Ionis And Ono Announce Global License Agreement For Sapablursen In Polycythemia Vera

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Ono Pharmaceutical Co., Ltd (Ono), today announced that the two companies have entered into a license agreement in which Ono obtains exclusive global rights for the development and commercialization of sapablursen, an investigational RNA-targeted medicine for polycythemia vera (PV), a rare and potentially life-threatening hematologic disease. Sapablursen is currently being evaluated in adults living with PV in the fully enrolled Phase 2 IMPRSSION study. Sapablursen was granted Fast Track designation and orphan drug designation in 2024 by the U.S. Food and Drug Administration (FDA).

Under the terms of the agreement, Ionis will receive a $280 million upfront payment, with the potential to earn up to $660 million in additional payments based on the achievement of development, regulatory and sales milestones. Ionis is also eligible to earn royalties in the mid-teen percentage range on annual net sales of sapablursen. Ionis will be responsible for the completion of the ongoing Phase 2 IMPRSSION study, while Ono will be solely responsible for subsequent development, regulatory filings and commercialization. The transaction is subject to the requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act).

https://www.businesswire.com/news/home/20250310343970/en/Ionis-and-Ono-announce-global-license-agreement-for-sapablursen-in-polycythemia-vera

Kennedy tells US food companies to remove artificial dyes

 In a closed-door meeting, the Health and Human Services secretary tells Kraft Heinz, General Mills, Tyson, W.K. Kellogg, Smucker and PepsiCo he wants artificial dyes removed from food products by the end of his time in office.

Health and Human Services Secretary Robert F. Kennedy Jr. told food industry leaders in a closed-door meeting on Monday that he wants them to remove synthetic color additives from their products by the end of his time in office, according to a Consumer Brands Assn. memo obtained by ABC News and Bloomberg.

"The Secretary made clear his intention to take action unless the industry is willing to be proactive with solutions," Melissa Hockstad, president/CEO of Consumer Brands, wrote in the memo.

“Kennedy expects ‘real and transformative’ change by ‘getting the worst ingredients out’ of food,” according to Bloomberg's reading of the Consumer Brands memo. 

@SecKennedy posted on social media site X: “Great discussion today with @ConsumerBrands [and] CEOs of @KraftHeinzCo, @GeneralMills, @TysonFoods, @KelloggsUS (W.K. Kellogg Co), @smuckers and @PepsiCo on advancing food safety and radical transparency to protect the health of all Americans, especially our children. We will strengthen consumer trust by getting toxins out of our food. Let’s Make America Healthy Again.”

Beneath the message was a photo of the eight smiling attendees, with the HHS secretary in the middle.

One can only suspect the CEOs were not as motivated to Tweet their excitement at meeting the new HHS secretary. But the calls for removal of synthetic color additives extend far beyond RFK Jr.

No specific color additives were mentioned in any of the reports we saw, although the FDA already has banned Red 3 effective Jan. 15, 2027. California and other states are also eyeing Red 40, Blue 1 & 2, Yellow 5 & 6 and Green 3.

Most large and international food companies already have reformulated their products without dyes for other countries, especially in Europe, but have resisted changes in the U.S.

"We will be working with your teams to gain as much alignment as possible about how we move forward and ensure the industry is positioned in the best possible way as we navigate next steps forward," said Hockstad’s memo, according to ABC News. "But to underscore, decision time is imminent."

Consumer Brands Assn. also posted a one-paragraph mention on its website, attributed to Hockstad: "Industry leaders met with Health and Human Services Secretary Robert F. Kennedy, Jr. to discuss his Make America Healthy Again agenda and working together to maintain consumer access to safe, affordable and convenient product choices. It was a constructive conversation and we look forward to continued engagement with the secretary and the qualified experts within HHS to support public health, build consumer trust and promote consumer choice."

https://www.foodprocessing.com/business-of-food-beverage/news/55273945/rfk-jr-tells-food-ceos-to-remove-synthetic-dyes

Two central banks, three nationalities, Goldman Sachs: Who is Mark Carney?

 Former governor of the Bank of Canada and the Bank of England, Mark Carney is promoted in charge of the country. A crisis manager who must now prove himself in politics.

Mark Carney takes on a major new challenge: leading Canada through a trade war with the United States. Succeeding Justin Trudeau after almost ten years in office, the former central banker becomes Prime Minister without ever having held a legislative or ministerial post. A meteoric rise for a man whose expertise lies first and foremost in economics and finance.

From field hockey to finance

Born in Fort Smith, Northwest Territories, Mark Carney grew up in Edmonton and played field hockey as a goalie before studying economics. After graduating from Harvard, he obtained a master's degree and a doctorate at Oxford before joining Goldman Sachs, where he spent 13 years and distinguished himself during the Russian financial crisis of 1998.

He then entered the public sector, becoming Deputy Governor of the Bank of Canada in 2003, before taking up a strategic position at the Ministry of Finance before being appointed Governor in 2008. As head of the central bank, he steered the country through the global financial crisis, introducing emergency loans and clear monetary policies. In 2013, he was appointed Governor of the Bank of England, a tenure marked by difficulties, notably around Brexit, until his departure in 2020. He then became United Nations Special Envoy for Finance and Climate Change.

After sitting on the board of Brookfield Asset Management and chairing the board of Bloomberg, Mark Carney left his business commitments to enter politics. On January 16, he applied for the leadership of the Liberal Party, saying he wanted to put his experience as a crisis manager to work for the country.

A surprising choice for the man who, in 2012, derided all political ambition when he told a journalist: "Why don't I become a circus clown?" Yet, backed by the Liberal Party, he won the October 20 election against Conservative Pierre Poilievre. His international expertise and financial background made him a seasoned negotiator, but his lack of political experience drew criticism.

A difficult political apprenticeship

His transition to politics was indeed a bumpy ride. When asked about his alleged role in a Brookfield Asset Management decision to move to the United States, he claimed he was no longer a board member at the time. This statement was quickly contradicted by a letter addressed to shareholders in December 2024, in which he recommended the relocation. In the face of conservative attacks, he admits: "Sometimes I answer questions that go into detail when I should stick to a higher level. That's part of the problem of not being a politician."

Now at the helm of Canada, Mark Carney will have to prove that his economic know-how can adapt to the realities of political power, and convince people of his legitimacy as the next election quickly becomes a priority.

https://www.marketscreener.com/quote/stock/GOLDMAN-SACHS-BDC-INC-21269364/news/Two-central-banks-three-nationalities-Goldman-Sachs-Who-is-Mark-Carney-Canada-s-new-strongman-49295620/

Global companies eye more US investment as Trump touts energy dominance

 Market upheaval from U.S. President Donald Trump's protectionist trade policies has not dampened foreign investment interest in the U.S. energy industry, executives said this week, as they lauded his promise to cut regulations and support fossil fuels.

Trump has made energy dominance a pillar of his administration, declaring a national energy emergency on his first day of office and pulling the U.S. from the Paris climate agreement. He has urged energy companies to boost fossil fuel production and promised to bring down prices for consumers.

The U.S. oil and gas industry, which has focused on returning capital to shareholders and reined in exploration and investment, has broadly welcomed Trump's pro-energy stance, even though lower prices typically hurt company bottom lines. The foreign companies did not yet commit a dollar amount to new investment in the United States.

Oil prices hit a three-year low in early March. On Monday global Brent crude futures settled under $70 a barrel as investors worried a trade war would slow economic growth.

Foreign energy companies see opportunity in America's vast natural resources and Trump's pro-energy policies. Their interest follows years of slower U.S. spending as investors pushed companies to focus on returns rather than explosive growth.

United Arab Emirates energy company ADNOC on Tuesday said it intended to make significant investments in the coming months in the U.S. through its fully-owned international investment arm XRG, which has about $80 billion in assets and is considering options for an initial public offering.

"Investing in the United States through XRG is not a priority; it's an absolute imperative," ADNOC CEO Sultan Al Jaber said on Tuesday.

He said those investments would include the natural gas supply chain. The UAE is a member of the Organization of the Petroleum Exporting Countries.

Australian oil and gas producer Santos also said it planned to increase its investment in the U.S., citing the Trump administration's pro-energy policies. That could include further capital toward its Pikka oil project in Alaska.

Last year, Australian company Woodside Energy acquired U.S. liquefied natural gas company Tellurian and plans to make a final investment decision on an LNG export project in Louisiana this year. The company also recently acquired an ammonia plant in Beaumont, Texas.

Santos on Sunday evening attended a dinner with U.S. Energy Secretary Chris Wright and executives from other major oil and gas firms. Wright promised to speed up permitting and support the industry.

While the industry has mostly applauded the administration's efforts roll back regulations and speed development of oil and gas projects, some executives have expressed concerns about rapid policy shifts.

"Swinging from one extreme to another is not the right policy approach," Chevron CEO Mike Wirth said on Monday at the conference. Trump last month ended a license granted to Chevron since 2022 to operate in Venezuela and export oil.

SPENDING STALLS

Spending by the U.S. oil and gas industry has slowed in recent years as producers have adopted a strategy of capital discipline and focus on shareholder returns. Some major oil companies, including SLB and Chevron, this year have announced job cuts and restructuring plans.

Oilfield producer SLB in a recent earnings presentation warned that its customers remain cautious about spending. On Monday Baker Hughes CEO Lorenzo Simonelli told Reuters the company did not expect customers to boost spending this year, with most output increases coming from efficiency gains.

ConocoPhillips CEO Ryan Lance on Tuesday said he anticipated U.S. oil production to plateau by the end of this decade, an outlook echoed by Vicki Hollub, CEO of Occidental Petroleum Corp.

The U.S. Energy Information Administration (EIA) on Monday lifted its 2025 forecast for domestic oil production to 13.61 million barrels per day, up 200,000 bpd from last month’s forecast. It raised its 2026 forecast 300,000 bpd from a previous outlook, to 13.76 million bpd.

It also raised its natural gas production outlook for this year and next.

"America is going to have a tremendous market opportunity, and I'd say opportunity on a global stage to really help bring energy security to the world," said Toby Rice, CEO of natural gas producer EQT Corp in an interview on Monday.

https://ca.finance.yahoo.com/news/global-companies-eye-more-us-222041387.html

RFK Jr. Seeks To End Rule Allowing Food Companies To Bypass FDA Ingredient Approval

 by Naveen Athrappully via The Epoch Times,

The U.S. Department of Health and Human Services (HHS) said on March 10 that it is seeking to terminate a rule allowing food manufacturers to use additives without formal regulatory approval.

The Generally Recognized As Safe (GRAS) rule allows companies to self-approve the inclusion of additives in food items without requiring a review and the approval of the U.S. Food and Drug Administration (FDA). The rule enables manufacturers to add an ingredient even if the FDA has not determined its safety.

On Monday, HHS Secretary Robert F. Kennedy Jr. directed the acting FDA commissioner to explore the possibility of eliminating the “self-affirmed GRAS pathway” available to companies, the department said in a statement.

“This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers,” HHS said.

As of now, manufacturers submit notices through the FDA’s GRAS notification program, which is not a mandatory process. The agency assesses 75 such submitted notices on average each year.

By eliminating the self-affirm pathway, companies would be required to publicly notify the FDA before introducing new ingredients to food items. The notification must include details such as underlying safety data and the intended use of the ingredients

A 2022 analysis conducted by the activist organization Environmental Working Group found that “nearly 99 percent of all food chemicals introduced since 2000 were greenlighted for use by the food and chemical industry” through the GRAS rule, without requiring FDA approval.

Out of the 766 new chemicals added to the food supply since 2000, only 10 involved companies petitioning the FDA to approve the ingredient.

Nine out of the 10 FDA petitions were filed before 2010. The only petition filed post-2010 was in 2018, EWG said.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” Kennedy said.

“Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

GRAS Risks, Health Commission

According to the 2022 EWG analysis, one of the additives in the GRAS list at the time was butylated hydroxyanisole (BHA), which the National Toxicology Program had identified as a potential carcinogen. BHA is widely used as a preservative in the meat industry.

Another additive was the green tea extract EGCG, which the group said “may increase risk of cancer but is classified as GRAS.”

In an interview with The Epoch Times, adjunct professor in the department of medicine at the Icahn School of Medicine at Mount Sinai, Mona Calvo, said that many of the commonly used food additives that have secured GRAS listing did so between 1970 and 1975, a time when “people could not foresee the situation today.”

During that period, people mostly consumed home-cooked meals that used natural ingredients, unlike today when ultra-processed foods are now part of everyday diets.

Dr. Jaime Uribarri, a nephrology specialist at the Icahn School of Medicine, said that “once an additive-containing packaged food is in the marketplace, the FDA does not have a mechanism for regularly testing its safety, such as through periodic sampling checks.”

The HHS crackdown on GRAS comes as President Donald Trump issued a presidential action last month establishing the Make America Healthy Again Commission.

One of the provisions includes assessing how the potential over-utilization of certain food ingredients and chemicals poses a health threat to children.

In a March 11 post on social media platform X, Kennedy said he had positive discussions with CEOs of food brands such as Kraft Heinz, General Mills, Tyson Foods, Kellogg’s, and Pepsi “on advancing food safety and radical transparency to protect the health of all Americans, especially our children.”

“We will strengthen consumer trust by getting toxins out of our food,” he wrote.

https://www.zerohedge.com/medical/rfk-jr-seeks-end-rule-allowing-food-companies-bypass-fda-ingredient-approval

House Passes Full-Year Stopgap As Democrat Crosses Party Lines, Massie Votes 'No'

 Update (1755ET): The House passed the stopgap resolution on Tuesday to avert a partial government shutdown and fund federal agencies through September.

House Speaker Mike Johnson (R-LA) was able to convince most Republicans to vote for the bill, with the exception of Rep. Thomas Massie (R-KY), while one Democrat - Jared Golden (D-ME) joined the Republicans in passing the measure which increases security spending by $4.4 billion, contains a $440 million boost for immigration enforcement, and cuts the IRS budget by $20 billion.

It also prevents Washington DC from spending $1 billion of its own tax dollars, and allows the Pentagon flexibility to buy new weapons - an odd provision in a stopgap bill that was demanded by GOP defense hawks.

The bill also has no new limits on DOGE, and does not prevent agency heads from firing federal workers or canceling federal grants and contracts - actions which are currently being challenged in the courts in what critics argue amount to illegal impoundments of money approved by Congress.

The bill passed in a 217 - 213 vote, and will now move to the Senate, where it needs at least 60 votes to pass - meaning around 10 Democrats will need to cross party lines.

Moderate Senate Democrats, including Jeanne Shaheen of New Hampshire, Jacky Rosen of Nevada, and Mark Kelly of Arizona have given no indication on how they'll vote, while Sen. John Fetterman (D-PA) said he would support it.

If a Saturday shutdown does occur, the White House budget office would have the flexibility to decide which federal workers are furloughed (and would receive backpay) and which essential staff must continue in their positions without pay. The military would remain on duty without pay until the shutdown was over.

Update (1240ET): JP Morgan has weighed in with the usual 'government shutdowns have meant little to the economy with the 5-week shutdown during 2018-19, real GDP fell by $11bn though $8bn was recovered after the gov’t reopened,' however the bank does note that 'equities have tended to fall in the days leading up to a shutdown before recovering all loses and resuming their trend higher,' while concluding "The setup is different this time and a gov’t shutdown is likely not on many investors’ radar."

Oh, fun...

*  *  *

With three days remaining before the next shutdown, the House is expected to pass a stopgap funding package on Tuesday after the House Freedom Caucus agreed to back it - which means Speaker Mike Johnson (R-LA) may be able to pass the bill, which would fund the government until September - without the help of Democrats.

That said, despite the Freedom caucus' buy-in, Johnson still has several GOP holdouts - with the only one to go public being Rep. Thomas Massie (R-KY) - who President Donald Trump dragged on social media, calling for him to be primaried, and comparing him to Rep. Liz Cheney.

On Sunday, Massie said on X "I'm not voting for the Continuing Resolution budget (cut-copy-paste omnibus) this week," adding "Why would I vote to continue the waste fraud and abuse DOGE has found?"

To which Trump replied on Truth Social: "Congressman Thomas Massie, of beautiful Kentucky, is an automatic ‘NO’ vote on just about everything, despite the fact that he has always voted for Continuing Resolutions in the past,” Trump said. “HE SHOULD BE PRIMARIED, and I will lead the charge against him."

To which Massie then replied: "Someone thinks they can control my voting card by threatening my re-election. Guess what? Doesn’t work on me."

Also potentially on the fence Punchbowl reports that Reps. Kat Cammack (R-FL) and Beth Van Duyne (R-TX) both raised concerns over the measure during a GOP whip meeting on Monday.

https://www.zerohedge.com/political/house-vote-stopgap-amid-trump-massie-feud-freedom-caucus-comes-around-senate-looms

Billed as Consumer Protection, Trump's ACA Proposal Adds Enrollment Restrictions

 The Trump administration issued its first major set of proposed changes to the Affordable Care Act (ACA) on Monday that federal officials said are intended to crack down on fraud in the program. Policy experts said they will make it harder for consumers to sign up for coverage, potentially reducing enrollment.

Details were releasedopens in a new tab or window Monday after a draft press release was inadvertently posted earlier.

About 24 million Americans signed upopens in a new tab or window for insurance plans sold under the ACA, known popularly as Obamacare, for 2025. The Biden administration achieved record enrollment levels after increasing premium subsidies for many lower-income people, which resulted in reducing the monthly cost of some plans to $0. It also made it easier for some very low-income people to sign up at any time of year, instead of waiting for an enrollment period each fall. But the program became plagued by fraudulent enrollmentopens in a new tab or window last year, generating about 274,000 consumer complaints through Augustopens in a new tab or window, most focused on rogue insurance agents and other bad actors, to the Centers for Medicare & Medicaid Services (CMS).

The Trump administration said in a statement Monday that the new regulations include "critical and necessary steps to protect people from being enrolled in Marketplace coverage without their knowledge or consent, promote stable and affordable health insurance markets, and ensure taxpayer dollars fund financial assistance only for the people the ACA set out to support."

Policy experts said the changes, though, will impose new paperwork burdens likely to hamper enrollment.

"Under this banner of trying to crack down on the bad actions of some insurance brokers, they are penalizing consumers, particularly low-income consumers, with more burdensome requirements and more limits on their access to coverage," said Sabrina Corlette, a research professor and the co-director of the Center on Health Insurance Reforms at Georgetown University.

Among other new requirements, consumers would have to provide more information proving their eligibility for special enrollment periods and for premium subsidies when they enroll. The regulation would also shorten the annual enrollment period by a month. And it touches on social issues, limiting eligibility for "Dreamers" -- a nickname for immigrants in the country illegally who were brought here as children, based on never-passed proposals in Congress called the DREAM Act.

The CMS proposal would eliminate the year-round opportunity for a special enrollment period for people with very low incomes. But it would also set new requirements for the remaining special enrollment periods, which allow people to sign up after major life events, such as when their income changes, they lose their job-based coverage, or they get divorced, marry, or move. They would now have to provide evidence of their eligibility when applying under those special situations.

People auto-reenrolled into zero-premium plans during the regular enrollment period would be charged a small monthly payment until they confirm or update their information.

The ACA marketplaces, according to the proposal, would have to seek additional data from consumers, including the self-employed or gig workers, who estimate their income for the coming year but don't have tax return data filed with the IRS for previous years.

The Biden administration made changes to reduce fraudulent enrollment last year including requiring three-way callsopens in a new tab or window among insurance brokers, their clients, and the federal insurance marketplace, healthcare.gov, when certain sign-ups or coverage changes were made.

Some of the Trump administration's proposed changes could help warn certain consumers that they've been unknowingly enrolled in an ACA plan, such as a requirement that some customers on even the least expensive plans receive a small, monthly premium bill.

However, the additional paperwork and other eligibility requirements "will probably have a downward effect on enrollment," said Cynthia Cox, MPH, a vice president and the director of the Program on the ACA at KFF, a health information nonprofit that includes KFF Health News. "Some of that could be protecting enrollees who were fraudulently signed up or don't realize they're still signed up."

Still, it could prove difficult for some people if they're not able to document an expected change in income. "They might have a legitimate claim but have a hard time demonstrating it," Cox said.

The annual open enrollment period would end Dec. 15, a month earlier than this year. The designated period is when most people sign up and is intended to prevent people from waiting until they get sick to enroll, a move that helps slow premium growth.

The Trump proposal also touches on social issues.

It would reverse the Biden administration policy that allows Dreamers to qualify for subsidized ACA coverage. That decision is already the subject of a court challenge brought by 19 states seeking to overturn itopens in a new tab or window.

Also under the Trump proposal, gender-affirming care would not be considered part of the essential health benefits (EHBs) that all plans must cover.

According to an FAQ that accompanied the initial press release of the proposed regulations, the provision could "lead to increased out-of-pocket costs for individuals requiring sex-trait modification services, as they may need to seek plans that offer this coverage as a non-EHB or pay for services out-of-pocket."

As a proposed rule, the measures now face a public comment period and potential revision before being finalized.

"None of it will go into effect right away," said Katie Keith, PhD, director of the Center for Health Policy and the Law at Georgetown University. "The question is how much will apply in 2025 versus 2026."

The FAQ acknowledged that some of the proposed changes, including ending year-round enrollment for very low-income people, "may increase the administrative burden for consumers associated with enrollment and verification processes or could deter some eligible low-income individuals from enrolling."

But, it continued, "we believe that enhancing program integrity and reducing improper enrollments outweighs these potential impacts on access to coverage."

Some lawmakers and conservative groups have pointed to the concernsopens in a new tab or window about unauthorized enrollment and the role, if any, that ACA subsidies or enrollment periods have in fueling the problem.

The right-leaning Paragon Health Institute, for example, released a report in Juneopens in a new tab or window that, among other things, called for the Biden administration's expansion of the special enrollment period for low-income people to be reversed.

"There is substantial amounts of fraud and waste in the ACA exchanges and the Biden administration pursued the enrollment-at-all costs strategy, and was tolerant of the waste, fraud, and abuse," said Brian Blase, PhD, a former health aide during Trump's first presidency who is president of the Paragon Health Institute and influential within the current Trump administration. "Clearly a different approach to protect legitimate enrollees and taxpayers is needed."

KFFopens in a new tab or window Healtopens in a new tab or windowhopens in a new tab or window Newsopens in a new tab or window is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF

https://www.medpagetoday.com/washington-watch/washington-watch/114593