us The 340B Program Reached $66 Billion in 2023—Up 23% vs. 2022: Analyzing the Numbers and HRSA’s Curious Actions By feeds.feedblitz.com Published On :: Tue, 22 Oct 2024 10:30:00 +0000 Reality has again failed to support the spin surrounding the 340B Drug Pricing Program. For 2023, discounted purchases under the 340B program reached a record $66.3 billion—an astounding $12.6 billion (+23.4%) higher than its 2022 counterpart. The gross-to-net difference between list prices and discounted 340B purchases also grew, to $57.8 billion (+$5.5 billion). 340B purchases are now almost 40% larger than Medicaid’s prescription drug purchases. Hospitals again accounted for 87% of 340B purchases for 2023. Purchases at every 340B covered entity type grew, despite drug prices that grew more slowly than overall inflation. Lobbyists claim that manufacturers’ 340B contract pharmacy changes are “stripping billions of dollars from the healthcare safety net.” But every year, the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut. Read on for full details and our analysis, along with fresh details of troubling behavior by the Health Resources and Services Administration (HRSA). Read more » Full Article 340B Channel Management Gross-to-Net Bubble Hospitals Inflation Reduction Act of 2022 PBMs Pharmacy Specialty Drugs
us ACRO Announces Diversity and Inclusion Site Resource Grants Program By www.businesswire.com Published On :: Mon, 15 Apr 2024 11:00:00 +0000 The ACRO D&I Site Resource Grants Program aims to help sites acquire the resources and skills that will get them selected for studies and improve the reach of clinical research into underrepresented communities. The post ACRO Announces Diversity and Inclusion Site Resource Grants Program first appeared on ACRO. Full Article Press Releases
us ACRO Announces Diversity and Inclusion Site Resource Grants Program By www.acrohealth.org Published On :: Wed, 17 Apr 2024 12:00:00 +0000 ACRO is pleased to announce the launch of the ACRO Diversity and Inclusion Site Resource Grants Program! The ACRO D&I Site Resource Grants Program aims to help sites acquire the resources and skills that will get them selected for studies and improve the reach of clinical research into underrepresented communities. “We are excited to invite […] The post ACRO Announces Diversity and Inclusion Site Resource Grants Program first appeared on ACRO. Full Article Newsletter
us 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
us Bonus Episode: ACRO’s Good Clinical Podcast By www.acrohealth.org Published On :: Tue, 21 May 2024 14:20:46 +0000 Bonus Episode: Fast Facts on the ACRO D&I Grants Program ACRO’s Good Clinical Podcast is back with bonus episode! Host Sophia McLeod sat down with Tafoya Hubbard (ACRO Site Resource Grants Program Manager) and Kristen Surdam (ACRO D&I Steering Committee Member) to discuss ACRO’s new D&I Site Resource Grants Program. They provide background on the […] The post Bonus Episode: ACRO’s Good Clinical Podcast first appeared on ACRO. Full Article Newsletter
us Sequestration Has Less Impact on FDA? Just Not True By www.fdamatters.com Published On :: Thu, 08 Aug 2013 20:11:21 +0000 “The Hill” newspaper recently reported that: “a survey of federal budgets devoted to developing and enforcing regulations found that many agencies will spend more in 2013 and 2014 than in previous years, indicating that the writing and enforcing of new regulations is largely unimpeded by the massive cuts, known as sequestration.” That certainly sounds authoritative…until you look at the analysis. In fact, the report’s authors appear to know nothing about the federal budget and have used inherently unreliable data in calculating FY 13 and FY 14 spending levels. One can only hope that the authors—allegedly academic experts--know more about regulatory policy than they do about federal budgets. Full Article FDA and Congress FDA and Industry FDA Appropriations
us Revised APRA Bill Clears House Subcommittee By cohealthcom.org Published On :: Wed, 05 Jun 2024 13:51:45 +0000 The proposed American Privacy Rights Act (APRA) has taken its first step U.S. House legislative process with several issue disagreements becoming more evident. On May 23, the U.S. House Committee on Energy and Commerce Subcommittee on Data, Innovation and Commerce approved the updated APRA, advancing the bill to full committee consideration. Just prior to the […] Full Article Data Privacy Legislative Washington Focus APRA child data privacy consumer privacy data privacy data privacy legislation federal legislation Jim Potter
us Massachusetts High Court Rules Online Tracking Doesn’t Violate State Wiretap Law By cohealthcom.org Published On :: Wed, 30 Oct 2024 12:23:03 +0000 Sorry, but you do not have permission to view this content. Full Article Courts/First Amendment
us Don’t Confuse the Art and Science of Medicine: PCI vs CABG for Left Main Disease By www.cardiobrief.org Published On :: Thu, 20 Aug 2020 15:56:47 +0000 It is often said that medicine is both an art and a science. In an imperfect world this is both inevitable and desirable. But it is extremely important that the two should not be confused with each other. In particular, because the “science” side of the equation has achieved overwhelming prestige and authority, it is...Click here to continue reading... Full Article Interventional Cardiology & Surgery People Places & Events Policy & Ethics CABG guidelines left main disease LMCA PCI
us Cardiology Research: Business As Usual During the Pandemic By www.cardiobrief.org Published On :: Thu, 29 Oct 2020 16:33:14 +0000 At this moment in time the pre-pandemic cardiology research agenda needs to be completely reprioritized. There are two broad areas that now take precedence over all existing research concerns. On the one hand, researchers need to achieve a better understanding of the staggering incidence of deferred or delayed treatment of cardiovascular events and conditions as...Click here to continue reading... Full Article Epidemiology & Outcomes People Places & Events Policy & Ethics coronavirus COVID-19 pandemic research agenda
us FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli By www.gabionline.net Published On :: Tue, 29 Oct 2024 09:49:30 +0000 <p>The US Food and Drug Administration (FDA) granted approval for two biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing Johnson & Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.</p> Full Article
us EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi By www.gabionline.net Published On :: Tue, 05 Nov 2024 09:15:00 +0000 <p>The European Commission (EC) granted marketing authorization for<b> </b>three ustekinumab biosimilars<b>: </b>Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s Otulfi on 25 September 2024.</p> Full Article
us Everything you should know about the coronavirus pandemic By www.pharmaceutical-journal.com Published On :: Mon, 15 Feb 2021 11:25 GMT The latest information about the novel coronavirus identified in Wuhan, China, and advice on how pharmacists can help concerned patients and the public. Full Article
us 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
us Half of asthma patients in the UK overusing SABAs, study finds By www.pharmaceutical-journal.com Published On :: Thu, 18 Feb 2021 17:10 GMT More than half of patients with asthma in the UK are “potentially overusing” short-acting β2-agonists, according to research. Full Article
us UK universities and NHS trusts that flout the rules on clinical trials identified in report to Parliament By www.alltrials.net Published On :: Thu, 24 Oct 2019 00:19:34 +0000 An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […] Full Article News Uncategorized
us Half of US clinical trials are breaking the law on reporting results By www.alltrials.net Published On :: Fri, 17 Jan 2020 23:30:00 +0000 New research has shown that the majority of clinical trials which should be following the US law on reporting results aren’t. Less than half (41%) of clinical trial results were reported on time and 1 in 3 trials (36%) remain unreported. The research also found that clinical trials sponsored by companies are the most likely […] Full Article News
us Megafund versus Megalosaurus: Funding Drug Development By www.placebocontrol.com Published On :: Mon, 13 Jan 2014 04:36:00 +0000 This new 10-minute TEDMED talk is getting quite a bit of attention: (if embedded video does not work, try the TED site itself.) In it, Roger Stein claims to have created an approach to advancing drugs through clinical trials that will "fundamentally change the way research for cancer and lots of other things gets done". Because the costs of bringing a drug to market are so high, time from discovery to marketing is so long, and the chances of success of any individual drug are so grim, betting on any individual drug is foolish, according to Stein. Instead, risks for a large number of potential assets should be pooled, with the eventual winners paying for the losers. To do this, Stein proposes what he calls a "megafund" - a large collection of assets (candidate therapies). Through some modeling and simulations, Stein suggests some of the qualities of an ideal megafund: it would need in the neighborhood of $3-15 billion to acquire and manage 80-150 drugs. A fund of this size and with these assets would be able to provide an equity yield of about 12%, which would be "right in the investment sweet spot of pension funds and 401(k) plans". Here's what I find striking about those numbers: let's compare Stein's Megafund to everyone's favorite Megalosaurus, the old-fashioned Big Pharma dinosaur sometimes known as Pfizer: Megafund (Stein) Megalosaurus (Pfizer) Funding $3-15 billion $9 billion estimated 2013 R&D spend Assets 80-150 81 (in pipeline, plus many more in preclinical) Return on Equity 12% (estimated) 9.2% (last 10 years) to 13.2% (last 5) Since Pfizer's a dinosaur, it can't possibly compete withthe sleek, modern Megafund, right? Right? These numbers look remarkably similar. Pfizer - and a number of its peers - are spending Megafund-sized budget each year to shepherd through a Megafund-sized number of compounds. (Note many of Pfizer's peers have substantially fewer drugs in their published pipelines, but they own many times more compounds - the pipeline is just the drugs what they've elected to file an IND on.) What am I missing here? I understand that a fund is not a company, and there may be some benefits to decoupling asset management decisions from actual operations, but this won't be a tremendous gain, and would presumably be at least partially offset by increased transaction costs (Megafund has to source, contract, manage, and audit vendors to design and run all its trials, after all, and I don't know why I'd think it could do that any more cheaply than Big Pharma can). And having a giant drug pipeline's go/no go decisions made by "financial engineers" rather than pharma industry folks would seem like a scenario that's only really seen as an upgrade by the financial engineers themselves. A tweet from V.S. Schulz pointed me to a post on Derek Lowe's In the Pipeline blog. which lead to a link to this paper by Stein and 2 others in Nature Biotechnology from a year and a half ago. The authors spend most of their time differentiating themselves from other structures in the technical, financial details rather than explaining why megafund would work better at finding new drugs. However, they definitely think this is qualitatively different from existing pharma companies, and offer a couple reasons. First, [D]ebt financing can be structured to be more “patient” than private or public equity by specifying longer maturities; 10- to 20-year maturities are not atypical for corporate bonds. ... Such long horizons contrast sharply with the considerably shorter horizons of venture capitalists, and the even shorter quarterly earnings cycle and intra-daily price fluctuations faced by public companies. I'm not sure where this line of though is coming from. Certainly all big pharma companies' plans extend decades into the future - there may be quarterly earnings reports to file, but that's a force exerted far more on sales and marketing teams than on drug development. The financing of pharmaceutical development is already extremely long term. Even in the venture-backed world, Stein and team are wrong if they believe there is pervasive pressure to magically deliver drugs in record time. Investors and biotech management are both keenly aware of the tradeoffs between speed and regulatory success. Even this week's came-from-nowhere Cinderella story, Intercept Pharmaceuticals, was founded with venture money over a decade ago - these "longer maturities" are standard issue in biotech. We aren't making iPhone apps here, guys. Second, Although big pharma companies are central to the later stages of drug development and the marketing and distributing of approved drugs, they do not currently play as active a role at the riskier preclinical and early stages of development Again, I'm unsure why this is supposed to be so. Of Pfizer's 81 pipeline compounds, 55 are in Phase 1 or 2 - a ratio that's pretty heavy on early, risky project, and that's not too different from industry as a whole. Pfizer does not publish data on the number of compounds it currently has undergoing preclinical testing, but there's no clear reason I can think of to assume it's a small number. So, is Megafund truly a revolutionary idea, or is it basically a mathematical deck-chair-rearrangement for the "efficiencies of scale" behemoths we've already got? [Image: the world's first known dino, Megalosaurus, via Wikipedia.] Full Article big pharma drug development Pfizer
us Chronic itch is miserable. Scientists are just scratching the surface By www.npr.org Published On :: Tue, 12 Nov 2024 13:33:46 -0500 Journalist Annie Lowrey has a rare disease that causes a near-constant itch that doesn't respond to most treatments. She likens the itchiness to a car alarm: "You can't stop thinking about it." Full Article
us Link Daftar Situs Slot Gacor Gampang Menang Maxwin Terpercaya Hari Ini By biosimilarnews.com Published On :: Sun, 02 Jun 2024 10:34:45 +0000 Keuntungan besar dan kegembiraan yang ditawarkan oleh mesin slot online membuatnya semakin populer. Namun, dalam lautan situs slot yang ada, bagaimana Anda bisa menemukan situs slot terbaik yang dapat memberikan… The post Link Daftar Situs Slot Gacor Gampang Menang Maxwin Terpercaya Hari Ini appeared first on Biosimilarnews. Full Article News Tips & Trik
us 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
us Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement By medcitynews.com Published On :: Thu, 07 Nov 2024 14:18:00 +0000 Three ways health plans can engage, connect with, and delight their pregnant members to nurture goodwill, earn long-term trust, and foster loyal relationships that last. The post Pregnant and Empowered: Why Trust is the Latest Form of Member Engagement appeared first on MedCity News. Full Article Daily MedCity Influencers Patient Engagement Payers health plans maternity member engagement pregnancy trust
us Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place By medcitynews.com Published On :: Fri, 08 Nov 2024 15:08:00 +0000 The vast majority of older adults want to age at home. To support that goal, doctors should encourage them to consider their care options — long before they need assistance. The post Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place appeared first on MedCity News. Full Article Community Daily MedCity Influencers Patient Engagement Physicians Social Determinants aging in place alzheimer's disease Caregivers elder care in-home care senior care
us The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know By medcitynews.com Published On :: Sun, 10 Nov 2024 14:16:00 +0000 Building trust while simultaneously building products, selling, recruiting, and fundraising can feel impossible. But it’s required whether you have the time or not, and it doesn’t stop no matter how big you grow. The post The Trust-Building Playbook: 5 Tips Every Digital Health Marketer Needs to Know appeared first on MedCity News. Full Article Daily MedCity Influencers Startups HLTH 2024 marketing in healthcare public relations trust
us ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer By medcitynews.com Published On :: Sun, 10 Nov 2024 17:32:00 +0000 Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability. The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News. Full Article BioPharma Daily Legal Pharma acute lymphoblastic leukemia Aucatzyl Autolus Therapeutics biopharma nl blood cancer cancer CAR-T cell therapy FDA
us How Can Healthcare Organizations Earn Trust with Marginalized Communities? By medcitynews.com Published On :: Sun, 10 Nov 2024 23:49:46 +0000 Access to care isn’t enough. Healthcare organizations need to build trust in order to reach underserved communities, experts said on a recent panel. The post How Can Healthcare Organizations Earn Trust with Marginalized Communities? appeared first on MedCity News. Full Article Consumer / Employer Daily Health Tech Payers SYN Top Story Alkeme Health Anise Health Behavioral Health Tech BlueCross BlueShield Minnesota Freespira humana health horizons trust
us How One Massachusetts Maternal Mental Health Program Scaled Across the Country By medcitynews.com Published On :: Mon, 11 Nov 2024 23:39:48 +0000 During a recent panel, experts discussed the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and how it achieved scale. The post How One Massachusetts Maternal Mental Health Program Scaled Across the Country appeared first on MedCity News. Full Article Daily Health Tech Policy SYN Top Story Behavioral Health Tech maternal mental health MCPAP for Moms
us Medications for Opioid Use Disorder Improve Patient Outcomes By www.pewtrusts.org Published On :: Thu, 17 Dec 2020 12:43:00 -0500 In 2018, opioid overdoses in the United States caused one death every 11 minutes, resulting in nearly 47,000 fatalities. The most effective treatments for opioid use disorder (OUD) are three medications approved by the Food and Drug Administration (FDA): methadone, buprenorphine, and naltrexone. Full Article
us Relaxed Federal Regulations Amid Pandemic Can Help Jails Better Treat Opioid Use Disorder By www.pewtrusts.org Published On :: Tue, 22 Dec 2020 12:50:58 -0500 Few correctional facilities in the United States have treatment programs for individuals with opioid use disorder (OUD), despite clear evidence that certain medications reduce the risk of overdose and death. Even in facilities where treatment is available, the COVID-19 pandemic has complicated efforts to provide such care. Full Article
us Extended Medicaid Coverage Would Help Postpartum Patients With Treatment for Opioid Use Disorder By www.pewtrusts.org Published On :: Thu, 14 Jan 2021 13:02:00 -0500 Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD. Full Article
us Expanding Treatment for Opioid Use Disorders By www.pewtrusts.org Published On :: Fri, 15 Jan 2021 13:49:00 -0500 As the coronavirus pandemic grips the world, the opioid epidemic continues to affect millions of Americans. Several states are developing innovative ways to tackle this public health issue. In this episode, we speak with Beth Connolly, who leads Pew’s research on substance use disorders, and Louisiana Representative Paula Davis, who helped ensure effective treatment in her state. Full Article
us Antibiotic Sales for Use in Food Animals Increased Again in 2019 By www.pewtrusts.org Published On :: Thu, 21 Jan 2021 16:33:00 -0500 Sales of medically important antibiotics for use in food-producing animals increased 3% in 2019, according to recent data from the U.S. Food and Drug Administration. This is the second year in a row that the quantities of antibiotics sold for animal use have risen, underscoring the need for further FDA action to ensure judicious use of these lifesaving drugs. Full Article
us FDA Proposal Will Not Sufficiently Curb Injudicious Use of Antibiotics in Food Animals By www.pewtrusts.org Published On :: Wed, 27 Jan 2021 14:10:00 -0500 The Food and Drug Administration published a concept paper in early January that describes a preliminary proposal for how the agency will ensure that companies developing antibiotics for administration to animals establish defined, evidence-based durations of use for all medically important antibiotics. Full Article
us 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
us Will an Anti-Nausea Drug Boost GLP-1 Sales? By worldofdtcmarketing.com Published On :: Thu, 07 Nov 2024 10:11:28 +0000 GLP-1 receptor agonists, used to treat Type 2 diabetes and now widely prescribed for weight loss, have seen […] The post Will an Anti-Nausea Drug Boost GLP-1 Sales? appeared first on World of DTC Marketing. Full Article Business of the drug industry
us Let us show you panel data modeling By www.sas.com Published On :: 2015-11-13T13:00:00Z Watch the video and learn basic principles of modeling panel data using SAS/ETS. Full Article Webcast/video
us SAS/STAT Users Still Moving to the SAS 9.4 Platform? By support.sas.com Published On :: 2016-08-18T12:00:00Z We introduced a Topics tab in the online documentation a few releases ago, and there are corresponding pages in our focus area that briefly describe the topic areas and the procedures that perform analyses for those areas. Full Article
us Using SAS Simulation Studio to Test and Validate SAS/OR Optimization Models By support.sas.com Published On :: 2016-08-25T12:00:00Z This paper begins with a look at both optimization modeling and discrete-event simulation modeling, and explores how they can most effectively work together to create additional analytic value. It then considers two examples of a combined optimization and simulation approach and discusses the resulting benefits. Full Article
us Fitting Multilevel Hierarchical Mixed Models Using PROC NLMIXED By support.sas.com Published On :: 2016-10-06T12:00:00Z This paper provides an example that shows you how to use multiple RANDOM statements in PROC NLMIXED to fit nested nonlinear mixed models, and it provides details about the computation that is involved in fitting these models. Full Article
us 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
us 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
us 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
us Thai drama under fire for drugging cat for real in death scene, allegedly causing it seizures By www.asiaone.com Published On :: Tue, 12 Nov 2024 17:56:00 +0800 The quest for realism in Thai drama The Empress of Ayodhaya went too far when a cat was reportedly drugged in a poisoning scene. In episode five of the show, the character Indravedi (Fern Nopjira Lerkkajornnamkul) suspects her drink has been drugged, so she asks nanny Thongdee (Ja Molywon Phantara) to test it out on the black feline. The cat can be seen convulsing and retching, and the camera moves to show Indravedi looking concerned, while Thongdee declares that it is dead. The scene caused public outrage with fears that the cat had actually been killed, and calls to ban the period drama were trending on X. On Nov 7, a now-deleted X account reportedly belonging to Ja posted: "The cat didn't actually die. We put it under anaesthesia, but while filming, the cat retched and seized." She and Fern initially thought the cat had actually died while filming and their faces "turned pale", she added. Full Article
us The legal status of assisted dying in different countries By www.asiaone.com Published On :: Wed, 13 Nov 2024 09:23:00 +0800 LONDON — Britain is to debate whether to legalise assisted dying for the terminally ill, potentially paving the way for the law to change. Below is a list of countries which allow people to choose to end their lives or are considering doing so. Switzerland Switzerland legalised assisted dying in 1942 on the condition the motive is not selfish, making it the first country in the world to permit the practice. Doctors can prescribe drugs and administer them or had them over for self-administration. A number of Swiss organisations such as Dignitas offer their services to foreign nationals. United States Medical aid in dying, also known as physician assisted dying is legal in 10 states: California, Colorado, Hawaii, Montana, Maine, New Jersey, New Mexico, Oregon, Vermont and Washington, plus the District of Columbia. Oregon was the first state to legalise it under a law which came into effect in 1997. It allows mentally competent patients who are terminally ill and with less than six months to live to ask for life-ending medication. People from outside Oregon may travel to the state to take advantage of the law. Full Article
us At UN, US warns Israel against forcible displacement, starvation in Gaza By www.asiaone.com Published On :: Wed, 13 Nov 2024 09:40:22 +0800 UNITED NATIONS — The United States stressed at the United Nations (UN) on Tuesday (Nov 12) that "there must be no forcible displacement, nor policy of starvation in Gaza" by Israel, warning such policies would have grave implications under US and international law. The remarks by US Ambassador to the UN Linda Thomas-Greenfield came just hours after Washington said its ally Israel was doing enough to address the humanitarian crisis in Israel to avoid facing potential restrictions on US military aid. "Still, Israel must ensure its actions are fully implemented - and its improvements sustained over time," Thomas-Greenfield told the UN Security Council. It was also urgently important that Israel pause implementation of a law banning the operation of the UN Palestinian relief agency UNRWA, she added. Full Article
us Trump names Musk to co-lead newly formed Department of Government Efficiency By www.asiaone.com Published On :: Wed, 13 Nov 2024 10:23:00 +0800 WASHINGTON — US President-elect Donald Trump said on Nov 12 that Elon Musk and former Republican presidential hopeful Vivek Ramaswamy will lead the newly created Department of Government Efficiency. Musk and Ramaswamy "will pave the way for my Administration to dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies", Trump said in a statement. Trump said their work would conclude by July 4, 2026, adding that a smaller and more efficient government would be a "gift" to the country on the 250th anniversary of the signing of the Declaration of Independence. Businessman and former Republican presidential candidate Vivek Ramaswamy attends Donald Trump's campaign event sponsored by conservative group Turning Point Action, in Las Vegas, Nevada, US, Oct 24, 2024. PHOTO: Reuters file The appointments reward two Trump supporters from the private sector. Full Article
us US aircraft carrier joins military drills with South Korea and Japan By www.asiaone.com Published On :: Wed, 13 Nov 2024 10:48:33 +0800 SEOUL - South Korea's military said it will hold a three-day joint exercise with the United States and Japan starting on Wednesday (Nov 13), featuring fighter jets and marine patrol aircraft as well as the US nuclear-powered aircraft carrier USS George Washington. The Freedom Edge exercise is a response to what the South Korean military said were threats from North Korea, which recently conducted an intercontinental ballistic missile test, drawing condemnation from Seoul, Tokyo and Washington. It also comes as the US State Department said North Korean troops have started engaging in combat operations in Russia's war with Ukraine. The exercise will include South Korean and Japanese fighter jets and maritime patrol aircraft, as well as the USS George Washington, Seoul's Joint Chiefs of Staff (JCS) said in a statement. The trilateral exercise follows a first round held earlier this year after the leaders of the three countries agreed at a summit in 2023 to hold annual training drills. Pyongyang has long condemned joint drills between South Korea and the United States, calling them a rehearsal for invasion. Full Article
us 'I just want closure': Qoo10 vendors, customers accept they will likely not get money back By www.asiaone.com Published On :: Wed, 13 Nov 2024 08:05:08 +0800 SINGAPORE - When an online retailer began selling his products on e-commerce platform Qoo10 in August 2023, he did not bat an eyelid when it took 30 to 45 days for the platform to disburse his first payout, compared with about three to seven days for other e-commerce sites he was using. But nearly a year later in July, payments owed to his business by Qoo10 had ballooned to about $1.6 million, as the platform’s payment delays exceeded two months and disbursements began trickling in, in smaller amounts. The Singaporean, who wanted to be known only as Mr T and did not wish to divulge what he sold, pulled the plug on his Qoo10 shop this year in the middle of July, and filed a civil claim with the courts. He obtained a default judgment in October for Qoo10 to pay him what he is owed, after the e-commerce site failed to serve a notice of intention to contest or not contest the claim. Mr T, who added that he had borrowed nearly $1 million from banks, friends and relatives to pay his suppliers, said: “I am not holding out hope that I will get much, or any, of my money back from Qoo10... By this point, I just want closure because it’s been so stressful.” Full Article
us Fugitive lawyer Charles Yeo in UK custody, awaiting extradition hearing By www.asiaone.com Published On :: Wed, 13 Nov 2024 13:12:41 +0800 Fugitive lawyer Charles Yeo, who is in custody in the UK, is currently awaiting an extradition hearing, reported CNA on Tuesday (Nov 12). A court date for the extradition hearing has not been determined, but Yeo is set to attend a bail hearing on Friday, according to the report. In an Instagram post on Nov 1, the former chairman of the Reform Party said the Singapore government had made a formal request for his extradition. In his post, Yeo also said that he will be presenting himself, together with his legal team, at Westminster Magistrates Court on Nov 11. Yeo left Singapore in July 2022 after being charged earlier that year with multiple offences relating to harassment and wounding the religious feelings of Christians in several social media posts. In August 2022, a warrant of arrest was issued against him for breaching the conditions for overseas travel while on bail. He was allowed to travel to Vietnam for work, but failed to return to Singapore and claimed he was seeking political asylum in the UK. Full Article
us Taiwan businessman Tsao to sue Chinese officials over sanctions By www.asiaone.com Published On :: Mon, 11 Nov 2024 16:32:00 +0800 TAIPEI — Taiwanese businessman Robert Tsao said on Nov 11 that he would sue in a Taiwan court senior Chinese officials over sanctions they had placed on him, saying he was seeking to counter China's intimidation of lawful activity. China, which claims Taiwan as its own territory, said in October it would punish and sanction Tsao, the retired founder of chipmaker United Microelectronics Corp (UMC), for alleged criminal and pro-Taiwan independence activities. China's Taiwan Affairs Office said the "Black Bear Academy" that Tsao has helped fund was seeking to incite separatism that would endanger cross-strait ties. Tsao, one of Taiwan's richest men who has pledged to provide millions to two civilian defence training programmes, told a press conference that China was threatening the lawful holding of political views in Taiwan and his personal safety. The lawsuit will be lodged in a Taipei court against Song Tao, head of China's Taiwan Affairs Office, and also the office's spokesman Chen Binhua. Taiwan courts have no jurisdiction in China and senior Chinese officials do not visit the island. Full Article