ph Rode's tiny $149 Wireless Micro kit is designed for smartphone users By www.engadget.com Published On :: Tue, 12 Nov 2024 15:00:40 +0000 Rode has announced the Wireless Micro, a two-mic kit with a smartphone receiver and charging case that costs just $149. The idea is to help TikTok and other creators capture much better-quality audio than their smartphone's microphone can offer. The receiver unit connects to the bottom of your smartphone via a USB-C or lightning port. Meanwhile, the microphones (aka transmitters) attach to the subject via integrated clips or magnetic attachments, then capture what Rode calls "pristine" quality sound. Specifically, they offer a 20-20 kHz frequency range and 73 dB signal-to-noise ratio, with a transmission range around 330 feet. Rode To use it, simply connect the receiver to your iOS or Android device and it will take over as the system microphone. From there, everything is automatic, as the transmitter mics are automatically paired to the receiver and sound will be captured to your camera app of choice. Levels are automatically controlled with the company's GainAssist technology. The omnidirectional transmitters weigh just 12 grams (0.42 ounces) and are tiny enough to be discreet when clipped onto your subject. The built-in microphones use what Rode calls "acoustic chambers" with a patent-pending design. That supposedly lets you capture clear and intelligible audio while reducing wind noise, though a pair of windmuffs is also included in the kit. Rode The Wireless Micro also includes a charging case that delivers two full recharges for up to 18 hours of battery life, while giving you a secure place to store everything. There are a few things missing, though. You can't connect an external mic to the transmitters, unlike with other Rode wireless mics or the DJI Mic 2. There's no smartphone Bluetooth capability, and it doesn't offer a 3.5mm connection for cameras — a feature that will supposedly exist on the rumored DJI Mic Mini. Still, this looks like a great option for creators who primarily use smartphones. It's now available in a two mic kit with a receiver and charging case for $150. This article originally appeared on Engadget at https://www.engadget.com/audio/rodes-tiny-149-wireless-micro-kit-is-designed-for-smartphone-users-150040695.html?src=rss Full Article Audio Technology Technology & Electronics site|engadget provider_name|Engadget region|US language|en-US author_name|Steve Dent
ph NFL : les Dolphins renouent avec la victoire By www.journaldemontreal.com Published On :: Mon, 11 Nov 2024 23:17:38 EST Miami a empêché les Rams de Los Angeles d’inscrire un touché et l’a emporté 23 à 15, lundi soir, au SoFi Stadium. Full Article
ph Cillian Murphy on the making of Small Things Like These By www.cbc.ca Published On :: Fri, 08 Nov 2024 17:56:14 EST Speaking with CBC News’s Eli Glasner, Cillian Murphy discusses ‘imploding emotionally’ in his role in Small Things Like These, his partnership with Matt Damon and Ben Affleck and how his experience on Oppenheimer influenced this film. CORRECTION: A previous version of this video interview includes reference to communities in Canada 'still finding bodies of Indigenous children in the ground' at 1:24. We have removed this portion of the interview. Searches at the sites of former residential schools using ground-penetrating radar have found evidence of possible unmarked graves. Full Article
ph Lockout at Port of Montreal could be 'catastrophic' for economy, port authority says By www.cbc.ca Published On :: Mon, 11 Nov 2024 08:48:11 EST A lockout at the Port of Montreal began Sunday night. The CEO of the Montreal Port Authority says if the dispute between dockworkers and the Maritime Employers Association drags on, it will have disastrous consequences for the economy. Full Article News/Canada/Montreal
ph «ALPHAS»: le masculiniste Joël McGuirk déplore la décision de le «désinviter» de «Tout le monde en parle» By www.journaldemontreal.com Published On :: Mon, 11 Nov 2024 18:15:00 EST Joël McGuirk a dénoncé son retrait imprévu du dernier plateau de «Tout le monde en parle», lundi, au micro de Sophie Durocher, à QUB radio. Full Article
ph Earthquake hits Philippines island By www.heraldsun.com.au Published On :: Tue, 10 Jan 2017 06:49:00 GMT BREAKING: A major undersea earthquake measuring 7.3 has struck the Philippines southeast of the island Jolo. Full Article
ph Apple’s biggest product since the iPhone By www.heraldsun.com.au Published On :: Wed, 11 Jan 2017 08:34:00 GMT APPLE could be set to make its biggest new product announcement since the iPhone, with the company believed to be working on a game changer. Full Article
ph Phoenix soaring above the rest By www.dailytelegraph.com.au Published On :: Mon, 30 May 2016 23:45:00 GMT ‘Self-taught’ athlete Phoenix Martin is a gold medal winner thanks to his determination to succeed, and the help of his coach...his dad. Full Article
ph Future stars bring home trophy By www.dailytelegraph.com.au Published On :: Thu, 16 Jun 2016 01:28:00 GMT Seth Messingham from Hornsby North Public School and Zac “Nugget” Bovis from Berowra Public School represented North Sydney in the NSW PSSA Boy’s football State Carnival at Valentine Sports Park in Glenwood to secure a win North Sydney hasn’t seen since 1969. Full Article
ph 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
ph 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
ph 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
ph 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
ph 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
ph Indian pharma stresses for enhanced fire safety measures and improved insurance coverage for employees By www.pharmabiz.com Published On :: Wednesday, November 13, 2024 08:00 IST The Indian pharmaceutical industry is advocating for enhanced fire safety measures and improved insurance coverage for employees working in pharmaceutical facilities. Full Article
ph The role of surface preparation in the application of hydrophilic and hydrophobic coatings By www.medicalplasticsnews.com Published On :: Thu, 07 Nov 2024 16:30:00 -0000 Joe Anderson, product and promotional marketing manager at Harland, explores the role of surface preparation in the application of hydrophilic and hydrophobic coatings. Full Article
ph 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
ph Leaders in Pharma: Thermo Fisher By www.medicalplasticsnews.com Published On :: Tue, 12 Nov 2024 10:00:00 -0000 In this episode of The MedTalk Podcast, we're bringing you something a little different. One of our sister publications, European Pharmaceutical Manufacturer, secured an interview with Thermo Fisher Scientific's Urmi Prasad Richardson. Full Article
ph Catastrophic Floods in Spain Kill at Least 95 People By www.scientificamerican.com Published On :: Thu, 31 Oct 2024 16:00:00 +0000 Torrential rain, made worse by climate change, has lashed Spain, with Valencia bearing the brunt of the floodwaters Full Article
ph Phone Attachment for Pupil Measurements with Any Skin Tone By www.medgadget.com Published On :: Mon, 20 Nov 2023 22:43:00 +0000 A research team at the University of California San Diego have developed a smartphone attachment that can provide information on changes in pupil size, which can be used to assess neurological phenomena, such as traumatic brain injury and Alzheimer’s disease. Such changes in pupil size have been difficult to characterize in the past in those […] Full Article Ophthalmology UCSD
ph Available for Preorder: The 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors By feeds.feedblitz.com Published On :: Tue, 17 Sep 2024 10:30:00 +0000 On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our fifteenth edition—remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. 9 chapters, 350+ pages, 178 exhibits, 750+ endnotes: There is nothing else available that comes close to this valuable resource. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2024-25 edition at special discounted prices. This means that you can be among the first to access our new report. Those who preorder will receive a download link before October 8. Review pricing/license options and place a preorder Download a free pre-publication report overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits) You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH. Special preorder and launch pricing discounts will be valid through October 23, 2024. Read on for more details. Read more » Full Article Biosimilars Buy-and-Bill Channel Management Group Purchasing Organizations (GPOs) Industry Trends Inflation Reduction Act of 2022 Physicians Specialty Drugs Wholesalers
ph 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
ph 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
ph NOW AVAILABLE: 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors By feeds.feedblitz.com Published On :: Tue, 08 Oct 2024 10:30:00 +0000 I am pleased to announce Drug Channels Institute's new 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors, available for purchase and immediate download. Download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) Review pricing/license options and download the full 2024-25 report We’re offering special discounted pricing if you order before October 23, 2024. 2024–25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors—our 15th edition--remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. This 2024-25 edition includes substantial new material—outlined on page vii of the report overview. 9 chapters, 380+ pages, 178 exhibits, more than 750 endnotes: There is nothing else available that comes close to this valuable resource. You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. Click here to contact us if you would like to pay by corporate check or ACH.Email Paula Fein (paula@drugchannels.net) if you’d like to bundle your report purchase with access to DCI’s video webinars. If you preordered the report, you should have already received an email with download instructions last week. Please contact us if you did not receive your email. Read on for some additional details. Read more » Full Article Industry Trends Wholesalers
ph Drug Channels News Roundup, October 2024: Humira Price War Update, PA vs. Providers, IRA vs. Physicians, My AI Podcast, New DCI Jobs, and Dr. G on Copayments By feeds.feedblitz.com Published On :: Tue, 29 Oct 2024 10:30:00 +0000 Eeek! It's time for Drug Channels’ Halloween roundup of terrifying tales to share with your ghoulish fiends. This month’s tricks and treats: Spooky! Blue Shield of California frightens away the gross-to-net bubble with its Humira biosimilar strategy Vampiric! Prior authorization sinks its fangs into providers’ time Wicked! How the IRA will put a stake through specialty physician practices Eerie! Google’s monstrous AI podcasts leave me petrified Zoinks! Join the vampire hunters at Drug Channels Institute Plus, Dr. Glaucomflecken tells us a frightening tale of copayments. P.S. Stretch out your arms and join the ever-growing zombie horde who shamble after me on LinkedIn. You’ll find my ghostly rantings along with commentary from the undead hordes in the DCI community. Read more » Full Article Average Sales Price (ASP) Biosimilars Buy-and-Bill Gross-to-Net Bubble Inflation Reduction Act of 2022 PBMs Physicians
ph Michelle E. Tarver, M.D., Ph.D. By www.flickr.com Published On :: Wed, 21 Aug 2024 08:42:37 -0700 The U.S. Food and Drug Administration posted a photo: Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Acting Center Director of the Center for Devices and Radiological Health (CDRH). She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture. Dr. Tarver has held various leadership positions while at the FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation, and the Program Director of Patient Science and Engagement. Learn more at www.fda.gov This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required. For more privacy and use information visit: www.flickr.com/people/fdaphotos/ Full Article
ph Orphan Drugs at 30: Will Success Become Too Expensive? By www.fdamatters.com Published On :: Mon, 14 Jan 2013 19:09:11 +0000 The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact. Amidst the celebrations, a reporter asked me a provocative question: can we afford more orphan drugs costing hundreds of thousands of dollars per year? FDA Matters answered “yes.” However, I added a caveat that should worry everyone eager for orphan drugs to succeed. When genomics and personalized medicine become successful, this will multiply the number of rare diseases and the overall cost of orphan drugs, perhaps beyond what the system can bear. Full Article FDA and Congress FDA and Industry Orphan Drugs
ph 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
ph 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
ph Pharmacy negotiators in talks over plans to distribute COVID-19 treatments in primary care By www.pharmaceutical-journal.com Published On :: Wed, 10 Feb 2021 15:25 GMT The Pharmaceutical Services Negotiating Committee is in talks with the government over potential plans to distribute COVID-19 treatments in primary care. Full Article
ph 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
ph 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
ph 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
ph 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
ph RPS pays tribute to pharmacy law and ethics pioneer Joy Wingfield By www.pharmaceutical-journal.com Published On :: Fri, 19 Feb 2021 16:10 GMT The Royal Pharmaceutical Society has expressed its sadness at the death of Joy Wingfield, honorary professor of Pharmacy Law and Ethics at the University of Nottingham. Full Article
ph Pharmacology: The Anchor for Nearly Every Diligence By lifescivc.com Published On :: Thu, 25 Apr 2024 11:00:33 +0000 By Haojing Rong and Aimee Raleigh, as part of the From The Trenches feature of LifeSciVC This blog post is the second in a series on key diligence concepts and questions. If you missed the intro blog post yesterday, click The post Pharmacology: The Anchor for Nearly Every Diligence appeared first on LifeSciVC. Full Article Biotech investment themes Drug discovery From The Trenches Science & Medicine Translational research Efficacy IVIVc PD pharmacology PK
ph Mariana Oncology’s Radiopharm Platform Acquired By Novartis By lifescivc.com Published On :: Mon, 06 May 2024 10:42:46 +0000 Novartis recently announced the acquisition of Mariana Oncology, an emerging biotech focused on advancing a radioligand therapeutics platform, for up to $1.75 billion in upfronts and future milestones. The capstone of its three short years of operations, this acquisition represents The post Mariana Oncology’s Radiopharm Platform Acquired By Novartis appeared first on LifeSciVC. Full Article Exits IPOs M&As Leadership Portfolio news Talent #RLT Mariana Oncology Novartis radioligand therapy Radiopharm
ph 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
ph Brave New Biopharm Blogging By www.placebocontrol.com Published On :: Wed, 25 Sep 2013 19:14:00 +0000 Although a few articles on this site are older, I really only began blogging in earnest about 15 months ago. However, I suppose that's long enough that I can count myself as at least somewhat established, and take a moment to welcome and encourage some interesting newcomers to the scene. Bloggers in dank basements their natural habitat. There are 3 relative newcomers that I've found really interesting, all with very different perspectives on drug development and clinical research: Pharmagellan The Big Pharma insider. With the exception of John LaMattina (the former Pfizer exec who regularly provides seriously thought provoking ideas over on Forbes), I don’t know of anyone from the ranks of Big Pharma who writes both consistently and well. Which is a shame, given how many major past, current, and future therapies pass through those halls. Enter Frank David, the Director of Strategy at AstraZeneca's Oncology Innovative Medicines unit. Frank started his Pharmagellan blog this April, and has been putting out a couple thoughtful perspective pieces a month since then. Frank also gets my vote for most under-followed Twitter account in the industry, as he’s putting out a steady stream of interesting material. ClinOps Toolkit Getting trials done. Clinical operations – the actual execution of the clinical trials we all talk about – is seriously underrepresented in the blogosphere. There are a number of industry blogs, but none that aren’t trying first and foremost to sell you something. I met Nadia Bracken on my last trip out to the San Francisco bay area. To say Nadia is driven is to make a rather silly understatement. Nadia is driven. She thinks fast and she talks fast. ClinOps Toolkit is a blog (or resource? or community?) that is still very much in development, but I think it holds a tremendous amount of potential. People working in ClinOps should be embracing her, and those of us who depend on operations teams getting the job done should keep a close eye on the website. Other Secrets of the Buy Side Watching the money. I am not a stock trader. I am a data person, and data says trust big sample sizes. And, honestly, I just don't have the time. But that doesn't stop me from realizing that a lot of great insight about drug development – especially when it concerns small biotechs – is coming from the investment community. So I tend to follow a number of financial writers, as I've found that they do a much better job of digging through the hype than can ever be expected of the mainstream media. One stock writer who I've been following for a while is Andrew Goodwin, who maintains the Biotech Due Diligence website and blog. Andrew clearly has a great grasp on a number of topics, so when he described a new blog as a “must-have addition” to one's reading list, I had to take a look. And the brand-new-this-month blog, by David Sable at Special Situations Fund, does seem like a great read. David looks both at the corporate dynamics and scientific stories of biotechs with a firmly skeptical view. I know most blogs this new will not be around 6 months from now (and David admits as much in his opening post), but I’m hoping this one lasts. . . . . . So, I encourage you to take a look at the above 3 blogs. I'm happy to see more and diverse perspectives on the drug development process starting to emerge, and hope that all 3 of these authors stick around for quite a while – we need their ideas. [Bloggerhole photo courtesy of Flikr user second_mouse.] Full Article big pharma drug development operations
ph Next-Gen Brain Implant Uses a Graphene Chip By spectrum.ieee.org Published On :: Sat, 20 Jul 2024 13:00:02 +0000 A Barcelona-based startup called Inbrain Neuroelectronics has produced a novel brain implant made of graphene and is gearing up for its first in-human test this summer. The technology is a type of brain-computer interface. BCIs have garnered interest because they record signals from the brain and transmit them to a computer for analysis. They have been used for medical diagnostics, as communication devices for people who can’t speak, and to control external equipment, including robotic limbs. But Inbrain intends to transform its BCI technology into a therapeutic tool for patients with neurological issues such as Parkinson’s disease.Because Inbrain’s chip is made of graphene, the neural interface has some interesting properties, including the ability to be used to both record from and stimulate the brain. That bidirectionality comes from addressing a key problem with the metallic chips typically used in BCI technology: Faradaic reactions. Faradaic reactions are a particular type of electrochemical processes that occurs between a metal electrode and an electrolyte solution. As it so happens, neural tissue is largely composed of aqueous electrolytes. Over time, these Faradaic reactions reduce the effectiveness of the metallic chips.That’s why Inbrain replaced the metals typically used in such chips with graphene, a material with great electrical conductivity. “Metals have Faraday reactions that actually make all the electrons interact with each other, degrading their effectiveness...for transmitting signals back to the brain,” said Carolina Aguilar, CEO and cofounder of Inbrain. Because graphene is essentially carbon and not a metal, Aguilar says the chip can inject 200 times as much charge without creating a Faradic reaction. As a result, the material is stable over the millions of pulses of stimulation required of a therapeutic tool. While Inbrain is not yet testing the chip for brain stimulation, the company expects to reach that goal in due time.The graphene-based chip is produced on a wafer using traditional semiconductor technology, according to Aguilar. At clean-room facilities, Inbrain fabricates a 10-micrometer-thick chip. The chip consists of what Aguilar terms “graphene dots” (not to be confused with graphene quantum dots) that range in size from 25 to 300 micrometers. “This micrometer scale allows us to get that unique resolution on the decoding of the signals from the brain, and also provides us with the micrometric stimulation or modulation of the brain,” added Aguilar.Testing the Graphene-Based BCIThe first test of the platform in a human patient will soon be performed at the University of Manchester, in England, where it will serve as an interface during the resection of a brain tumor. When resecting a tumor, surgeons must ensure that they don’t damage areas like the brain’s language centers so the patient isn’t impaired after the surgery. “The chip is positioned during the tumor resection so that it can read, at a very high resolution, the signals that tell the surgeon where there is a tumor and where there is not a tumor,” says Aguilar. That should enable the surgeons to extract the tumor with micrometric precision while preserving functional areas like speech and cognition.Aguilar added, “We have taken this approach for our first human test because it is a very reliable and quick path to prove the safety of graphene, but also demonstrate the potential of what it can do in comparison to metal technology that is used today.”Aguilar stresses that the Inbrain team has already tested the graphene-based chip’s biocompatibility. “We have been working for the last three years in biocompatibility through various safety studies in large animals,” said Aguilar. “So now we can have these green lights to prove an additional level of safety with humans.”While this test of the chip at Manchester is aimed at aiding in brain tumor surgery, the same technology could eventually be used to help Parkinson’s patients. Toward this aim, Inbrain’s system was granted Breakthrough Device Designation last September from the U.S. Food & Drug Administration as an adjunctive therapy for treating Parkinson’s disease. “For Parkinson’s treatment, we have been working on different preclinical studies that have shown reasonable proof of superiority versus current commercial technology in the [reduction] of Parkinson’s disease symptoms,” said Aguilar.For treating Parkinson’s, Inbrain’s chip connects with the nigrostriatal pathway in the brain that is critical for movements. The chip will first decode the intention message from the brain that triggers a step or the lifting of the arm—something that a typical BCI can do. But Inbrain’s chip, with its micrometric precision, can also decode pathological biomarkers related to Parkinson’s symptoms, such as tremors, rigidity, and freezing of the gait. By determining these biomarkers with great precision, Inbrain’s technology can determine how well a patient’s current drug regimen is working. In this first iteration of the Inbrain chip, it doesn’t treat the symptoms of Parkinson’s directly, but instead makes it possible to better target and reduce the amount of drugs that are used in treatment.“Parkinson’s patients take huge amounts of drugs that have to be changed over time just to keep up with the growing resistance patients develop to the power of the drug,” said Aguilar. “We can reduce it at least 50 percent and hopefully in the future more as our devices become precise.” Full Article Graphene Brain computer interface Parkinson's disease Neurotechnology Brain implants
ph Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M By medcitynews.com Published On :: Wed, 06 Nov 2024 22:48:20 +0000 Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome. The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News. Full Article BioPharma Daily Legal Pharma Acadia Pharmaceuticals biopharma nl Daybue FDA priority review voucher Rett syndrome
ph An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance By medcitynews.com Published On :: Mon, 11 Nov 2024 14:47:00 +0000 Top challenges impacting specialty pharmacy outcomes, and how health systems may achieve efficiencies and enhance performance for optimal outcomes. The post An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance appeared first on MedCity News. Full Article BioPharma Daily MedCity Influencers Pharmacy biopharma nl operational efficiency pharmaceuticals pharmacist prescription specialty pharmacy
ph AbbVie Drug Expected to Rival Bristol Myers’s New Schizophrenia Med Flunks Phase 2 Test By medcitynews.com Published On :: Mon, 11 Nov 2024 18:25:01 +0000 AbbVie schizophrenia drug candidate emraclidine failed to beat a placebo in two Phase 2 clinical trials. The drug, once projected to compete with Bristol Myers Squibb’s Cobenfy, is from AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics. The post AbbVie Drug Expected to Rival Bristol Myers’s New Schizophrenia Med Flunks Phase 2 Test appeared first on MedCity News. Full Article BioPharma Daily Pharma AbbVie biopharma nl Cerevel Therapeutics Clinical Trials emraclidine schizophrenia
ph Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry By www.lifescienceslawblog.com Published On :: Tue, 19 Jan 2016 17:34:48 +0000 Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading Full Article Biotechnology FDA Intellectual Property Legislation
ph CMS Cuts Medicare Physician Payments: What It Means By worldofdtcmarketing.com Published On :: Mon, 04 Nov 2024 10:02:18 +0000 The Centers for Medicare and Medicaid Services (CMS) recently announced a 2.9% cut to Medicare physician payments for […] The post CMS Cuts Medicare Physician Payments: What It Means appeared first on World of DTC Marketing. Full Article Cost of healthcare in the U.S. in the news CMS Cuts
ph An Overview of ODS Statistical Graphics in SAS 9.4 By support.sas.com Published On :: 2016-09-16T12:00:00Z This paper presents the essential information that you need to get started with ODS Graphics in SAS 9.4. Full Article
ph Police probing deepfake nude photos of Singapore Sports School students; school meting out disciplinary actions By www.asiaone.com Published On :: Tue, 12 Nov 2024 16:55:49 +0800 SINGAPORE – The police are investigating deepfake nude photos of Singapore Sports School (SSP) students that were created and spread by other students. In response to queries from The Straits Times, school principal Ong Kim Soon said SSP is “aware of the incident involving the creation and sharing of deepfake photos by our student-athletes”. “The school does not condone such harmful behaviour,” he said, adding that it has launched an investigation and lodged a police report. The police, in response to queries from ST, confirmed that a report was lodged and investigations are ongoing. A reader who identified himself as a parent of a victim had alerted ST in an e-mail on Nov 12 about the deepfake nude images that were being circulated. “Many parents of affected female students in Singapore Sports School are making police reports about deepfake nude photos of their daughters generated by male students from the school,” the parent said. When contacted, the parent said that female teachers were also targeted, and that the school has offered affected students counselling. Full Article
ph Philippines says it's under pressure from China to cede claims in South China Sea By www.asiaone.com Published On :: Tue, 12 Nov 2024 16:03:11 +0800 CANBERRA — China is putting ever-greater pressure on the Philippines to cede its sovereign rights in the South China Sea, Secretary of National Defence Gilberto Teodoro said on Nov 12 after a meeting with his Australian counterpart in Canberra. "What we see is an increasing demand by Beijing for us to concede our sovereign rights in the area," he said, adding that the Philippines was a "victim of Chinese aggression". China and the Philippines have sparred repeatedly this year over disputed areas of the South China Sea, including the Scarborough Shoal, one of Asia's most contested features. Teodoro's meeting with his Australian counterpart Richard Marles, their fifth since August 2023, reflects growing security ties between the countries, both of whom have expressed concern about Chinese activity in areas of the South China Sea claimed by the Philippines and other Southeast Asian nations. The two nations signed a strategic partnership in September 2023 and held their first joint sea and air patrols in the South China Sea several months later. The Philippines also joined war games in Australia this year for the first time. Full Article
ph A Couple and Their Country, The Telegraph By ramachandraguha.in Published On :: Sat, 20 May 2023 15:52:15 +0000 I have had a long-standing interest in South Africa, and in 1995 briefly contemplated moving there to work. The country had just had its first multi-racial election, and the great Nelson Mandela had been elected President. I was deeply curious to see, at first-hand, what the land and its people would make of their hard [...] Full Article Biography Enuga S Reddy Judge Robert Broomfield Nelson Mandela Robert Sobukwe Winnie and Nelson by Johnny Steinberg apartheid
ph After Sobers, Who? The Telegraph By ramachandraguha.in Published On :: Sat, 15 Jul 2023 16:01:05 +0000 In one of the first books I read, the writer had posed the question: ‘Who was the greatest all-rounder in the history of cricket?’, before providing this answer: ‘He was a left-arm bowler and a right-hand batsman, who was born in the village of Kirkheaton’. I now forget the title of the book, but remember [...] Full Article Culture A A Thomson Adam Gilchrist Ben Stokes F S Jackson G A Faulkner G H Hardy George Hirst Ian Botham Imran Khan Jacques Kallis Keith Miller Kumar Sangakkara Mahender Singh Dhoni Monty Noble Richard Hadlee Wilfred Rhodes kapil dev