& Santé buccale et cancer du côlon By www.journaldemontreal.com Published On :: Sun, 27 Oct 2024 20:00:00 EDT Une étude récente montre qu’un type de bactérie associée aux maladies des gencives pourrait participer au développement du cancer colorectal. Full Article
& L’excellente santé des sportifs du week-end By www.journaldemontreal.com Published On :: Sun, 03 Nov 2024 16:00:00 EST 150 minutes d’activité physique durant le week-end procure des bénéfices similaires à la même durée d’exercice répartie sur sept jours. Full Article
& Infections respiratoires: un nouveau facteur de risque de mortalité identifié By www.journaldemontreal.com Published On :: Sun, 10 Nov 2024 17:00:00 EST Une découverte biochimique intrigante pourrait permettre d’identifier rapidement les patients à haut risque. Full Article
& Les légumes d’ici, toute l’année By www.journaldemontreal.com Published On :: Sun, 10 Nov 2024 17:30:00 EST Si octobre célèbre la fin des récoltes, plusieurs légumes demeurent disponibles lors de la saison froide. Full Article
& Pharmaceutical water systems in transformation mode with advanced processes & shift towards analytics By www.pharmabiz.com Published On :: Thursday, November 7, 2024 08:00 IST Indian and multinational pharma companies are leading the charge by investing in digital transformation and aligning Indian operations with global standards. Essentially, pharmaceutical water systems are Full Article
& AIOCD urges DCGI to immediately stop partnership between Swiggy & PharmEasy for rapid drug delivery By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST Raising deep concern over the partnership between Swiggy Instamart and PharmEasy for a rapid drug delivery model, the All India Organization of Chemists and Druggists (AIOCD) has apprised the Drug Controller Full Article
& DoP rejects Aristo Pharma's review application for its multivitamin tablets By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST The Department of Pharmaceuticals (DoP) has upheld the retail price fixation of National Pharmaceutical Pricing Authority (NPPA) for Mumbai─based Aristo Pharmaceuticals for its multivitamin tablets with Full Article
& 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
& SEC recommends marketing approval for Dr Reddy's SPMS drug Siponimod tablets By www.pharmabiz.com Published On :: Friday, November 8, 2024 08:00 IST 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 Full Article
& 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
& 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
& Indian pharma & biotech cos confident of new US President Trump's support to Indian pharma By www.pharmabiz.com Published On :: Saturday, November 9, 2024 08:00 IST Indian pharma and biotech companies are confident that under the new US President Donald Trump, its strengths in high quality generics manufacture and export will continue to command respect. This view is Full Article
& Karnataka Ayush sector upbeat on recent amendment to renew manufacturing & loan licenses to perpetuity By www.pharmabiz.com Published On :: Monday, November 11, 2024 08:00 IST The recent amendments brought by the Union Ministry of Ayush to the Drugs and Cosmetics Rules, 1945 are significant, as they introduce new regulatory requirements for the manufacturing and sale of traditional Full Article
& Oversimplification about integration of traditional & modern treatment systems creates confusion: Dr Kotecha By www.pharmabiz.com Published On :: Tuesday, November 12, 2024 08:00 IST Oversimplification about integration of traditional and modern treatment systems often creates confusion among the stakeholders, and nobody understands the reality of the integration and what it is meant for, said Dr. Full Article
& Industry hails DoP's new scheme for strengthening of medical devices industry By www.pharmabiz.com Published On :: Wednesday, November 13, 2024 08:00 IST The centrally sponsored scheme for strengthening of medical devices industry (SMDI), launched by the Central government last week, was widely welcomed by the medical devices industry in the country. Full Article
& Asahi Kasei Medical launches Planova FG1 next-generation virus removal filter By www.medicalplasticsnews.com Published On :: Wed, 30 Oct 2024 15:30:00 -0000 Asahi Kasei Medical has launched the Planova FG1, a next-generation virus removal filter featuring higher flux for the manufacture of biotherapeutics, in October 2024. Full Article
& Q&A: Bringing sustainability into the medical industry By www.medicalplasticsnews.com Published On :: Tue, 05 Nov 2024 16:00:00 -0000 Brightmark CEO Bob Powell discusses Plastics Renewal technology and how to bring sustainability into the medical industry. Full Article
& Informa Connnect's Pharma/Biotech GTN Summit By feeds.feedblitz.com Published On :: Mon, 23 Sep 2024 10:30:00 +0000 Informa Connnect's Pharma/Biotech GTN Summit November 18-20, 2024 | W Philadelphia Hotel, Philadelphia, PA Drug Channels Readers Receive 15% Off* with Code 24DGC15. View the Complete Agenda Book Your Place The complex components of gross-to-net management requires cross-functional collaboration in order to effectively develop sound accrual estimates, proper forecasting, optimized pricing and contracting models and accurate financial reporting, all with minimal disruption to market access strategies. The CPE-accredited Pharma/Biotech GTN Summit is the ideal opportunity to engage in comprehensive sessions for end-to-end GTN excellence, connect with peers to exchange experiences and solutions to common challenges, and participate in interactive discussions that address real-world scenarios to enhance GTN accuracy and efficiency. Featured Thought-Leaders Leading the Dialogue Include: Nancy Bell, Vice President, Head of US Patient Value & Access, Takeda Oncology Chris Boneham, Vice President, Market Access US, Y-mAbs Therapeutics Prakash Chainani, Vice President – Finance, HR & IT, Lifestar Pharma LLC (a Mankind Group Company) George Kappus, Associate Director, M&S Controlling (GtN, Boehringer Ingelheim Sherri Cirota, Executive Director, Contracts & Pricing, Alkermes Chris Rocco, Senior Director, Market Access Data, Reporting & Analytics, GSK Rosalind Davis, Director, Government Pricing & Contracts, CSL Vifor Dan Sacchetta, Director Managed Markets Finance- Gross-to-Net, Novartis Eckart Beuttenmueller, Director, Gross-to-Net Execution, Bayer Kinneret Klein, Executive Director, Commercial Financial Planning & Analysis, Biocryst James Engel, Controller, Finance, Collegium Pharmaceuticals Brett Nussbaum, Head of Gross to Net Accounting, Novartis Timothy Kocses, Executive Director, US Commercial Controller, Bristol Myers Squibb Robert Lucchesi, Director, FP&A Sales Reporting & Forecasting, Novo Nordisk Funso Olufade, PhD, MBA, Sr. Director – Head, Commercial Finance, Ascendis Pharma Amy Ramazio, Contract Forecasting & Analytics Director, GSK US Market Access Ranish Singhvi, Vice President, Finance, Accord Healthcare Jeffrey Miller, Assistant Vice President & Corporate Controller, Lannett Company Bal Ram, SVP Finance, US Operations, Indivior Matthew Pellegrini, Sr. Director - Revenue Optimization Contracting & Compliance N.A, Teva Pharmaceuticals Michael Domanico, Vice President Finance, Revenue, Sandoz Christopher Wang, Corporate Controller, Revance Therapeutics Melissa Norton, Assistant Controller, Revenue, Tolmar Michael Christiano, Director, Revenue, Ardelyx Learn more and see why the GTN Summit remains a great choice for education and benchmarking on strategic forecasting, estimates, analytics and reporting through best practices for gross-to-net management. Drug Channels subscribers — Save 15% when you reserve your place using the VIP code 24DGC15. *Offer applies to the current rate and maybe not be applied to existing registrations; additional terms may apply, see website for full details. 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 Sponsored Post
& Informa Connect's Copay, Reimbursement and Access Congress By feeds.feedblitz.com Published On :: Mon, 30 Sep 2024 04:30:00 +0000 Informa Connect's Copay, Reimbursement and Access Congress November 18-20, 2024 | Hilton Penn’s Landing in Philadelphia, PA Drug Channels readers save 10% with code USAVE24* The access and affordability landscape is undergoing a seismic shift. Evolving legislation, disruptive market forces and the ever-growing complexities of cost sharing programs threaten patient adherence and commercialization strategies. Are you ready? A program driven by marketplace insights and led by industry trailblazers, Copay, Reimbursement and Access Congress is back November 18-20 and will deliver up-to-date insights necessary to enhance patient affordability, ensure program sustainability and navigate the regulatory landscape. In a time where remaining compliant has never been more complex and program innovation has never been more important, be sure to join your industry counterparts to drive adherence, access and commercialization forward. Why attend the Copay, Reimbursement and Access Congress? Keeping up with shifting market dynamics in the midst of maximizing access, while also meeting business objectives is a challenging task and brings about many questions for access professionals. Is your program sustainable and innovative to better support patients? Accumulators, maximizers, AFPs – What are your next steps to ensure effective reimbursement strategies? In an election year, what is the future of health policy? Experts will tackle these questions and more as the industry comes together to benchmark best practices to accelerate access and commercialization. Do not miss your chance to join seasoned leaders, your peers and leading solution providers as they navigate marketplace trends and dive into the impact coupons, benefit design, accumulators, maximizers, alternative funding programs and drug pricing legislation have on patient affordability and out-of-pocket costs. This is your chance to gain critical insights on industry standards, forward-thinking strategies to optimize your copay and cost sharing programs and so much more. Content highlights: Over 20 hours of content, including 7+ dedicated sessions to help decipher copay legislation Crucial perspectives from Pfizer, Sanofi, Janssen, Teva, Ascendis Pharma, Melinta Therapeutics, GSK, HIV + Hepatitis Policy Institute and more Insights direct from enforcement agents on the top trends and actions within the copay and patient services space Illuminating case study, Navigating the Patient Journey in a Shifting Copay Landscape from Spark Therapeutics 465 minutes of valuable in-person networking with colleagues and counterparts to expand your network and establish powerful partnerships Additional content access through Streamly, a platform that gives you 12-month access to all of the available conference content** to review at your leisure And more! Download the agenda and register today—Be sure to use your exclusive promo USAVE24 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. **Pending speaker permissions 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 Sponsored Post
& Hospitals Are Relying More on PBMs to Manage Manufacturers' 340B Contract Pharmacy Restrictions: DCI's 2024 Market Analysis (rerun) By feeds.feedblitz.com Published On :: Wed, 02 Oct 2024 10:30:00 +0000 This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Click here to see the original post from June 2024. The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that:About 33,000 pharmacy locations—more than half of the entire U.S. pharmacy industry—act as contract pharmacies for the hospitals and federal grantees that participate in the 340B program. Five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers (PBMs)—Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via OptumRx), and Walgreens, Walmart—continue to dominate the 340B contract pharmacy market.Federal grantees are aligned primarily with the vertically intergated organizations' retail pharmacies, while hospitals rely on mail and specialty pharmacies.Over the past four years, manufacturers’ restrictions on 340B contract pharmacies have led hospitals to deepen their relationships with the largest PBMs—even as those PBMs have simultaneously limited hospitals’ direct participation in specialty pharmacy networks. For an updated look at what’s next for the 340B contract pharmacy market, join Adam J. Fein, Ph.D., on June 21 for his latest live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook. Read more » Full Article 340B Channel Management Hospitals Inflation Reduction Act of 2022 Pharmacy Specialty Drugs
& Bonus Episode: Fast Facts on the ACRO D&I Grants Program By mailchi.mp Published On :: Tue, 21 May 2024 10:13:00 +0000 ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard and Kristen Surdam to discuss ACRO’s new D&I Site Resource Grants Program. The post Bonus Episode: Fast Facts on the ACRO D&I Grants Program first appeared on ACRO. Full Article DEI News
& ¿Cómo aprueba la FDA los medicamentos nuevos? By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:27 -0700 The U.S. Food and Drug Administration posted a video: Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546 Full Article
& ¿Cuál es el papel de la FDA en la regulación de los medicamentos? By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:27 -0700 The U.S. Food and Drug Administration posted a video: Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546 Full Article
& ¿Qué hace la FDA después de que aprueba los medicamentos? By www.flickr.com Published On :: Mon, 12 Aug 2024 11:55:28 -0700 The U.S. Food and Drug Administration posted a video: La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Vea esta serie de tres partes: www.youtube.com/playlist?list=PL0AE2C851E6968546 Full Article
& ¿Cuál es el papel de la FDA en la regulación de los medicamentos? (30 segundos) By www.flickr.com Published On :: Tue, 13 Aug 2024 12:15:55 -0700 The U.S. Food and Drug Administration posted a video: Quizás sepa que la FDA es responsable de aprobar los medicamentos nuevos, como medicamentos de receta, genéricos, biosimilares y de venta libre, y de garantizar que esos medicamentos sean seguros, de alta calidad y funcionen como se supone que deben hacerlo. Pero nuestro trabajo no termina ahí. Continuamos monitoreando la seguridad y calidad de los medicamentos aprobados en los años venideros. Aprenda más sobre nuestro papel en la regulación de estos medicamentos. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Full Article
& ¿Cómo aprueba la FDA los medicamentos nuevos? (30 segundos) By www.flickr.com Published On :: Tue, 13 Aug 2024 12:19:23 -0700 The U.S. Food and Drug Administration posted a video: Los medicamentos de receta pasan por muchos pasos y fases importantes antes de que los aprobemos. Las investigaciones, los datos y la evidencia deben demostrar que el medicamento es seguro y eficaz para el uso previsto. Aprenda más sobre el proceso de aprobación de la FDA de principio a fin. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Full Article
& ¿Qué hace la FDA después de que aprueba los medicamentos? (30 segundos) By www.flickr.com Published On :: Tue, 13 Aug 2024 12:23:26 -0700 The U.S. Food and Drug Administration posted a video: La FDA monitorea continuamente datos en tiempo real de pacientes, fabricantes de medicamentos y profesionales de la salud, incluyendo informes de reacciones adversas a los medicamentos de receta. Según estos datos, podemos actualizar las etiquetas de los medicamentos o, en casos excepcionales, solicitar la retirada del mercado. Aprenda más sobre el proceso de la FDA para el monitoreo continuo de los medicamentos aprobados. Para obtener más información sobre el papel de la FDA en la regulación y la aprobación de medicamentos, visite nuestro sitio web en www.fda.gov/drugs/information-consumers-and-patients-drug... Full Article
& California Adopts a Bundle of AI & Privacy Laws, Most Controversial Bills Vetoed (Updated) By cohealthcom.org Published On :: Mon, 30 Sep 2024 19:05:07 +0000 Sorry, but you do not have permission to view this content. Full Article Artificial Intelligence (AI) Data Privacy Legislative child data privacy CO Colorado consumer privacy data privacy legislation Jim Potter
& RPS and pharmacy students' association call for rethink over overseas exam decision By www.pharmaceutical-journal.com Published On :: Tue, 9 Feb 2021 16:42 GMT The Royal Pharmaceutical Society and the British Pharmaceutical Students’ Association have called for all overseas candidates to sit the March 2021 registration assessment in their home countries. Full Article
& 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
& Prime minister vows to reimburse community pharmacy's COVID-19 costs 'as soon as possible' By www.pharmaceutical-journal.com Published On :: Thu, 11 Feb 2021 12:29 GMT Community pharmacies should be reimbursed for their additional costs during the COVID-19 pandemic “as soon as possible”, the prime minister has told The Pharmaceutical Journal. Full Article
& Regulator looking at 'flexibility' that would allow overseas candidates to sit registration assessment By www.pharmaceutical-journal.com Published On :: Thu, 11 Feb 2021 14:53 GMT The General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence. Full Article
& IFM’s Hat Trick and Reflections On Option-To-Buy M&A By lifescivc.com Published On :: Wed, 13 Mar 2024 11:00:37 +0000 Today IFM Therapeutics announced the acquisition of IFM Due, one of its subsidiaries, by Novartis. Back in Sept 2019, IFM granted Novartis the right to acquire IFM Due as part of an “option to buy” collaboration around cGAS-STING antagonists for The post IFM’s Hat Trick and Reflections On Option-To-Buy M&A appeared first on LifeSciVC. Full Article Capital efficiency Exits IPOs M&As External R&D IFM option deals Option To Buy
& Keeping It Simple: What Really Matters For Emerging Enterprises By lifescivc.com Published On :: Wed, 04 Sep 2024 11:00:46 +0000 By Ankit Mahadevia, chairman of Spero Therapeutics, as part of the From The Trenches feature of LifeSciVC A common theme in startup literature is that by cutting a range of unnecessary tasks, a step-change in results will follow. I’ve found The post Keeping It Simple: What Really Matters For Emerging Enterprises appeared first on LifeSciVC. Full Article Bioentrepreneurship Biotech startup advice Corporate Culture From The Trenches
& Can FDA's New Transparency Survive Avandia? By www.placebocontrol.com Published On :: Wed, 05 Jun 2013 03:53:00 +0000 PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty. I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else. However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama. Two words that make us mistrust Duke: Anil Potti Christian Laettner Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue). And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail. The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti: I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. (One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?) Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach. I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented. And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone? Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive? Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks? I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators. Where is this coming from? As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data: When they're frothing at the mouth, even Atticusdoesn't let them publish a review A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information. (Emphasis mine.) Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency. The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack: In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013. I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor. [Update June 6: Further bolstering the idea that the AdCom is just as much about FDA's ability to transparently manage differences of expert opinion in the face of uncertain data, CDER Director Janet Woodcock posted this note on the FDA's blog. She's pretty explicit about the bigger picture: There have been, and continue to be, differences of opinion and scientific disputes, which is not uncommon within the agency, stemming from varied conclusions about the existing data, not only with Avandia, but with other FDA-regulated products. At FDA, we actively encourage and welcome robust scientific debate on the complex matters we deal with — as such a transparent approach ensures the scientific input we need, enriches the discussions, and enhances our decision-making. I agree, and hope she can pull it off.] Full Article data quality drug safety Duke FDA GSK Tom Marciniak transparency
& Questionable Enrollment Math at the UK's NIHR By www.placebocontrol.com Published On :: Mon, 16 Sep 2013 18:04:00 +0000 There has been considerable noise coming out of the UK lately about successes in clinical trial enrollment. First, a couple months ago came the rather dramatic announcement that clinical trial participation in the UK had "tripled over the last 6 years". That announcement, by the chief executive of the Sweet creature of bombast: is Sir John writing press releases for the NIHR? National Institute of Health Research's Clinical Research Network, was quickly and uncritically picked up by the media. That immediately caught my attention. In large, global trials, most pharmaceutical companies I've worked with can do a reasonable job of predicting accrual levels in a given country. I like to think that if participation rates in any given country had jumped that heavily, I’d have heard something. (To give an example: looking at a quite-typical study I worked on a few years ago: UK sites were overall slightly below the global average. The highest-enrolling countries were about 2.5 times as fast. So, a 3-fold increase in accruals would have catapulted the UK from below average to the fastest-enrolling country in the world.) Further inquiry, however, failed to turn up any evidence that the reported tripling actually corresponded to more human beings enrolled in clinical trials. Instead, there is some reason to believe that all we witnessed was increased reporting of trial participation numbers. Now we have a new source of wonder, and a new giant multiplier coming out of the UK. As the Director of the NIHR's Mental Health Research Network, Til Wykes, put it in her blog coverage of her own paper: Our research on the largest database of UK mental health studies shows that involving just one or two patients in the study team means studies are 4 times more likely to recruit successfully. Again, amazing! And not just a tripling – a quadrupling! Understand: I spend a lot of my time trying to convince study teams to take a more patient-focused approach to clinical trial design and execution. I desperately want to believe this study, and I would love having hard evidence to bring to my clients. At first glance, the data set seems robust. From the King's College press release: Published in the British Journal of Psychiatry, the researchers analysed 374 studies registered with the Mental Health Research Network (MHRN). Studies which included collaboration with service users in designing or running the trial were 1.63 times more likely to recruit to target than studies which only consulted service users. Studies which involved more partnerships - a higher level of Patient and Public Involvement (PPI) - were 4.12 times more likely to recruit to target. But here the first crack appears. It's clear from the paper that the analysis of recruitment success was not based on 374 studies, but rather a much smaller subset of 124 studies. That's not mentioned in either of the above-linked articles. And at this point, we have to stop, set aside our enthusiasm, and read the full paper. And at this point, critical doubts begin to spring up, pretty much everywhere. First and foremost: I don’t know any nice way to say this, but the "4 times more likely" line is, quite clearly, a fiction. What is reported in the paper is a 4.12 odds ratio between "low involvement" studies and "high involvement" studies (more on those terms in just a bit). Odds ratios are often used in reporting differences between groups, but they are unequivocally not the same as "times more likely than". This is not a technical statistical quibble. The authors unfortunately don’t provide the actual success rates for different kinds of studies, but here is a quick example that, given other data they present, is probably reasonably close: A Studies: 16 successful out of 20 Probability of success: 80% Odds of success: 4 to 1 B Studies: 40 successful out of 80 Probability of success: 50% Odds of success: 1 to 1 From the above, it’s reasonable to conclude that A studies are 60% more likely to be successful than B studies (the A studies are 1.6 times as likely to succeed). However, the odds ratio is 4.0, similar to the difference in the paper. It makes no sense to say that A studies are 4 times more likely to succeed than B studies. This is elementary stuff. I’m confident that everyone involved in the conduct and analysis of the MHRN paper knows this already. So why would Dr Wykes write this? I don’t know; it's baffling. Maybe someone with more knowledge of the politics of British medicine can enlighten me. If a pharmaceutical company had promoted a drug with this math, the warning letters and fines would be flying in the door fast. And rightly so. But if a government leader says it, it just gets recycled verbatim. The other part of Dr Wykes's statement is almost equally confusing. She claims that the enrollment benefit occurs when "involving just one or two patients in the study team". However, involving one or two patients would seem to correspond to either the lowest ("patient consultation") or the middle level of reported patient involvement (“researcher initiated collaboration”). In fact, the "high involvement" categories that are supposed to be associated with enrollment success are studies that were either fully designed by patients, or were initiated by patients and researchers equally. So, if there is truly a causal relationship at work here, improving enrollment would not be merely a function of adding a patient or two to the conversation. There are a number of other frustrating aspects of this study as well. It doesn't actually measure patient involvement in any specific research program, but uses just 3 broad categories (that the researchers specified at the beginning of each study). It uses an arbitrary and undocumented 17-point scale to measure "study complexity", which collapses and quite likely underweights many critical factors into a single number. The enrollment analysis excluded 11 studies because they weren't adequate for a factor that was later deemed non-significant. And probably the most frustrating facet of the paper is that the authors share absolutely no descriptive data about the studies involved in the enrollment analysis. It would be completely impossible to attempt to replicate its methods or verify its analysis. Do the authors believe that "Public Involvement" is only good when it’s not focused on their own work? However, my feelings about the study and paper are an insignificant fraction of the frustration I feel about the public portrayal of the data by people who should clearly know better. After all, limited evidence is still evidence, and every study can add something to our knowledge. But the public misrepresentation of the evidence by leaders in the area can only do us harm: it has the potential to actively distort research priorities and funding. Why This Matters We all seem to agree that research is too slow. Low clinical trial enrollment wastes time, money, and the health of patients who need better treatment options. However, what's also clear is that we lack reliable evidence on what activities enable us to accelerate the pace of enrollment without sacrificing quality. If we are serious about improving clinical trial accrual, we owe it to our patients to demand robust evidence for what works and what doesn’t. Relying on weak evidence that we've already solved the problem ("we've tripled enrollment!") or have a method to magically solve it ("PPI quadrupled enrollment!") will cause us to divert significant time, energy, and human health into areas that are politically favored but less than certain to produce benefit. And the overhyping those results by research leadership compounds that problem substantially. NIHR leadership should reconsider its approach to public discussion of its research, and practice what it preaches: critical assessment of the data. [Update Sept. 20: The authors of the study have posted a lengthy comment below. My follow-up is here.] [Image via flikr user Elliot Brown.] Ennis L, & Wykes T (2013). Impact of patient involvement in mental health research: longitudinal study. The British journal of psychiatry : the journal of mental science PMID: 24029538 Full Article NIHR patient recruitment trial delays UK trials
& Can a Form Letter from FDA "Blow Your Mind"? By www.placebocontrol.com Published On :: Mon, 06 Jan 2014 22:14:00 +0000 Adam Feuerstein appears to be a generally astute observer of the biotech scene. As a finance writer, he's accosted daily with egregiously hyped claims from small drug companies and their investors, and I think he tends to do an excellent job of spotting cases where breathless excitement is unaccompanied by substantive information. However, Feuerstein's healthy skepticism seems to have abandoned him last year in the case of a biotech called Sarepta Therapeutics, who released some highly promising - but also incredibly limited - data on their treatment for Duchenne muscular dystrophy. After a disappointing interaction with the FDA, Sarepta's stock dropped, and Feuerstein appeared to realize that he'd lost some objectivity on the topic. However, with the new year comes new optimism, and Feuerstein seems to be back to squinting hard at tea leaves - this time in the case of a form letter from the FDA. He claims that the contents of the letter will "blow your mind". To him, the key passage is: We understand that you feel that eteplirsen is highly effective, and may be confused by what you have read or heard about FDA's actions on eteplirsen. Unfortunately, the information reported in the press or discussed in blogs does not necessarily reflect FDA's position. FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular. Feuerstein appears to think that the fact that FDA "has reached no conclusions" may mean that it may be "changing its mind". To which he adds: "Wow!" Adam Feuerstein: This time, too much froth, not enough coffee? I'm not sure why he thinks that. As far as I can tell, the FDA will never reach a conclusion like this before its gone through the actual review process. After all, if FDA already knows the answer before the full review, what would the point of the review even be? It would seem a tremendous waste of agency resources. Not to mention how non-level the playing field would be if some companies were given early yes/no decisions while others had to go through a full review. It seems fair to ask: is this a substantive change by FDA review teams, or would it be their standard response to any speculation about whether and how they would approve or reject a new drug submission? Can Feuerstein point to other cases where FDA has given a definitive yes or no on an application before the application was ever filed? I suspect not, but am open to seeing examples. A more plausible theory for this letter is that the FDA is attempting a bit of damage control. It is not permitted to share anything specific it said or wrote to Sarepta about the drug, and has come under some serious criticism for “rejecting” Sarepta’s Accelerated Approval submission. The agency has been sensitive to the DMD community, even going so far as to have Janet Woodcock and Bob Temple meet with DMD parents and advocates last February. Sarepta has effectively positioned FDA as the reason for it’s delay in approval, but no letters have actually been published, so the conversation has been a bit one-sided. This letter appears to be an attempt at balancing perspectives a bit, although the FDA is still hamstrung by its restriction on relating any specific communications. Ultimately, this is a form letter that contains no new information: FDA has reached no conclusions because FDA is not permitted to reach conclusions until it has completed a fair and thorough review, which won't happen until the drug is actually submitted for approval. We talk about "transparency" in terms of releasing clinical trials data, but to me there is a great case to be made for increase regulatory transparency. The benefits to routine publication of most FDA correspondence and meeting results (including such things as Complete Response letters, explaining FDA's thinking when it rejects new applications) would actually go a long way towards improving public understanding of the drug review and approval process. Full Article accelerated approval Adam Feuerstein DMD FDA Sarepta Therapeutics transparency
& Cat's Eye Camera Can See Through Camouflage By spectrum.ieee.org Published On :: Thu, 19 Sep 2024 14:30:06 +0000 Did that rock move, or is it a squirrel crossing the road? Tracking objects that look a lot like their surroundings is a big problem for many autonomous vision systems. AI algorithms can solve this camouflage problem, but they take time and computing power. A new camera designed by researchers in South Korea provides a faster solution. The camera takes inspiration from the eyes of a cat, using two modifications that let it distinguish objects from their background, even at night. “In the future … a variety of intelligent robots will require the development of vision systems that are best suited for their specific visual tasks,” says Young Min Song, a professor of electrical engineering and computer science at Gwangju Institute of Science and Technology and one of the camera’s designers. Song’s recent research has been focused on using the “perfectly adapted” eyes of animals to enhance camera hardware, allowing for specialized cameras for different jobs. For example, fish eyes have wider fields of view as a consequence of their curved retinas. Cats may be common and easy to overlook, he says, but their eyes actually offer a lot of inspiration.This particular camera copied two adaptations from cats’ eyes: their vertical pupils and a reflective structure behind their retinas. Combined, these allowed the camera to be 10 percent more accurate at distinguishing camouflaged objects from their backgrounds and 52 percent more efficient at absorbing incoming light.Using a vertical pupil to narrow focus While conventional cameras can clearly see the foreground and background of an image, the slitted pupils of a cat focus directly on a target, preventing it from blending in with its surroundings. Kim et al./Science AdvancesIn conventional camera systems, when there is adequate light, the aperture—the camera’s version of a pupil—is small and circular. This structure allows for a large depth of field (the distance between the closest and farthest objects in focus), clearly seeing both the foreground and the background. By contrast, cat eyes narrow to a vertical pupil during the day. This shifts the focus to a target, distinguishing it more clearly from the background.The researchers 3D printed a vertical slit to use as an aperture for their camera. They tested the vertical slit using seven computer vision algorithms designed to track moving objects. The vertical slit increased contrast between a target object and its background, even if they were visually similar. It beat the conventional camera on five of the seven tests. For the two tests it performed worse than the conventional camera, the accuracies of the two cameras were within 10 percent of each other. Using a reflector to gather additional light Cats can see more clearly at night than conventional cameras due to reflectors in their eyes that bring extra light to their retinas.Kim et al./Science AdvancesCat eyes have an in-built reflector, called a tapetum lucidum, which sits behind the retina. It reflects light that passes through the retina back at it, so it can process both the incoming light and reflected light, giving felines superior night vision. You can see this biological adaptation yourself by looking at a cat’s eyes at night: they will glow.The researchers created an artificial version of this biological structure by placing a silver reflector under each photodiode in the camera. Photodiodes without a reflector generated current when more than 1.39 watts per square meter of light fell on them, while photodiodes with a reflector activated with 0.007 W/m2 of light. That means the photodiode could generate an image with about 1/200th the light. Each photodiode was placed above a reflector and joined by metal electrodes to create a curved image sensor.Kim et al./Science AdvancesTo decrease visual aberrations (imperfections in the way the lens of the camera focuses light), Song and his team opted to create a curved image sensor, like the back of the human eye. In such a setup, a standard image sensor chip won’t work, because it’s rigid and flat. Instead it often relies on many individual photodiodes arranged on a curved substrate. A common problem with such curved sensors is that they require ultrathin silicon photodiodes, which inherently absorb less light than a standard imager’s pixels. But reflectors behind each photodiode in the artificial cat’s eye compensated for this, enabling the researchers to create a curved imager without sacrificing light absorption. Together, vertical slits and reflectors led to a camera that could see more clearly in the dark and isn’t fooled by camouflage. “Applying these two characteristics to autonomous vehicles or intelligent robots could naturally improve their ability to see objects more clearly at night and to identify specific targets more accurately,” says Song. He foresees this camera being used for self-driving cars or drones in complex urban environments.Song’s lab is continuing to work on using biological solutions to solve artificial vision problems. Currently, they are developing devices that mimic how brains process images, hoping to one day combine them with their biologically-inspired cameras. The goal, says Song, is to “mimic the neural systems of nature.”Song and his colleague’s work was published this week in the journal Science Advances.This article appears in the November 2024 print issue. Full Article Image sensors Biomimicry Night vision Cameras
& AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges? By medcitynews.com Published On :: Thu, 07 Nov 2024 15:09:00 +0000 Navigating the regulatory and ethical requirements of different medical data providers across many different countries, as well as safeguarding patient privacy, is a mammoth task that requires extra resources and expertise. The post AI is Revolutionizing Healthcare, But Are We Ready for the Ethical Challenges? appeared first on MedCity News. Full Article Artificial Intelligence Daily Health IT MedCity Influencers AI AI bias bias challenges discrimination ethics health IT
& Inside Providence’s Health Equity & Medicaid Strategy By medcitynews.com Published On :: Sun, 10 Nov 2024 20:10:11 +0000 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. Full Article Health Tech Hospitals Providers health equity HLTH HLTH 2024 HLTH Events Medicaid Providence
& J&J must pay $19m to man who says its talc caused his cancer, jury finds By www.asiaone.com Published On :: Wed, 16 Oct 2024 09:54:11 +0800 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. Full Article
& 'I try not to think about myself': Woman battles breast cancer while caring for mum who has gall bladder cancer By www.asiaone.com Published On :: Sat, 19 Oct 2024 09:18:00 +0800 To mark Breast Cancer Awareness Month, we speak to inspiring Singaporeans about their journey in battling and overcoming cancer. Warda Ismail gets anxious about things easily, especially when it comes to her health. So much so that her doctor once told her that she is a "borderline hypochondriac", she shared with AsiaOne in an interview. For the uninitiated, hypochondria is a condition where a person is excessively and unduly worried about having a serious illness. To keep her mind at ease, the 44-year-old preschool educator has the habit of going for regular medical checkups. Though she was vigilant, her worst nightmare came true — she was diagnosed with breast cancer on May 8 this year. And in the midst of her recovery journey, she got more terrible news — her mother, who had been caring for her, was diagnosed with stage-three gall bladder cancer. Despite the string of unfortunate events, Warda persevered and tried to have a more positive outlook on life and her health. Full Article
& McDonald's E. coli crisis reveals why vegetable contamination is harder problem than tainted beef By www.asiaone.com Published On :: Sat, 26 Oct 2024 10:29:00 +0800 NEW YORK – Moves by major US fast-food chains to temporarily scrub fresh onions off their menus on Oct 24, after the vegetable was named as the likely source of an E. coli outbreak at McDonald’s, laid bare the recurring nightmare for restaurants: Produce is a bigger problem for restaurants to keep free of contamination than beef. Onions are likely the culprit in the McDonald’s E. coli outbreak across the Midwest and some Western states that has sickened 49 people and killed one, the US Department of Agriculture said late on Oct 23. The company pulled the Quarter Pounder off its menu at one-fifth of its 14,000 US restaurants. In past years, beef patties dominated the dockets of food-borne-illness lawyers, before US federal health regulators cracked down on beef contamination after an E. coli outbreak linked to Jack in the Box burgers hospitalised more than 170 people across states and killed four. As a result, beef-related outbreaks became much rarer, experts say. Full Article
& McDonald's rules out beef patties as source of E. coli outbreak By www.asiaone.com Published On :: Mon, 28 Oct 2024 12:07:54 +0800 NEW YORK — McDonald's on Sunday (Oct 27) ruled out beef patties as a source of the E. coli outbreak linked to Quarter Pounder hamburgers, which has killed at least one person and sickened nearly 75 others. "We remain very confident that any contaminated product related to this outbreak has been removed from our supply chain and is out of all McDonald's restaurants," the fast-food chain's chief supply chain officer Cesar Pina said in a statement. The Colorado Department of Agriculture said that all subsamples from multiple lots of McDonald's brand fresh and frozen beef patties had tested negative for E. coli, adding that it had completed beef testing and does not anticipate receiving further samples. McDonald's said it would resume distribution of fresh supplies of the Quarter Pounder and that it is expected to be available in all restaurants in the coming week, according to the statement. Full Article
& Onions were likely source of McDonald's E. coli outbreak, US CDC says By www.asiaone.com Published On :: Thu, 31 Oct 2024 09:40:34 +0800 The US Centers for Disease Control and Prevention said on Wednesday that slivered onions served on McDonald's, opens new tab Quarter Pounder hamburgers and other menu items were the likely source of an E. coli outbreak that sickened 90 people. The outbreak linked to Quarter Pounder was first reported on Oct 22, and slivered onions were suspected to be the source of the infections. The US Food and Drug Administration and the company have confirmed that Taylor Farms was the supplier for the affected locations, and it has since recalled several batches of yellow onions produced in a Colorado facility. The FDA on Wednesday said it had initiated inspections at a Taylor Farms processing center in Colorado, a state where 29 people have fallen ill due to the outbreak. An onion grower of interest in Washington state is also being investigated, the FDA added. The CDC said the number of infected people has risen by 15 people from 75 and 27 persons have been hospitalised due to the illness, which has already killed one person. Full Article
& David Duchovny and Gillian Anderson didn't speak to each other for 'weeks at a time' while working on The X Files By www.asiaone.com Published On :: Tue, 12 Nov 2024 10:17:31 +0800 David Duchovny and Gillian Anderson didn't speak to each other for "weeks at a time" when they worked on The X Files. The 64-year-old actor and Gillian, 56, enjoyed huge success with the iconic sci-fi series — but the duo actually had a turbulent relationship for many years. David said on the Fail Better podcast: "There was a long time, working on the show, where we were just not even dealing with one another off-camera. And there was a lot of tension. Which didn't matter, apparently, for the work cause we're both f****** crazy, I guess. We could just go out there and do what we needed to do." Gillian was amazed that they achieved so much success while their off-screen relationship was so tense. Full Article
& Michelle Yeoh hadn't heard of musical Wicked before being asked to join cast of movie By www.asiaone.com Published On :: Tue, 12 Nov 2024 12:14:38 +0800 Michelle Yeoh had never heard of Wicked before she was asked to join the cast of the movie-musical. The Oscar-winning actress plays Madame Morrible in the new film version of the hit stage show, which is based around characters first seen on screen in 1939 movie The Wizard of Oz. She's confessed she knew nothing about the popular musical before she was approached by director Jon M. Chu about joining the cast. According to The Hollywood Reporter, she said: "At that point, I had no clue what he was talking about because I had not seen Wicked the musical before. I knew Wizard of Oz, who doesn't, but not Wicked because I hadn't been going to the theatres and was not doing what I love which is watching musicals for quite a while, I hate to say." The new movie stars Cynthia Erivo as Elphaba and Ariana Grande as Glinda during their time at Shiz University in the Land of Oz with Michelle's character Madame Morrible serving as the school's headmistress. Michelle went on to say: "So I read it [the script] and called Jon back and said, 'This is a musical and she sings'. And he said, 'Oh easy, you'll have fun, you're up for the challenge.' Full Article
& Blackpink's Lisa holds 1st Singapore fan-meet; fans fight over signed T-shirts while others dress up for chance to meet her By www.asiaone.com Published On :: Tue, 12 Nov 2024 17:03:00 +0800 Monday blues were non-existent at the Singapore Indoor Stadium yesterday (Nov 11) as fans of Blackpink's Lisa strolled into the venue in their Y2K-style outfits inspired by the Thai singer's Rockstar music video. Singapore was the first stop for the 27-year-old's first solo fan-meet tour and needless to say, the excitement could be felt, and heard. Once the lights turned off and Lisa appeared, the screams were deafening. The show started with a bang, fittingly with her self-titled hit song Lalisa. Usually at fan-meets of K-pop idols, the special effects are kept to a minimum unlike concerts. PHOTO: UnUsUaL Entertainment But at Lisa's, the performances were elevated with bursts of pyrotechnics and visual effects. After the first song, she sat down for a few interactive segments. During Welcome Lisa, she tried local delicacies like kaya toast and chicken rice. Full Article
& Armie Hammer's mum got him a vasectomy for his birthday By www.asiaone.com Published On :: Wed, 13 Nov 2024 10:35:52 +0800 Armie Hammer's mom got him a vasectomy for his birthday. The Call Me by Your Name actor — who has two children, Harper, nine, and Ford, seven, with his ex-wife Elizabeth Chambers — has revealed the bizarre gift Dru Hammer got him for his 38th birthday in August. Speaking to his mom on the second episode of a two-part chat on his new podcast Armie HammerTime Podcast, she said: "Let's talk about what I gave you for your birthday this year." She continued: "I call Armie, and I go, 'What would you like for your birthday this year?' He was like, 'I don't know. Maybe money. Whatever.' And I was like, 'I believe I'm going to give you a vasectomy.'" Full Article
& Teen in critical condition with Canada's first presumptive human case of bird flu By www.asiaone.com Published On :: Wed, 13 Nov 2024 09:30:33 +0800 TORONTO — A teenager is in critical condition in a British Columbia children's hospital, sick with Canada's first presumptive human case of avian influenza. "This was a healthy teenager prior to this, so no underlying conditions," said provincial health officer Bonnie Henry in a news conference on Tuesday (Nov 12). "It just reminds us that in young people this is a virus that can progress and cause quite severe illness and the deterioration that I mentioned was quite rapid." British Columbia health officials said on Saturday the province had detected Canada's first human case of H5 bird flu in a teenager. Full Article