'Google wearable AI can 'learn the language of our bodies''

 Tech giant Google has developed a new family of sensor–language foundation models that could underpin a coming generation of health and wellness wearable devices.

The SensorLM platform has been trained on 60 million hours of user data and – according to Google – can move the sensor needle from merely providing information on what is occurring on our bodies, to "the crucial context of 'why'."

According to a blog post from Google researchers Yuzhe Yang and Kumar Ayush, an example is that a heart rate monitor can detect if there is a sharp increase, but determining the context – for example, an uphill run or a stressful public speaking event – is generally not possible.

"This gap between raw sensor data and its real-world meaning has been a major barrier to unlocking the full potential of these devices," they wrote, adding that SensorLM bridges that gap, as it can interpret and generate "human-readable descriptions from high-dimensional wearable data."

SensorLM was trained on de-identified multimodal sensory data from more than 103,000 people across 127 countries, over a three-month period, from Fitbit or Pixel Watch devices – both owned by Google – with users' consent.

Turning the rich, continuous stream of raw, fine-grained sensor data from wearable devices into comprehensible insights into human health and behaviour could open up new avenues for clinical decision-making, user engagement, and behavioural interventions, according to a paper on SensorLM published on the ARXIV.org prepress server.

"The SensorLM family of models represents a major advance in making personal health data understandable and actionable," according to Yang and Ayush. "By teaching AI to comprehend the language of our bodies, we can move beyond simple metrics and toward truly personalised insights."

The next stages for the research team are to layer in new types of sensor readings, including metabolic health and sleep analysis data.

"We envision SensorLM leading to a future generation of digital health coaches, clinical monitoring tools, and personal wellness applications that can offer advice through natural language query, interaction, and generation," they said.

The foundational model could also assist Google and partner Samsung in an ongoing rivalry with Apple, currently the leader in the consumer wearables sector with its Apple Watch device, which is also investing heavily in wearable health applications.

Earlier this month, Apple researchers published another paper on arxiv.org that detailed how it aims to apply AI to behavioural data – the way people move, exercise, and sleep – to create future health functions on the Apple Watch.

https://pharmaphorum.com/news/google-wearable-ai-can-learn-language-our-bodies

Tech giants back unified health data-sharing platform in US

 The Trump administration wants to build an interoperable digital health platform for handling patient records, medical operating systems, and apps – helped by the private sector – that can improve patient care.

The initiative will be supported by tech giants, including Amazon, Anthropic, Apple, Google, and OpenAI, and will focus on developing a framework that would be administered by the Centers for Medicare and Medicaid Services (CMS), which said it would "improve patient outcomes, reduce provider burden, and drive value."

The emphasis is on voluntary participation from companies, healthcare systems, insurers, and other health actors, rather than rulemaking, and CMS is hoping to start running the first 'Aligned Networks' in the first quarter of 2026.

"For decades, bureaucrats and entrenched interests buried health data and blocked patients from taking control of their health," said Health and Human Services (HHS) Secretary Robert F Kennedy Jr at an event this week to launch the 'Make Health Tech Great Again' plan.

"That ends today. We're tearing down digital walls, returning power to patients, and rebuilding a health system that serves the people."

Looking at the nuts and bolts of the CMS Digital Health Ecosystem, it revolves around the creation of a system that will allow the sharing of medical and patient data between patients and providers, and an effort to develop digital health tools to help people manage and prevent health conditions.

That will involve big changes to data networks, electronic health record (EHR), and health apps already being used across US healthcare systems, and questions are already being raised about patient confidentiality implications, given the involvement of private companies. CMS has insisted, however, that "nothing…is intended to contravene, supersede, or preempt federal or state healthcare or privacy laws."

Anyone who wants to share their data in this way will have to opt in to the ecosystem, which will initially focus on apps for diabetes and obesity management, conversational AI assistants to help patients check symptoms, navigate care options, and schedule appointments, and an effort to replace any digital forms with electronic versions.

"We have the tools and information available now to empower patients to improve their outcomes and their healthcare experience," said CMS Administrator Dr Mehmet Oz.

"For too long, patients in this country have been burdened with a healthcare system that has not kept pace with the disruptive innovations that have transformed nearly every other sector of our economy," he added.

"With the commitments made by these entrepreneurial companies today, we stand ready for a paradigm shift in the US healthcare system for the benefit of patients and providers."

https://pharmaphorum.com/news/tech-giants-back-unified-health-data-sharing-platform-us

Biogen’s Leqembi Push Getting Easier as CEO Eyes Early-Stage Pipeline Restock

 

Rumors of Biogen’s disagreements with Eisai have been greatly exaggerated, CEO Chris Viehbacher said during a second quarter earnings call. The partnered Alzheimer’s drug Leqembi saw sales climb 20% for the period.

Biogen and partner Eisai’s hard work pushing Alzheimer’s disease drug Leqembi uphill may finally be paying off. Analysts were pleasantly surprised—but still characteristically cautious—as Biogen reported a 7% increase in revenue to $2.6 billion for the second quarter.

Leqembi’s sales rose 20% in the U.S. to $63 million, for $160 million globally, according to Biogen’s second quarter earnings report, released Thursday. This includes, however, a one-time stock up shipment to China worth $35 million. The global sales represented a 58% increase overall, according to BMO Capital Markets Analyst Evan David Seigerman. William Blair still called this modest growth.

Leqembi, despite pressure from Eli Lilly’s Kisunla, still holds 70% of the market, Alisha Alaimo, president and head of North America operations, said on the earnings call.

The drug has seen slow market uptake as physicians adapt to the diagnostic testing requirements and other challenges. But Alaimo said the biomarker testing has picked up considerably as faster and more convenient tests receive approval, leading to more patients being diagnosed and put in line for treatment.

“It’s way more than what we thought it was going to be at this time point, and so we do believe this is a pivotal moment,” she said.

CEO Chris Veihbacher said the blood-based biomarker tests are helping to “remove some of the bottlenecks in the system.”

Biogen has been partnered with Eisai in Alzheimer’s for a decade. Viehbacher addressed rumors that the relationship may be souring in light of news that Biogen has filed arbitration in Europe over commercial allocations there. Viehbacher admitted that there have been disagreements over the years, but said the relationship is “better than it has ever been.”

“It’s not always easy for companies to work together, and it’s normal, because a lot of things are just never black and white in terms of how we approach them,” Viehbacher said on the call. “There are times where you know there is going to be a disagreement, and I think we have that in terms of how we launch in Europe, and we’re just following the process in our contract … It happens in relationships, but it hasn’t affected the overall working relationship with Eisai.”

Biogen executives have met with Eisai’s team since the arbitration was filed, particularly the manufacturing team, the CEO noted.

A Cautious Half To Come

As always, Veihbacher spoke to Biogen’s business development efforts: “definitely early stage is on the cards.” In particular, more deals like the City Therapeutics research collaborations will be coming. In that partnership from May, Biogen paid $46 million upfront, with up to $1 billion in milestones for new RNAi therapies for central nervous system diseases.

He also likened the early-stage hunt to the $1.8 billion acquisition of HI-BIO, which Biogen has integrated and kept intact. This allows the biotech to do what it does best with the backing of Biogen’s global clinical trials network, the CEO explained, adding: “That’s what we’d like to do on the early stage.”

While Viehbacher has an eye to filling any pipeline gaps ten years out, Biogen could jump on some later-stage assets, but they would have to have the right valuation.

“As we look at opportunities, I always say, you can never have enough pipeline. [But] it has to fit strategically with what we’re already doing. We don’t want to stretch our teams more than we need to, and it has to make financial sense,” Viebacher said. “And there are some assets out there. Not everybody thinks that they’re appropriately valued, and that makes it difficult sometimes to get deals done.”

Biogen expects revenue to slow in the second half, leading the company to raise guidance to represent flat growth for the year. Revenue guidance increased to $15.50 and $16, up from $14.50 and $15.50. This will be in line with what was achieved in 2024, and Jefferies labeled the guidance raise as “conservative.”

While the Alzheimer’s news was a positive sign of the momentum behind Biogen’s commercial work, the real boost to earnings was an outperformance of Biogen’s multiple sclerosis franchise. This area of the business outperformed BMO’s consensus by 17%, notching sales of $1.11 billion. Tysabri in particular brought in $77 million more than Jefferies had expected, for total global sales of $454 million. This compares to $462 million for the same quarter last year.

The overall performance of the MS franchise was actually a slight decline from the same period a year earlier, when it took in $1.15 billion. But Biogen’s multiple sclerosis products are in decline, so the beat was welcomed by BMO. William Blair expects the franchise to further erode going forward as more generics and new anti-CD20 therapies come in to replace Biogen’s products.

Biogen’s other new product, Zurzuvae for post-partum depression, also contributed with a 41% consensus beat. The Sage-partnered drug collected $46 million for the quarter, a 68% increase over the same quarter a year ago. Sage has now been acquired by Supurnus Pharmaceuticals.

Alaimo said that Biogen expanded its field team to market Zurzuvae, so the results today are due to their work.

The quarter’s results were also aided by Biogen’s “Fit for Growth” program, which aimed to find $1 billion in cost savings by 2025, BMO noted. Because of that, Biogen’s R&D expenses were lower than previous quarters at $399 million, compared to $505 million for the second quarter of 2024.

Speaking to the “Fit for Growth” program, which began 18 months ago, Alaimo said: “Today, we believe we’re seeing the results of those decisions.”

https://www.biospace.com/business/biogens-leqembi-push-getting-easier-as-ceo-eyes-early-stage-pipeline-restock

'After Prasad’s Ouster, Makary Looks for Better Drug, Biologic Alignment at FDA'

 

The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.

FDA Commissioner Marty Makary wants to foster more harmony between the FDA units that regulate drug and biologic products.

Several CEOs of biotech and pharma companies attended Makary’s “listening tour” stop in New York, a private event where the commissioner met with industry leaders and got feedback on the regulatory environment the FDA is fostering. Alongside Makary was George Tidmarsh, newly appointed director of the Center for Drug Evaluation and Research and, following Vinay Prasad’s ouster earlier this week, temporarily also the head of the Center for Biologics Evaluation and Research.

Speaking to several attendees of said event, Endpoints News reported on Thursday that Makary wants both drug and biologic centers to operate more harmoniously, instead of acting as “fiefdoms.” Sources spoke on the condition of anonymity given the private nature of the event. Aside from New York, Makary will also visit North Carolina and Georgia; the commissioner has already gone to Maryland, Massachusetts and California.

“The idea is that given the fact that both ‘centers’ are under identical regulatory frameworks and fiercely compete with each other for funding and influence, they should be under the same roof,” Sean Khozin, founder and principal at New York-based Phyusion Bio, told Endpoints. Khozin, who attended the New York leg of Makary’s tour, had previously served for more than 7 years as a senior official at the FDA’s Oncology Center of Excellence.

Speaking to Endpoints, an official at the FDA denied that the agency has plans to combine the CDER and CBER into one unit.

However, Politico, citing three sources familiar with the matter, reported Wednesday that the government is considering splitting CBER into two entities: one focused on regulating vaccines and another dedicated to therapeutics.

This, according to the publication, would allow Health and Human Services Secretary Robert F. Kennedy Jr. to respond to anti-vaccine groups like Children’s Health Defense, which have voiced concerns that he has been less aggressive on the vaccine front than they had hoped.

In the lead-up to Prasad’s exit, the FDA went head-to-head with Sarepta Therapeutics, whose gene therapy portfolio has been linked with three deaths over the past months. In response to the deaths, the FDA asked the biotech to halt all shipments of its Duchenne muscular dystrophy treatment Elevidys. Sarepta pushed back initially but ultimately gave in.

Last week, media outlets reported that the FDA was considering asking Sarepta to run additional trials before allowing Elevidys back on the market, with senior officials at CBER unanimously against a commercial comeback for the therapy. Just days later, however—and shortly after the agency opened a probe into another death of a patient who had taken Elevidys—the FDA determined that the fatality was not linked to the gene therapy and recommended that the hold on Elevidys shipments for ambulatory patients be lifted.

This confusing back-and-forth gave many conservative quarters enough kindling to push President Donald Trump to fire Prasad. According to a July 30 report from Politico, Trump overrode the wishes of both Makary and Kennedy to kick Prasad out, partly influenced by his allies.

“I just texted President Trump on Monday just to make sure he was aware of the situation,” Sen. Ron Johnson (R-Wis.) said on Wednesday, according to Politico. “The Duchenne muscular dystrophy community is very concerned about some recent actions the FDA took, I just thought he ought to be aware of it.”

https://www.biospace.com/policy/after-prasads-ouster-makary-looks-for-better-drug-biologic-alignment-at-fda

Moderna’s Bancel Nay on M&A, Yay on R&D Partnerships

 

It’s not often that a CEO outright dismisses M&A prospects, but Moderna CEO Stéphane Bancel says the mRNA biotech has enough programs on its hands.

Investors watching Moderna’s quarter-after-quarter losses and restructuring shouldn’t expect a major M&A deal anytime soon. Instead, CEO Stéphane Bancel said the famed mRNA biotech has more late-stage programs than it can handle and will instead be looking for partners to access new technologies.

Asked directly on a second-quarter earnings call Friday if Moderna is looking for deals in China or anywhere else, Bancel said no, instead extolling the value the company sees in partnering.

“We’ve always thought that partnering is a great way to access assets that are non-mRNA technology,” he added, pointing to the company’s work with Merck in oncology that pairs Moderna’s mRNA vaccines with immuno-oncology heavyweight Keytruda.

It’s rare for a CEO to dismiss M&A prospects so outright, but Bancel seemed confident in Moderna’s platform, which has been cranking out candidates. The company has had to sideline a number of assets that Bancel believes are promising, including its Epstein-Barr virus vaccine candidates that include a prophylactic and a therapeutic agent.

“We believe those programs have to move forward, which is why . . . we are actively talking to potential pharmaceutical partner[s] and potential product financing partners for several good assets that we cannot prosecute forward alone, because they are great assets, but we need to be financially disciplined at the same time,” Bancel told investors on the call.

For now, Moderna’s pipeline boasts dozens of candidates with a blank spot next to the hopeful “partner” label for most assets. Existing partners include, of course, Merck, along with Immatics and Vertex, and government agencies like the National Institutes of Health and Biomedical Advanced Research and Development Authority.

The Decline Continues

With the expected summer slump in COVID-19 vaccine sales in full swing, Moderna’s reported $800 million net loss for the second quarter was not a surprise. But the biotech needs to get its cash burn down to bring investors back on side, Jefferies analysts said Friday.

Moderna’s second-quarter results were slightly better than expected despite missing estimates, according to Jefferies. The company reported vaccine sales of $114 million for the period compared to analyst expectations of $188 million. Sales of the respiratory syncytial vaccine mRESVIA were “negligible,” Moderna reported. This, too, was expected, according to the analysts.

This has been the story for the past few quarters. Instead of focusing on sales and revenue, analysts and investors have been keenly watching Moderna’s aggressive efforts to slash spending in R&D to steady itself for a slew of launches. A day before the earnings release, Moderna announced the latest major step: a 10% headcount reduction to bring its workforce under 5,000 people.

Bancel provided a bit of clarification on where the cuts will hit—particularly in manufacturing and R&D—where Moderna has previously communicated plans to trim Phase III respiratory activities as those studies naturally wind down. But the CEO also noted that Moderna is hiring elsewhere, flagging 150 currently open roles that are geared toward new product launches.

CFO Jamey Mock said the company has already cut $4 billion in costs from the business and has an achievable plan to remove another $1 billion by the end of the year. That particularly hit Moderna’s R&D portfolio, as the discovery engine had been cranking out programs.

“We did have greater ambitions, but we will continue to adjust, and have adjusted, and I think that’s what we’re seeing,” Mock said.

Moderna ended the quarter with $7.5 billion in cash, down from $8.4 billion at the end of the first quarter. Jefferies predicts the company will end the year with $2 billion spent from that pile, for a total of $6 billion. Cash is expected to further dwindle to $4 billion in 2026.

Moderna’s approved products are extremely seasonal, meaning earnings will ebb and flow with the need for the vaccines. This is why revenue was expected to dip this quarter—and it did. Mock pointed to Moderna’s work in rare diseases, oncology and the cytomegalovirus (CMV) vaccine as diversification from this seasonality. While a virus, CMV does not exhibit seasonality like common respiratory diseases do.

Otherwise, analysts peppered executives with questions about clinical programs, particularly that CMV vaccine mRNA-1647, which has which has reached the pre-specified event threshold of 112 in a Phase III study, the company reported Friday. But Moderna remains blinded to the results and will analyze the data when it’s available. Still, President Stephen Hoge couldn’t shake the inquiries.

“We are completely blind, so the company does not know the results on the primary or any of the secondaries,” Hoge insisted. “We are just making sure to protect the integrity of the study, that we update the statistical analysis plan and receive approvals for it prior to initiating that analysis with an unblinded team.”

https://www.biospace.com/business/modernas-bancel-nay-on-m-a-yay-on-r-d-partnerships

Trump Issues Further Explanation On Moving 2 Nuclear Submarines 'Closer To Russia'

 President Trump has in a newly published interview with Newsmax explained more about his decision to send a pair of nuclear submarines "closer to Russia" after the "fresh mouth" of former Russian president Dmitry Medvedev - who currently serves deputy chair of the country's Security Council - made reference to atomic apocalypse in written remarks about the Ukraine war and standoff with Washington.

Trump told "Finnerty" show host Rob Finnerty at the White House that his "eyes light up" when nuclear weapons are mentioned, particularly by a Russian official like Medvedev.

"Well, a former president of Russia who's now in charge of one of the most important councils, Medvedev, said some things that were very bad, talking about nuclear."

Trump continued, "And when you mention the word 'nuclear,' you know, my eyes light up and I say, 'We better be careful,' because it's the ultimate threat."

Medvedev had on Thursday posted on Telegram that Trump should recall "his favorite films about the 'walking dead'" and while referencing Soviet Union nuclear strike doctrine.

Trump explained in the new interview, "He shouldn't have said it. He's got a fresh mouth. He's said things in the past, too. And so we always want to be ready. And so I have sent to the region two nuclear submarines. I just want to make sure that his words are only words and nothing more than that."

When asked by the interviewer whether the submarines are in fact now closer to Russia, the US Commander-in-Chief responded:

"They're closer to Russia. Yeah, they're closer to Russia."

The question remains whether these submarines are merely nuclear-powered or nuclear-armed. Certainly the latter scenario would mark a huge and dangerous escalation, and yet the US has always exercised strategic ambiguity in this regard.

It has been longstanding US national security policy to not disclose if a particular sub is deployed with nuclear warheads on board or not. And the reality is that these submarines are in all kinds of locations, and probably pass Russia's shores not infrequently - but their locations are never really known. Trump had told reporters previously at the White House:

"Well, you just have to read what he said. He was talking about nuclear. When you talk about nuclear, we have to be prepared. And we’re totally prepared."

Still, the Trump online statement caught the world's - and certainly Moscow's - attention, driving world headlines all day Friday...

Trump in the Newsmax interview continued by giving his assessment of the current status of the war and negotiations:

"This is [former President Joe] Biden's war. This is not my war. This war would have never happened. It didn't happen for four years. It was never even talked about other than anything I had conversations with [Russian President Vladimir] Putin," Trump said. "It was the apple of his eye, but he wasn't going to go into Ukraine. And I will say this, that's a war that should end. That's a terrible war."

On the new Aug. 8 deadline for peace, he reiterated that if a deal is not in place, "we'll put sanctions on, and he's pretty good with sanctions. He knows how to avoid sanctions."

"I talked to Putin a lot, and I think we had a great conversation. Then I go home and I see that a bomb was dropped in Kyiv and some of the various cities, killing people. I say, you know, I just had this great conversation with him, and it looked like we were going to — I thought we had it worked out three different times, and maybe he wants to try and take the whole thing. I think it's going to be very hard for him," he said. But clearly Trump is seeking to manage expectations, and seems to be admitting his planned punitive action is unlikely to have huge impact.

Further on Putin, the US President said, "He's obviously a tough cookie, so it hasn't changed in that way. But I'm surprised. We had numerous good conversations where we could have ended this thing, and all of a sudden bombs start flying."

https://www.zerohedge.com/geopolitical/trump-issues-further-explanation-moving-2-nuclear-submarines-closer-russia

FDA Mandates Major Labeling Changes On Opioid Pain Medication

 The Food and Drug Administration is requiring pharma companies selling opioid pain medications to “better emphasize and explain the risks associated with their long-term use” on medication labels, the Department of Health and Human Services (HHS) said in a July 31 statement.

“These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long periods,” the department said.

Drug labels must now show clearer risk information, describing a summary of study results showing estimated risks of addiction, overdose, and misuse of the medication over the long term.

The labels must have stronger dosage warnings that higher doses come with greater risks to users and that such risks remain over time.

Pharma companies are required to remove any language on the labels that could be misinterpreted as being supportive of long-term opioid use.

For users physically dependent on opioids, the labels must emphasize not to abruptly stop their usage, warning that such a move can cause serious harm

“Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate,” HHS said.

The companies must also warn about drug interactions, effects on digestive health, and new risks associated with overdosing, such as toxic leukoencephalopathy—a serious brain condition that could occur following an overdose.

“I know firsthand how devastating addiction is—not just for individuals, but for entire families and communities,” Health Secretary Robert F. Kennedy Jr said.

“Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”

As Naveen Athrappully reports for The Epoch Times, HHS gave the example of OxyContin, an opioid whose initial drug application was approved without proper data supporting the medication’s long-term use among people to treat pain, it said.

OxyContin is a brand name for oxycodone, an opioid used to manage moderate to severe pain, according to data from the DrugBank, an online medication database. It is also sold under brand names Endocet, Targin, Roxybond, Roxicodone, Xolox, and Nalocet.

According to HHS, two large FDA observational studies recently provided new data on the serious side effects that can result from long-term opioid use. This information will be reflected in the updated labeling for OxyContin and other opioids.

One of the studies was discussed during the FDA’s May public advisory committee meeting, according to a May 5 briefing document.

The study looked at 1,212 patients who suffered from arthritis, neck pain, back pain, and neuropathy. Participants were taking extended-release/long-acting opioids or immediate-release/short-acting opioids. Oxycodone was one of the most commonly used opioids.

According to the study, “the overall prevalence of past-three-month opioid misuse was 14.6 percent, past-three-month opioid abuse was 6.0 percent,” said the document.

In addition, 2.7 percent of the study population were found to have past-year moderate-to-severe pain-adjusted opioid use disorder, it said.

After reviewing results from the two FDA observational studies as well as “public comments, medical research, and recognizing the absence of adequate and well-controlled studies on long-term opioid effectiveness, the FDA decided to require safety labeling changes,” HHS said.

Tackling the Opioid Crisis

According to HHS, the FDA has sent letters to pharma companies outlining the new label changes. The companies must submit their labeling updates for review by the FDA within 30 days.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” FDA Commissioner Marty Makary said.

“This long-overdue labeling change is only part of what needs to be done—we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

In a June 9 post, the Centers for Disease Control and Prevention said roughly 806,000 people died from an opioid overdose between 1999 and 2023, including from illegal opioids.

Since 2013, there has been a “substantial” increase in overdose deaths involving synthetic opioids, specifically illegally made fentanyl and fentanyl analogs, it said.

https://www.zerohedge.com/medical/fda-mandates-major-labeling-changes-opioid-pain-medication