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Thursday, May 15, 2025

RFK Jr. says he’s ordered a ‘complete review’ of chemical abortion pill

 Health and Human Services Secretary Robert F. Kennedy Jr. revealed Wednesday that he has ordered the Food and Drug Administration (FDA) to conduct a “complete review” of a chemical abortion pill amid reports that the drug isn’t as safe as advertised.  

“It’s alarming,” RFK Jr. said of a recent study conducted by the Ethics & Public Policy Center that found nearly 11% of women who used the popular abortion pill mifepristone experienced a “serious adverse event.” 

“I have asked Marty Makary, who is the director at FDA, to do a complete review and report back,” the HHS secretary revealed during a Senate Health, Labor, Education and Pensions Committee hearing. 

The FDA will conduct a “complete review” of mifepristone after reports that the drug isn’t as safe as advertised.REUTERS

The Ethics & Public Policy Center study – the “largest-known” on the abortion pill – analyzed insurance claims data from 865,727 prescribed mifepristone abortions between 2017 and 2023. 

The study found 10.93% of women experience sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following a mifepristone abortion.

Sen. Josh Hawley (R-Mo.) cited the group’s research as he questioned RFK Jr. during the hearing and noted that the study showed the rate of serious adverse health effects “is 22 times higher than the FDA’s current label” for mifepristone, “which says it’s just 0.5%.”

“Clearly [the study] indicates, at the very least, that the label should be changed,” Kennedy Jr. told Hawley. 

Mifepristone was originally approved by the FDA in 2000.

Health and Human Services Secretary Robert F. Kennedy Jr. ordered the FDA to review mifepristone after reports of safety concerns.Jack Gruber-USA TODAY via Imagn Images
Demonstrators rallied in support of abortion rights at the US Supreme Court in Washington, DC, on April 15, 2023.AFP via Getty Images

The Ethics & Public Policy Center, which released its findings last month, argued that the FDA should implement “stronger patient safety protocols to ensure physician responsibility for women who take mifepristone under their care, as well as mandate full reporting of its side effects,” in light of its study.

“The FDA should further investigate the harm mifepristone causes to women and, based on objective safety criteria, reconsider its approval altogether,” the group concluded. 

The FDA initially OK’d mifepristone for chemical abortions up to seven weeks into a pregnancy — a timeframe that was later extended to 10 weeks under former President Barack Obama.

Former President Joe Biden opened the door to FDA approval of mifepristone prescriptions online or through the mail, which the Supreme Court upheld in a unanimous ruling last year.

The Washington, DC-based Ethics and Public Policy Center is a conservative think tank and advocacy group that seeks “to apply the riches of the Jewish and Christian traditions to contemporary questions of law, culture, and politics, in pursuit of America’s continued civic and cultural renewal,” according to the group’s website.

https://nypost.com/2025/05/15/us-news/hhs-chief-rfk-jr-says-hes-ordered-a-complete-review-of-chemical-abortion-pill/

Belite Positive Interim Analysis for Phase 3 Trial of Tinlarebant in Adolescent Stargardt Disease

 Belite Bio, Inc. announced positive developments regarding its lead drug candidate, Tinlarebant, for treating Stargardt disease (STGD1) and ongoing trials for geographic atrophy (GA). Following an interim analysis, an independent Data Safety Monitoring Board (DSMB) endorsed the continuation of the pivotal Phase 3 DRAGON trial without modifications and recommended submitting interim data for regulatory review. The trial is expected to complete by Q4 2025, with a three-month follow-up period. Additionally, Belite is conducting the Phase 3 PHOENIX trial for GA, currently with 464 enrolled subjects out of 500. The firm raised $15 million in funding and reported a net loss of $14.3 million for the first quarter of 2025. A conference call is scheduled for May 14, 2025, to discuss these results and provide further updates.



  • Following a pre-specified interim analysis, an independent Data Safety Monitoring Board (DSMB) recommended the pivotal Phase 3 trial (DRAGON) of Tinlarebant in adolescent Stargardt disease (STGD1) patients proceed without any modification; trial completion expected Q4 2025 (including a three-month follow-up period)


  • DSMB also recommended the Company submit the interim data for further regulatory review for drug approval


  • A pivotal global Phase 3 trial (PHOENIX) of Tinlarebant in geographic atrophy (GA) patients is ongoing with 464 of targeted 500 subjects enrolled


  • Raised $15 million in gross proceeds in a registered direct offering on February 5, 2025




  • Conference call and webcast on Wednesday, May 14, 2025, at 4:30 p.m. ET

Webcast Information





Belite Bio will host a webcast on Wednesday, May 14, 2025, at 4:30 p.m. Eastern Time to discuss the Company’s financial results and provide a business update. To join the webcast, please visit

https://events.q4inc.com/attendee/137642555

. A replay will be available for approximately 90 days following the event at the Company’s Investor Relations website at

https://investors.belitebio.com/presentations-events/events

https://www.nasdaq.com/articles/belite-bio-announces-positive-interim-analysis-phase-3-dragon-trial-tinlarebant-adolescent

China pauses rare earth export restrictions on 28 US entities after trade truce

 In a significant step toward easing trade tensions, China on Wednesday lifted export restrictions on rare earths and military-use technologies for 28 U.S. entities.

The move comes just two days after Washington and Beijing struck a breakthrough agreement to temporarily lower tariffs, marking the first major de-escalation in a trade war that had threatened to upend global supply chains and economic stability.\The deal, reached during high-level negotiations in Geneva on May 12, includes a 90-day pause and a sweeping 115-percentage-point reduction in reciprocal tariffs.

The decision is being hailed as a reset in bilateral ties between the world’s two largest economies after months of tit-for-tat escalation.

Reset after retaliation

The suspension of rare earth export curbs took effect Wednesday and will last for 90 days, China’s Ministry of Commerce said in a statement.

During this window, exporters of rare earths and other dual-use goods with military potential can apply for licenses to resume shipments, according to the ministry.\The trade war had entered a particularly volatile phase last month, with U.S. President Donald Trump imposing tariffs of up to 245% on a broad swath of Chinese imports.

Beijing responded in kind with retaliatory measures and a pledge to “fight the tariffs till the end,” a standoff that sent stock markets into a tailspin and raised fears of a global recession.

In retaliation, China halted exports of seven types of rare earth elements to 16 U.S. entities on April 4 and expanded the restrictions to 12 additional firms just five days later.

These included critical materials such as samarium, gadolinium, terbium, dysprosium, lutetium, scandium, and yttrium — essential components in the manufacture of semiconductors, electric vehicles, missile systems, and aerospace technologies.

In a separate announcement on Wednesday, China’s Ministry of Commerce also said it would temporarily lift a trade and investment ban on 17 U.S. companies, signaling further willingness to dial down tensions.

Race for resources

China currently dominates the global supply of rare earths, accounting for about 90% of production. For certain heavy rare earths like dysprosium and terbium, its market share was as high as 99% until recently.

These elements are vital for the production of clean energy technologies, defense equipment, and other high-tech industries.

The U.S. remains particularly exposed to disruptions in these supply chains. According to the U.S. Geological Survey, China supplied half of America’s critical mineral imports in 2024, including rare earths and other strategic materials such as yttrium, antimony, bismuth, and arsenic.

Reducing this dependence has become a strategic priority for Washington. On Inauguration Day in January, President Trump declared a national energy emergency, citing high energy prices and foreign supply vulnerabilities as threats to national security.

In March, he invoked the Defense Production Act to boost domestic mining of critical minerals, unlocking federal support through loans, tax incentives, and investment partnerships.

The administration is also looking beyond U.S. borders—eyeing rare earth deposits in Greenland and Ukraine and pushing forward plans for deep-sea mining in international waters to secure future supplies.

https://www.msn.com/en-us/money/markets/china-pauses-rare-earth-export-restrictions-on-28-us-entities-after-trade-truce/ar-AA1EMLo8

South Africa’s Land Bank in Talks to Raise as Much as $1 Billion




A state-owned South African bank that finances farmers is in talks with funders to raise as much as $1 billion as it recovers from a default five years ago.

The Land & Agricultural Development Bank of South Africa has an indicative term sheet for that amount from a development financing institution, Chief Executive Officer Themba Rikhotso said. It will engage with the National Treasury before the end of the month to get its support for the plans, he said.

https://www.bloomberg.com/news/articles/2025-05-15/south-africa-s-land-bank-in-talks-to-raise-as-much-as-1-billion

French Minister To Meet Crypto Firms After Kidnapping Attempt

 by Adrian Zmudzinski via CoinTelegraph.com,

The French interior minister reportedly plans to meet cryptocurrency professionals in the aftermath of a violent kidnapping attempt on the family of a crypto exchange executive in Paris.

According to a May 14 France24 report, Interior Minister Bruno Retailleau has invited crypto professionals to meet him after a brazen attempt to kidnap the daughter and grandson of Pierre Noizat, the co-founder and CEO of French crypto exchange Paymium.

”I will assemble businesspeople working in cryptocurrencies, and we have a few of those in France, at the interior ministry to work with them on their security,” Retailleau reportedly told the Europe 1/CNews broadcaster.

On May 13, three masked men attacked Noizat’s daughter while she was walking in Paris’ 11th district with a man and her son. The attackers tried to force Noizat’s daughter and her son into a white van.

Passersby intervened, with one scaring the assailants while brandishing a fire extinguisher before throwing it at them as they fled. The event is now being investigated by local authorities, with the vehicle used being found abandoned nearby on the same day.

Growing risk for cryptoholders

Jameson Lopp, a cypherpunk and co-founder of self-custodial firm Casa, has created a list on GitHub recording dozens of offline crypto robberies, with 22 incidents of in-person crypto-related theft so far this year. Many in the crypto industry highlight that anonymity is the only way to effectively protect holders and their close circle against so-called “$5 wrench attacks.”

$5 wrench attack explanation. Source: XKCD

Lopp’s list is likely undercounting the total number of attacks targeting people over their involvement in the crypto industry. A University of Cambridge study in September 2024 found that these so-called “wrench attacks” are often underreported due to revictimization fears.

France saw its fair share of cases

Paris is also no stranger to these attacks. Earlier this month, Paris police freed the father of a crypto entrepreneur who was held for several days in connection with a 7 million euro ($7.8 million) kidnapping plot.

At the start of this year, David Balland, co-founder of leading crypto hardware wallet manufacturer Ledger, was abducted from his home in central France. He was held captive until a police operation on the night of Jan. 22 secured his release.

https://www.zerohedge.com/crypto/french-minister-meet-crypto-firms-after-kidnapping-attempt

Wednesday, May 14, 2025

Jefferies not seeing significant impact to Merck, Bristol from draft guidance

 Jefferies analyst Akash Tewari notes that new Medicare Part B & D draft guidance has been released and that Merck (MRK) and Bristol Myers (BMY) are trading down due to updated language on single source qualifying drugs. The updated language on single source qualifying fixed dose combo products in the draft makes it seem as if subcutaneous Keytruda/Opdivo will be eligible for negotiation in 2028, but “We’re not sure this is true,” says the analyst, who is not seeing a significant impact to Merck and Bristol. The firm thinks subQ Keytruda/Opdivo may be exempt from IRA negotiation on biosimilar entry, similar to HD Eylea, and believes changes may create an opening for Merck to settle with some biosimilars before Keytruda’s ’28 loss of exclusivity and “therefore be EXCLUDED from IRA negotiation.” Since subQ and IV Keytruda are now both “considered the same drug,” theoretically subQ Keytruda “may never get IRA negotiated,” the analyst added.

https://www.tipranks.com/news/the-fly/jefferies-not-seeing-significant-impact-to-merck-bristol-from-draft-guidance

Neuberger, Franklin Sign Investment Deals With Saudi Wealth Fund

 


Franklin Resources Inc. and Neuberger Berman reached multibillion-dollar investment deals with Saudi Arabia’s sovereign wealth fund, the latest signs that the country is attracting US money managers to invest in the kingdom.

Neuberger will work with the nation’s Public Investment Fund to start a Riyadh-based platform supporting as much as $6 billion of investments, according to an emailed statement Wednesday. Franklin signed a similar non-binding agreement for up to $5 billion of investment in Saudi stocks, bonds and private assets.

https://www.bloomberg.com/news/articles/2025-05-14/neuberger-franklin-sign-investment-deals-with-saudi-wealth-fund