Canada's Culture Minister: Regulating Online Content A Duty Of Federal Government

 by Olivia Gomm via The Epoch Times (emphasis ours),

Culture Minister Marc Miller says the federal government has the role of regulating content on the internet and that Canada is years behind other countries when it comes to regulating “online harms.”

Minister of Canadian Identity and Culture Marc Miller rises during Question Period in the House of Commons on Parliament Hill in Ottawa, on Feb. 25, 2026. The Canadian Press/Spencer Colby

Miller told reporters on Parliament Hill April 29 that when it comes to the regulation of online content and social media, that role is “assumed by the federal government, whether we’re talking about moratoriums or the proper regulation of egregious online harms.”

“That’s stuff that we’re, frankly, a couple years behind in regulating, as we see other jurisdictions like Australia, like Britain, like France taking action,” Miller said, as was first covered by Blacklock’s Reporter. “We need to take action as well.”

Asked to comment on when the government plans on tabling a new online harms bill, Miller said “we’re working on it” and declined to share a timeline.

Miller told reporters earlier this month that a new online harms legislation is in the works and the government is “seriously” thinking about adding a social media ban for children to the bill, but did not provide a status or timeline for the introduction of the legislation then either.

The upcoming legislation will be the government’s third attempt to legislate on “online harms,” following previous proposals in 2021 and 2024, neither of which passed before Parliament was dissolved. Conservatives and civil liberties advocates had criticized both bills as posing a risk to freedom of expression.

In March, the federal government reconvened the same group of experts first formed in 2022 that made recommendations to the government on how to address online content deemed to be harmful, which led to Bill C-63.

The department of industry said in a recent report to the Senate social affairs committee that Ottawa is examining a “future online safety regime” meant to reduce content deemed as being harmful, such as hateful content and cyberbullying on large platforms.

“To advise on this proposal, the government has recently reconvened the Expert Advisory Group on Online Safety whose members previously contributed to the development of online harms legislation, to engage on new and emerging issues related to online harms,” the department said.

“Any future legislative proposal would be subject to parliamentary scrutiny, and details will be made public at the appropriate time.”

In 2021, Bill C-36 proposed a regulatory framework for harmful online content, but faced criticism from the opposition over its scope, including concerns about definitions of harmful speech and the extent of proposed oversight powers.

In 2024, Bill C-63 placed a stronger focus on protecting children and addressing specific categories of harmful content, and proposed the creation of new regulatory bodies such as a digital safety commissioner and ombudsperson. It also included amendments to the Criminal Code and human rights law, with stricter penalties for certain hate-related offences.

After pushback on the 2024 bill, the government said it was open to splitting the bill in two to facilitate the passage of measures protecting children, but the bill lapsed after Parliament was prorogued in January of last year.

Justice Minister Sean Fraser said last November that new legislation regulating online content would be different from the government’s previous proposals. Meanwhile, former Heritage Minister Steven Guilbeault said a few months earlier that upcoming online harms legislation would be similar to the versions tabled in 2024 and 2021.

The Liberals’ election platform last spring promised to “introduce legislation to protect children from horrific crimes including online sexploitation and extortion and give law enforcement and prosecutors the tools to stop these crimes and bring perpetrators to justice.”

The Liberals also pledged to “make it a criminal offence to distribute non-consensual sexual deepfakes” and to “increase penalties for the distribution of intimate images without consent.”

Jennifer Cowan, Noé Charter, and Paul Rowan Brian contributed to this report.

https://www.zerohedge.com/political/canadas-culture-minister-regulating-online-content-duty-federal-government

Japan Likely Spent About $34.5 Billion on Yen Intervention

 

Japan likely spent around $34.5 billion Thursday in its first currency intervention to prop up the yen since July 2024, according to a Bloomberg analysis of central bank accounts.

The scale of intervention was probably around ¥5.4 trillion, based on a comparison of Bank of Japan accounts released Friday and money broker forecasts. In 2024, authorities spent an average of ¥3.8 trillion on four occasions to support the yen.

https://www.bloomberg.com/news/articles/2026-05-01/japan-likely-spent-34-5-billion-in-fx-intervention-to-boost-yen

Axsome breaks new ground in Alzheimer's with Auvelity OK

 Axsome Therapeutics' Auvelity has become the first non-antipsychotic therapy for agitation in patients with Alzheimer's disease to be approved by the FDA, which called the drug a "significant advancement" in care.

Auvelity (dextromethorphan/bupropion) – a first-in-class oral NMDA receptor antagonist and sigma-1 receptor agonist – is already approved to treat major depressive disorder (MDD) and made more than $500 million in sales last year.

The new indication is expected to lead to an acceleration in growth, as more than 7 million people are living with Alzheimer's in the US, and agitation – which can include verbal and physical aggression – is a very common symptom that affects an estimated 50% to 70% of all patients.

Antipsychotic medications are currently the main therapy for Alzheimer's agitation, but carry serious risks, including an increased risk of death, due to side effects. They also offer only modest, short-term benefits and may also accelerate cognitive decline, so are typically used as a last resort; for example, when there is a risk of harm to the patient or those around them.

While many antipsychotics are used off-label, the only FDA-approved option is Otsuka/Lundbeck's dopamine- and serotonin-targeting Rexulti (brexpiprazole), which got a green light for this use in 2023.

Auvelity is thought to target pathways involved in mood regulation and stress responses in the brain. In the ADVANCE-1 trial, it outperformed placebo in improving agitation scores over five weeks' follow-up, while in ACCORD-2 patients who switched from Auvelity to placebo had a shorter time to relapse than those who continued treatment with the drug.

According to geriatric psychiatry expert George Grossberg of Saint Louis School of Medicine in the US, Auvelity is the only FDA-approved product to show a statistically significant increase in time to relapse of agitation symptoms, compared to placebo, in a long-term study.

"Agitation in patients with dementia due to Alzheimer's disease is distressful, consequential, and challenging for patients, their caregivers and healthcare providers," he said, adding that Auvelity also showed "a compelling safety and tolerability profile, with rates of discontinuation due to adverse events that were low and matched those of placebo."

That profile should give Auvelity an immediate edge over Rexulti, which carries a boxed warning that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Analysts have said that Alzheimer's agitation could be a $1.5 billion market for Auvelity, on top of its potential in MDD, which has been estimated at between $1 billion and $3 billion at peak. Axsome, meanwhile, is hoping to extend the label for Auvelity even further, with a phase 2/3 clinical trial already running in smoking cessation.

Shares in the company rose nearly 13% on the news, driving its market cap to almost $10.7 billion.

https://pharmaphorum.com/news/axsome-breaks-new-ground-alzheimers-auvelity-ok

FDA's ODAC delivers one loss, one win for AstraZeneca

 In its first meeting for months, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against AstraZeneca's oral selective oestrogen receptor degrader (SERD) drug camizestrant.

By a margin of six votes to three, the panel concluded that the results of the SERENA-6 trial of camizestrant did not support use of camizestrant in combination with CDK inhibitors – Pfizer's Ibrance (palbociclib), Novartis' Kisqali (ribociclib), or Eli Lilly's Verzenios (abemaciclib) – as a first-line treatment for HR-positive, HER2-negative breast cancer with ESR1 mutations.

AZ had proposed a biomarker-based approach to treatment that involved measuring circulating tumour DNA (ctDNA) to detect ESR1 mutations – which point to the emergence of resistance to treatment – and switching patients from their current therapy to its oral SERD.

According to SERENA-6 data reported at last year's ASCO congress, that approach reduced the risk of disease progression or death by 56% compared to the CDK 4/6 inhibitors given in combination with an aromatase inhibitor. Mutations in ESR1 are the most common mechanism of acquired resistance to that treatment regimen.

The sticking point for panellists appeared to be that the improvement in progression-free survival (PFS) was not accompanied by a statistically significant gain in overall survival (OS), which is considered a more rigorous outcome measure. Some panellists suggested that an OS benefit should be seen before approval, given that AZ is proposing a step-change in established clinical practice for these patients.

That view was also laid out in the FDA review document (PDF), which suggested that there is not sufficient evidence from SERENA-6 to show the clinical benefit from a strategy in which patients receive camizestrant at ESR1 mutation detection, rather than at radiographic progression as at present.

"We are disappointed with the mixed outcome of today's ODAC meeting," said Susan Galbraith, AZ's head of oncology and haematology R&D.

"We strongly believe in the results of the SERENA-6 trial, and are encouraged that the committee saw camizestrant as a safe and effective potential new medicine," she added. "We remain confident in the clinical benefit the combination can bring to patients by changing therapeutic strategy at the earliest opportunity."

The company may have an opportunity to make its case when additional results from SERENA-6 are presented at this year's ASCO congress, which will start later this month in Chicago. Meanwhile, regulatory applications for camizestrant in this setting are also under review in the EU, Japan, and several other countries.

The FDA does not have to abide by the advice of the ODAC, but the vote suggests the ongoing SERENA-4 clinical trial of camizestrant in an all-comer HR-positive breast cancer population, with and without ESR1 mutations, is likely to be crucial for AZ as it tries to position the SERD as a new first-line treatment option for the disease – and build towards peak sales it has modelled at $5 billion a year. SERENA-4 data is due to read out in the latter half of this year.

There are currently two marketed drugs in the oral SERD class – Menarini/Stemline's Orserdu (elacestrant) and Eli Lilly's Inluriyo (imlunestrant) – which are both approved for second-line treatment of HR+, HER- breast cancer with ESR1 mutations.

Truqap backed for prostate cancer

The ODAC delivered better news for AZ with a seven-to-one vote in favour of its AKT inhibitor Truqap (capivasertib) in combination with Johnson & Johnson's Zytiga (abiraterone) and androgen deprivation therapy (ADT) for PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

This form of prostate cancer is known to be aggressive, progressing quickly to more advanced disease, and has limited treatment options. Estimates for the frequency of PTEN mutations in prostate cancer vary widely, between around 15% and 60%, depending on the type and stage of the disease, but testing for the biomarker isn't widespread at the moment.

Truqap is already approved for relapsed or refractory HR+/HER2- advanced breast cancer, but AZ's efforts to expand its use into other indications like triple-negative breast cancer have so far been unsuccessful.

The mHSPC filing is based on the results of the CAPItello-281 study, which showed that Truqap achieved a statistically significant 19% reduction in the risk of radiographic disease progression or death compared to placebo.

https://pharmaphorum.com/news/fdas-odac-delivers-one-loss-one-win-astrazeneca

UK Navy: Hormuz traffic dropped by 90%

 The United Kingdom's Royal Navy said on Friday that ship traffic through the Strait of Hormuz has dropped by 90% since the war in Iran began on February 28.

The Navy noted that the UK Maritime Trade Operations (UKMTO) reported 41 incidents in regional waters, particularly in the Strait of Hormuz, with vessels attacked, damaged, or forced to turn back.

"The most distressing calls are those from ships under attack," UKMTO Head of Operations Commander Jo Black commented. "It's an absolutely terrifying experience for them – they're civilians, they're not prepared for this – drones, missiles, small arms fire aimed at their bridge or engine room, and threats to their safety – so they're stressed," he added.

https://breakingthenews.net/Article/UK-Navy:-Hormuz-traffic-dropped-by-90/66200372

Amgen beats, raises guidance as growth drivers offset Prolia/Xgeva erosion

 

• Amgen beat Q1 2026 estimates with non-GAAP EPS $5.15, up 5% YoY, on revenue $8.6B, up 6% YoY.
• Key growth drivers grew 24% YoY to $5.6B and now represent ~70% of sales.
• Overall product sales rose 4% YoY despite a 32% decline in Prolia/Xgeva from biosimilar erosion.
• Repatha, EVENITY and TEZSPIRE all posted strong double-digit growth, with Repatha sales up 34% YoY.
• Non-GAAP operating margin was 45%, while cost of sales increased to 19.5% on mix and royalties.
• 2026 revenue guidance was raised to $37.1–$38.5B and non-GAAP EPS to $21.70–$23.10.
• Management reiterates 2026 as a "springboard year," ramping R&D 16% to fund MariTide, IMDELLTRA, Olpasiran.
• MariTide Phase III program expanded with switch and maintenance studies targeting less-frequent dosing and better GI tolerability.
• TAVNEOS faces an FDA proposal to withdraw approval; Amgen defends its benefit‑risk and plans further engagement.
• IRS draft tax adjustments for 2016–2018 could be material if upheld, but Amgen strongly contests the methodology.
• Free cash flow was $1.5B; capex of $700M supports expanded manufacturing, including for an eventual MariTide launch.
• Main concern: Regulatory and tax overhangs (TAVNEOS withdrawal proposal, IRS disputes) amid accelerating Prolia/Xgeva erosion.
• Strong quarter, driven by diversified growth assets that more than offset loss-of-exclusivity headwinds.

https://finviz.com/quote?t=AMGN&p=d

Senators ban themselves from betting in prediction markets

 The U.S. Senate has passed a bipartisan resolution that bans senators from making bets on prediction markets like Kalshi (KALSHI) and Polymarket (POLYMARKET) amid mounting insider trading concerns.

The ban was passed unanimously and is effective immediately. The measure applies to senators, officers and staff at the Senate.

"Serving in Congress is an honor, not a side hustle," Sen. Bernie Moreno (R-OH), who introduced the resolution, posted on X after the vote. "Americans deserve to know that their leaders are here for the right reason!"

Polymarket (POLYMARKET) said it is in full support of this. "Our Rulebook & Terms of Service already prohibit such conduct, but codifying this into law is a step forward for the industry," it added.

"Kalshi (KALSHI) already proactively blocks members of Congress and enforces against insider trading," its CEO Tarek Mansour said. "This is a great step to increase trust in our markets by making it an industry standard. Now, let's pass this in the House!"

The Senate ban comes a week after a U.S. soldier involved in the capture of Nicolás Maduro was charged with using classified information to make $400,000 by betting on the Venezuelan leader's ouster.

Earlier this month, the White House warned staffers against using confidential, privileged information to trade on prediction markets.

https://www.msn.com/en-us/money/general/senators-ban-themselves-from-betting-in-prediction-markets/ar-AA228TQ9