunities to improve forest understory and the overall ecological condition of natural areas through deer reductions beyond standard state hunting regulations. Reducing deer overpopulation also improves public safety by reducing deer-vehicle collisions.

No CBDM hunting will occur in areas that participate in the County’s traditional deer management hunting program until after the regular season concludes.

The additional measures permitted in the CBDM program will allow a professional culling firm to perform management activities during an extended season through March 31 at Howell Farm, County owned golf courses including Mountain View, Hopewell Valley, Princeton Country Club, Mercer Oaks East and West, and select regions of Mercer Meadows in Hopewell Township.

Management activities approved in the Park Commission’s permit include deer harvest by crossbow and firearm, culling during evening hours, and periodic closures for culling outside of the traditional State hunting season through March 31,2023.

At Mercer Meadows, the Curlis Woods region is included in the permit. Beginning February 19, 20245, this area will allow for crossbow culling Monday through Saturday through March 31 until 9 p.m. The Curlis Woods region will remain open to the public during this period of crossbow hunting. Park users are advised to remain on trails and wear bright colored clothing. All culling activity will take place from an elevated tree stand with a 75-foot safety buffer in place on either side of all County-recognized trails.

The Curlis Woods region will BE CLOSED to the public for shotgun culling on:

  • Wednesdays from February 21 through March 27

At County-owned golf courses including Princeton Country Club, Mountain View and Hopewell Valley Golf Courses, the permit allows for crossbow culling to take place Monday through Saturday, from sunrise until 9 p.m. January 1 though March 31. At Mercer Oaks East and West golf courses, crossbow culling may occur starting February 19 through March 31. The golf courses will be closed to the public during shotgun culling.

Golf courses will BE CLOSED to the public for shotgun culling as follows:

  • Hopewell Valley closed January 1 through January 31
  • Mercer Oaks East February 19 through February 29
  • Mountain View closed February 1 through February 29

At Howell Farm, the permit allows for extended evening culling (sunset through 9 p.m.) January 29 through March 31. Beginning in January, bow culling may take place Monday through Saturday, from sunrise to 9 p.m. until March 31. Howell Farm will be closed to the public during shotgun culling.

Howell Farm will BE CLOSED to the public for shotgun culling on:

  • Mondays January 29 through March 31
  • Tuesday through Friday from 4 p.m. to 9 p.m. January 20 through March 29

The above dates do not include closures as part of the Park Commission’s existing deer management program. Please visit mercercountyparks.org for details on all closures for deer manage

More information can be found by visiting the Mercer County Park Commission’s Deer Management page

Categories
Business Culture Lifestyle Perspectives Regulations & Security

AM Best assigns Credit Ratings to Federal Life Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best has assigned a Financial Strength Rating of A- (Excellent) and a Long-Term Issuer Credit Rating of “a-” (Excellent) to Federal Life Insurance Company (Fed Life) (Riverwoods, IL). The outlook assigned to these Credit ratings (ratings) is stable.

The ratings reflect Fed Life’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management (ERM).

 

The ratings also reflect AM Best’s assessment that, based on Fed Life’s business plan, the company will build and maintain a balance sheet assessment of very strong supported by risk-adjusted capitalization also at the very strong level, as measured by Best Capital Adequacy Ratio (BCAR). Capital contributions in 2023 and retained earnings through the forecast period are expected to support net premium growth. Direct premium growth is expected to be relatively rapid based on projections, but capital at Fed Life is anticipated to be managed through affiliated reinsurance and capital infusions as necessary. Financial flexibility is viewed as positive as the company has access to additional capital at the holding company level (Federal Life Group, Inc.), and from its ultimate parent organization, Insurance Capital Group, LLC (ICG). The holding company has access to additional capital from the ultimate owner, ICG. Investment risk is projected as low but may increase to moderate depending on the evolution of the liability profile of the company, which could impact future balance sheet metrics.

 

The adequate operating performance assessment and the neutral business profile assessment are based on Fed Life’s business plans presented to AM Best. The plan includes an expectation of rapid premium growth and improving operating profitability that supports an adequate operating performance assessment. In addition, it also includes the introduction of additional products, which in combination with a larger and more geographically diversified premium base, would support a neutral business profile assessment. Should Fed Life materially underperform its business plan these assessments would no longer be supported. An ERM structure has been established and is expected to evolve alongside the product risks and operational complexity of the business.

 

Fed Life, originally incorporated in 1899 and mutualized in 1962, was demutualized in 2018 and under its new ownership is focused now on a portfolio of accident and health, as well as life and annuity (L/A) products, which it plans to market nationwide. The company engaged with a largely new management team in 2022 and 2023 to support the plan, and introduced its first new product, a hospital indemnity product, in 2022. Additional new products are in development to supplement the company’s hospital indemnity product and legacy L/A book of business. Rapid premium growth in 2022 and 2023 evidence early successes of the plan; however, successful launches of new products and further development of distribution are key to realizing the growth and expansion milestones presented to AM Best. AM Best will monitor the performance of Fed Life against key milestones set out in the business plan and internal expectations to evaluate if ongoing performance remains supportive of the adequate operating performance and neutral business profile assessments.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

John McGlynn

Senior Financial Analyst
+1 908 882 2106
john.mcglynn@ambest.com

Joseph Zazzera
Director
+1 908 882 2442
joseph.zazzera@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com