News & Updates

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 the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s oral cancer drug for a pair of rare tumors.

Sales of the company’s copycat to J&J’s blockbuster medicine reached $150 million in the first quarter, adding to a surge in revenue for Amgen's biosimilar business.

The FDA pushed back its decision date on Cytokinetics’ heart drug, while AstraZeneca got Phase 3 results that could help it expand use of a top drug.

Following challenges with its drug candidate bexotegrast and announcement of a limited-duration stockholder rights program, Pliant is paring back its workforce.

Brightseed is collaborating with Haleon by using its Forager AI platform to aid in the discovery of plant-based, small molecules which may have human health implications.

No Patient Left Behind says that drug value assessments used in countries like Canada and Germany undervalue innovative medicines by 90% and mislead U.S. policymakers into thinking Americans are overpaying.

Microorganisms present in fermented products, fresh produce and probiotic supplements play a key role in influencing metabolic health, according to new research.

The National Animal Supplement Council held its annual conference in Columbus, Ohio from April 22-24. Attendees discussed everything from macroeconomic concerns to which trends remain ‘hot’ in the pet supplement category.

Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions.

Learn about how to request a Patient Listening Session with the FDA to share your experiences and perspectives.

View a suggested sample agenda an FDA Patient-Led Listening Session

Learn the steps for planning an FDA Patient-Led Listening Session.

After multiple rounds of layoffs that cut Kronos down to just 10 people, the small molecule biotech has accepted a buyout offer from Kevin Tang’s Concentra Biosciences.

As the Trump administration—including HHS Secretary Robert F. Kennedy Jr.—plays fast and loose with scientific studies and facts, there may be a more sinister force at play: censorship.

Some 20 travel staff at the FDA, who made arrangements for the regulator’s inspectors, will be getting their jobs back, as per the Associated Press. Some food scientists involved in testing will also be reinstated.

In an internal memo, the World Health Organization signaled its support for anti-obesity drugs like Wegovy and Zepbound, which the agency decided against listing in 2023, the last time the Essential Medicines list was updated.

Like fellow Big Pharmas Eli Lilly and Johnson & Johnson, Amgen is urging the Trump administration to consider tax policy instead of tariffs to promote domestic pharma manufacturing.

Additional data required by the FDA are the latest evidence of what one analyst described as a “higher bar” for vaccines.

The flu, measles, pneumonia, and other microbial infections once were easy to treat with antibiotic, antifungal, and antiviral medications. The conditions have become more resistant to drugs, however, increasing the chances of deadly outcomes caused by bacterial, viral, fungal, and parasitic infections. Antimicrobial resistance (AMR) caused more than 1 million deaths in 2021, according to a 2024 report published in The Lancet. The World Health Organization declared in 2023 that AMR had become a major global health threat.

AMR can be blamed on a number of things including the overuse of antibiotics in people, animals, and plants; inadequate sanitation; and a lack of new medications. Other factors include ineffective prevention measures and a dearth of new tools to detect infections.

To discuss how technology can assist with preventing the spread of AMR, the Engineering Research Visioning Alliance held a two-day event last year, attracting more than 50 researchers, industry leaders, and policymakers. The ERVA, funded by the U.S. National Science Foundation, identifies areas that address national and global needs that any parties that fund research—companies, government agencies, and foundations—should consider. The alliance has more than 20 affiliate partners including IEEE.

“ERVA is not necessarily about finding a solution tomorrow,” says Anita Shukla, who chaired the February 2024 event. “It’s about creating long-term research directions that may help minimize, mitigate, or eradicate problems over the long term. We’re enabling research or ideas for research.”

Shukla, a professor of engineering at Brown University, in Providence, R.I., researches biomaterials for applications in drug delivery, including the treatment of bacterial and fungal infections.

The alliance recently released “Engineering Opportunities to Combat Antimicrobial Resistance.” The report identified five grand challenges for researchers: diagnostic biosensors and wearables, engineered antimicrobial surfaces, smart biomaterials, cell engineering, and advanced modeling approaches.

Biosensors to speed up detection

Faster, more accurate, and less expensive diagnostic tools and wearables are needed to better detect infections, the report says. It suggests the development of diagnostic biosensors, which could detect specific components of pathogens within a sample. The biosensors could collect the sample from the patient in a minimal or noninvasive way, according to the report.

The traditional method to find out if someone has an infection is to collect samples of their cells, tissue, blood, mucus, or other bodily fluids and send them to a laboratory for analysis. Depending on the type of infection and test, it can take a few days to get the results.

The alliance suggested the development of diagnostic biosensors that could detect bacteria, viruses, fungi, and parasitic pathogens within the sample on-site. Results need to be provided quickly—ideally in a few hours or less, the report says—in order to reduce the spread of the infection, lessen recovery time for patients, and lower health care costs.

But first, research is needed to develop biosensors that can detect low levels of infection-related biomarkers from patient samples, the report says. A biomarker is a measurable indicator, such as a gene, that can provide information about a person’s health. Currently it can take several days to weeks for a person’s immune system to produce enough antibodies to be detected, delaying a diagnosis.

“I think IEEE members have the right skill set and could make quite a difference if they, along with other engineers, work together to solve this very complex problem.” —Anita Shukla, engineering professor at Brown University, in Providence, R.I.

The authors call for engineers, clinicians, and microbiologists to collaborate on creating devices and designing them for use in clinical settings.

The advancements, the report says, can be incorporated into existing smart devices, or new ones could be designed that are infection-specific.

Another area that should be explored, it says, is developing wearable devices to allow patients to accurately diagnose themselves.

“Engineers, particularly electrical engineers who have a lot of knowledge on various biosensor design and wearable technologies, are the individuals who need to innovate in this space and produce these technologies,” Shukla says.

Cleaner surfaces to stop germ propagation

One way infections spread is from bacteria-contaminated surfaces including hospital beds, medical equipment, doorknobs, and desks. No matter how stringent hospital protocols are for sterilization, sanitation, and disinfection, bacteria attach to most things. The ERVA report notes that more than 90 percent of curtains used by hospitals for privacy between patients in shared rooms are contaminated after one week.

The authors say it’s imperative to develop antimicrobial surfaces that can kill bacterial and fungal pathogens on contact. Also needed are materials that release antimicrobial agents when touched, including metals, polymers, and composites.

New engineered antimicrobial surfaces have to be durable enough to withstand the sanitation and sterilization methods used in hospitals and other clinical settings, Shukla says.

Other locations where antimicrobial surfaces should be installed, she adds, include schools and office buildings.

Smarter materials to deliver medication

Dressings and other biomaterial-based drug delivery methods used today to deliver antibiotics directly to a potential infection site aren’t advanced enough to control the amount of medication they release, according to the report.

That can lead to overuse of the drug and can exacerbate AMR, the report says.

Smarter biomaterials-based delivery systems that release antimicrobials are an urgent area of research, the authors say. Nano- and microscale particles and polymer gels that can release drugs only when a bacterial infection is present are a few examples cited in the report.

“These are materials that can release therapeutics on demand,” Shukla says. “You expose the infection to the therapeutic only when it’s needed so that you’re not introducing more of the drug [than required]—which potentially could accelerate resistance development.”

The materials also should contain components that sense the presence of a bacteria or fungus and signal whether the patient’s immune system is actively fighting the infection, the report says. The germ’s presence would trigger an encapsulated antibiotic or antifungal to be released at the infection site.

There’s an opportunity for electrical engineers to develop components that would be incorporated into the smart material and respond to electric fields to trigger drug release or help detect infection, Shukla says.

Drug-free cellular engineering

Another area where electrical engineers could play a big role, Shukla says, involves immune cells. A potential alternative to antibiotics, engineered white blood cells could enhance the body’s natural response for fighting off infections, according to the report. Such a drug-free approach would require advances in cellular engineering, however, as well as a better understanding of genetically manipulating cells.

For people with persistent infections, it’s important to study long-term interactions between engineered immune cells and bacteria, the report says. Research into creating engineered microbes with antimicrobial activity could help reduce antibiotic use and might prevent infections, it says.

Using advanced modeling to develop new drugs

The alliance says significant research is needed for developing computational modeling. The technology could be used to rapidly develop complex bacterial infection models to evaluate the effectiveness of new antimicrobial drugs and therapeutics.

“Modeling has the opportunity to speed up the development of new drugs and potentially predict the outcomes of new treatments, all in a way that’s less expensive and less subject to the variability that often happens with laboratory-based tests,” Shukla says.

AI-based tools are already being used to predict or develop potential therapeutics, she adds, but new algorithms and approaches are still needed.

“I think IEEE members have the right skill set and could make quite a difference if they, along with other engineers, work together to solve this very complex problem of AMR,” Shukla says. “People working in silos is a problem. If we can get people working together to really tackle this problem, that’s how AMR is going to be solved.”

You can watch Shukla discuss the findings of the visioning event in this webinar, produced on 27 March.

Drugmaker executives have projected confidence they can mitigate the impact of any levies Trump imposes on the industry. Yet they're adjusting inventory and production nonetheless.

The deal could expand access to its in-demand obesity drug at the expense of Eli Lilly, whose shares fell by double digits on Thursday.

Eli Lilly CEO David Ricks is confident that weight loss med Zepbound is gaining market share at the expense of Wegovy, even as its rival strikes deals with CVS and Hims & Hers pharmacies.

The new policy, revealed by the Department of Health and Human Services on Wednesday, would make vaccines “less available and less affordable,” according to vaccine expert Paul Offit. It could also further complicate the picture for companies like Novavax.

Most people have heard about the environmental impact of today’s AI boom, stemming from sprawling data centers packed with power-hungry servers. In the United States alone, the demand for AI is projected to push data-center electricity consumption to 6.7 to 12.0 percent of the nation’s total by 2028. By that same date, water consumption for cooling these data-center facilities is predicted to double, or even quadruple, compared to the 2023 level.

But many people haven’t made the connection between data centers and public health. The power plants and backup generators needed to keep data centers working generate harmful air pollutants, such as fine particulate matter and nitrogen oxides (NOx). These pollutants take an immediate toll on human health, triggering asthma symptoms, heart attacks, and even cognitive decline.

But AI’s contribution to air pollution and the public health burden is often missing from conversations about responsible AI design. Why?

Because ambient air pollution is a “silent killer.” While concerns about the public health impacts of data centers, including potential links to cancer rate increases, are beginning to surface, most AI-model developers, practitioners, and users simply aren’t aware of the serious health risks tied to the energy and infrastructure powering modern AI systems.

The Danger of Ambient Air Pollution

Ambient air pollution is responsible for approximately 4 million premature deaths worldwide each year. The biggest culprit are tiny particles 2.5 micrometers or less in diameter (referred to as PM 2.5), which can travel deep into the respiratory tract and lungs. Along with high blood pressure, smoking, and high blood sugar, air pollution is a leading health risk factor. The World Bank estimates the global cost of air pollution at US $8.1 trillion, equivalent to 6.1 percent of global gross domestic product.

Contrary to common belief, air pollutants don’t stay near their emission sources: They can travel hundreds of miles. Moreover, PM 2.5 is considered a “nonthreshold” pollutant, meaning that there’s no safe level of exposure.

With the danger of this pollution well established, the question becomes: How much is AI responsible for? In our research as professors at Caltech and the University of California, Riverside, we’ve set out to answer that question.

Quantifying the Public Health Cost of AI

To ensure that AI services are available even during grid outages, data centers rely on large sets of backup generators that usually burn diesel fuel. While the total operation time of backup generators is limited and regulated by local environmental agencies, their emission rates are high. A typical diesel generator can release 200 to 600 times more NOx than a natural gas power plant producing the same amount of electricity.

A recent report by the state of Virginia revealed that backup generators at Virginia’s data centers emitted about 7 percent of what permits allowed in 2023. According to the U.S. Environmental Protection Agency’s COBRA modeling tool, which maps how air pollution affects human health at the local, state, and federal levels, the public health cost of those emissions in Virginia is estimated at $150 million, affecting communities as far away as Florida. Imagine the impact if data centers maxed out their permitted emissions.

Further compounding the public health risk, a large set of data-center generators in a region may operate simultaneously during grid outages or grid shortages as part of demand-response programs, potentially triggering short-term spikes in PM2.5 and NOx emissions that are especially harmful to people with lung problems.

Next, let’s look beyond the backup generators to the supply of energy from the grid. The bulk of the electricity powering AI data centers comes from power plants that burn fossil fuels, which release harmful air pollutants, including PM 2.5 and NOx. Despite years of progress, power plants remain a leading source of air pollution in the United States.

We calculated that training a single large generative AI model in the United States, such as Meta’s Llama 3.1, can produce as much PM 2.5 as more than 10,000 round trips by car between Los Angeles and New York City.

According to our research, in 2023, air pollution attributed to U.S. data centers was responsible for an estimated $6 billion in public health damages. If the current AI growth trend continues, this number is projected to reach $10 billion to $20 billion per year by 2030, rivaling the impact of emissions from California’s 30 million vehicles.

Why Carbon and Energy Efficiency Aren’t the Whole Story

To date, efforts to mitigate AI’s environmental footprint have focused mostly on carbon emissions and energy efficiency. These efforts are important, but they may not alleviate health impacts, which strongly depend on where the emissions occur.

Carbon anywhere is carbon everywhere. The climate impact of carbon dioxide is largely the same no matter where it’s emitted. But the health impact of air pollution depends heavily on regional factors such as local sources of energy, wind patterns, weather, and population density.

Even though carbon emissions and health-damaging air pollutants have some shared sources, an exclusive focus on cutting carbon does not necessarily reduce, and could even exacerbate, public health risks. For instance, our latest (and unpublished) research has shown that redistributing Meta’s energy loads in 2023 across its U.S. data centers to prioritize carbon reductions could potentially lower overall carbon emissions by 7.2 percent, but would increase public health costs by 2.8 percent.

Likewise, focusing solely on energy efficiency can reduce air pollutant emissions, but doesn’t guarantee a decrease in health impact. That’s because training the same AI model using the same amount of energy can yield vastly different health outcomes depending on the location. Across Meta’s U.S. data centers, we’ve found that the public health cost of training the same model can vary by more than a factor of 10.

We Need Health-Informed AI

Supply-side solutions, such as using alternative fuels for backup generators and sourcing electricity from clean fuels, can reduce AI’s public health impact, but they come with significant challenges.

Clean backup generators that offer the same level of reliability as diesel are still limited. And despite advancements in renewable energy, fossil fuels remain deeply embedded in the energy fuel mix. The U.S. Energy Information Administration projects that coal-based electricity generation in 2050 will remain at approximately 30 percent of the 2024 level under the alternative electricity scenario, in which power plants continue operating under rules existing prior to April 2024. Globally, the share of coal and other fossil fuels in electricity generation has remained nearly flat over the past four decades, underscoring the difficulty of entirely changing the energy supply that powers data centers.

We believe that demand-side strategies that consider the spatial and temporal variations in health impacts can provide effective and actionable solutions immediately. These strategies are particularly well-suited for AI data centers with substantial operational flexibility. For example, AI training can often run at any available data centers and typically do not face hard deadlines, so those jobs can be routed to locations or deferred to times that have less impact on public health. Similarly, inference jobs—the work a model does to create an output—can be routed among multiple data centers without affecting user experience.

By incorporating public health impact as a key performance metric, these flexibilities can be harnessed to reduce AI’s growing health burden. Crucially, this health-informed approach to AI requires minimal changes to existing systems. Companies simply need to consider public health costs when making decisions.

While the public health cost of AI is growing rapidly, AI also holds tremendous promise for advancing public health. For example, within the energy sector, AI can navigate the complex decision space of real-time power plant dispatch. By aligning grid stability with public health objectives, AI can help minimize health costs while maintaining a reliable power supply.

AI is rapidly becoming a public utility and will continue to reshape society profoundly. Therefore, we must examine AI through a public lens, with its public health impact as a critical consideration. If we continue to overlook it, the public health cost of AI will only grow. Health-informed AI offers a clear path forward for advancing AI while promoting cleaner air and healthier communities.

Announcing first-quarter results, Biogen CEO Chris Viehbacher admitted that tariffs are “a new topic for us,” but said he does not expect major impacts—at least for 2025.

Global employee engagement fell two percentage points in 2024, according to Gallup, while BioSpace found that workforce sentiment decreased among biopharma professionals. Additionally, a recent BioSpace poll suggests engagement could continue to decline in 2025.

Jefferies analysts said Moderna’s first quarter was “in line,” with a miss on revenue offset by a beat on earnings per share.

Suzanne Shelton has spent years creating a well-regarded public relations firm, the Shelton Group, which services the supplement industry.

Probiota Americas is the leading event for the probiotics, prebiotics and microbiome community in North America and a must-attend conference, with sessions covering CRISPR probiotics, maternal and infant health, weight management, regulations, prebiotics and more.

According to CEO Daniel Vitt, clinical and disability-related outcomes are more relevant than brain volume change for drug development in multiple sclerosis.