ari Court Bars Florida Tax Return Preparer from Preparing Returns for Others By www.justice.gov Published On :: Wed, 17 Sep 2014 15:40:34 EDT A federal district judge in the U.S. District Court for the Middle District of Florida has permanently barred Jeanne Covington, of Tampa, Florida, and her company, Jeanne’s Tax Preparation and Bookkeeping Inc., from preparing federal income tax returns for others. Full Article OPA Press Releases
ari Sutro Biopharma Reports Updated Data From Ovarian Cancer Study By www.rttnews.com Published On :: Mon, 27 Apr 2020 11:35:52 GMT Sutro Biopharma Inc.'s (STRO) interim phase I updated clinical data for a dose-escalation study of antibody drug-conjugate STRO-002 in ovarian cancer has been encouraging. Full Article
ari FDA Warns Of Risks Related To Use Of Anti-malaria Drugs For COVID-19 By www.rttnews.com Published On :: Mon, 27 Apr 2020 13:03:03 GMT Though it issued an Emergency Use Authorization (EUA) for anti-malaria drugs to treat or prevent coronavirus (COVID-19), the U.S. Food and Drug Administration (FDA) reiterated its warning about the known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems. Full Article
ari CYCC In STOPCOVID, EXEL Hits New High, NVS Trialing Malaria Drug For COVID-19 By www.rttnews.com Published On :: Tue, 21 Apr 2020 05:39:42 GMT Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19. Full Article
ari Promoting Universal Health Coverage: Sharing a Prosperous and Healthy Future By www.apec.org Published On :: Tue, 24 Sep 2019 21:10:00 +0800 Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World. Full Article
ari Statement from the Executive Director of the APEC Secretariat Dr Rebecca Fatima Sta Maria By www.apec.org Published On :: Thu, 31 Oct 2019 09:43:00 +0800 President Sebastián Piñera, Chair of APEC Chile 2019, announced that APEC Leaders’ Week will not be held in Chile this year. Full Article
ari No Need for a Crystal Ball in Some Scenarios By strengthenfda.org Published On :: Fri, 01 May 2020 17:05:32 +0000 FDA — along with NIH, CDC, and other front-line public health agencies — is caught up in the urgent COVID-19 efforts. Appropriately, enormous resources are being devoted to fighting the pandemic and more funding will come, if needed. At the same time, we are getting positive reports on the FDA’s efforts to carry out the […] Full Article Analysis and Commentary appropriations complex planning Resources science vaccine workload
ari Menarini set to acquire Stemline for $677m By www.biopharma-reporter.com Published On :: Thu, 07 May 2020 14:53:00 +0100 Menarini adds Stemlineâs lead product, Elzonris, and its presence in the US with buyout deal. Full Article Markets & Regulations
ari Preparing for Pricing in DTC TV By regulatoryrx.blogspot.com Published On :: Tue, 02 Jul 2019 19:27:00 +0000 UPDATE 2: On August 21, 2019, the government filed a notice of appeal in this case.UPDATE: On July 8, 2019, the judge in the pending litigation described below issued an order setting aside the CMS rule. The full opinion is available here.If nothing changes, the new rule about including drug pricing in TV ads from CMS will go into effect one week from today on July 9, 2019.There are a few wrinkles to keep in mind as we approach this deadline. First, there's a lawsuit pending that could delay the rule's implementation. Second, the operational challenges of abiding by the rule are the biggest hurdle including the expanded 2253 filing requirements. Third, the rule's scope is still unclear. Fourth, the rule doesn't preclude or preempt the PhRMA Principles change from April. Finally, the overlapping but non-identical scope of the rules could lead to some confusion and compliance hiccups. This post addresses each of these points in turn.Pending LitigationAs I noted in a previous post, several pharmaceutical companies along with the Association of National Advertisers filed a complaint seeking to overturn the CMS rule. The full complaint is available here. The plaintiffs have filed a motion to stay the rule's implementation, and the judge has set a date of July 8 for issuing a decision. So, it is possible that companies will not actually be required to include their drug pricing in TV spots on July 9; however, as a practical matter, companies airing spots on July 9 and soon thereafter have most likely already developed them with the required pricing information included. All promotional materials for prescription drugs, biologics, and vaccines must be submitted to the FDA at time of initial dissemination or publication, so the FDA has most likely already begun receiving submissions of TV spots that include the information, and it is unlikely that a company would go to the time and expense of producing two versions of their TV spots (one with the pricing and one without) and submit both the FDA, only to determine on July 8 which spot to air the next day. Consequently, even if the judge issues a stay on the rule, there's a good chance that you'll see at least a few TV spots featuring pricing on July 9.And that points to one of the issues the rule raises: operational challenges.Operational Challenges Adding a line of copy to a TV ad is not a massive creative endeavor, and because the rule only requires the copy to appear on screen for a long enough time to be read, there are no audio implications, but the CMS rule requires that the pricing information presented is kept up to date. Specifically, the new rule requires that the pricing information provided be:"as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast." 42 CFR 403.1202 (not yet live on the code of federal regulations itself).That means the pricing information must potentially be updated every quarter. Of course, most companies don't change their drug pricing quarterly, but it is common to have pricing updates twice per year. So, every time a company changes its pricing, it will have to determine what ads are currently airing and whether the pricing updates affect those ads. If the pricing changes affect the ads, then the ads will have to be updated. An updated TV ad both means an expense for the advertiser, but it also means a new 2253 filing with the FDA because updated materials must be resubmitted to the Agency.And that means that the media buyers placing the ads will have one additional wrinkle to keep in mind as they manage the ad placements. They'll need to make sure that as new pricing comes into affect and ads are updated that the old ads are removed from the rotation, lest they be placed on CMS's naughty list.That operational challenge is compounded by the fact that the scope of the rule is unclear, so it's not currently possible to say exactly what ads must include drug pricing.Rule Scope UnclearAs I noted in a previous post, CMS made it clear that the requirement to include pricing does not apply to ALL direct to consumer (DTC) ads, but only to a limited subset of DTC ads. Specifically, the new requirement applies to only ads that appear on broadcast, cable, satellite, and streaming television. Unfortunately, CMS never explained what "streaming television" is. I tried to find a definition somewhere but wasn't able to do so. This matters because there are tons of DTC video ads that MIGHT be considered subject to the rule that are definitely not presented on "broadcast, cable, or satellite television."Because of this scope unclarity, the operational challenges of managing ad inventory is compounded, and of course, companies must decide how to handle ads that are used on television when they appear in places where the pricing information is not required. It would certainly be easier to develop a version of the ad that doesn't require quarterly updates, but it also is easier to traffic fewer total ad units.CMS Rule Adds to (Doesn't Replace) PhRMA's Pricing RequirementsThe Pharmaceutical Research and Manufacturers of America (PhRMA) updated its Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines in October of 2018. The most significant change was the addition of a requirement for television ads to include a destination where people can find pricing information about the prescription drug being advertised. This requirement became operative in April of 2019. All members of PhRMA are obligated to follow the PhRMA guiding principles, and most companies that are not members of PhRMA also abide by the guiding principles. Consequently, almost all television commercials currently airing include a link to a webpage with pricing information.Adhering to the CMS rule does NOT meet the PhRMA guiding principles. Consequently, most companies will be providing both a link to a page with additional information and the pricing information required by CMS. We'll see how companies execute this, but my expectation is that a single screen at the end of a television commercial will accommodate both pieces of information.Of course, not all ads are required to include both pieces (or even either piece!) of information.Non-identical Overlapping ScopesThe new CMS rule applies to all advertised indications of a pharmaceutical product that are reimbursed via Medicare or Medicaid and whose cost is at least $35 per month (or for a typical course of treatment). 42 CFR 403.1200. Note that some drugs have multiple indications, where only some of the indications are reimbursed by CMS. For those products, only the ads that promote an indication reimbursed by CMS are required to include the pricing information; and only if the drug's list price is at least $35 per month (or for a typical course of treatment).By contrast, the PhRMA guiding principles apply to all ads for prescription medicines regardless of whether the drug is reimbursed by CMS and regardless of the cost. Of course, the guiding principles are only binding on members of PhRMA and any non-member companies that have chosen to abide by the guiding principles.TL;DRSome commercials (but we don't know exactly which ones) might start having pricing information in one week. The addition of this information is allegedly going to address the allegedly high price of prescription drugs. The only guaranteed aspect of the recent changes from PhRMA and CMS is that marketing and regulatory operations groups are going to have challenges ensuring ongoing compliance, and the FDA is about to start getting more 2253 filings, including a likely surge of revised television spots in the next few days. Full Article 2253 filing ad inventory Amgen ANA CMS Drug pricing Lily media buying Merck OPDP PhRMA
ari Transcending boundaries: the role of pharmacists in gender identity services By feeds.pjonline.com Published On :: Thu, 30 Apr 2020 14:42 GMT There has been a surge in demand for gender identity services in the UK over the past five years. Although the current role of pharmacists is limited, their potential contribution within a multidisciplinary team supporting transgender patients is beginning to emerge. To read the whole article click on the headline Full Article
ari Newron ditches sarizotan program after pivotal trial flop, sees shares crater By www.fiercebiotech.com Published On :: Mon, 04 May 2020 07:54:54 +0000 Newron will terminate work on its experimental Rett syndrome drug sarizotan after a complete failure in its pivotal STARS trial. Full Article
ari BioMarin pens gene therapy pact with little-known Swiss biotech By www.fiercebiotech.com Published On :: Tue, 05 May 2020 10:12:40 +0000 BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor. Full Article
ari Despite sales bump, brands that are not preparing for stormy seas ahead could struggle, consultant says By www.nutraingredients-usa.com Published On :: Tue, 05 May 2020 13:22:00 +0100 The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future. Full Article Markets
ari Andy Serkis (and maybe Gollum?) will read 'The Hobbit' for coronavirus charities By www.latimes.com Published On :: Thu, 7 May 2020 14:39:50 -0400 Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday. Full Article
ari Column: No, wearing a mask isn't for libs. It's for people who don't want to die By www.latimes.com Published On :: Fri, 8 May 2020 06:00:39 -0400 The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America. Full Article
ari Comparing outcomes of SMP and Miniperc By feeds.nature.com Published On :: 2020-05-05 Full Article
ari Sarkari Naukri 2020: 25000 + Vacancies for Banking Assistant, Teacher, Officer, GDS and Other Posts in Reputed Orgs. By www.jagranjosh.com Published On :: 2020-03-27T14:57:00Z A total of 10529 vacancies have been notified. Job Aspirants can go through the list of Government Jobs in this article. Full Article
ari CBSE Result 2020: After KV’s & State Boards’ Decision To Pass Students of Classes 1 to 9, Scholars & Parents Seeking Clarity from the Board By www.jagranjosh.com Published On :: 2020-03-27T15:24:00Z CBSE Result 2020: Amid COVID - 19 pandemic & lockdown, Kendriya Vidyalaya Sangathan (KVS) and many state boards (like Gujarat, Haryana, Puducherry) have decided to promote school students (Classes 1st to 9th & Class 11th). After this, many students & parents are seeking clarity from the Central Board of Secondary Education (CBSE). Check updates. Full Article
ari Kalaari Capital’s Dev Bajaj joins sports tech firm Dream Sports By www.dealstreetasia.com Published On :: Tue, 05 May 2020 23:44:08 +0000 At Kalaari Capital, he was working as a venture capital partner evaluating and managing early-stage investments. The post Kalaari Capital’s Dev Bajaj joins sports tech firm Dream Sports appeared first on DealStreetAsia. Full Article Kalaari Capital
ari Uber leads $170m investment round for bike-sharing startup Lime By www.dealstreetasia.com Published On :: Fri, 08 May 2020 00:42:21 +0000 As a part of the investment, Lime acquired electric bicycle service JUMP Bikes. The post Uber leads $170m investment round for bike-sharing startup Lime appeared first on DealStreetAsia. Full Article
ari Cadmium isotope fractionation reveals genetic variation in Cd uptake and translocation by <i>Theobroma cacao</i> and role of natural resistance-associated macrophage protein 5 and heavy metal ATPase-family transporters By feeds.nature.com Published On :: 2020-05-01 Full Article
ari A pentaploid-based linkage map of the ancestral octoploid strawberry <i>Fragaria virginiana</i> reveals instances of sporadic hyper-recombination By feeds.nature.com Published On :: 2020-05-07 Full Article
ari Concurrent germline and somatic pathogenic BAP1 variants in a patient with metastatic bladder cancer By feeds.nature.com Published On :: 2020-03-23 Full Article
ari <i>ATP7B</i> variant c.1934T > G p.Met645Arg causes Wilson disease by promoting exon 6 skipping By feeds.nature.com Published On :: 2020-04-08 Full Article
ari Challenges in returning results in a genomic medicine implementation study: the Return of Actionable Variants Empirical (RAVE) study By feeds.nature.com Published On :: 2020-05-04 Full Article
ari The role of single-cell mechanical behaviour and polarity in driving collective cell migration By feeds.nature.com Published On :: 2020-05-04 Full Article
ari Hydrocortisone and bronchopulmonary dysplasia: variables associated with response in premature infants By feeds.nature.com Published On :: 2020-05-07 Full Article
ari Natural genetic variation in Stim1 creates stroke in the spontaneously hypertensive rat By feeds.nature.com Published On :: 2020-04-17 Full Article
ari Coronavirus diaries: creature comforts By feeds.nature.com Published On :: 2020-05-01 Full Article
ari Tunable correlated states and spin-polarized phases in twisted bilayer–bilayer graphene By feeds.nature.com Published On :: 2020-05-06 Full Article
ari Coronavirus diaries: All the things we do not do By feeds.nature.com Published On :: 2020-05-08 Full Article
ari Author Correction: Metabolic activity analyses demonstrate that Lokiarchaeon exhibits homoacetogenesis in sulfidic marine sediments By feeds.nature.com Published On :: 2020-04-29 Full Article
ari Various Faculty Position (Professor, Associate Professor and Assistant Professor/Lecturer) at School of Materials Science and Engineering , Southeast University (SEU) By feeds.nature.com Published On :: Wed, 23 Oct 2019 06:49:08 +0000 About us Southeast University (SEU), located at Nanjing, is a prestigious higher education institution with its origin traced back to 1902. As one of the national key universities under direct administration of the Ministry of Education of China and jointly established with Jiangsu Province, it is selected in various programs, such National “Project 211” , “Program 985” and “Class A first-rate world universities” sponsored by the Central Government to build world-class universities. *M… Full Article
ari Various Faculty Position (Professor, Associate Professor and Assistant Professor/Lecturer) at School of Materials Science and Engineering , Southeast University (SEU) By feeds.nature.com Published On :: Thu, 21 Nov 2019 07:45:01 +0000 About us Southeast University (SEU), located at Nanjing, is a prestigious higher education institution with its origin traced back to 1902. As one of the national key universities under direct administration of the Ministry of Education of China and jointly established with Jiangsu Province, it is selected in various programs, such National “Project 211” , “Program 985” and “Class A first-rate world universities” sponsored by the Central Government to build world-class universities. *M… Full Article
ari Various Faculty Position (Professor, Associate Professor and Assistant Professor/Lecturer) at School of Materials Science and Engineering , Southeast University (SEU) By feeds.nature.com Published On :: Wed, 18 Dec 2019 10:32:28 +0000 About us Southeast University (SEU), located at Nanjing, is a prestigious higher education institution with its origin traced back to 1902. As one of the national key universities under direct administration of the Ministry of Education of China and jointly established with Jiangsu Province, it is selected in various programs, such National “Project 211” , “Program 985” and “Class A first-rate world universities” sponsored by the Central Government to build world-class universities. *M… Full Article
ari The untapped potential of ascites in ovarian cancer research and treatment By feeds.nature.com Published On :: 2020-05-08 Full Article
ari Does multiparametric imaging with <sup>18</sup>F-FDG-PET/MRI capture spatial variation in immunohistochemical cancer biomarkers in head and neck squamous cell carcinoma? By feeds.nature.com Published On :: 2020-05-08 Full Article
ari Comparative efficacy of a hydroxyapatite and a fluoride toothpaste for prevention and remineralization of dental caries in children By www.nature.com Published On :: 2019-12-09 Full Article
ari Short-term NAD<sup>+</sup> supplementation prevents hearing loss in mouse models of Cockayne syndrome By feeds.nature.com Published On :: 2020-01-07 Full Article
ari CMV-independent increase in CD27−CD28+ CD8+ EMRA T cells is inversely related to mortality in octogenarians By feeds.nature.com Published On :: 2020-01-21 Full Article
ari Donor-derived DNA variability in fingernails of acute myeloid leukemia patients after allogeneic hematopoietic stem cell transplantation detected by direct PCR By feeds.nature.com Published On :: 2020-05-09 Full Article
ari Genocea's mark on malaria By feeds.nature.com Published On :: 2014-12-18 Genocea has identified an immunological imprint in patients with malaria and is using a $1.2 million grant from the Gates Foundation to turn the findings into a vaccine. Full Article
ari Cardamonin protects against lipopolysaccharide-induced myocardial contractile dysfunction in mice through Nrf2-regulated mechanism By feeds.nature.com Published On :: 2020-04-21 Full Article
ari Colons or semi-colons: punctuating the regional variation of intestinal microbial–immune interactions By feeds.nature.com Published On :: 2020-04-22 Full Article
ari History Against Sectarianism, The Telegraph By ramachandraguha.in Published On :: Sat, 07 Dec 2019 12:03:46 +0000 In December 1947, the annual Indian History Congress was held in Bombay. The President-elect that year was Professor Mohammad Habib of the Aligarh Muslim University, a historian of early medieval India, known especially for his studies of the Delhi Sultanate. From the late 1930s, many students and faculty at AMU had been active supporters of [...] Full Article Politics and Current Affairs Biography Abbas Tyabji Aligarh Muslim University Citizens Amendment Act Jinnah Mohammad Habib communalism democracy secularism
ari Why Authoritarianism is Bad for Science, But Bigotry is Even Worse By ramachandraguha.in Published On :: Sat, 21 Dec 2019 12:43:19 +0000 There have been many protests against the Citizenship Amendment Bill (now Act), and there will be many more. This piece of legislation strikes at the heart of the Constitution, seeking to make India another country altogether. It is thus that so many people from so many different walks of life have raised their voices against [...] Full Article Politics and Current Affairs Citizens Amendment Act Venkatraman Ramakrishnan Venki Ramakrishnan democracy pluralism science
ari Accesibilidad informacional y diversidad funcional en el contexto universitario: el caso de la Universidad Complutense de Madrid By eprints.rclis.org Published On :: Fri, 24 Apr 2020 06:16:32 +0200 Cuevas-Cerveró, Aurora and Razquín-Zazpe, Pedro and Parra-Valero, Pablo and Barrios-Martínez, Cristina and Gómez-Hernández, José-Antonio . Accesibilidad informacional y diversidad funcional en el contexto universitario: el caso de la Universidad Complutense de Madrid., 2020 In: Competencia en Información y Políticas para Educación Superior: Estudos Hispano-Brasileiros. Universidad Complutense de Madrid, pp. 132-146. [Book chapter] Full Article
ari Centros de documentación de diarios en el siglo XXI. Panorama después del tsunami By eprints.rclis.org Published On :: Fri, 24 Apr 2020 16:16:28 +0200 Guallar, Javier and Cornet, Anna Centros de documentación de diarios en el siglo XXI. Panorama después del tsunami. BiD, 2020, n. 44. [Journal article (Unpaginated)] Full Article
ari El libro y la lectura en los recintos penitenciarios de la región de Valparaíso By eprints.rclis.org Published On :: Sun, 26 Apr 2020 22:07:15 +0200 Sequeiros, Paula and Silveira, Fabrício José Nascimento da and Rivera Donoso, Miguel and Armingol Jaime, Karla and Díaz Rubio, Sara and Sáez Alarcón, Daniela and Muñoz Muño, Alexia and Saurin Parra, Julia and Cosgrove, Kimberly and Parra, Pablo and Barbosa, Andreza Gonçalves and Piñeiros, Gabriela . El libro y la lectura en los recintos penitenciarios de la región de Valparaíso., 2019 Universidad de Playa Ancha. [Book] Full Article
