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On May 30, 2025, the FDA sent a letter of approval to the pharmaceutical company Moderna to manufacture and sell its new COVID-19 vaccine.1 But even more dismaying, Robert F. Kennedy, Jr., the world's most prominent advocate for vaccine safety, has now gone out on a political limb and committed himself to promoting Moderna's latest version of the mRNA Covid jab.2 In doing so, Kennedy is supporting the continuation of the world's most lethal medical or wartime assault on humanity, one that many see as a bioweapons attack on America by the globalists, including Communist China.   There are more than 38,000 reports of death to date to the CDC and FDA from the COVID-19 vaccines. Nothing like this catastrophe has ever before happened in medicine or public health. In addition, there is a deluge of reports and independent studies verifying the almost infinite harms caused by these mRNA vaccines. These harms include infertility, a declining birth rate, multiple harms to infants and mothers, cardiovascular disorders, including myocarditis in children and strokes in adults, tumors, a wide range of neurological and psychiatric disorders, and Acquired Immunodeficiency Syndrome (AIDS), which results in greater susceptibility to infections and cancer. But for every reported death and other serious adverse event, we know that there are more than 100 actual deaths or harms. These “vaccines” are killing and maiming millions in America and millions more around the world.3   Here is Kennedy's entire defense of his atrocious actions:     Actually, there is nothing “limited” about the approval letter. The letter specifically empowers Moderna to manufacture and distribute the drug. They will go ahead with this before completing any additional studies supposedly promised to Kennedy, which would take years more. Besides, once a drug company has spent multi-millions getting a drug approved, as they have already done, I've never seen a company actually complete additional studies that could invalidate their drug. Moderna's survival is at stake, and drug companies don't commit economic suicide. And this one has the backing of Bill Gates!   Kennedy has broken many recent promises to get himself into this bizarre situation of betraying his previously voiced ideals. He is approving the Moderna COVID-19 vaccine without so much as a placebo-controlled clinical trial or even a review by the FDA Vaccine Committee. On top of that, pregnant women are not protected as he promised to do. But worst of all, he has never even promised to stop the heavily documented murder of the elderly who are killed by the mRNA covid vaccines at a rate of eight times more than the rest of the population.4   Many of us will remain eternally grateful for RFK, Jr's support for Donald Trump's election campaign. But now he must resign or be removed.   Kennedy's acceptance of the FDA's approval of Moderna's Covid vaccine is more than sufficient reason to fire him. But in addition, he is also grossly undermining the Trump administration and literally threatening the well-being of all our citizens by advocating the use of extremely dangerous neurotoxins, including methylene blue, MDMA or Ecstasy, and psychedelics. Trump's choice for Surgeon General, based on Kennedy's recommendation, is devoted to psychedelics! It's as if  RFK, Jr. has become a toxic mole within the America First movement.   For an in-depth scientific analysis and presentation about everything in this synopsis, please read the full article: RFK, Jr. blatantly supports the mRNA COVID shots and must be forced to resign - Full Article   End Notes:   1 May 30, 2025 Approval Letter – MNEXSPIKE   2 Secretary Kennedy on X: “I want to address those of you who have anxieties about @US_FDA's limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine, which is similar to the existing mRNA vaccine but uses a smaller” / X. Actually, there is nothing “limited” about the approval letter. Besides,  once a drug has spent multi-millions getting a drug approved, I've never seen one fulfill a promise to do studies that could invalidate their drug.   Besides, if a study of safety is still needed, it's ridiculous to put off until after it's been approved, by which time many could be harmed.   3 New FDA Plans for the Covid Vaccines Will Kill Millions More   4 New FDA Plans for the Covid Vaccines Will Kill Millions More   ______   Learn more about Dr. Peter Breggin's work: https://breggin.com/   See more from Dr. Breggin's long history of being a reformer in psychiatry: https://breggin.com/Psychiatry-as-an-Instrument-of-Social-and-Political-Control   Psychiatric Drug Withdrawal, the how-to manual @ https://breggin.com/a-guide-for-prescribers-therapists-patients-and-their-families/   Get a copy of Dr. Breggin's latest book: WHO ARE THE “THEY” - THESE GLOBAL PREDATORS? WHAT ARE THEIR MOTIVES AND THEIR PLANS FOR US? HOW CAN WE DEFEND AGAINST THEM? Covid-19 and the Global Predators: We are the Prey Get a copy: https://www.wearetheprey.com/   “No other book so comprehensively covers the details of COVID-19 criminal conduct as well as its origins in a network of global predators seeking wealth and power at the expense of human freedom and prosperity, under cover of false public health policies.”   ~ Robert F Kennedy, Jr Author of #1 bestseller The Real Anthony Fauci and Founder, Chairman and Chief Legal Counsel for Children's Health Defense.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why seemingly routine comments from Vinay Prasad, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, that he would stay away from daily review decisions were notable (:26), as well as the impact of proposed FDA budget cuts by the White House and the House of Representatives (17:16). More On These Topics From The Pink Sheet Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors: https://insights.citeline.com/pink-sheet/rare-diseases/prasad-says-involvement-in-us-fda-product-approvals-will-mirror-prior-cber-directors-KF4LJWX5U5DLBMSM6D4YFL7ZOA/ To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/to-compete-with-china-us-fda-must-deregulate-early-gene-therapy-studies-car-t-inventor-says-VDVXZGZIJZFHHNGGQXYILBI7RM/ FDA's FY 2026 Budget Request Lacks New Policy Proposals: https://insights.citeline.com/pink-sheet/legislation/fdas-fy-2026-budget-request-lacks-new-policy-proposals-WV3LE2AYBRAC7LIYJEU4WZDNGU/ User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-funded-staff-would-drop-in-fy-2026-us-fda-budget-TQZMEB57V5GELNPMYGTY5BEGOY/ House Gives US FDA More Non-User Fee Funds Than Requested: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/house-gives-us-fda-more-non-user-fee-funds-than-requested-PCQZCBHOB5ARPICMJJQ6VYIJ5M/

An expert from ISACA shares her insights into medtech's Voluntary Improvement Program (VIP), a collaboration among participants, ISACA, MDIC, and US FDA formed to enhance patient safety and product quality in medical device manufacturing. Listen to learn more about attaining measurable improvements with the VIP.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the potential comments that US Food and Drug Administration Commissioner Martin Makary and other senior agency leaders could receive during their pharma CEO listening tour (:30), as well as the impact of Health and Human Services Secretary Robert F. Kennedy Jr.'s decision to change US Centers for Disease Control and Prevention policy and no longer recommend healthy children and pregnant women receive COVID-19 vaccines (15:47). More On These Topics From The Pink Sheet US FDA Makary's Pharma CEO Tour Goes Against Transparency Rhetoric: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-makarys-pharma-ceo-tour-goes-against-transparency-rhetoric-3E5RP5IATVD73DRPQHZPSTHKRA/ HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role: https://insights.citeline.com/pink-sheet/vaccines/hhs-rescinds-covid-19-vaccine-advice-usurping-us-cdc-role-YNFI7TU5CFGERIGFG7ISOJ4X5Q/

Dr. Shalabh Gupta, founder and CEO of Unicycive Therapeutics, shares his inspiring journey from practicing medicine to leading groundbreaking innovations in kidney disease treatment. Dr. Gupta discusses his comprehensive framework for identifying and developing medical solutions, his vision for Unicycive's future, and the importance of focus and execution in medical startups. He reveals the challenges and triumphs of bringing life-changing products to market and offers profound advice for new entrepreneurs in the industry.   Guest links: https://unicycive.com/  Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 056 - Dr. Shalabh Gupta [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am so excited to introduce you to my guest, Dr. Shalabh Gupta. Dr. Gupta is the founder and CEO of Unicycive Therapeutics. He is a visionary in healthcare, leading groundbreaking efforts to design innovative therapies and reimagine how we approach unmet medical needs. His work goes beyond the lab as he's driving a healthcare revolution by developing innovative therapies addressing critical gaps in treatment. His perspective combines decades of experience and expertise in drug design with a deep commitment to equity in health care. Well, welcome to the show, Shalabh. I'm so excited that you're here with me today. [00:01:35] Dr. Shalabh Gupta: Thank you. Thank you for hosting me. [00:01:36] Lindsey Dinneen: Of course. I'd love if you wouldn't mind just telling us a little bit about yourself, your background, and what led you to MedTech. [00:01:45] Dr. Shalabh Gupta: By way of background, I'm a physician, trained, practiced, did my medical training in internal medicine, residency in physical medicine and rehab, research fellowship in cardiac and pulmonary rehabilitation, board certified physician, practice in New York at NYU hospital, NYU Medical Center. This is where I did my medical training for roughly decade after finishing medical school. I also have a graduate degree in finance management from NYU. While I was doing my residency training, I realized that I wanted to find a way to have a broader impact on society as well as what we were working on in learning medicine. So, I started my career working initially with a biotechnology company at the time to help them get their drug with FDA through a regulatory approval process. The beginning of the process is called IND following a investigation new drug application, IND application. I actually visited FDA on their behalf, met with FDA back in the time when everything used to be in person. Built from there onward, joined Wall Street from working as a stock analyst. So I covered biotech companies as a stock analyst, and the weekend and holidays that were available, I worked to continue to practice the medicine at NYU as an attending physician, and then joined another bank and covered pharmaceutical stocks and worked covering six of the largest pharma companies that include Pfizer, Merck, Viacom, Selling Power, Eli Lilly, Bristol Myers Squibb. From there, I moved to California. I worked for Genentech in corporate strategy. Genentech, at the time, and continues to be, one of the largest biotechnology companies. And from working at Genentech, I got my inspiration to start my own companies. So I founded two companies prior to finding starting Unicycive. All my companies are focused on aesthetic therapeutic area. Unicycive is focused on nephrology, treatment of kidney diseases, and we have two drugs in development. We have a lead drug that is pending approval from the US FDA in June of 2025 this year. And the second, I guess, finish phase 1 clinical trial in the UK. And we are in discussion with the agency to proceed with the next stage of clinical trial in the US. So that's a quick background. [00:04:14] Lindsey Dinneen: Wow. That's incredible. Thank you for sharing your story. Yeah. So let's talk about your company now. You've become CEO of this company. You're developing these products that are going to change lives. What first made you realize that there was a gap that needed to be filled in the market for this? And then, what prompted you to go, "You know what? Hey, I think I can have the solution for this or I can have the answer to this." [00:04:38] Dr. Shalabh Gupta: The first question that you ask, understanding the unmet need in medicine, there are a lot of problems that you can address. So, to give you a framework, if I am thinking about a problem, I want to understand if a couple of things, and in order of priorities, these are: can I find a solution that with my resources-- resources is time, energy, and money-- can I create a product that will truly make it to the market? Number two is that I also feel that one can get very blindsided that "I have a solution," but not understand what other solutions exist in the market. So understanding the competitive landscape. If I create this drug, this device, this product, and it is going to take three to four years in the market to come to the market-- which, by the way, in medical word is a still very fast track because it takes much longer-- what will the competitive landscape look like for 5 years down the road? So that's the second part. And third is that what is the solution that I'm developing? Is it unique in terms of having a novel, either as a drug device or drug device combination, or as a patented drug, patented device, because in our industry, it's not really possible to scale up something until unless you have an IP or intellectual property protection. And then from there onward, the last thing is also, who's going to fund me, how I think about funding, not for next six months a year, but also a continuum of the product development. If I think about all these 4-5 problems, then you start to narrow it down. There are some problems that are very much worthy of exploration. For example, treatment of Alzheimer's, we all know it's a big unmet need, we all know there's a big market opportunity. But I realized that was something we couldn't do it with the products or the development candidates that I had seen. So, being able to define where is the end point and goal. Being able to understand, can I make an impact? And when I say I, I speak for myself, but each one of us, I always remind entrepreneurs, we each one of us have our own deck of cards. We have to play with our cards, we can't compare ourselves with somebody else, or we can compare some other cases study. So understanding more about what is so unique that I can bring to table that can I make a difference and then making a business around this where the thesis lies. Once you identify that, then there's a question about continuing to execute and keep changing your plan as you go along. [00:07:11] Lindsey Dinneen: Yeah, absolutely. Well, I love your framework for thinking through all of those things. And so of course you use that when you thought, "Hey, here's this issue. I could potentially have a solution," and you went through this process. And then can you tell us about your innovation now and how that is helping and how you expect it to help change all these wonderful lives? [00:07:33] Dr. Shalabh Gupta: So, so for treatment of kidney diseases, first of all, it has been one area of development that has not had that much of innovation. And, and I think that is where the initial part of the thesis was that focusing on nephrology of kidney diseases is not same as developing a drug for cancer treatment. Cancer treatment changes every six months a year. The standard of care continues to evolve. Is there an unmet need in cancer treatment? A hundred percent, but the part is that the pace of innovation is very rapid. Is it same in nephrology? It's getting there, but it's still the development of a new products in nephrology still is not at the same pace. So I thought there was something we could make a difference by a small company. The drug that I acquired from another company was a drug that had finished a clinical trial. So it had shown that the drug is safe. It had also shown some signal of it working in healthy volunteers. That's a phase one trial. And the innovation came from a car battery company that had figured out how to make a big, large size pill to make it smaller. And sometimes greatest innovation, greatest insight come from the fact that when I talk to the kidney doctors, the physicians who take care of these patients there with the treatment of kidney diseases, they said the problem for these patients are the patients have to take 12 to 15 pills per day. And this innovation allowed us to be able to make that number of pills go down from 13 to 12 or 15 to three pills per day, one pill with each meal. And then the regulatory pathway became a bit more clear that if I can show that our drug is similar to the drug that was in the market, maybe there was an opportunity to go through expedited pathway, which is what we did. And I acquired the drug in 2018, went to FDA right after acquiring the drug to expedite the pathway again, thinking about de risking the development pathway. And as I mentioned in 2025, we are expecting the approval. So that is the process about it. And that's the story behind the lead drug. [00:09:51] Lindsey Dinneen: Great. Excellent. So that is really exciting. And as you continue to go forward with this company and the innovations that you're creating, what is your ultimate goal or dream that you're really striving for? [00:10:06] Dr. Shalabh Gupta: So, the focus for Unicycive is building new novel treatment for kidney diseases. Our lead drug is expecting approval in June 2025. But we have a second drug in development, and we continue to think about what will be something that we as a small company can bring to market. There are other areas of unmet need in kidney treatment. But instead of doing too many things at the same time, we continue to think, "How do we grow our company? What will be the vision for the company three years down the road, five years down the road?" And what we want to continue doing is to develop the drug candidates, advance them. Right now, after the first drug we get through approval, it will be the second drug. There is a thought process behind it. One of the biggest challenges that I've seen for smaller companies and startups is that they end up in doing too many things at the same time, which is difficult to do, even for big companies. You know, big companies, they have a one product that is a marquee product, they launch that and then they develop other things. So, being able to stay focused is also key because you can have a lot of energy, you can have a lot of ideas, but you have to focus on which one you can do first. [00:11:22] Lindsey Dinneen: Yeah, that is so true. It's such great advice, a good reminder. Yes, focus is so important. You know, honestly, that's probably one of the tricky things that startups in this particular field might struggle with is that focus. So I'm wondering what kind of advice do you have for say a brand new entrepreneur in the industry who has these great ideas, but you know, maybe has so many that they're a little too scattered. [00:11:52] Dr. Shalabh Gupta: Right. So, I think you may start with 10 ideas but the framework I gave you that: can this idea in this given timeframe with my resources and the funds that I can raise, can it make a difference? So you start to narrow it down. You start with a big funnel, narrow it down. And then maybe you have two or three ideas. Instead of thinking to yourself that "No, I'm not going to tell my idea to anyone because somebody else can take it away," find people who will be willing to pressure test those ideas. Then you will have identified something, maybe one Idea that is worth the pursuit. So then you focus on that. So that's one part of how to triage it because we all have ideas, but those ideas may not be worth developing once you go and talk to the marketplace. And marketplace is your investors, the physicians, and the patients. I keep saying about these three stakeholders, because if physicians cannot prescribe what you are developing, then it's of no use. If patients don't necessarily benefit, then it's of no use. And if you cannot get insurance companies a reimbursement for that means the product will never get here. So it's a process, but nobody can come up with an idea. And there is no great idea. There are ideas that you have to, and then once you find that one idea that resonates with all the stakeholders, physicians are excited about it. If you talk to patients, and you want to do that early on, you don't want to develop an idea and then go, you know, that is the greatest idea but nobody really perceives it that way that except you and a couple of your friends and people who work with you. I don't mean in a bad way. I mean, that you want to be able to test this idea very quickly. So once you get that idea, once you identify what is that the company should be focused on, then the question about is actually building an execution plan. And the only advice I can give is that at any given day for a company, startup, especially whether you're a founder or you're a founding team member, the list of priorities is 50, 5, 0, or maybe 100. It takes time to figure out of those 50, which are the top three that are most important and then being able to focus on those three. You know, the reason I say that no one can work on 50 priorities at the same time. But we all can take two or three priorities and say, "These are the three things that I'm going to work on today. That is this week. Those are the things I'm going to do this month." And therefore you start to develop identifying priorities. The right ones takes time. Sometimes it is a fundraising. Sometimes it's a building a team. Sometimes it's a product development. Sometimes it's all three of them, but being able to allocate your time and energy and focus is a key. People say it's the question of money. I don't think it's a question of money. Money is one of the resources, but the biggest resource we all have is a time and energy and focus. In a company of our size, we are a publicly listed company, and we now have grown from where we used to be, and it's still small. Even today, there are a lot of things we choose not to do. We choose not to go to conferences. We choose not to publish papers. If something is a priority to us, we say, "This is the only thing we're going to focus on. This is the next three months, this is our main goal." And every team meeting I have, I always remind people, three priorities. More than three, way too many. One may not be enough. But because if you can't remind people, what is the priority for the company, then you will not succeed. It is a very challenging environment to think about a startup company or companies in general. And when you have too many priorities, you tend to lose focus on. By building priorities, having priorities, executing them. You create momentum, you create confidence. They create success and you keep climbing the ladder. But truly the biggest challenge for us in the beginning of the career is that identifying which are those three priorities that matter. And once you have had some experience, then the challenge is to keep those priorities and change them as you go along, right? As you go along, you have to continue to grow. For example, in the beginning, it may be the five people you have and that may be enough. But as where we are in the company, it's a question about growth of the organization, right size, not too many people, not too little, hiring enough people so we can continue to execute on our vision and the promises that we made to ourself and to our investors. [00:16:27] Lindsey Dinneen: Thank you for that advice. That was fantastic. And such a great way to narrow it down and help people understand how to narrow down so that they can actually focus and succeed before moving on. I love that. Thank you. So, you know, looking back over your life, and of course, you've had such an incredible career that has really taken you in a lot of different directions. Could 10 year old you have ever anticipated where you'd be today? [00:16:54] Dr. Shalabh Gupta: I don't think so. I think I think we all have a what I call a true north compass. What I did think at the 10 years of age, if I can go back, maybe 10 is too early but maybe 15 or 16 or 17, that hasn't changed. Let me tell you 2 things that I always felt most inspired and excited about. Number one was that I wanted to be in healthcare because, intellectually, I like biological sciences. I felt, "My gosh, what could I do with that if I could make a difference?" And number two was that I, from very early on, I wanted to be something which could help people directly. As you know, there are many ways you can help people, but being in medicine or healthcare, I felt there was a direct impact. Now, looking back after several decades, I feel that part of the influence was my dad. My dad is a physician, continues to see patients and do pro bono work. So that had a very lasting influence on me. That helped me to think about, okay, this is what I want to do. Then being trained as a physician, then going to work on Wall Street, then there was a question about understanding how the impact can be broadened, if you will. The way to think about what I do today versus what I did, say, as a physician, physicians see, say, 10 patients, maybe 12 patients if you're seeing an outpatient basis per day. And if you're in an ICU or ICU doctor, an ER doctor, you could see more number of patients, but then smaller time. And you multiply that impact that many patients, let's just say 10 patients per day, and you work at 300, 350 days, 360 days, 365 days, don't take any break, but that is that many patients a year. What we do today has a potential to impact hundreds and thousands and millions of patients and not just in the U S, globally. So from one vantage point is just magnifying the impact. And the other vantage point is doing what I would have done before. I still love sciences every day. My job is to not just talk about business, but also think about, "How do we fundamentally solve the problem?" And having had those experiences you know, it helps you to keep yourself grounded. One part, I know this wasn't your question, but one advice I can give people who are thinking about developing their careers as an entrepreneur, if you are a founder and CEO, especially think about your career or skill set as I spoke, a wheel, a circle. Every skill that you have, some of us start with more technical background, like me and MD. Then you have to develop their finance and business skills and the business development skills. So sometimes people say, "Well, you know, ABC went to grad school and they dropped out of grad school and they started a company." That's wonderful, but think about much longer beyond a two-year, three-year, five-year time horizon. And that's what helped me to think about my career. So I worked on the Wall Street, but that gave me a finance and understanding about how public companies are valued, not just by the company, but how stock analysts value the company, how investors value the company, what moves the stock, what did Genentech to understood. That gave me the chance to understand how a big biopharma company thinks about their product development. And at Genentech, in some interactions we have had, we were looking at the products from other smaller companies, either to collaborate with them or to acquire those products. So that's a different skill set. I went very early on, as I said, in my career, I went to FDA. So even though I'm not regulatory expert, but I understand how agencies think about the product approval so that helps you to make a more of a holistic viewpoint because the business has become more complex, and you cannot just have a only business degree and you say, "Well, I'm going to succeed." Some people have rounded that up by years and years of experiences. And then there is also innate desire to learn. I learned from not just doing the work I do every day, but my, my, you know, talked a lot about it. I read anytime I get I read books that are not related to medicine, that are not necessarily related to health care, because you have to understand how to grow a revolution. You have to understand leadership skills that are not necessarily taught in schools. So, you have to find a way to continue to refine yourself, because the only way you can create a great company is to become a better version of yourself. [00:21:31] Lindsey Dinneen: Thank you so much for talking about that and for sharing your advice. And I love that image of the wheel. It's a good reminder that sometimes life takes you on very interesting tangents, but sometimes they all do merge at some point. You've got this little sliver of this knowledge that you're working on, and then this experience, and then they start building and I really love that, that, that way of thinking about it and also remembering that It's very useful. So, so like even earlier, I was struck, you talked about how there was inspiration from car batteries, right? And so how interesting is that to go from, what you might expect within your industry, here's how to solve a problem. But then you guys went outside and said, how do other people solve problems? Like maybe we can borrow from that. And I think that's really cool. [00:22:21] Dr. Shalabh Gupta: And I also think that if you stop focusing on only in your industry, learn from anywhere. Some of the best learnings that I have personally, that felt inspirational to me, did not come from biotech companies. They come from tech companies, truly. When you think about the worst, most successful tech companies like Amazon, Apple. I can go on and on, but there are things that you can learn from them. There are things you can learn from the founder of Amazon, Jeff Bezos. He talks about building Amazon and he talks about doing many experiments at a smaller scale that fail at Amazon in order for them to succeed at a few that really work. And this is where I was saying that culling the ideas, you may start with 10 ideas, but no one can develop 10 ideas, no one. And it's not because of money. People say, "Well, that if I had money." There have been numerous examples where companies have been funded with lots of money and the companies fail. Part of the problem is that when you get too much money, I think you may not realize that you still have to deliver. Because focus and execution takes really knowing what the target is, and then hitting the target and not one time and time again. Targets may change, but the companies cannot focus in 20 different things. In the beginning, you have to start with a very key thesis. [00:23:39] Lindsey Dinneen: Yeah. Absolutely. Absolutely. And yeah, so learning from other industries, and that actually kind of also brings up a thought. So as you've gone along in your career and you've had many different iterations of who you are and what you bring to the world, now, are there any moments that really stand out to you as affirming, "Yes, I am in the right place at the right time?" [00:24:04] Dr. Shalabh Gupta: Yeah, that's a very good question. And I have had a chance to think about it every now and then. So there are there, there are certain observations I'll make. You know, people always say, " What will be your dream job?" And I think the dream job for someone is the job that which you will do any given day, and you will feel a joy that you're doing it and you're not doing for remuneration. You're not doing because you're going to get paid. And we all have those different moments in time. People talk about "flow" where the time stops because you're doing something so deeply engaging that you lost track of time. You forgot where you are. You're not feeling tired. For me building of this company and the team that we have assembled at Unicycive is that flow. Any day that I'm not traveling, I am in my office. I don't work from home. I am every single day in my office. And sure we have a small team, but when we work with the team, these are motivated, driven people with decades of experiences. We feel that we are in a common mission, like we are solving the world's greatest problem. And I know that may be exaggeration, but that's how it feels. And being with them in a room and thinking about a complex problem-- and not just thinking of a problem like how big companies think about it-- but thinking of the problem in a scientific way, but delivering it a solution that only a small company can do that to me is a joy. Number two part is that as I've gone further on my career, I, I am a mentor to a number of startups from Stanford and UCSF, and many Stanford companies, many of them come with a very different problem than purely a biotech company. Since the pro bono work, I do this because I find by telling other people from their problem, I get to reflect on my own problem, and I do that on every quarter. There's one or two companies and I've been really privileged. I feel one of the greatest joys to meet with these great CEOs and Stanford has been a great collaborator. They have a program called Start X in which they have these companies that are participating in a accelerator program. And Stanford's accelerator is different and unique that they don't take any equity. They provide you the opportunity for mentorship. I was part of that program many years ago. So I meet with the CEOs and many of these CEOs will come very different problem. As an example, there is a company that's focused on artificial intelligence using interaction between a physician or healthcare provider and patient, and being able to use AI to streamline that interaction. That is a point that I saw of 10 years of clinical practice, how that communication is broken, literally is broken. Patients go to doctors, not because doctors are the world's greatest knowledge source, but patients at the end of day, they need someone to help them feel better, help them understand the problem that the physician can solve it. What ended up in being in today's healthcare system in the U. S. is that doctors have become mechanical and not because doctors are bad, because we are given these many things to document these many things to chart. If you talk to a physician, a primary care physician, many times the physician is sitting behind the computer screen. Those bedside manners are gone, like literally they are not there until you go into concierge medicine because the physician has to fill up this chart. I practice medicine. So understanding how this company and this CEO, this entrepreneur is trying to solve that problem, I lean back to the years of clinical practice. Then I lean back to the building the company. They're prioritizing it, having three priorities, having five priorities, and then being able to understand. And every company has some things which are similar, growth of your product development, continuing to advance the company, continuing to tell the story, attracting the right team members. It just gets magnified at a broader level. But the problems start similar, very similar. You know, think about when we talk about tech companies, Apple, the first thing they had to do, develop a product, then build a team, then sell the product, tell the, sell the vision, you know, and then continue to raise money. And that part is seems sometime very lonely. It also seems that I am uniquely burdened with these problems. And I always remind people, "You know, as much as you would like to think that you are unique. I assure you, it is not a problem that we are gifted with. We all have to face the same set of problems, sometimes more, sometimes less." So then you start to take them less personally. You start to say, "Okay, I'm not the first one to face this problem. These problems have happened to people like me before and they will overcome. How can I do it?" Then you'd become safe, a solution based thinking versus a place where you get overwhelmed with the problem because problems exist. And if anyone is listening to this podcast and if they've developed a started a company, I can assure you the problems come with a flood. They are not going to end ever. So it is disappointing. Sometime it feels that, "Oh my gosh, it is me versus the world," but it is not so. If you have good set of mentors, people who are not directly involved in day to day in your business, there are people who can help you think through it. And that is something that I find a great joy in talking to these CEOs, being able to help them understand the problem. And I say, you know, a couple of hours a month, but then when I go back to my own work, one that I realized this was the same problem I faced a few years ago. Two, it's a similar version of the problem I face at a slightly larger scale today. And three, being able to step out of from your own narrow zone, it gives you perspective. Then what I said to you about that problems are not, these are not personal problems. These are the problems we all face developing a product. It doesn't matter whether you healthcare. People tell me health care or product development is really hard. You talk to my colleagues, our CEOs who are running tech companies. Products in development and tech companies may seem easier, but to create a great product that truly solves customers problem, it's not easy. [00:30:30] Lindsey Dinneen: Yeah, and well, I love that mentorship and sort of teaching and guiding, giving advice to the next generation is something is of a core value of yours and something you really care about. And it actually is a great segue into my next question, which is just pivoting the conversation for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, what you're doing right now, but it doesn't have to be. What would you choose to teach? [00:31:02] Dr. Shalabh Gupta: I think as much as we all feel that entrepreneurship is an external game, I think it's a lot of internal mindset, being able to understand yourself better. Being able to understand who you are, what are your true core values, what really drives you. It takes time and it requires a continuous interrogation, asking yourself, "Is this really what I enjoy?" Some of us feel it's a glamour that we feel like we want to be CEO. Some of us would be better off as a CTO, Chief Technology Officer. Some of us would not want to do startups. It's not for everybody. And it's okay because you can work in a bigger company and can be, you know, people talk about entrepreneurial pursued within a large organization. Maybe that's what for you. But being able to understand yourself, it's a very important part. And I think unfortunately, formal education does not help us no matter what degrees and which schools. And it really doesn't matter whether you a science degree, MD, PhD, or your business school degree like MBA, we're all very uniquely different, and we have different values. What one person sees inspired by, for somebody else, it may be a nightmare, you know. It's a thing that people think that startups are so much fun. I read a joke. It says, "People leave 9 to 5 job to work from 5 to 9, which is 5 a. m. to 9 p. m." So I think that's because this is some truth to it. And I've said to people again and again that if making money is your objective, please don't go as to run a startup. It is probably the worst way to think about pursuing the financial part. You do something because you have a faith and belief in something. And it doesn't have to be the faith about changing humanity. It's about something that you have a unique skill set or unique product idea that you believe you can bring to the marketplace. The biggest focus we all can have is making an impact. If I can serve a large number of patients, I can serve a large physician, I will have a product that will make money, therefore, that will make money for enterprise that will make money for investors. And therefore, as a company, we will make money. It's a very simple truth, but we like to make it complicated. I really mean it. The more I got to understand this part of the process better, which goes back to the basic thing that I said to you, if you said that you have a master class, the one thing I will say to you, it's spend time to understand yourself. And it's okay to realize that what I thought I like, I don't like it. The part that I talked to you about flow, it takes efforts. I've had many careers, but when I work in my company, the time can stop for four or five hours, literally we can be working on something. And I have a team and it's not just me alone. I have a team that when we think about a problem, these are people who have spent three decades in working in different companies, large, small, many size companies, we could work cohesively, collectively, think about a problem. And that to me, it's a joy. For me, that is a creation, right? You know, we're thinking about the problem, which may be a design of a clinical trial, because we have to think we have to use brains. And I always say, "God gave us a gift, which is a neuron. So use it, let's use them." And challenge yourself, right? And the challenge in a good way, not be a condescending ending jerk and say "No, how could you do it?" I try to say to people, "Look, I understand this is how it is done, but I want to do two things. Number one, please believe me that we can do better, faster, cheaper. And number two, I promise you that whatever I'm telling you, I'm not going to tell you and walk out of the conference room. I will work hand to hand." We call it a hand to hand combat is essentially that I'm not just telling you I'm going to work with you. I want to find the solution, but we can't do that thing that are you used to. Every trial, people tell me it's going to take 18 months, 12 months, it's going to cost as much. We shrink that thing timeline cost by not 10, 20%. We talking 50%. And these are people have done this before. So, so I need the courage to be honest and say, "No, we can't do it. We have to do it faster, better, cheaper, but how?" And then asking them. So, I say, "It's okay that we walk away and we don't have a clue. It's okay. Today's Thursday. Let's come back. Take three days to think about it." But the reason is that because when you ask yourself from a place that I can't do it, the mind is start to find solution versus when you say, no, I can't do it. Because in that case, it's a subconscious mind that keeps on giving you 15 reasons why you can't do it. People talk about growth mindset. I've always said to people, "We may not be able to do this thing today, but the understanding that with a little bit of help, a little bit of patience, a little bit of it, making ourself better, we can become that company, we can become that organization." And that really requires challenging ourself. And that's where I went back to. I want to go back to this question you asked earlier. People talk a lot about entrepreneurship as if it is some very specific skill set. I think because if you know yourself, you know what is your true zone is, then you want to surround yourself places that you are either not good at, or you don't enjoy doing it, right? In the beginning, it is just you and a vast amount of problems to face. Then you start to build your team. Then you start to see yourself, "You know, maybe Bob can do this work. I really, I'm not that good at it. I don't like doing it." Then you start to rely and surround yourself with not same skill set, but the people who are complementary skill set. And that's how you build a team. That's the foundation of team. Then you build trust and you say to Bob, "Whatever you do, it's not your fault. I'm here to protect you." You don't point fingers at each other. We always remind the example of Navy SEAL. You know, I've never worked in the US Army. I was not an Army veteran, but the ethos that Navy SEAL uses where the team wins, I always tell people we are a winning team. We are not looking for MVPs, you know, because the teams win. Teams create products, teams create value. Individual glories is not useful and this is something you have to keep reminding us that we keep drilling it down and say " No, it's not Bob. It's not John. It's not James. It's us. It's as a team." Again, as you grow through the company stages, your skill set has to continue to evolve and people always say, "Well, how do you lead a team?" The first thing that I always said, "Every single person in my team, you are a leader. Why? You wake up in the morning, brush your teeth. You're leading yourself." Really! Like, what do you do with your day? If you happen to be a parent or partner, a spouse or somebody, you have people you influence around yourself, right? So instead of worrying about, "Oh, you know, I want to lead a company." First, you have to lead yourself and you have to lead with courage. It's starting a company, building a company, right? Yeah. No matter what the media tells you, it is hard. It's hard to develop a product. It's hard because the challenges are not one or two. There are many. Being able to drill down, saying "These are the three things I'll focus on. These are the only things that matter." And then if something new comes up, you have to face that challenge and put the third in your list. It comes in a different page. You know, I use this basic exercise. I have a notebook, a physical notebook and not electronic one, and a piece of paper. What are the top three priorities? And then the other part is that I've asked people to do this exercise when startup companies, CEOs come and tell me all their problems, all the things they want to do. I said, "Humor me if you will. This is the end of the year. And let's say today is we are in 2025. What would you like to tell yourself a year from now? If everything happened the best you could imagine, how many customers, how many products, what will be the stage of product, who would have funded you? Who are the people behind you?" And I asked him to write in a whiteboard. And I say, imagine, no, this is the five thing. If they write 25 things, I say, "No, this is down to five things. What are those five things you would like?" And again, everything has just gone and you can't believe you're sitting there. What will it take? Is it this? And then you start to have a goalpost, right? It's a target. Then you work backward. [00:39:37] Lindsey Dinneen: Yeah. Yeah. Well, that's great. That is such great advice. So thank you, first of all, for sharing, but I think in general, your masterclass would be so much-- you'd have to have a full day or more. That's great though. I love that. How would you wish to be remembered after you leave this world? [00:39:57] Dr. Shalabh Gupta: That's a very good question. That's one that I ask myself every day. The most important thing for me is to be who I am to make a difference for people who are around me. For me, my family is very important. I have kids and I always think about it. What will my children remember? Then it comes down to people who work with me. We want to give an experience to people. I've had people who have worked for I keep saying it two or three decades. My true wish is that I always say for whatever time they work at Unicycive, I want them to be remembering this is the best time they work for a company and that is the best hope we can do it. Because as a entrepreneur, if I can make our company the best experience, best environment, then that creates the best products. And a company like us, we realize that we are going to face challenges and it's not a question of this, the question is how many challenges. The question is not going to be, "Will the challenge defeat us?" The question is, "How do we overcome the challenges?" So it's about growth mindset, having a very distinct, clear vision and empowering people. And last thing is that what we do in healthcare affects millions of people people. Our drug is not going to be just in the U. S. We have partnerships outside U. S. We think about patients in China, South Korea, Southeast Asia. We are talking to companies in Europe. It's an opportunity to make a difference globally. And that is what keeps us going. That's what, you know, when that's when I talk with flow, that is what makes you want to work, whether it's a weekend or whether it's a late evening. And I think that is something which we all need to do to find something that is meaningful. And meaning means different things to different people in different phases of life. So it doesn't have to be, you know, I tell even my own team member, " Unicycive does not have to be the purpose of your life, but let me help you to manifest your best version so you can work well, because you are working here, you are spending your time, might as well make it meaningful for you and for the company." So finding that balance is key and it's a constant challenge. I never take anything for granted. It's a constant to my own team members. How can we make it better? You know, people always say the company grows and we started with the company. We went to IPO with one person. That was just me as an employee, which is not a common thing. I frankly don't know any other company that I've ever seen that went to a straight IPO with one employee. But that wasn't about me. It was about building the company, building the team. Today, we have 25 or so more, but it's still a small team. And people always ask me, "How do we go from 25 to 50 and it still remain the same." I said "Exactly how we became 5 to 10 to 15, 15 to 20." Because if you keep the culture same, focus same, and you remind people that it's not about who we are individually, but it's what we could be collectively. And you have it going and you know, something you're passionate about, you will give all that you got and then some more or else there is not worth fighting for because life is hard and building a product developing a technology or running a company is hard. So, either you are a full believer or else you can't do it. I mean, if you can do it, it's going to be miserable on both front. You want to do a good job and you will find it very difficult. So. [00:43:24] Lindsey Dinneen: Yeah. Indeed. Yeah. Excellent. Well, and then final question. What is one thing that makes you smile every time you see or think about it? [00:43:36] Dr. Shalabh Gupta: I think when you look back on the challenges that you once thought were unsurmountable, and then you say to yourself, "Huh, that was just a curve in the road, not a roadblock." Then you start to smile because of not because how smart you are, but how much together a team can accomplish. And you start to find, if you're working in a company setting, you start to feel that people start to feel empowered. My team says that you did it. I said, "No, we did it. I just showed you a judicious path, but you did it. I didn't do it. All I said to you is to change your framework." Because it's a framework. It's a mindset. And I keep saying about mindset because if you come with the idea that " No, I only, I need this much money, this much time, these many resources," you'll find you the subconscious mind keeps on validating those challenges. But if you say, "No, people like us have done it before I can do it, we can do it." And give them the time and space and say, "Look, you don't have to have an answer right now, but please go back and just think about it." Then they come back with the answer and they themselves surprised. But it truly requires a authenticity, a vulnerability, and being absolutely willing to fall on your face and get up and just fight again. And that's part people don't realize. People think about that every company is a smooth road up, but the companies go through the cycle. It's not when you're going up, it's what happens when you fall down. Can you pick yourself up? And it's not just with your team, but with your investors too. You know, we thought that we're going to file an NDA in 2020. You know, 2024, we had planned for everything and the whole thing was there, but we ended up in having to run an additional trial and then you have to communicate with integrity through transparency. This is what happened. This is what is there, but we can accomplish that. So then that all of all that helps you to look back a smile, laugh and say, "Okay, I accomplished that. We can do the next one." And that keeps the growth happening. And at the end of the day, we are not happy because we accomplished small things by doing small effort. Most of us as human beings want to be challenged in the right way and we feel joy in doing hard things that take a lot of efforts and once seemed just impossible to do it. And the question is, can you do it with your entire team, not just personally? And that's what inspires people. We want to be that company that people want to work for not because they need a job, not because we can take care of their 401k. I mean, those are a wonderful thing and I'm blessed that we can do all of that, because once upon a time, we didn't have any of that. So I don't take it for granted, it is something. But the fact is that what was the mission hasn't changed ever. And you know, that that is something which is worth pursuing it. And I think if people start to see that they can accomplish that, these challenges are not personal, that they are bound to come. And then they have a support group, you know, we all need somebody other than ourselves and people whom we are surrounded with somebody to hold our hand and say no, you fell down, but it's okay. You can get up. I think it's that support system, right? The more you can have it, the more different types of people you can relate to and call them friends, mentors, that helps. And I have tons and tons of them because my gosh, I mean, there are days seems like, how would I ever get out of this? As much as you may think that I have all the source of inspiration, but then if somebody else holds your hand, they say, no, you can do it. That is what gets you going to the next step. [00:47:25] Lindsey Dinneen: Absolutely. Well, goodness, this has been an amazing conversation, just packed full of incredible, helpful advice, and just very practical down to earth sharing. So thank you so much for your time today. I really appreciate everything you're doing to, to make an impact. So thanks again for your time. [00:47:44] Dr. Shalabh Gupta: Thank you very much. Thank you for hosting me and thank you for your time and interest. Really appreciate it. [00:47:49] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:48:31] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the limited label that Novavax received for its new COVID-19 vaccine Nuvaxovid, the impact of the new COVID-19 vaccine development policy announced by the US Food and Drug Administration and additional upcoming indicators of the evolving policy. More On These Topics From The Pink Sheet Novavax's COVID-19 Vaccine Label Narrowed After Political Officials Intervened: https://insights.citeline.com/pink-sheet/vaccines/novavaxs-covid-19-vaccine-label-narrowed-after-political-officials-intervened-56OPC7DJ6NCXFLQYGE27SVTEH4/ Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy: https://insights.citeline.com/pink-sheet/vaccines/legal-process-problems-may-plague-new-us-fda-covid-19-vaccine-policy-HAUDHEREXZCA5DAZ47HZ6L544U/ Observational, Retrospective Trials Could Retest Vaccines, HHS' Kennedy Says: https://insights.citeline.com/pink-sheet/vaccines/observational-retrospective-trials-could-retest-vaccines-hhs-kennedy-says-BOFKDMMHGVDNXKXMFEILOXAH4E/ US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems: https://insights.citeline.com/pink-sheet/vaccines/us-fda-covid-19-booster-strategy-may-not-be-as-controversial-as-it-seems-ZEAHMHE5LJB6HLBT2WRZW4L3AY/ US FDA Punts On New COVID-19 Framework's Impact On Fall Shots: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-punts-on-new-covid-19-frameworks-impact-on-fall-shots-QSB6OPEB4ZCEFLS36JG3Y7XSPE/

Dr. Don and Professor Ben talk about the risks of consuming dairy products given recent cuts to FDA Dr. Don - not risky

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider early excitement and concern about Vinay Prasad's potential impact on product development as director of the US Food and Drug Administration's Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00). More On These Topics From The Pink Sheet Tougher Approval Standards May Follow Vinay Prasad's Appointment To Lead US FDA's CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PGDGE44/ US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-guidance-roadblock-writing-continues-but-publication-has-slowed-or-stopped-TZF4DMPEMVHT3JJPRUX7LJJIHU/

Ananda Pharma Plc (AQSE:ANA, OTCQB:ANANF) co-founder and CEO Melissa Sturgess talked with Proactive's Stephen Gunnion about the company's progress towards beginning its first clinical trial in Australia for its cannabinoid-based drug candidate. Sturgess confirmed that the drug development stage is now complete, allowing the company to move into trials involving healthy volunteers. The trial will compare the pharmacokinetic profile of with the only CBD drug currently approved by regulators. Sturgess discussed the recent appointments of Giles Moss and Chris Tovey—both former senior executives at GW Pharmaceuticals—as strategic moves to strengthen Ananda's commercial and regulatory capabilities as it enters the clinical phase. The Australian Therapeutic Goods Administration has acknowledged Ananda's first trial. Sturgess noted that Australia offers both strong tax incentives and compatibility with US FDA requirements, helping the company advance its program cost-effectively while also preparing for potential regulatory pathways in the United States. Each step forward, Sturgess said, brings Ananda closer to dosing its first volunteers in what she described as a critical phase of development. For more updates, visit Proactive's YouTube channel. Don't forget to like this video, subscribe to the channel, and enable notifications for future content. #AnandaPharma #CBDClinicalTrial #MelissaSturgess #CannabinoidResearch #PharmaNews #BiotechUpdate #DrugDevelopment #AustraliaTrials #FDAPathway

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider the impact of FDA Commissioner Martin Makary directing one of his assistants to take over the review of Novavax's COVID-19 vaccine (:40), as well as how states or courts could respond (19:19). They also discuss several announcements of missed user fee deadlines and whether FDA layoffs could have contributed (28:33). More On These Topics From The Pink Sheet Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review: https://insights.citeline.com/pink-sheet/vaccines/political-official-pushing-novavax-to-conduct-covid-19-vaccine-postmarket-rct-BZTIWKSTK5G77BUQGGD3G2IOFY/ How States And Courts Could Insulate America From An Anti-Vaccine Executive Branch: https://insights.citeline.com/pink-sheet/vaccines/how-states-and-courts-could-insulate-america-from-an-anti-vaccine-executive-branch-DARDVWDMLVFCHM6DE75AJQHSBQ/ US FDA Commissioner's Office Plans Involvement In Many Approvals In Potential Major Change: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioners-office-plans-involvement-in-many-approvals-in-potential-major-change-JFPWOQ2VF5D2JAFKXKGK54REZU/ US FDA Miss On Stealth's Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts: https://insights.citeline.com/pink-sheet/product-reviews/us-fda-miss-on-stealths-elamipretide-boosts-signal-of-broader-delays-due-to-staff-cuts-5ITZREGXX5H75ID6IL4Q2MHKBE/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of the departures of several senior leaders in the US Food and Drug Administration's facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary's intent to combine the agency's many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16). More On These Topics From The Pink Sheet US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-retirements-continue-unabated-with-drug-inspectorate-leaders-former-chief-counsel-JRKHCHZHMBC4RLRJRBDTSIP7E4/ FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-leadership-shuffle-continues-lowell-zeta-returns-as-opdp-ogd-leaders-depart-FONMRWR37VGAFL2JJ5S27QIU2E/ US FDA's Makary Floats Vague ‘Plausible Mechanism' Approval Pathway For Rare Diseases: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/us-fdas-makary-floats-vague-plausible-mechanism-approval-pathway-for-rare-diseases-RJJJCPDUDFHINMPDE5VK4OFDVQ/ US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-commissioner-makary-wants-to-combine-adverse-event-reporting-systems-UJ4QUEM72ZC25J7JHAC3LAKKKA/ Political Influence And The US FDA: A New Era?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/political-influence-and-the-us-fda-a-new-era-SL6ZBNKHNVFEXCLQLCYTDJIETQ/

On episode #78 of the Infectious Disease Puscast, Daniel and Sara review the infectious disease literature for the weeks of 3/27/25 – 4/9/25. Hosts: Daniel Griffin and Sara Dong Subscribe (free): Apple Podcasts, RSS, email Become a patron of Puscast! Links for this episode Viral Demise of the Milwaukee protocol for rabies (CID) A natural experiment on the effect of herpes zoster vaccination on dementia (Nature) Taking a shot at dementia(microbeTV: TWiV) Recommendations from the 10th European Conference on Infections in Leukaemia for the management of cytomegalovirusin patients after allogeneic haematopoietic cell transplantation and other T-cell-engaging therapies (LANCET: Infectious Diseases) Epstein-Barr virus exposure precedes Crohn`s disease development (Gastroenterology aga) Bacterial Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older (GSK) GSK wins FDA nod for first oral UTI antibiotic in almost 30 years(BioSpace) Efficacy and safety of individualised versus standard 10-day antibiotic treatment in children with febrile urinary tract infection (INDI-UTI): a pragmatic, open-label, multicentre, randomised, controlled, non-inferiority trial in Denmark (LANCET: Infectious Diseases) Frequency and severity of Myasthenia Gravis exacerbations associated with the use of ciprofloxacin, levofloxacin, and azithromycin (Muscle & Nerve) The cost of blood cultures: a barrier to diagnosis in low-income and middle-income countries (LANCET: Microbe) Rethinking blood culture (LANCET: Microbe) Trends in Anaplasmosis Over the Past Decade: A Review of Clinical Features, Laboratory Data and Outcomes(CID) Fungal The Last of US Season 2 (YouTube) Cracks in the curriculum: the hidden deficiencies in fungal disease coverage in medical books (OFID) Kazachstania slooffiae fungemia: a case report and literature review on an emerging opportunistic pathogen in humans (OFID) Plasma microbial cell-free DNS metagenomic sequencing for diagnosis of invasive fungal diseases among high risk outpatient and inpatient immunocompromised hosts (CID) Parasitic Fatal Case of Splash Pad–Associated Naegleria fowleri Meningoencephalitis — Pulaski County, Arkansas, September 2023 (CDC: MMWR) Notes from the Field: Fatal Acanthamoeba Encephalitis in a patient who regularly used tap water in an electronic nasal irrigation device and a continuous positive airway pressure machine at home — new Mexico, 2023 (CDC: MMWR) Malaria (NEJM) Miscellaneous FDA grants marketing authorization of first home test for chlamydia, gonorrhea and trichomoniasis (FDA) Music is by Ronald Jenkees Information on this podcast should not be considered as medical advice.

Wall Street started the new trading week in the green as investors welcomed the latest tariff exemption from Trump in the form of smartphones and computers in addition to other devices and components like semiconductors. The Dow Jones rose 0.78% on Monday, the S&P500 gained 0.79% and the tech-heavy Nasdaq ended the day up 0.64%. While the tariff exemption is welcome right now, Trump teased on Sunday that the exemptions are not permanent, i.e. the Trump tariff rollercoaster continues.In Europe on Monday, markets closed higher as Trump exemptions boosted investor sentiment, temporarily. The STOXX 600 rose 2.7%, Germany's DAX gained 2.6%, the French CAC added 2.4% and, in the UK, the FTSE100 ended the day up 2.4%.Across Asia to start the week, markets in the region rallied as investor appetite for growth and tech stocks rose on Trump's latest exemption announcement. Hong Kong's Hang Seng rose 2.4%, China's CSI index added 0.23%, Japan's Nikkei rose 1.18%, and South Korea's Kospi Index ended the day up 0.95%.Locally on Monday, the ASX200 started the new trading week with a significant rise of 1.3% as investors hold high hopes tariff relief after President Trump began scaling back some tariffs in recent days. Mining stocks regained momentum yesterday with the materials sector rising %, while 10 of the 11 sectors ended the day in the green.Neuren Pharmaceuticals soared 21% yesterday after the drug maker announced the US FDA has approved the outcomes of a key trial of the company's second drug candidate for the treatment of Phelan-McDermid Syndrome in Children, which paves the way for the company's final US FDA approval of the drug before it hits the market.Gold miners are again drawing investor attention as the price of the precious commodity rallied to yet another fresh record high on Monday and UBS lifted its gold price forecast for the second time in a week, this time to an average of US$3500/ounce in 2026.On the commodities front this morning, oil is trading 0.18% higher at US$61.61/barrel, gold is down 0.74% at US$3212.46/ounce and iron ore is up just 0.06% at US$99.95/tonne.What to watch today:The Aussie dollar has further strengthened against the greenback overnight to buy 63.24 US cents, 90.50 Japanese Yen, 48.11 British Pence and 1 New Zealand dollar and 8 cents.Ahead of Tuesday's trading session here in Australia, the SPI Futures are anticipating the local market will open the day up 0.23% tracking global market gains overnight.Trading Ideas:Bell Potter has raised the 12-month price target on De Grey Mining (ASX:DEG) from $1.97 to $2.58 and maintain a hold rating on the gold exploration and development company after Gold Road Resources announced its intention to vote in favour of the proposed all-scrip acquisition of DEG by Northern Star, as Gold Road Resources has an approximate 17.3% stake in DEG.Trading Central has identified a bullish signal on SRG Global (ASX:SRG) following the formation of a pattern over a period of 21-days which is roughly the same amount of time the share price may rise from the close of $1.25 to the range of $1.38 to $1.42 according to standard principles of technical analysis.

Alan's Soaps https://www.AlansArtisanSoaps.comUse coupon code TODD to save an additional 10% off the bundle price.Bioptimizers https://Bioptimizers.com/toddEnter promo code TODD to get 10% off your order of MassZymes today.Bizable https://GoBizable.comUntie your business exposure from your personal exposure with BiZABLE.  Schedule your FREE consultation at GoBizAble.com today.  Bonefrog https://BonefrogCoffee.com/toddThe new GOLDEN AGE is here!  Use code TODD at checkout to receive 10% off your first purchase and 15% on subscriptions.Bulwark Capital Bulwark Capital Management (bulwarkcapitalmgmt.com)Get a second opinion on the health of your retirement portfolio today. Schedule your free Know Your Risk Portfolio review. go to KnowYourRiskRadio.com today.Renue Healthcare https://Renue.Healthcare/ToddYour journey to a better life starts at Renue Healthcare. Visit https://Renue.Healthcare/ToddYou might have missed this, but it was World Health Day. But why do I feel sick? Why does the nation feel physically, mentally, and spiritually sick? Abraham Hamilton III joins the show.Episode Links:This pretty funny coming from the World “Health” Organization: Today is #WorldHealthDay! The health of mums and babies affects every single one of us. Yet, millions lose their life each year due to causes that could be prevented with timely, high quality care. Health is a right, not a privilege. Let's work together and invest in healthy beginnings and #HopefulFutures for all. This week, I announced Operation Stork Speed to expand options for safe, reliable, and nutritious infant formula for American Families. The @US_FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them. Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.USDA Secretary of Agriculture Brooke Rollins, in an exclusive Breitbart interview following her Wall Street Journal piece, has pulled bird flu vaccines off the table for good. Initially, she thought vaccinating hundreds of millions of chickens might end the crisis faster. But after digging into the data, she found countries like Mexico, which vaccinate egg-laying hens, still see 80-83% of those birds contract avian flu—despite getting jabbed 3-5 times eachThis teacher tells her student to take off his MAGA hat. When he refuses she swipes it off his head and slams it to the ground. He picks it up & puts it back on. She then tells him to get out of her classroom and starts physically shoving him out. She should be fired immediately.

In his weekly clinical update, Dr. Griffin and Vincent Racaniello lament about the continuing measles outbreak, whether or not the measles outbreak was predicted, the FACTS about vaccination, high pathogenic influenza, H5N1 contaminated raw pet food, children's deaths, before Dr. Griffin reviews recent statistics on RSV, influenza and SARS-CoV-2 infections and vaccination schedules and the efficacy of Moderna's seasonal mRNA vaccine, societal burden of COVID-19 and influenza, the FDA missed deadline for approving Novovax COVID vaccine, the WasterwaterScan dashboard, where to find PEMGARDA, provides information for Columbia University Irving Medical Center's long COVID treatment center, where to go for answers to your long COVID questions, long COVID interventions, and Canada's long COVID dashboard. Subscribe (free): Apple Podcasts, RSS, email Become a patron of TWiV! Links for this episode CDC buried a measles forecast that stressed the need for vaccinations….TRANSPARENCY? (Politico) Measles cases and outbreaks (CDC Rubeola) Measles 159 in Texas…. (Texas Health and Human Services) 2025 Measles outbreak guidance (New Mexico Health) Measles and rubella weekly monitoring report (Government of Canada) Enhanced epidemiological summary Measles in Ontario (Public Health Ontario) Measles and rubella weekly monitoring report (Government of Canada) Enhanced epidemiological summary Measles in Ontario (Public Health Ontario) Measles exposures in Ontario (Public Health Ontario) Measles vaccine recommendations from NYP (jpg) Get the FACTS about measles (NY State Department of Health) Measles (CDC Measles (Rubeola)) Measles vaccine (CDC Measles (Rubeola)) Presumptive evidence of measles immunity (CDC) Contraindications and precautions to measles vaccination (CDC) Measles (CDC Measles (Rubeola)) Raw cat food tests positive for H5N1 (CIDRAP) Influenza: Waste water scan for 11 pathogens WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Respiratory virus activity levels (CDC Respiratory Illnesses) FDA-CDC-DOD: 2025-2046 influenza vaccine composition (FDA) RSV: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) RSV-Network (CDC Respiratory Syncytial virus Infection) Early impact of RSV vaccination in older adults in England (Lancet) Waste water scan for 11 pathogens (WastewaterSCan) COVID-19 deaths (CDC) COVID-19 national and regional trends (CDC) COVID-19 variant tracker (CDC) SARS-CoV-2 genomes galore (Nextstrain) Evaluating the effectiveness of 2024-2025 seasonal mRNA-1273 vaccination against covid-19-associated hospitalizations and medically attended covid-19 among adults aged ≥ 18 years in the united states(medRxiv) Current Moderna vaccine 53% effective against COVID hospitalization?(CIDRAP) Preliminary estimates of COVID-19 burden for 2024-2025 (CDC COVID-19) Estimated range of annual burden of flu in the US from 2010 – 2024 (CDC-flu burden) US FDA missed the deadline for decision on Novavax's COVID-19 vaccine (Reuters) Interim clinical considerations for use of COVID-19 vaccines in the United States (CDC Vaccines & Immunizations) Where to get pemgarda (Pemgarda) EUA for the pre-exposure prophylaxis of COVID-19 (INVIYD) Fusion center (Prime Fusions) CDC Quarantine guidelines (CDC) NIH COVID-19 treatment guidelines (NIH) Metformin alleviates inflammatory response and severity rate of COVID-19 infection in elderly individuals(Scientific Reports) Drug interaction checker (University of Liverpool) Infectious Disease Society guidelines for treatment and management (ID Society) Cost-effectiveness analysis of nirmatrelvir/ritonavir for high-risk individuals with COVID-19….does this mean use the big button calculator? (OFID) Molnupiravir safety and efficacy (JMV) Convalescent plasma recommendation for immunocompromised (ID Society) What to do when sick with a respiratory virus (CDC) When your healthcare provider is infected/exposed with SARS-CoV-2 (CDC Managing healthcare staffing shortages (CDC) Steroids, dexamethasone at the right time (OFID) Anticoagulation guidelines (hematology.org) Daniel Griffin's evidence based medical practices for long COVID (OFID) Long COVID hotline (Columbia : Columbia University Irving Medical Center) The answers: Long COVID Reinfection with SARS-CoV-2 in the omicron era is associated with increased risk of post-acute sequelae of SARS-CoV-2  infection: a recover-EHR cohort study(medRxiv) CAN-PCC RecMap, your one-stop shop for recommendations about Post COVID-19 Condition (Long COVID) (Canadian Guidelines for post COVID-19 condition) Letters read on TWiV 1206 Dr. Griffin's COVID treatment summary (pdf) Timestamps by Jolene Ramsey. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv Content in this podcast should not be construed as medical advice.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the impact of the 1 April reduction-in-force on the US Food and Drug Administration, which targeted about 3,500 employees (:30). They also consider how and whether service levels will change (13:28), and new Commissioner Martin Makary's first address to the drastically smaller staff the day after the RIF was announced (29:22). More On These Topics From The Pink Sheet Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-layoffs-us-likely-to-lose-its-first-approver-advantage-5C37YQ73DNBEFF7SHRYV4MJUIA/ Are Bigger Ad Policy Changes Coming After US FDA's Drug Promotion Office Hit Hard By Layoffs?: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/are-bigger-ad-policy-changes-coming-after-us-fdas-drug-promotion-office-hit-hard-by-layoffs-FQLHKJ4GWRCXLEIZCEMX37SUYU/ Dramatic HHS Layoffs A Response To ‘Existential Crisis,' Kennedy Advisor Argues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dramatic-hhs-layoffs-a-response-to-existential-crisis-kennedy-advisor-argues-XZKO5PJF6RHGHLABD2TZY7K2N4/ CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cdrh-staff-cuts-focus-on-administrative-workers-spare-reviewers-DL3L63CAGFGYTDAICFSXG5JP34/ Makary Pledges To Uphold Gold Standard Science, But First Address Confuses Some US FDA Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-pledges-to-uphold-gold-standard-science-but-first-address-confuses-some-us-fda-staff-WE7A5TQARBHX3MS6LGDIQT5CRY/ US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-restructuring-may-be-next-after-drugs-center-loses-more-than-1000-people-HOZ7IYGEC5BYBMNNUPAT2TBNI4/

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and Senior Editor Sue Sutter discuss the impact of the 3,500 layoffs on the US Food and Drug Administration, including the areas where the agency could lose some autonomy (:28). They also consider worries that the agency's preparations for user fee reauthorization negotiations may be slowing because of the upcoming staffing cuts (24:09). More On These Topics From The Pink Sheet Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/power-play-us-fda-likely-losing-more-than-just-staff-with-restructured-health-department-BT5YZ4U7WNANBEZN7OBF42LCEE/ US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-staffing-uncertainty-could-impact-upcoming-user-fee-negotiations-EAUTZOANHVB3PK6NKCLJCYTOLA/ Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/can-new-us-fda-commissioner-makary-calm-agency-during-turbulent-times-STBAXTWCIFEGJPDYZ6LZKMRPE4/

#AskDrJohnWattsPatients often have numerous questions about baldness, hair grafts, hair loss, hairlines, hair transplant procedures, post-transplant care, and medical treatments for hair loss. This is especially true for followers of Dr. John Watts, who frequently inundate his popular channel with queries on these hair-related topics.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss industry stakeholders' complaints about US Food and Drug Administration productivity declines in the weeks since President Trump took office and began making changes and the potential recourse for industry (:24). They also review the expected and emerging problems with the agency requiring nearly all of its Washington, D.C.-area staff to return to in-office work at its White Oak headquarters and consider its impact on workflow going forward (15:35). More On These Topics From The Pink Sheet US FDA's Speed Of Work Under Trump Quietly Raising Industry Concerns: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-speed-of-work-under-trump-quietly-raising-industry-concerns-ZWM522FIDJAO7DVAJYZRLLDFAI/ US FDA Survives First Day Of Return To In-Office Work, But True Test Upcoming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-survives-first-day-of-return-to-in-office-work-but-true-test-upcoming-AZOWC5ITNNGGVG3TIGGWR5VMBA/ Cramped Quarters, Limited Parking And Water Concerns Await US FDA's Return To Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cramped-quarters-limited-parking-and-water-concerns-await-us-fdas-return-to-office-YWHJRM6RTZF4NJP2MZX4Y6LLQA/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration's early retirement and buyout programs to further cut its workforce (:25), leadership departures in the Center for Biologics Evaluation and Research (9:13), the quick arrival and resignation of a new FDA chief counsel (12:35), and Commissioner nominee Martin Makary closing in on confirmation, as well as the impact of the staffing changes on the agency he likely will be running (22:45). More On These Topics From The Pink Sheet US FDA Reviewers, Inspectors Not Eligible For HHS Buyouts: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-reviewers-inspectors-not-eligible-for-hhs-buyouts-PHAPCCR7NZBCRKRL6NPQANGGW4/ User Fee Deadline Concerns Emerge As US FDA Buyout Offer Sweetened With Paid Leave: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/user-fee-deadline-concerns-emerge-as-us-fda-buyout-offer-sweetened-with-paid-leave-WRCP4JYKTJHZPP3QTLGJQPTS54/ CBER Losing Cell, Gene Therapy Leadership As Workforce Culling Continues: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/cber-losing-cell-gene-therapy-leadership-as-workforce-culling-continues-CAWLALTKUVFADETC7HZEXMJQKA/ US FDA May Lose Some Autonomy Under Health Department's General Counsel Reorg: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-may-lose-some-autonomy-under-health-departments-general-counsel-reorg-VUS3GIMCLBE2TC2BUL7UHMIEP4/ Makary US FDA Nomination Advances, Last Minute Hiccup May Offer Clues On Mifepristone: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-us-fda-nomination-advances-last-minute-hiccup-may-offer-clues-on-mifepristone-XQXLBN7HRNGUPCNV3XEUHR3ASA/ Don't Ask, Don't Tell: Senate Democrats Ready To Embrace Makary Heading US FDA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/dont-ask-dont-tell-senate-democrats-ready-to-embrace-makary-heading-us-fda-AOZR6OAM5RHF5ECCOYGQPV77HQ/

Dr. Tania Small joined Bristol Myers Squibb as Senior Vice President, Global Medical Affairs in January 2024. Tania brings a strong scientific track record leading Medical Affairs teams in driving innovation that improves the experience and supports better outcomes of people living with cancer and rare diseases. She has successfully built and led global and regional medical organizations in Drug Development and Medical Affairs, advancing access to Oncology, Rare Disease and Hematology patients globally.Tania is a board-certified pediatric hematology, oncology, and bone marrow transplant specialist with deep experience in clinical research and drug development. She has extensive research experience in oncology, hematology, gene therapy and stem cell transplantation, receiving NIH grants for her translational research in gene therapy and regenerative medicine.Most recently, Tania served as Head of Global Medical Oncology and was the sponsor of the Global R&D Inclusion Diversity Council at GSK. Prior to GSK, Tania worked for IPSEN as Vice President, Head of Oncology and Rare Disease Global Drug Development.She is energized by revolutionizing the experience and outcomes for people with cancer, and has worked closely with the US FDA, Congress, and the American Society of Clinical Oncology (ASCO) to improve the diversity of enrollment in oncology clinical trials and elderly programs."I'm passionate about partnering to create programs that treat the person - not just the disease. Producing groundbreaking solutions that can change the trajectory of serious diseases and help write the next chapter of patient-driven science is what motivates me every day."Tania received her medical degree from Albert Einstein College of Medicine. She has a long-standing affiliation with the Morgan Stanley Children's Hospital of New York Presbyterian/Columbia University where she completed her residency and hematology/oncology fellowship with an academic research appointment in heme and bone marrow transplant.Currently, Tania serves on the ASCO Membership Advisory Committee and is a Board Member of Accreditation Council for Medical Affairs (ACMA).

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the issues that dominated the Senate confirmation hearing for US Food and Drug Administration Commissioner nominee Martin Makary, including vaccines (1:03) and mifepristone (14:45), as well as several questions that were not asked (23:31). They also consider the potential impact of his answers on the agency. More On These Topics From The Pink Sheet Makary Plans To Review Mifepristone Data, Raising Concerns Of Abortion Pill Access Rollbacks: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/makary-plans-to-review-mifepristone-data-raising-concerns-of-abortion-pill-access-rollbacks-24NTRIXLKJD23OKNBB5Z7UAFL4/ Senators Scrutinize US FDA Commissioner Nominee Makary Over VRBPAC Cancellation: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/senators-scrutinize-us-fda-commissioner-nominee-makary-over-vrbpac-cancellation-HVW5VNH55ZFUPBL64BK2VNOYJA/ Science Vs. Politics: Hearing Could Reveal Makary's Approach To Unusual Administration Involvement: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/science-vs-politics-hearing-could-reveal-makarys-approach-to-unusual-administration-involvement-LGWBJEWWNRCIXPVEJ4AEAJRLN4/

Strong rebound or a temporary pause? Zydus Life, TCS in focus In today's episode of Market Minutes, Vaibhavi Ranjan takes you through the key market trends for March 5. Indian equities are set for a mildly positive open, with GIFT Nifty signaling a green start for Sensex and Nifty 50. Benchmark indices ended their losing streak in the previous session, staging a strong rebound from oversold levels. However, concerns over global trade tensions continue to cloud investor sentiment. Meanwhile, Zydus Life is in the spotlight after securing US FDA approval for a cancer drug, and TCS makes headlines with its latest partnership with Vantage Towers. Tune in for market insights, expert opinions, and all the latest stock action!

In today's episode of Market Minutes, Vaibhavi Ranjan takes you through the key market trends for March 5. Indian equities are set for a flattish open, with GIFT Nifty hinting at a muted start for Sensex and Nifty 50. The benchmark indices extended their losing streak in the previous session, with Nifty recording its 10th straight day of declines—a first in history. Meanwhile, global markets remain on edge as Trump's tariff policies fuel economic uncertainty. On the stock radar, Biocon gains attention after its US FDA approval for two cancer drugs, while Adani Wilmar's acquisition of GD Foods Manufacturing puts it in the spotlight. Tune in for market insights, expert opinions, and all the latest stock action!

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr, discuss the US Food and Drug Administration's decision to call back many workers that were laid off and the next steps for the Trump Administration's effort to reduce the size of the federal government (:29), the FDA decision to cancel an upcoming Vaccines and Related Biological Products Advisory Committee meeting on strain selection for the 2025-2026 flu vaccine (12:42), and the motives for Eli Lilly's plan to increase domestic manufacturing (23:18). More On These Topics From The Pink Sheet Drug Reviewers And Legal Staff Among Those Called Back to US FDA, But Why?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/drug-reviewers-and-legal-staff-among-those-called-back-to-us-fda-but-why-YWONQYDHARESFLLY26YEP6RIHI/ DOGE-ing US FDA: Three Scenarios For What Comes Next: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/doge-ing-us-fda-three-scenarios-for-what-comes-next-XUDLPX3WNNH55JCHOMTOS2NXBA/ Breaking: US FDA Cancels Upcoming Adcomm Discussing 2025-2026 Flu Vaccine: https://insights.citeline.com/pink-sheet/vaccines/breaking-us-fda-cancels-upcoming-adcomm-discussing-2025-2026-flu-vaccine-AGBZQHYGZFHZLOK2PU5CCKBNK4/ Lilly $27Bn US Manufacturing Investment Linked To Trump's Tariff, Tax Agenda: https://insights.citeline.com/pink-sheet/compliance/manufacturing/lilly-27bn-us-manufacturing-investment-linked-to-trumps-tariff-tax-agenda-FN55MQ3V75EU5J42TIYTFLTH4Q/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs, as well as Medtech Insight Managing Editor Elizabeth Orr and HBW Insight Managing Editor Malcolm Spicer, discuss the most up-to-date information on the layoffs at the US Food and Drug Administration that were instituted by the Trump Administration (:42). They also consider the layoffs' impact on the drug, device and consumer health divisions, including application review and facility inspections, as well as industry's response to them (17:58). More On These Topics From The Pink Sheet US FDA Staff Cuts: Biopharma Industry Braces For Impact, But First Wants Clarity On Losses: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-staff-cuts-biopharma-industry-braces-for-impact-but-first-wants-clarity-on-losses-C45JIJX7IRD5FON2BNNKHTTBZU/ CMS Layoffs Broader Than Reports Indicate, Former Administrator Brooks-LaSure Says: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/cms-layoffs-broader-than-reports-indicate-former-administrator-brooks-lasure-says-A6XEKATFPRFXZCHSD7VDKO53HA/ Weekend US FDA Layoffs Cost Device Center Many AI And Digital Health Staffers: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/weekend-us-fda-purge-costs-device-center-many-ai-and-digital-health-staffers-VSCWD67JAJARTP7S3EZYB6KSIQ/ US FDA Food Safety Leader Resigns In Protest Of White House-Ordered Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-food-safety-leader-resigns-in-protest-of-white-house-ordered-layoffs-ZJSIV3VWTNBB7MPGPOV7TUWWJU/ FDA Cosmetics Office Braces For Agency-Wide Staff Cuts; MoCRA Implementation Likely Delayed: https://insights.citeline.com/hbw-insight/beauty/policy-and-regulation/fda-cosmetics-office-braces-for-agency-wide-staff-cuts-mocra-implementation-likely-delayed-5CNPONAL2JBGRIOVLTPSISLCFY/ PhRMA Still All In For Trump Despite Chaos Hitting US Health Sector: https://insights.citeline.com/pink-sheet/market-access/phrma-still-all-in-for-trump-despite-chaos-hitting-us-health-sector-MSNPGI66H5AABGVJVGG2MLNZIA/

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs, and special guest Michael McCaughan of Prevision Policy look at new Health and Human Services Secretary Robert F. Kennedy Jr.'s first assignment, a presidential commission on reducing chronic disease (:29), as well as former US Food and Drug Administration Commissioner Scott Gottlieb's suggestion that industry extend the existing user fee program rather than negotiate a new agreement in the current political environment (13:30). They also discuss the impact of President Trump's executive order mandating a reduction in force across the federal government on the US Food and Drug Administration and communications questions affecting the agency's advisory committee schedule (25:16). More On These Topics From The Pink Sheet Commission Led By HHS Secretary Kennedy Will Probe ‘Threats' To Children, Including Medicines: https://insights.citeline.com/pink-sheet/agency-leadership/commission-led-by-hhs-secretary-kennedy-will-probe-threats-to-children-including-medicines-Q5YF65T23JEOXDWQ7I72X556KQ/ Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step: https://insights.citeline.com/pink-sheet/agency-leadership/bracing-for-rfk-at-hhs-vaccine-safety-commission-likely-first-step-O5XKOSVYYVE7RMQUAIHZ4I2OLY/ User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/user-fees-industry-should-push-for-extension-of-current-agreement-in-reconciliation-bill-gottlieb-says-YOWZW2CMSZA4BDP23MR2FLQJB4/ Could PDUFA VIII Align With Trump's Efficiency Emphasis?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/could-pdufa-viii-align-with-trumps-efficiency-emphasis-5WGLRU6N2FG4XABILEMHBYDXYI/ US FDA Advisory Committee Freeze Raises Concerns Of Delayed, More Controversial Approvals: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-advisory-committee-freeze-raises-concerns-of-delayed-more-controversial-approvals-CWT2HOAQ3JBHNCMKSSOOXVAYYU/ ‘This Is Not Good For Business': Trump's Workforce Shakeups Could Harm Industry: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/this-is-not-good-for-business-trumps-workforce-shakeups-could-harm-industry-JJTMQ5RXOFDC7DQDVIZ3S2NJG4/

⁠This panel was recorded 30 January 2025.⁠⁠Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical.Join part two of our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable insights for medical device manufacturers.Our panel of industry experts will provide clear, implementable guidance on:Practical strategies for meeting EU MDR and US FDA cybersecurity requirements - with real-world examples and documentation approachesEssential security considerations for medical devices, IVDs and SaMD developmentHow to integrate cybersecurity requirements into your quality management system from the startStandards for risk management, pre- and post-market considerations that satisfy both regulatory requirements and long-term security objectivesStrategic planning for maintaining security throughout your product lifecycleCommon pitfalls to avoid in cybersecurity implementation and regulatory submissionsThe role of SBOMs (Software Bills of Materials) in achieving transparency and regulatory complianceWho Should Attend:This session is essential for medical device manufacturers, software developers, quality professionals, and regulatory teams working with connected devices or SaMD. Whether you're bringing your first connected device to market or optimizing your current cybersecurity approach, you'll gain practical insights for ensuring both compliance and security.Panelists:Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation, RQM+Mirko Raner – Cybersecurity Consultant, RQM+Hrishikesh Gadagkar – Senior Principal, RQM+Moderator:Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+Register now to gain practical insights that will help you navigate the evolving cybersecurity landscape with confidence, backed by RQM+'s extensive experience in medical device regulatory compliance and software validation.Part one is available on demand here.Chapters00:00 Introduction to Medical Device Cybersecurity03:21 Navigating FDA Regulations and Cybersecurity11:38 Effective Documentation Frameworks for Cybersecurity15:47 Understanding Medical Device Data Systems (MDDS)24:12 Cybersecurity Challenges for In Vitro Diagnostic (IVD) Devices27:02 Addressing Cybersecurity in Interconnected Devices32:41 Risk Assessment and Cybersecurity Documentation37:12 Understanding FDA Regulations for Medical Devices40:54 Cybersecurity Considerations in Medical Devices42:00 Assessing Cybersecurity Threats and Vulnerabilities49:02 The Role of Risk Analysis in Cybersecurity Documentation56:46 Integrating Cybersecurity and Safety Risk Assessments01:09:53 Future-Proofing Against Cyber Threats--

Introduction: Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the many commitments Robert F. Kennedy Jr. gave Sen. Bill Cassidy, R-LA, to secure his vote to move his Health and Human Services Secretary nomination to the Senate floor (:25). They also consider the slow restoration of some US Food and Drug Administration public communications and the impact of HHS postponing activities not deemed “mission-critical” (10:36). More On These Topics From The Pink Sheet HHS Nominee Kennedy's Behind-The-Scenes Vaccine Reassurances Win Senate Swing Vote: https://insights.citeline.com/pink-sheet/vaccines/hhs-nominee-kennedys-behind-the-scenes-vaccine-reassurances-win-senate-swing-vote-F45HDCJQJJDIDKJOFXYODP6DJQ/ Kennedy Would Issue Trial Diversity Guidance, But Not Necessarily Roll Back All Anti-DEI Actions: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/kennedy-would-issue-trial-diversity-guidance-but-not-necessarily-roll-back-all-anti-dei-actions-4SDSMJ5V7NFPHKVUX5XYBMRMEE/ FDA Communications In Flux As HHS Assesses Mission-Critical Activities: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-communications-in-flux-as-hhs-assesses-mission-critical-activities-H5UQ7BRSSZBVJDJBAXSVTDLIR4/ As US FDA Communications Freeze Thaws, Approvals Accumulate: https://insights.citeline.com/pink-sheet/product-reviews/approvals/as-us-fda-communications-freeze-thaws-approvals-accumulate-JA4WVLHMGJEZDHYB7LRNZAOYT4/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the effect of Acting US Food and Drug Administration Commissioner Sara Brenner's use of MAHA in her introductory memo (:35), the issues that emerged during MAHA founder and Health and Human Services Secretary nominee Robert F. Kennedy Jr.'s Senate confirmation hearings (7:22), return to office plans for senior FDA staff (14:27), and postponed meetings and other impacts of the Trump Administration's freeze on agency communications (19:30). More On These Topics From The Pink Sheet US FDA Acting Commissioner Tells Staff She's Ready To MAHA: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-acting-commissioner-tells-staff-shes-ready-to-maha-D3VJ2JORKVEC5MKJNBRNY2XAOE/ Beyond Vaccines: Kennedy's Anti-Pharma Side On Display At Senate Hearings: https://insights.citeline.com/pink-sheet/agency-leadership/beyond-vaccines-kennedys-anti-pharma-side-on-display-at-senate-hearings-EATXNW5MNBATFDTUWSIDDO6RDA/ Will Republican Senator's Concerns About Kennedy's Vaccine Views Endanger Nomination?: https://insights.citeline.com/pink-sheet/vaccines/will-republican-senators-concerns-about-kennedys-vaccine-views-endanger-nomination-ZQMM3G6NIFAQ7NPS2WF6F22PFE/ Medicare Price Negotiation Will Continue Under Trump With Possible ‘Improvements': https://insights.citeline.com/pink-sheet/geography/north-america/united-states/medicare-price-negotiation-will-continue-under-trump-with-possible-improvements-BD6JAB25KZDLXO7MCVDCTLEESE/ US FDA Senior Staff Return To Office In February, Next Steps for Schedule F Reclassification: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-senior-staff-return-to-office-in-february-next-steps-for-schedule-f-reclassification-ETI5TGY5XRACLA76GCYY2PEZ74/ US FDA Opioids Adcomm Postponed; Are Communications Freeze, Travel Ban To Blame?: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-opioids-adcomm-postponed-are-communications-freeze-travel-ban-to-blame-H4WQ4DLAJBD5HOZAWBCSRDBTIA/ Approvals The US FDA Is Not Talking About: A Communication Freeze Calendar: https://insights.citeline.com/pink-sheet/product-reviews/approvals-the-us-fda-is-not-talking-about-a-communication-freeze-calendar-DHS4X56LNNFELPXQ6JAZSGJMGA/

Pink Sheet reporter and editors try to answer some emerging questions about the US Food and Drug Administration now that President Donald Trump has taken office. They discuss the FDA's acting leadership (:43), an ongoing communications freeze (7:45), along with the hiring freeze and travel ban (20:49). They also discuss the impact of several executive orders on the US Centers for Medicare and Medicaid Services (26:23) and try to put the entire week's events into perspective (33:40). Editor's Note: This episode was recorded prior to Sara Brenner being officially named acting FDA commissioner, but the discussion about other aspects of the presidential transition still is relevant. More On These Topics From The Pink Sheet Who's Running The US FDA? Interim Team May Not Have Assumed Control: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/whos-running-the-us-fda-interim-team-may-not-have-assumed-control-S5HIPYKBZNFY3J2VHNJRY4JDYQ/ Deciphering Trump's Executive Order On Medicare, Medicaid Payment Models: https://insights.citeline.com/pink-sheet/market-access/government-payers/medicare/deciphering-trumps-executive-order-on-medicare-medicaid-payment-models-MEWAWGHDNVES3IHTJJUJNAZJVI/ US FDA's Trump Transition Relatively Smooth, Except For Diversity, Equity Work: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/diversity-and-inclusion/us-fdas-trump-transition-relatively-smooth-except-for-diversity-equity-work-V367EFJBVRGLBIVJ7VGWIYUSJ4/

Pink Sheet editors consider ex-FDA officials' advice for the Trump Administration on implementing FDA reforms (:24), comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters (12:35), and diverging trends between CDER and CBER novel application approvals (21:53). More On These Topics From The Pink Sheet Trump's US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trumps-us-fda-reforms-need-center-director-staff-support-to-succeed-former-leaders-say-VCCGXSBJGZGXPHEYJFAHIHEI7A/ Exit Interview: US FDA's Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible': https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/exit-interview-us-fdas-patrizia-cavazzoni-says-cder-staff-in-best-place-possible-IN6GTBFEJZDSNOI4T23CRYK7OY/ Innovation Drives Divergence: US FDA Drugs and Biologics Centers Follow Own Trajectories: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/innovation-drives-divergence-us-fda-drugs-and-biologics-centers-follow-own-trajectories-MDZ5DSCKKNEYPF6PVTXAMFHGF4/ US FDA's Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/us-fdas-median-review-time-remains-less-than-one-year-despite-swell-of-missed-goal-dates-VIEE6AVOQRGMZNKB53B52GPQG4/ Clocking The Speed Of US FDA 2024 Novel Approvals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/clocking-the-speed-of-us-fda-2024-novel-approvals-3HT7CAIO4VBJDIJZVGBHLAUCSY/

Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni's surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA's decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48). More On These Topics From The Pink Sheet Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway': https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/accelerated-approval-us-fda-explains-when-a-confirmatory-trial-is-underway-YP2DRCCKFBHJHOJ7K7LKH2AX4U/ Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/off-label-communications-us-fda-clarifies-safe-harbor-for-firm-generated-presentations-DEDRJWWNWBAUJPTEVI2GLHGI4M/ US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-still-reviewing-rare-pediatric-disease-designation-requests-despite-program-lapse-EJSANI3SL5GATG66ZMVYVCME4E/

John Konsin is co-founder and CEO of Prapela, a company pioneering noninvasive stimulation to improve infant breathing and oxygenation. The company's infant mattress technology has already received two Breakthrough Device designations from the US FDA, which expedites clearance for clinical usage. Prapela expects to debut an additional application based on the technology in 2025.  John and Wendy connected at the Redefining Early Stage of Investment (RESI) Conference in Boston, which Life Science Nation hosted. (Wendy recently interviewed Dennis Ford, founder and CEO of Life Science Nation, which specializes in fundraising for life sciences companies.) In this episode, John describes three clinical applications for Prapela's technology and outlines the company's global expansion strategy, focusing on providing valuable insight into navigating international markets, regulatory challenges, and cross-cultural communication.  The Science Behind Safer Sleep  At the heart of Prapela's innovation is that 62% of healthy infants experience irregular breathing patterns and oxygen desaturation in their first three months of life. The Collaborative Home Infant Monitoring Evaluation (CHIME) study monitored over 1,000 healthy infants at home using hospital-grade equipment to track their respiration, cardiac activity, movement, and oxygen saturation levels. Episodes varied in frequency, severity, and duration among babies—some experienced them once, while others showed multiple occurrences.  Most significantly, these breathing irregularities occurred not just in at-risk infants but in otherwise healthy babies, highlighting a previously unrecognized challenge in early infant development. (Ramanathan, R., et al. (2001). Cardiorespiratory events recorded on home monitors: Comparison of healthy infants with those at increased risk for SIDS. JAMA, 285(17), 2199-2207.)  Prapela's infant mattress helps to regulate babies' breathing through a gentle, barely perceptible vibration. The innovation grew out of research by Dr. David Paydarfar, who, in the 1990s, discovered that a specific type of random vibration, known scientifically as "stochastic" vibration, could improve the “pacemaker function,” the neurons in a baby's brain that controls automatic breathing. The vibration is so subtle it moves less than half the diameter of a human hair, making it effective and non-disruptive to sleep patterns.  The Hospital-First Strategy  The company has secured over $8 million in funding through grants and awards, allowing them to maintain control while developing their technology. John says this will enable the company to seek equity investment from a position of strength, with FDA clearance on the horizon and a clear path to commercialization.  Their market strategy began in hospitals, aiming to directly and immediately impact infant care in critical settings. This approach is grounded in decades of successful medical device launches, which built a foundation of clinical credibility before venturing into the broader consumer landscape. The technology has already demonstrated its potential, reducing reliance on supplemental oxygen and minimizing the need for traditional breathing interventions.  John envisions a future where "Prapela Inside" becomes as recognizable in infant care as "Intel Inside" is in computers, starting with the 52 global manufacturers of hospital bassinets and incubators:  [W]e we can make this mattress fit any infant sleep device worldwide. So it doesn't matter if it's an incubator, bassinet, crib, or cot, as they use the term in international markets, right? We can make it fit those products. So, our strategy is similar to that of Intel with the microchip. You'll see a little badge when you buy a computer from Dell or some other company. It says Intel inside.  By positioning their technology as a vital component that transforms standard infant care equipment into advanced breathing support systems, Prapela aims to revolutionize hospital infant care worldwide. Following FDA approval, Prapela plans to pursue regulatory clearance in other markets, initially focusing on Europe, India, and the Middle East. The sequential approach allows them to leverage their FDA clearance while adapting to local regulatory requirements in each new market.  Cultural Intelligence in Global Marketing  John offers valuable insight into cross-cultural communication and marketing. He emphasizes several key principles for successful global expansion:  Language Simplification: English is widely spoken in international business, but vocabulary depth varies significantly. John advocates using simpler terms and friendly communication to bridge language gaps.  Local Market Adaptation: Success in one market doesn't guarantee success in another. Companies must adapt messaging, pricing, and marketing approaches to local market conditions rather than forcing an American-centric approach.  Brand Management: While maintaining global brand consistency is essential, give local managers some latitude in adapting messages to their markets. This is particularly critical when moving from clinical to consumer marketing, where terms like "calmness" might carry different cultural connotations across markets.  He underscores the importance of remaining open to and respectful of local customs and traditions in international business relationships with a memorable story from his early career in Mexico. The general managers of manufacturing operations presented him with a stuffed armadillo. Initially puzzled by the gift, he later learned it symbolized appreciation for his patience and understanding of their culture.  Brand Identity Across Borders  John explains that "Prapela" was carefully constructed from Latin roots to create a unique name that wouldn't carry unintended meanings in other languages. This thoughtful approach helps avoid the pitfalls that some major companies have encountered, such as the famous case of Chevrolet's Nova in Latin American markets, where the name unfortunately translated to "doesn't go."  The company's branding strategy balances global consistency with local flexibility from the outset. It maintains core clinical messaging that resonates with medical professionals worldwide while recognizing the need for nuanced consumer-market approaches. John explains that exercise is particularly important when communicating concepts like infant calmness or comfort, as cultural interpretations can vary significantly.  Listen to the full episode to learn more about Prapela's innovative approach to their technology and market entry strategy.    Links:   Website: https://www.prapela.com/  LinkedIn: https://www.linkedin.com/in/jkonsin/    Connect with Wendy - https://www.linkedin.com/in/wendypease/  Music: Fiddle-De-Dee by Shane Ivers - https://www.silvermansound.com 

In this week's Digital Health Roundup, Medtech Insight's Marion Webb brings highlights from Deloitte's 2025 Life Sciences Outlook Report with medtech leaders' forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA's newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA's final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST. Related Links: https://insights.citeline.com/medtech-insight/pickleball-smart-homes-brain-games-caregiving-agetech-take-centerstage-at-aarps-ces-2025-presence-CIGK5RS7EVG2XH3XBQSUYDQXI4/

In this JCO Article Insights episode, Giselle de Souza Carvalho provides a summary on  "Navigating Treatment Pathways in Metastatic Hormone Receptor–Positive, HER2-Negative Breast Cancer: Optimizing Second-Line Endocrine and Targeted Therapies" by Bhardwarj, et al and "US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA/AKT1/PTEN Alterations" by Dilawari et al published in the Journal of Clinical Oncology.  TRANSCRIPT Giselle Carvalho: Hello and welcome to JCO Article Insights episode for the December issue of the Journal of Clinical Oncology. I'm your host Giselle Carvalho, Medical Oncologist in Brazil focusing on breast cancer and melanoma skin cancers and one of the ASCO Editorial Fellows at JCO this year. Today, I will be discussing two articles. The first one is “Navigating Treatment Pathways in Metastatic Hormone Receptor–Positive, HER2-Negative Breast Cancer: Optimizing Second-Line Endocrine and Targeted Therapies,” and the second one is the “US FDA Approval Summary on Capivasertib with Fulvestrant  for HR-positive HER2-negative Locally Advanced or Metastatic Breast Cancer with PIK3CA/AKT1/PTEN Alteration.”  As we know, 65% to 70% of all breast cancers are HR-positive HER2-negative and this is also the most common subtype of metastatic breast cancer. The current standard of care for frontline therapy of patients with luminal metastatic disease is a CDK4/6 inhibitor in combination with endocrine therapy. However, as new endocrine and targeted therapies gain approval, choosing the best systemic therapy upon disease progression after frontline therapy is a topic of ongoing debate. Nearly 40 to 50% of HR-positive breast cancers have actionable genomic alterations and molecular testing should be a routine recommendation for patients with metastatic HR-positive HER2-negative disease. This can be performed repeating tissue biopsy at the time of progression or from archival tissue. Treatment options after progression on CDK4/6 inhibitors include alpelisib in combination with fulvestrant in patients with PIK3CA mutant tumors as seen in the SOLAR-1 trial, or capivasertib with fulvestrant in patients with a tumor mutation in (PI3K)–AKT–PTEN pathway as seen in the CAPItello-291 study, which will be discussed further.  In approximately 30% of patients, progression on frontline endocrine plus CDK4/6 inhibitor treatment is caused by endocrine resistance, frequently involving activating mutations in ESR1. For those tumors, elacestrant, an oral SERD is an option as demonstrated in the EMERALD trial. For patients with a BRCA mutation, PARP inhibitors represent another option. If no mutations are detected, everolimus, an mTOR inhibitor, can be used based on the BOLERO-2 results. The phase 2 MAINTAIN and PACE trials, along with the phase 3 postMONARCH trial support changing the endocrine therapy backbone with or without switching the CDK4/6 inhibitor. In less resourced areas, fulvestrant monotherapy is still an option to delay cytotoxic chemotherapy, though its efficacy is limited when used as a single agent. Finally, after progression on at least one line of chemotherapy, antibody drug conjugates including sacituzumab govitecan or trastuzumab deruxtecan may be an option.  Now focusing on the PI3K AKT PTEN signaling pathway, activating mutations in PIK3CA and AKT1 and inactivating alterations in PTEN occur in approximately half of luminal breast cancers. In June 2023, the CAPItello-291 trial was published and treatment with fulvestrant plus capivasertib, a PTEN AKT inhibitor, demonstrated a 3.6 month PFS benefit compared to fulvestrant alone, regardless of the presence of AKT pathway alterations. However, for those with tumors without AKT pathway alteration, an exploratory analysis showed that although there was a numerical improvement in PFS, it did not meet statistical significance, indicating that the biomarker positive population primarily drove the positive results noted in the overall population. Therefore, capivasertib plus fulvestrant was approved by the US FDA in November 2023 exclusively for patients with PI3K/AKT1/PTEN tumor alterations after progression on an aromatized inhibitor with or without a CDK4/6 inhibitor. The approved schedule of capivasertib is slightly different from that of other agents used in breast cancer. It is 400 milligrams taken orally twice a day for four days per week every week in a 28-day cycle in combination with fulvestrant. Diarrhea, rash and hyperglycemia were the most commonly reported grade three or four adverse events in the interventional group. I would like to highlight that even though the CAPItello trial excluded patients with glycosylated hemoglobin levels higher than 8% or those diagnosed with diabetes who required insulin, hyperglycemia occurred in 19% of biomarker positive patients treated with capivasertib, with nearly 2% of this population experiencing grade 3 or 4 hyperglycemia and some patients experiencing life threatening outcomes such as diabetic ketoacidosis.  By way of comparison, hyperglycemia of any grade was three times higher with alpelisib therapy in the SOLAR-1 trial, occurring in 64% of the patients and grade three or higher hyperglycemia was seen in 37% of the patients. Diarrhea was the most common treatment related adverse event experienced by 77% of the biomarker positive population. Prompt use of the antidiarrheal drugs when needed, such as loperamide must be encouraged as untreated diarrhea can lead to dehydration and renal injury. Cutaneous rash occurred in 56% of the biomarker positive population in the interventional group and 15% experienced a grade 3 or 4 rash. Nearly half of the patients with cutaneous adverse reactions required treatment and this was the leading reason for dose reduction of capivasertib.  In the biomarker positive population, the improvement in medium PFS were 4.3 months by investigator assessment. Overall survival data from the CAPItello-291 trial is still immature, but quality of life data was recently published in September this year and was assessed by the 30 item QLQ C30 questionnaire and the QLQ BR23, the breast module. According to Oliveira et al, global health status and quality of life were maintained for a longer period with capivasertib fulvestrant than with placebo fulvestrant except for symptoms of diarrhea which were significantly worse in the capivasertib group. The median time of deterioration of global health status and quality of life was twice as long in the capivasertib group being almost 25 months versus 12 months in the placebo fulvestrant group. These data reinforced the use of capivasertib in combination with fulvestrant for the treatment of HR-positive HER2-negative advanced breast cancer patients with PIK3CA/AKT1/PTEN tumor alterations who have progressed after an aromatase inhibitor-based therapy with or without a CDK4/6 inhibitor.  Thank you for listening to JCO Article Insights. This is Giselle Carvalho. Don't forget to give us a rating or review and be sure to subscribe so you never miss an episode. You can find all ASCO shows at asco.org/podcasts. See you next time.   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.  Guests on this podcast express their own opinions, experience and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity or therapy should not be construed as an ASCO endorsement.  

(2:00) Omni-BS Part Deux — Epic Fraud, Epic FailWith the horrible bill by Speaker Mike Johnson rejected, what was the poison pill in Plan B that also failed?What will a government shut down look like?Can Musk be Speaker of the House when he's already President?(35:11) LIVE comments (43:23) Pump & Dump: Bitcoin Reserve Idea is Trashed by PowellTrump euphoria takes a hit a bit early as Powell throws cold water on the idea of a Bitcoin ReserveWhat are other central banks saying?What will happen when Trump doesn't immediately deliver all the things he promised?It's not just Bitcoin, Powell trashed stocks, bonds, gold, silver to varying degreesSome say Powell's comments were a deliberate market manipulation.  Isn't that the point of the Fed Reserve?The world's central banks are starting inflation up again!(1:04:02) LIVE comments / questions, & thank you to supporters (1:16:43) Flatulent Earth SocietyInsane, unhinged, recycled false prophecies about Climate floods on coastal areasEPA boasts about the "first climate arrest" - for someone using refrigerant (that used to be mandated)(1:34:45) Green Grift PotatoesEuropeans don't want GMO foofd so one corporations describes their GMO potatoes as "climate resistant".  Did it work? (1:41:35) Free Energy?  Open Source designs invites people to give it a try (1:55:22) They all knew about the bioweapon shotThe rats are jumping off the ship and one of the biggest rats, former CDC Director Redfield, is throwing shade at Fauci's lies and mandatesDNA-Gate: Australia's equivalent of the US FDA lied to people about DNA harms — and now emails show they conspired to liePelosi Profits — Look at the unbelievable way she profited from PPP during the pandemic(2:28:30f) Mask Mania is coming back at hospitals but one Canadian woman suffering from asthma gets compensated for the unconscionable bullying she suffered over not wearing a mask (2:46:04) "Sweeping Parental Rights Bill" or are they sweeping the problem under the rug? (2:54:58) Is Santa Claus a false idol to replace ChristMegyn Kelly may tell us "everyone knows Santa is white" but do you really know what Santa is?If you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-show Or you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7 Money should have intrinsic value AND transactional privacy: Go to DavidKnight.gold for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to TrendsJournal.com and enter the code KNIGHTBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-david-knight-show--2653468/support.

(2:00) Omni-BS Part Deux — Epic Fraud, Epic FailWith the horrible bill by Speaker Mike Johnson rejected, what was the poison pill in Plan B that also failed?What will a government shut down look like?Can Musk be Speaker of the House when he's already President?(35:11) LIVE comments (43:23) Pump & Dump: Bitcoin Reserve Idea is Trashed by PowellTrump euphoria takes a hit a bit early as Powell throws cold water on the idea of a Bitcoin ReserveWhat are other central banks saying?What will happen when Trump doesn't immediately deliver all the things he promised?It's not just Bitcoin, Powell trashed stocks, bonds, gold, silver to varying degreesSome say Powell's comments were a deliberate market manipulation.  Isn't that the point of the Fed Reserve?The world's central banks are starting inflation up again!(1:04:02) LIVE comments / questions, & thank you to supporters (1:16:43) Flatulent Earth SocietyInsane, unhinged, recycled false prophecies about Climate floods on coastal areasEPA boasts about the "first climate arrest" - for someone using refrigerant (that used to be mandated)(1:34:45) Green Grift PotatoesEuropeans don't want GMO foofd so one corporations describes their GMO potatoes as "climate resistant".  Did it work? (1:41:35) Free Energy?  Open Source designs invites people to give it a try (1:55:22) They all knew about the bioweapon shotThe rats are jumping off the ship and one of the biggest rats, former CDC Director Redfield, is throwing shade at Fauci's lies and mandatesDNA-Gate: Australia's equivalent of the US FDA lied to people about DNA harms — and now emails show they conspired to liePelosi Profits — Look at the unbelievable way she profited from PPP during the pandemic(2:28:30f) Mask Mania is coming back at hospitals but one Canadian woman suffering from asthma gets compensated for the unconscionable bullying she suffered over not wearing a mask (2:46:04) "Sweeping Parental Rights Bill" or are they sweeping the problem under the rug? (2:54:58) Is Santa Claus a false idol to replace ChristMegyn Kelly may tell us "everyone knows Santa is white" but do you really know what Santa is?If you would like to support the show and our family please consider subscribing monthly here: SubscribeStar https://www.subscribestar.com/the-david-knight-show Or you can send a donation throughMail: David Knight POB 994 Kodak, TN 37764Zelle: @DavidKnightShow@protonmail.comCash App at: $davidknightshowBTC to: bc1qkuec29hkuye4xse9unh7nptvu3y9qmv24vanh7 Money should have intrinsic value AND transactional privacy: Go to DavidKnight.gold for great deals on physical gold/silver For 10% off Gerald Celente's prescient Trends Journal, go to TrendsJournal.com and enter the code KNIGHTBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-real-david-knight-show--5282736/support.

⁠This panel was recorded 12 December 2024. ⁠Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠at RQMplus.com. Thank you for tuning in.

Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccine pediatric indications under the Trump Administration (:24), the DOGE commission's search for spending cuts and its impact on the FDA (12:52), as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program's costs (22:52). More On These Topics From The Pink Sheet Pediatric COVID Shots, Still Under EUA, Would Be Vulnerable In Anti-Vax HHS: https://insights.citeline.com/pink-sheet/vaccines/pediatric-covid-shots-still-under-eua-would-be-vulnerable-in-anti-vax-hhs-UWJRLYQUCJEWTLC42IFR7X2XFY/ Can US FDA Dodge DOGE? Return To Office Mandate May Be Biggest Hit: https://insights.citeline.com/pink-sheet/legislation/elections/can-us-fda-dodge-doge-return-to-office-mandate-may-be-biggest-hit-5G5SYM3ACNAKLHSSHQL32KJN5Y/ 340B Plan B: Pharma Pivots To Rebate Pricing Model After Pharmacy Restrictions Fall Short: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/340b-plan-b-pharma-pivots-to-rebate-pricing-model-after-pharmacy-restrictions-fall-short-M5DTVTFXVZA37IQ6CXMTDW4QMI/

With the health and wellness and moderation trends booming, the non-alcoholic wine market has been growing quickly off a small base. Launched in 2019, the Giesen 0% range has solidified its position as one of the leaders in the NA wine market. Duncan Shouler, Director of Innovation, explains how the 0% range was developed, the critical elements of non-alcoholic wine, the current market conditions, and what it will take for the non-alcoholic wine market to succeed.Detailed Show Notes: Duncan's background - was in marine biology and shifted to wine ~20 years agoGiesen - family owned, 40 years old, large winery (crushes ~20k tons/year), a broad range of wines from large scale to single vineyardStarted non-alcoholic (“NA”) range 5 years ago (2019)~17% of production today, growingHas a more significant reach and impact on the market vs. regular winesThe creation of the NA range came from a fitness challenge in 2019, when he could not drink alcohol for 1 month and discovered there were no good choices in the NA space. Spinning cone technology (good for quality as it uses lower temps than other processes) also became available in NZ at that timeNA winemaking process - create regular wine, then remove alcohol; for red wine, you need to balance the tannins (need ripe, soft tannins)More expensive to make - costs 15-20% moreNeed to replace ~25% of volumeNeed to go through spinning cone technologyLower cost from no alcohol excise taxesNA taste - loses some of alcohol's texture, body, heatNA wines age similarly to regular wine (except in cans)NA wine markets - still in growth mode, needs higher quality wines to succeedThe US is ahead of most markets, and the UK is slower with more traditional drinkersMainland Europe is booming, and NZ is behindMost off-premise, some growing pains (e.g., Boisson closed its stores), mostly bought where people buy alcoholOn-premise still embracing category (Giesen launching super premium range to target on-premise)Most large players (e.g., Constellation, Treasury) are looking at NA wineNA wine drinkers - originally abstainers driving growth, now people substituting wine driving growth from moderation trend; broad market from boomers to legal age Gen Z; 35-60 females largest cohortPrice points aligned with regular wine ($9 low end, up to $18/bottle, some products ~$55/bottle)Removed alcohol of high quality can be used for other things (e.g., gin, biofuel)NA wines can have up to 0.5% abv, Giesen wines 0.4-0.5% abvYou need to consume 5 bottles of NA wine to get 1 glass of 13.5% ABV wine.45% abv similar to ripe bananas, some fruit juices, breadNA wine should still be kept away from children as it is still a wine experienceMarketing NA winesLow calorie is significant; Giesen is low in sugar (drives calories), which plays into the health and wellness trendMost effective - social media and influencers - play well with Millennial and older Gen Z's, essential NA wine growth categoryOlder consumers know Giesen from regular wineNutritional and ingredient labeling - mandatory for regular wine in the EU; NA is a food product and requires itGiesen back labels specific for each wine, the main driver of differences are in sugar contentNutritional data has some positive elements (e.g., potassium)Large serving size (12 ounces, ~½ bottle) driven by US FDA, looking to change back to a 5-ounce glass Get access to library episodes Hosted on Acast. See acast.com/privacy for more information.

Synopsis: In this insightful conversation on Biotech2050, host Rahul Chaturvedi sits down with Bharatt Chowrira, CEO, and Eric Elenko, Co-Founder and President of PureTech Health. They explore the company's pioneering R&D model and how it reshapes drug development by focusing on solving specific problems rather than pushing predefined solutions. Bharatt and Eric share their professional journeys and key insights, emphasizing the importance of simplicity and unwavering commitment to impactful ideas. The episode delves into the story behind Karuna Therapeutics, highlighting the challenges of obtaining funding and skepticism from the industry before its success with a groundbreaking schizophrenia drug. Bharatt and Eric underline the importance of patient-centered innovation and reflect on the lessons learned, including overcoming obstacles with persistence. They also discuss the need for more efficient pathways in drug development and share a glimpse into PureTech's upcoming projects. Biography: Bharatt Chowrira, PhD, JD, is the chief executive officer and a member of the board of directors at PureTech. Dr. Chowrira has been a member of the PureTech management team since March 2017, leading various departments including Operations, Finance and Business Development. Dr. Chowrira plays a key role in the Founded Entity fundraisings and provide strategic guidance as a Board member to many Founded Entities, including co-founding Seaport Therapeutics. Prior to joining PureTech, he held various leadership roles including Chief Executive Officer, President, Chief Operating Officer and General Counsel in multiple biotech companies over the past 30+ years, including Auspex Pharmaceuticals Inc., which was acquired by Teva Pharmaceuticals for $3.5 billion and Sirna Therapeutics that was acquired by Merck for $1.1 billion and as a Vice President at Merck & Co. Dr. Chowrira received a JD from the University of Denver's Sturm College of Law, a PhD in molecular biology from the University of Vermont College of Medicine, an MS in molecular biology from Illinois State University and a BS in microbiology from the UAS, Bangalore, India. Eric Elenko, PhD, is the president at PureTech where he has led the development of a number of programs, including three that have received US FDA approvals (EndeavorRx, Plenity and Cobenfy). Dr. Elenko plays a key role in the Founded Entity drug discovery and fundraisings, including co-founding Seaport Therapeutics. Prior to joining PureTech, Dr. Elenko was a consultant with McKinsey and Company where he advised senior executives of both Fortune 500 and specialty pharmaceutical companies on a range of issues such as product licensing, mergers and acquisitions, research and development strategy and marketing. Dr. Elenko received his BA in biology from Swarthmore College and his PhD in biomedical sciences from the University of California, San Diego.

Pink Sheet reporter and editors discuss potential changes that the incoming Trump Administration could make on the FDA, as well as worries about political interference in decision-making, and policy and staffing changes. More On These Topics From The Pink Sheet US FDA's Drug Approval Norms Could Be Upended In Second Trump Term: https://insights.citeline.com/pink-sheet/legislation/elections/us-fdas-drug-approval-norms-could-be-upended-in-second-trump-term-ICH6FUN4OBHRJPN4QFJ4OPLHNU/ Warp Speed For All And A Boost For Small Biotechs In Trump's Second Term, Ex-Official Says: https://insights.citeline.com/pink-sheet/legislation/elections/warp-speed-for-all-and-a-boost-for-small-biotechs-in-trumps-second-term-ex-official-says-DA3BUPKEWVGVNDEPG6JMVLV7UI/ With Trump's Return, Pharma Trades Disagreeable Knowns For Uncertainty: https://insights.citeline.com/pink-sheet/legislation/elections/with-trumps-return-pharma-trades-disagreeable-knowns-for-uncertainty-N7ZMT6QOEZEUDEXOROKXAZBP6E/ FTC Under Trump Likely to Maintain PBM Focus But M&A Oversight May Moderate: https://insights.citeline.com/pink-sheet/legislation/elections/ftc-under-trump-likely-to-maintain-pbm-focus-but-ma-oversight-may-moderate-H3XQ4S3YJBDSBK2NIDZFM4ZQ34/

Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations (:25), legal wrangling related to compounding GLP-1 drugs for obesity and diabetes (14:20), and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable (29:08) #pharma #business More On These Topics From The Pink Sheet Keytruda, Opdivo SubQ Conversions Cloud Near-Term Medicare Negotiation Savings Forecasts: https://insights.citeline.com/pink-sheet/keytruda-opdivo-subq-conversions-cloud-near-term-medicare-negotiation-savings-forecasts-BJNQCECWVNESHGCKNPJSKVIH4I/ GLP-1s: Compounders Get Temporary Reprieve But US FDA May Be Building Stronger Case: https://insights.citeline.com/pink-sheet/legalandip/litigation/glp-1s-compounders-get-temporary-reprieve-but-us-fda-may-be-building-stronger-case-2SJVLIMS5FDERNWA7UQV3IM7JM/ US FDA Opinions Vary On AI's Black Box Issues. Will Uncertainty Follow?: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/us-fda-opinions-vary-on-ais-black-box-issues-will-uncertainty-follow-PPMN3R3FJ5BTZOXWDFHPHZVLNQ/

Introduction: Pink Sheet reporter and editors discuss experts' experience helping drug sponsors negotiate prices with CMS (:33) and the FDA's proposal for a new pathway to update vaccines before a pandemic is declared (12:02). More On These Topics From The Pink Sheet: Perspectives From The Front Lines: Navigating The First Round Of Medicare Price Negotiation: https://pink.citeline.com/PS155353/Perspectives-From-The-Front-Lines-Navigating-The-First-Round-Of-Medicare-Price-Negotiation US FDA Proposes New ‘Inter-Pandemic' Pathway For Updating Flu Vaccines: https://pink.citeline.com/PS155345/US-FDA-Proposes-New-Inter-Pandemic-Pathway-For-Updating-Flu-Vaccines US FDA Advisors Urge Faster Movement, mRNA Consideration, In Updating Pandemic Flu Vaccines: https://pink.citeline.com/PS155358/US-FDA-Advisors-Urge-Faster-Movement-mRNA-Consideration-In-Updating-Pandemic-Flu-Vaccines

Consider this: Skittles, Pop-Tarts, Gatorade, Little Debbie's, Coffee-mate, Ritz Crackers, Pillsbury biscuits, Wheat Thins and Frosted Flakes are common staples in the US kitchen, but due to their food colorings, BHT (butylated hydroxytoluene), and hydrogenated soybean and cottonseed oils they are actually banned in numerous countries, from Iceland and Austria to Hungary, Japan, and much of the European Union. The US FDA has recently decided to ban BVO (brominated vegetable oil), found in Mountain Dew and Powerade among other products, but this is a result of public outrage rather than objective science. Why do so many countries have the same conclusion about this junk but the US can't figure it out? Many of these products, if they are sold in thee above countries, have completely different ingredients. So even if someone were a huge fan of Frosted Flakes can they explain why the product only needs BHT in the United States? -FREE ARCHIVE & RSS: https://www.spreaker.com/show/the-secret-teachings Twitter: https://twitter.com/TST___Radio Facebook: https://www.facebook.com/thesecretteachings WEBSITE (BOOKS, RESUBSCRIBE for early show access): http://thesecretteachings.info Paypal: rdgable@yahoo.com CashApp: $rdgable EMAIL: rdgable@yahoo.com / TSTRadio@protonmail.com

New survey data from the Federal Reserve Bank of New York shows that the percentage of Americans who expect to get laid off in the next four months has gone up. On the other hand, the share of Americans who expect to get a job offer in the next four months is also up. So what gives? We'll get into the labor market unease and why the Federal Reserve will be paying close attention. Then, we’ll smile about a new tool that could help prevent death from life threatening injuries. Here’s everything we talked about today: “Expectation of Losing One's Job at Record High in NY Fed Survey” from Bloomberg “More and more Americans are worried they will lose their job” from CNN Business “US FDA clears use of Cresilon’s gel to stop severe bleeding in seconds” from Reuters Tweet from Jesse Byrnes about errors in the Democratic Party’s 2024 platform We love to hear from you. Email your comments and questions to makemesmart@marketplace.org or leave us a voicemail at 508-U-B-SMART.

New survey data from the Federal Reserve Bank of New York shows that the percentage of Americans who expect to get laid off in the next four months has gone up. On the other hand, the share of Americans who expect to get a job offer in the next four months is also up. So what gives? We'll get into the labor market unease and why the Federal Reserve will be paying close attention. Then, we’ll smile about a new tool that could help prevent death from life threatening injuries. Here’s everything we talked about today: “Expectation of Losing One's Job at Record High in NY Fed Survey” from Bloomberg “More and more Americans are worried they will lose their job” from CNN Business “US FDA clears use of Cresilon’s gel to stop severe bleeding in seconds” from Reuters Tweet from Jesse Byrnes about errors in the Democratic Party’s 2024 platform We love to hear from you. Email your comments and questions to makemesmart@marketplace.org or leave us a voicemail at 508-U-B-SMART.

New survey data from the Federal Reserve Bank of New York shows that the percentage of Americans who expect to get laid off in the next four months has gone up. On the other hand, the share of Americans who expect to get a job offer in the next four months is also up. So what gives? We'll get into the labor market unease and why the Federal Reserve will be paying close attention. Then, we’ll smile about a new tool that could help prevent death from life threatening injuries. Here’s everything we talked about today: “Expectation of Losing One's Job at Record High in NY Fed Survey” from Bloomberg “More and more Americans are worried they will lose their job” from CNN Business “US FDA clears use of Cresilon’s gel to stop severe bleeding in seconds” from Reuters Tweet from Jesse Byrnes about errors in the Democratic Party’s 2024 platform We love to hear from you. Email your comments and questions to makemesmart@marketplace.org or leave us a voicemail at 508-U-B-SMART.

It's In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: A weekly basal plus semaglutide is in the works, but not for the US right now, Tandem updates it's app recall, liver targeted insulin study, a weird walking story, and Lance Bass educates about LADA.  Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens  Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Novo Nordisk moves ahead with a new combination: once-weekly insulin icodec and semaglutide. Called IcoSema, Novo plans to submit for approval in Europe, Canada, Japan and Australia but NOT the US. As we told you earlier this summer, icodec – once weeky basal insulin – was not approved by the US FDA. Semaglutide is the molecule underpinning Novo's immensely popular GLP-1 drugs Ozempic and Wegovy. Icodec has been approved as Awiqli in places like Europe, Canada, Japan and Australia but was snubbed by the FDA last month. The FDA has left the door open for another application, but Novo says they don't expect to iron it out this year. In studies, the combination worked well to lower A1C for people with type 2 and they lost weight. They also had fewer lows. https://www.fiercepharma.com/pharma/corrected-after-icodec-rejection-novo-nordisk-wont-file-application-once-weekly-insulin-and   XX An update from Tandm on their app recall. Back in March they notified users of the recall because of an issue that can cause rapid depletion of a user's t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to experience even after an updated version of the app was released. Notices were emailed to impacted customers on August 9, 2024 with updated information and recommendations for helping avoid pump battery depletion. Tandem plans to release a new version of the app to address the remaining issues and will notify all users by email and app push notifications following its release. Impacted customers in the U.S. with questions about this recall can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at techsupport@tandemdiabetes.com or (877) 801-6901. https://www.businesswire.com/news/home/20240812040222/en/Tandem-Diabetes-Care-Provides-Update-on-March-2024-Nationwide-Recall-of-tconnect-Mobile-App-for-iOS-Devices XX If you are an adult who has type 1 diabetes, you may be eligible to participate in a trial examining the impact of an investigational liver-targeted insulin on blood glucose control, A1C, and nighttime lows. This study is researching whether administering a liver-targeting insulin called HDV-L insulin (Hepatocyte-directed Vesicles-insulin lispro), will improve glycemic control. HDV-L insulin is designed to act on the liver to enhance glucose storage and decrease the frequency of severe hypoglycemia in individuals requiring insulin. It is not currently approved for use. For this trial, researchers are recruiting roughly 230 adults with type 1 diabetes aged 18-79 who are on multiple daily injections (MDI). This study is recruiting in California, Colorado, Florida, Georgia, Illinois, Indiana, New York, North Carolina, Ohio, and Texas. To enroll or learn more about this study, contact Todd Hobbs, MD at Diasome Pharmaceuticals at thobbs@diasome.com or call 216-780-9324. Clinical Trials Identifier: NCT06238778 https://diatribe.org/diabetes-research/new-study-tests-liver-targeted-insulin-type-1-diabetes XX Sanofi is investing heavily to boost insulin production. They opened a new facility in Germany for the basal insulin Lantus and they announced they will invest over one billion dollars to expand production capacity in France. Sanofi's considerable investment in insulin production is especially important given that other insulin companies appear to be focusing their efforts on production of GLP-1 medications like Mounjaro and Ozempic, rather than insulin. This has left some patients worried that Novo Nordisk and Lilly will leave them behind to pursue more lucrative products for weight loss, especially after Novo Nordisk decided to discontinue the basal insulin Levemir. https://diatribe.org/diabetes-medications/sanofi-build-new-state-art-insulin-plant   XX Hoping to talk to Abbott and Medtronic soon about their partnership announced earlier this month. The companies announced that Abbot will create an integrated continuous glucose monitor that works only with Medtronic's diabetes technology and be sold exclusively by Medtronic. Along with announcing the partnership, Medtronic said Wednesday it received FDA approval for its Simplera CGM, which does not require fingersticks or overtape, unlike the company's previous sensors. The Simplera Sync sensor, which is designed to work with Medtronic's automated insulin delivery algorithm, is under FDA review separately. https://www.medtechdive.com/news/abbott-medtronic-partnership-automated-insulin-delivery/723600/ XX Researchers have developed a novel computer algorithm that can predict various diseases like diabetes or stroke, just by analysing the colour of the human tongue with 98 per cent accuracy. The imaging system developed by Middle Technical University (MTU) and the University of South Australia (UniSA) in Australia can diagnose conditions such as diabetes, stroke, anaemia, asthma, liver and gallbladder issues, Covid-19, and other vascular and gastrointestinal diseases. "The colour, shape, and thickness of the tongue can reveal a litany of health conditions," said Ali Al-Naji, adjunct Associate Professor at MTU and UniSA. The paper published in Technologies describes how the system analyses tongue colour to provide real-time diagnoses, demonstrating that AI can advance medical practices significantly. The breakthrough was achieved through a series of experiments using 5,260 images to train machine-learning algorithms to detect tongue colour. Researchers received 60 tongue images from two teaching hospitals in the Middle East, representing patients with diverse health conditions. The AI model matched tongue colour with the correct disease in nearly all cases. https://www.ndtv.com/world-news/new-algorithm-analyses-tongue-to-predict-diabetes-stroke-with-98-accuracy-6327124 XX Big roundup article from the UK Guardian all about 6 projects all around smart insulin. Not a lot new here, but it caused a lot of chatter. I'll link it up – good summary of all of the research happening in the space right now. Glucose-responsive insulin is the idea that you could give one injection and the insulin would respond to the rise and fall of glucose levels without further action by the person.   https://www.theguardian.com/society/article/2024/aug/11/scientists-hail-smart-insulin-responds-changing-blood-sugar-levels-real-time-diabetes XX Edgepark Commercial XX Lance Bass (like glass) continues to keep the public posted on his recent LADA diagnosis. The boy band singer showing his IG audience more about what's also called diabetes 1.5 and explaining how he was first diagnosed with type 2. XX Ok, brace yourself – I promise this is a real story. The Fart Walk is actually good for you. Ok.. stay with me. This is really just a great silly reframing of something we all know, and I couldn't resist putting it in here. A wellness influencer put this out – you may have seen it – claiming the after dinner stroll can limit your risk of type 2 diabetes. A lot of studies confirm that – along with it having benefits if you already have diabetes. The flatulence part – or a release of gastric pressure – is also a known benefit of moving more after meals. So it's funny, farts are always funny, but if it gets more people to walk after they eat I'm all for it.   https://people.com/fart-walk-benefits-what-is-it-type-2-diabetes-8694630#:~:text=Wellness%20influencer%20Mairlyn%20Smith%20has,of%20day%20you%20do%20it XX Join us again soon!