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Monday, October 6, 2025

Biogen Leqembi at-home maintenance dose for Alzheimer's available

 New LEQEMBI CompanionTM program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more

LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial treatment of 18 months

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). After 18 months of LEQEMBI (lecanemab-irmb) intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector.

Eisai and Biogen have also launched the LEQEMBI CompanionTM program, an initiative rooted in both companies' commitment to providing access to LEQEMBI and resources for people living with early Alzheimer's disease. The program aims to provide expanded resources that support patients throughout their LEQEMBI treatment journey, from initiation through maintenance therapy.

In addition to the current resources already provided (e.g., help with understanding insurance coverage and potential out-of-pocket costs and identifying financial support programs), the new LEQEMBI Companion program will now offer patients:

  • Injection education through Nurse Educators either in-person or virtually to provide patients with training on injecting their maintenance dose using the LEQEMBI IQLIK (nurse educators train on the device only; patients should discuss any treatment-related questions with their doctor).

  • A welcome kit that includes educational resources to help patients and care partners know what to expect, prepare for at-home injections, and more.

Designed to serve as a digital solution to help support patients and care partners along their treatment journey, the LEQEMBI Companion app was developed with Medisafe, a digital patient engagement and medication management platform. From educational information about the injection process to a tool for tracking where and when injections occur, the LEQEMBI Companion app offers resources and more all in one place. Patients can visit LEQEMBI.com/CompanionAppSignUp to get started.

To further support access to LEQEMBI for certain patients who need help paying for their medicines, Eisai's Patient Assistance Program (PAP) will provide LEQEMBI and LEQEMBI IQLIK at no cost, for eligible uninsured and underinsured patients, who meet financial need and other program criteria.

To learn more, or if you are already enrolled and have questions, visit LEQEMBI.com/PatientSupport or call 1-833-4-LEQEMBI (1-833-453-7362), Monday-Friday, 8 a.m. to 8 p.m. Eastern Time.

https://au.finance.yahoo.com/news/eisai-biogen-announce-u-availability-203000828.html

Novo Nordisk Loses Bid to Revive Suit Over Drug Price Talks

A federal appeals court dealt a blow Monday to Novo Nordisk A/S when it ruled the US government lawfully selected its insulins for a program that allows the Medicare agency to negotiate their drug prices.

The Centers for Medicare & Medicaid Services correctly followed federal statute when it grouped together Novo’s insulin products to be subject to federal price negotiations, Judge Thomas Hardiman wrote for the US Court of Appeals for the Third Circuit.

The court supported the decision pointing to its other rulings that struck down similar cases filed by Johnson & Johnson, Bristol Myers Squibb Co., and Novartis AG.

Novo challenged the CMS in 2023 alleging the agency unlawfully deemed six of its products as a single biologic product and subjected all of them to price controls under the government’s Medicare Drug Price Negotiation Program.

The plan, created under President Joe Biden’s signature Inflation Reduction Act, empowers the government to engage in talks with manufacturers over drug prices covered under Medicare. The negotiated prices for the first round of drugs are set to go into effect Jan. 1, 2026.

Novo alleged the program violated the First Amendment compelled speech doctrine, Fifth Amendment due process clause, separation of powers doctrine, and the Administrative Procedure Act.

A lower court judge in July 2024 struck down the company’s claims and ruled participating in the negotiation program is voluntary.

“We have held that the Act provides an escape hatch for a company that declines to participate in the Program,” Hardiman said in the ruling Monday. The law, Hardiman said, offers “manufacturers a 30-day exit from the Coverage Gap Discount and Manufacturer Discount Programs upon request” to avoid facing an excise tax for failing to comply with the Medicare negotiations.

A Novo spokesperson said in an emailed statement that the company is “disappointed with the decision,” and is “assessing our options to appeal this ruling.”

“Novo Nordisk remains opposed to government price setting through the Inflation Reduction Act and has significant concerns about the law and with how CMS implemented the statute,” the spokesperson said.

Judges Peter Phipps and Arianna Freeman joined the opinion.

The case is Novo Nordisk Inc. v. Secretary US Dept & Health and Human Services, 3d Cir., No. 24-02510, opinion issued 10/6/25

Trump: We're talking to Dems for better healthcare

 United States President Donald Trump said on Monday that his administration is negotiating with the Democrats and that "some very good things could happen" regarding healthcare, if a right deal is reached.

While answering questions from the press in the White House, Trump noted that even though he is a Republican, he is open to making a deal with the Democrats. "We're talking to the Democrats... I'd like to see a deal made for great healthcare," he said.

Trump boasted that zero illegal immigrants have entered the US during his current term and that he intends to keep it so by refusing to offer them free services while "the American people are unable to get good healthcare."

https://breakingthenews.net/Article/Trump:-We're-talking-to-Dems-for-better-healthcare/64933555

Netherlands, Ukraine to partner on drone production

 Dutch Prime Minister Dick Schoof shared on Monday that the Netherlands and Ukraine agreed to work together on drone production.

In a post on X, Schoof announced that he visited the Drone Line facility in Ukraine, where he was told about the types of unmanned aerial vehicles (UAVs) being manufactured there. "Drones are playing a growing role in modern warfare. Adapting to the enemy is paramount and the time to do so is getting shorter. The Russian war of aggression in Ukraine is no exception," he commented.

Earlier today, the Dutch official promised that he would try to prevent Dutch-made components from ending up in Russian weapons, after Ukrainian President Volodymyr Zelensky said that a "massive" amount of foreign-made parts are in Moscow's weapons.

https://breakingthenews.net/Article/The-Netherlands-Ukraine-to-partner-on-drone-production/64933582

Shareholders Are Right To Ask Microsoft Questions

 When investors ask serious questions about corporate practices, they deserve more than a brusque dismissal. Yet that appears to be how Microsoft responded to a shareholder proposal filed by the National Center for Public Policy Research (NCPPR). (Microsoft’s answer came in the form of an opposition statement to the proposal, which is on file with the author of this op ed.)

The proposal sought basic transparency about the company’s European Security Program and its potential implications for political expression. Instead of engaging, Microsoft waved away the concerns, insisting that it “fail[s] to see” how its activities could chill free speech. That answer is not good enough.

The shareholder proposal at issue was straightforward. It asked Microsoft to clarify whether its work in Europe—particularly in partnership with governments and nongovernmental organizations—could expose the company to pressures that would compromise viewpoint neutrality. Shareholders should be told what safeguards exist to prevent European-style speech restrictions from influencing how Microsoft’s technology is employed. The proposal did not ask the company to change its business model or stop protecting customers from cyberattacks. It asked for transparency.

Microsoft’s opposition statement seemed designed to shut down the conversation rather than open it. The company appeared to assert that defending against cyberattacks is unrelated to free expression, as though the two issues exist in isolation. But investors know that the line between cybersecurity and speech regulation is not always so neat. Authoritarian regimes, and even democratic governments, sometimes justify censorship under the banner of “safety” or “security.” That is why shareholders are right to ask how Microsoft ensures that its partnerships in Europe do not bleed into viewpoint discrimination.

There are reasons for concern. Independent watchdogs have flagged Microsoft for ideological bias in how it evaluates and manages content. Reports from the 1792 Exchange (here and here) and Alliance Defending Freedom’s Viewpoint Diversity Score project (here) point to a pattern of one-sided decision-making that tends to disfavor conservative or dissenting perspectives. Then there are the House Judiciary Committee subpoenas from earlier this year related to apparent corporate involvement, including Microsoft, in censorship of U.S. citizens at the behest of foreign governments. None of this proves that the company’s European programs are censorious. But it does demonstrate a track record that justifies scrutiny.

Equally troubling is Microsoft’s lack of engagement with NCPPR, the shareholder proponent of the proposal. While SEC rules contemplate corporate engagement with proposal proponents, and Microsoft’s own public disclosures tout its commitment to engaging with shareholders, Microsoft never engaged NCPPR on this matter beyond sending its opposition statement. (Elsewhere, Microsoft states: “Effective corporate governance includes regular, constructive conversations with our shareholders to proactively seek shareholder insights and to answer shareholder inquiries.”) If Microsoft is confident its programs pose no risk to free expression, why not walk NCPPR through its reasoning? Why not demonstrate safeguards? Silence only invites suspicion.

Then there is Microsoft’s reliance on the Global Network Initiative (GNI) as a proxy for accountability. In its opposition statement, the company pointed to its founding membership in GNI as evidence that it takes free expression seriously. Yet shareholders are entitled to ask whether GNI oversight is sufficient. Where are the conservative voices in that process? Does the initiative provide real ideological diversity, or does it reinforce the same perspectives shareholders are already concerned about? All these concerns could ultimately be unfounded, but by not engaging NCPPR directly Microsoft just fosters suspicion.

To be clear, no one is disputing the importance of cybersecurity. Protecting citizens and institutions from digital threats is a vital service. Nor is anyone claiming to have definitive proof that Microsoft’s European Security Program will inevitably be repurposed to include censorship. NCPPR would welcome evidence that these fears are unfounded. But the absence of such evidence—combined with the company’s seemingly dismissive response only underscores the need for greater transparency. For example, the proposal specifically references two concerning organizations that tout their commitment to combatting “online hate speech” and “harmful content” directly identified by Microsoft as participating in the program, but Microsoft either ignores the substance of those concerns or ignores the named entity entirely.

Shareholders are not asking for micromanagement of Microsoft’s operations. They are asking for accountability on a matter that goes directly to reputational and financial risk. If Microsoft were found to be complicit in ideologically driven censorship abroad, the fallout could significantly damage shareholder value. As NCPPR notes in its proposal, Facebook lost roughly $134 billion in market value in connection with the Cambridge Analytica  scandal. Transparency is the best protection against that outcome.

Microsoft’s leadership had an opportunity to reassure investors by addressing the proposal seriously. Instead, it chose to minimize the issue and rely on vague appeals to trust. That may be expedient in the short term, but it is shortsighted in the long run. A company of Microsoft’s size and influence cannot afford to appear indifferent to legitimate shareholder concerns about free expression.

The path forward is simple: engage with critics, demonstrate safeguards, and commit to viewpoint neutrality in all partnerships. If Microsoft is as confident as it claims, it should have nothing to hide. Until it does so, shareholders are right to keep asking hard questions.

Stefan Padfield is Director of the Free Enterprise Project at the National Center for Public Policy Research. Prior to joining FEP, Stefan spent over 15 years teaching law at the University of Akron School of Law, publishing over 15 law review articles and a book chapter. He co-authored a two-volume mini-treatise on the history of economic thought and contributed to the Business Law Prof Blog.

Stefan previously worked in private practice at Cravath, Swaine & Moore, LLP, and clerked for two federal court judges. Stefan originally emigrated to the U.S. as a child, later becoming a U.S. citizen and serving 6 years in the U.S. Army.
Stefan earned his Juris Doctorate from the University of Kansas and a Bachelor of Arts degree from Brown University.

Putin talks Middle East situation in call with Netanyahu

 Russian President Vladimir Putin held a phone conversation with Israeli Prime Minister Benjamin Netanyahu and discussed the current situation in the Middle East, as well as United States President Donald Trump's 20-point plan for ending the war in Gaza, the Kremlin revealed on Monday.

"Vladimir Putin reaffirmed Russia's unwavering position in favor of a comprehensive settlement of the Palestinian issue based on established international legal principles," the Russian government said in a press release. "In addition, an exchange of views on other regional issues took place. In particular, interest was expressed in finding a negotiated solution to the situation surrounding the Iranian nuclear program and in further stabilization in Syria," the Kremlin added.

The Russian president previously stated that his country is prepared to support Trump's plan for Gaza, and that he thinks that former United Kingdom Prime Minister Tony Blair would be a good choice for heading the international body overseeing the post-war Gaza.

https://breakingthenews.net/Article/Putin-talks-Middle-East-situation-in-call-with-Netanyahu/64932943

Queue-it & Akamai Launch "Hype Event Protection" to Stop Bots from Hijacking High-Demand Sales



Akamai (NASDAQ: AKAM) and Queue-it launched Hype Event Protection on October 6, 2025, a joint solution combining Akamai Bot Manager and Queue-it virtual waiting room to protect high‑demand sales from bots.

The solution limits bots' speed and scale by controlling traffic into events, randomizing customers into queues, and blocking or re‑queuing detected bots. A European ticketing provider used the solution in August 2025; in one on‑sale it reportedly mitigated over 2 million bots (≈98% of traffic) and gave real fans a 50x higher chance of securing tickets. Hype Event Protection is available to organizations using both Akamai Bot Manager and Queue-it virtual waiting rooms.