The United States agrees with Israel that its ongoing war against Palestinian Islamist group Hamas in Gaza "could go on for months," but Washington was discussing about more surgical operations in scope and scale, the White House said.
"We agree with the Israelis that this conflict could go on for months," White House national security spokesperson John Kirby told reporters on Friday.
The number of U.S. farm acres owned by foreign entities grew more than 8% in 2022, though the 43.4 million acres of foreign-owned forest and farm land is just 3.4% of the country's agricultural land, said a government report on Friday.
The issue of who owns American farmland, and whether foreign ownership of farmland presents a national security risk, has been hotly discussed in Washington, and some members of Congress have proposed limits on foreign farmland ownership.
Foreign entities bought 3.4 million acres of U.S. farmland in 2022, with the biggest increases in Colorado, Alabama and Michigan, said the latest report on foreign agricultural landholdings by the U.S. Department of Agriculture.
Canada remains the largest foreign investor, accounting for 32% of the acres, much of which are forest in Maine.
China's holdings, a primary concern of lawmakers who want to restrict foreign ownership of farms, account for less than 1% of foreign-owned acres at 350,000, a slight decrease from 2021.
The pace of foreign farmland acquisitions has increased since 2017, averaging nearly 3 million acres annually, USDA said.
USDA also said on Friday that it plans to update how it collects such data to better understand the impact of foreign land holdings on rural communities and the exact location of foreign-owned acres.
"This process ... will lead to more insightful reporting to Congress and the public," said Under Secretary for Farm Production and Conservation Robert Bonnie in a statement.
USDA is collecting public comment on its proposed updates through Feb. 16.
The FDA has placed a clinical hold on three of CARsgen Therapeutics’ CAR-T cell therapy candidates following an inspection of the Chinese biotech’s manufacturing facility in Durham, North Carolina.
CARsgen notified the Hong Kong Stock Exchange that the FDA clinical hold had gone into effect on three of its CAR-T products: CT053, CT071 and CT041. According to CARsgen, the clinical hold on its products are due to chemistry, manufacturing, and controls-related “questions” that arose due to the FDA inspection.
The company said in the notice that it plans to conduct a “comprehensive review” and improve its Current Good Manufacturing Practices (cGMP) at the facility, which was opened in February 2022.
CARsgen also said in the notice it is “committed to working closely with the FDA to address the findings to ensure the smooth progress and production quality for clinical trials and launching applications.”
In a statement emailed to BioSpace, a CARsgen spokesperson said that “lingering concerns” surrounding employee training and “other legacy issues” need to be addressed for the facility to be in compliance.
“The FDA's feedback did not pertain to process issues. This provides the company with clear areas of observation, helping us improve in a more targeted manner. We are confident that it will be completed soon and will provide the rectification plan to the FDA as soon as possible, maintain follow-up communication and implement rectifications,” the spokesperson said.
The FDA’s clinical hold comes at a time when CARsgen was making headway for its CAR-T products.
CARsgen’s CT041 product is a candidate that targets Clauidin18.2 positive solid tumors and is focused on treating gastric, gastroesophageal junction and pancreatic cancer. In August 2023, CARsgen and Moderna announced a partnership to combine an mRNA cancer vaccine with the CT041 CAR-T therapy. Patient enrollment in a Phase II trial for CT041 started in May 2023.
The company’s CT071 targets the G protein-coupled receptor Class C group 5 member D and is placed to treat relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia. The product received IND clearance from the FDA in December 2023 and already has an investigator-initiated trial underway in China.
CT053 is designed to treat refractory and relapsed multiple myeloma. Last year, CARsgen presented data from a Phase I/II trial showing that 14 people treated with the candidate had an objective response rate of 100% and a complete response or stringent complete response rate of 78.6%.
CARsgen’s CAR-T cell therapies are not the only ones hit by clinical holds from the FDA. In August 2023, the regulator placed a clinical hold on 2seventy bio’s Phase I trial of its CAR-T therapy for acute myeloid leukemia.
Earlier this month, Roche’s BTK inhibitor fenebrutinib was slapped with a clinical hold after two patients enrolled in a Phase III program for relapsing multiple sclerosis had abnormal elevations in hepatic transaminase levels after receiving the drug.
Pfizer on Thursday entered into an exclusive license agreement with Massachusetts-based biotech Nona Biosciences to develop the mesothelin-targeting antibody-drug conjugate HBM9033 in solid tumors.
Under the deal, Pfizer will pay Nona $53 million in upfront and near-term payments and will pledge up to $1.05 billion in certain development and commercial milestones. Nona will also be eligible for tiered royalties on net sales, ranging from high-single digits to the high teens.
Thursday’s licensing agreement is centered on HBM9033, an investigational antibody-drug conjugate (ADC) that targets the human mesothelin protein, which is a known tumor-associated antigen that is typically highly expressed in different solid tumors.
Preclinical studies have demonstrated “superior potency and safety” of HBM9033 in various tumor models, making the candidate a “potential globally best-in-class therapeutic option,” according to Nona’s announcement on Thursday. In August 2023, Nona announced that the FDA had cleared its Investigational New Drug application for HBM9033, allowing the candidate to enter clinical studies.
HBM9033 was developed using Nona’s Harbour Mice platform, which leverages the company’s two proprietary transgenic mouse platforms that it uses to produce human therapeutic antibodies. According to the biotech’s website, these mouse platforms have “extensive potential for generating both conventional as well as the next-gen biologics.”
Nona Chairman Jingsong Wang in a statement said that the partnership with Pfizer is a “significant milestone” for Harbour Mice and affirms Nona’s capabilities for discovering and developing therapeutic antibodies.
For Pfizer, Thursday’s contract with Nona comes on the heels of its $43 billion acquisition of ADC pioneer Seagen, which it closed on the same day.
Announced in March 2023, Pfizer’s buyout of Seagen will enrich the pharma’s cancer ADC portfolio with four FDA-approved drugs—including Adcetris (brentuximab vedotin), indicated for Hodgkin lymphoma and Padcev (enfortumab vedotin-ejfv), for the treatment of locally advanced or metastatic urothelial cancer—as well as nearly a dozen new molecules and an ADC development platform.
The deal attracted antitrust scrutiny, with the FTC requesting more information in July 2023. However, the acquisition cleared all regulatory hurdles earlier this week.
Pfizer’s big investments in ADCs come as the company weathers tough financial times. On Wednesday, Pfizer revealed its 2024 outlook announcing that its expected revenues would only be flat or could even fall compared to this year’s. In its third-quarter 2023 earnings report, the company posted a 42% drop in revenues compared to the prior year, marking its first quarterly loss since 2019.
In October 2023, Pfizer launched a sweeping cost-cutting program, including layoffs, which originally was designed to generate $3.5 billion in savings through 2024 but which is now targeting to save $4 billion.
Danish shipping company A.P. Moller-Maersk will pause all container shipments through the Red Sea until further notice, a spokesperson for the company told Reuters on Friday.
"Following the near-miss incident involving Maersk Gibraltar yesterday and yet another attack on a container vessel today, we have instructed all Maersk vessels in the area bound to pass through the Bab al-Mandab Strait to pause their journey until further notice," the company said in a statement.
Maersk on Thursday said its vessel Maersk Gibraltar was targeted by a missile while travelling from Salalah, Oman, to Jeddah, Saudi Arabia and that the crew and vessel were reported safe.
Earlier on Friday Maersk denied a claim by Yemen's Iran-aligned Houthi movement that the militia had struck a Maersk vessel sailing towards Israel.
"The vessel was not hit," a Maersk spokesperson told Reuters in an emailed statement following the Houthi claim.
The Houthis had claimed they carried out a military operation against a Maersk container vessel, directly hitting it with a drone. The Houthis, who made the claim in a statement, did not release any evidence.
Maersk said the company was deeply concerned about the highly escalated security situation in the southern Red Sea and Gulf of Aden.
"The recent attacks on commercial vessels in the area are alarming and pose a significant threat to the safety and security of seafarers," it wrote in the statement.
https://news.yahoo.com/maersk-pause-container-shipments-red-153707354.html
Here we go again...
In a hilarious repeat from 2016, ivory tower leftists are absolutely freaking out about the prospect of Donald Trump getting back into the White House, now that multiple polls show that Trump isn't just on track to sweep the GOP primary field - but he'd smoke Biden if a malarkey-free 2024 election were held today.
In early December, several news outlets published articles warning that a second Trump term would turn America into a dictatorship.
And as Victor Davis Hanson noted earlier this week, the Left has gone hysterical, after experiencing a trifecta of frightening 2024 news.
At the same time, establishment talking heads have taken to the air waves to 'remind' the American public what a threat Trumpus Julius Caesar is to the Republic (perhaps with Vivek Antony as VP?).
Tom Elliott of Grabian has put together a supercut of leftists and Rinos losing their minds over a Trump return. A few snippets:
"He cannot be the next president, because if he is..."
"You can't imagine the things that he's going to do. Mexico. Canada. We can't go to Canada because eventually Canada will become annex to America."
"He can shoot the first lady"
"We're going to see violence, the likes of which we didn't even see on January 6th"
"He will make himself into the fuhrer, and he will make everybody raise their hand and salute him."
"Using Marshall Law against the American people."
"Terminate the constitution."
Watch:
Orange man Caesar!
A transgender volleyball player and high school junior from California verbally committed to play for the University of Washington, which could make him the first known male recipient of a women’s Division 1 athletic scholarship.
If the university signs athlete Tate Drageset’s offer next fall, he will take one of 12 National Collegiate Athletic Association DI volleyball scholarships available for women at the school, Reduxx reported Wednesday.
An anonymous source whom Reduxx identified as “the parent of a minor player within the Southern California Volleyball Association (SCVA) community” expressed concerns to the outlet about “the steady escalation of Drageset’s participation in women’s volleyball,” according to the news outlet.
“As he got older, it became more obvious that something was off,” the source told Reduxx. “Anytime the subject of [Drageset] would come up EVERY PARENT from any SCVA team already knew about him. Parents look around before they speak in hushed tones. Some will wait to discuss until outside the gym.”
“Everyone is scared of how their child will be treated if they speak up,” according to the parent. “The stealing of positions and opportunities has been infuriating and so sad when you see how it affects the girls. There is no concern for their mental health or safety after being replaced.”
Former University of Kentucky swimmer and women’s sports activist Riley Gaines posted to social media about Drageset on Wednesday, writing that he is “stealing the already few opportunities for women at the collegiate level.”
Tuition at the University of Washington is $12,645 for state residents and $41,997 for non-residents for the 2023-24 academic year, according to the school’s admissions website.
The Los Angeles Daily News named Drageset, then a high school sophomore, in its “Daily News Girls Athlete of the Week” in November 2022. “Drageset had 23 kills, 10 digs and three aces for the Griffins in their first-ever appearance in the CIF State finals,” it reported.
Marshi Smith, co-founder of the Independent Council on Women’s Sports, told Reduxx that her organization knows “many of the girls [Drageset]’s playing against do not know that they are competing against a male.”
“There has been no consideration from his family to tell female athletes or coaches the truth,” Smith said. “They have not been transparent, so girls are repeatedly and unknowingly put at a disadvantage and not given the chance to opt out over increased safety risks.”
Smith is also a former NCAA champion, according to her X bio.
She told Reduxx that “the NCAA guidelines and the upcoming Biden Administration’s Title IX reinterpretations incentivize male athletes and their families to hide their sex from women and girls.”
“The only solution to provide women with fair and safe sport is to have a female-protected category with no exceptions,” Smith said.
