HoYoverse has begun pre-installation for the major Genshin Impact (Free) version 5.0 “Flowers Resplendent on the Sun-Scorched Sojourn" update for …

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Following pre-installation going live earlier in the week, HoYoverse has just released the major Genshin Impact (Free) version 5.0 “Flowers …

Continue reading "‘Genshin Impact’ Version 5.0 Update Is Now Available Worldwide on iOS, Android, PC, PS5, and More"

Hello everyone, and welcome to the week! It’s time once again for our look back at the noteworthy updates of …

Continue reading "Best iPhone Game Updates: ‘Peglin’, ‘Brawl Stars’, ‘Genshin Impact’, ‘Royal Match’, and More"

Can’t do global work if the White House is forcing sale of US business, Mayer said.

As-yet unnamed “NewCo” will handle IBM’s “managed infrastructure services.”

Libra and Capricorn compatibility blends charm and ambition. Discover how this air-earth duo balances romance and practicality in love, friendship, and relationships.

Discover if Cancer and Aquarius can make a love match! Learn about their compatibility, strengths, challenges, and what to expect in a relationship.

Discover the compatibility between Libra and Aquarius in love, friendship, and more. Explore their strengths, challenges, and what makes this zodiac pairing unique.

Media figures making that claim are blaming everyone but the bad candidate herself.

THE soap opera continues for SurfStitch as the surfwear brand sheds 40 jobs in a bid to return to profit.

Via Rail's service standards have eroded substantially over the last decade, with many more trains arriving late.

The union representing Canada Post workers said it will be in a legal strike position on Friday, exactly one year after talks on a new contract began. But the union is holding back on deciding whether a job action will take place immediately.

The Embassy of India in Iraq has extended an invitation to Indian businesses to participate in the "Medico Expo," officially known as the Erbil International Health Exhibition. This prestigious event, set to be the

WITTMANN BATTENFELD will present the latest solutions for time and cost optimisation in the production of parts with nano structures at Compamed, booth No. F03-1 in hall 8b.

Ampacet has introduced ProVital+ Gamma-Protect, a medical-grade additive designed to preserve mechanical and optical properties of polypropylene-based medical and pharmaceutical articles during gamma and e-beam sterilisation processes.

Accumold, with over 40 years of experience in micromoulding technology, is set to participate at Compamed, taking place in Düsseldorf, Germany, from 11-14 November. The company will highlight its small and complex parts for medical device OEMs.

Syensqo, previously part of Solvay Group and a global provider of advanced performance materials and chemical solutions, is making its debut at Compamed 2024.

Trelleborg Medical Solutions showcases its comprehensive polymer-based solutions and capabilities for the medical technology and biopharmaceutical industries at Compamed 2024 in Dusseldorf from November 11 to 14, at stand F02 in hall 8A.

Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx.

Chris examines three key trends that will affect patient support programs: the Inflation Reduction Act (IRA), legal/regulatory battles over copay adjustment programs, and uncertainties following a national election. He then outlines three actions that should guide manufacturers' preparation.

To learn more, register for ConnectiveRx’s free webinar on December 11: The Perfect Storm? Patient Support Programming in 2025 and Beyond.

Read on for Chris’s insights.
Read more »

“The Hill” newspaper recently reported that: “a survey of federal budgets devoted to developing and enforcing regulations found that many agencies will spend more in 2013 and 2014 than in previous years, indicating that the writing and enforcing of new regulations is largely unimpeded by the massive cuts, known as sequestration.” That certainly sounds authoritative…until you look at the analysis. In fact, the report’s authors appear to know nothing about the federal budget and have used inherently unreliable data in calculating FY 13 and FY 14 spending levels. One can only hope that the authors—allegedly academic experts--know more about regulatory policy than they do about federal budgets.

A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

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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.

Many companies are entering the digital youth mental health space, but it’s important to know which ones are effective, according to a panel of investors at the Behavioral Health Tech conference.

The post Measuring Impact in Digital Youth Mental Health: What Investors Look For appeared first on MedCity News.

The upcoming U.S. presidential election is stirring discussions around healthcare, especially the cost of prescription drugs and the […]

The post Impact of Trump and Harris on Prescription Drug Pricing appeared first on World of DTC Marketing.

With Trump’s victory, healthcare and the pharmaceutical industry could shift significantly. Based on Trump’s first-term policies, his administration […]

The post Impact of Trump on Drug Pricing Policies appeared first on World of DTC Marketing.

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

The post Why Biotech Companies Fail: Lessons for CEOs appeared first on World of DTC Marketing.

LONDON — The world's biggest food and beverage companies on average sell products in low-income countries that are less healthy than what they sell in high-income countries, according to a new report. Products sold by companies including Nestle, Pepsico and Unilever were assessed as part of a global index published by the Access to Nutrition Initiative (ATNI), its first since 2021. The non-profit group found that across 30 companies, the products sold in low-income countries scored lower on a star rating system developed in Australia and New Zealand than those sold in high-income countries. In the Health Star Rating system, products are ranked out of five on their healthiness, with five the best, and a score above 3.5 considered to be a healthier choice.

Pakistan concern that freedom of expression be balanced with respect for religion as "we are not as advanced as you are" in terms of respect for freedom of religion and could not always control the reactions of sometimes ignorant crowds.

Aug 12, 2022

Companies that rely on certain countries in Asia for their supply lines will face continued challenges as geopolitical stresses, let alone global pandemics, cause supply shortages. Beyond causing economic harm, these shortages pose a direct threat to U.S. national security interests.

Apr 5, 2024

6 months on: What is the impact of the war in Gaza?
Brookings experts reflect on the conflict

Apr 15, 2024

Brookings scholars offer their insights following Iran’s drone and missile attack against Israel on April 13, 2024. Their responses provide perspectives on the implications for various actors as well as a range of policy issues.

Mar 28, 2024

On March 26, the study group met for the first time to examine recent democratic progress and backsliding in African countries. The session focused on ongoing conflicts in different regions of Africa and examined their political underpinnings. Participants also discussed the role of third-party actors in supporting and facilitating conflict mediation and peacebuilding efforts in the continent. The study group counted with the presence of external expert guest Dr. Antje Herrberg, Chief of Staff of the European Union Capacity Building Mission in Niger (EUCAP Sahel Niger). Dr. Herrberg brings more than two decades of professional and personal experience in transition and conflict resolution, intractable conflict, and terrorism with a deep interest to alleviate the suffering of people. Furthermore, Florian Dirmayer, Master in Public Policy Candidate at Harvard Kennedy School, delivered a memo briefing on European Union Security Cooperation with Niger After the 2023 Military Coup.

Apr 17, 2024

Mariana Budjeryn presents "Russia's Invasion of Ukraine and Its Impact on the Global Nuclear Order" at the DOE/NNSA Administrator's Strategy Forum

Apr 8, 2024

Behavioral economist Hunt Allcott, Professor of Global Environmental Policy at the Doerr School of Sustainability at Stanford University, questioned the impact of new and used electric vehicle (EV) subsidies in the latest episode of “Environmental Insights: Discussions on Policy and Practice from the Harvard Environmental Economics Program.”

May 8, 2024

Electric vehicles (EVs) can challenge or support electricity systems depending on how they are charged. Controlled charging that combines technical solutions with heterogenous EV user behaviors can reduce peak demand to avoid grid constraints and support the integration of renewable energy.

The Bank

Growth Unlocked: Closing the Strategy-to-Execution Gap

UBS launches global brand campaign (1)

The Investor Desk - Featured Company - US Highland - UHLN

Barclaycard Travel Community presents the #IHAVEARRIVED contest. Sign up and tell us your most memorable travel story for a chance to win an unforgettable vacation experience!

CEPSA's logo installation

Farmers Insurance "We Know From Experience" Ad Campaign Spot

Lee and Lucille Allen share the story of how their Clayton Home changed their lives.

Crystal Lagoons Corporate Video

With the support of mentor Orbi Rosario, Hannah Strope overcame financial and family instability to become the first in her family to graduate high school. She is currently a college student.