- Findings reveal promising early signs that lacutamab may help alleviate some of the most distressing symptoms of cutaneous T cell lymphomas
Monday, December 9, 2024
Innate Pharma Presents Phase 2 Study in Cutaneous T Cell Lymphoma
Affimed Call on Combo for Non-Small Cell Lung Cancer
Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will host a conference call on Tuesday, December 17, at 8:30 a.m. EST / 14:30 CET to review clinical data from AFM24-102, the combination trial of its AFM24 innate cell engager ICE® with atezolizumab in non-small cell lung cancer.
The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link
https://register.vevent.com/register/BI9c2d6fa7af764cb7b550c5ce464ce5cf, and you will be provided with dial-in details and a pin number.
Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.
Sellas Positive Overall Survival, Response Rate Data in Phase 2 in r/r AML
- Median Overall Survival (mOS) Not Yet Reached, Now Exceeds 7.7. Months at Latest Follow-Up in the 30 mg BIW Cohort in Patients Relapsed or Refractory to Venetoclax-Based Regimens -
- Overall Response Rate (ORR) of 56% Achieved to Date in Patient with Acute Myeloid Leukemia with Myelodysplasia Related Changes (AML MRC) Prospectively Enrolled in Two Expansion Cohorts; Exceeding Prespecified Target Response Rate of 33% -
American Airlines suspends flights to Haiti indefinitely
American Airlines is no longer resuming its daily service out of Miami into Port-au-Prince's Toussaint Louverture International Airport. American had initially suspended flights through February 12. The suspension is now indefinite.
A spokesperson for the U.S.-based carrier said that it will evaluate a possible resumption in late 2025 of the only daily service out of Miami International Airport into Haiti by a major U.S. airline.
This comes after The Federal Aviation Administration prohibited U.S. airlines from flying to Haiti for 30 days after gangs shot three planes. Further, the United Nations temporarily suspended flights to Port-au-Prince on Tuesday, limiting humanitarian aid coming into the country.
The American Airlines statement read in part: "American has made the difficult decision to suspend daily service between Miami (MIA) and Port-au-Prince, Haiti (PAP)," the spokesperson said. "We are proud of our more than 50-year-commitment to Haiti and we will continue to monitor the situation, assessing safety, security, and customer demand, in evaluating a return of service. We will proactively reach out to impacted customers to offer a full refund of their travel itinerary."
Multiple airlines avoiding potential violence
Last month, several air carriers — including American Airlines, JetBlue Airways and Spirit Airlines — announced the suspension of daily flights into Haiti after confirmation their planes were hit by gunfire while in Haitian airspace in early November.
Neither Spirit nor JetBlue has said if and when they will resume Haiti flights.
JetBlue Airways operates flights both out of Fort Lauderdale-Hollywood International Airport and John F. Kennedy International Airport into Port-au-Prince.
Spirit Airlines, which was approaching Toussaint Louverture International Airport with passengers when the bullets struck, also suspended its service between Fort Lauderdale and Cap-Haïtien in the north of the country.
No passengers were injured.
The ban on commercial and cargo flights has created severe problems for Haitians. The roads in and out of the capital are controlled by armed gangs, and mudslides last week buried two major roads connecting Cap-Haïtien and the capital.
Those making it out of the capital have either had to beg for a ride on a government-leased helicopter meant for the purpose of moving security forces to hot zones or pay $2,500 for a ride on a privately leased helicopter with a 20-pound weight limit.
The FAA initially placed all of Haiti under the flight ban. It later amended its decision to exclude airports outside of the capital.
The only other airport that can receive commercial international flights, Hugo Chavez International Airport, is in the northern city of Cap-Haïtien.
Today, the small airport serves as the only air bridge in and out of the country. The airspace between Haiti and the Dominican Republic is still closed. The Bahamas suspended flights into the country. The only direct service to the U.S. currently is via Haiti-owned Sunrise Airways.
Despite that, it has not stopped the United States from deporting Haitians back to the country. Last week, the Department of Homeland Security flew 70 deportees into Cap-Haïtien despite days of heavy rains that had left the city flooded and all access out of the city to other parts of Haiti blocked.
https://www.cbsnews.com/miami/news/american-airlines-suspends-flights-to-haiti/
California AG Asks Residents To Report State Agencies That Assist Immigration Authorities
by Travis Gillmore via The Epoch Times (emphasis ours),
State Attorney General Rob Bonta requested Dec. 4 that Californians report to his office any violations of state laws that limit state institutions, agencies, and local law enforcement’s ability to cooperate with federal immigration enforcement actions.
Senate Bill 54—passed in 2017 and known as the California Values Act—blocks state and local agencies from using resources to assist immigration enforcement by arresting, detaining, detecting, interrogating, or investigating individuals suspected of entering the country illegally.
The appeal came in an announcement that courts, health care facilities, libraries, and other public institutions in California were advised to craft policies meant to make it more difficult for federal law enforcement authorities to deport illegal immigrants.
Such advisement is in response to comments made by President-elect Donald Trump during his campaign and after the election that deportations will be a prime component of his national security policies, according to the attorney general, and updates guidance first issued in 2018 during Trump’s first term.
“We will not allow safe spaces like libraries, hospitals, and courthouses to be co-opted and commandeered for [Trump’s] inhumane immigration agenda,” Bonta said in a statement. “My office will continue to use the full force of the law and every tool at our disposal to protect the rights of California’s immigrants, and we need staff at these critical locations to do the same.”
He said fear of immigration enforcement could harm the 1.8 million—as calculated by the nonpartisan Pew Research Center—illegal immigrants residing in California.
“We cannot let the Trump deportation machine create a culture of fear and mistrust that prevents immigrants from accessing vital public services,” Bonta said.
State courts, public schools, and publicly funded health care facilities are required by law to follow the order and craft policies in line with the attorney general’s guidelines. All other institutions are encouraged to comply.
According to the guidance, cooperation between federal immigration officers and state institutions is problematic because it “diverts state resources, blurs lines of accountability, and threatens trust between immigrant communities and state and local agencies that provide critical public services.”
Courts are advised to create policies that limit support for federal immigration actions by prohibiting Immigration and Customs Enforcement agents from entering certain areas of facilities unless they present court warrants.
Customs agency warrants can be ignored, according to the attorney general’s guidance, because they do not carry the authority of a court warrant, and state law prohibits local agencies from consenting to immigration officers’ search requests.
The use of pseudonyms is also suggested to shield victims, witnesses, and other individuals from potential enforcement action.
Additionally, courts are prompted to minimize in-person appearances and to consider not penalizing individuals who fail to appear due to fear of immigration authorities.
All institutions are advised to prohibit the disclosure of information that could reveal an individual’s illegal immigrant status.
Policies should defer requests from federal authorities to legal counsel or administrators, and all instances should be documented, according to the guidelines.
Staff should receive training about how to respond to immigration enforcement requests and should direct individuals who access services to privacy rights information, according to the attorney general’s orders.
Trump’s choice for border czar, Tom Homan, recently warned state officials against interfering with the federal government.
“I’m sending a message to those people who said they’re going to get in our way ... don’t cross that line,” Homan said during a press conference at the border with Texas Gov. Greg Abbott on Nov. 26. “It is a felony to knowingly harbor an illegal alien from an immigration authority. Don’t test us.”
He said plans are underway to deport millions of illegal immigrants.
“Let me be clear. There is going to be a mass deportation because we just finished a mass illegal immigration crisis,” Homan said. “If you let them stay, you’ll never fix the border. This is a nation of laws, and we’re going to enforce those laws.”
California Gov. Gavin Newsom said during a Dec. 5 press conference at the border in San Diego County that the state does not interfere with the federal government using its own resources to enforce federal laws and cooperates “in many cases.”
He expressed concern about possible widespread deportations because about half of farmworkers in California entered the country illegally, according to the governor.
“The impacts of mass deportation on the cost of food in this state and this nation are off the charts,” Newsom said. “This is serious business.”
The president-elect’s transition team said his wide margin of victory is evidence the American people want him to prioritize his agenda of securing the border and bolstering public safety.
“President Trump will marshal every federal and state power necessary to institute the largest deportation operation of illegal criminals, drug dealers, and human traffickers in American history while simultaneously lowering costs for families,” Karoline Leavitt, Trump-Vance transition spokesperson, told The Epoch Times by email on Nov. 27.
“The American people reelected President Trump by a resounding margin giving him a mandate to implement the promises he made on the campaign trail, like deporting migrant criminals and restoring our economic greatness. He will deliver.”
Huge Small Biz Break: Judge Suspends Enforcement Of FinCEN Reporting Requirement
Just a few weeks before a poorly-publicized Jan. 1 deadline, a judge has issued a nationwide injunction barring the enforcement of a controversial mandate that would compel tens of millions of small and large businesses to file beneficial ownership reports with an obscure federal agency. The ruling doesn't kill the requirement altogether, but it does bar the Treasury Department from enforcing it until lawsuits challenging the requirement's constitutionality are fully resolved.
"There are now CTA cases pending in the Fourth, Fifth, Ninth, and Eleventh Circuits," notes attorney and Forbes contributor Kelly Phillips Erb, posting as @taxgirl on X. "It’s looking more like it could end up at the Supreme Court." There's also the possibility that the next Trump administration -- either unilaterally or via cooperation with Congress -- could find a way to kill or at least narrow the requirement.
The rule imposed by the Corporate Transparency Act (CTA) swept the vast majority of "legal entities created to do business in the United States" into a new bureaucratic net, directing them to dump information about themselves and their "beneficial owners" into a federal database managed by the Financial Crimes Enforcement Network (FinCEN) -- which most Main Street businesses and single-member LLC's have probably never even heard of. Those who failed to comply faced severe penalties, ranging from civil fines of up to $591 a day to criminal consequences of up to $250,000 and a five-year prison term.
Advertised by the Feds as necessary to crack down on criminals' use of shell companies, it's the kind of heavy-handed bureaucratic burden that incoming president Donald Trump and his sidekicks at his nascent "Department of Government Efficiency" -- Elon Musk and Vivek Ramaswamy -- have promised to eradicate. Indeed, FinCEN itself estimated that compliance would cost $22.7 billion in the first year alone, and then $5.6 billion in subsequent years into perpetuity.
The rule sought to put the ownership information of more than 32 million entities in a US Treasury database. It's fair to say that a huge proportion of them had no idea that a deadline backed by harsh penalties was rapidly approaching -- and still don't. In August, FinCEN said fewer than 4 million had complied with the requirement. The CTA exempts 23 categories of entities from the reporting requirement -- most of them are various types of financial institutions.
Writing at at Forbes, attorney Matthew F. Erskine explains District Judge Amos Mazzant's rationale for siding with the multiple plaintiffs in the case, which include the National Federation of Independent Business (NFIB), Texas Top Cop Shop and the Libertarian Party of Mississippi:
Judge Mazzant's opinion strongly rebuked the CTA for overstepping constitutional boundaries. He noted that corporate regulation has traditionally fallen within the states' jurisdiction. By mandating federal oversight of corporate ownership, the CTA disrupts the balance of power foundational to the U.S. federalist system.
The Treasury Department quickly announced that it will appeal the ruling, with a spokeswoman claiming that the CTA “plays a vital role in protecting the U.S. financial system...We continue to believe—consistent with the conclusions of other federal courts—that the CTA is constitutional." Not all courts feel that way: Earlier this year, an Alabama judge imposed an injunction that only applied to NFIB members, finding that the Constitution provides no basis for a law requiring the collection of ownership information.
After the Texas judge issued his 80-page ruling on Tuesday, FinCEN posted an alert to its website informing business owners that "reporting companies are not currently required to file their beneficial ownership information with FinCEN and will not be subject to liability if they fail to do so while the preliminary injunction remains in effect." In the meantime, entities are free to voluntarily submit the reports if they want to. A post pinned to the agency's X account it "may take 20 minutes or less" -- which is hardly encouraging.
“This ruling is a huge victory for small businesses nationwide, and just in time” said Beth Milito, Executive Director of NFIB’s Small Business Legal Center. “Many Main Street small businesses...were a mere four weeks away from the deadline to file their information in accordance with the CTA. The BOI [Beneficial Ownership Information] reporting requirements are a harmful invasion of small business owners’ privacy and a misuse of their valuable time."
There's more to privacy concerns than just putting the names of beneficial owners in front of the Feds' eyes: FinCEN has already demonstrated an inability to keep its reports secure from leaks. In 2020, Buzzfeed published a report drawing on more than 2,000 leaked "suspicious activity reports" that had been filed with the agency.
Erskine is hopeful that the case -- Texas Top Cop Shop v Garland -- could help bolster federalism: "Judge Mazzant reaffirmed that the Constitution’s constraints on federal power remain relevant even in addressing modern challenges. This case could set a precedent for courts to scrutinize federal initiatives that intrude into areas historically managed by states."
Let's hope so.
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