Adam J. Fein, Ph.D., president of Drug Channels Institute (DCI) and the author of Drug Channels, invites you to join him for DCI’s new live video webinar:

Friday, December 13, 2024,

from 12:00 p.m. to 1:30 p.m. ET

This post describes the event and explains how to purchase a registration. (Or, just click here to order.) The webinar will be broadcast from the Drug Channels studio in beautiful downtown Philadelphia.

This event is part of The Drug Channels 2024 Video Webinar Series. (Please note that our December 2024 webinar is *not* included with next year’s 2025 Video Webinar Series.)

WHAT YOU WILL LEARN

Join Dr. Fein as he helps you and your team get ready for 2025 by outlining key issues and uncertainties that will surely affect your planning. This event can be both a capstone of your annual learning and a touchpoint for the future. DCI’s Outlook webinars have proven to be reliable and informative guides to crucial aspects of the ever-evolving healthcare industry.

During the event, Dr. Fein will share his latest thinking and projections on a wide range of topics, including:

• Latest predictions for the Inflation Reduction Act

• Expectations for the Medicare Part D market in 2025 and beyond

• Update on 340B Drug Pricing Program’s controversies

• Impact of the new Trump administration and Congress on the drug channel

• Vertical integration and consolidation trends—and prospects for dis-integration and de-consolidation

• The state of biosimilar markets

• What’s next for PBMs’ private label products and GPOs

• Retail pharmacy’s future

• Prospects for direct-to-patient channels

• What’s ahead for discount cards and cash-pay pharmacies

• The outlook for state and federal legislation on PBMs and the drug channel

• Gross-to-net bubble developments

• And much more!

PLUS: During the webinar, Dr. Fein will give participants an opportunity to unmute themselves and ask live questions. The webinar will last at least 90 minutes to accommodate audience questions.

As always, Dr. Fein will clearly distinguish his opinions and interpretations from the objective facts and data. He will draw from exclusive information found in DCI's economic reports .

Read on for full details on pricing and registration.
Read more »

The U.S. Food and Drug Administration posted a video:

¿Qué son los biosimilares? Los biosimilares son un tipo de medicamento que se usa para tratar una variedad de afecciones, como enfermedades crónicas de la piel y los intestinos, artritis, diabetes, afecciones renales, degeneración macular y algunos tipos de cáncer. Un biosimilar es un tipo de medicamento biológico. La mayoría de los medicamentos biológicos se elaboran usando fuentes vivas, como células animales, bacterias o levaduras. Debido a que en su mayoría provienen de fuentes vivas, todos los tipos de productos biológicos tienen diferencias menores que ocurren naturalmente entre los lotes de producción. Así como los medicamentos de marca tienen versiones genéricas, los biológicos originales pueden tener biosimilares. La cuidadosa revisión de datos, estudios y pruebas por parte de la FDA ayuda a garantizar que los productos biosimilares brinden los mismos beneficios de tratamiento que el producto biológico original aprobado por la FDA. Los biosimilares pueden brindarle más acceso a tratamientos importantes y también pueden ahorrarle dinero, dependiendo de su cobertura de seguro. Se han aprobado muchos biosimilares diferentes y se esperan aún más. Para obtener más información, visite www.fda.gov/biosimilars

The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […]

The New York legislature passed two bills on June 7, 2024 directed at children’s use of online technologies – the Stop Addictive Feeds Exploitation (SAFE) for Kids Act (S7694) that restricts access to addictive algorithmic feeds and the New York Child Data Protection Act (S7695) that bans sites from collecting, using, sharing or selling personal […]

Effective on October 21st of this year, the Federal Trade Commission (FTC) issued a new final rule that is intended to better combat ​“fake” reviews and testimonials by prohibiting the sale or purchase of “fake reviews” as well as granting the agency the opportunity to seek civil penalties against ​willful violators. The FTC made only […]

<p>On 19&nbsp;September 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)&nbsp;adopted a positive opinion,&nbsp;recommending the granting of marketing authorization&nbsp;for&nbsp;two aflibercept biosimilars:&nbsp;&nbsp;Sandoz’s Afqlir and Samsung Bioepis’s Opuviz.&nbsp;These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.</p>

<p>On 3^&nbsp;June 2024,&nbsp;Resolution&nbsp;RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1],&nbsp;modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).</p>

<p>The global biologicals market surged to an impressive US$419.07 billion in 2023. Blood and blood products led the market, commanding a dominant 66% share. Oncology stood out as the leading application segment, accounting for 36% of the market. North America held the largest revenue share, at 46%, while the Asia-Pacific region emerged as a rising star, poised to be the fastest-growing region over the next decade.</p>

<p>The US Food and Drug Administration (FDA) granted approval for two&nbsp;biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing&nbsp;Johnson &amp; Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p>

<p> <b>BIOSIMILAR RED TAPE ELIMINATION ACT (S2305):</b><br /> <b><i>Weakening FDA Regulatory Standards for Biosimilars, Undermining Physician Confidence and Jeopardizing Patient Health</i></b><br /><b>31 October 2024&nbsp;|&nbsp;</b><b><a href="https://youtu.be/X6-dYZ7fjhM" target="_blank">WATCH REPLAY</a></b></p>

<p>In October 2024, China based Bio-Thera Solutions&nbsp;(Bio-Thera)&nbsp;and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to&nbsp;Johnson &amp; Johnson’s Stelara (ustekinumab).</p>

<p>The European Commission (EC) granted marketing authorization for<b>&nbsp;</b>three ustekinumab biosimilars<b>:&nbsp;</b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s&nbsp;Otulfi on 25 September 2024.</p>

<p> <b>Abstract</b><br />CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr&nbsp;Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI<i>&nbsp;</i>(Generics and Biosimilars Initiative) about the company’s strategic focus, which includes expanding its product portfolio, entering highly regulated global markets, and advancing affordable treatments for conditions such as multiple sclerosis and&nbsp;immunological diseases—transforming healthcare in underserved regions.</p><p><b>Keywords</b>: Biosimilars, clinical development, commercialization, MENA</p>

The General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence.

Venture creation in biotech is witnessing a sustained contraction. After the pandemic bubble’s over-indulgence, the venture ecosystem appears to have reset its pace of launching new startups. According to the latest Pitchbook data, venture creation in biotech hit its slowest

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A person has tested positive in British Columbia, Canadian health officials said, though the results must be sent to another lab for confirmation.

Sweat: We all do it. It plays an essential role in controlling body temperature by cooling the skin through evaporation. But it can also carry salts and other molecules out of the body in the process. In medieval Europe, people would lick babies; if the skin was salty, they knew that serious illness was likely. (We now know that salty skin can be an indicator for cystic fibrosis.)

Scientists continue to study how the materials in sweat can reveal details about an individual’s health, but often they must rely on gathering samples from subjects during strenuous exercise in order to get samples that are sufficiently large for analysis.

Now researchers in China have developed a wearable sensor system that can collect and process small amounts of sweat while providing continuous detection. They have named the design a “skin-interfaced intelligent graphene nanoelectronic” patch, or SIGN for short. The researchers, who described their work in a paper published in Advanced Functional Materials, did not respond to IEEE Spectrum’s interview requests.

The SIGN sensor patch relies on three separate components to accomplish its task. First, the sweat must be transported from the skin into microfluidic chambers. Next, a special membrane removes impurities from the fluid. Finally, this liquid is delivered to a bioreceptor that can be tuned to detect different metabolites.

The transport system relies on a combination of hydrophilic (water-attracting) and hydrophobic (water-repelling) materials. This system can move aqueous solutions along microchannels, even against gravity. This makes it possible to transport small samples with precision, regardless of the device’s orientation.

The fluid is transported to a Janus membrane, where impurities are blocked. This means that the sample that reaches the sensor is more likely to produce accurate results.

Finally, the purified sweat arrives at a flexible biosensor. This graphene sensor is activated by enzymes designed to detect the desired biomarker. The result is a transistor that can accurately measure the amount of the biomarker in the sample.

At its center, the system has a membrane that removes impurities from sweat and a biosensor that detects biomarkers.Harbin Institute of Technology/Shenyang Aerospace University

One interesting feature of the SIGN patch is that it can provide continuous measurements. The researchers tested the device through multiple cycles of samples with known concentrations of a target biomarker, and it was about as accurate after five cycles as it was after just one. This result suggests that it could be worn over an extended period without having to be replaced.

Continuous measurements can provide useful longitudinal data. However, Tess Skyrme, a senior technology analyst at the research firm IDTechEx, points out that continuous devices can have very different sampling rates. “Overall, the right balance of efficient, comfortable, and granular data collection is necessary to disrupt the market,” she says, noting that devices also need to optimize “battery life, calibration, and data accuracy.”

The researchers have focused on lactate—a metabolite that can be used to assess a person’s levels of exercise and fatigue—as the initial biomarker to be detected. This function is of particular interest to athletes, but it can also be used to monitor the health status of workers in jobs that require strenuous physical activity, especially in hazardous or extreme working conditions.

Not all experts are convinced that biomarkers in sweat can provide accurate health data. Jason Heikenfeld, director of the Novel Device Lab at the University of Cincinnati, has pivoted his research on wearable biosensing from sweat to the interstitial fluid between blood vessels and cells. “Sweat glucose and lactate are way inferior to measures that can be made in interstitial fluid with devices like glucose monitors,” he tells Spectrum.

The researchers also developed a package to house the sensor. It’s designed to minimize power consumption, using a low-power microcontroller, and it includes a Bluetooth communications chip to transmit data wirelessly from the SIGN patch. The initial design provides for 2 hours of continuous use without charging, or up to 20 hours in standby mode.

The future of an innovative retinal implant and dozens of its users just got brighter, after Science, a bioelectronics startup run by Neuralink’s cofounder, Max Hodak, acquired Pixium’s technology at the last minute.

Pixium Vision, whose Prima system to tackle vision loss is implanted in 47 people across Europe and the United States, was in danger of disappearing completely until Science stepped in to buy the French company’s assets in April, for an undisclosed amount.

Pixium has been developing Prima for a decade, building on work by Daniel Palanker, a professor of ophthalmology at Stanford University. The 2-by-2-millimeter square implant is surgically implanted under the retina, where it turns infrared data from camera-equipped glasses into pulses of electricity. These replace signals generated by photoreceptor rods and cones, which are damaged in people suffering from age-related macular degeneration (AMD).

Early feasibility studies in the E.U. and the United States suggested Prima was safe and potentially effective, but Pixium ran out of money last November before the final results of a larger, multiyear pivotal trial in Europe.

“It’s very important to us to avoid another debacle like Argus II.”

With the financial and legal clock ticking down, the trial data finally arrived in March this year. “And the results from that were just pretty stunning,” says Max Hodak, Science’s founder and CEO, in his first interview since the acquisition.

Although neither Pixium nor Science has yet released the full dataset, Hodak shared with IEEE Spectrum videos of three people using Prima, each of them previously unable to read or recognize faces due to AMD. The videos show them slowly but fluently reading a hardback book, filling in a crossword puzzle, and playing cards.

“This is legit ‘form vision’ that I don’t think any device has ever done,” says Hodak. Form vision is the ability to recognize visual elements as parts of a larger object. “It’s this type of data that convinced us. And from there we were like, this should get to patients.”

As well as buying the Prima technology, Hodak says that Science will hire the majority of Pixium’s 35 engineering and regulatory staff, in a push to get the technology approved in Europe as quickly as possible.

The Prima implant receives visual data and is powered by near-infrared signals beamed from special spectacles.Pixium

Another priority is supporting existing Prima patients, says Lloyd Diamond, Pixium’s outgoing CEO. “It’s very important to us to avoid another debacle like Argus II,” he says, referring to another retinal implant whose manufacturer went out of business in 2022, leaving users literally in the dark.

Diamond is excited to be working with Science, which is based in Silicon Valley with a chip foundry in North Carolina. “They have a very deep workforce in software development, in electronic development, and in biologic research,” he says. “And there are probably only a few foundries in the world that could manufacture an implant such as ours. Being able to internalize part of that process is a very big advantage.”

Hodak hopes that a first-generation Prima product could quickly be upgraded with a wide-angle camera and the latest electronics. “We think that there’s one straight shrink, where we’ll move to smaller pixels and get higher visual acuity,” he says. “After that, we’ll probably move to a 3D electrode design, where we’ll be able to get closer to single-cell resolution.” That could deliver even sharper artificial vision.

In parallel, Science will continue Pixium’s discussions with the FDA in the United States about advancing a clinical trial there.

The success of Prima is critical, says Hodak, who started Science in 2021 after leaving Neuralink, a brain-computer interface company he cofounded with Elon Musk. “Elon can do whatever he wants for as long as he wants, but we need something that can finance future development,” he says. “Prima is big enough in terms of impact to patients and society that it is capable of helping us finance the rest of our ambitions.”

These include a next-generation Prima device, which Hodak says he is already talking about with Palanker, and a second visual prosthesis, currently called the Science Eye. This will tackle retinitis pigmentosa, a condition affecting peripheral vision—the same condition targeted by Second Sight’s ill-fated Argus II device.

“The Argus II just didn’t work that well,” says Hodak. “In the end, it was a pure bridge to nowhere.” Like the Argus II and Prima, the Science Eye relies on camera glasses and an implant, but with the addition of optogenetic therapy. This uses a genetically engineered virus to deliver a gene to specific optic nerve cells in the retina, making them light-sensitive at a particular wavelength. A tiny implanted display with a resolution sharper than an iPhone screen then enables fine control over the newly sensitized cells.

That system is still undergoing animal trials, but Hodak is almost ready to pull the trigger on its first human clinical studies, likely in Australia and New Zealand.

“In the long term, I think precision optogenetics will be more powerful than Prima’s electrical stimulation,” he says. “But we’re agnostic about which approach works to restore vision.”

One thing he does believe vehemently, unlike Musk, is that the retina is the best place to put an implant. Neuralink and Cortigent (the successor company of Second Sight) are both working on prosthetics that target the brain’s visual cortex.

“There’s a lot that you can do in cortex, but vision is not one of them,” says Hodak. He thinks the visual cortex is too complex, too distributed, and too difficult to access surgically to be useful.

“As long as the optic nerve is intact, the retina is the ideal place to think about restoring vision to the brain,” he says. “This is all a question of effect size. If someone has been in darkness for a decade, with no light, no perception, and you can give them any type of visual stimulus, they’re going to be into it. The Pixium patients can intuitively read, and that was really what convinced us that this was worth picking up and pursuing.”

For the first time, a small group of patients with amputations below the knee were able to control the movements of their prosthetic legs through neural signals—rather than relying on programmed cycles for all or part of a motion—and resume walking with a natural gait. The achievement required a specialized amputation surgery combined with a non-invasive surface electrode connection to a robotic prosthetic lower leg. A study describing the technologies was published today in the journal Nature Medicine.

“What happens then is quite miraculous. The patients that have this neural interface are able to walk at normal speeds; and up and down steps and slopes; and maneuver obstacles really without thinking about it. It’s natural. It’s involuntary,” said co-author Hugh Herr, who develops bionic prosthetics at the MIT Media Lab. “Even though their limb is made of titanium and silicone—all these various electromechanical components—the limb feels natural and it moves naturally, even without conscious thought.”

The approach relies on surgery at the amputation site to create what the researchers call an agonist-antagonist myoneural Interface, or AMI. The procedure involves connecting pairs of muscles (in the case of below-the-knee amputation, two pairs), as well as the introduction of proprietary synthetic elements.

The interface creates a two-way connection between body and machine. Muscle-sensing electrodes send signals to a small computer in the prosthetic limb that interprets them as angles and forces for joints at the ankle and ball of the foot. It also sends information back about the position of the artificial leg, restoring a sense of where the limb is in space, also known as proprioception.

Video 1 www.youtube.com

“The particular mode of control is far beyond what anybody else has come up with,” said Daniel Ferris, a neuromechanical engineer at the University of Florida; Ferris was not involved in the study, but has worked on neural interfaces for controlling lower limb prostheses. “It’s a really novel idea that they’ve built on over the last eight years that’s showing really positive outcomes for better bionic lower legs.” The latest publication is notable for a larger participant pool than previous studies, with seven treatment patients and seven control patients with amputations and typical prosthetic legs.

To test the bionic legs, patients were asked to walk on level ground at different speeds; up and down slopes and stairs; and to maneuver around obstacles. The AMI users had a more natural gait, more closely resembling movement by someone using a natural limb. More naturalistic motion can improve freedom of movement, particularly over challenging terrain, but in other studies researchers have also noted reduced energetic costs, reduced stress on the body, and even social benefits for some amputees.

Co-author Hyungeun Song, a postdoctoral researcher at MIT, says the group was surprised by the efficiency of the bionic setup. The prosthetic interface sent just 18 percent of the typical amount of information that’s sent from a limb to the spine, yet it was enough to allow patients to walk with what was considered a normal gait.

Next Steps for the Bionic Leg

AMI amputations have now become the standard at Brigham and Women’s Hospital in Massachusetts, where co-author Matthew Carty works. And because of patient benefits in terms of pain and ease of using even passive (or non-robotic) prosthetics, this technique—or something similar—could spread well beyond the current research setting. To date, roughly 60 people worldwide have received AMI surgery above or below either an elbow or knee.

In principle, Herr said, someone with a previously amputated limb, such as himself, could undergo AMI rehabilitation, and he is strongly considering the procedure. More than 2 million Americans are currently living with a lost limb, according to the Amputee Coalition, and nearly 200,000 lower legs are amputated each year in the United States.

On the robotics side, there are already commercial leg prosthetics that could be made compatible with the neural interface. The area in greatest need of development is the connection between amputation site and prosthesis. Herr says commercialization of that interface might be around five years away.

Herr says his long-term goal is neural integration and embodiment: the sense that a prosthetic is part of the body, rather than a tool. The new study “is a critical step forward—pun intended.”

In the United States alone, more than 100,000 people currently need a lifesaving organ transplant. Instead of waiting for donors, one way to solve this crisis in the future is to assemble replacement organs with bio-printing—3D printing that uses inks containing living cells. Scientists in Israel have found that origami techniques could help fold sensors into bio-printed materials to help determine whether they are behaving safely and properly.

Although bio-printing something as complex as a human organ is still a distant possibility, there are a host of near-term applications for the technique. For example, in drug research, scientists can bio-print living, three-dimensional tissues with which to examine the effects of various compounds.

Ideally, researchers would like to embed sensors within bio-printed items to keep track of how well they are behaving. However, the three-dimensional nature of bio-printed objects makes it difficult to lodge sensors within them in a way that can monitor every part of the structures.

“It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them.” —Ben Maoz, Tel Aviv University

Now scientists have developed a 3D platform inspired by origami that can help embed sensors in bio-printed objects in precise locations. “It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them,” says Ben Maoz, a professor of biomedical engineering at Tel Aviv University in Israel.

The new platform is a silicone rubber device that can fold around a bio-printed structure. The prototype holds a commercial array of 3D electrodes to capture electrical signals. It also possesses other electrodes that can measure electrical resistance, which can reveal how permeable cells are to various medications. A custom 3D software model can tailor the design of the origami and all the electrodes so that the sensors can be placed in specific locations in the bio-printed object.

The scientists tested their device on bio-printed clumps of brain cells. The research team also grew a layer of cells onto the origami that mimicked the blood-brain barrier, a cell layer that protects the brain from undesirable substances that the body’s blood might be carrying. By folding this combination of origami and cells onto the bio-printed structures, Maoz and his colleagues were able to monitor neural activity within the brain cells and see how their synthetic blood-brain barrier might interfere with medications intended to treat brain diseases.

Maoz says the new device can incorporate many types of sensors beyond electrodes, such as temperature or acidity sensors. It can also incorporate flowing liquid to supply oxygen and nutrients to cells, the researchers note.

Currently, this device “will mainly be used for research and not for clinical use,” Maoz says. Still, it could “significantly contribute to drug development—assessing drugs that are relevant to the brain.”

The researchers say they can use their origami device with any type of 3D tissue. For example, Maoz says they can use it on bio-printed structures made from patient cells “to help with personalized medicine and drug development.”

The origami platform could also help embed devices that can modify bio-printed objects. For instance, many artificially grown tissues function better if they are placed under the kinds of physical stresses they might normally experience within the body, and the origami platform could integrate gadgets that can exert such mechanical forces on bio-printed structures. “This can assist in accelerating tissue maturation, which might be relevant to clinical applications,” Maoz says.

The scientists detailed their findings in the 26 June issue of Advanced Science.

Cochlear implants—the neural prosthetic cousins of standard hearing aids—can be a tremendous boon for people with profound hearing loss. But many would-be users are turned off by the device’s cumbersome external hardware, which must be worn to process signals passing through the implant. So researchers have been working to make a cochlear implant that sits entirely inside the ear, to restore speech and sound perception without the lifestyle restrictions imposed by current devices.

A new biocompatible microphone offers a bridge to such fully internal cochlear implants. About the size of a grain of rice, the microphone is made from a flexible piezoelectric material that directly measures the sound-induced motion of the eardrum. The tiny microphone’s sensitivity matches that of today’s best external hearing aids.

Cochlear implants create a novel pathway for sounds to reach the brain. An external microphone and processor, worn behind the ear or on the scalp, collect and translate incoming sounds into electrical signals, which get transmitted to an electrode that’s surgically implanted in the cochlea, deep within the inner ear. There, the electrical signals directly stimulate the auditory nerve, sending information to the brain to interpret as sound.

But, says Hideko Heidi Nakajima, an associate professor of otolaryngology at Harvard Medical School and Massachusetts Eye and Ear, “people don’t like the external hardware.” They can’t wear it while sleeping, or while swimming or doing many other forms of exercise, and so many potential candidates forgo the device altogether. What’s more, incoming sound goes directly into the microphone and bypasses the outer ear, which would otherwise perform the key functions of amplifying sound and filtering noise. “Now the big idea is instead to get everything—processor, battery, microphone—inside the ear,” says Nakajima. But even in clinical trials of fully internal designs, the microphone’s sensitivity—or lack thereof—has remained a roadblock.

Nakajima, along with colleagues from MIT, Harvard, and Columbia University, fabricated a cantilever microphone that senses the motion of a bone attached behind the eardrum called the umbo. Sound entering the ear canal causes the umbo to vibrate unidirectionally, with a displacement 10 times as great as other nearby bones. The tip of the “UmboMic” touches the umbo, and the umbo’s movements flex the material and produce an electrical charge through the piezoelectric effect. These electrical signals can then be processed and transmitted to the auditory nerve. “We’re using what nature gave us, which is the outer ear,” says Nakajima.

Why a cochlear implant needs low-noise, low-power electronics

Making a biocompatible microphone that can detect the eardrum’s minuscule movements isn’t easy, however. Jeff Lang, a professor of electrical engineering at MIT who jointly led the work, points out that only certain materials are tolerated by the human body. Another challenge is shielding the device from internal electronics to reduce noise. And then there’s long-term reliability. “We’d like an implant to last for decades,” says Lang.

In tests of the implantable microphone prototype, a laser beam measures the umbo’s motion, which gets transferred to the sensor tip. JEFF LANG & HEIDI NAKAJIMA

The researchers settled on a triangular design for the 3-by-3-millimeter sensor made from two layers of polyvinylidene fluoride (PVDF), a biocompatible piezoelectric polymer, sandwiched between layers of flexible, electrode-patterned polymer. When the cantilever tip bends, one PVDF layer produces a positive charge and the other produces a negative charge—taking the difference between the two cancels much of the noise. The triangular shape provides the most uniform stress distribution within the bending cantilever, maximizing the displacement it can undergo before it breaks. “The sensor can detect sounds below a quiet whisper,” says Lang.

Emma Wawrzynek, a graduate student at MIT, says that working with PVDF is tricky because it loses its piezoelectric properties at high temperatures, and most fabrication techniques involve heating the sample. “That’s a challenge especially for encapsulation,” which involves encasing the device in a protective layer so it can remain safely in the body, she says. The group had success by gradually depositing titanium and gold onto the PVDF while using a heat sink to cool it. That approach created a shielding layer that protects the charge-sensing electrodes from electromagnetic interference.

The other tool for improving a microphone’s performance is, of course, amplifying the signal. “On the electronics side, a low-noise amp is not necessarily a huge challenge to build if you’re willing to spend extra power,” says Lang. But, according to MIT graduate student John Zhang, cochlear implant manufacturers try to limit power for the entire device to 5 milliwatts, and just 1 mW for the microphone. “The trade-off between noise and power is hard to hit,” Zhang says. He and fellow student Aaron Yeiser developed a custom low-noise, low-power charge amplifier that outperformed commercially available options.

“Our goal was to perform better than or at least equal the performance of high-end capacitative external microphones,” says Nakajima. For leading external hearing-aid microphones, that means sensitivity down to a sound pressure level of 30 decibels—the equivalent of a whisper. In tests of the UmboMic on human cadavers, the researchers implanted the microphone and amplifier near the umbo, input sound through the ear canal, and measured what got sensed. Their device reached 30 decibels over the frequency range from 100 hertz to 6 kilohertz, which is the standard for cochlear implants and hearing aids and covers the frequencies of human speech. “But adding the outer ear’s filtering effects means we’re doing better [than traditional hearing aids], down to 10 dB, especially in speech frequencies,” says Nakajima.

Plenty of testing lies ahead, at the bench and on sheep before an eventual human trial. But if their UmboMic passes muster, the team hopes that it will help more than 1 million people worldwide go about their lives with a new sense of sound.

The work was published on 27 June in the Journal of Micromechanics and Microengineering.

CDMO Avid Bioservices is being acquired by the private equity firms GHO Capital Partners and Ampersand Capital Partners. Avid specializes in manufacturing biologic products for companies at all stages of development.

The post Private Equity Is Picking Up Biologics CDMO Avid Bioservices in $1.1B Acquisition appeared first on MedCity News.

The Pew Charitable Trusts joined dozens of research, health care, and nonprofit stakeholders in urging President-elect Joe Biden to prioritize and strengthen the national response to antibiotic resistance.

Dr. Cassandra Quave’s path to her work as a leader in antibiotic drug discovery research initiatives at Emory University in Atlanta started when she was a child and she and her family dealt with her own serious health issues that have had life-long repercussions.

The Pew Charitable Trusts today commended Michigan Governor Gretchen Whitmer (D), state Senate Majority Leader Mike Shirkey (R), and Lee Chatfield (R)—whose term as state House Speaker ended last month—for passing and signing a bipartisan package of bills aimed at protecting public safety while reducing the number of people in county jails.

Sales of medically important antibiotics for use in food-producing animals increased 3% in 2019, according to recent data from the U.S. Food and Drug Administration. This is the second year in a row that the quantities of antibiotics sold for animal use have risen, underscoring the need for further FDA action to ensure judicious use of these lifesaving drugs.

The Food and Drug Administration published a concept paper in early January that describes a preliminary proposal for how the agency will ensure that companies developing antibiotics for administration to animals establish defined, evidence-based durations of use for all medically important antibiotics.

We’re seeing an alarming increase in the number of failed biotech companies. While the biotechnology industry holds enormous […]

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OTTAWA - Canada has detected its first presumptive case of H5 bird flu in a person, a teenager in the western province of British Columbia, health officials said on Saturday (Nov 9). The teenager likely caught the virus from a bird or animal and was receiving care at a children's hospital, the province said in a statement. The province said it was investigating the source of exposure and identifying the teenager's contacts. The risk to the public remains low, Canada's Health Minister Mark Holland said in posting on X. "This is a rare event," British Columbia Health Officer Bonnie Henry said in a statement. "We are conducting a thorough investigation to fully understand the source of exposure here in B.C." H5 bird flu is widespread in wild birds worldwide and is causing outbreaks in poultry and US dairy cows, with several recent human cases in US dairy and poultry workers. There has been no evidence of person-to-person spread so far. But if that were to happen, a pandemic could unfold, scientists have said.

Armie Hammer's mom got him a vasectomy for his birthday. The Call Me by Your Name actor — who has two children, Harper, nine, and Ford, seven, with his ex-wife Elizabeth Chambers — has revealed the bizarre gift Dru Hammer got him for his 38th birthday in August. Speaking to his mom on the second episode of a two-part chat on his new podcast Armie HammerTime Podcast, she said: "Let's talk about what I gave you for your birthday this year." She continued: "I call Armie, and I go, 'What would you like for your birthday this year?' He was like, 'I don't know. Maybe money. Whatever.' And I was like, 'I believe I'm going to give you a vasectomy.'"

TORONTO — A teenager is in critical condition in a British Columbia children's hospital, sick with Canada's first presumptive human case of avian influenza. "This was a healthy teenager prior to this, so no underlying conditions," said provincial health officer Bonnie Henry in a news conference on Tuesday (Nov 12). "It just reminds us that in young people this is a virus that can progress and cause quite severe illness and the deterioration that I mentioned was quite rapid." British Columbia health officials said on Saturday the province had detected Canada's first human case of H5 bird flu in a teenager.

WASHINGTON — Donald Trump is expected to take a slew of executive actions on his first day as president to ramp up immigration enforcement and roll back signature Biden legal entry programs, a sweeping effort that will be led by incoming "border czar" Tom Homan and other Republican immigration hardliners, three sources familiar with the matter told Reuters. The executive actions would give federal immigration officers more latitude to arrest people with no criminal records, surge troops to the US-Mexico border and restart construction of the border wall, the sources said. Homan, who served as acting director of US Immigration and Customs Enforcement from 2017-2018 under Trump, will bring a deep understanding of the US immigration system after a four-decade career that took him from a frontline Border Patrol agent to head of the agency that arrests and deports immigrants in the US illegally.

Donald Trump has begun the process of choosing a cabinet and selecting other high-ranking administration officials following his presidential election victory. Here are the early picks and top contenders for some of the key posts overseeing defence, intelligence, diplomacy, trade, immigration and economic policymaking. Some are in contention for a range of posts. Susie Wiles, chief of staff Susie Wiles reacts as Republican presidential nominee and former US President Donald Trump speaks, following early results from the 2024 US presidential election in Palm Beach County Convention Center, in West Palm Beach, Florida, US on Nov 6, 2024. PHOTO: Reuters Trump announced last week that Wiles, one of his two campaign managers, will be his White House chief of staff.

SINGAPORE – The police are investigating deepfake nude photos of Singapore Sports School (SSP) students that were created and spread by other students. In response to queries from The Straits Times, school principal Ong Kim Soon said SSP is “aware of the incident involving the creation and sharing of deepfake photos by our student-athletes”. “The school does not condone such harmful behaviour,” he said, adding that it has launched an investigation and lodged a police report. The police, in response to queries from ST, confirmed that a report was lodged and investigations are ongoing. A reader who identified himself as a parent of a victim had alerted ST in an e-mail on Nov 12 about the deepfake nude images that were being circulated. “Many parents of affected female students in Singapore Sports School are making police reports about deepfake nude photos of their daughters generated by male students from the school,” the parent said. When contacted, the parent said that female teachers were also targeted, and that the school has offered affected students counselling.

As a group of friends circled a hearse, chants were heard. Then, they stopped and bowed to the portrait displayed at the front of the vehicle. This was not a typical Buddhist funeral, but rather the unconventional birthday celebration of a funeral director, reported Shin Min Daily News. According to the Chinese evening daily, a video circulating online showed the friends chanting a birthday song. The hearse's interior had been decorated with balloons and a birthday banner, with the man even laying inside for photos. The clip garnered criticism from netizens, with some deeming it overboard and disrespectful to the funeral industry. In an interview with Shin Min, director of Xin An Funeral Services Chen Weisong (transliteration) explained that he had celebrated his birthday at the company's premises with his friends and family last week. Halfway through the performances by singers, his employees and business partners had surprised him with the birthday-themed hearse bearing his portrait. Chen told 8world he was not angry and did not think it was taboo. "I was too embarrassed to turn down their gesture," he said. 

In July 2024, internet personality Bobby Saputra posted a video of himself living it up at what appeared to be the star-studded, ultra-lavish wedding of Radhika Merchant and Anant Ambani, the youngest child of Indian billionaire and Asia's richest man, Mukesh Ambani. The video featured clips of Saputra dancing, feasting and soaking up the "completely crazy" celebrations. He gushes in the voiceover: "It was like watching a Bollywood production." The video quickly went viral, racking up 6.6 million views on Instagram, 5.1 million on TikTok, and another 2.2 million on YouTube. Thousands left comments, including some celebrities who claimed they spotted him there. Except… he never set foot in the party. As it turns out, he had pieced together clips from a wedding he attended a few months prior — complete with him in full Indian attire, dancing with friends — and spliced in shots from the Ambani wedding that he found online. The result? Social media magic.

ISLAMABAD — The International Monetary Fund's Pakistan mission chief Nathan Porter on Tuesday (Nov 12) opened unusual talks with Pakistan over a US$7 billion (S$9.4 billion) bailout approved by its board in September, the finance ministry and sources said. The unscheduled visit of the IMF mission and talks beginning with meeting the country's finance team are too early for first review of the IMF's Extended Fund Facility (EFF), which is due in the first quarter of 2025. The chiefs of Pakistan's central bank and federal board of revenue also attended the meeting besides other officials from both the sides, the statement said. The ministry and the IMF have not officially released details of the visit. Sources in the finance ministry said the Nov 11-15 visit will discuss recent developments and programme performance to date, adding the mission was not part of the first review. The sources declined to be identified as they were not authorised to speak with the media. Pakistan has been struggling with boom-and-bust economic cycles for decades, leading to 23 IMF bailouts since 1958.

The average time spent on discussing a Bill dropped from 213 minutes in 2019 to 85 minutes in 2021

Elections in Karnataka have increasingly become bipolar, with 77% of the seats recording bipolar contests in 2018

Jun 10, 2022

This book is intended to advance the next phase of the U.S.-Colombia relationship. In a rapidly changing world, the following chapters present a roadmap for a new type of engagement that challenges our ambitions and extends the ties that bind our countries. 

Nov 17, 2022

The speakers included Yale Law School professor Harold H. Koh ’75, and Patrick W. Pearsall, Director of the International Claims and Reparations Project at Columbia Law School. Koh and Pearsall discussed their experiences representing Ukraine in legal proceedings against Russia before the International Court of Justice.

Nov 18, 2022

Former Colombian President Iván Duque discussed Latin America’s resurgent left wing and advocated for environmental action at the Harvard Kennedy School on Thursday afternoon.

Feb 20, 2023

U.S. President Joe Biden spent five hours in the Ukrainian capital on Monday, meeting President Volodymyr Zelensky and even taking a stroll through the streets of Kyiv – despite the sound of air sirens – to visit The Wall of Remembrance, which displays portraits of the approximately 4,500 Ukrainian soldiers who have died since Russia annexed Crimea in 2014.

The trip was kept under a media blackout until a few hours after Biden’s arrival, with the president’s official schedule only saying he would fly in the evening to Warsaw for a planned visit. The New York Times reported, quoting an anonymous official source, that Biden arrived in Kyiv early this morning after making the same 10-hour long journey from Poland that every world leader visiting Ukraine since the start of the war has.