BIOSECURE Act Left Out of Department of Defense Spending Bill by House Rules Committee

The House Rules Committee on Tuesday left the BIOSECURE Act out of the final list of amendments to be discussed for inclusion in National Defense Authorization Act for the 2025 fiscal year.

Of the nearly 1,400 amendments filed, the House Rules Committee settled on 350 amendments, which House members will discuss and vote on to identify the final items to be included in the annual defense authorization bill. The National Defense Authorization Act (NDAA) is a bicameral agreement that specifies the budget and spending of the U.S. Department of Defense.

Reps. Brad Wenstrup (R-Ohio) and Raja Krishnamoorthi (D-Ill.), along with other House members from across the political aisle, introduced the BIOSECURE Act for inclusion in the NDAA. However, during the House Rules Committee meeting on Tuesday, neither Democratic nor Republican members backed the amendment for the NDAA vote.

First introduced in January 2024 by Reps. Krishnamoorthi and Mike Gallagher (R-Wis.), the BIOSECURE Act lays down legal groundwork to guarantee that “foreign adversary biotech companies” that pose a threat to national security “do not gain access to U.S. taxpayer dollars.”

The BIOSECURE Act explicitly targets Chinese biotechs that are allegedly connected with their government. The initial bill named four companies of concern—WuXi AppTec, Beijing Genomics Institute, Complete Genomics and MGI. The latest draft has been amended to explicitly identify WuXi Biologics—and would prevent biopharma companies that work with these entities to also work with the U.S. government.

In May 2024, Krishnamoorthi and Wenstrup introduced a new draft of the BIOSECURE Act, which included a grandfather clause that gave leeway to existing contracts with China-based companies until January 1, 2032.

If passed into law, the BIOSECURE Act will have extensive implications for the industry. Many pharma companies rely on China-based contract manufacturers for their products. These include Merck, Iovance Biotherapeutics and Kyverna Therapeutics, which in April 2024 detailed how the fallout from the bill could affect their programs.

In addition to manufacturing, the BIOSECURE Act could also affect the industry’s lobby efforts in Washington. In March 2024, trade group Biotechnology Industry Organization (BIO) and WuXi AppTec parted ways following pressure from Gallagher.

BIO has since affirmed its support for the bill, which its CEO John Crowley in a May 2024 statement argued “reinforces the national security imperative of the biotechnology industry as a critical strategic asset” of the U.S. The new draft “provides a reasonable timeframe for companies to decouple their reliance on China-based biomanufacturing” and ensures that the transition will not disrupt critical biomedical research, according to Crowley.

The BIOSECURE Act could also lead to an investor relations crisis as investors pull out of China-based companies en masse, as part of their risk management strategies.

https://www.biospace.com/article/biosecure-act-left-out-of-department-of-defense-spending-bill-by-house-rules-committee/

Biden Approves Sending 2nd Patriot System To Ukraine Ahead Of G7

 "We’re going to continue to drive up costs for the Russian war machine," White House spokesman John Kirby has said as President Biden departs for meetings with Group of Seven leaders in Italy.

The Thursday through Saturday meeting will focus in large part on unveiling new sanctions and export controls against Moscow, particularly the expected widening of sanctions on the sale of semiconductor chips for Russia, but also targeting third parties in China that deal with Russia.

Additionally the US will press allies on a plan to use frozen Russian assets to generate profits for Ukraine's defense. "We will announce new steps to unlock the value of the immobilized Russian sovereign assets to benefit Ukraine and to help them recover from the destruction that Mr. Putin’s army has caused," Kirby previewed additionally Tuesday.

The proposal involves utilizing future interest on nearly $300 billion of frozen Russian central bank funds to back a $50 billion loan to Ukraine, which can be used for arms, defense, infrastructure, and rebuilding.

During the summit of the world's wealthiest democracies (Canada, France, Germany, Italy, Japan, UK, US, and with the EU a "non-enumerated member"), Biden will also meet with Ukraine's Zelensky, where more US weapons for Kiev will be unveiled, especially the deployment of another Patriot missile system for Ukraine.

The NY Times details that "The new Patriot system — the second that the United States has sent to Ukraine — will come from Poland, where it has been protecting a rotational force of American troops who will be returning to the United States, officials said."

"The system could be deployed to Ukraine’s front lines in the next several days, U.S. officials said, depending on any maintenance or modifications it needs," the report adds.

Biden is also expected to seek to assure Zelensky that Washington is staying firmly behind his government for the long haul. However, as the Times also points out, significant political change is looming over Europe amid a general war-weariness and perhaps greater willingness to pursue peaceful settlement with Russia: 

Now, Europe is bracing for the possibility that former President Donald J. Trump, who has spoken openly of pulling out of NATO, could be back in power by the time the group next meets, in 2025. And several of the leaders present — including Prime Minister Rishi Sunak of Britain and President Emmanuel Macron of France — are facing elections that could redefine Europe.

Interestingly, the Pentagon has remained reluctant to provide more Patriot batteries, especially ones that would have to be moved from defending US soil, or else batteries currently in vital hotspots.

"With tensions rising on the Korean Peninsula, moving any Patriot batteries from defending against a possible North Korean attack was also deemed too risky, officials said," NYT notes. The Israel-Gaza conflict is also a major concern.

"Pentagon officials did not want to move any batteries from the United States," the report emphasizes. "There is a Patriot battery at Fort Sill, Okla., for training American and Ukrainian troops, but moving it would take away training, officials said. Other batteries protecting bases and troops in the United States, including in Hawaii, were either deemed too far away or necessary for homeland defense."

This shows a greater pragmatism that is apparently on the rise among America's generals and the defense establishment. Perhaps it's also the result of the realization that Ukraine cannot 'win' under the current circumstances of the ongoing manpower and ammo crisis.

https://www.zerohedge.com/geopolitical/biden-approves-sending-2nd-patriot-system-ukraine-ahead-g7

Biden's Problems Are The Real Threats

 by Newt Gingrich via RealClearPolicy,

Democratic analysts don’t seem to understand why the all-out legal assault on President Donald Trump isn’t working. It’s because they keep talking among themselves and not with the American people.

The American people don’t live and work in the New York-Washington political-media-government bubble. If reporters and analysts listened to Americans, as we do at America's New Majority Project, they would learn how decisive the choice between President Joe Biden or President Trump is. They would also see how difficult, if not impossible, it will be for President Biden to get easily re-elected.

The propaganda media is trying to focus the election on what it sees as President Trump’s flaws. The Democrats, including the Biden campaign, are trying to focus the election on what they see as the threat President Trump represents.

But the 2024 election is ultimately going to come down to a simple question: Can the American people afford four more years of Biden’s policies and principles?

President Trump’s problems all involve his own alleged behavior and activities. Even the totally phony legal attacks remain locked into a Trump-centered issue. No American is hurt by the things President Trump has supposedly done. Indeed, few Americans pay any attention to the outlandish, manipulated legal attacks on President Trump.

Most Americans see the case against Trump as political lawfare. If anything, they are offended by the left’s assault on the rule of law and the Constitution. This is why the conviction in the so-called hush money trial led to an enormous surge of contributions to Trump’s campaign. Far from running away from President Trump, the American people found themselves running to defend him. They saw him as a champion being persecuted unfairly and took the conviction as a direct warning of what could happen to them.

By contrast, President Biden’s problems all impact everyday Americans. Bidenflation continues to drive already high prices higher. Child care costs increased 4.1 percent in the last year. Young parents are having to take on third and fourth jobs just to break even on costs. Grocery prices are forcing Americans to make tough decisions about how to feed their families. Young people can’t afford to buy houses – which is more than offsetting any good will Biden might have generated by (illegally) waiving student loan repayments.

President Biden’s policies are causing millions of Americans real pain.

Biden’s open border policy allows Venezuelan criminals to go to New York City and murder policemen. Biden’s open border policy allows fentanyl and other drugs to flood our country and poison our communities. When more than 100,000 Americans a year are dying from drug overdoses, it is hard worry about how Trump valued his apartment or paid his attorney.

The average American can’t afford groceries, gasoline, or the electricity bill thanks to Bidenflation. Democrats want Americans to focus on these legal attacks. But Americans are focused on their own survival in the terrible economy President Biden and Democrats created.

For the elite establishment Democrats, this is all still about politics. For the American people, it’s about survival.

Economically, Biden’s destructive policies make life more expensive. Culturally, people are sick of radical dictates which denigrate religious liberty and seek to indoctrinate children against the will of their parents. Finally, as a matter of safety, Americans realize that Biden does not have the knowledge, ability, or wits to defend our nation against our adversaries.

The 2024 election isn’t about what the establishment media thinks. It’s about America’s survival.

https://www.zerohedge.com/political/bidens-problems-are-real-threats

Suicide Drone Boat Hits Bulk Carrier Near Yemen

 Yemen's Houthi movement might have expanded its weapon arsenal by attacking a bulk carrier in the Red Sea with a suicide drone boat (the first time in this conflict). This marks a shift from the terror group's usual anti-ship ballistic missiles and or kamikaze aerial drones. 

On X, the British military's United Kingdom Maritime Trade Operations said, "The vessel was hit on the stern by a small craft" about 66 nautical miles southwest of Al Hudaydah, Yemen. 

Bloomberg said the commodity-hauling bulk carrier is called "Tutor." Ship tracking data shows the vessel switched off its Automatic Identification System late last week after entering the Suez Canal. 

Maritime security company Diaplous said a suicide drone boat hit Tutor, adding the vessel's engine compartment was taking on water. 

There is no confirmation if Houthi rebels carried out the attack. However, the terror group has been on a half-year rampage across major shipping lanes in the Red Sea and Gulf of Aden, attacking Western-linked vessels with missiles and drones. 

According to an International Maritime Organization document obtained by the Middle East Eye, Houthi rebels have attacked 28 bulk carriers, tankers, container ships, cargo ships, and crude oil tankers.

Nine of the vessels were Marshall Island-flagged and three were US-flagged. Others were from Malta, Barbados, Panama, Belize, Greece, Palau, Liberia, Singapore, and Portugal.

On Monday, new images published on social media showed missile attack damage to the previously owned US bulk carrier "True Confidence" from March 6.

Source: The Sea In Arabic

These attacks have snarled global supply chains and sent containerized shipping costs soaring in recent months. 

Next up is US CENTCOM responding to the incident. They usually do not comment on the specific weapons used and often say "projectile." This report of the attack should be out this evening or tomorrow morning. 

Furthermore, this won't be the last time Houthi rebels use suicide boats against commercial vessels linked to the West in the Red Sea and or the Gulf of Aden. The group has also warned about expanding its threat coverage into the Mediterranian Sea. 

https://www.zerohedge.com/geopolitical/suicide-drone-boat-hits-bulk-carrier-near-yemen

Corbus at Goldman meet

 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will provide a corporate update and participate in one-on-one investor meetings at the 45th Annual Goldman Sachs Global Healthcare Conference to be held June 10-13, 2024 in Miami Beach, FL.

45th Annual Goldman Sachs Global Healthcare Conference
Format: Presentation and one-on-one investor meetings
Presentation Date: Wednesday, June 12, 2024
Presentation Time: 2:40 p.m. ET
Webcast: Click Here

https://finance.yahoo.com/news/corbus-pharmaceuticals-present-45th-annual-120000458.html

Affimed Q1 Update

 Program Updates

Acimtamig (AFM13; CD30 / CD16A)
Independent read data from the first 7 patients show an ORR of 85.7 % with 4 CRs and 2 PRs.

• All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7 patients) had also failed after prior autologous stem cell transplantation (ASCT).
• Treatment related adverse events were consistent with previous experience and were mainly mild to moderate IRR/CRS in nearly two thirds of the patients (4/7). One patient developed a short-lasting grade 3 CRS but was also diagnosed to have acute cytomegalovirus infection. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK® related adverse events. No cases of bleeding, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were observed. Enrollment in cohorts 1 and 2 is completed; cohorts 3 and 4 are now open and enrolling.
• Continued updates from the study to be provided on upcoming earnings calls and scientific conferences.

Upcoming Milestones:

• Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK® cells) study in Q3 2024.
• ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024.
• ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024.

https://www.globenewswire.com/news-release/2024/06/12/2897400/0/en/Affimed-Reports-First-Quarter-2024-Financial-Results-Business-Update.html

Avidity: > 50% Reduction in DUX4 Regulated Genes, Functional Improvement in Facioscapulohumeral Muscular Dystrophy

 Avidity plans to accelerate the initiation of registrational cohorts in FORTITUDE™ trial

Delpacibart braxlosiran (AOC 1020), the first investigational therapy to target the underlying cause of FSHD, provided greater than 50% mean reduction across multiple DUX4 regulated gene panels (2 mg/kg at four months)

Trends of functional improvement including muscle strength, reachable workspace, and positive trends in patient and clinician reported outcomes demonstrated in people treated with delpacibart braxlosiran 2 mg/kg at four months

Delpacibart braxlosiran data demonstrate favorable safety and tolerability with all adverse events mild or moderate

Volume 9 of virtual investor and analyst series today, Wednesday, June 12 at 8:00 a.m. ET

Video Webcast Information
The company is hosting Volume 9 of its investor and analyst event series on June 12, 2024, beginning at 8:00 a.m. ET to discuss the initial data from the FORTITUDE™ trial of del-brax in people living with FSHD. The virtual event will be available via a live video webcast and can be accessed here or from the "Events and Presentations" page in the "Investors" section of Avidity's website. A replay of the webcast will be archived on Avidity's website following the event.

The management team will be joined by Jeffrey M. Statland, M.D., Professor of Neurology, University of Kansas Medical Center, and FORTITUDE™ trial investigator. Dr. Statland is one of the principal investigators in the ReSolve study, an ongoing natural history study being led by the FSHD Clinical Trial Research Network (CTRN).

https://www.prnewswire.com/news-releases/avidity-announces-unprecedented-aoc-1020-data-from-phase-12-fortitude-trial-demonstrating-greater-than-50-percent-reduction-in-dux4-regulated-genes-and-trends-of-functional-improvement-in-people-living-with-facioscapulohumeral-m-302170099.html