Novartis: Adding twice-yearly* Leqvio after statin therapy significantly reduces LDL-C

 

• V-INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively)1
• A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment1
• Results from usual care arm reinforce the urgent need for more aggressive LDL-C lowering in ASCVD patients, 92% of whom did not reach their LDL-C goal with statins alone1
• The Leqvio safety profile was consistent with the Phase III clinical studies and long-term open-label extension trials for up to 6 years of treatment

https://www.prnewswire.com/news-releases/new-novartis-data-show-early-addition-of-twice-yearly-leqvio-inclisiran-following-maximally-tolerated-statin-therapy-significantly-reduces-ldl-c-in-ascvd-patients-in-real-world-setting-302109623.html

SEC Forced To Halt Climate Reporting Mandate For Businesses

 by Naveen Athrappully via The Epoch Times,

The U.S. Securities and Exchange Commission (SEC) paused the implementation of its climate disclosure requirements for companies as legal challenges against the rules are pending in a circuit court.

In March, the SEC finalized a controversial rule requiring publicly traded companies to disclose any climate-related risks to their business. The SEC’s Final Rules also required some midsize and large firms to reveal how much CO2 is emitted from their operations. This led to several Republican states, companies, and business groups filing lawsuits against the regulations, asking for the SEC rule to be stayed. Two energy companies—Liberty Energy Inc. and Nomad Proppant Services LLC—sought an administrative stay on the rule, which was granted by the Fifth Circuit court on March 15.

According to SEC rules, businesses must report on the potential impact climate risks may have on their financial condition as well as the strategies undertaken to mitigate such risks. Businesses have to disclose their climate targets and the losses suffered due to severe weather events.

Other legal challenges against the rule were filed at the Second, Sixth, Eighth, Eleventh, and D.C. Circuit courts. All the lawsuits, including the Fifth Circuit one, were consolidated into a single case, with the Eight Circuit set to hear the challenge.

On March 26, the Chamber of Commerce of the United States of America, the Texas Association of Business, and the Longview Chamber of Commerce filed a motion in the Eighth Circuit, seeking a stay of the SEC rules pending judicial review.

Challenging SEC

Lawsuits from Republican states claim that the SEC breached their rule-making authority by asking public firms to disclose climate risks while such regulations have not received approval from Congress.

SEC’s rules create costly, unnecessary “red tape” for businesses. They accused the climate rules of being part of the Biden administration’s push to make sure investment decisions in the country are driven by climate considerations rather than financial returns.

On April 4, SEC Secretary Vanessa Countryman issued an order staying the agency’s climate rule requirements while litigation proceeded in the Eighth Circuit.

Ms. Countryman argued that given the procedural complexities involved in litigating the multiple cases filed against the climate rules, the SEC’s stay “will facilitate the orderly judicial resolution of those challenges.”

In addition, “a stay avoids potential regulatory uncertainty if registrants were to become subject to the Final Rules’ requirements during the pendency of the challenges to their validity.”

Though the SEC is issuing a stay on the climate rule, the agency continues to hold the view that the regulations are “consistent with applicable law” and within the authority of the commission, the order stated.

“Thus, the Commission will continue vigorously defending the Final Rules’ validity in court and looks forward to expeditious resolution of the litigation.”

‘Outrageous’ Climate Mandate

Iowa Attorney General Brenna Bird, one of the Republican AGs that led 25 states to file lawsuits against the climate rules, called the SEC’s April 4 stay a “victory” that “shuts down the most outrageous climate mandate for businesses since Biden took office.”

“The SEC’s job is to protect people from fraud. It has no business slapping companies with extremist climate mandates. We are making it clear that Biden has to follow the law like everyone else,” she said.

“By halting this mandate, we are protecting businesses from costly red tape, securing our supply chain, and defending family farms. Next, we are going to make this win permanent!”

In addition to Iowa, other states in the lawsuit are Alabama, Alaska, Arkansas, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, and Wyoming.

The SEC rule “will also require businesses to disclose climate-related risks, including higher insurance rates from weather disasters, and release a plan to adapt to climate-agenda recommendations. The plan is estimated to cost businesses billions of dollars every year.”

SEC Votes

When the SEC finalized its climate rules in March, agency commissioners had voted 3–2 to pass the measure. The votes were done along party lines, with all Democrats voting in favor of the rule and Republican commissioners voting against it.

Republican commissioner Hester Peirce had pointed out that the climate rules would be expensive and burdensome for businesses while creating a large amount of inconsistent information overwhelming investors.

“However well-intentioned, these particularized interests don’t justify forcing investors who don’t share them to foot the bill,” he said. The SEC estimates the climate rule to impact around 2,800 American firms.

The rules adopted in March were a watered-down version of an earlier draft that contained more stringent measures, including requiring companies to report certain indirect emissions. These stringent measures triggered intense opposition from the business community.

In an interview with The Epoch Times in June 2022, Sean Griffith, a professor at Fordham University School of Law, suggested that SEC rules enforce viewpoint discrimination since the regulations are essentially forcing companies to endorse certain assumptions about how the earth’s climate is being affected by human actions.

“The reason why the climate rules are so problematic is that either they’re politically driven—which is very plausible—or they are driven by this desire to appease the institutional asset manager community, which has its own profit interest because they generate revenue from the assets under management of those ESG portfolios. At the end of the day, it’s not about investors.”

https://www.zerohedge.com/political/sec-forced-halt-climate-reporting-mandate-businesses

Zelenskiy hopes to set Swiss world peace summit date within days

 Ukrainian President Volodymyr Zelenskiy said in remarks broadcast on Saturday that he hoped that he and Swiss President Viola Amherd would set a date within days for a world peace summit in Switzerland with 80 to 100 countries.

Russia has said such a meeting would be pointless if it did not participate. Kyiv has previously proposed a world peace summit but has said Russia would not be invited.

Zelenskiy said in a television interview that he and the Swiss president would have to agree on the date between them and then send invitations to world leaders.

"We expect to have 80 to 100 countries." He added, "This is the number of countries, I believe, that will be able to at least try to force Russia to a fair peace."

In the interview, recorded during a visit to Chernihiv region, where he visited fortifications work on Friday, Zelenskiy said that they did not yet have a specific list of countries. "We will agree how it will happen in coming days," he said. "Days, I hope, not even weeks."

Asked about the role of Turkey, Zelenskiy said he was grateful to Turkish President Tayyip Erdogan for his support and desire to mediate, noting Turkey also had other interests and strong relations with Russia.

"Turkey as a mediator is not enough for us," he said. "Undoubtedly, they will be among those leaders, countries that can perform a mediation mission but not the mediation," he added.

Zelenskiy said the format of the summit would be very complex, bearing in mind the many interests involved in a summit involving so many countries, including historical and contemporary relations with Russia, Europe and elsewhere.

"Nevertheless, get all of them together, find the format, the way we go forward, and agree on it," he said.

https://www.yahoo.com/news/zelenskiy-hopes-set-swiss-world-213251186.html

Mexico to require visas for Peru nationals after migration spike

 Mexico will require a visa application for Peruvian nationals seeking to enter Mexican territory, according to an announcement published in the official gazette on Friday, amid a recent surge of migrants from the South American country.

The measure, issued by Mexico's interior minister, will be temporary and take effect in 15 days, according to the gazette.

In 2012, Mexico eliminated an earlier visa requirement for Peruvians who visit the country for up to 180 days. The measure led to Peruvians securing a place among the top 10 nationalities visiting Mexico.

The country has since seen a "substantial" increase in the number of Peruvians entering its territory "whose profile does not fit that of the genuine visitor or tourist and present inconsistencies in their documentation," the ministry asserted in the gazette entry.

In recent years, Mexico has imposed visas for visitors of different nationalities, arguing that they were using its territory to surreptitiously enter the United States.

https://www.yahoo.com/news/mexico-require-visas-peru-nationals-010906396.html

Venezuela to allow safe passage to Argentina for Machado aides, government source says

 Venezuela's government will allow six aides of opposition leader Maria Corina Machado who are currently at the Argentine embassy in Caracas to travel safely to Argentina, a government source said on Friday.

The aides, including campaign manager Magalli Meda, previously tipped as a potential replacement for Machado in this year's presidential election, sought protection at the embassy in March after the attorney general's office announced warrants for their arrest.

"We have granted safe passage to those six people. We are waiting for Argentina to take them to Buenos Aires," the government source said. "The Venezuelan government has exceptionally allowed them to leave the country for humanitarian reasons."

While the aides will be allowed to leave, the criminal case against them will continue, the source added.

Venezuela's attorney general Tarek Saab said in March that two people close to Machado had been arrested, while seven other members of her team had warrants out for their detention. The arrests and warrants were for alleged involvement in planned conspiracies, Saab said.

Machado has denied any allegations of misconduct by her team.

She told journalists that safe passage for the aides was "being managed between the foreign ministries of Argentina and Venezuela," offering no further details.

Last week, the office of Argentine President Javier Milei said it was concerned about the persecution of political opposition leaders in Venezuela, shortly after Argentina confirmed the six people were at the embassy.

Argentine Foreign Minister Diana Mondino told an event on Friday that Milei's government was working to bring the six aides to Argentina.

"We're working on it, it's not so easy," Mondino said.

Venezuela's opposition is subsumed in internal negotiations about how to run a candidate in the July 28 election and who that candidate could be.

Machado, who resoundingly won the opposition primaries last October, cannot run because she is barred from holding public office, a decision she says is unfair. Machado named Corina Yoris as her successor, but the 80-year-old academic was also unable to register her candidacy.

Two opposition candidates were able to register and possible substitutes can be named until April 20.

At least six other people from Machado's team have been arrested since January.

https://www.yahoo.com/news/venezuela-allow-safe-passage-argentina-165004333.html

FDA Greenlights BMS, J&J CAR-T Therapies for Earlier Multiple Myeloma Treatment

 The FDA has approved two CAR-T cell therapies for the earlier treatment of multiple myeloma. The first approval, for Bristol Myers Squibb and 2seventy Bio’s Abecma, came Thursday, followed by that of Johnson & Johnson and Legend Biotech’s Carvykti on Friday. 

The approvals come three weeks after an FDA advisory committee unanimously recommended Carvykti as a second-line treatment for patients with refractory multiple myeloma, and backed Abecma by a vote of 8-3 for patients who had received at least two previous drug regimens. Carvykti joins seven other therapies that can be used as second-line treatments for multiple myeloma if initial therapies fail.

Both Abecma and Carvykti reprogram a patient’s T-cells to eliminate cells that express B-cell maturation antigen (BCMA), which is present in normal B-cells but overexpressed in multiple myeloma.

While the FDA’s Oncologic Drugs Advisory Committee expressed concerns about higher rates of early deaths in the treatment arms of trials for both drugs, it ultimately determined that the benefits of the therapies outweighed the risks. 

Prior to Thursday’s approval, Abecma was authorized to treat patients with relapsed or refractory multiple myeloma in adult patients who have previously received four or more treatment regimens. It is the first CAR T cell therapy approved for earlier use for triple-class exposed relapsed and/or refractory multiple myeloma, according to BMS. 

“Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma,” Bryan Campbell, senior vice president and head of commercial, cell therapy at BMS, said in a statement.

In the Phase III KarMMa-3 trial, treatment with Abecma led to a 51% reduction in the risk of disease progression or death. Patients treated with the CAR-T therapy survived a median 13.3 months without progression, while those in the control group lived only 4.4 months without their disease advancing. Abecma’s safety profile was well-established, according to BMS, though the therapy does come with a boxed warning for cytokine release syndrome, neurologic toxicities, HLH/MAS, prolonged cytopenia and secondary hematologic malignancies.

The FDA nod comes three weeks after the European Commission authorized Abecma for the third-line treatment of multiple myeloma.

Carvykti Wins Second Line Nod

Carvykti, which won expanded approval late Friday evening, is the first BCMA-Targeted therapy for the second-line treatment of multiple myeloma, according to Legend Biotech. 

The CAR-T cell therapy is authorized for patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide. 

J&J and Legend Biotech supported their application with data from the  CARTITUDE-4 study, where treatment with Carvykti led to "statistically significant and clinically meaningful improvement of progression-free survival compared to two standard of care treatment regimens," according to the companies. 

Carvykti was also tagged with a boxed warning for potential side effects, including cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and secondary malignancies, including myelodysplastic syndrome, acute myeloid leukemia and T-cell cancers. 

The therapy was originally approved in February 2022 as a fifth-line treatment. It was also conditionally approved in Europe for patients who had tried at least three other therapies. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently supported approving Carvykti as a second-line treatment for multiple myeloma.

The FDA has demonstrated caution toward CAR-T therapies in recent months. In November 2023, the agency began investigating the “serious risk” of T-cell malignancies in patients treated with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. In January 2024, the FDA called for boxed warnings for all currently marketed CAR-T therapies after three of 22 cases were found to have likely causal links. However, the regulator stated that the overall risk of T-cell cancers in people receiving CAR-T therapies “appears to be quite low.”

https://www.biospace.com/article/fda-greenlights-bms-j-and-j-car-t-therapies-for-earlier-multiple-myeloma-treatment-/

IRS Still Targeting Middle Class

Liar, liar: Back in August 2022, when some of us were fresh-faced and naive, the Internal Revenue Service (IRS) assured us that their $80 billion infusion of cash (over the course of a decade, so they could hire some 87,000 new workers, including but not limited to men with guns) would actually be a means of targeting millionaire and billionaire scofflaws, not ordinary middle-class earners.

At the time, I voiced skepticism: Correspondence audits and other audits on low- and middle-income earners are simply the easiest to conduct. The IRS has historically spent an awful lot of time targeting these groups, not monied tax dodgers who can hire teams of accountants, so why would this time be different?

Vindicated: "The Internal Revenue Service got an audit of its own in time for Tax Day, and two irregularities jump out," reports The Wall Street Journal, having labored through the latest Treasury Inspector General for Tax Administration (TIGTA) reports. "President Biden's plan to hire a new army of tax collectors is falling flat, and the agents already at work are targeting the middle class."

"As of last summer, 63% of new audits targeted taxpayers with income of less than $200,000," reports the Journal. "Only a small overall share reached the very highest earners, while 80% of audits covered filers earning less than $1 million."

Compare these real-world outcomes with the assurances of the IRS, given less than two years ago.

Empty assurances: "These resources are absolutely not about increasing audit scrutiny on small businesses or middle-income Americans. As we've been planning, our investment of these enforcement resources is designed around the Department of the Treasury's directive that audit rates will not rise relative to recent years for households making under $400,000," wrote IRS commissioner Charles Rettig in an August 2022 letter to concerned senators.

Treasury Secretary Janet Yellen was a bit sassier. "Contrary to the misinformation from opponents of this legislation, small business or households earning $400,000 per year or less will not see an increase in the chances that they are audited," she wrote in a letter to Rettig.

It's almost like they didn't tell us the truth the first time around. But that's not even the most embarrassing thing in the report: The IRS had set a goal of hiring 3,700 new agents in the first year of boosted funding. Instead, in the first six months, they'd hired 34.

Awkwardly, "revenue agent staffing had actually decreased by 8%, or more than 650 employees, between the end of fiscal 2019 and March 2023," per a previous watchdog report. And it's not just hiring that's in trouble: The agency has completed just 33 percent of its fiscal year 2023 milestones outlined in its strategic operating plan, which is…tough given that the year is over.

https://reason.com/2024/04/05/promise-breaking-irs/