The Portuguese midfielder is settling into life in east London well after his loan move.

Adam Peaty is right about Commonwealths not being the pinnacle

Peaty accused of disrespecting Games after roaring into 50m final

British Cycling ‘confident’ they can replace Kenny if she retires

Englishman Jake Jarman wins fourth gymnastics gold medal

Daily Games schedule – plus key events to watch out for

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NASA discovered the cause of a pulsating noise coming from a speaker on the Boeing Starliner spacecraft after astronaut Butch Wilmore reported the sound.

A chemical produced by gut bacteria could be the basis for a non-invasive test for endometriosis – and mouse experiments suggest it might also help treat the condition

Cases of prostate cancer are surging alarmingly around the world. Thankfully, we are developing more accurate tests that can catch the condition early

Rats perform better on memory tests when certain brainwave-producing neurons are stimulated while they sleep. If we can boost these brainwaves in people, it could help treat memory impairments in those with dementia

A teenager who tested positive for avian flu is in critical condition with acute respiratory distress according to Provincial Health Officer Dr. Bonnie Henry.

A man who authorities said was upset over his divorce settlement rammed his car into a crowd of people exercising at a sports complex in southern China, police said.

Private ownership, consumer choice, and competition would deliver better benefits to veterans — and force policy-makers to confront the costs of military engagements.

Amazon is reportedly developing smart glasses for its delivery drivers, according to sources who spoke to Reuters. These glasses are intended to cut “seconds” from each delivery because, well, productivity or whatever. Sources say that they are an extension of the pre-existing Echo Frames smart glasses and are known by the internal code Amelia.

These seconds will be shaved off in a couple of ways. First of all, the glasses reportedly include an embedded display to guide delivery drivers around and within buildings. They will allegedly also provide drivers with “turn-by-turn navigation” instructions while driving. Finally, wearing AR glasses means that drivers won’t have to carry a handheld GPS device. You know what that means. They’ll be able to carry more packages at once. It’s a real mitzvah.

I’m being snarky, and for good reason, but there could be some actual benefit here. I’ve been a delivery driver before and often the biggest time-sink is wandering around labyrinthine building complexes like a lost puppy. I wouldn’t have minded a device that told me where the elevator was. However, I would not have liked being forced to wear cumbersome AR glasses to make that happen.

To that end, the sources tell Reuters that this project is not an absolute certainty. The glasses could be shelved if they don’t live up to the initial promise or if they’re too expensive to manufacture. Even if things go smoothly, it’ll likely be years before Amazon drivers are mandated to wear the glasses. The company is reportedly having trouble integrating a battery that can last a full eight-hour shift and settling on a design that doesn’t cause fatigue during use. There’s also the matter of collecting all of that building and neighborhood data, which is no small feat.

Amazon told Reuters that it is “continuously innovating to create an even safer and better delivery experience for drivers” but refused to comment on the existence of these AR glasses. "We otherwise don’t comment on our product roadmap,” a spokesperson said.

The Echo Frames have turned out to be a pretty big misfire for Amazon. The same report indicates that the company has sold only 10,000 units since the third-gen glasses came out last year.

This article originally appeared on Engadget at https://www.engadget.com/big-tech/amazon-reportedly-wants-drivers-to-wear-ar-glasses-for-improved-efficiency-until-robots-can-take-over-174910167.html?src=rss

London, UK (SPX) Nov 13, 2024
Mangrove forests in the Maldives are facing a severe threat as they succumb to rising sea levels and climate changes, according to a new study led by Northumbria University researchers and published in *Scientific Reports*. The study highlights that the Maldives, known for its low-lying islands, experienced significant mangrove dieback since 2020 due to rapid sea-level rise and the effects

The Subject Expert Committee (SEC), which advises the national drug regulator on approval of new drugs and clinical trials, has recommended grant of market authorisation for Dr Reddy's Laboratories' Siponimod

The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinical trials, has recommended grant of market authorisation for

The Indian pharmaceutical industry is advocating for enhanced fire safety measures and improved insurance coverage for employees working in pharmaceutical facilities.

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.

Regulatory experts LFH Regulatory have announced their attendance at MEDICA 2024 to provide insights and support to healthcare innovators facing the complexities of the UK and EU markets.

A science photo book probes the colors we can see—and even “forbidden” colors we can’t

Researchers at the National University of Singapore have developed a magneto-responsive hydrogel wound dressing that also contains two different regenerative cell types. The hydrogel is also embedded with magnetic particles that can be stimulated using an external magnetic field. The action of the magnetic field on the gel-encapsulated particles causes mechanical stresses within the gel […]

A team at the University of Technology Sydney has developed an assistive technology for blind people and those with low vision. The system consists of glasses that can view their surroundings through an on-board camera, appraise the objects nearby using computer vision technology, and then play a sound that provides a cue for the wearer […]

Today’s guest post comes from Timothy Nielsen, Vice President of Customer Success at AssistRx.

Timothy discusses the affordability and patient journey challenges of specialty-lite products for patients, manufacturers, and health care providers. He explains how AssistRx's Advanced Access Anywhere (AAA) solution streamlines processes for specialty-lite products and facilitates enrollment via a digital hub.

To learn more, register for AssistRx's free webinar on October 8: Meet Your Patients Where They Are & Gain Visibility: Even at Retail.

Read on for Timothy’s insights.
Read more »

Today’s guest post comes from Shabbir Ahmed, Chief Commercial Officer at CareMetx.

Shabbir explains the barriers that providers face when dealing with branded portals for multiple products. He then maintains that patients can access new therapies more quickly when the manufacturer relies on a brand-agnostic hub connected to a large network of providers and integrated with the systems those providers use daily.

To learn more, download CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for Shabbir’s insights.
Read more »

Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats:

• Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy

• Vampiric! Prior authorization sinks its fangs into providers’ time

• Wicked! How the IRA will put a stake through specialty physician practices

• Eerie! Google’s monstrous AI podcasts leave me petrified

• Zoinks! Join the vampire hunters at Drug Channels Institute

Plus, Dr. Glaucomflecken tells us a frightening tale of copayments.

P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community.
Read more »

Today’s guest post comes from Kimberley Chiang, Vice President of Biopharma Commercial Solutions at CoverMyMeds

Kimberley highlghts the crucial roles of field reimbursement managers in removing access and reimbursement barriers. She then identifies the keys to successful implementation of field reimbursement services.

To learn more, register for CoverMyMeds' November 13, 2024, webinar: Specialty Therapies & Field Reimbursement Services: Driving Better Outcomes for Brands and Patients.

Read on for Kimberley’s insights.
Read more »

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

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

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

What happens after a drug is approved? And how and why do drug recalls happen? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

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

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

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

Prescription drugs go through many steps and phases before they’re approved by the FDA, from research to clinical trials. What does this process look like from beginning to end? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).

<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>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>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>

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

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:

This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:

My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?

That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:

What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?

This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs

Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS

are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:

What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?

This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.

• Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
• Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 

But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.

This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]

Participant reported relief from chronic low back pain and reduced need for pain-relief medications.

Industri slot online terus mekar dan mengukir epik baru dalam dunia judi online. Tahun 2024 menjadi saksi bagi loncatan tinggi dalam inovasi dan hiburan, terutama dari para provider terkemuka yang…

The post Nama-Nama Provider Slot Online Terbaik 2024 appeared first on Biosimilarnews.

Seolah-olah melintasi portal waktu, kita memasuki tahun 2024 dengan deretan provider judi slot online yang tidak hanya menemani, tetapi juga menggoda imajinasi. Setiap klik, setiap putaran gulungan, membuka lembaran baru…

The post Provider Judi Slot Gacor Online Terbaik serta Populer di Tahun 2024 appeared first on Biosimilarnews.

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.

By fostering collaboration and seamless data integration into healthcare systems, the industry is laying the groundwork for a future in which “personalized medicine” is so commonplace within clinical practice that we will just start calling it “medicine.”

The post Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence appeared first on MedCity News.

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.

Whitney Haggerson — vice president of health equity and Medicaid at Providence — discussed the significance of her role, as well as how her health system is working to give all employees, regardless of title, the skills needed to help reduce health inequities.

The post Inside Providence’s Health Equity & Medicaid Strategy appeared first on MedCity News.

In 2018, opioid overdoses in the United States caused one death every 11 minutes, resulting in nearly 47,000 fatalities. The most effective treatments for opioid use disorder (OUD) are three medications approved by the Food and Drug Administration (FDA): methadone, buprenorphine, and naltrexone.

In vitro diagnostics (IVDs) play an indispensable role in modern medicine. Health care providers routinely rely on these tests—which analyze samples such as blood or saliva—to help diagnose conditions and guide potentially life-altering treatment decisions. In 2017, for example, clinicians ordered blood tests during about 45% of emergency room visits in the United States, according to the Centers...

The United States is grappling with two severe health crises: the COVID-19 pandemic and an opioid epidemic that appears to be worsening as more people deal with stress and isolation as they face increased barriers to medical care. Preliminary numbers for 2020 show that overdose deaths were outpacing the record-setting number of more than 71,000 fatalities in 2019.

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

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. 

Feb 28, 2023

Policymakers need to act now and place child welfare professionals, not law enforcement actors, at the border to effectively screen and interview migrant children. Information sharing practices need to be improved, with a movement away from paper documents that can easily get lost to an approach that is digital, secure, and accessible by the child, their guardian, their lawyer, and their doctor. Further, the enforcement processing facilities need to undergo an immediate infrastructural transformation with the addition of new design features that are necessary and sensitive to the majority demographic that are held within facilities—children and families.

These actions are doable and require no legislative action. Migrant children deserve decisive action to ensure that their health, safety, and well-being is not jeopardized as they seek refuge in the United States.