Podcasts about vascepa

My co-host Ken Suzan and I are welcoming you to episode 171 of our podcast IP Fridays! Today's interview guest is the president of the German Patent and Trademark Office Eva Schewior! But before we jump into this very interesting interview, I have news for you: The US Supreme Court has taken up an important patent law case concerning so-called “skinny labels” for generic drugs. Specifically, the highest US court is reviewing a case in which Amarin accuses generic drug manufacturer Hikma of inciting doctors to use the cholesterol drug Vascepa in violation of patents by providing a limited package insert. In two landmark decisions, the UPC Court of Appeal clarified the criteria for inventive step and essentially confirmed the EPO’s typical “problem-solution” approach (Amgen v Sanofi and Meril v Edwards). However, experts are not entirely sure whether the Court of Appeal’s decisions, particularly those relating to the determination of the closest prior art, deviate from EPO practice. As a result of Brexit, mutual recognition of trademark use between the EU and the UK will cease to apply from January 1, 2026. Use of a trademark only in the UK will then no longer count as use of an EU trademark for the purpose of maintaining rights – and conversely, EU use will no longer count for British trademarks. Bayer is attacking several mRNA vaccine manufacturers in the US (Pfizer, BioNTech, Moderna, and J&J separately). The core allegation: patent infringements relating to old (Monsanto) patents on mRNA stabilization; Bayer is seeking damages, not sales bans. DISCO Pharmaceuticals from Cologne signs an exclusive license agreement with Amgen (potentially up to USD 618 million plus royalties) for novel cancer therapies targeting surface structures. Relevant from an IP perspective: license scope, milestones, data/know-how allocation. And now let's jump into the interview with Eva Schewior! The German IP System in Transition: Key Insights from DPMA President Eva Schewior In an in-depth conversation on the IP Fridays podcast, Eva Schewior, President of the German Patent and Trademark Office (DPMA), outlined how Germany's IP system is responding to rising demand, technological change, and a fundamentally altered European patent landscape. The interview offers valuable insights for innovators, companies, and IP professionals navigating patent, trademark, and design protection in Europe. Sustained Demand and Procedural Efficiency Despite the introduction of the Unitary Patent system, national German IP rights continue to see strong and growing demand. According to Schewior, application numbers at the DPMA have been increasing for years, which she views as a strong vote of confidence in the quality and reliability of German IP rights. At the same time, this success creates pressure on examination capacity. The average duration of patent proceedings at the DPMA is currently around three years and two months from filing to grant, provided applicants request examination early and avoid extensions. Internationally, this timeframe remains competitive. Nevertheless, shortening procedures remains a strategic priority. Search requests alone have risen by almost 50% over the past decade, yet the DPMA still delivers search reports on time in around 90% of cases. To better reflect applicant needs, the DPMA distinguishes between two main user groups: applicants seeking a rapid grant, often as a basis for international filings, and applicants primarily interested in a fast, high-quality initial assessment through search or first examination. Future procedural adjustments are being considered to better serve both groups. The Role of Artificial Intelligence Artificial intelligence already plays a practical role at the DPMA, particularly in patent search, classification, and the translation of Asian patent literature. Schewior emphasized that the office is closely monitoring rapid developments in AI to assess where these tools can further improve efficiency. However, she made clear that AI will remain a supporting technology. In public administration, and especially in IP examination, final decisions must always be taken and reviewed by humans. AI is seen as a way to relieve examiners of routine tasks so they can focus on substantive examination and quality. Maintaining and Monitoring Examination Quality Quality assurance is a central pillar of the DPMA's work. Schewior reported consistently positive feedback from users, but stressed that maintaining quality is a continuous task. The office applies systematic double checks for grants and refusals and uses internal quality management tools to randomly review searches and first office actions during ongoing proceedings. External feedback is equally important. The DPMA's User Advisory Board, which includes patent attorneys, startups, and patent information centers, plays a key role in identifying issues and suggesting improvements. Several of its recommendations have already been implemented. Trademark Filings and Bad-Faith Applications The trademark side of the DPMA has experienced particularly strong growth. In 2025, the office received around 95,000 trademark applications, an increase of approximately 18% compared to the previous year. Much of this growth came from abroad, especially from China. While new trademark types such as sound marks, multimedia marks, and holograms have so far seen only moderate uptake, word marks and figurative marks remain dominant. A growing challenge, however, is the rise in bad-faith trademark filings. The DPMA has responded by intensively training examiners to identify and handle such cases. Procedural reforms following EU trademark law modernization have also shifted competencies. Applicants can now choose whether to bring revocation and invalidity actions before the courts or directly before the DPMA. While courts may act faster, proceedings before the DPMA involve significantly lower financial risk, as each party generally bears its own costs. Accelerated Examination as a Practical Tool Despite rising filing numbers, the DPMA aims to avoid significant delays in trademark proceedings. Organizational restructuring within the trademark department is intended to balance workloads across teams. Schewior highlighted the option of accelerated trademark examination, available for a relatively modest additional fee. In practice, this can lead to registration within a matter of weeks, without affecting priority, since the filing date remains decisive. New Protection for Geographical Indications A major recent development is the extension of EU-wide protection for geographical indications to craft and industrial products. Since late 2025, the DPMA acts as the national authority for German applications in this area. The first application has already been filed, notably for a traditional German product. Under the new system, applications undergo a national examination phase at the DPMA before being forwarded to the EUIPO for final decision. Products eligible for protection must originate from a specific region and derive their quality or reputation from that origin, with at least one production step taking place there. The EU estimates that around 40 German products may qualify. Outreach, SMEs, and Education Schewior underlined the DPMA's statutory duty to inform the public about IP rights, with a particular focus on small and medium-sized enterprises. The office has significantly expanded its presence on platforms such as LinkedIn and YouTube, offering accessible and practical IP content. Studies show that fewer than 10% of European SMEs use IP rights, despite evidence that IP-owning companies generate higher revenues. To address this gap, the DPMA is expanding outreach formats, strengthening cooperation with educational institutions, and publishing new empirical studies, including a forthcoming analysis of patenting behavior among innovative German startups conducted with WIPO. Strategic Challenges Ahead Looking forward, Schewior identified several key challenges: insufficient awareness of IP protection among SMEs and startups, a tendency in some sectors to rely solely on trade secrets, and the growing problem of product and trademark piracy linked to organized crime. From an institutional perspective, the DPMA must remain attractive and competitive in a European system offering multiple routes to protection. This requires legally robust decisions, efficient procedures, qualified staff, and continuous investment in IT and training. Careers at the DPMA Finally, Schewior highlighted recruitment as a strategic priority. The DPMA recently hired around 50 new patent examiners and continues to seek experts in fields such as electrical engineering, e-mobility, IT, and aerospace, as well as IT specialists, lawyers, and staff in many other functions. She emphasized the DPMA's role as Europe's largest national patent office and a globally significant, stable, and family-friendly employer at the forefront of technological development. German and European Patents as Complementary Options In her closing remarks, Schewior addressed the post-UPC patent landscape. Rather than competing, German and European patent systems complement each other. For many SMEs, a German patent alone may be sufficient, particularly where Germany is the core market. At the same time, the possibility of holding both a European patent and a national German patent offers strategic resilience, as national protection can survive even if a European patent is revoked. Her key message was clear: the range of options has never been broader, but making informed strategic choices is more important than ever. If you would like, I can also adapt this article for a specialist legal audience, condense it for a magazine format, or rework it as a thought-leadership piece for LinkedIn or your website. Rolf Claessen: Today's interview guest is Eva Schewior. If you don't know her yet, she is the President of the German Patent and Trademark Office. Thank you very much for being here. Eva Schewior: I'm very happy that you're having me today. Thank you, Mr. Claessen. Rolf Claessen: Shortening the length of procedures has been a stated goal since you took office. What is the current situation, and which measures are in place to achieve this goal? Eva Schewior: First of all, I'm very glad that German IP rights are in high demand. Even though applicants in Europe have multiple options today to obtain protection for their innovations, we have seen increasing application numbers for years at my office, even after the introduction of the Unitary Patent system. I see this as very positive feedback for our work. It is clear, however, that the high number of applications leads to a constantly increasing workload. At the same time, we want to remain attractive for our applicants. This means we must offer not only high-quality IP rights but also reasonable durations of proceedings. Ensuring this remains a central and permanent objective of our strategy. The average duration of proceedings from filing to grant is currently about three years and two months, provided that applicants file an examination request within the first four months after application and do not request extensions of time limits. In other cases, the average duration of proceedings is admittedly longer. With these three years and two months, we do not have to shy away from international comparison. Nonetheless, we strive to get better. In the last few years, we were able to improve the number of concluded proceedings or to keep them at a high level. In some areas, we were even able to shorten durations of proceedings a bit, though not yet to the extent that we would have wished for. Our efforts are often overtaken by the increasing demand for our services. Just to give you an example, in the last ten to fifteen years, search requests increased by nearly fifty percent. Despite this, we managed to deliver search reports in ninety percent of all cases in time, so that customers have enough time left to take a decision on a subsequent application. I have to admit that we are not equally successful with the first official communication containing the first results of our examination. Here, our applicants need a bit more patience due to longer durations of proceedings. But I think I do not have to explain to your expert audience that longer processing times depend on various reasons, which are in no way solely to be found on our side as an examination office. To further reduce the length of proceedings, we need targeted measures. To identify them, we have analyzed the needs of our applicants. It has been shown that there are two main interests in patent procedures. About three quarters of our applicants have a very strong interest in obtaining a patent. They mainly expect us to make fast decisions on their applications. Here we find applicants who want to have their invention protected within Germany but often also wish for subsequent protection outside Germany. The remaining quarter consists of applicants that are solely interested in a fast and high-quality first assessment of the application by means of a search or a first official examination. We observe that these applicants use our services before they subsequently apply outside Germany. This latter group has little interest in continuing the procedure before my office here in Germany. We are currently considering how we can act in the best interest of both groups. What I can certainly say is that we will continue to address this topic. And of course, in general, it can be said that if we want to shorten the duration of proceedings, we need motivated and highly skilled patent examiners. Therefore, we are currently recruiting many young colleagues for our offices in Munich and Jena, and we want to make our procedures more efficient by using new technical options, thus taking workload from patent examiners and enabling them to concentrate on their core tasks and on speedy examination. Rolf Claessen: Thank you very much. I also feel that the German Patent and Trademark Office has become quite popular, especially with the start of the UPC. Some applicants seem to find that it is a very clever option to also file national patents in Germany. Eva Schewior: I think you're perfectly right, and I think we will come to this point later. Rolf Claessen: In 2023, you mentioned artificial intelligence as an important tool for supporting patent examiners. What has happened regarding AI since then? Eva Schewior: Of course, we are already successfully using AI at our office. For instance, in the field of patent search, we use AI-based tools that make our examiners' work easier. We also use AI quite successfully for classification and for the translation of Asian patent literature into English. In the meantime, we have seen a rapid development of AI in the market. I think it is strategically imperative to get an overview and to make realistic assessments of what AI is capable of doing to make our procedures more efficient. Therefore, we are observing the market to find out where AI can perform tasks so that we enable examiners to concentrate on their core business. There are many ideas right now in our office where artificial intelligence can help us tackle challenges, for instance demographic change, which certainly also affects our office, and maintaining our quality standards. We will strategically promote new tools in this field to cope with these challenges. But this much is also clear: humans will always stay in our focus. Especially in public administration, I consider it a fundamental principle that in the end, decisions must be taken and reviewed by humans. AI may help us reach our goals in a more efficient way, but it can never replace patent or trademark examiners. Rolf Claessen: You have made quality improvements in patent examination a priority and have already implemented a number of measures. How would you describe the current situation? Eva Schewior: I often receive positive feedback from different sides that our users are very satisfied with the quality of our examination, and I'm very glad about that. But maintaining this quality standard is a permanent task, and we must not become careless here. For years, for instance, we have established double checks for all grants and rejections. In addition, we have introduced a quality management tool that enables us, even during the examination process, to randomly check the quality of first office communications and searches. This helps us detect critical trends and take appropriate countermeasures at a very early stage. What is also very important when it comes to patent quality is to actively ask our customers for their feedback. We do this in different ways. Just to give you an example, we have a User Advisory Board, which is a panel of external experts implemented a couple of years ago. Discussing questions of quality is regularly on the agenda of this board. We carefully listen to criticism, ideas, and suggestions, and we have already implemented some of them for the benefit of the office and our users. Rolf Claessen: The German Patent and Trademark Office, as the largest patent and trademark office in Europe, records very high numbers of trademark applications. What are you currently especially concerned with in the trademark area? Eva Schewior: In 2025, we saw around ninety-five thousand trademark applications. This is an increase of eighteen percent compared to the previous year, and I have to say that this took us by surprise. Especially applications from outside Germany, and above all from China, have risen significantly. It is of course challenging to cope with such a sudden increase on an organizational level. Another challenge is dealing with trademark applications filed in bad faith, which we are currently seeing more and more of. We have thoroughly trained our trademark examiners on how to identify and handle such applications. As regards the new types of trademarks, the rush has been moderate so far. Sound marks, multimedia marks, or holograms are apparently not yet common solutions for the majority of applicants. The key focus remains on word marks and combined word and figurative marks. Nevertheless, I believe that the new trademark types are a meaningful supplement and may play a greater role as digitization advances. The most significant changes, however, concern procedures. Applicants can now choose whether to file revocation or invalidity actions with the courts or with our office. While courts may proceed somewhat faster, the financial risk is higher. Before the DPMA, each party generally bears its own costs, apart from exceptional cases. Rolf Claessen: How does this dynamic filing development impact the duration of trademark proceedings? Eva Schewior: This is indeed a major organizational challenge. For a long time, our trademark department managed to keep durations of proceedings very short, especially with regard to registration. Despite the recent increases in applications, especially in 2025, we hope to avoid a significant extension of processing times. We have restructured the organization of the trademark department to distribute applications more equally among teams. Applicants should also be aware that it is possible to request accelerated examination for a relatively moderate fee of two hundred euros. This often leads to registration within a very short time. The filing date, of course, always determines priority. Rolf Claessen: Since December 2025, the EU grants protection not only for agricultural products but also for craft and industrial products through geographical indications. Has your office already received applications? Eva Schewior: Yes, we have received our first application, and interestingly it concerns garden gnomes. Protected geographical indications are an important topic because they help maintain traditional know-how in regions and secure local jobs. The DPMA is the competent authority for Germany. Applications go through a national examination phase at our office before being forwarded to the EUIPO, which takes the final decision on EU-wide registration. Eligible products must originate from a specific region and derive their quality, reputation, or characteristics from that origin, with at least one production step taking place there. Rolf Claessen: The DPMA has expanded its outreach activities, including social media. What else is planned? Eva Schewior: Raising awareness of IP rights, especially among small and medium-sized enterprises, is part of our statutory duty. We currently use LinkedIn and YouTube to communicate IP topics in an understandable and engaging way. We also plan dedicated LinkedIn channels, for example for SMEs. Studies show that fewer than ten percent of European SMEs use IP rights, even though those that do earn significantly more on average. In 2026, we will further expand outreach activities, cooperate more closely with universities and educational institutions, and publish new studies, including one on the patenting behavior of innovative German start-ups conducted together with WIPO. Rolf Claessen: Where do you see the biggest future challenges in IP? Eva Schewior: Germany depends on innovation, but awareness of IP protection is still insufficient, particularly among SMEs and start-ups. Some companies deliberately avoid IP rights and rely on trade secrets, which I consider risky. Another growing concern is the increase in product and trademark piracy, often linked to organized crime. For our office, remaining attractive and competitive is crucial. Applicants have many options in Europe, so we need fast procedures, legally robust decisions, qualified staff, and modern IT systems. Rolf Claessen: The DPMA is currently recruiting. Which areas are you focusing on? Eva Schewior: Our focus is on patent examination and IT. We recently hired fifty new patent examiners and are particularly looking for experts in fields such as electrical engineering, e-mobility, IT, and aerospace. We are Europe's largest national patent office and offer meaningful, secure jobs with fair compensation and strong development opportunities. Rolf Claessen: Is there a final message you would like to share with our listeners? Eva Schewior: The Unitary Patent system has created many new options. German and European patent systems do not compete; they complement each other. For many SMEs, a German patent may already be sufficient, especially where Germany is the core market. Holding both European and national patents can also be a strategic advantage. My key message is: be aware of the options, stay informed, and choose your IP strategy deliberately. Rolf Claessen: Thank you very much for being on IP Fridays. Eva Schewior: Thank you for having me. It was a pleasure.

In this 194th in a series of live discussions with Bret Weinstein and Heather Heying (both PhDs in Biology), we discuss the state of the world through an evolutionary lens. In this episode we discuss the 2023 Nobel Prize in Physiology or Medicine, which was awarded for nucleoside base modifications that enabled the development of mRNA vaccines against COVID-19. We discuss the innovation for which the prize was awarded, what some of the known effects are, and what has been claimed about the (lack of) effects. We review some Nature news articles, including the finding that mRNA vaccines are linked to unexpected menstrual events. And we compare the costs and benefits of eating fish, supplementing with fish oil, and pharmaceutical drugging with Vascepa, and discuss connections between the three. ***** Our sponsors: Seed: Start a new healthy habit today with Seed probiotics. Use code darkhorse at https://seed.com/darkhorse to get 25% off your first month of Seed's DS-01® Daily Synbiotic. UnCruise: Get $500 off any adventure cruise on a small ship into destinations including Galapagos, Panama, Alaska, and the San Juan Islands: https://uncruise.com/pages/darkhorse/ Mindbloom: at-home ketamine therapy. Use code DARKHORSE at www.Mindbloom.com to receive $100 off your first six session program. ***** Join us on Locals! Get access to our Discord server, exclusive live streams, live chats for all streams, and early access to many podcasts: https://darkhorse.locals.com/ Heather's newsletter, Natural Selections (subscribe to get free weekly essays in your inbox): https://naturalselections.substack.com Our book, A Hunter-Gatherer's Guide to the 21st Century, is available everywhere books are sold, including from Amazon: https://a.co/d/dunx3at Check out our store! Epic tabby, digital book burning, saddle up the dire wolves, and more: https://darkhorsestore.org ***** Q&A Link: https://rumble.com/v3my788-your-questions-answered-bret-and-heather-194th-darkhorse-podcast-livestream.html Mentioned in this episode: Nobel press release: https://www.nobelprize.org/prizes/medicine/2023/press-release/ Chinese journalist asking Nobel committee about safety: https://x.com/refugeofsinner5/status/1709225153429737584 Nobel laureate Weissman discussing safety of mRNA shots in January 2021: https://x.com/TheChiefNerd/status/1708912252487684588 Fraiman et al 2022. Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults. Vaccine, 40(40): 5798-5805:https://www.sciencedirect.com/science/article/pii/S0264410X22010283 COVID vaccines linked to unexpected vaginal bleeding. Nature News 9-25-23:https://www.nature.com/articles/d41586-023-02996-6 Covid vaccines and safety: what the research says. Nature News Explainer 2-16-21: https://www.nature.com/articles/d41586-021-00290-x How Covid unlocked the power of RNA vaccines (“Side effects can be troubling.”). Nature News feature 1-12-21: https://www.nature.com/articles/d41586-021-00019-w Fish, fishy, and fish adjacent: https://open.substack.com/pub/naturalselections/p/fish-fishy-and-fish-adjacentJob opportunity: https://amarincorp.com/job/key-account-managerSupport the show

For more information, contact us at 859-721-1414 or myhealth@prevmedheartrisk.com. Also, check out the following resources: ·Newsletter Sign Up·Purchase an Appointmen Today!·PrevMed's Locals·PrevMed's Rumble·PrevMed's website·PrevMed's YouTube channel·PrevMed's Facebook page·PrevMed's Instagram·PrevMed's LinkedIn·PrevMed's Twitter ·PrevMed's Pinterest

The landmark Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT®) was a global outcomes study designed to assess the cardioprotective efficacy and safety of VASCEPA® (icosapent ethyl) as an add-on to statin therapy in reducing major cardiovascular (CV) events in a high-risk patient population. Join endocrine experts Eliot A. Brinton, MD, FAHA, FNLA, FACE, President of Utah Lipid Center, and Past President, of the American Board of Clinical Lipidology, and Betul Hatipoglu MD, Professor of Medicine at CWRU School of Medicine, and Medical Director for Diabetes & Obesity Center at University Hospital Cleveland Medical Center, to learn about the results of the REDUCE-IT® trial and new developments in CV prevention.

Printable Tip Sheet: Diabetes and Cardiovascular Disease: Are Statins Enough?Recorded Webinar: Focus on Persistent Cardiovascular RiskPrescribing Information and more information on VASCEPA.This podcast episode and the participation of Dr. Jennifer Goldman is sponsored by Amarin Pharma, Inc., makers of VASCEPA® (icosapent ethyl). To learn more about VASCEPA and to access the full prescribing information, visit VASCEPA.com. 

For more information, contact us at 859-721-1414 or myhealth@prevmedheartrisk.com. Also, check out the following resources:  ·PrevMed's website·PrevMed's YouTube channel·PrevMed's Facebook page

If you have a high TG level, there are ways to lower it—a healthy diet, lose weight, address medical conditions like prediabetes/diabetes. Sometimes, the doctor may prescribe meds, like Vascepa (icosapent ethyl). But is taking Vascepa worth it?For more information, contact us at 859-721-1414 or myhealth@prevmedheartrisk.com. Also, check out the following resources:  ·PrevMed's website·PrevMed's YouTube channel·PrevMed's Facebook page

Goop London closes, Bon Appetit video relaunches, and we talk vegan cheese, Vascepa, Theragun, Wim Hof, marriage problems, subscription services and more! 

On this episode, we revisit the management of of dyslipidemia. We review the basic pathophysiology of atherosclerosis and the four statin treatment groups. We also discuss where ezetimibe and PCSK9 inhibitors fit into the treatment regimens. We close with an overview of the EVAPORATE trial with icosapent ethyl (Vascepa) and the bempedoic acid (Nexletol) CVOT called CLEAR Outcomes. Thanks for listening! If you want to support the podcast, check out our Patreon account. Subscribers will have access to all previous and new pharmacotherapy lectures as well as downloadable Power Point slides for each lecture. You can find our account at the website below:  www.patreon.com/corconsultrx If you have any questions for Cole or me, reach out to us on any of the following: Text - 415-943-6116 Mike - mcorvino@corconsultrx.com Cole - cswanson@corconsultrx.com Instagram and other social media platforms - @corconsultrx This podcast reviews current evidence-based medicine and pharmacy treatment options. This podcast is intended to be used for educational purposes only and is intended for healthcare professionals and students. This podcast is not for patients and not intended as advice or treatment.   

This week's monologue touches on the credibility of expert speakers, evaluating the COVID-19 lockdown as health policy, and the anti-affirmative action white paper written by Dr. Norman Wang and its controversy. In the second half of the episode we interview Professor Darrel Francis of Imperial College London on COVID-19 cardiology and Vascepa. Anti-Affirmative Action: doi.org/10.1161/JAHA.120.015959 Back us on Patreon! www.patreon.com/plenarysession Check out our YouTube channel: www.youtube.com/channel/UCUibd0E2kdF9N9e-EmIbUew

We have a number of topics for you this week! Among them, we cover the issue of colon cancer screening, especially in the light of Chadwick Boseman's recent passing. We interview Jonathan Darrow, an Assistant Professor at Harvard Medical School and faculty at Brigham and Women's Hospital, on patent litigation and the recent patent appeal for Vascepa. Finally, we interview Dr. Toby Richards, Professor of Surgery, on running clinical trials and, specifically, the results of his recent trial PREVENTT, out now in The Lancet. PREVENTT: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31539-7/fulltext Back us on Patreon! www.patreon.com/plenarysession Check out our YouTube channel: www.youtube.com/channel/UCUibd0E2kdF9N9e-EmIbUew

Patent management is the hot topic of this episode. The focus is on AMARIN's leading product, VASCEPA, a drug made up of natural derivatives such as fish oil and was approved by the FDA in December 2019. Healthcare consultant Jared Wolff is joined by Bruna Favetta who has experience with the development of patent strategy, and Kate Jones who has a background in law. AMARIN has recently found themselves in unchartered territory as VASCEPA's drug patent is being challenged by generic producers, this episode explores: Why this case of VASCEPA is significantHow this may set a future precedent in drug patent law  Thanks for listening!

The District Court of Nevada rules that Amarin's Vascepa patents are invalid, but an appeal has already been filed! Axsome therapeutics fails their Phase 3 trial in treatment-resistant depression, but plans on moving forward with another trial. Finally, I talk about Athersys and their Multistem Cell Therapy for Acute Respiratory Distress Syndrome after receiving a "Highly Relevant" designation from the Biomedical Advanced Research and Development Authority (BARDA) of United States HHS.For more details on the Amarin patent case, check out Zachary Silbersher's blog here: https://www.markmanadvisors.com/blog/2020/3/31/can-amarin-win-on-appeal-in-the-vascepa-patent-litigationDisclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt's opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast.Support Breaking Biotech by donating to their Tip Jar: https://tips.pinecast.com/jar/breaking-biotech

03/06/20 - In this episode, Host Doug Stephan and Dr. Ken Kronhaus of Lake Cardiology (352-735-1400) offer the latest update on the Coronavirus. There seems to be two strains, one that is a little milder and seems to have affected 80% of those diagnosed. Keep in mind that 17-thousand Americans died from the last Pandemic, which was in 2009 and 2010. Dr. Ken explains the symptoms to look for, in detail. A new study shows that people with irregular sleep patterns are more prone to Heart Disease than others. Do you know your Body Mass Index? Dr. Ken explains how to calculate it and the recommended guidelines. Fish oil is also known to help keep your heart healthy and will not cause Cancer. The FDA has recently approved a drug that can help with Heart Disease, Vascepa. Plus, lots more tips and great ideas to help you maintain your Good Health.

Hosted by: Dr. Danielle Belardo  Instagram: @daniellebelardomd Twitter: @dbelardomd Facebook: Dr. Danielle Belardo, MD   Produced by: Dr. Kasey Johnson Instagram: @drkaseyjohnson   Also be sure to follow today's guest, Dr. Martha Gulati! Instagram: @drmarthagulati Twitter: @drmarthagulati   In this brilliant episode with expert Cardiologist Dr. Martha Gulati, in less than 90 minutes you will learn everything you ever wanted to know about preventing, diagnosing, and treating cardiovascular disease. We discuss the epidemic of cardiovascular disease in women, and learn how pregnancy can elucidate certain risk factors for heart disease down the road. We discuss what’s hot in prevention, from coronary artery calcium scores to PCSK9 inhibitors, SGLT2 inhibitors, Vascepa and more!    Martha Gulati, MD, MS, FACC, FAHA, FASPC is a Professor of Medicine and the Chief of Cardiology at theUniversity of Arizona (Phoenix). She held the Sarah Ross Soter Chair in Women’s Cardiovascular Health and was the Section Director for Women’s Cardiovascular Health and Preventive Cardiology at The Ohio State Universityuntil 2015. She is the author of the best-seller, “Saving Women’s Hearts”. She is the Editor-in-Chief of the American College of Cardiology “CardioSmart”, the patient education and empowerment initiative. She serves as the chair of the national chest pain guidelines. Her exceptional commitment to the study of women and cardiac diseases has won her numerous awards and distinctions, including being named by Crain’s Chicago Business as one of Chicago’s “Top 40 under 40,” a list that honors 40 outstanding individuals who have made a major impact in their respective industries before the age of 40. In 2011, she received the first CREDO (Coalition to Reduce Racial and Ethnic Disparities in Cardiovascular Outcomes) Award from the American College of Cardiology that was given to honor her contributions to improve cardiovascular healthcare of women patients. In 2012, she was awarded the National Red Dress Awardfor her efforts in raising awareness of heart disease in women and advancing research in this field. In 2019, she was chosen as the most influential woman in Arizona and received the 2019 American College of Cardiology’s Bernadine Healy Award for her leadership and accomplishment in the field of cardiovascular disease in women. Dr. Gulati is passionate about the study of women and heart disease and prevention of heart disease.  She is the principal investigator of the St. James Women Take Heart Project, a study examining cardiac risk factors in women, which set new standards for women’s fitness levels and heart rate response to exercise in women. She also is a co-investigator on the Women Ischemic Syndrome Evaluation (WISE) and previously served as a co-investigator on the Women’s Health Initiative (WHI).   She is a member of numerous advisory boards and societies, including the American Heart Association(AHA), the American College of Cardiology and the American Society of Preventive Cardiology (ASPC). She serves on the board of the ASPC, the Phoenix chapter of the American Heart Association and the board of WomenHeart.  She has published articles in peer-reviewed publications, including The New England Journal of Medicine, Circulation, and Journal of theAmerican Medical Association (JAMA).  Her research has been featured in hundreds of newspapers across the world, including The New York Times and USA Today. She has also been featured on Oprah and been feature on CBS National News, The Today Show, Canada AM, in addition to many others. She recently was listed on the Marquis 2019 Who’s Who in America, Who’s Who in the World, and Who’s Who in American Women. Dr. Gulati completed medical school at the University of Toronto, Canada.  She went on to complete her internship, residency, and cardiology fellowship at the University of Chicago.  She received a Master in Science at the University of Chicago and is a fellow of the American College of Cardiology and the American Heart Association.  She is board certified in cardiovascular disease.

Here are the links for everything discussed in Episode 14. Xtandi added indication Xeljanz XR added indication Approval of Padcev for urothelial cancer Approval of Vyondys 53 for Duchenne Muscular dystrophy Vascepa approval to reduce the risk of cardiovascular events. Connect with The Rx Daily Dose:Twitter      Instagram      YouTube      Linkedin       WebsiteEmail: therxdailydose@gmail.comConnect with Ian Parnigoni PharmD. on social media:Twitter       Instagram       Linkedin  ★ Support this podcast on Patreon ★

Vascepa approved for cardiovascular risk reduction The FDA’s decision on cutting events in high-risk patients was based primarily on the REDUCE-IT trial. ENGAGE AF-TIMI: Insulin linked to greater risk for stroke, CV death, bleeding Novel oral anticoagulants may be preferred over warfarin in patients with diabetes and AFib. HHS drug importation proposals aim to address high costs Trump administration drops key health care proposal on day of impeachment vote. End ‘therapeutic nihilism’ in care of older diabetic patients, says expert ‘It’s not hyperglycemia that’s killing people; it’s heart disease and renal disease.’ *  *  *   For more MDedge Podcasts, go to mdedge.com/podcasts Email the show: podcasts@mdedge.com Interact with us on Twitter: @MDedgeTweets

Amarin finally receives label expansion for Vascepa, which can now be marketed to patients with Triglyceride levels of greater or equal to 150mg/dl and existing Cardiovascular Disease or Diabetes Mellitus plus two other risk factors for CVD. In this video, I go through what I think is the potential market for this drug and the company's valuation.I also talk about a number of other companies that had updates at ASH2019 or around that time, including BLUE, FATE, DTIL, KOD, SRPT, SNY.Follow me on twitter @matthewlepoire Email me at matthewlepoire@gmail.com www.breakingbiotech.comRelevant sources: Fan W. Diabetes. 2018:67(Suppl 1) 2019 AHA Heart Disease and Stroke Statistics Fan W. J Clin Lipidol. 2018:13(1) Einarson TR. Cardio Diabetol. 2018 17(83)Disclaimer: All opinions expressed by Matt in this podcast are solely his opinions. You should not treat any opinion expressed by Matt in this podcast as a specific inducement to make a particular investment or follow a particular strategy, but only as an expression of his opinion. Matt's opinions are based upon information he considers reliable, but Matt cannot warrant its completeness or accuracy, and it should not be relied upon as such. Matt is not under any obligation to update or correct any information provided in this podcast. Past performance is not indicative of future results. Matt does not guarantee any specific outcome or profit. You should be aware of the real risk of loss in following any strategy or investment discussed in this podcast.Support Breaking Biotech by donating to their Tip Jar: https://tips.pinecast.com/jar/breaking-biotech

Monologue Dr. Joel Wallach begins the show discussing mental health issues. Outlining several mental health challenges such as Autism. Contending they are all due to nutritional defciencies. Stating that if nutrients were put in the water these challenges would stop. Citing the Texas study where two counties were compared the numbers of violent acts. One county had a lot more vionet acts. But were missing a certain mineral in the water. The county with much less violence did have the mineral in it's water. Pearls of Wisdom Doug Winfrey and Dr. Wallach discuss a news article regarding the FDAs approval of Vascepa. The drug is touted to help prevent heart attacks, strokes and death in people with cardiovascular disease. Doc asserts that people should just Youngevity's EFAs. As the EFA Plus contains fish oils and are easily absorbed. Callers Venita has several health challenges including high blood pressure, weight gain and hypothyroidism. David has questions concerning a skin rash in his genital area. Roger is experiencing peripheral neuropathies in his hands and feet. Call Dr. Wallach's live radio program weekdays from noon until 1pm pacific time at 831-685-1080 or toll free at 888-379-2552.

Vascepa was just approved by the FDA to reduce cardiovascular risk among certain patients with elevated triglyceride levels as an add-on to maximally tolerated statin therapy. In a recent study Vascepa significantly reduced the risk of death due to cardiovascular causes, heart attack, and stroke in patients who remained at increased risk despite statin therapy.

Survival Medicine Podcast #375 In survival, the medicines eventually run out no matter how well you’ve prepared if the disaster knock you off the grid for long enough. This is especially true for drugs for which you can only stockpile a limited quantity, simply because they’re too expensive. One item that isn’t too expensive is fish oil, commonly available in supplement or in FDA-approved prescription items. The scientific data shows that they can reduce triglycerides in your blood, a factor in coronary artery disease, and perhaps help in other ways. So what is fish oil and is it of any use off the grid? Should you accumulate it in quantity in your medical storage. That's your decision, but you'll know a lot more about it after listening to Dr. Joe Alton of doomandbloom.net! Also, Dr. Alton answers a question from someone suffering from symptoms similar (but not exactly) to carpal tunnel syndrome. Could he have Guyon's Syndrome instead? Learn about it in this episode of the new-format Survival Medicine Podcast! Wishing you the best of health in good times or bad, Joe Alton MD/Amy Alton ARNP Hey, show your support for our mission to put a medically prepared person in every family by subscribing to our website at doomandbloom.net and checking out Nurse Amy's often-imitated, never-equaled medical kits and supplies at store.doomandbloom.net!  

Survival Medicine Podcast #375 In survival, the medicines eventually run out no matter how well you’ve prepared if the disaster knock you off the grid for long enough. This is especially true for drugs for which you can only stockpile a limited quantity, simply because they’re too expensive. One item that isn’t too expensive is fish oil, commonly available in supplement or in FDA-approved prescription items. The scientific data shows that they can reduce triglycerides in your blood, a factor in coronary artery disease, and perhaps help in other ways. So what is fish oil and is it of any use off the grid? Should you accumulate it in quantity in your medical storage. That's your decision, but you'll know a lot more about it after listening to Dr. Joe Alton of doomandbloom.net! Also, Dr. Alton answers a question from someone suffering from symptoms similar (but not exactly) to carpal tunnel syndrome. Could he have Guyon's Syndrome instead? Learn about it in this episode of the new-format Survival Medicine Podcast! Wishing you the best of health in good times or bad, Joe Alton MD/Amy Alton ARNP Hey, show your support for our mission to put a medically prepared person in every family by subscribing to our website at doomandbloom.net and checking out Nurse Amy's often-imitated, never-equaled medical kits and supplies at store.doomandbloom.net!  

Icosapent ethyl cost effective in REDUCE-IT analysis Treatment with the fish-derived drug Vascepa for CV event reduction is more effective and less costly than placebo. *  *  *   Help us make this podcast better! Please take our short listener survey: https://www.surveymonkey.com/r/podcastsurveyOct2019 *  *  *   DAPA-HF: Dapagliflozin benefits regardless of age, HF severity The SGLT2 inhibitor had similar efficacy in the elderly and across the spectrum of baseline symptom status. Colchicine cut post-MI CVD events Colchicine fulfilled the promise first seem in CANTOS that anti-inflammatory treatment can reduce cardiovascular disease events. Cardiac arrests peak with pollution in Japan The incidence of out-of-hospital cardiac arrests in Japan increased on days when counts of particulate matter spiked from the day before. *  *  *   For more MDedge Podcasts, go to mdedge.com/podcasts Email the show: podcasts@mdedge.com Interact with us on Twitter: @MDedgeTweets

Amarin's shares rocketed higher after a key FDA committee recommended expanding the label of its triglycerides lowering drug, Vascepa, to include data showing it can reduce the risk of heart attack and stroke. Meanwhile, shares in CRISPR Therapeutics and partner Vertex Pharmaceuticals are also soaring following the release of interim, early-stage results for its gene-editing therapy for beta thalassemia and sickle cell disease therapy. Stocks: AMRN, CRSP, VRTX Check out more of our content here: TMF's podcast portal YouTube Twitter Join Our Motley Fool Podcast Facebook Group LinkedIn StockUp, The Motley Fool's weekly email newsletter

Hey everyone! In this video, I discuss the relationship history between Amarin and the FDA regarding their EPA medication (Vascepa) for the lowering of triglycerides. I believe the difficulty #AMRN has had with the FDA in the past has made the market concerned about Vascepa's future given recent announcement of an advisory committee meeting for label expansion of Vascepa. I also talk about Sarepta, Novartis and Gilead.This is not investment advice. Please do your own due diligence before ever investing in equity markets.www.breakingbiotech.com http://epadruginitiative.com/press/why-the-fda-got-it-wrongSupport Breaking Biotech by donating to the tip jar: https://tips.pinecast.com/jar/breaking-biotech

Every week, The American Journal of Managed Care® recaps the top managed care news of the week, and you can now listen to it on our podcast, Managed Care Cast. This week, the top managed care news included the FDA's approval of a $2.1 million gene therapy; a study revealing that the worldwide need for palliative care will nearly double by 2060; the FDA granting priority review to Amarin’s Vascepa for a cardiovascular indication. Read more about the stories in this podcast: FDA Approves Gene Therapy With $2.1M Price Tag for Spinal Muscular Atrophy in Pediatric Patients: https://www.ajmc.com/newsroom/fda-approves-gene-therapy-with-21m-price-tag-for-spinal-muscular-atrophy-in-pediatric-patients Serious Health-Related Suffering to Nearly Double by 2060, Highlighting Need to Ramp Up Palliative Care Efforts: https://www.ajmc.com/focus-of-the-week/serious-healthrelated-suffering-to-nearly-double-by-2060-highlighting-need-to-ramp-up-palliative-care-efforts What We're Reading: FDA Grants Priority Review for Amarin's Vascepa; HHS Rule Challenged; Military Mental Health Proposal: https://www.ajmc.com/newsroom/what-were-reading-fda-grants-priority-review-for-amarins-vascepa-hhs-rule-challenged-military-mental-health-proposal Amarin's High-Dose Fish Oil Pill Cuts Total CV Event Risk 30% in Study: https://www.ajmc.com/conferences/acc-2019/amarins-highdose-fish-oil-pill-cuts-total-cv-event-risk-30-in-study The American Journal of Managed Care—May 2019: https://www.ajmc.com/journals/issue/2019/2019-vol25-n5 Open Doors to Primary Care Should Add a “Screen” to Reduce Low-Value Care: https://www.ajmc.com/journals/issue/2019/2019-vol25-n5/open-doors-to-primary-care-should-add-a-ldquoscreenrdquo-to-reduce-lowvalue-care American Society of Clinical Oncology Annual Meeting 2019: https://www.ajmc.com/conferences/asco-2019

In this week’s episode, John reviews some pharma breakthroughs—along with one major setback—and discusses the bold statement by the Department of Justice (DOJ) regarding the Affordable Care Act (ACA). Highlights include: The Department of Justice issued a letter stating that it agrees with a federal judge who struck down the entire ACA as unconstitutional. The FDA approved the first drug to treat postpartum depression: Sage Therapeutics’ Zulresso (brexanolone). Amarin Corp. presented updated results for its ongoing Vascepa (icosapent ethyl) clinical trial, REDUCE-IT, at the American College of Cardiology Annual Meeting. Biogen is scrapping its investigational treatment for Alzheimer’s disease, and is canceling its Phase III ENGAGE and EMERGE clinical trials. About Darwin Research Group Darwin Research Group Inc. provides advanced market intelligence and in-depth customer insights to health care executives, with a strategic focus on health care delivery systems and the global shift toward value-based care. Darwin’s client list includes forward-thinking biopharmaceutical and medical device companies, as well as health care providers, private equity, and venture capital firms. The company was founded in 2010 as Darwin Advisory Partners, LLC and is headquartered in Scottsdale, Ariz. with a satellite office in Princeton, N.J.

In this episode we discuss John Ioannidis' article on the uselessness of medical conferences, published in JAMA: "Are Medical Conferences Useful? And for Whom?", followed by an interview with return-guest Dr. Adam Obley on a few recent clinical trials: Vascepa, fish oil, vitamin D, and methotrexate. Medical conferences: doi.org/10.1001/jama.2012.360

Amarin recently published data from their REDUCE-IT cardiovascular outcomes trial. Their EPA medicine, Vascepa, showed a 25% relative risk reduction compared to placebo. EPA is an omega-3 fatty acid that previously showed a 19% relative risk reduction in cardiovascular outcomes in a Japanese study (JELIS, 2007). Amarin saw a hazard ratio of 0.75 in their primary endpoint, which evaluated cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and unstable angina. In this video, I go through two critiques of the study: 1) Lack of mechanistic insight 2) Mineral oil use in the placebo group I believe Vascepa is likely to get FDA approval for the indication of reducing cardiovascular disease in patients with over 150mg/dl Triglycerides on statin therapy. This is not investment advice, do your own due diligence.Relevant links: https://investor.amarincorp.com/ https://www.nejm.org/doi/full/10.1056/NEJMoa1812792 https://www.nejm.org/doi/full/10.1056/NEJMe1814004

-Amarin's EPA medicine, Vascepa, recently showed a 25% relative risk reduction in newly announced data from the cardiovascular outcomes trial, REDUCE-IT. -Today I breakdown the results and talk about how it compares to other CVOT data and whether Amarin is likely to rival companies with a LDL-c lowering drug pipelines.this is not investment/trading advice Follow me @matthewlepoire www.breakingbiotech.comRelevant links: http://investor.amarincorp.com/node/15741/pdf http://investor.amarincorp.com/system/files-encrypted/nasdaq_kms/assets/2018/09/27/10-23-58/AMRN%20Investor%20Deck%20Sept%20Post%20R-IT%20v3.pdf https://www.ncbi.nlm.nih.gov/pubmed/29935936

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