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Friday, June 20, 2025

'Could a Novo error set up early GLP-1 generics in Canada?'

It has been reported that Novo Nordisk may have inadvertently allowed generics of its GLP-1 agonist semaglutide, the active ingredient in diabetes therapy Ozempic and obesity drug Wegovy, into the Canadian market early.

According to an article in Science, which references an Endpoints interview, the Danish drugmaker made a monumental error by failing to pay modest patent maintenance fees to the tune of a few hundred dollars to the Canadian patent office.

The result? Its main patent for semaglutide expired in 2020 and – while it still has protection for a few months under Canada's data exclusivity rules – it has been reported that generic drugmakers, including Sandoz and Apotex, are preparing to launch copycat versions as soon as January next year.

That is in stark contrast to the US, where Novo Nordisk is expecting to have patent protection until at least 2032. And while Canada may be a modest market for the drug in its own right, it is thought there is cross-border trade in semaglutide from Canada to the US that has a bearing on sales booked north of the border – and in fact makes Canada the second-largest semaglutide market in the world.

The Canadian patent office’s register shows that the last time that Novo Nordisk paid its annual maintenance fee was in 2018, the year when Ozempic launched in Canada.

Novo Nordisk made more than $24 billion from Ozempic and Wegovy, with another $3 billion from Rybelsus, an oral semaglutide product for diabetes, which means that the drug accounted for almost two-thirds of its total group revenues.

The company is already facing strong competition from rival therapies, including Eli Lilly's tirzepatide medicines for diabetes (Mounjaro) and obesity (Zepbound), that could also be affected if low-cost generics launch in Canada.

But was it actually an error? According to some commentators on this illuminating thread on LinkedIn, Novo Nordisk may have made a calculation that its patent and data exclusivity were both due to end in 2026, and simply decided not to extend the protection on the patent.

Another possibility is that it sacrificed the patent to ensure that Canada – with a public health system, price controls, and mechanisms that allow medicines to be excluded from the market if deemed too expensive – would continue to support use of semaglutide at a reasonable, profitable price.

https://pharmaphorum.com/news/could-novo-error-set-early-glp-1-generics-canada

Madrigal closes on EU approval of first MASH treatment

Madrigal Pharma could be just weeks away from becoming the first drugmaker to claim EU approval for a treatment for metabolic dysfunction-associated steatohepatitis (MASH).

The EMA's human medicines committee, the CHMP, has recommended a conditional marketing authorisation for Madrigal's oral thyroid hormone receptor (THR) β-selective agonist Rezdiffra (resmetirom) for adults with MASH – also known as non-alcoholic steatohepatitis (NASH) – who have moderate to advanced liver scarring (fibrosis), but who have not developed cirrhosis.

The positive opinion covers wording that is very close to the indication approved for Rezdiffra by the US FDA in March 2024. Since then, US sales of Rezdiffra have ramped up quickly, reaching $137 million in the first three months of 2025, even though the company estimates that only around 5% of eligible MASH patients are being treated with the drug. Sales rose a third over the fourth quarter of 2024.

Madrigal has said that it thinks Europe is ahead of the US in terms of guidelines and preparation for a MASH product rollout, so is expecting the approval – expected in August – to inject additional growth momentum into the product.

MASH is a form of non-alcoholic fatty liver disease (NAFLD) that affects millions of people and which, for several years, has been billed as pharma's next big growth area, with some analysts predicting a market potentially worth tens of billions of dollars a year. The condition is largely associated with obesity and an unhealthy diet and lifestyle, and is on the rise in industrialised nations.

The EU's conditional approval, based on the MAESTRO-NASH study, means that the EMA will have to see positive results in two supportive studies in order for Rezdiffra to stay on the EU market in the long term.

"Today's positive CHMP opinion represents another historic first for the global MASH community," said Madrigal's chief executive Bill Sibold.

"MASH is the fastest-growing indication for liver transplantation in Europe, and we believe resmetirom has the potential to address the urgent unmet need for a foundational, liver-directed therapy to treat patients with this serious disease."

The current approvals for Rezdiffra are in patients with F2 and F3 (moderate to advanced) liver fibrosis due to MASH, and Madrigal is also running a trial in patients with F4 fibrosis and compensated cirrhosis (MAESTRO-NASH-OUTCOMES), which it reckons could potentially double the size of the market for the drug.

https://pharmaphorum.com/news/madrigal-closes-eu-approval-first-mash-treatment

FDA blocks trials that send US cells to 'hostile' countries

The FDA has launched a review of clinical trials that plan to send American citizens' living cells to 'hostile' countries – including China – for genetic modification.

The just-announced initiative is focusing on cell therapies that are harvested from patients, modified to turn them into therapeutics such as CAR-Ts, and then re-infused into patients.

The rationale for the move is that the international transfer and genetic engineering may have been carried out without patient knowledge or consent and "may have exposed Americans' sensitive genetic data to misuse by foreign governments, including adversaries," said the FDA.

China has emerged as a force in cell therapy development in recent years, by some estimates having the second largest clinical pipeline in this area after the US, thanks to recent regulatory initiatives that have made it easier to carry out studies.

The crackdown ties in with other anti-China measures that have been proposed in the US, notably the BIOSECURE Act, which has not yet been enacted into law despite clearing a House of Representatives vote last year, but would prohibit federal agencies and businesses in the US from contracting with various Chinese firms on national security grounds.

It is also in line with two executive orders signed by President Donald Trump that seek to prevent the bulk transfer of sensitive personal data to countries of concern and so-called 'gain-of-function' research that can change the properties of biological agents and pathogens.

The FDA claimed the Biden administration has allowed the cross-border transfer of this type of cellular material by allowing an exemption in recently updated data security legislation for trial participants' biological samples – including DNA – that are processed overseas as part of FDA-regulated clinical trials.

The agency said it is actively reviewing all relevant trials that relied on this exemption and will require companies to demonstrate "full transparency, ethical consent, and domestic handling of sensitive biological materials."

Meanwhile, new trials that cannot meet these standards will not be allowed to proceed, and the regulator said it was working with the NIH to ensure that no federally funded research is "compromised" by these practices.

"The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants," said FDA Commissioner Marty Makary in a statement.

"The integrity of our biomedical research enterprise is paramount," he added. "We are taking action to protect patients, restore public trust, and safeguard US biomedical leadership."

Shake-up in FDA's cell and gene therapy leadership

The new policy was announced as it emerged that two senior figures at the FDA's Office of Therapeutic Products (OTP), director Nicole Verdun and deputy director Rachael Anatol, have been placed on administrative leave.

The two have been credited with modernising the FDA's regulatory approach to cell and gene therapy (CGT) over the last couple of years. The news has been criticised by the Alliance for Regenerative Medicine (ARM), which pointed out that there are five regulatory decisions pending on CGT products this year, plus a pipeline of nearly 2,000 CGT clinical trials ongoing globally.

Given that level of activity, "it is critical that CBER and OTP operate at the highest level of productivity, efficiency, and scientific rigour," said the organisation.

https://pharmaphorum.com/news/fda-blocks-trials-send-us-cells-hostile-countries

Waller Says Fed Could Cut Interest Rates as Soon as July

Federal Reserve Governor Christopher Waller said the central bank can lower interest rates as soon as next month.

“We could do this as early as July,” Waller said Friday in an interview on CNBC. The Federal Open Market Committee next meets July 29-30 in Washington.

https://www.bloomberg.com/news/articles/2025-06-20/waller-says-fed-could-cut-interest-rates-as-soon-as-july

'The legal status of assisted dying in different countries'

British lawmakers will vote on Friday on whether to proceed with legislation to legalize assisted dying for the terminally ill, in what would be the biggest social reform in the country for a generation.

Below is a list of countries which let people choose to end their lives, or are considering doing so.

SWITZERLAND

Switzerland legalized assisted dying in 1942 on the condition the motive is not selfish, making it the first country in the world to permit the practice. A number of Swiss organizations such as Dignitas offer their services to foreign nationals.

UNITED STATES

Medical aid in dying, also known as physician assisted dying, is legal in 10 states: California, Colorado, Hawaii, Montana, Maine, New Jersey, New Mexico, Oregon, Vermont and Washington, plus the District of Columbia. Oregon was the first state to legalize it under a law which came into effect in 1997.

NETHERLANDS

The “Termination of Life on Request and Assisted Suicide (Review Procedures) Act” came into effect in 2002. A doctor is immune from punishment for euthanasia and assisted suicide where patients are experiencing “unbearable suffering with no prospect of improvement”. Minors can request euthanasia from the age of 12 but require parental permission before the age of 16.

BELGIUM

Belgium legalized medically assisted dying in 2002 for the terminally ill and for people experiencing unbearable suffering, which includes patients with psychiatric conditions. Since 2014, those under 18 who are terminally ill are covered by the law as long as they have parental permission.

CANADA

Canada introduced “Medical Assistance in Dying” in 2016 for those whose death was deemed to be “reasonably foreseeable”. Five years later, the law was extended to permit people with a “grievous and irremediable” medical condition to request assisted dying.

AUSTRALIA

Voluntary assisted dying for the terminally ill or those with a condition that is causing intolerable suffering is legal in most Australian states, after being introduced first in Victoria in 2019.

SPAIN

Spain approved a law in 2021 which allows euthanasia and medically assisted suicide for people with incurable or debilitating diseases who want to end their life.

GERMANY

Assisted dying had been legal in Germany until 2015 when the country outlawed its provision on an organized or commercial basis, effectively banning it in many cases. Five years later the country’s top court ruled in favor of groups providing terminally ill adults with assisted suicide services, but lawmakers are yet to finalize new rules.

FRANCE

Doctors in France have been allowed to put a person who is close to death and in great pain under deep sedation since 2016. But they were not allowed to administer life-ending medication.

French lawmakers voted in May 2025 to give some people in the later stages of a terminal illness the right to end their lives using a lethal substance, a law change supported by President Emmanuel Macron. The bill was approved by the National Assembly and is now being considered by the Senate. It could become law by 2027.

IRELAND

A cross-party Irish parliamentary committee recommended this year that the government should legalize assisted dying in certain restricted circumstances.

A majority of lawmakers in 2024 voted in favor of “noting” the committee’s findings. Steps could now be taken to consider a law change.

https://www.bworldonline.com/health/2025/06/20/680466/the-legal-status-of-assisted-dying-in-different-countries/

Bayer: towards a new indication for Nubeqa in Europe

Bayer announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of Nubeqa in a third indication for advanced prostate cancer.

This positive opinion concerns the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with anti-androgen hormone therapy (ADT).

Bayer says that this combination reduced the risk of radiographic disease progression or death by 46% in Phase III clinical trials compared to placebo and ADT.

The German pharmaceutical group adds that the CHMP's positive opinion reinforces Nubeqa's potential to become a standard treatment for various stages of prostate cancer, with or without chemotherapy, thereby expanding the therapeutic options available to physicians.

The European Commission's final decision on marketing authorization is expected in the coming months.

It should be noted that the US Food and Drug Administration (FDA) has also just approved Nubeqa for this indication.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-towards-a-new-indication-for-Nubeqa-in-Europe-50294576/

Sam Altman says Meta tried to poach top OpenAI talent with $100M offers

Meta Platforms has tried to lure top OpenAI talent with signing bonuses reaching $100 million and promises of even more generous annual compensation, according to OpenAI CEO Sam Altman.

“They (Meta) started making giant offers to a lot of people on our team,” Altman said on the “Uncapped” podcast released Tuesday.

“You know, like $100 million signing bonuses, more than that (in) compensation per year.”

Despite the aggressive recruitment efforts, Altman noted that “at least, so far, none of our best people have decided to take them up on that.”

The Post has sought comment from OpenAI. A Meta representative declined to comment.

Altman framed the poaching attempts as part of a broader and intensifying battle for elite AI talent, likening the current climate to the free-agent frenzy of professional sports.

“I’ve heard that Meta thinks of us as their biggest competitor,” he said.

“Their current AI efforts have not worked as well as they have hoped and I respect being aggressive and continuing to try new things.”

The comments come at a pivotal moment in Meta’s artificial intelligence strategy. The company recently invested $14.3 billion in Scale AI and hired the startup’s founder, Alexandr Wang, to head up a new “superintelligence” division.

The much-ballyhooed “acquihire” deal included a 49% stake in Scale AI and saw a handful of Wang’s colleagues follow him to Meta.

Meta CEO Mark Zuckerberg has reportedly taken a personal interest in accelerating the company’s AI capabilities.

According to Bloomberg, Zuckerberg has directly participated in high-profile recruitment, including the recent hiring of Jack Rae, a leading researcher from DeepMind, Google’s AI research lab.

Altman, however, questioned whether throwing large sums of money at individuals creates the right environment for innovation.

“I think that there’s a lot of people, and Meta will be a new one, that are saying ‘We’re just going to try to copy OpenAI,’” he said.

“That basically never works. You’re always going to where your competitor was, and you don’t build up a culture of learning what it’s like to innovate.”

Meta has historically championed open-source AI, particularly with its Llama series of large language models. Yet the company has faced setbacks.

The release of its newest flagship AI model was delayed amid internal concerns about its readiness, according to the Wall Street Journal.

Zuckerberg’s deep investment in AI infrastructure, however, has not gone unnoticed. Some industry observers argue that Meta is still playing a critical role in shaping the field.

“They basically built the rails for open source AI development, and so much of what is happening in AI is being built on Meta,” said Daniel Newman, CEO of Futurum Group, during an appearance on CNBC’s Power Lunch on Tuesday.

Meta’s open-source approach has enabled a wide range of third-party developers to build applications on top of its models. Proponents argue this could ultimately offer a counterbalance to the more closed strategies of rivals like OpenAI.

Meanwhile, OpenAI has been active on the M&A front as well. Last month, the company completed a $6.4 billion all-equity acquisition of io, a startup founded by former Apple design chief Jony Ive.

Ive has since joined OpenAI, bringing with him a design-forward approach to AI hardware and interfaces.

https://nypost.com/2025/06/18/business/openai-ceo-sam-altman-says-meta-offering-his-top-talent-100m-to-defect/

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Friday, June 20, 2025