MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…
EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…
This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…
On September 9, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA (Foundation), will convene a public meeting to hear public comments on perspectives regarding the use of opioid medications for the management of pain and addiction.
Capricor Therapeutics’ CEO Linda Marbán believes the FDA is willing to work with the biotech as the Aug. 22 deadline approaches for its Duchenne muscular dystrophy cell therapy deramiocel, with the biotech’s stock climbing 68% on the update.
The FDA approves Zenbexus just as copycat competitors depress sales of Bristol Myers Squibb’s multiple myeloma drugs Pomalyst and Revlimid, which crashed 71% and 49% year-on-year, respectively, in the second quarter.
Sponsors of the pivotal study behind Amgen’s rare disease drug Tavneos saw unblinded findings for the drug and re-adjudicated data from nine patients to make the drug seem effective, according to European regulators.
Companies that manufacture MDMA and psilocybin for patients in other countries are looking to use their experience to access the potential U.S. market.
On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy incl
The terms of the agreement with Royalty Pharma suggest the market potential of Zealand Pharma’s polycythemia vera drug candidate may be undervalued, according to Jefferies analysts.
PTC Therapeutics emerged as the winning bidder over Astellas for Sangamo Therapeutics’ Fabry disease gene therapy, while Eli Lilly is purchasing the biotech’s prion disease program and several platforms.
In this episode of Denatured, you’ll hear from Diana Saraceni, founder and managing partner at Panakès Partners and Fabrizio Calisti, medical director at Angelini Ventures. We explore how Italy’s life sciences ecosystem has evolved over the last decade—from stronger tech transfer and growing venture capital to the gaps that still keep it from matching the UK, Germany or France in company creation and scale.
When Ryan Hudson-Peralta, a self-described “Apple fanboy,” isn’t using the computer, he’s on his phone. But all of this screentime—and mouse use—can take a toll on his body. Hudson-Peralta, a designer, speaker, and disability advocate, was born with no hands and uses a wheelchair. “With my disability, I was born without shoulder sockets,” he says, and using a traditional computer mouse for an extended period leads to shoulder pain.
Through a consultancy he founded, Equal Accessibility, Hudson-Peralta sometimes requests test products, whether they’re designed for people with disabilities or not. In 2024, in exchange for feedback on the device, he received a prototype of Mouthpad, an experimental tongue-computer interface, similar to a touchpad on a retainer, which allows hands-free wireless interaction with computers and smartphones.
In addition to a touch-sensitive area on the roof of the mouth, the Mouthpad incorporates other assistive technologies: a barometer that detects “sip” gestures while also sensing tongue presses; and an accelerometer and gyroscope that track head movement. Designed to be as thin as possible to allow users to speak easily while wearing the device, it is compatible with dictation or voice commands. The device, which communicates via Bluetooth, is removable and rechargeable.
“The product is incredible,” says Hudson-Peralta. “I thought it was going to be a little bit of a learning curve, but it absolutely was not at all.” He still uses the Mouthpad, generally preferring to control a cursor with head movements and click with the tongue, in rotation with a computer mouse. For the first time in his life, Mouthpad has allowed Hudson-Peralta to do things on a computer away from the desktop, perhaps from the comfort of a couch, and give his shoulder a rest. He believes the device could have even greater benefits for others, for example, some of his friends with paralysis in their upper limbs.
Now, the Mouthpad may reach a wider audience. In July, it became commercially available to the public. Although the device has been developed prioritizing feedback from people with disabilities that can make it difficult to operate off-the-shelf electronics, such as quadriplegia, it is not being sold as a medical device.
“If you design for those who are most constrained, you design better interfaces for everybody,” says Tomás Vega, a co-founder of Augmental, developers of the Mouthpad.
Mouthpad can connect to any device that accepts a Bluetooth mouse. It is expected to be used as an assistive device, directly or indirectly controlling a range of devices including tablets, smartphones, powered wheelchairs, and even sexual aids—all tech used in everyday life that people with physical disabilities may have difficulty controlling.
Beyond its uses as assistive tech, Mouthpad could also augment workflows or videogame experiences as a novel input option; find roles in occupational safety when both device access and free hands are important; and perhaps benefit scientific research. “We believe in universal design,” Vega says.
Over roughly six years of development, Augmental has added ways to customize Mouthpad inputs to match user preferences and abilities. The physical device also needed to be custom fit because of natural variation in mouth shape and size, and the hardware needed to be thin and flexible, yet durable. “The mouth is the most hostile environment in the body,” says Vega. Despite this, as long as users don’t grind their teeth, Vega expects the number of battery cycles to be the limiting factor for the lifespan of the device, at least two years.
A single Mouthpad costs US $1,400, which would not be covered by medical insurance, with additional fees for a dental fitting. As one Mouthpad reviewer notes, the device may be eligible for other forms of reimbursement, such as vocational rehabilitation programs.
Though less expensive computer input options may be available, Hudson-Peralta says that the Mouthpad is “much cheaper” than many of the assistive technologies that he uses and must pay for out of pocket. These devices do not generally have the same economies of scale as mass market electronics.
Vox tunes in on nearly silent speech
For many users, the Mouthpad will be one of multiple inputs for devices. Other hands-free computer controllers include mouth-operated joysticks, eye-tracking, and more experimental brain computer interfaces. Voice control is now a common method for inputting text, and along with the release of Mouthpad, Augmental announced a new necklace microphone device, called Vox. If Mouthpad is the mouse, the company says, then Vox is the keyboard.
Vox is currently able to understand “low volume speech,” says Vega, but as with most other speech recognition devices, can struggle with outside noise, or lack user privacy. One long-term goal for the Mouthpad, then, is a fully silent speech interface. That is, the ability to provide the benefits of modern speech interfaces without the need for users to speak audibly, even at a whisper.
Mouthpad currently only tracks the tip of the tongue, however articulating certain speech sounds (e.g. k, r, and o-sounds) involves the main body of the tongue and the back of mouth, so silent speech may require following movement of the entire tongue. This whole-tongue tracking could open up therapeutic and research applications related to speech.
For example, some people can articulate their tongue and mouth, but are unable to speak conventionally, perhaps due to a removed or damaged voice box. “These patients may experience social isolation and even depression due to their speech or sound disorders,” says Jun Wang, a speech-language pathologist at the University of Texas, Austin, who has worked on a tongue-tracking device.
Expanding access to tongue-tracking tech
Augmental is not alone in its efforts to develop mouth-based interfaces.
Hananeh Esmailbeigi, for instance, is a biomedical engineer at the University of Illinois Chicago who develops wearable technologies, including a “tongue-trackpad.” Without the opportunity to examine the Mouthpad closely, Esmailbeigi declined to comment on specifics of the device, but applauded expanded access to the technology.
“I am encouraged to see growing attention and investment in this modality and greater public awareness of the potential of intraoral interfaces,” says Esmailbeigi. Beyond computer interaction, she is interested in the devices as a source of quantitative information in rehabilitation for motor control problems that affect speech.
“I think [tongue interfaces] have great potential due to the high flexibility and endurance of the tongue,” says Lotte N. S. Andreasen Struijk, a biomedical engineer at Aalborg University in Denmark. She helped develop iTongue, which is available in the European Union for computer and powered wheelchair control. Earlier versions of the device required a barbell-shaped tongue piercing to track the tip of the tongue, however the newest version no longer requires the piercing.
Assistive devices like Mouthpad can facilitate computer interaction and build technical skills, says Hudson-Peralta. But he emphasizes that access to technology can “help people grow not just in careers, but in social life.”
Baxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.
Sixteen viruses is not a large number. But the 16 bacteria-infecting viruses described on 6 August in Science were no ordinary specimens.
They were not fished out of a sewage outflow or dug up from a soil sample, which is where such things normally come from. They were written by a genomic language model trained on vast troves of DNA sequences. Researchers at Stanford University designed the small viruses from scratch, producing the first complete, functional genomes ever generated by AI.
And they worked. Delivered together as a cocktail, the designer viruses—known as bacteriophages, or phages—infected E. coli strains that had already evolved resistance to the natural virus they were modeled on, something a comparable mix of natural phages could not do.
The advance offers a glimpse of a future in which bespoke phage therapies are made to order to combat bacterial infections that antibiotics can no longer touch.
Phage therapies have been used to treat infectious diseases for more than a century, but the field has struggled with a combination of biological and commercial hurdles: Individual phages often kill only a narrow range of bacteria, resistance can evolve quickly, and naturally occurring phages can be difficult to patent.
AI-designed phages offer a way around some of those limitations—and Brian Hie, the Stanford computational biologist who led the new study, says collaborators have already begun asking to use their model to create phages capable of killing disease-causing bacteria, rather than targeting a laboratory strain of E. coli.
But the same AI methods also lower the technical barrier to building other kinds of biological agents on demand, including viruses with the potential to cause disease, sharpening a long-standing worry that systems developed for medicine and biotechnology could be turned, without much modification, into biological weapons.
“The question is no longer whether generative viral genome design will exist,” a pair of biosecurity experts at the Johns Hopkins Center for Health Security wrote in an accompanying commentary. “It is whether society can build oversight that allows its benefits to unfold while preventing it from enabling serious harm.”
How the Phages Were Made
Inside the phrase “designed from scratch” sits a long engineering pipeline.
The researchers used their Evo 2 foundation model, which was trained on a dataset that included more than 2 million bacteriophage genomes. But for this experiment, the researchers further focused the model on the particular kind of phage they wanted to build—a redesigned version of a much-studied bacteriophage called ΦX174—by fine-tuning it on an additional set of some 15,000 genomes from the target phage’s own relatives.
They then added computational constraints and quality-control filters to maximize the chances that the AI-generated ΦX174-like sequences would produce working phages. That process yielded 302 candidate genomes.
Seventeen of these could not be synthesized. Of the remaining 285, the vast majority still failed to infect and kill bacteria—the most basic function of any phage. Only 16 could ultimately be “rebooted,” meaning converted from synthetic DNA sequences into infectious, bacteria-killing phages.
The result shows that machines can, in fact, write functional viral genomes, albeit relatively small ones containing just 5,400 DNA letters and only 11 genes. But considering the painstaking process it took to produce those 16 working phages, it’s worth asking what exactly the AI contributed, and what would have to change before the method could yield a truly dangerous human pathogen.
“Right now, I think it would still take a lot of work,” says Hie, who holds a joint appointment at the Arc Institute in Palo Alto, California. “It would definitely require a very talented interdisciplinary team to do this at the moment,” he says—never mind the $100,000–$200,000 in DNA synthesis costs that Hie estimates the project would have cost his team if they had to pay market prices. (Twist Bioscience provided the service at a discount.)
Hie continues: “Every single virus that you want to reboot in the lab is different and has different experimental conditions that need to be optimized. It needs a lot of domain-specific expertise.” Plus, he adds, “We don’t have a sufficient understanding of how the genetic changes proposed by the AI system lead to improved pathogenicity.”
How New Are These AI-Designed Phages?
Before looking too far ahead at what AI-designed viruses might become, it’s also worth asking how much novelty these viruses actually represent.
An independent analysis of the Stanford data—led by Oliver Crook, a computational biochemist at the University of Oxford—found that the 16 viable phage genomes were on average about 97 percent identical to their ΦX174 template. Placed on a family tree, the AI-designed viruses fell inside the existing spread of phage diversity, rather than branching away from it, Crook concluded.
In other words, the model was mainly rearranging familiar genetic material into new combinations. “What we saw, at a very plain view, were brothers and sisters of the original virus,” says Crook. “They’re not fundamentally behaving in a new way or using molecular mechanisms that they didn’t before.”
Sequence novelty, however, does not tell the whole story. Several of the AI-generated phages differed from ΦX174 in their three-dimensional protein structures, growth kinetics, and infection dynamics—properties that ultimately determine how a virus behaves, notes synthetic biologist Samuel King, a graduate student in Hie’s Laboratory of Evolutionary Design and the paper’s first author.
For example, one of the designed viruses carried an unusually truncated protein that packs DNA into new viral particles. The AI had borrowed this protein from an evolutionarily distant phage and made it work on the ΦX174 genomic backbone by rewiring the surrounding DNA. Notably, an analogous gene swap had previously been shown to be nonviable when introduced into ΦX174 through conventional genetic engineering. “That’s quite a new configuration,” King says.
For Chase Beisel, a chemical engineer at the Botnar Institute of Immune Engineering, in Switzerland, and cofounder of the phage therapy company Locus Biosciences, such moments show where the real promise of AI-designed phages lies: not in conjuring viruses wholly unlike anything in nature, but in searching through combinations of genetic changes that evolution has never produced and that scientists might never think to test.
“It’s a novel way to explore sequence space and uncover new attributes,” he says. “That’s going to be really useful in the long run.”
Reports of seven deaths in patients who had taken Neurocrine Biosciences’ Vykat and the official termination of Aardvark Therapeutics’ Phase 3 trial after cardiac complications marked a tough day for the Prader-Willi syndrome community.
It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression.
Beyond the legal action, Eli Lilly is calling on healthcare providers, regulatory authorities, online platforms and even logistics companies to help stem the illegal sale of its next-generation asset for weight loss.
BridgeBio Pharma’s transthyretin amyloidosis medicine Attruby is off to a strong launch, while Alnylam lowered full-year sales guidance for competitor Amvuttra.
After two rejections, Replimune has made it across the regulatory finish line with its advanced melanoma therapy. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again.
Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 2 – tracked changes
Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe – Chapter 2
A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what a missed promotion is actually telling you—and what it isn’t.
Medline is correcting affected convenience kits by removing included ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
