<![CDATA[New US patent backs Denovo’s ANK3 biomarker guiding DB104 for treatment‑resistant depression, highlighting promising efficacy in selected patients.]]>
<![CDATA[Lifestyle medicine pillars help reshape depression and anxiety treatment in psychiatry.]]>

STAT+: A patent win for Pfizer and BridgeBio

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. Several biotech leaders were named in this list of the most influential Bostonians. Is there anyone you think should have made the list who didn’t? Let me know your thoughts.

The need-to-know this morning

  • The Italian pharma company Chiesi is buying KalVista Therapeutics for $1.9 billion, adding an approved treatment for a genetic swelling disorder to its rare-disease portfolio. The deal values KalVista at $27 per share, or a 40% premium to its Tuesday closing stock price. The KalVista medicine, called Ekterly, is a pill used to treat acute swelling attacks in people with hereditary angioedema.
  • Biogen, AstraZeneca, Regeneron Pharma, Abbvie and GSK reported first-quarter earnings.

FDA plans to review AZ, Amgen trials in real time

In an effort to get drugs on the market faster, the FDA announced yesterday it will start reviewing trial data in real time, starting with oncology studies conducted by AstraZeneca and Amgen.

Continue to STAT+ to read the full story…

STAT+: Pharmalittle: We’re reading about the FDA speeding up trials, a Supreme Court hearing on ‘skinny labels,’ and more

Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. Our choice today is chocolate raspberry. Meanwhile, we have assembled the latest menu of tidbits to help you along. So please dig in. Have a smashing day, and please feel free to forward any secrets you come across. Our “in basket” is always open. …

The U.S. Food and Drug Administration announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen, STAT writes. The agency also asked the public to weigh in on a potential pilot program to work with companies that use AI to enhance safety monitoring and medication dose selections, identify safety signals, and improve patient recruitment in clinical trials. The trials will rely on a real-time data platform built by Paradigm Health, and the goal is to cut down on the time regulators and companies spend sending data back and forth. FDA Commissioner Marty Makary said at a press conference that agency reviewers will be able to view safety signals and clinical endpoints via Paradigm’s platform.  

Pfizer settled ‌patent disputes with three generic drugmakers over its blockbuster heart drug Vyndamax, effectively extending its patent protection until 2031 and delaying cheaper ​copies from entering the market, Reuters says. The deals resolve ​patent infringement lawsuits against Dexcel Pharma, Hikma Pharmaceuticals, ⁠and Cipla in Delaware federal court over Pfizer’s ​oral drug Vyndamax. A trial over the patent had started ​this week. Pfizer sold nearly $6.4 billion of Vyndamax and related drugs, which treat a serious heart condition called transthyretin amyloid cardiomyopathy, in 2025. The settlements extend ​U.S. patent protection for Vyndamax until June 1, ​2031, subject to other pending litigation. The company had previously expected ‌a ⁠sharp drop in U.S. revenue for the drug in 2029 but now expects sales to hold relatively steady from 2028 through mid-2031.

Continue to STAT+ to read the full story…

<![CDATA[Learn how clinicians safely add esketamine nasal spray: REMS setup, two-hour monitoring, vitals checks, referrals, and patient-centered collaboration.]]>
<![CDATA[Learn how clinics start esketamine safely: REMS setup, two-hour monitoring, vitals, risk screening, and referral-friendly team care.]]>
<![CDATA[Interim analysis suggests tazbentetol may regrow synapses, improving cognition and schizophrenia symptoms.]]>

The Download: storing nuclear waste and orchestrating agents

This is today’s edition of The Download, our weekday newsletter that provides a daily dose of what’s going on in the world of technology.

It’s time to make a plan for nuclear waste

Today, nuclear energy enjoys rare support across the political spectrum. Public approval has spiked, and Big Tech is throwing money around to meet rising electricity demand. That newfound interest is exactly why it’s time to talk about an old problem: nuclear waste.

In the US, nuclear reactors produce about 2,000 metric tons of high-level waste each year—and there’s nowhere to put it. Now, the need for a permanent storage solution is becoming urgent. Here’s what’s at stake.

—Casey Crownhart

This article is from The Spark, MIT Technology Review’s weekly climate newsletter. Sign up to receive it in your inbox every Wednesday.

Orchestrated agents are coming for white-collar work

When people say AI will transform industries, what they have in mind—whether they know it or not—are AI agents. ChatGPT showed AI can talk. But to change the world, it needs to do stuff.

The real power comes when agents work as teams, coordinating multiple roles to tackle complex tasks. Apps like Codex and Claude Cowork offer a glimpse of this shift, bringing multi-agent general-purpose productivity tools.

In theory, networks of AI agents could do to white-collar knowledge work what assembly lines did to manufacturing. That’s the vision. But as agents move into real-world systems, the risks grow too. Read the full story.

—Will Douglas Heaven

Agent Orchestration is one of the 10 Things That Matter in AI Right Now, MIT Technology Review’s guide to what’s really worth your attention in the busy, buzzy world of AI. We’re unpacking one item from the list each day here in The Download, so stay tuned.

MIT Technology Review Narrated: no one’s sure if synthetic mirror life will kill us all

In February 2019, a group of scientists proposed a high-risk, cutting-edge, irresistibly exciting idea that the National Science Foundation should fund: making “mirror” bacteria.

These lab-created microbes would be organized like ordinary bacteria, but their proteins and sugars would be mirror images of those found in nature. Researchers believed they could reveal new insights into building cells, designing drugs, and even the origins of life.

But now, many of them have reversed course. They’ve become convinced that mirror organisms could trigger a catastrophic event threatening every form of life on Earth. Find out why.

—Stephen Ornes

This is our latest story to be turned into an MIT Technology Review Narrated podcast, which we publish each week on Spotify and Apple Podcasts. Just navigate to MIT Technology Review Narrated on either platform, and follow us to get all our new content as it’s released.

The must-reads

I’ve combed the internet to find you today’s most fun/important/scary/fascinating stories about technology.

1 Elon Musk says Sam Altman “stole a charity” at the OpenAI trial
Musk testified for the first time yesterday in the landmark legal showdown. (FT $)
+ He said OpenAI was founded as a non-profit to avoid a “Terminator outcome.” (Wired $)
+ And claimed he came up with the idea for the company. (Reuters $)
+ The trial could upend the global AI race. (MIT Technology Review)

2 The White House has plans to bypass Anthropic’s blacklisting
It’s drafting guidance to sidestep the supply-chain risk designation. (Axios)
+ The White House is also meeting other tech firms to discuss AI risks. (Politico)
+ The Pentagon’s culture war against Anthropic has backfired. (MIT Technology Review)

3 OpenAI is tightening ties with Amazon after retreating from Microsoft
AWS customers are getting extra access to OpenAI systems. (NBC News)
+ While OpenAI gets new users and cloud-computing capabilities. (CNBC)

4 AI bots told scientists how to create biological weapons
And unleash them in public spaces. (NYT $)
+ AI will change war forever. (MIT Technology Review)

5 China has suspended robotaxi licenses after a scary outage
Dozens of Baidu vehicles suddenly stopped last month. (The Verge)
+ Chinese robotaxi firms are planning global expansions. (Guardian)

6 Meta has been found in breach of EU rules on protecting children
After failing to block access to Facebook and Instagram. (Guardian)
+ Parents are forcing schools to roll back classroom tech use. (NYT $)

7 AI is spotting pancreatic cancer years before symptoms appear
 A study found it could catch the tumor early enough to treat. (Bloomberg)

8 The Iran war is disrupting data center rollouts
Oaktree-owned Pure DC is the latest firm to pause investments. (CNBC)

9 SpaceX is tying Elon Musk’s pay to Mars colonization goals
It’s set lofty goals for his jaw-dropping compensation. (Reuters $)

10 AI has reconstructed the face of an ancient Pompeii victim
 Technology is reshaping our understanding of the distant past (NPR)

Quote of the day

“Overnight, without you even knowing it, your own life chances, the life chances of your children, will be dependent on people continuing to prop up Musk’s visions of how the world should look.”

—Elon Musk biographer Michel Martin tells NPR how the Tesla tycoon is shaping our lives.

One More Thing

a person with luggage walks through and airport setting

NEIL WEBB


Inside Clear’s ambitions to manage your identity beyond the airport

If you’ve ever been through a large US airport, you’re probably aware of Clear, the identity verification service that uses biometric scans to whisk travelers past standard security checks.

Now Clear wants to expand that “face-first” experience from airports to just about everywhere, from retailers and banks to even your doctor’s office. Its CEO has designs on making Clear the “identity layer of the internet” and the “universal identity platform” of the physical world.

All you have to do is show up—and show your face. But as biometric identity systems go mainstream, concerns about privacy, security, and control are becoming harder to ignore. And the cost of convenience may not be shared equally. Discover what’s at stake


—Eileen Guo

We can still have nice things

A place for comfort, fun and distraction to brighten up your day. (Got any ideas? Drop me a line.)

+ Discover why the eight-hour night is a modern invention.
+ This artist creates masterpieces using only a vintage typewriter and a lot of patience.
+ Test your local knowledge with this game that drops you in a random Street View location.
+ Watch this incredible feat of precision piloting as a race aircraft touches down on a 120km/h cargo train.

Bibliometric analysis of neurite orientation dispersion and density imaging: research patterns, evolution, and frontier

BackgroundNeurite orientation dispersion and density imaging (NODDI), an emerging diffusion MRI technique for estimating the microstructural pathology of brain tissue in vivo, has attracted significant research interest. However, a systematic bibliometric analysis of this field remains unexamined. This study aims to perform a bibliometric analysis of the NODDI literature to explore the current research landscape, identify emerging trends, and provide insights for future investigations.MethodsNODDI-related publications were retrieved from the Web of Science (WOS) and Scopus databases during the period of 2012 to 2025. CiteSpace, VOSviewer, and Bibliometrix R package were used to generate visualization maps.ResultsA total of 679 publications related to NODDI were identified from WOS, including 653 research articles and 26 review papers. 844 relevant publications were retrieved from the Scopus database. After 2012, the number of publications on NODDI increased rapidly. Sweden demonstrated the highest average citation per paper, while the United States contributed the largest number of publications. University College London was the most productive institution. Hui Zhang was identified as the most prolific author, while Alexander DC achieved the highest average citation count. NeuroImage was recognized as the leading journal in terms of publication frequency. Common keywords included “diffusion magnetic resonance imaging,” “NODDI,” “brain,” and “multiple sclerosis.” Recent studies show the research focus is shifting from methodological development to clinical application, especially in the field of neuropsychiatric disorders, and is being integrated with emerging methodologies such as Mendelian randomization.ConclusionsThis bibliometric analysis highlights potential directions for future NODDI-related research. Future studies may focus on optimizing imaging techniques, investigating neuropsychiatric disorders, and integrating advanced methodologies.

Autonomic-vascular dysregulation in CKD-associated hypertension: a narrative review with evidence hierarchy

Hypertension and chronic kidney disease frequently coexist and mutually accelerate cardiovascular and renal injury. This narrative review prioritizes direct human autonomic phenotyping (Level 1: microneurography, HRV/BRS), human vascular correlates (Level 2: PWV, FMD), and complementary preclinical evidence (Level 3) to elucidate autonomic-vascular mechanisms. Autonomic imbalance, characterized by sympathetic overactivity and reduced parasympathetic restraint, represents a key interface between neural control and vascular pathology in this setting. This narrative review synthesizes experimental and clinical evidence on how the autonomic nervous system shapes vascular function in hypertension and CKD. We outline physiological autonomic control of vascular tone (baroreflex pathways, central networks, brain–kidney communication), characteristic autonomic alterations in hypertension (elevated MSNA, impaired HRV/BRS), and their vascular consequences (endothelial dysfunction, arterial stiffness). We emphasize CKD-specific autonomic drivers (renal afferents, uremic toxins, inflammation) and their translation to exaggerated vascular injury and adverse BP phenotypes. Finally, we discuss pharmacological/device-based strategies targeting autonomic–vascular pathways, highlighting opportunities for neuromodulation, biomarker-guided risk stratification, and individualized treatment. By integrating multidisciplinary evidence, this review frames CKD hypertension as amplified autonomic–vascular injury and positions the autonomic nervous system as a promising therapeutic target.