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Labour minister sends ports dispute to binding arbitration, orders end to lockouts

Labour Minister Steven MacKinnon has sent labour disputes at ports in Quebec and British Columbia to binding arbitration and has ordered people back to work after the disputes reached what he called a "total impasse."




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App winning plenty of friends

A phone app that allows people to videochat in groups of up to eight has become a huge hit.




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Passengers in safe hands

Flying has never been safer for Australians on commercial aircraft, according to a new report from the ATSB.




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Life-saving defibs for sports grounds

MORE than 100 defibrillators will be placed in all sport venues in Blacktown making it the first council in the state to roll out the life-saving machines.




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SEC recommends marketing approval for Dr Reddy's SPMS drug Siponimod tablets

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




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SEC recommends approval for MSN Laboratories' sleep disorder drug

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




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The latest trends and challenges in sterilisation

James Hicks, healthcare application development and processing engineer at Syensqo explores the latest trends, challenges and solutions in sterilisation.




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Editors letter: current regulatory landscape

Olivia Friett, editor of Medical Plastics News takes a look at the current regulatory landscape.




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Surgical Holdings attends MEDICA 2024

Surgical Holdings, a British manufacturer and repairer of medical devices, will return to MEDICA 2024 for the third consecutive year, focused on strengthening its partnerships across Europe and expanding its reach in key markets.




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Rainwater Could Help Satisfy AI’s Water Demands

A few dozen ChatGPT queries cost a bottle’s worth of water. Tech firms should consider simpler solutions, such as harvesting rainwater, to meet AI’s needs




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Five Crucial Trends Facing U.S. Drug Wholesalers in 2024 and Beyond

As regular readers of Drug Channels know, U.S. distribution and dispensing channels for prescription drugs are undergoing significant evolution and consolidation as the changing economics of pharmaceuticals challenge conventional business models.

During this period of volatility, the core business model of the Big Three public pharmaceutical distribution companies—Cardinal Health, Cencora, and McKesson—remains intact. Put simply: Buy low, sell high, collect early, and pay late.

But as I explain below, wholesalers continue to position themselves as essential intermediaries by expanding their industry position and strengthening their economic fundamentals.

Read on for five key pricing, pharmacy, provider, and manufacturer trends that are driving the U.S. drug wholesaling industry.

For even more, check out DCI's new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, the fifteenth edition of our deep dive into wholesale distribution channels.Click here to download a free report overview (including key industry trends, the table of contents, and a list of exhibits)
Read more »
       




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What does the FDA do after drugs are approved? (15 seconds)

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).




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What does the FDA do after drugs are approved? (30 seconds)

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).




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What is FDA’s role in regulating drugs? (15 seconds)

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

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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What is FDA’s role in regulating drugs? (30 seconds)

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

The FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. But what is the FDA’s role when it comes to drug regulation? Learn more in this short video from FDA’s Center for Drug Evaluation and Research (CDER).




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How does the FDA approve new drugs? (15 seconds)

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).




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How does the FDA approve new drugs? (30 seconds)

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).




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EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz

<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>




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Risk of mortality drops in COVID-19 patients given anticoagulation within a day of hospital admission, research finds

Starting COVID-19 patients on prophylactic anticoagulation within 24 hours of being admitted to hospital has been linked to a reduced risk of mortality.




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Half of asthma patients in the UK overusing SABAs, study finds

More than half of patients with asthma in the UK are “potentially overusing” short-acting β2-agonists, according to research.




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Neuralink’s Blindsight Device Is Likely to Disappoint



Neuralink’s visual prosthesis Blindsight has been designated a breakthrough device by the U.S. Food and Drug Administration, which potentially sets the technology on a fast track to approval.

In confirming the news, an FDA spokesperson emphasized that the designation does not mean that Blindsight is yet considered safe or effective. Technologies in the program have potential to improve the current standard of care and are novel compared to what’s available on the market, but the devices still have to go through full clinical trials before seeking FDA approval.

Still, the announcement is a sign that Neuralink is moving closer to testing Blindsight in human patients. The company is recruiting people with vision loss for studies in the United States, Canada, and the United Kingdom.

Visual prostheses work by capturing visual information with a video camera, typically attached to glasses or a headset. Then a processor converts the data to an electrical signal that can be relayed to the nervous system. Retinal implants have been a common approach, with electrodes feeding the signal to nerves in the retina, at the back of the eye, from where it travels on to the brain. But Blindsight uses a brain implant to send the signal directly to neurons in the visual cortex.

In recent years, other companies developing artificial vision prosthetics have reached clinical research trials or beyond, only to struggle financially, leaving patients without support. Some of these technologies live on with new backing: Second Sight’s Orion cortical implant project is now in a clinical trial with Cortigent, and Pixium Vision’s Prima system is now owned by Science, with ex-Neuralink founder Max Hodak at the helm. No company has yet commercialized a visual prosthetic that uses a brain implant.

Elon Musk’s Claims About Blindsight

Very little information about Blindsight is publicly available. As of this writing, there is no official Blindsight page on the Neuralink website, and Neuralink did not respond to requests for comment. It’s also unclear how exactly Blindsight relates to a brain-computer interface that Neuralink has already implanted in two people with paralysis, who use their devices to control computer cursors.

Experts who spoke with IEEE Spectrum felt that, if judged against the strong claims made by Neuralink’s billionaire co-founder Elon Musk, Blindsight will almost certainly disappoint. However, some were still open to the possibility that Neuralink could successfully bring a device to market that can help people with vision loss, albeit with less dramatic effects on their sense of sight. While Musk’s personal fortune could help Blindsight weather difficulties that would end other projects, experts did not feel it was a guarantee of success.

After Neuralink announced on X (formerly Twitter) that Blindsight had received the breakthrough device designation, Musk wrote:

The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see.

Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.

To set expectations correctly, the vision will be at first be [sic] low resolution, like Atari graphics, but eventually it has the potential be [sic] better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge.

Musk included a picture of La Forge, a character from the science-fiction franchise Star Trek who wears a vision-enhancing visor.

Experts Puncture the Blindsight Hype

“[Musk] will build the best cortical implant we can build with current technology. It will not produce anything like normal vision. [Yet] it might produce vision that can transform the lives of blind people,” said Ione Fine, a computational neuroscientist at the University of Washington, who has written about the potential limitations of cortical implants, given the complexity of the human visual system. Fine previously worked for the company Second Sight.

A successful visual prosthetic might more realistically be thought of as assistive technology than a cure for blindness. “At best, we’re talking about something that’s augmentative to a cane and a guide dog; not something that replaces a cane and a guide dog,” said Philip Troyk, a biomedical engineer at the Illinois Institute of Technology.

Restoring natural vision is beyond the reach of today’s technology. But among Musks recent claims, Troyk says that a form of infrared sensing is plausible and has already been tested with one of his patients, who used it for help locating people within a room. That patient has a 400-electrode device implanted in the visual cortex as part of a collaborative research effort called the Intracortical Visual Prosthesis Project (ICVP). By comparison, Blindsight may have more than 1,000 electrodes, if it’s a similar device to Neuralink’s brain-computer interface.

Experts say they’d like more information about Neuralink’s visual prosthetic. “I’m leery about the fact that they are very superficial in their description of the devices,” said Gislin Dagnelie, a vision scientist at Johns Hopkins University who has been involved in multiple clinical trials for vision prosthetics, including a Second Sight retinal implant, and who is currently collaborating on the ICVP. “There’s no clear evaluation or pre-clinical work that has been published,” says Dagnelie. “It’s all based on: ‘Trust us, we’re Neuralink.’”

In the short term, too much hype could mislead clinical trial participants. It could also degrade interest in small but meaningful advancements in visual prosthetics. “Some of the [Neuralink] technology is exciting, and has potential,” said Troyk. “The way the messaging is being done detracts from that, potentially.”




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‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

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.




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J&J must pay $19m to man who says its talc caused his cancer, jury finds

Johnson & Johnson must pay US$15 million (S$19.6 million) to a Connecticut man who alleges that he developed mesothelioma, a rare form of cancer, as a result of using the company's talc powder for decades, a jury found on Tuesday (Oct 15). Plaintiff Evan Plotkin sued the company in 2021 soon after his diagnosis, saying he was sickened by inhaling J&J's baby powder. The jury in Fairfield County, Connecticut Superior Court also found that the company should pay additional punitive damages, which will be determined later by the judge overseeing the case. "Evan Plotkin and his trial team are thrilled that a jury once again decided to hold Johnson & Johnson accountable for their marketing and sale of a baby powder product that they knew contained asbestos," Ben Braly, a lawyer for Plotkin, said in an email. Erik Haas, J&J's worldwide vice president of litigation, said in a statement that the company would appeal "erroneous" rulings by the trial judge that kept the jury from hearing critical facts about the case.




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Iran's Hiding Behind Deadly Friends Should Have a Price

Assaf Zoran argues that it is crucial to hold Iran accountable and convey the cost associated with arming, training, financing, and promoting violence through proxies.




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114010: monitoring Pakistan's coalition support funds

Pending post verification are claims that total $279 million for the March-May 2007 period. The areas of greatest concern to us include costs for helicopter operations ($83 million annually), radar maintenance ($65 million annually) and Joint Staff operations ($5 million annually).








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Iran's New Best Friends

Mohammad Tabaar argues that the attacks on Red Sea ships unintentionally advance the Houthis agenda by allowing it to claim that it is fighting imperialism, and the attacks help Iran by fortifying its political foothold in the Middle East. Washington should therefore cease the strikes. It should, instead, work to halt the war in Gaza. The United States should also try to strengthen the region's diplomatic agreements and shore up its security framework. Otherwise, the Houthi-Iranian partnership will only grow stronger, as will Tehran's leverage in the region.




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The Iran-Russia Friendship Won't Wither Under Raisi's Successor

Nicole Grajewski describes former Iranian President Raisi’s hardline stance and his willingness to deepen ties with Russia as assets. Collaboration with a like-minded authoritarian with a bent for confronting the West proved particularly valuable after Russia invaded Ukraine.





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CrissCross Expands Representative Payee Services to Serve as a National Resource for Qualified Beneficiaries - CrissCross Representative Payee Services

CrissCross Representative Payee Services




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Survey Finds Gap Between Home Protection Concerns And Consumer Actions - Kristin Chenoweth Protect It Or Lose It Video

Kristin Chenoweth teamed up with Allstate to quiz homeowners on the value of the possessions in their home - see what they know, and don't know!




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Smart is Evolving: Efficient High-rise Changes Corporate Landscape with 'Urban Genius' Concept - Video OneTitle

Virtual tour of 350 Fifth, a new 20-story office building in one of the top-ranked U.S. cities for sustainable buildings. Pt. 1 Pittsburgh-Gateway to the World & 350 Fifth Urban Genius.




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Institutional investors' shifting allocation strategies are driving hedge funds towards new products - EY�s Natalie Deak on how hedge fund managers are pursuing growth

EY�s Natalie Deak on how hedge fund managers are pursuing growth






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Rules are Changing for Corporate Reputation Management, According to Sodexo 2015 Workplace Trends Report - 2015 Sodexo Workplace Trends Overview

2015 Sodexo Workplace Trends Overview





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AARP Unveils the 2016 Top 7 Travel Trends for Baby Boomers - AARP's Travel Ambassador Samantha Brown Unveils the 2016 Top Travel Trends for Baby Boomers

AARP's Travel Ambassador Samantha Brown Unveils the 2016 Top Travel Trends for Baby Boomers




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Barometer Promise - BNP Exane "Exclusivity & Desirability" 2015: The Wealthiest Chinese Women Rank Luxury Brands - Philippe Jourdan: Partner - Promise Consulting

Philippe Jourdan: Partner - Promise Consulting





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How To Use Disney Pixar Movies To Teach Kids About Friendship - Hide and Seek

Watch Arlo and Spot�s friendship grow in this heartwarming clip. THE GOOD DINOSAUR Available on Digital HD, Blu-ray and Disney Movies Anywhere today!




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End Brush Time Negotiations with Naturally Friendly Kids' Toothpastes from hello - hello ends negotiations

hello products are a solution to the struggle at the sink. This advertisement shows the frustrations moms and dads can face when it�s brush time and they need to negotiate with their kids to brush.




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Hennessy Ascends Higher, Ventures Deeper with New "Wild Rabbit" Advertising Creative - New Ad Creative, �The Piccards�

Hennessy V.S new ad creative celebrates the true story of Auguste Piccard, the first man to reach the stratosphere, and his son Jacques, the first man to reach the deepest depths of the ocean.




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Informe reciente resalta la necesidad de concentrarse más en que las familias planifiquen para estar preparadas - Waiting 30 Seconds Spanish

Waiting 30 Seconds Spanish




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The American Society For Aesthetic Plastic Surgery Reports Americans Spent More Than $12 Billion In 2014; Procedures For Men Up 43% Over Five Year Period - 2014 Plastic Surgery Trends

2014 Plastic Surgery Trends





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Amway Rallies Thousands to Raise Awareness of Malnutrition and Break GUINNESS WORLD RECORDS� Record Title - GUINNESS WORLD RECORDS�: Largest collage of cutout handprints

The Nutrilite� Power of 5 Campaign engaged over 260,000 people worldwide to �raise their hand� to fight childhood malnutrition and accomplished a GUINNESS WORLD RECORDS� title for Largest collage of cutout handprints.