ies David Jason decries lack of TV roles for older stars By www.independent.co.uk Published On :: 2024-11-12T10:08:10+00:00 Jason, 84, said senior actors had a ‘tremendous amount to offer’ Full Article News TV & Radio Culture
ies The dark world of Nineties boybands: ‘They put a bucket by the stage so I could spew’ By www.independent.co.uk Published On :: 2024-11-12T17:05:39+00:00 Screaming girls. Sudden riches. Your face on the cover of Smash Hits magazine. Life in a Nineties boyband sounds like a dream, but one survivor of the maelstrom likens it more to being in the military. Jessie Thompson goes behind the scenes of revealing new BBC documentary ‘Boybands Forever’ Full Article Features TV & Radio Culture
ies Summer bodies are built in winter By www.starobserver.com.au Published On :: Fri, 31 Jul 2015 10:03:13 +0000 DID you ever really believe that the Netflix launch coinciding with the beginning of winter was just a coincidence? Surely those execs weren’t insinuating that you were going to be ... The post Summer bodies are built in winter appeared first on Star Observer. Full Article Healthy Living
ies First ferret babies born from a clone bring new hope for their species By www.cbc.ca Published On :: Wed, 06 Nov 2024 17:48:37 EST Sibert and Red Cloud, black-footed ferret siblings at the Smithsonian’s National Zoo and Conservation Biology Institute, are the first members of an endangered species born to a cloned animal. Full Article Radio/As It Happens
ies Moss Agate: Meaning, Metaphysical Properties, and Healing Uses By science.howstuffworks.com Published On :: Fri, 18 Oct 2024 05:00:05 -0400 Moss Agate meaning revolves around growth, emotional healing, and nature's balance. Discover its grounding energy and how it fosters abundance and inner peace. Full Article
ies 10 Dirtiest Cities in the U.S. (L.A. Shockingly Isn't One of Them) By science.howstuffworks.com Published On :: Wed, 23 Oct 2024 10:10:03 -0400 Living in a city offers a lot of excitement and opportunity on a daily basis, but it also comes with some downsides like pollution, trash and health risks. So, which cities have it worst? LawnStarter did a deep dive on this very topic to uncover the dirtiest cities in the U.S. Full Article
ies Apophyllite Crystal: Meaning, Healing Properties, and Benefits By science.howstuffworks.com Published On :: Sat, 02 Nov 2024 00:27:03 -0400 Apophyllite: Discover the healing powers of apophyllite crystals, known for enhancing clarity, intuition, and spiritual growth. Perfect for meditation and relaxation. Full Article
ies The Most Beautiful Countries in the World, Sorted by Region By science.howstuffworks.com Published On :: Wed, 06 Nov 2024 10:35:02 -0500 Any avid traveler knows there are far too many gorgeous landscapes and jaw-dropping views to make one all-encompassing list of the most beautiful countries in the world. We're lucky to have such a diverse world, and beauty is subjective. Full Article
ies Apple now has replacement parts for the iPhone 16 series By www.engadget.com Published On :: Mon, 11 Nov 2024 14:30:00 +0000 It's no secret that most technology nowadays isn't exactly built to last forever, with new product models regularly on sale on replace malfunctioning items. However, Apple, which famously announces new products each September, is taking new steps to let people repair their own devices. Apple has launched parts and tools for the iPhone 16, including the Plus, Pro and Pro Max. Now, if you have an iPhone 16 model that's acting up, you can go to Apple's self service repair store and — possibly — get what you need to fix it. Choose the product type and model then pick from the iPhone 16's choices of back glass, battery, camera, top speaker, TrueDepth camera, SIM tray and more. Apple's iPhone 16 should be easier to fix than its predecessor, receiving a 7/10 on the iFixit repairability scale, compared to a 4/10 for the iPhone 15. You can either get kits or just the necessary part with prices varying based on your phone model. For example, a battery and screw kit for the iPhone 16 Pro Max is $119, but its $99 for the regular iPhone 16. You can get quite a lot of money back on the kit prices if you return the replaced piece afterward. The iPhone 16 Pro Max, for instance, goes down to $61.88 after you send back the old battery. Apple created its self-service program in 2022, giving its customers access to actual Apple parts when something in their device failed. However, Apple states that the service "is intended for individuals with the knowledge and experience to repair electronic devices. If you are experienced with the complexities of repairing electronic devices." So, repairs might not be as accessible if you or someone you know isn't savvy in making the swaps. This article originally appeared on Engadget at https://www.engadget.com/big-tech/apple-now-has-replacement-parts-for-the-iphone-16-series-143100070.html?src=rss Full Article Smart Phones Technology & Electronics Handheld & Connected Devices site|engadget provider_name|Engadget region|US language|en-US author_name|Sarah Fielding
ies Spread of dengue fever in Bangladesh worries medics By www.terradaily.com Published On :: Wed, 13 Nov 2024 05:57:03 GMT Dhaka (AFP) Nov 7, 2024 Bangladesh is struggling to tamp down a surge in dengue cases as climate change turns the disease into a year-round crisis, leaving some paediatric wards packed with children squeezed two to a bed. The Aedes mosquito that spreads dengue - identifiable by its black and white striped legs - breeds in stagnant pools, and cases once slowed after the monsoon rains faded. "Normally, around t Full Article
ies Blitz recalls a long line of war movies going back decades, but that doesn't mean it's not relevant By www.cbc.ca Published On :: Mon, 11 Nov 2024 04:00:30 EST Following a mother and son during the the Blitz, Nazi Germany's bombing campaign on London during the Second World War, director Steve McQueen's new drama understands the war film — perhaps a bit too well. Full Article News/Entertainment
ies «Ce n’est pas légal»: des enfants sélectionnés selon l’ethnie ou la religion dans des garderies By www.journaldemontreal.com Published On :: Tue, 12 Nov 2024 13:28:41 EST La sélection d’enfants selon des critères ethniques ou religieux pour l’admission dans des CPE du grand Montréal n’est pas légale. Full Article
ies Scandale des drones: c’est terminé avec le Canada pour Bev Priestman By www.journaldemontreal.com Published On :: Tue, 12 Nov 2024 15:43:02 EST Canada Soccer a définitivement coupé les ponts avec la sélectionneuse de l’équipe féminine Bev Priestman. Full Article
ies Sueurs froides pour deux Swifties québécoises: leurs billets volés... puis retrouvés à temps pour le concert de Taylor Swift vendredi à Toronto By www.journaldemontreal.com Published On :: Tue, 12 Nov 2024 17:50:00 EST Florence et Marianne seront finalement au concert de leur idole, vendredi, à Toronto, mais elles ont eu toute une frousse. Full Article
ies Annual rental prices fell for the 1st time in over three years, but only in big cities By www.cbc.ca Published On :: Thu, 07 Nov 2024 13:23:14 EST Canadian rental prices fell 1.2 per cent in October compared to the same time last year. It's the first time that annual rents have declined since July 2021, according to a new report. Full Article News/Business
ies CSIS had concerns about Abdelrazik's motives ahead of trip to Sudan, investigator testifies By www.cbc.ca Published On :: Tue, 12 Nov 2024 17:17:18 EST Canada's intelligence agency amassed a sizable file on Abousfian Abdelrazik's suspected terrorism ties in the early 2000s, although the validity of that intelligence was called into question during the Montreal man's Federal Court case. Full Article News/Politics
ies Footy boss denies bombshell accusation By www.news.com.au Published On :: Tue, 21 Jun 2016 04:16:00 GMT ADELAIDE’S Mark Ricciuto has denied orchestrating a campaign to cut dollars from the contract of one of his star players. Full Article
ies Pies board accepts McGuire apology By www.news.com.au Published On :: Tue, 21 Jun 2016 08:17:00 GMT UPDATE: EDDIE McGuire has the backing of the Collingwood board to remain president after accepting his apology for his explosive radio comments about Caroline Wilson. Full Article
ies Des Swifties québécois témoignent: «En spectacle, le monde arrête de tourner» By www.journaldemontreal.com Published On :: Sun, 10 Nov 2024 00:00:00 EST Des Swifties québécoises racontent leur expérience durant un concert de la tournée «Eras». Full Article
ies Des arnaqueurs ciblent les Swifties: «90% des billets à vendre sur les réseaux sociaux sont de l’arnaque», croit un expert By www.journaldemontreal.com Published On :: Mon, 11 Nov 2024 20:25:46 EST La majorité des billets encore offerts en ligne pour aller voir Taylor Swift à Toronto sont des arnaques, constate un expert en cybersécurité. Full Article
ies Galaxies collide in stunning picture By www.heraldsun.com.au Published On :: Wed, 11 Jan 2017 09:33:00 GMT A NEW image captured by NASA Hubble space telescope shows ‘doomed duo’ galaxies colliding and then trying to destroy one another. Full Article
ies ALP told to ‘get better policies’ By www.theaustralian.com.au Published On :: Wed, 11 Jan 2017 13:00:00 GMT A review of Labor’s City of Sydney council campaign finds earlier preselections and better policies are needed. Full Article
ies FOPE spots potential opportunities for Indian cos in Australia & ECTA seen to propel easy market access By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST The Federation of Pharmaceutical Entrepreneurs (FOPE) has identified potential opportunities for Indian pharmaceutical companies to expand in Australia. Further, the India─Australia Economic Cooperation and Trade Full Article
ies Indian health, pharma companies invited to participate in Iraq's 'Medico Expo' from Feb 5─8, 2025 By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST 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 Full Article
ies SEC recommends approval for MSN Laboratories' sleep disorder drug By www.pharmabiz.com Published On :: Saturday, November 9, 2024 08:00 IST 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 Full Article
ies KPPA to organize webinar series from November 17 to 23 as part of NPW celebration By www.pharmabiz.com Published On :: Saturday, November 9, 2024 08:00 IST As part of the National Pharmacy Week (NPW) celebration, the Kerala Private Pharmacist Association (KPPA) is organizing a high─impact webinar series from November 17th to 23rd, connected by the common Full Article
ies Centre notifies rules for recruitment of medical device officers in CDSCO By www.pharmabiz.com Published On :: Monday, November 11, 2024 08:00 IST In an effort to strengthen the regulatory activities for medical devices in the country, the Union health ministry has framed and finalised rules regulating the method of recruitment to various posts under the Central Full Article
ies DGTR releases list of registered parties on anti─dumping investigation on sodium citrate imports from China By www.pharmabiz.com Published On :: Monday, November 11, 2024 08:00 IST The Directorate General of Trade Remedies (DGTR), under the ministry of commerce and industry, has released a list of registered interested parties regarding the ongoing Second Sunset Review anti─dumping Full Article
ies Protecting vital medical implants with epoxies By www.medicalplasticsnews.com Published On :: Wed, 06 Nov 2024 17:00:00 -0000 Mike Hodgin, director of strategic applications, Meridian Electronics Division discusses enabling and protecting vital medical implants with epoxies. Full Article
ies Bormioli Pharma partners with Chiesi to supplypackaging in Carbon Capture PET By www.medicalplasticsnews.com Published On :: Fri, 08 Nov 2024 12:00:00 -0000 Bormioli Pharma has announced a partnership with Chiesi, an international, research-focused biopharmaceutical company (Chiesi Group), to supply Carbon Capture PET bottles. Full Article
ies The FemTech Series: How to fix inequality in healthcare By www.medicalplasticsnews.com Published On :: Mon, 11 Nov 2024 09:30:00 -0000 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. Full Article
ies One in Three Tree Species Is at Risk of Extinction By www.scientificamerican.com Published On :: Wed, 30 Oct 2024 16:00:00 +0000 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 Full Article
ies How the 2024 Election Could Change Access to Health Care in the U.S. and Influence Global Nuclear Policies By www.scientificamerican.com Published On :: Fri, 01 Nov 2024 10:30:00 +0000 The outcome of the 2024 U.S. presidential election could reshape policies from health care at home to nuclear proliferation abroad Full Article
ies Let African Communities Manage Their Climate Adaptation Plans By www.scientificamerican.com Published On :: Fri, 08 Nov 2024 15:00:00 +0000 Outside groups often offer their solutions for climate adaptation in Africa. But the best people to manage the climate crisis are the people in those communities themselves. For climate adaptation to succeed in Africa, let communities and local leaders show the way Full Article
ies NEW: The Drug Channels 2025 Video Webinar Series By feeds.feedblitz.com Published On :: Wed, 25 Sep 2024 10:00:00 +0000 Drug Channel Institute is pleased to announce The Drug Channels 2025 Video Webinar Series.Join Dr. Adam J. Fein for three live video webinars during 2025. These live, interactive events will be broadcast via Zoom from the Drug Channels Video studio in beautiful downtown Philadelphia. During these events, Dr. Fein will address the latest issues confronting the U.S. drug channel. Topics will be determined based on what’s happening—trends, policy changes, company announcements, and more. He’ll share DCI’s latest market data to help you stay on top of new developments. You will be able to use these events as both a capstone of your current learning and a touchpoint for the future. The three events are scheduled for 12:00 p.m. to 1:30 p.m. ET on the following dates: April 4, 2025 June 20, 2025 December 12, 2025 (Drug Channels Outlook 2026) For 2025, we are offering a Corporate Pricing option that will allow larger organizations to register hundreds of colleagues for one fixed price. Please contact Paula Fein (paula@drugchannels.net) for details. Read on for full details on pricing, including substantial discounts for multiple sites. P.S. If you're not familiar with our webinars, click here to watch brief excerpts from our video webinars. Read more » Full Article Industry Trends Video
ies Innovative Models for Improving Access and Visibility for Specialty-Lite and Retail Therapies By feeds.feedblitz.com Published On :: Fri, 04 Oct 2024 11:23:00 +0000 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 » Full Article Guest Post Sponsored Post
ies Informa Connect’s Trade and Channel Strategies By feeds.feedblitz.com Published On :: Mon, 21 Oct 2024 11:00:00 +0000 Informa Connect’s Trade and Channel Strategies December 10-12, 2024 at the W Hotel in Philadelphia, PA Drug Channels readers save 10% with code 24DC10* Pharmacy and distribution models are growing increasingly complex. Stop running in circles—It’s time to unlock proven strategies to propel market access. What is the secret to success? Trade and Channel Strategies is bringing together industry experts to deliver specific strategies and talk best practices in tackling the latest industry challenges. As the landscape rapidly evolves, there are only two choices—Adapt or risk falling behind. With policy changes and market fluctuations, specifically surrounding the DSCSA and IRA, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of innovations within the pharmacy sector, there has never been a more important time for industry to unite. A program driven by market dynamics and led by champions of channel strategy, join your peers now to master the complexities of pharmacy and distribution models to accelerate market access—It's all happening December 10-12. Why do trade and channel professionals choose this pivotal event? The challenge of staying viable among shifting market dynamics while meeting business objectives is heavy. Professionals are left with many questions, including: How will the new administration affect the distribution channel? Is my organization haemorrhaging money to stay afloat with the shift to alternative distribution and pharmacy models? Does the DSCSA deadline change affect my organization? Am I still prepared? Join the experts for three dedicated days of collaborative discussions that will give you the answers to these questions and so many more. Leaders in the landscape are uniting and will dive into the top trends for innovative distribution, integrated pharmacy models and talk the truth about the future of trade. WHAT CAN YOU EXPECT? Vital insights from industry’s leading pharmacy and distribution experts, including: Bill Roth, Senior Vice President of Consulting, Blue Fin Group, An IntegriChain Company Patrick Lupo Group Vice President, Pharmacy Trade and Specialty, Walgreens Amanda Salindong, Associate Director, Channel & Distribution, Alnylam Pharmaceuticals Chris Rocco, Senior Director, Market Access Data, Reporting & Analytics, GSK Eliane Maalouf, Director Trade and Fulfillment, Mass General Brigham Specialty Pharmacy Stephanie Wirkes, Head of Distribution and Strategy Execution, Bayer John Harlow, Chief Commercial Officer, Melinta Therapeutics Aria Cohen, Vice President, Head of Market Access, Alkeus Pharmaceuticals, Inc. Elizabeth Cherry, Program Director for Trade Relations, Vanderbilt Specialty Pharmacy Danielle Bryan, PharmD, CSP, Program Director, Specialty Pharmacy Trade Relations, Vanderbilt University Medical Center Thomas Scalone, Director, Trade Strategy and Operations, Bristol Myers Squibb Dina Lynch, VP, Market Access and Reimbursement, Renibus Therapeutics And more! Tackle the hottest topics facing industry right now, including: Keynote Address: Access and Channel 2024 In-Review and Preview of 2025 Pharmacy Evolved—Aligning Commercialization to the Changing Pharmacy Channel Advanced Trade Leaders Executive Session Navigate and Operationalize the IRA Focused Multi-Track Offerings: Supply Chain, Distribution and Logistics Pharmacy Models and Reimbursement Strategies Data, Innovation and Analytics Health Systems and Pharma Partnering Symposium Balancing the GTN Bubble with Market Access Priorities What’s Happening in Retail—Brick and Morter, Home Delivery and Cash Pay Pharmacies Navigating Post Deadline Challenges—DSCSA Compliance and Serialization Updates Four Roundtable Breakout Discussions: What Good Looks Like in a 3PL/Manufacturer Partnership Optimizing Healthcare Partnerships Women in Trade GLP-1s and New Product Archetypes Actions Needed to Mitigate and Prevent Drug Shortages Case Study: Master Your Organization Chart—Ensuring Higher Cross Functional Interactions Three Interactive Workshops: Trade 101 Advanced Trade Leaders Executive Session Health Systems Fundamentals And more! Exclusive Offer—Download the agenda and register today—Be sure to use your exclusive promo 24DC10 to save 10% off* of your registration. See you there! * Cannot be combined with other offers, promotions or applied to an existing registration. Other restrictions may apply. The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net). Full Article
ies Government 'miscommunicated' PPE stock levels to pharmacies during first COVID-19 wave, MPs told By www.pharmaceutical-journal.com Published On :: Wed, 10 Feb 2021 12:17 GMT The government implied wholesalers had more personal protective equipment in stock than was the case during the first wave of the COVID-19 pandemic, the Healthcare Distribution Association has said. Full Article
ies Pharmacies estimated to receive one referral per month through hospital-to-pharmacy referral service By www.pharmaceutical-journal.com Published On :: Mon, 15 Feb 2021 15:27 GMT Community pharmacies will receive an estimated 12 referrals from the Discharge Medicines Service per year. Full Article
ies Health boards say around half of pharmacies have expressed interest in providing COVID-19 vaccines By www.pharmaceutical-journal.com Published On :: Tue, 16 Feb 2021 15:19 GMT Around half of Wales’ community pharmacies have expressed interest to health boards in providing COVID-19 vaccinations as part of the national programme. Full Article
ies Chiesi launches postal asthma inhaler recycling scheme By www.pharmaceutical-journal.com Published On :: Wed, 17 Feb 2021 14:34 GMT The UK’s first postal inhaler recycling scheme has been launched by pharmaceutical company Chiesi to support a more sustainable way of living for people with respiratory illnesses. Full Article
ies Pharmacy negotiators discuss patient registration with community pharmacies By www.pharmaceutical-journal.com Published On :: Thu, 18 Feb 2021 17:07 GMT Pharmacy negotiators have discussed proposals to take “a patient registration-based approach” to the community pharmacy contractual framework. Full Article
ies To B or Not to (Series) B By lifescivc.com Published On :: Tue, 18 Jun 2024 11:00:03 +0000 By Robert Clarke, CEO of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC Strategic considerations of when and how to consider raising additional capital to support clinical development in an improving but still volatile market. As The post To B or Not to (Series) B appeared first on LifeSciVC. Full Article Biotech financing From The Trenches Fundraising
ies Looking for Opportunities to Accelerate Clinical Research in Rare Diseases By lifescivc.com Published On :: Wed, 17 Jul 2024 11:00:40 +0000 By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets. Identifying The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC. Full Article Business Development From The Trenches Portfolio news Rare Diseases Science & Medicine CFTR Cystic Fibrosis NBD1 Sionna Therapeutics
ies ESMO Reflections: Glimmers of Hope with the Next Wave of I-O Therapies? By lifescivc.com Published On :: Thu, 10 Oct 2024 11:00:02 +0000 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. Full Article From The Trenches Portfolio news Science & Medicine
ies UK universities and NHS trusts that flout the rules on clinical trials identified in report to Parliament By www.alltrials.net Published On :: Thu, 24 Oct 2019 00:19:34 +0000 An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […] Full Article News Uncategorized
ies Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA? By www.placebocontrol.com Published On :: Wed, 31 Jul 2013 16:54:00 +0000 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. [Image credit: Shamless lawlessness via Flikr user willytronics.] 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 Full Article Ben Goldacre clinicaltrials.gov FDA FDAAA JCO oncology trials pharma legislation Pharmalot transparency
ies Patrick Dempsey aims to raise awareness of cancer disparities and encourage screening By www.npr.org Published On :: Mon, 11 Nov 2024 05:18:50 -0500 NPR's Leila Fadel talks with actor Patrick Dempsey about his efforts to raise money for cancer treatment and prevention. Full Article
ies “Snake-like” Probe Images Arteries from Within By spectrum.ieee.org Published On :: Wed, 15 May 2024 18:00:04 +0000 Neurosurgeon Vitor Mendes Pereira has grown accustomed to treating brain aneurysms with only blurry images for guidance.Equipped with a rough picture of the labyrinthine network of arteries in the brain, he does his best to insert mesh stents or coils of platinum wire—interventions intended to promote clotting and to seal off a bulging blood vessel.The results are not always perfect. Without a precise window into the arterial architecture at the aneurysm site, Pereira says that he and other neurovascular specialists occasionally misplace these implants, leaving patients at a heightened risk of stroke, clotting, inflammation, and life-threatening ruptures. But a new fiber-optic imaging probe offers hope for improved outcomes. Pereira et al./Science Translational MedicineAccording to Pereira’s early clinical experience, the technology—a tiny snake-like device that winds its way through the intricate maze of brain arteries and, using spirals of light, captures high-resolution images from the inside-out—provides an unprecedented level of structural detail that enhances the ability of clinicians to troubleshoot implant placement and better manage disease complications.“We can see a lot more information that was not accessible before,” says Pereira, director of endovascular research and innovation at St. Michael’s Hospital in Toronto. “This is, for us, an incredible step forward.”And not just for brain aneurysms. In a report published today in Science Translational Medicine, Pereira and his colleagues describe their first-in-human experience using the platform to guide treatment for 32 people with strokes, artery hardening, and various other conditions arising from aberrant blood vessels in the brain.Whereas before, with technologies such as CT scans, MRIs, ultrasounds, and x-rays, clinicians had a satellite-like view of the brain’s vascular network, now they have a Google Street View-like perspective, complete with in-depth views of artery walls, plaques, immune cell aggregates, implanted device positions, and more.“The amount of detail you could get you would never ever see with any other imaging modality,” says Adnan Siddiqui, a neurosurgeon at the University at Buffalo, who was not involved in the research. “This technology holds promise to be able to really transform the way we evaluate success or failure of our procedures, as well as to diagnose complications before they occur.”A Decade of Innovation The new fiber-optic probe is flexible enough to snake through the body’s arteries and provide previously unavailable information to surgeons.Pereira et al./Science Translational MedicineThe new imaging platform is the brainchild of Giovanni Ughi, a biomedical engineer at the University of Massachusetts’ Chan Medical School in Worcester. About a decade ago, he set out to adapt a technique called optical coherence tomography (OCT) for imaging inside the brain’s arteries.OCT relies on the backscattering of near-infrared light to create cross-sectional images with micrometer-scale spatial resolution. Although OCT had long been used in clinical settings to generate pictures from the back of the eye and from inside the arteries that supply blood to the heart, the technology had proven difficult to adapt for brain applications owing to several technical challenges.One major challenge is that the fiber-optic probes used in the technology are typically quite stiff, making them too rigid to twist and bend through the convoluted passageways of the brain’s vasculature. Additionally, the torque cables—traditionally used to rotate the OCT lens to image surrounding vessels and devices in three dimensions as the probe retracts—were too large to fit inside the catheters that are telescopically advanced into the brain’s arteries to address blockages or other vascular issues.“We had to invent a new technology,” Ughi explains. “Our probe had to be very, very flexible, but also very, very small to be compatible with the clinical workflow.”To achieve these design criteria, Ughi and his colleagues altered the properties of the glass at the heart of their fiber-optic cables, devised a new system of rotational control that does away with torque cables, miniaturized the imaging lens, and made a number of other engineering innovations.The end result: a slender probe, about the size of a fine wire, that spins 250 times per second, snapping images as it glides back through the blood vessel. Researchers flush out blood cells with a tablespoon of liquid, then manually or automatically retract the probe, revealing a section of the artery about the length of a lip balm tube. St. Michael’s Foundation Clinical ConfirmationAfter initial testing in rabbits, dogs, pigs, and human cadavers, Ughi’s team sent the device to two clinical groups: Pereira’s in Toronto and Pedro Lylyk’s at the Sagrada Familia Clinic in Buenos Aires, Argentina. Across the two groups, neurosurgeons treated the 32 participants in the latest study, snaking the imaging probe through the patients’ groins or wrists and into their brains.The procedure was safe and well-tolerated across different anatomies, underlying disease conditions, and the complexity of prior interventions. Moreover, the information provided frequently led to actionable insights—in one case, prompting clinicians to prescribe anti-platelet drugs when hidden clots were discovered; in another, aiding in the proper placement of stents that were not flush against the arterial wall.“We were successful in every single case,” Ughi says. “So, this was a huge confirmation that the technology is ready to move forward.”“We can see a lot more information that was not accessible before.” —Vitor Mendes Pereira, St. Michael’s HospitalA startup called Spryte Medical aims to do just that. According to founder and CEO David Kolstad, the company is in discussions with regulatory authorities in Europe, Japan, and the United States to determine the steps necessary to bring the imaging probe to market.At the same time, Spryte—with Ughi as senior director of advanced development and software engineering—is working on machine learning software to automate the image analysis process, thus simplifying diagnostics and treatment planning for clinicians.Bolstered by the latest data, cerebrovascular specialists like Siddiqui now say they are chomping at the bit to get their hands on the imaging probe once it clears regulatory approval.“I’m really impressed,” Siddiqui says. “This is a tool that many of us who do these procedures wish they had.” Full Article Optical coherence tomography Fiber optics Brain imaging
ies Scary Stories: Establishing a Field Amid Skepticism By spectrum.ieee.org Published On :: Wed, 30 Oct 2024 11:00:02 +0000 In the spirit of the Halloween season, IEEE Spectrum presents a pair of stories that—although grounded in scientific truth rather than the macabre—were no less harrowing for those who lived them. In today’s installment, Robert Langer had to push back against his field’s conventional wisdom to pioneer a drug-delivery mechanism vital to modern medicine.Nicknamed the Edison of Medicine, Robert Langer is one of the world’s most-cited researchers, with over 1,600 published papers, 1,400 patents, and a top-dog role as one of MIT’s nine prestigious Institute Professors. Langer pioneered the now-ubiquitous drug delivery systems used in modern cancer treatments and vaccines, indirectly saving countless lives throughout his 50-year career.But, much like Edison and other inventors, Langer’s big ideas were initially met with skepticism from the scientific establishment. He came up in the 1970s as a chemical engineering postdoc working in the lab of Dr. Judah Folkman, a pediatric surgeon at the Boston Children’s Hospital. Langer was tasked with solving what many believed was an impossible problem—isolating angiogenesis inhibitors to halt cancer growth. Folkman’s vision of stopping tumors from forming their own self-sustaining blood vessels was compelling enough, but few believed it possible. Langer encountered both practical and social challenges before his first breakthrough. One day, a lab technician accidentally spilled six months’ worth of samples onto the floor, forcing him to repeat the painstaking process of dialyzing extracts. Those months of additional work steered Langer’s development of novel microspheres that could deliver large molecules of medicine directly to tumors. In the 1970s, Langer developed these tiny microspheres to release large molecules through solid materials, a groundbreaking proof-of-concept for drug delivery.Robert LangerLanger then submitted the discovery to prestigious journals and was invited to speak at a conference in Michigan in 1976. He practiced the 20-minute presentation for weeks, hoping for positive feedback from respected materials scientists. But when he stepped off the podium, a group approached him and said bluntly, “We don’t believe anything you just said.” They insisted that macromolecules were simply too large to pass through solid materials, and his choice of organic solvents would destroy many inputs. Conventional wisdom said so.Nature published Langer’s paper three months later, demonstrating for the first time that non-inflammatory polymers could enable the sustained release of proteins and other macromolecules. The same year, Science published his isolation mechanism to restrict tumor growth. Langer and Folkman’s research paved the way for modern drug delivery.MIT and Boston Children’s Hospital Even with impressive publications, Langer still struggled to secure funding for his work in controlling macromolecule delivery, isolating the first angiogenesis inhibitors, and testing their behavior. His first two grant proposals were rejected on the same day, a devastating blow for a young academic. The reviewers doubted his experience as “just an engineer” who knew nothing about cancer or biology. One colleague tried to cheer him up, saying, “It’s probably good those grants were rejected early in your career. Since you’re not supporting any graduate students, you don’t have to let anyone go.” Langer thought the colleague was probably right, but the rejections still stung.His patent applications, filed alongside Folkman at the Boston Children’s Hospital, were rejected five years in a row. After all, it’s difficult to prove you’ve got something good if you’re the only one doing it. Langer remembers feeling disappointed but not crushed entirely. Eventually, other scientists cited his findings and expanded upon them, giving Langer and Folkman the validation needed for intellectual property development. As of this writing, the pair’s two studies from 1976 have been cited nearly 2,000 times.As the head of MIT’s Langer Lab, he often shares these same stories of rejection with early-career students and researchers. He leads a team of over 100 undergrads, grad students, postdoctoral fellows, and visiting scientists, all finding new ways to deliver genetically engineered proteins, DNA, and RNA, among other research areas. Langer’s reputation is further bolstered by the many successful companies he co-founded or advised, like mRNA leader Moderna, which rose to prominence after developing its widely used COVID-19 vaccine.Langer sometimes thinks back to those early days—the shattered samples, the cold rejections, and the criticism from senior scientists. He maintains that “Conventional wisdom isn’t always correct, and it’s important to never give up—(almost) regardless of what others say.” Full Article Cancer treatments Drug delivery Medicine Mit Moderna