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…

J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy.

Elinzanetant proved effective for managing disruptive vasomotor symptoms in women on endocrine therapy, supporting a Bayer application for approval.

Drinking at least four cups of coffee a day may help people age better by reducing their risk of frailty, according to a seven-year study.

Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about one-quarter of patients. But Syndax’s Revuforj also has priority review in this indication, with a PDUFA date two months earlier.

The cancer conference overwhelms the senses and shows off the might of the pharmaceutical industry.

According to J&J, Akeega is the first PARP inhibitor combination that’s proven effective treating earlier-stage prostate tumors that harbor mutations in genes beyond BRCA.

The candidate is being positioned as a potential oral competitor to Sanofi and Regeneron’s blockbuster Dupixent in allergy and inflammation indications.

Analysts said the data suggest “a strong treatment effect.” Jazz has filed for FDA approval for the combination, which could offer an alternative to monotherapy treatments from Roche and AstraZeneca.

False Alarm Issue with Infusion Pump from Smiths Medical

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Phase 1 results disclosed Monday indicate the company’s protein-degrading drug can affect a tough-to-reach target called STAT6 that’s implicated in many autoimmune conditions.  

Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have played an important role in expediting the drug approval process while ensuring their safety and efficacy. PDUFA must be reauthorized every five years, and in September 2022, the President signed into law the six

Parkinson’s disease can be difficult to diagnose, but one common symptom of the progressive neurodegenerative condition is small, frequent tremors in the hands.

Now, with an eye toward screening and early detection of the disease, researchers have developed what they call a diagnostic pen to detect those hand motions. The pen does not write in the traditional sense. Instead, a flexible magnetic tip and ferrofluid ink convert movement into fluctuations in their magnetic field, taking advantage of what is known as the magnetoelastic effect. The magnetic flux produces an electrical current in a conductive coil built into the barrel of the pen.

In a small pilot study, that electrical signal was used to train a convolutional neural network to accurately differentiate between the writing of patients with Parkinson’s disease and a healthy group. The diagnostic pen and human study were presented in Nature Chemical Engineering today.

“While the underlying sensing mechanisms are well established, the true strength of this work lies in how the authors have ingeniously integrated them into a functional device,” says Pradeep Sharma, an engineer at the University of Houston who studies soft magnetic materials similar to the one used in the tip of the new stylus; he was not involved in the current research.

Who Created the Diagnostic Pen?

Because the device is capable of detecting small, high-frequency movements, it’s a good fit for examining hand tremors, says Gary Chen, lead author of the study and a Ph.D. candidate at the University of California, Los Angeles. The authors are primarily based in the bioengineering research group led by Jun Chen (no relation), which has been investigating uses for the magnetoelastic effect for around five years.

“We view it as a very promising technology,” says Gary Chen, “but as we indicate in our paper, our current study has some shortcomings.” Chiefly, larger follow-up studies with a more diverse pool of subjects are necessary to answer questions about the device and its potential applications. In the pilot study, training data came from only two patients with Parkinson’s disease and 10 healthy control participants, and validation added an additional four participants, including one with Parkinson’s.

In addition to validating early results, further research could also help determine if the pen is able to distinguish between Parkinson’s and other conditions with tremor symptoms, and whether it can identify different stages of the same disease. What’s more, the researchers want to study whether the subject’s native language or dominant handedness affect the results, which might be important for clinical applications.

How Does the Diagnostic Pen Work?

The new pen’s tip is made of small neodymium magnets mixed into Ecoflex, a brand of silicone rubber advertised for production of prosthetics and film props. The body contains a reservoir of ferrofluid “ink,” which is surrounded by a barrel with a built-in coil of conductive yarn.

As a user draws or writes with the stylus, deformations in the tip change the magnetic field, and movement of the ferrofluid makes the pen sensitive to acceleration both across a writing surface or in the air. Minute magnetic fluctuations produce a current in the coil, and changes to that current were analyzed rather than the on-paper results of experimental writing or drawing tasks, as is commonly done in today’s neurological assessments.

Participants were asked to perform several tasks, including drawing loops and writing letters. Normalized data was used to train several types of machine learning algorithms, and the best performing analysis came from a one-dimensional convolutional neural network, which reached over 96 percent accuracy in identifying subjects with Parkinson’s.

Current fluctuations in testing were sometimes less than a microampere, and the study version of the pen connected to a current amplifier with a cable. Eventually, the group would like to transfer data wirelessly from pen to computer or smartphone, says Chen.

Other Applications for Magnetoelastic Materials

Soft magnetic materials similar to that used for the tip of the pen, sometimes called magnetorheological elastomers, are being investigated for a variety of uses, including how their properties change when exposed to an external magnetic field. The Jun Chen research group has also looked at using magnetoelastic materials for neck-worn patches for speech assistance and more general human-machine interfaces, among other applications.

Earlier this year, a study estimated that there are around 12 million people living with Parkinson’s disease globally, a number that will double by 2050.

Chen emphasizes the importance of larger-scale studies for evaluating the usefulness of the pen. “Admitting that does not compromise the promise,” he says, “though it may take many years or decades to finally get it delivered.”

Regeneron’s shares have declined nearly 17% following the failure of the company’s Dupixent follow-up itepekimab.

Blueprint has a next-generation systemic mastocytosis treatment, called elenestinib, that Sanofi CEO Paul Hudson told analysts provides an “opportunity to grow through the ‘30s.”

Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space.

AstraZeneca has put hundreds of millions of dollars into AI deals, with an eye toward not just accelerating the development of drugs that treat cancer after it appears but also in creating diagnostics that can catch cancer earlier than current methods allow.

Arguably the most notable of the FDA’s upcoming decisions is that regarding Gilead’s twice-yearly HIV prophylaxis lenacapavir.

Here’s how companies can ensure they’re in compliance with new requirements that go into effect in August.

An colon cancer study highlighted the importance of the National Cancer Institute, while cancer doctors got a look at a bispecific antibody newly licensed by Pfizer.

Data presented at ASCO show that swapping in the oral drug camizestrant for an older therapy helped sustain the benefit of initial treatment, potentially opening a novel step in patient care.

The medium-sized biopharma is showing off new results from dordaviprone and Zepzelca, both of which were acquired through Jazz Pharmaceuticals’ dealmaking over the last five years.

The shot, dubbed mNexspike, is approved for older adults and people whose health conditions put them at higher risk of severe disease. 

The Food and Drug Administration Modernization Act of 1997 requires FDA to publish annually a notice in the Federal Register containing information on the performance of postmarket studies and clinical trials that FDA requires, or has requested, of manufacturers. Learn more.

Generic Drug Facilities, Sites and Organization Lists

Aishwarya Bandla tries to center her work around passion, people, and purpose, following the Japanese concept of ikigai, or a sense of purpose.

For the IEEE senior member, that involves transforming patient care through innovative health technology. Bandla is developing a means to help prevent nerve damage in cancer patients resulting from chemotherapy treatment, a condition known as chemotherapy-induced peripheral neuropathy

Chemotherapy is known to cause a variety of side effects including nausea, fatigue, and hair loss, according to the American Cancer Society. But one lesser-known effect is neuropathy, Bandla says.

Aishwarya Bandla

Employer:

Paxman Coolers of Huddersfield, England

Title:

Clinical innovation manager

Member grade:

Senior member

Alma maters:

Anna University in Chennai, India, and the National University of Singapore in Queenstown

Peripheral neuropathy nerve damage—which also can stem from diabetes, vitamin deficiencies, and other causes—affects mostly the tips of the patient’s hands and feet. Symptoms range from persistent tingling to excruciating pain. Currently there are no approved preventative measures for the condition; cancer patients try to manage it with painkillers or, in severe cases, reducing or stopping their chemotherapy, Bandla says.

Bandla is the clinical innovation manager at Paxman Coolers, a medical equipment manufacturer headquartered in Huddersfield, England. She is developing a wearable device that cools a person’s limbs. Called the Paxman limb cryocompression system (PLCS), it’s designed to help prevent nerve damage from certain types of intravenous chemotherapy drugs. The cold temperature slows blood flow to the area, allowing less of the injected medication to reach the nerves there.

Bandla, who is based in Singapore, is also a principal investigator at the N.1 Institute for Health, the National University of Singapore (NUS), and at the National University Cancer Institute of Singapore.

An active IEEE volunteer, she follows ikigai in her work with the organization, she says, and she encourages other young professionals to do the same. She has overseen the launch of several career development and mentorship programs for IEEE Women in Engineering Singapore, IEEE Region 10 Women in Engineering, and IEEE Region 10 Young Professionals.

“Being an IEEE member,” she says, “has helped me nurture my purpose in rallying my efforts toward creating meaningful impact.”

For “her leadership in patient-centric health technology innovation and inspiring IEEE Young Professionals to drive meaningful change,” she is the recipient of this year’s IEEE Theodore W. Hissey Outstanding Young Professional Award. The award is sponsored by the IEEE Photonics and IEEE Power & Energy societies, as well as IEEE Young Professionals.

“This recognition fuels me to continue the work IEEE is doing globally to make the world a better place,” she says.

Engineering is a superpower

Bandla had a difficult time deciding whether to pursue medicine or engineering as a career, she says, but she chose the latter because it’s “a superpower that can help you create things to make life better.”

After earning her bachelor’s degree in electrical and electronics engineering in 2009 from Anna University, in Chennai, India, she joined software engineering company Infosys in Mysuru, India, as a technical consultant. She left three years later after being accepted into the neurotechnology doctoral program at NUS in Queenstown. Neurotechnology encompasses ways of directly engaging with the human brain and nervous system, including brain-computer interfaces, magnetic resonance imaging, and brain-wave monitors.

Bandla conducted her research under biomedical engineer Nitish V. Thakor, who specializes in developing brain-monitoring technologies and neuroprostheses. The IEEE Life Fellow is a professor of biomedical engineering at Johns Hopkins University, in Baltimore. He also is director of the Singapore Institute for Neurotechnology, SINAPSE, a collaboration among six research universities including Johns Hopkins, NUS, and the University of Patras, in Greece.

Under Thakor’s tutelage, Bandla began her work in developing the technology she is involved with today.

Using technology to address nerve damage

In 2012 Bandla and other researchers from Thakor’s lab met with neurologist Einar Wilder Smith and oncologist Raghav Sundar from National University Hospital in Kent Ridge, Singapore, to explore how the technology could help cancer patients with peripheral neuropathy.

During chemotherapy, patients are injected with an individualized drug mixture that kills fast-dividing cells or prevents them from multiplying by damaging the cells’ DNA. But the mixture also can attack healthy cells and damage nervous-system structures, causing pain and sensitivity in the patient’s hands and feet, as explained in an article published in the International Journal of Molecular Sciences.

In the meeting, the team learned about a scalp-cooling technology that helps prevent a different side effect: hair loss. A special cap is placed on the patient’s head to cool the scalp.

Inspired by that cold cap, the team set out to develop similar technology for the hands and feet. But first, in 2014, the SINAPSE lab conducted a clinical trial with National University Hospital to see if cooling the limbs would help patients with peripheral neuropathy. Existing localized cryotherapy machines used for sports therapy—which circulate ice-cooled liquid to cool an area on the body, were tested on 15 chemotherapy patients at the hospital. The team found that patients could not comfortably tolerate temperatures below 22 °C during the three-hour treatment, Bandla says.

“Being an IEEE member has helped me nurture my purpose in rallying my efforts toward creating meaningful impact.”

She suggested conducting another clinical trial, this time testing cryocompression tools rather than cryotherapy ones. Cryocompression is used for sports therapy and rehab. It combines cooling and compression—which helps reduce swelling. In the second trial, the team found that patients could tolerate temperatures as low as 11 °C for three hours, Bandla says.

The second trial ended in 2017. Bandla earned her Ph.D. that year but continued to work on the project as a SINAPSE research fellow.

In 2018 the team members began another clinical study, testing if they could safely cool a patient’s scalp and limbs simultaneously to prevent multiple side effects at once.

Throughout the five-year trial period, Bandla collected data to understand the best way to deliver cooling therapy that was safe, comfortable, and effective. The feedback she received from patients, caregivers, and the medical staff demonstrated a clear need for a device to use in the chemotherapy suite.

After the pilot trials ended in 2019, the team began designing a device alongside Richard Paxman and his team at Paxman Coolers, who leveraged their expertise in cryotherapy for side-effect management.

The portable PLCS connects to four insulated wraps, each containing a bladder filled with coolant. The wraps cover a patient’s forearms, hands, shins, and feet and include velcro flaps that can be adjusted for a better fit. The PLCS circulates the coolant through the wraps and powers the compression. It also keeps the coolant temperature at 11 °C.

During every chemotherapy cycle, 30 minutes before the medication is administered, the wraps are placed on the patient’s forearms and shins to begin the cooling process. After the session ends, the device is used on the patient for 30 more minutes, Bandla says.

The team was granted two U.S. patents for the PLCS.

In 2022 Bandla joined Paxman as a research and development manager, and she was promoted to clinical innovation manager two years later.

The impact her work has had keeps her motivated to continue, she says.

The PLCS is being tested in a large-scale clinical trial in 25 U.S. hospitals in collaboration with the National Cancer Institute.

Two years ago Bandla attended a social innovation camp for school students in India.Aishwarya Bandla

Starting her IEEE volunteer journey

Thakor introduced Bandla to IEEE. An active member of the IEEE Engineering in Medicine and Biology Society, he encourages his students to participate in its conferences and to publish papers in its journals.

Bandla says volunteering with IEEE was a no-brainer for her. Her volunteerism began in 2012 with IEEE Women in Engineering Singapore. In 2019 she became its chair and launched the WIE Singapore Networking Night to help build camaraderie between the IEEE Singapore Section and technologists in industry, academia, and government. The annual event includes panel discussions.

In 2021 Bandla joined the IEEE Region 10 Women in Engineering committee as the technical and Young Professionals lead. There she helped launch MentorHer, an eight-week program in which experts help their mentees design and implement a professional development plan. Bandla created the program’s framework.

“After the pilot program was completed in 2021, we received nice feedback from participants,” she says. “Many people said they interacted with people they wouldn’t normally work with and enjoyed the experience.”

In 2020 Bandla began participating in virtual events and conferences held by Region 10’s Young Professionals group as a speaker and panel moderator. Last year she became the chair.

Guiding young professionals

Volunteering for the YP group is special to her, she says, because she has been able to “build a community and help other young professionals become well-rounded leaders and decision-makers.”

She helped develop the Career and Leadership Aid Program (CLAP) at the Region 10 Students, Young Professionals,Women in Engineering,Life Members Congress held in August in Tokyo.

She introduced the concept of ikigai to young professionals by centering the event around it. The congress included what she calls a “human library” session. Ten IEEE members from different engineering fields were positioned around the meeting room, and attendees had an hour to learn about each of the “human books.”

The group received positive feedback, with participants saying they enjoyed the focus on professional and leadership development. They said they liked how extraordinary the event was, in particular the “human library” session.

Based on the success of the CLAP event, the team is building an IEEE Hive. The immersive professional development program is available for students and early career professionals at technical conferences and congresses around the world.

The ability to make an impact, build a community, and connect with people resonates with her, Bandla says.

“Volunteering with IEEE gives me so much energy!” she says.

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion’s untitled letters. FDA may have redacted or edited some of the letters to remove confidential information.

Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified a potential accelerated approval pathway. The company has pared down its staff to conserve resources to fund a potential resubmission.