Schultz Medical, a single use instrument company based in Southport, Merseyside have announced they will be exhibiting at MEDICA 2024 in Germany and on the UK Pavilion in Hall 15 hosted by Medilink UK.

Mike Hodgin, director of strategic applications, Meridian Electronics Division discusses enabling and protecting vital medical implants with epoxies.

In this episode of The FemTech series Olivia Friett is joined by Jane Kennedy and Dr. MaryAnn Ferreux where we will discuss the inequality in women's health and how we can overcome the obstacles that come with this.

A review of 47,282 tree species by the International Union for Conservation of Nature found that more than one third are at risk of extinction

Scientific American staff and sleep experts share advice on how to get better sleep in the stressful days leading up to the U.S. presidential election—and those that come after

When chemist Dora Richardson’s employer decided to terminate the breast cancer research on the drug Tamoxifen in the early 1970s, she and her colleagues continued the work in secret.

Humans and pigs could both serve as mixing vessels for a bird flu–seasonal flu hybrid, posing a risk of wider spread

People are really stressed about the U.S. presidential election. A psychiatrist offers several self-help methods to reduce feelings of despair

Analysis of a strain of the virus circulating in Central Africa shows genetic mutations indicative of sustained human-to-human spread

A galaxy cluster bends light from seven background galaxies around it, letting astronomers peer into space and time

This year won’t just be the hottest on record—it could be the first to surpass 1.5 degrees Celsius. The Paris climate accord aims to keep warming below that level when looking over multiple years

The 3.2-million-year-old human ancestor known as Lucy rose to fame through an incredible combination of circumstances

Two years of experimentation taught a Nashville guitarist not every musical myth makes sense

Autumn is here! Curl up with your favorite pumpkin-spiced blog and savor these acorns that we’ve squirrelled away for you:

• Johnson & Johnson Innovative Medicines gives a peek inside its $43 billion gross-to-net bubble

• Optum Rx joins the private label biosimilar bandwagon

• Biosimilars boom for provider-administered drugs

• Fresh evidence of how copay accumulators hurt patients

Plus, words of wisdom from Cencora's soon-to-be-former CEO Steve Collis.

P.S. Join my more than 58,000 LinkedIn followers for daily links to neat stuff along with thoughtful and provocative commentary from the DCI community.

There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

Read more »

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
Read more »

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

Catherine Dasenbrock, director of the U.S. Food and Drug Administration’s National Forensic Chemistry Center, speaks to guests prior to officially reopening the center during a ribbon-cutting ceremony, Sept. 24, 2024, celebrating the completion of the 64,000-square-foot expansion and renovation of the facility in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

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

U.S. Food and Drug Administration officials and General Services Administration leaders officially reopen the National Forensic Chemistry Center during a ribbon-cutting ceremony, Sept. 24, 2024, highlighting the completion of the 64,000-square-foot expansion and renovation of the center in Cincinnati, Ohio. The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

(From left)
Marie Maguire, Assistant Special Agent in Charge, Headquarters Operations, Office of Criminal Investigations, FDA
James Sigg, Deputy Commissioner for Operations and Chief Operating Officer, Office of the Commissioner, FDA
Catherine Dasenbrock, Director, National Forensic Chemistry Center, Office of Inspections and Investigations (OII), FDA
Duane Satzger, Associate Director, Office of Medical Products and Specialty Laboratory Operations, OII, FDA
Katy Kale, Deputy Administrator, GSA
Douglas Stearn, Principal Deputy Associate Commissioner, OII, FDA

FDA photo by Matthew MacRoberts

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

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

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

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

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

Scientists explain the work they do to guests attending a ribbon-cutting ceremony celebrating the completion of a 64,000-square-foot expansion and renovation of the U.S. Food and Drug Administration’s National Forensic Chemistry Center in Cincinnati, Ohio, Sept. 24, 2024.

The NFCC is a specialty laboratory that serves as the FDA’s national forensic laboratory providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration/contamination, counterfeiting, and product tampering of FDA regulated commodities including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices.

FDA photo by Matthew MacRoberts

The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact. Amidst the celebrations, a reporter asked me a provocative question: can we afford more orphan drugs costing hundreds of thousands of dollars per year? FDA Matters answered “yes.” However, I added a caveat that should worry everyone eager for orphan drugs to succeed. When genomics and personalized medicine become successful, this will multiply the number of rare diseases and the overall cost of orphan drugs, perhaps beyond what the system can bear.

<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 Royal Pharmaceutical Society and the British Pharmaceutical Students’ Association have called for all overseas candidates to sit the March 2021 registration assessment in their home countries.

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.

Around half of Wales’ community pharmacies have expressed interest to health boards in providing COVID-19 vaccinations as part of the national programme.

By Mike Cloonan, CEO of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC An insightful piece on this blog following the JPM healthcare conference noted the “refreshing burst of enthusiasm” in the biotech sector. It’s true

The post Lessons From A Private Funding Round: Science, Relationships, And Experience appeared first on LifeSciVC.

By Ankit Mahadevia, former CEO of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC Drug development is complex. So is running a business. Sometimes, the work of doing both can make your head spin. In my

The post Boiling It Down: Conveying Complexity For Decision-makers appeared first on LifeSciVC.

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC In an industry where boom and bust cycles occur regularly and 90 percent of drug candidates fail to reach the market, an outstanding

The post Reflections On My Experience As A Board Member appeared first on LifeSciVC.

By Jonathan Montagu, CEO of HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC HotSpot’s trip to Barcelona for the recent European Society of Medical Oncology (ESMO) Annual Meeting was no ‘European Vacation,’ but it was certainly

The post ESMO Reflections: Glimmers of Hope with the Next Wave of I-O Therapies? appeared first on LifeSciVC.

Maybe those pesky sites are good for something after all. 

It's been six years since Pfizer boldly announced the launch of its "clinical trial in a box". The REMOTE trial was designed to be entirely online, and involved no research sites: study information and consent was delivered via the web, and medications and diaries were shipped directly to patients' homes.

Despite the initial fanfare, within a month REMOTE's registration on ClinicalTrials.gov was quietly reduced from 600 to 283. The smaller trial ended not with a bang but a whimper, having randomized only 18 patients in over a year of recruiting.

Still, the allure of direct to patient clinical trials remains strong, due to a confluence of two factors. First, a frenzy of interest in running "patient centric clinical trials". Sponsors are scrambling to show they are doing something – anything – to show they have shifted to a patient-centered mindset. We cannot seem to agree what this means (as a great illustration of this, a recent article in Forbes on "How Patients Are Changing Clinical Trials" contained no specific examples of actual trials that had been changed by patients), but running a trial that directly engages patients wherever they are seems like it could work.

The less-openly-discussed other factor leading to interest in these DIY trials is sponsors' continuing willingness to heap almost all of the blame for slow-moving studies onto their research sites. If it’s all the sites’ fault – the reasoning goes – then cutting them out of the process should result in trials that are both faster and cheaper. (There are reasons to be skeptical about this, as I have discussed in the past, but the desire to drop all those pesky sites is palpable.)

However, while a few proof-of-concept studies have been done, there really doesn't seem to have been another trial to attempt a full-blown direct-to-patient clinical trial. Other pilots have been more successful, but had fairly lightweight protocols. For all its problems, REMOTE was a seriously ambitious project that attempted to package a full-blown interventional clinical trial, not an observational study.

In this context, it's great to see published results of the TAPIR Trial in vasculitis, which as far as I can tell is the first real attempt to run a DIY trial of a similar magnitude to REMOTE.

TAPIR was actually two parallel trials, identical in every respect except for their sites: one trial used a traditional group of 8 sites, while the other was virtual and recruited patients from anywhere in the country. So this was a real-time, head-to-head assessment of site performance.

And the results after a full two years of active enrollment?

• Traditional sites: 49 enrolled
• Patient centric: 10 enrolled

Even though we’re six years later, and online/mobile communications are even more ubiquitous, we still see the exact same struggle to enroll patients.

Maybe it’s time to stop blaming the sites? To be fair, they didn’t exactly set the world on fire – and I’m guessing the total cost of activating the 8 sites significantly exceeded the costs of setting up the virtual recruitment and patient logistics. But still, the site-less, “patient centric” approach once again came up astonishingly short.
Krischer J, Cronholm PF, Burroughs C, McAlear CA, Borchin R, Easley E, Davis T, Kullman J, Carette S, Khalidi N, Koening C, Langford CA, Monach P, Moreland L, Pagnoux C, Specks U, Sreih AG, Ytterberg S, Merkel PA, & Vasculitis Clinical Research Consortium. (2017). Experience With Direct-to-Patient Recruitment for Enrollment Into a Clinical Trial in a Rare Disease: A Web-Based Study. Journal of medical Internet research, 19 (2) PMID: 28246067

Your daily light exposure impacts your health. A new study finds that too much light at night and not enough natural light during the day can be harmful. This story first aired on Morning Edition on Nov. 4, 2024.

Mesin slot sering kali memiliki istilah maxwin yang mengacu pada jumlah tertinggi yang bisa dimenangkan seorang pemain dalam permainan. Maxwins dalam slot biasanya dikaitkan dengan kombinasi simbol tertentu yang, jika…

The post Cara Melihat Maxwin Saat Bermain Slot appeared first on Biosimilarnews.

Keuntungan besar dan kegembiraan yang ditawarkan oleh mesin slot online membuatnya semakin populer. Namun, dalam lautan situs slot yang ada, bagaimana Anda bisa menemukan situs slot terbaik yang dapat memberikan…

The post Link Daftar Situs Slot Gacor Gampang Menang Maxwin Terpercaya Hari Ini appeared first on Biosimilarnews.

A Barcelona-based startup called Inbrain Neuroelectronics has produced a novel brain implant made of graphene and is gearing up for its first in-human test this summer.

The technology is a type of brain-computer interface. BCIs have garnered interest because they record signals from the brain and transmit them to a computer for analysis. They have been used for medical diagnostics, as communication devices for people who can’t speak, and to control external equipment, including robotic limbs. But Inbrain intends to transform its BCI technology into a therapeutic tool for patients with neurological issues such as Parkinson’s disease.

Because Inbrain’s chip is made of graphene, the neural interface has some interesting properties, including the ability to be used to both record from and stimulate the brain. That bidirectionality comes from addressing a key problem with the metallic chips typically used in BCI technology: Faradaic reactions. Faradaic reactions are a particular type of electrochemical processes that occurs between a metal electrode and an electrolyte solution. As it so happens, neural tissue is largely composed of aqueous electrolytes. Over time, these Faradaic reactions reduce the effectiveness of the metallic chips.

That’s why Inbrain replaced the metals typically used in such chips with graphene, a material with great electrical conductivity. “Metals have Faraday reactions that actually make all the electrons interact with each other, degrading their effectiveness...for transmitting signals back to the brain,” said Carolina Aguilar, CEO and cofounder of Inbrain.

Because graphene is essentially carbon and not a metal, Aguilar says the chip can inject 200 times as much charge without creating a Faradic reaction. As a result, the material is stable over the millions of pulses of stimulation required of a therapeutic tool. While Inbrain is not yet testing the chip for brain stimulation, the company expects to reach that goal in due time.

The graphene-based chip is produced on a wafer using traditional semiconductor technology, according to Aguilar. At clean-room facilities, Inbrain fabricates a 10-micrometer-thick chip. The chip consists of what Aguilar terms “graphene dots” (not to be confused with graphene quantum dots) that range in size from 25 to 300 micrometers. “This micrometer scale allows us to get that unique resolution on the decoding of the signals from the brain, and also provides us with the micrometric stimulation or modulation of the brain,” added Aguilar.

Testing the Graphene-Based BCI

The first test of the platform in a human patient will soon be performed at the University of Manchester, in England, where it will serve as an interface during the resection of a brain tumor. When resecting a tumor, surgeons must ensure that they don’t damage areas like the brain’s language centers so the patient isn’t impaired after the surgery. “The chip is positioned during the tumor resection so that it can read, at a very high resolution, the signals that tell the surgeon where there is a tumor and where there is not a tumor,” says Aguilar. That should enable the surgeons to extract the tumor with micrometric precision while preserving functional areas like speech and cognition.

Aguilar added, “We have taken this approach for our first human test because it is a very reliable and quick path to prove the safety of graphene, but also demonstrate the potential of what it can do in comparison to metal technology that is used today.”

Aguilar stresses that the Inbrain team has already tested the graphene-based chip’s biocompatibility. “We have been working for the last three years in biocompatibility through various safety studies in large animals,” said Aguilar. “So now we can have these green lights to prove an additional level of safety with humans.”

While this test of the chip at Manchester is aimed at aiding in brain tumor surgery, the same technology could eventually be used to help Parkinson’s patients. Toward this aim, Inbrain’s system was granted Breakthrough Device Designation last September from the U.S. Food & Drug Administration as an adjunctive therapy for treating Parkinson’s disease. “For Parkinson’s treatment, we have been working on different preclinical studies that have shown reasonable proof of superiority versus current commercial technology in the [reduction] of Parkinson’s disease symptoms,” said Aguilar.

For treating Parkinson’s, Inbrain’s chip connects with the nigrostriatal pathway in the brain that is critical for movements. The chip will first decode the intention message from the brain that triggers a step or the lifting of the arm—something that a typical BCI can do. But Inbrain’s chip, with its micrometric precision, can also decode pathological biomarkers related to Parkinson’s symptoms, such as tremors, rigidity, and freezing of the gait.

By determining these biomarkers with great precision, Inbrain’s technology can determine how well a patient’s current drug regimen is working. In this first iteration of the Inbrain chip, it doesn’t treat the symptoms of Parkinson’s directly, but instead makes it possible to better target and reduce the amount of drugs that are used in treatment.

“Parkinson’s patients take huge amounts of drugs that have to be changed over time just to keep up with the growing resistance patients develop to the power of the drug,” said Aguilar. “We can reduce it at least 50 percent and hopefully in the future more as our devices become precise.”

Mental health experts are hopeful about the de-stigmatization of behavioral health, the promise of AI and other areas, they shared at a recent conference.

The post 4 Areas Within Mental Health Care that Give Executives Hope appeared first on MedCity News.

Value-based care contracting is especially difficult for behavioral health providers, Taft Parsons III, chief psychiatric officer at CVS Health/Aetna, pointed out during a conference this week.

The post CVS Health Exec: Payers Need to Stop Making Behavioral Health Providers Jump Through Hoops In Order to Participate in Value-Based Care appeared first on MedCity News.

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference.

The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.

AbbVie schizophrenia drug candidate emraclidine failed to beat a placebo in two Phase 2 clinical trials. The drug, once projected to compete with Bristol Myers Squibb’s Cobenfy, is from AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics.

The post AbbVie Drug Expected to Rival Bristol Myers’s New Schizophrenia Med Flunks Phase 2 Test appeared first on MedCity News.

Fort Health’s $5.5 million in funding was led by Twelve Below and Vanterra and included participation from Redesign Health, Blue Venture Fund and True Wealth Ventures.

The post Fort Health Secures $5.5M to Expand Access to Integrated Pediatric Mental Health Care appeared first on MedCity News.

As winter arrives and daylight hours decrease, it gets easier to hit the snooze button and stay in bed. It turns out that there’s a scientific reason behind this phenomenon that helps to explain why people struggle to adjust their internal clocks—also known as circadian rhythm or sleep-wake cycle—when the weather turns colder.

Few correctional facilities in the United States have treatment programs for individuals with opioid use disorder (OUD), despite clear evidence that certain medications reduce the risk of overdose and death. Even in facilities where treatment is available, the COVID-19 pandemic has complicated efforts to provide such care.

The Pew Charitable Trusts sent comments Jan. 4 to the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) urging them to support the easy exchange of individuals’ health records through a pair of regulations.

Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD.

As the coronavirus pandemic grips the world, the opioid epidemic continues to affect millions of Americans. Several states are developing innovative ways to tackle this public health issue. In this episode, we speak with Beth Connolly, who leads Pew’s research on substance use disorders, and Louisiana Representative Paula Davis, who helped ensure effective treatment in her state.

Technology has revolutionized the way people live their lives. Individuals can use smartphones to access their bank account, shop from almost any store, and connect with friends and family around the globe. In fact, these personal devices have tethered communities together during the coronavirus pandemic, allowing many people to maintain much of their lives remotely.

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading

This paper provides recommendations for circumventing memory problems and reducing execution times for your mixed-modeling analyses, as well as showing the new HPMIXED procedure can be beneficial for certain situations, as with large sparse mixed models.

This paper provides a high-level tour of five modern approaches to model building that are available in recent releases of SAS/STAT.

This paper provides an example that shows you how to use multiple RANDOM statements in PROC NLMIXED to fit nested nonlinear mixed models, and it provides details about the computation that is involved in fitting these models.

David Duchovny and Gillian Anderson didn't speak to each other for "weeks at a time" when they worked on The X Files. The 64-year-old actor and Gillian, 56, enjoyed huge success with the iconic sci-fi series — but the duo actually had a turbulent relationship for many years. David said on the Fail Better podcast: "There was a long time, working on the show, where we were just not even dealing with one another off-camera. And there was a lot of tension. Which didn't matter, apparently, for the work cause we're both f****** crazy, I guess. We could just go out there and do what we needed to do." Gillian was amazed that they achieved so much success while their off-screen relationship was so tense.