Bristol Myers Squibb on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of its Augtyro cancer drug in a pair of indications.
The Princeton, N.J., biopharmaceutical company said the recommendation cover Augtyro as a treatment for adults with ROS1-positive advanced non-small cell lung cancer and for certain patients 12 and older with advanced solid tumors expressing a NTRK gene fusion.
The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in January.
Bristol Myers said Augtyro, if approved, has the potential to be a best-in-class treatment for patients with advanced ROS1-positive non-small cell lung cancer in the European Union.
The U.S. Food and Drug Administration last year approved Augtyro for adults with ROS1-positive non-small cell lung cancer and earlier this year gave a green light to the drug in patients with NTRK-positive solid tumors.
Bristol Myers reported Augtyro sales of $23 million for the first nine months of 2024
Chinese-owned meat processing giant Smithfield has been fined $2 million to resolve a child labor compliance dispute with the Minnesota Department of Labor and Industry.
Local paper Minnesota Reformer reports a Minnesota DLI investigation from 2021 and 2023 found at least 11 children between the ages of 14 and 17 worked at Smithfield's St. James area plant.
"It is unacceptable for a company to employ minor children to perform hazardous work late at night. This illegal behavior impacts children's health, safety and well-being and their ability to focus on their education and their future," DLI Commissioner Nicole Blissenbach wrote in a statement, adding, "Combatting unlawful child labor in Minnesota is a priority for DLI and it will continue to devote resources to addressing and resolving these violations."
Smithfield released a statement denying "that we knowingly hired anyone under the age of 18 to work in our St. James facility. We have not admitted liability as part of this settlement; however, in the interest of preventing the distraction of prolonged litigation, we have agreed to settle this matter."
The meatpacker noted that it utilizes E-Verify, a Department of Homeland Security database, to determine the eligibility of workers who are US or foreign citizens.
"Each of the 11 alleged underage individuals passed the E-Verify system by using false identification. Each used a different name to obtain employment with Smithfield than the name by which DLI identified them to Smithfield," the company said.
The Chinese-owned company noted it is opposed to child labor and has "taken proactive steps to enforce our policy prohibiting the employment of minors."
There was no word on the citizenship status of the minors. However, we suspect some of those underage individuals were probably migrants. After all, many of the migrants - and illegal aliens - the Biden-Harris team allowed to flood the nation ended up somewhere in America's food supply chain - this is no secret.
This brings us to an entirely different issue: the exploitation of migrant children by mega-corporations...
"This shadow work force extends across industries in every state, flouting child labor laws that have been in place for nearly a century. Twelve-year-old roofers in Florida and Tennessee. Underage slaughterhouse workers in Delaware, Mississippi and North Carolina. Children sawing planks of wood on overnight shifts in South Dakota," a recent New York Times article stated.
Earlier this week, we informed readers that at least one non-profit was funneling migrants into mega corps.
The reports of trafficking networks and labor mules across the country because of Biden-Harris' open southern borders are disturbing.
Incoming "border czar," Tom Homan, noted earlier this week: "Where do we find most victims of sex trafficking and forced labor trafficking? At worksites."
Lining America's food supply chain with migrants - some of which are illegal... This should be one of the biggest national security stories of the decade.
BMS has so far been on a winning streak in the contingent value right cases, which allege that the pharma intentionally delayed regulatory activities for Breyanzi in order to avoid a $6.4 billion payout to Celgene shareholders.
Just weeks after a judge ruled in its favor in a similar case, Bristol Myers Squibb on Thursday was hit with a $6.7 billion lawsuit from former shareholders of Celgene alleging that the pharma took steps to avoid paying out contingent value rights associated with regulatory milestones for three therapies, according to Reuters.
The complaint, filed in the U.S. District Court for the Southern District of New York, alleged that BMS had intentionally delayed regulatory filings for the CAR T therapy Breyanzi (lisocabtagene maraleucel), alongside two other treatments, in an effort to avoid an extra $9-per-share payout to Celgene shareholders, as per a contingent value right (CVR) clause.
Breyanzi was originally developed by Celgene, which BMS acquired in 2019 for $74 billion. The CVR was part of this buyout and gave Celgene’s shareholders the right to certain payments for each share that they owned, contingent on regulatory milestones.
This CVR agreement has been a fraught legal battlefront between BMS and former Celgene shareholders in recent years. UMB Bank, representing the plaintiffs, first filed the lawsuit in June 2021, alleging that BMS “delayed the development and production” of Breyanzi, causing it to miss the deadline for the regulatory milestone by 36 days. Without these intentional delays, BMS would have been on the hook for $6.4 billion in CVR payments, according to the lawsuit.
“Bristol-Myers breached the CVR Agreement, which requires Bristol-Myers to use “Diligent Efforts” to secure approval from the Federal Drug Administration . . . by December 31, 2020,” the lawsuit read, calling BMS’s delaying tactics “blatant misconduct.” The complaint sought monetary damages for Celgene shareholders.
Last month, a federal New York judge handed BMS a legal victory in the matter. In his ruling, Judge Jesse Furman argued that UMB Bank had no standing to bring the case against BMS as the bank had not been properly appointed as a trustee for the shareholders who held the CVR. “The court does not reach that conclusion lightly,” Furman wrote at the time, especially given that there is “so much money at stake.”
BMS has also scored several previous favorable rulings on the CVR lawsuits. According to its second-quarter 2024 business report, New York and New Jersey courts earlier this year dismissed multiple similar complaints from CVR holders, though at least one of these cases is being appealed.
Los Angeles Mayor Karen Bass said on Monday that her city doesn’t have a law officially designating it as a “sanctuary” for illegal immigrants and that this should be changed quickly before President-elect Donald Trump assumes office.
Trump has vowed to carry out mass deportations of illegal immigrants and said he would push Congress to adopt legislation outlawing sanctuary cities, which enact policies that shield illegal immigrants from federal immigration authorities.
In a Nov. 11 interview on KNX News, a local radio station, Bass said past policies related to the status of Los Angeles as a sanctuary were never codified into law. She pledged to push for a City Council vote that would formally designate Los Angeles as a sanctuary city before the end of the year.
“I imagine that the council will be voting on sanctuary cities hopefully very, very soon,” she told the outlet. “We will stand with the immigrant community and whatever policy they put forward, we will make sure that people in Los Angeles are not hurt and families are not separated.”
The City Council approved a motion in July 2023 calling on various city departments to take steps for Los Angeles to formally become a sanctuary city, which would prohibit city cooperation with federal immigration authorities.
Later, in September 2024, several City Council members introduced a motion for a new sanctuary city law to legally codify Los Angeles’ status as a sanctuary city. The law has not yet returned to the council for a vote.
In addition to advocating for the City Council to finalize and enact the law before Trump assumes office, Bass also expressed doubt that the president-elect’s pledge to deport millions of illegal immigrants could be implemented.
Trump, who won the race for the White House vowing a vast crackdown on illegal immigration, said last week that his incoming administration has “no choice” but to press ahead with the deportations, regardless of the cost.
“It’s not a question of a price tag,” Trump told NBC News on Nov. 8, adding that “really, we have no choice.”
“When people have [been] killed and murdered, when drug lords have destroyed countries,“ Trump continued. ”And now they’re going to go back to those countries because they’re not staying here. There is no price tag.”
It’s unclear how many illegal immigrants there are in the United States, with estimates ranging from around 10 million to more than 20 million and beyond. American Immigration Council, an immigrant advocacy group, recently estimated that the cost of deporting 13 million immigrants residing in the United States illegally could total $968 billion over a little more than a decade.
Trump recently tapped Tom Homan, former acting director of U.S. Immigration and Customs Enforcement (ICE), to serve as the incoming administration’s border czar in charge of mass deportations. Homan said in an October interview that the scale of the deportations would depend on the available budget, detention space, and officers assigned to the project. After Trump nominated Homan to oversee border security, the former acting ICE chief said that the effort would prioritize the removal of criminals and gang members who are in the country unlawfully.
In the meantime, Homan urged other illegal immigrants to self-deport, saying it’s just a matter of time before they’re caught and removed from the country.
“Criminals and gang members get no grace period,” Homan told Fox News on Nov. 11. “While we’re out prioritizing the public safety threats and national security threats, if you want to self-deport, you should self-deport because, again, we know who you are, and we’re going to come and find you.”
Trump has also vowed to use federal power against sanctuary cities. During a campaign speech in North Carolina at the end of September, Trump said he would push Congress to pass a law banning sanctuary cities nationwide.
In 2017, Trump signed an executive order that called on federal agencies to withhold funds from sanctuary jurisdictions. The order made federal money to state and local governments conditional upon their giving immigration officials access to their jails and advance notice when illegal immigrants were being released from custody.
Shortly after taking office, President Joe Biden rescinded Trump’s executive order.
Eli Lilly said on Thursday it sued the federal Health Resources and Services Administration (HRSA) over allegedly blocking the company's plan to change the way it offers drug discounts to hospitals.
The case centers on the federal 340B program, in which drugmakers provide discounts to eligible healthcare providers that serve low-income populations. Drugmakers must participate in the program to receive funds from government health insurance programs like Medicare and Medicaid.
Eli Lilly said its program is designed to pay cash directly to 340B covered entities every week, ensuring they pay no more than the 340B ceiling price.
The company added that the HRSA, which is part of the U.S. Health and Human Services Department, rejected Lilly's model stating that it was inconsistent with the 340B law, Lilly said in a lawsuit filed in a federal court in Washington D.C.
HRSA did not immediately respond to a Reuters request for comment.
Lilly follows fellow drugmaker Johnson & Johnson, who sued the Health and Human Services Department on Tuesday, accusing the agency of blocking its plan to sell its psoriasis treatment Stelara and blood thinner Xarelto to some hospitals at full price before applying drug rebates.
The 340B program has been the focus of broad legal scrutiny over the years.
A U.S. appeals court last year said drug manufacturers can limit health providers' use of outside pharmacies for dispensing drugs under the 340B program. HHS had ordered the drugmakers to stop curtailing sales to contract pharmacies.
The governors of Illinois and Colorado, both Democrats, have announced the formation of a new alliance to resist President-elect Donald Trump’s policies, just weeks before he is set to assume office.
The alliance, named “Governors Safeguarding Democracy” (GSD), is being billed as a nonpartisan coalition of governors who will work together to prevent “authoritarianism” and the “undermining of democratic institutions,” including executive agencies, elections, and state courts, according to a Nov. 13 statement announcing the group.
Through the group, governors will leverage their “unique legislative, budgetary, executive, and administrative powers to deliver results for the American people,” the statement said.
The alliance will also develop “playbooks” to enable governors and their teams to “anticipate and swiftly respond to emerging threats,” according to the statement. The group did not specify what those threats were.
Govs. JB Pritzker of Illinois and Jared Polis of Colorado launched the group and will act as co-chairs overseeing the coalition. The group will be supported by a network of senior staff designated by each governor.
Democrats currently govern 23 states while Republicans govern 27. Neither Polis nor Pritzker said how many governors have joined the coalition so far.
A spokesperson for Trump’s transition team, Karoline Leavitt, said in response to the group’s formation that the president-elect “will serve all Americans, even those who did not vote for him in the election.”
“He will unify the country through success,” Leavitt said.
The coalition says it will be supported by the Governors Action Alliance (GovAct), a nonpartisan organization that will collaborate with think tanks, legal experts, and democracy advocates to tackle the “unique challenges facing American democracy today,” according to the statement.
According to its official website, GovAct is advised by a board that includes former Republican and Democratic governors from states such as Minnesota and Massachusetts, as well as a former deputy attorney general.
Specifics regarding how exactly the alliance would function were not provided.
In a statement, Pritzker said the alliance was formed amid a “critical moment in our history ... to protect the foundations of our democracy and ensure our institutions withstand threats and persevere in their mission to improve the lives of our people.”
Trump, who campaigned on proposals including deporting illegal immigrants and imposing tariffs, scored a decisive victory over Vice President Kamala Harris in last week’s election.
The alliance was unveiled as multiple leaders from the Democratic Party vowed to uphold various policies related to access to abortion, climate, diversity programs, and LGBT issues following the former president’s election win.
On Nov. 7, California Gov. Gavin Newsom announced plans to convene a special session later this year to address Trump policies, which he said threaten the state’s values.
According to a statement from Newsom’s office, the special session will respond to public statements and proposals put forward by Trump and his advisers, as well as actions taken during his previous time in office, which the statement described as “an agenda that could erode essential freedoms and individual rights, including women’s rights and LGBTQ+ rights.”
The special session will begin on Dec. 2, when the Legislature convenes.
Last week, Washington Attorney General Bob Ferguson said that his legal team had been preparing for months to respond to future Trump policies, while New York Gov. Kathy Hochul said she is working with her attorney general on how to “protect New Yorkers’ fundamental freedoms.”
Minnesota Gov. Tim Walz, who was Harris’s running mate in the recent presidential election, told supporters during a Nov. 8 speech in Eagan, Minnesota, that he would “stand ready to stand up and fight” if the incoming Trump administration brings a “hateful agenda” to the state.
The American people are expressing joy about President-elect Trump's selection of Tom Homan as the incoming "border czar" to combatBiden-Harris' illegal alien invasionat the open southern border, which has been linked to thousands of armed Venezuela prison gang Tren de Aragua members storming communities nationwide.
Tennessee Bureau of Investigation Director David Rausch is the latest official to warn about TdA members taking over his cities. He said these illegal alien criminals have been spotted in all major cities in Tennessee.
Local media outlet WVLT News quoted Rausch, who warned that TdA members have been involved in human trafficking within the state.
"They are back in all of our major cities. They are running human trafficking operations, and that's where they start," said Rausch.
Rausch told Governor Bill Lee on Tuesday that the foreign prison gang was active across the state in 2023, but after a number of arrests, activity slumped. However, he said, in just the past few months, TdA activity has surged once again.
The TBI director said TdA members were also involved in organized retail theft and drug crimes within the state.
"They will not hesitate to attack their opponents in public or in broad daylight," Rausch warned.
A recently leaked US Army North Division report showed an estimated 5,000 TdA members running amok nationwide.
These disastrous globalist policies pushed by the far-left Biden-Harris admin neglected to uphold national security for citizens while ten-plus million unvetted illegal aliens stormed the nation.
Tennessee voters shifted toward Trump in last week's presidential election, signaling frustration with the globalist in the White House.
Months ago, Homan had a message to the illegals...
This is Tom Homan, President Trump's Border Czar. His message to all the illegals who crossed the border will give you goosebumps, "You better start packing now... cause you're going home."
And to the cartels, he said, "Trump will wipe you off the face of the Earth! YOU'RE… pic.twitter.com/ygZICaVVJb
