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Monday, September 9, 2024

AbbVie sues rival BeiGene over alleged theft of cancer therapy secrets

Pharmaceutical giant AbbVie ABBV.N has sued cancer treatment maker BeiGene 6160.HK in Chicago federal court, accusing it of stealing trade secrets to develop a competing cancer-fighting therapy after hiring away a former longtime senior AbbVie scientist.

AbbVie's lawsuit , filed on Friday, alleged it had invested millions of dollars and “years of research” into developing a compound that might treat certain types of blood and bone marrow cancers that are associated with the growth of “B cells.”

The lawsuit focuses on the companies' development of a cancer therapy drug called a “BTK degrader,” which targets and destroys a molecule present in B cell growth. These cells produce antibodies that fight infection.

North Chicago-based AbbVie alleged that BeiGene, which has administrative offices in Basel, Beijing and Cambridge, Massachusetts, “enticed and encouraged” former AbbVie scientist Huaqing Liu to use his former employer's trade secrets “to advance and accelerate” BeiGene's BTK degrader program. Liu was named a defendant.

BeiGene in a statement on Monday denied AbbVie's allegations and said the company will “vigorously defend our intellectual property rights against this lawsuit.”

AbbVie's lawsuit was “introduced to hamper” the development of BeiGene's competing BTK degrader, called BGB-16673, BeiGene's statement said.

BeiGene said it filed patent applications for BGB-16673 before AbbVie made a patent filing for its BTK degrader. The company also said the US Food and Drug Administration this year granted “fast track” designation to its drug, which is being used in a study to treat types of leukemia and lymphoma.

AbbVie and attorneys for the company at law firm Jones Day did not immediately respond to a request for comment.

Liu started working at BeiGene in September 2019 after retiring from AbbVie, the lawsuit said. He had worked on AbbVie's BTK degrader program for at least a year, according to the complaint.

“BeiGene encouraged and induced Liu to disclose AbbVie's BTK degrader trade secret designs and information knowing he had an obligation to AbbVie to maintain their secrecy,” the lawsuit said.

AbbVie said it was seeking unspecified monetary damages and a court order to “recover and protect its trade secret and confidential information.”

The case is AbbVie v BeiGene Ltd et al, US District Court for the Northern District of Illinois, No. 1:24-cv-08167.

https://www.xm.com/fr/research/markets/allNews/reuters/abbvie-sues-rival-beigene-over-alleged-theft-of-cancer-therapy-secrets-53921602

FDA lifts partial clinical hold on Rezolute's low blood sugar treatment

Rezolute Inc said on Monday the U.S. Food and Drug Administration had lifted its partial clinical hold on a late-stage study testing the company's treatment for low blood sugar, sending its shares up 10.3% in early trading.

The hold was placed last year due to historical data that reflected liver toxicity in lab rats following the company's therapy, ersodetug.

The health regulator also imposed a minimum age restriction of 12 years for U.S. patients and dose level restrictions for studies involving ersodetug.

The FDA concluded that the liver toxicity observed was likely specific to a particular type of rats called Sprague Dawley, and not otherwise relevant to humans, Rezolute CEO Nevan Elam said in a statement on Monday.

Sprague Dawley rats are commonly used in research studies.

The company had in May completed a toxicology study in lab rats that showed that there were no observed liver abnormalities.

Rezolute now anticipates potential U.S. enrollment for the study to begin in early 2025, and expects to announce results in the second half of 2025.

Ersodetug, the company's only drug candidate in late-stage trials, is being tested outside the U.S. in participants with congenital hyperinsulinism, a genetic disorder that causes low blood sugar.

The study is enrolling up to 56 participants in more than a dozen countries, with eligibility ranging from three months to 45 years of age, the company said.

https://www.yahoo.com/news/us-fda-lifts-partial-clinical-114709680.html

Yale settles fertility clinics patients claims over diverted fentanyl

Yale University reached a settlement with 95 patients of its fertility clinic who underwent treatments without pain relief because a nurse diverted fentanyl for her own use, lawyers for the plaintiffs announced on Monday.

The settlement, whose terms were not disclosed, covers 154 total plaintiffs, some of whom are patients' partners, who had accused Yale's Reproductive Endocrinology and Infertility clinic in Orange, Connecticut, of maintaining a shoddy system for monitoring controlled substances in a series of lawsuits. As a result, they said, one nurse was able to systematically swap out the painkiller fentanyl with saline solution.

Yale agreed to pay "substantial damages," the lawyers said, without disclosing the amount.

The university in a statement said that it had adopted new measures to prevent diversion in the future, including more staff training and supervision.

"We will continue to do everything we can to ensure our patients and staff feel heard and that we have the strongest protections in place for them," it said.

Plaintiffs said that Yale initially ignored numerous complaints from patients about excruciating pain during egg retrieval procedures for in vitro fertilization, and acknowledged a problem only when an employee noticed a loose cap on a fentanyl vial.

"Our clients walked into this clinic during the most vulnerable time of their lives expecting their medical providers to listen to and believe them," said Kelly Fitzpatrick of the law firm Koskoff, Koskoff & Bieder, a lawyer for the plaintiffs. "Instead, their complaints of agonizing pain were repeatedly dismissed, and they were gaslit."

The diversion was ultimately revealed through a criminal investigation, which resulted in the nurse's 2021 guilty plea to one count of tampering with a consumer product. Investigators said that about 75% of fentanyl given to patients from June to October 2020 was adulterated with saline, though plaintiffs in the lawsuits say the diversion took place over a longer period.

Egg retrieval is an invasive procedure that is normally done with painkillers.

The nurse, Donna Monticone, was sentenced to three months of home confinement.

https://www.yahoo.com/news/yale-settles-fertility-clinics-patients-213959870.html

'Workers at several large US tech companies overwhelmingly donate to Harris'

Workers at many of the largest U.S. tech companies overwhelmingly back Democratic presidential candidate Kamala Harris, according to donation data, even as some of the most powerful tech billionaires have thrown their support to Republican rival Donald Trump.

Workers at Alphabet, Amazon and Microsoft are donating millions of dollars to the Harris campaign, significantly more than employees who are opting to send money to former President Trump’s camp, according to the data compiled by political watchdog OpenSecrets. The data includes donations made by company employees, owners, and workers' and owners' immediate family members.

However, tech billionaires like Tesla Chief Executive Elon Musk and venture capital firm Andreessen Horowitz co-founders Marc Andreessen and Ben Horowitz are rallying behind Trump, citing the former president's stances on the economy, taxes and big business.

The Nov. 5 presidential election has riven Silicon Valley, once a bastion of democratic and liberal support. Venture capitalist Reid Hoffman from Greylock and entrepreneur Mark Cuban are pledging support for Harris’ White House bid, with hopes of seeing more abortion rights for workers and pro-tech policies.

But in recent years several other tech leaders have bristled at Democratic President Joe Biden’s business policies, including a broad attack on mergers and acquisitions and clamping down on data privacy.

Companies themselves can not directly donate to federal campaigns, including presidential ones, according to campaign finance laws. Corporations often donate to congressional and state-level campaigns through political action committees, which are funded by employee donations and limited on how much candidates can receive.

“Many businesses serve customers on both sides of the political aisle, and they don't want to alienate customers by making contributions that support just one party or one candidate in a partisan race,” said Michael Beckel, research director at campaign finance reform nonprofit Issue One. While corporations are blocked from sending money directly to presidential candidates, their employees aren't, and tech employees are overwhelmingly giving to Harris.

Employees at Alphabet and its subsidiaries, which includes Google, and their family members have donated $2.16 million so far to Harris’ campaign, nearly 40 times as much as Trump has received, according to OpenSecrets.

Amazon and Microsoft employees and family members donated $1 million and $1.1 million, respectively. Trump’s campaign pulled in $116,000 from Amazon workers and $88,000 from Microsoft workers, as well as their family members.

Employees at Amazon, which is also a top U.S. retailer and the second largest employer in the country, are outpacing donations from other e-commerce and brick-and-mortar retail workers.

For example, Walmart workers have donated a total of $275,000 to both Harris and Trump, with both presidential candidates receiving nearly the same amount in funding. Trump’s campaign is taking in $144,000 from Walmart workers, about $14,000 more than Harris’.

Campaign donations mostly come from corporate employees who have more disposable income than the typical warehouse worker or cashier, said Sarah Bryner, director of research and strategy for OpenSecrets. Bryner said Amazon and other tech company corporate employees often make more money than those at Walmart, giving them more leeway to contribute to political campaigns.

Amazon corporate employees on average make more money than Walmart corporate employees, who are often based in Bentonville, Arkansas. Amazon’s U.S. corporate employees take home an average of $133,000 per year, while Walmart’s corporate workers’ average annual salary is $85,000, according to data from job marketplace ZipRecruiter.

Workers and family members at Meta and Apple haven’t hit the $1 million mark in donations to Harris yet, but they are continuing the trend of outpacing contributions to Trump. Meta employees have donated $25,000 to Trump compared with $835,000 to Harris, while Apple employees donated $44,000 to Trump compared with $861,000 to Harris.

Silicon Valley has traditionally been seen as more left-leaning in the U.S. In August, more than 100 venture capitalists said in a letter they would support Harris, who has been considered pro-innovation on business and technology.

https://finance.yahoo.com/news/workers-several-large-us-tech-101108829.html

Germany tightens controls at all borders in immigration crackdown

Germany's government announced plans to impose tighter controls at all of the country's land borders in what it called an attempt to tackle irregular migration and protect the public from threats such as Islamist extremism.

The controls within what is normally a wide area of free movement - the European Schengen zone - will start on Sept. 16 and initially last for six months, Interior Minister Nancy Faeser said on Monday.

The government has also designed a scheme enabling authorities to reject more migrants directly at German borders, Faeser said, without adding details on the controversial and legally fraught move.

The restrictions are part of a series of measures Germany has taken to toughen its stance on irregular migration in recent years following a surge in arrivals, in particular people fleeing war and poverty in the Middle East.

Chancellor Olaf Scholz's government is seeking to seize back the initiative from the opposition far-right and conservatives, who have seen support rise as they tap into voter worries about stretched public services, integration and security.

"We are strengthening internal security and continuing our hard line against irregular migration," Faeser said, noting the government had notified the European Commission and neighboring countries of the intended controls.

Recent deadly knife attacks in which the suspects were asylum seekers have stoked concerns over immigration. The Islamic State group claimed responsibility for a knife attack in the western city of Solingen that killed three people in August.

The AfD earlier this month became the first far-right party since World War Two to win a state election, in Thuringia, after campaigning heavily on the issue of migration.

Polls show it is also voters' top concern in the state of Brandenburg, which is set to hold elections in two weeks.

Scholz and Faeser's centre-left Social Democrats (SPD) are fighting to retain control of the government there, in a vote billed as a test of strength of the SPD ahead of next year's federal election.

"The intention of the government seems to be to show symbolically to Germans and potential migrants that the latter are no longer wanted here," said Marcus Engler at the German Centre for Integration and Migration Research.

A TEST FOR EUROPE

A backlash had been building in Germany ever since it took in more than a million people mostly fleeing war-torn countries such as Syria during the 2015/2016 migrant crisis, migration experts say.

It reached a tipping point in the country of 84 million people after it automatically granted asylum to around a million Ukrainians fleeing Russia's 2022 invasion even as Germany was struggling through an energy and economic crisis.

Since then, the German government has agreed tighter deportation rules and resumed flying convicted criminals of Afghan nationality to their home country, despite suspending deportations after the Taliban took power in 2021 due to human rights concerns.

Berlin last year also announced stricter controls on its land borders with Poland, the Czech Republic and Switzerland. Those and controls on the border with Austria had allowed it to return 30,000 migrants since October 2023, it said on Monday.

Faeser said a new model would enable the government to turn back many more - but it could not talk about the model before confidential negotiations with the conservatives.

The controls could test European unity if they lead to German authorities requesting other countries to take back substantial numbers of asylum seekers and migrants.

Under EU rules countries in the Schengen area, which encompasses all of the bloc bar Cyprus and Ireland, are only allowed to introduce border checks as a last resort to avert threats to internal security or public policy.

Germany shares its more than 3,700-km-long (2,300 miles) land border with Denmark, the Netherlands, Belgium, Luxembourg, France, Switzerland, Austria, the Czech Republic and Poland.

Austria's Interior Minister Gerhard Karner told Bild newspaper on Monday that his country would not take in any migrants turned away by Germany at the border.

"There's no room for manoeuvre there," he said.

The measures may not immediately result in many more migrants being turned away at the border, but they could result in more returns to other European countries down the line, as well as acting as a deterrent, said Susan Fratzke at the Migration Policy Institute.

The number of asylum applications in Germany already fell 21.7% in the first eight months of the year, according to government statistics.

https://www.yahoo.com/news/germany-put-temporary-controls-land-133353896.html

California Touts Universal Coverage, Reduces Care

CalMatters, California Governor Gavin Newson’s political publication, just announced that “nearly all” – 94 percent – of Golden State residents have health insurance. The majority are enrolled in MediCal, the state’s Medicaid program.

Newsom emulates the great magician, Harry Houdini, by diverting attention from what he doesn’t want us to see to what he does. Newsom wants the world to see “universal access to care.” He doesn’t want people to see that his insurance does not lead to care.

CalMatters repeatedly conflates coverage with care, making readers believe that having insurance gets you the medical care you need when you need it. Just because someone has a health insurance policy, especially no-charge Medicaid, does not mean care is available. In California, only 60 percent of physicians accept new Medicaid patients. Second, the combination of too few doctors with constantly increasing numbers of enrollees has lengthened wait times to see a primary physician to medically hazardous levels, viz., 132 days to see a primary care physician.

The result is death-by-queue, especially for Medicaid patients: people dying while waiting in line (a queue) for care that doesn’t come in time to save them. What good is having insurance for 94 percent of Californians if 40 percent of them don’t have a doctor?

Doctors give two reasons for refusal to see new Medicaid patients: low payments, often below cost-of-doing-business; and the regulatory/administrative burden. Newsom’s expansion of Medicaid, now enrolling illegals, will further increase the regulatory burden. More important, Newsom’s insurance expansion will divert more healthcare spending from care providers to pay for bureaucracy.

Newsom pledges to raise taxes, increase federal contributions to MediCal, and use that money to pay more to physicians. There are three problems with his promise.

Any increase in taxes will drive even more doctors to out-migrate. Second, he plays a shell game with hospitals to increase – effectively embezzle – federal Medicaid funds (taxpayer dollars) and has in the past used additional revenue for crony capitalism rather than the intended purpose. Third, attempting to defray part of his state’s $45 billion budget deficit, he has announced plans to take money away from paying care providers. So much for his promise to pay more for care.

The fundamental flaw in Newsom’s actions is the damage to patients caused by the seesaw effect. As more people are given no-charge Medicaid insurance, access to care goes down. Fewer doctors for more patients. Wait times increase. More death-by-queue.

The seesaw effect is magnified by adding illegal immigrants to Medicaid rolls. Across the country, from San Francisco to Chicago and New York, people in sanctuary cities are bitter that social and particularly medical services are being given to illegals while taking these services away from legal residents. Newsom doesn’t merely seem to give preference to one group, illegals, over another, citizens: he is.

The last thing Americans need is more divisiveness and less medical care. Newsom accomplishes both.

Deane Waldman, M.D., MBA is Professor Emeritus of Pediatrics, Pathology, and Decision Science; former Director of Center for Healthcare Policy at Texas Public Policy Foundation; former Director of New Mexico Health Insurance Exchange; and author of 12 books, including multi-award winning, Curing the Cancer in U.S. Healthcare: StatesCare and Market-Based Medicine. Contact him at www.deanewaldman.com.

https://www.realclearhealth.com/blog/2024/09/09/california_touts_universal_coverage_reduces_care_1057024.html

NYC schools big took bribes, pushed tainted chicken to kids, gets off easy in fowl move

A disgraced city schools big who pushed tainted food to students in exchange for lucrative bribes dodged serious prison time Monday while crying to a judge — who decided he is “fundamentally good.”

Eric Goldstein, a former executive at the Department of Education, got off with a light sentence of just two years behind bars in Brooklyn federal court after pleading with the jurist, saying his life is already ruined.

A weeping Goldstein — who took kickbacks from a company that provided kids with oozing chicken laden with metal and plastic — said his family members “have suffered tremendously these past few years.

“I ask that you show mercy on them,” the convict said, reiterating a letter he sent the judge where he contended his family is “barely hanging on” because of the case.

“I hope you find a way to punish me without punishing them,” said Goldstein — who reportedly made millions of dollars off the “$3 billion” scheme.

Goldstein, 56, was facing more than six years behind bars after he and three defendants — Michael Turley, Brian Twomey, and Blaine Iler — were found guilty in 2023 of extortion and bribery for the scheme involving Texas-based meat supplier Somma Foods.

His lawyer, Neil Kelly, seemed to strike a chord with Judge Denny Chin when he painted the shamed city bigwig as a visionary who helped shape local public schools — and who had already allegedly been punished enough by having his face “splashed” on the front page of The Post and other publications.

“He has lost his career. He has been publicly pilloried,” Kelly said.

Goldstein pushed for “healthier food” in city schools, his lawyer claimed — but prosecutors have said he also lobbied for Somma’s shoddy chicken products in return for kickbacks that included nearly $100,000 in bribes and a share in the company.

Some of Somma’s offerings involved chicken drumsticks oozing a thick-red liquid and other chicken products that contained plastic, bones or metal.

Goldstein fast-tracked getting Somma foods into nearly 2,000 public city school starting in 2015 — to the point where the company was struggling to keep up with the demand after the millions of dollars’ worth of food orders were placed.

City school workers eventually discovered shipments with bleeding chicken and “wire-like” metal and blue plastic in the poultry.

A food-service manager even needed the Heimlich maneuver after choking on a bone in a chicken tender.

The DOE eventually removed all Somma products from schools in April 2017 after repeated complaints, prosecutors said at trial.

Brooklyn federal prosecutor Robert Polemeni said Goldstein was looking for “a way out of the DOE” by accepting the bribes and making millions of dollars — while Somma bigs were aiming to use the city lunch contract for resume-building to spread their products to cafeterias around the country.

“[Goldstein] ran a nearly $3 billion operation,” Polemeni said, This is not a maybe a corruption case, a maybe a bribery case. It is.”

Iler’s lawyer, James McGovern, tried arguing that it wasn’t a “typical public corruption case” because it didn’t have “gold bars or Bentleys” — while other defense lawyers claimed any jail time would destroy the lives of their clients’ families and children.

Those arguments seemed to sway the judge to let the quartet off with a lighter sentence — despite saying that the Goldstein and Co. knew “exactly what they were doing” when they kept pushing chicken on the menus.

“These four defendants are indeed fundamentally good men. They’ve lived good lives. I acknowledge the case,” the judge said before adding that they went “severely astray” from their normal lives.

Turley and Twomey were both sentenced to 15 months in prison, while Iler landed a year and one day behind bars.

Both Iler and Twomey will have to pay a $10,000 fine, too, the judge ruled.

All four defendants will surrender at a later date.

https://nypost.com/2024/09/09/us-news/nyc-schools-big-eric-goldstein-gets-off-easy-in-chicken-bribe-case/

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Monday, September 9, 2024