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The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW's Bruno Quinney narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. In this week's news, AstraZeneca has halted its £200 million research investment in the UK. Elsewhere, the US Food and Drug Administration (FDA) has fast-tracked a gene therapy, CAR-T therapy could be an effective cancer treatment, and the National Institute for Health and Care Excellence (NICE) has updated its thresholds for ultra-rare disease drugs. You can listen below, or find The Drug Discovery World Podcast on Spotify, Google Play and Apple Podcasts. 

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs look at the potential consequences of the US Food and Drug Administration's upcoming crack down on direct-to-consumer advertising (:30), including the first publicly released letter, which went to AstraZeneca for a Flumist TV commercial (2:50), as well as vaccine policy and other major issues that were listed in the Make America Healthy Again Commission's Strategy Report (21:45). More On These Topics From The Pink Sheet Direct-To-Consumer Ads: Manufacturers Face ‘Cease And Desist' Orders Now, Uncertain Future: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/direct-to-consumer-ads-manufacturers-face-cease-and-desist-orders-now-uncertain-future-6XLXAWS7WJBYNPHSBRAQVTBARU/ Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/limited-detail-in-maha-strategy-report-could-catch-pharma-off-guard-TVL7CCBQONA7PHCLUDJ7WTEJC4/

It seems there are news stories every week about the accelerating pace of innovation in gene therapy, but only about 50 therapies have been approved so far by the US Food and Drug Administration. Our guest today, Dr. Bobby Gaspar, leads a UK-based biotech company, Orchard Therapeutics, that developed one of those treatments using gene-modified stem cells in your blood that self-renew, so a single administration can give you potentially a lifelong effect. “Our approach is about correcting those hematopoietic stem cells and allowing them to give rise to cells that can then correct the disease,” explains Dr. Gaspar.  The therapy in focus is lenmeldy, the first approved treatment for metachromatic leukodystrophy, also known as MLD, a devastating inherited disorder that affects roughly 600 children worldwide. But Dr. Gaspar is optimistic that learnings from Orchard's work on MLD could be useful in treating much more common disorders including frontotemporal dementia, Crohn's disease and others. This highly informative conversation with host Lindsey Smith also explores the importance of newborn screening, community collaboration in advancing clinical trials for rare diseases, and a future in which each gene therapy will be used as a tool for specific applications.  “There will be many gene therapies available, some of which will become the standard of care for certain diseases, but it won't be for every disease.”Mentioned in this episode:Orchard Therapeutics If you like this podcast, please share it on your social channels. You can also subscribe to the series and check out all of our episodes at www.osmosis.org/raisethelinepodcast

The three major averages on Wall St rose to record territory on Tuesday as investors looked past current concerns over the US economic stability and bought into market opportunities. The Dow Jones rose added 0.43%, the S&P500 climbed 0.27% and the tech-heavy Nasdaq ended the day up 0.37%. Revisions to payrolls data of late has been the key catalyst spooking investors with the latest revision by the labour department coming in at a reduction of 911,000 for the 12-months to March this year signalling weakness in the US labour stability. In Europe overnight, markets closed mostly higher with the STOXX600 rising 0.09%, while Germany's DAX fell 0.37%, the French CAC added 0.23% and, in the UK, the FTSE100 ended the day up 0.23%.Across the Asia region on Tuesday, markets closed mixed with Japan's Nikkei falling 0.42% while South Korea's Kospi index gained 1.26%, Hong Kong's Hang Seng rose 1.19% and China's CSI index fell 0.7%.The local market sell-off to start September has extended into the new trading week with the key index ending Tuesday's session down 0.52% as investor sentiment has been hit lately by further tariff, US economic and rate outlook uncertainty.Westpac consumer confidence data for September and NAB business confidence data for August were also both released yesterday with declines in both readings more than economists were expecting amid uncertainty on an economic level.Energy stocks continued their slide this week following OPEC+'s weekend decision to increase production of oil starting in October.Telix Pharmaceuticals (ASX:TLX) gained over 2% after reaching a deal with the US Food and Drug Administration to file a revised application for its brain cancer imaging agent, incorporating further clinical data. What to watch today:On the commodities front this morning oil is trading 0.71% higher at US$62.71/barrel, gold is up 0.12% at US$3640/ounce and iron ore is up 0.42% at US$104.93/tonne.The Aussie dollar has weakened against the greenback to buy 65.84 US cents, 97.06 Japanese Yen, 48.62 British Pence and 1 New Zealand dollar and 11 cents.Ahead of the midweek trading session the SPI futures are anticipating the ASX will open the day down 0.05%. Trading Ideas:Bell Potter has increased the 12-month price target on Lynas Rare Earths (ASX:LYC) from $7.65 to $9.35 and maintain a sell rating on the leading rare earths producer following the company highlighting its ‘Towards 2030 strategy'. The analyst sees LYC is priced for perfection, with little room for error, highlighting FY25 had higher depreciation which drove a miss on results, however, does recognise that the current themes pushing LYC higher are likely to persist as tailwinds over the short term.And Trading Central has identified a bearish signal on Breville Group (ASX:BRG) following the formation of a pattern over a period of 33-days which is roughly the same amount of time the share price may fall from the close of $30.89 to the range of $25 - $26.25 according to standard principles of technical analysis.

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit's VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration's COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). More On These Topics From The Pink Sheet COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA's Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/ A US FDA Move to Revoke Pfizer's Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/ Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/

Uploaded every Friday, Nikkei Asia News Roundup delivers a collection of articles from Nikkei's English language media, Nikkei Asia. ・A selection of news headlines ・A glimpse into a notable story for deeper understanding ・A highlight of our best stories Today we focus on:“China's snooker craze and US food chains scramble in Southeast Asia” ・You can read more at: https://asia.nikkei.com/Spotlight/Podcast/Podcast-News-Roundup  

When a shortage of brand-name weight-loss drugs like Ozempic and Wegovy cleared the way for companies like Hims to fill the gap with cheaper, compounded versions, customers came flocking. But in February, the US Food and Drug Administration announced the shortage was over, leaving the company's strategy in flux and some investors worried. On today’s Big Take podcast, host David Gura and Bloomberg healthcare reporter Madison Muller track how Hims became the king of copycat weight-loss drugs and what’s next for the company as it fights to hold onto the crown. Read more: How Hims Became the King of Knockoff Weight-Loss Drugs Cheap Ozempic Knockoffs Are Suddenly Everywhere. Are They Safe? The Weight-Loss Drug Boom’s Prescription Problem Listen and follow The Big Take on Apple Podcasts, Spotify or wherever you get your podcasts.See omnystudio.com/listener for privacy information.

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration's Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49). More On These Topics From The Pink Sheet Will Tidmarsh's Industry Experience Translate As US FDA's Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/ Business Background Of New CDER Director George Tidmarsh: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/business-background-of-new-cder-director-george-tidmarsh-BROCYQDUYFE3LIQDJ2JNBDWD6Y/ US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-cancer-reviewers-heading-for-the-exits-potentially-impacting-review-timelines-YMOFTXDFDZBGVGBIKFXHJY5XTY/ US FDA's Biologics Center Departures Grew Before More Than 100 RIFs Exited: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-biologics-center-departures-grew-before-more-than-100-rifs-exited-2LR3ZFYOBND3DLIWXSFFWWLFYE/ After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/after-sarepta-reversed-course-on-elevidys-could-an-adcomm-be-next-ZA5ODQB3DJF4LBDFODMB52DM3M/ Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-asks-sarepta-to-stop-elevidys-shipments-after-third-death-linked-to-gene-therapy-vector-GLJ2YJDJGNBPLD3SSKKE6UVM34/

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss why Center for Biologics Evaluation and Research Director Vinay Prasad cited an unproven theory alleging politics influenced the 2020 COVID-19 vaccine emergency use authorizations to justify his decision to overrule reviewers on more recent indication updates (:35). They also consider the impact of hundreds of staff departures after the US Food and Drug Administration's reduction-in-force was allowed to proceed, including 600 in the Center for Drug Evaluation and Research (20:14). More On These Topics From The Pink Sheet Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/prasad-cites-unproven-theory-defending-his-covid-19-vaccine-decisions-QFAGD35QOFA5VCZS4WXDPCNWV4/ US FDA's Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-drugs-center-lost-hundreds-of-staff-through-june-with-600-rifs-coming-GYSWOX6RIZEXTK5LZ4KWF3PPDY/

This week, something extraordinary happened: menopause took center stage at the highest levels of US government in an unprecedented way. The US Food and Drug Administration (FDA) convened leading experts from across the country to discuss what millions of women have been waiting to hear: their experiences matter, their suffering is real, and there may be evidence-based solutions that have been withheld. This historic hearing offers tremendous hope for women navigating menopause.Are you ready to awaken your sensuality and feel more empowered in your body? Access the FREE Pleasure Upgrade Bundle at https://www.pleasureinthepause.com/gift.I am your host, Gabriella Espinosa, and in this special episode, I dive into the profound implications of this gathering. The FDA panel, the first of its kind in over two decades, aimed to fundamentally reimagine how we approach women's health during menopause, going beyond mere symptom management. This signifies a cultural awakening, recognizing that dismissing this universal experience has real consequences for women's health, careers, relationships, and quality of life.In this episode, we discuss:The End of Silence: Menopause, once a shamed and dismissed topic, has finally entered serious public discourse, moving beyond quiet endurance to high-level recognition.A Personal Story Driving Change: The head of the FDA shared his personal story about his mother who suffered greatly due to outdated fears around hormone therapy, emphasizing that bone fractures in older women can be fatal.Dismantling Dogma: Experts revealed that vaginal estrogen is categorically safe for all women, with no systemic absorption, directly challenging the black box warning.The Cost of Fear: Data revealed that tens of thousands of women died over the past two decades simply by avoiding estrogen, highlighting the tragic triumph of fear over facts.Brain and Bone Health: Researchers presented alarming data on how estrogen decline impacts brain function and bone density, emphasizing that hormone therapy can be a critical prevention tool, not just a treatment for the elderly.This hearing signals a critical shift: women's health matters, our experiences are valid, and we deserve care based on current science, not outdated assumptions. Whether or not you choose hormone therapy, there is now hope that you can make informed decisions based on facts.Your voice matters in this conversation!The FDA is opening a public comment period on this topic. Please go to the FDA YouTube channel, listen to the full hearing, and leave your public comment. This is our opportunity to ensure today's expert testimony translates into policy changes that will help millions of women.Help us spread more pleasure in the world!Please subscribe, rate, and review this episode, and share it with someone you love. Your voice is crucial in creating ripples of pleasure and connection throughout our communities.Until we meet again, remember, your pleasure matters.FDA HearingFDA InstagramCONNECT WITH GABRReclaim your sensuality and step into a powerful new chapter. The Midlife Pleasure Collective is a monthly membership designed to help midlife women reconnect with their bodies, embrace their desires, and cultivate deeper pleasure. Join the founding members for just $20/month - spots are limited, so apply now at pleasure-in-the-pause.com/collective. Full episodes on YouTube.

We were joined at The Pit Recording Studio in Sunland, CA by Nitisart “Mike” Chaiburi and Kitti “Ole” Suwan of the great WHISPERS, all the way from Bangkok, Thailand.A truly unbelievable group of people both personally and musically, they've broken through every barrier imaginable through their undeniable spirit, infectiously unique and hard and passionate love for hardcore music.Being the first band from Bangkok to achieve so much of what they have achieved, we're honored to talk to Whispers about their origin from local band in Bangkok who evolved into the definitive band that represents not only their city, but all of Thailand around the world. We can't think of a better group or a better band for the job, and just five minutes of this conversation is all you'll need to hear to understand why.______________________________________ Edited by Steven Grise (@iamoneonenineseven) • Title sequence by Nicholas Marzluf (@marzluf) HardLore: A Knotfest Series Join the HARDLORE PATREON to watch every single weekly episode early and ad-free, alongside exclusive monthly episodes: https://patreon.com/hardlorepodJoin the HARDLORE DISCORD: https://discord.gg/jA9rppggef_____________________________________ Cool links:HardLore Official Website/HardLore Records store: https://hardlorepod.comTry AG1 at DrinkAG1.com/HARDLORE to receive a free 1-year supply of vitamin D and 5 travel packs of AG1.Get 15% off MADD VINTAGE with code HARDLORE15! https://maddvintage.com/___________________________________ FOLLOW WHISPERS:INSTAGRAM | https://www.instagram.com/whispershc/TWITTER | https://www.twitter.com/whispershc FOLLOW MIKE:INSTAGRAM | https://www.instagram.com/mikelaw307/ FOLLOW OLE:INSTAGRAM | https://www.instagram.com/oletalifez/ FOLLOW HARDLORE:INSTAGRAM | https://www.instagram.com/hardlorepod/TWITTER | https://twitter.com/hardlorepodSPOTIFY | https://spoti.fi/3J1GIrpAPPLE | https://apple.co/3IKBss2 FOLLOW COLIN:INSTAGRAM | https://www.instagram.com/colinyovng/TWITTER | https://www.twitter.com/ColinYovng FOLLOW BO:INSTAGRAM | https://www.instagram.com/bosxe/TWITTER | https://www.twitter.com/bosxe #HARDLORE #HARDCORE 00:00:00 - Start00:01:02 - Introduction00:02:20 - Finding Hardcore in Thailand00:08:25 - 555555555555500:10:19 - Their Many Many Vintage Stores00:12:15 - Friendships before Whispers00:13:33 - H8000 Bands00:15:45 - Finding European Hardcore00:18:17 - Activities Outside of Whispers00:20:13 - Mike's Vocal Style00:21:19 - Whispers Through the Years00:24:34 - Bangkok During Covid00:26:00 - Relax Time00:27:57 - Stories With Stéphen Kickback00:31:02 - Pardon This Interruption00:33:40 - Meeting Gap00:37:01 - First Whispers Tour Ever00:39:00 - Asian Countries Played00:39:42 - Response To Whispers Across The World00:41:00 - Linking Up with Speed00:42:09 - Touring Europe00:43:16 - Yom Ma Lok00:47:24 - Flatspot Records00:48:15 - First US Tour00:51:00 - Future Aspirations for Whispers00:51:59 - Tied Down Fest00:53:41 - Tour Essentials (Hot Dogs)00:54:49 - US Food vs Thailand Food01:00:18 - Sound and Fury01:03:21 - Top 4 HC Records01:06:38 - Ghosts?01:10:45 - Patreon Q&A01:11:38 - Top 4 Thai HC01:12:38 - Greatest Breakdown Of All Time01:14:50 - Inspirations / Influences

This week hosts Tiffany Cross, Angela Rye, and Andrew Gillum cover a VERY important topic: housing and financial literacy. We’re doing some hardcore adulting today y’all. Why is it so hard to buy a home these days? How do we build wealth for a down payment–or anything for that matter? These questions may sound dry but the answers as to how we got into this housing crisis are INVALUABLE. They’ll include some advice and personal stories from our hosts (and guest) on how you can secure your finances and get your life. PLUS stories and tips on how to navigate systemic inequities when it comes to things like securing a loan. Our guest, Elizabeth Booker Houston, is an influencer and political commentator with a Juris Doctorate (scholarly legal mastermind) and a Masters in public health. In 2017, she relocated to Washington, DC to serve in the US Food and Drug Administration. In the years since, she has combined her love of politics, law, science, and comedy into a second career as a political standup comedienne, writer, and content creator. You can find Elizabeth @bookersquared on all platforms. And our hosts answer a couple of fun questions all about TV shows and books submitted by YOU, our audience. If you’d like to submit a question, check out our tutorial video: http://www.instagram.com/reel/C5j_oBXLIg0/ and send to @nativelandpod. We are 481 days away from the midterm elections. Welcome home y’all! —--------- We want to hear from you! Send us a video @nativelandpod and we may feature you on the podcast. Instagram X/Twitter Facebook NativeLandPod.com Watch full episodes of Native Land Pod here on YouTube. Native Land Pod is brought to you by Reasoned Choice Media. Thank you to the Native Land Pod team: Angela Rye as host, executive producer and cofounder of Reasoned Choice Media; Tiffany Cross as host and producer, Andrew Gillum as host and producer, and Lauren Hansen as executive producer; Loren Mychael is our research producer, and Nikolas Harter is our editor and producer. Special thanks to Chris Morrow and Lenard McKelvey, co-founders of Reasoned Choice Media. Theme music created by Daniel Laurent.See omnystudio.com/listener for privacy information.

The author and former commissioner of the US Food and Drug Administration talks to Mark about his new book, Diet, Drugs, and Dopamine: The New Science of Achieving a Healthy Weight; why self-control isn't enough when it comes to losing—and keeping off—weight; the problem with 'eat less, exercise more"; and his own personal weight loss journey.Read an excerpt from DIET, DRUGS, AND DOPAMINE on the Bittman Project: https://bittmanproject.com/diet-drugs-and-dopamine/Subscribe to Food with Mark Bittman on Apple Podcasts, Spotify, or wherever you like to listen, and please help us grow by leaving us a 5 star review on Apple Podcasts.Follow Mark on Twitter at @bittman, and on Facebook and Instagram at @markbittman. Want more food content? Subscribe to The Bittman Project at www.bittmanproject.com. Hosted on Acast. See acast.com/privacy for more information.

The US Food and Drug Administration recently announced that, for the development of certain…

This spring, the US Food and Drug Administration made legally available a treatment for…

The US Food and Drug Administration recently announced that, for the development of certain drugs, it will be phasing out animal testing in favor of more effective, human-centered methods —...

This spring, the US Food and Drug Administration made legally available a treatment for a parasitic disease that commonly affects fish often kept in home aquariums and outdoor ponds. Informally...

Resources for the Community:___________________________________________________________________https://linktr.ee/theplussidezpodcast Ro - Telehealth for GLP1 weight management https://ro.co/weight-loss/?utm_source=plussidez&utm_medium=partnership&utm_campaign=comms_yt&utm_content=45497&utm_term=55______________________________________________________________________Dr. David Kessler, former FDA Commissioner and author of Diet, Drugs, and Dopamine, joins us to break down the science behind food addiction, obesity, and GLP-1 medications like Ozempic and Zepbound.He doesn't just study this—he lives it. Dr. Kessler has obesity, takes GLP-1s, and knows firsthand what it's like to battle food noise and weight stigma.In this episode, we discuss:What makes ultra-processed food addictiveHow GLP-1s affect the brain and reduce cravingsWhether some people can stop taking GLP-1sHis personal experience starting, stopping, and restartingWhy weight regain happens and what the body is really fightingHis bold policy ideas to regulate Big Food like Big TobaccoDr. Kessler helped bring HIV drugs to market faster, led Operation Warp Speed, and took on the tobacco industry. Now, he's focused on the next public health crisis: food addiction and obesity.Subscribe to The Plus SideZ Podcast for more expert conversations on GLP-1s, weight, and wellness.Specialist and Community Guest Dr. David KesslerBIO: David. A. Kessler, MD, served as chief science officer of the WhiteHouse COVID-19 Response Team under President Joe Biden and previouslyserved as commissioner of the US Food and Drug Administration underPresidents George H.W. Bush and Bill Clinton. He is the author of the_New York Times_ bestsellers _The End of Overeating_ and_ Capture_ andtwo other books:_ Fast Carbs, Slow Carbs_ and _A Question of Intent_.Dr. Kessler is a pediatrician and has been the dean of the medicalschools at Yale and the University of California, San Francisco. He is agraduate of Amherst College, the University of Chicago Law School, andHarvard Medical School.Social Media:https://x.com/DavidAKesslerMDLink to Book:https://www.audible.com/pd/B0D5KS9P4D?source_code=ASSORAP0511160006&share_location=pdpSpecial community guest Mike on a Health Mission Social MedSend us Fan Mail! Support the showKim Carlos, Executive Producer TikTok https://www.tiktok.com/@dmfkim?is_from_webapp=1&sender_device=pc Instagram https://www.instagram.com/dmfkimonmounjaro?igsh=aDF6dnlmbHBoYmJn&utm_source=qr Kat Carter, Associate Producer TikTok https://www.tiktok.com/@katcarter7?is_from_webapp=1&sender_device=pc Instagram https://www.instagram.com/mrskatcarter?utm_source=ig_web_button_share_sheet&igsh=ZDNlZDc0MzIxNw==

Stakeholders from across the healthcare industry, including members of Congress, the US Food and Drug Administration, and the Center for Medicare and Medicaid Services, recently convened in Washington D.C. for the Medical Device Manufacturers Association (MDMA) Annual Meeting. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott, Nate Beaton, and Bill McConagha, and associate Danny Machado share their key takeaways from the meeting, including compliance hot topics and what the industry can expect in terms of regulatory enforcement in 2025.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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/

Donate (no account necessary) | Subscribe (account required) Join Bryan Dean Wright, former CIA Operations Officer, as he breaks down today's biggest stories shaping America and the world. Chinese Nationals Charged with Agro-Terrorism in Michigan – The FBI arrests a Chinese student and her boyfriend for smuggling a wheat-killing fungus into the U.S., potentially targeting America's food supply. One suspect expressed loyalty to Xi Jinping and is linked to the Communist Party. FBI Director Kash Patel calls it a wake-up call for food security and national defense. Trump Expands Emergency Powers to Boost Weapons and Rare Earth Mining – In response to Chinese rare earth blackmail and global supply chain vulnerabilities, President Trump invokes the Defense Production Act to increase U.S. arms and mineral output. Allies warn China's squeeze on magnets may signal an impending Taiwan blockade or invasion. Elon Musk vs. Trump Over “Disgusting” Spending Bill – Musk lashes out at Trump's Big Beautiful Bill, calling it reckless and bloated. The rift deepens after Trump withdraws NASA nominee Jared Isaacman and House Republicans defend cuts to EV subsidies and NPR. A rescission bill is introduced to walk back $9.4B in spending. Vietnam Faces U.S. Trade Pressure, South Korea Elects Pro-China Socialist – Vietnam agrees to buy $2B in U.S. goods but resists Trump's demand to curb Chinese transshipping. Meanwhile, South Korea elects Lee Jae-myung, a Bernie Sanders-style leftist who questions U.S. troop presence and cozies up to Beijing, complicating future Taiwan conflict strategy. China's Auto Glut and Rare Earth Strategy Spark Global Tensions – Chinese car dealers beg automakers to slow production as $7,500 vehicles swamp the market. Simultaneously, China ramps up global espionage, especially targeting Dutch chip firms, while tightening its grip on global rare earth exports. Dutch Government Collapses Over Immigration – The Netherlands' ruling coalition falls apart after nationalist leader Geert Wilders demands mass deportations. European voters cite economic hardship and cultural tensions as driving factors. Gaza Aid Effort Stalls, Hamas Rejects Peace Deal – Israeli military progress in Gaza is overshadowed by disrupted food distribution. Hamas kills civilians to create propaganda, and U.S.-backed aid operations struggle internally. Peace remains elusive as Hamas refuses to accept Israel's right to exist. Study Confirms Diverse Diet Key to Long-Term Health – A decade-long international study finds that consuming a variety of colorful fruits and vegetables delivers the best antioxidant and anti-inflammatory benefits - great news for your brain, heart, and longevity. "And you shall know the truth, and the truth shall make you free." – John 8:32        

The Smart 7 is an award winning daily podcast, in association with METRO that gives you everything you need to know in 7 minutes, at 7am, 7 days a week...With over 18 million downloads and consistently charting, including as No. 1 News Podcast on Spotify, we're a trusted source for people every day and the Sunday 7 won a Gold Award as “Best Conversation Starter” in the International Signal Podcast Awards If you're enjoying it, please follow, share, or even post a review, it all helps...Today's episode includes the following guests:Guests Dr Morgaine Gaye - Food Futurologist and Phd in Quantum Philosophy Dr David Kessler - Author and former Commissioner with the US Food and Drug AdministrationWill Guyatt - The Smart 7's Tech Guru Butch Wilmore & Sunni Williams - NASA Astronauts Dr Sam Chapman - Co-Founder and Executive Director of Kenoteq Lucy Black - Kenoteq's Head of Business Development Robert F Kennedy Jr - United States Secretary of Health Doctor Molly O'Shea - Spokesperson for the American Academy of Pediatrics Marcus Beard - Former Government Digital Counter-Misinformation StrategistJamie Christon - CEO of Chester Zoo Ros Clubb - Head of Wild Animal Science and Policy at the RSPCA Contact us over @TheSmart7pod or visit www.thesmart7.com or find out more at www.metro.co.uk Presented by Jamie East, written by Liam Thompson, researched by Lucie Lewis and produced by D Hosted on Acast. See acast.com/privacy for more information.

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/

A recent US Food and Drug Administration decision updates the rule for "healthy" claims for seafood, allowing seafood products that meet the new FDA criteria to voluntarily make "healthy" claims on their packaging and other marketing materials. Under the final rule, the FDA notes that seafood without added ingredients except for water automatically qualifies for use of the “healthy” claim due to its nutritional attributes and role in healthy diets as recommended by the Dietary Guidelines for Americans.In this interview, Anna Benevente, director of regulatory affairs for Registrar Corp, discusses the impact this change will have on the seafood industry, including:FDA's new "healthy" claim regulation shifts focus from individual nutrients to overall dietary patterns, benefiting seafood marketersSeafood (including high-fat fish like salmon) now automatically qualifies for the "healthy" claim if single-ingredient or water-packed.

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/

The US Food and Drug Administration (FDA) is set to revise its approval process for COVID-19 vaccines, potentially limiting future boosters to older adults and those at higher risk of severe illness. The move has sparked questions about how this change could influence Australia's vaccine strategy and access to boosters in the future.

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW's Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. Our news highlights this time focus on two major regulatory agencies, in a week that saw the European Commission (EC) launch a new fund designed to tempt US researchers to EU countries, and the US Food and Drugs Administration (FDA) roll out extensive new AI systems. You can listen below, or find The Drug Discovery World Podcast on Spotify, Google Play and Apple Podcasts. 

Recently, there has been a lot of interest generated by a new FDA approval. Suzetrigine (Journavx) was recently approved by the US Food and Drug Administration for the management of pain. Although there is a lot of excitement about having a new tool in the toolbox, there are certain limitations that are important to consider. In this episode of Verified Rx, Dave Peterson, pharmacist and drug information specialist for the University of Utah Health joins us to discuss this exciting new non opioid medication.   Guest speakers:  Dave Peterson, PharmD, BCPS Drug Information Specialist University of Utah Drug Information Service   Host:  Kerry Schwarz, PharmD, MPH Senior Clinical Manager, Evidence-Based Medicine and Outcomes Center for Pharmacy Practice Excellence (CPPE) VerifiedRx Host   Show Notes:  [00:54-02:24] Information about Suzetrigine [02:25-04:06] What distinguishes suzetrigine from other non-opioid analgesics [04:07-05:09] What suzetrigine is indicated for [05:10-06:14] How suzetrigine is being studied [06:15-08:40] Surgical models and the endpoints that we commonly see in these studies [08:41-10:25] Making sense of discordant study results [10:26-12:02] Moving beyond the evidence to real world utilization of suzetrigine [12:03-14:03] How cost factors into real-world utilization [14:04-16:21] What Dave is keeping his eye on in terms of clinical concerns [16:22-17:28] What Dave is excited about with the advent of suzetrigine   Links | Resources: No pain, much gain?   Subscribe Today! Apple Podcasts Amazon Podcasts Spotify Android RSS Feed

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/

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Gene-editing technology which makes pigs immune to a highly infectious virus, developed at Edinburgh University's Roslin Institute, has been approved for use by the US Food and Drug Administration. The virus causes a disease called PRRS or Porcine Reproductive and Respiratory Syndrome, which causes premature births in pigs as well as other painful symptoms and costs the pig industry billions. Current legislation doesn't permit its use in the UK. We speak to one of the scientists who's been working on the project for more than seven years.All week we've been taking a closer look at pulses, the dried seeds of crops like beans, lentils and peas, for both human and animal food. In the UK the peas we eat are generally frozen or fresh but dried peas are a major source of protein to millions of people around the world. Scientists at the John Innes Centre in Norwich have been working with researchers in China, the USA and France to uncover the genome of 700 different varieties of pea, from many different countries, to help develop better commercial varieties.The sudden suspension of England's biggest environmental scheme, the Sustainable Farming Incentive, earlier this year was met with horror and disbelief by farmers and environmentalists alike - we preview a special documentary which charts the transition of agricultural policy from the old EU farm subsidy system and the Common Agricultural Policy to the new 'public money for public goods' approach that we have in England today. Presenter = Caz Graham Producer = Rebecca Rooney

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/

AP correspondent Haya Panjwani reports on the phasing out of artificial dyes in the US food supply.

Send us a textOn this episode we speak with Dr. Jesse Goodman about the spread of the H5N1 virus.  We will discuss what a virus is, how viruses migrate from animal populations to humans and assess the chances for a new pandemic.Jesse L. Goodman, M.D., M.P.H., directs Georgetown COMPASS, which focuses on science based policy and research to address unmet public health needs with an emphasis on product development and access and antimicrobial resistance and stewardship. Until February 2014 he served as the Chief Scientist of the US Food and Drug Administration (FDA), a position he assumed in 2009 along with Deputy Commissioner for Science and Public Health (2009-2012). As FDA's Chief Scientist he had broad responsibility for strategic leadership of crosscutting scientific and public health efforts, including developing and implementing FDA's Strategic Plan for Regulatory Science and FDA's public health preparedness and response and medical countermeasures efforts.A graduate of Harvard, Dr. Goodman received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training in Medicine, Infectious Diseases and Oncology at the Hospital of the University of Pennsylvania and at the University of California in Los Angeles (UCLA), where he was also Chief Medical Resident. https:/natureandsciencepodcast.com

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/

‘Friendship benches', a mental health intervention first piloted in Zimbabwe, are now being handed over to the government in that country. It is hoped that this will allow the program to become more widespread.Also on the show, a new device can convert brain signals to speach in nearly real time for those who have been paralysed, a medicine for rare genetic disorders could also make human blood deadly to mosquitos, and the US Food and Drug administration has approved a new first-in-class antibiotic for uncomplicated urinary tract infections.Presenter: Claudia Hammond Producer: Margaret Sessa-Hawkins and Katie Tomsett

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/

Prothrombin complex concentrates (PCCs) are frequently used off label for the management of factor Xa inhibitor-associated major bleeding. In 2018, accelerated approval was granted for andexanet alfa, a specific factor Xa inhibitor reversal agent, for reversal of apixaban and rivaroxaban in the setting of life-threatening or uncontrolled bleeding. Following accelerated approval, some clinical practice guidelines were updated to include recommendations for andexanet alfa preferentially over PCCs for reversal of life-threatening or uncontrolled bleeding due to rivaroxaban or apixaban. Other guidelines stated no preference of andexanet alfa over PCC. In 2020, Vizient convened an expert panel to critically appraise the literature and provide consensus-based, expert opinions on the utilization of pharmacological reversal agents for factor Xa-related major bleeding. Since then, the body of literature evaluating these agents has expanded to include a randomized controlled trial, ANNEXa-I, the results of which were submitted to the US Food and Drug Administration to convert the approval of andexanet alfa from accelerated to full approval. Dr. Lisa Baumann-Kreuziger, Associate Professor of Hematology and Oncology, Medical College of Wisconsin and medical director of the Antithrombotic Therapy Management Program at Froedtert Health discusses the current status of management of factor Xa inhibitor-associated major bleeding with Dr. Kerry Schwarz, Senior Clinical Manager of Evidence-Based Medicine and Outcomes with the Vizient Center for Pharmacy Practice Excellence, and your program host.   Guest speakers:  Liza Baumann-Kreuziger, MD, MS Investigator, Blood Research Institute, Versiti  Associate Professor of Hematology and Oncology, Medical College of Wisconsin Medical Director, Antithrombotic Therapy Management Program at Froedtert Health   Host:  Kerry Schwarz, Pharm.D, MPH Senior Clinical Manager of Evidence-Based Medicine and Outcomes  Vizient Center for Pharmacy Practice Excellence   Show Notes: [02:25-04:26] The current state of hemostatic management in the setting of factor Xa inhibitor-related major bleeding [04:27- 05:35] Limitations of available evidence making clinical practice and formulary decision making so challenging [05:35 – 10:52] Publication of the first randomized controlled trial, ANNEXa-I, comparing andexanet alfa to usual care [10:52-14:49] Meeting of the FDA advisory committee and subsequent complete response letter [14:50-16:45] How we can approach clinical management of patients and formulary decision-making in the current state   Subscribe Today! Apple Podcasts Amazon Podcasts Spotify Android RSS Feed

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/

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Episode 10 highlights examples of how patient advocacy groups influenced pharmaceutical decisions at the US Food and Drug Administration (FDA). In a conversation with health policy researcher, author and activist, Sharon Batt PhD, we explore regulatory decisions on Relyvrio (AMX0035), Avastin (bevacizumab), and Addyi (flibanserin) within the context of our latest report “What Needs to Change at the FDA?Protecting and Advancing Public Health.”Pharmanipulation is produced by PharmedOut, a project at Georgetown University Medical Center that advances evidence-based prescribing. Additional Resources Full Report “What Needs to Change at the FDA? Protecting and Advancing Public Health”: https://georgetown.box.com/s/n87us836fpmdhtcvdaqopyobfwx7bymx  Webinar on “What Needs to Change at the FDA?”: https://www.youtube.com/watch?v=4g9br3wZW-k&t=11s  Article on “How some drug companies manipulate patient advocates” by Judith Garber: https://lowninstitute.org/how-some-drug-companies-manipulate-patient-advocates/  

The initial months of the Trump administration have been marked by a flurry of executive orders and significant activity by the Department of Government Efficiency (DOGE). The US Food and Drug Administration is a key target of these efforts. In this episode of Connected With Latham, Washington, D.C. partners Chris Schott and Ben Haas and associate Danny Machado explore how FDA may be affected, particularly as it relates to novel tobacco and nicotine products, which can be a bellwether for approval and enforcement trends more generally.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

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/

The US Food and Drug Administration (FDA) issued new draft regulatory guidance for pulse oximeters related to skin pigment. The guidance is a step forward but it may have unintended consequences. Authors Michael Lipnick, MD, and Philip Bicker, MD, PhD, professors of anesthesia at University of California, San Francisco, discuss this and more with JAMA Executive Editor Gregory Curfman, MD. Related Content: Pulse Oximetry and Skin Pigmentation—New Guidance From the FDA Adherence to FDA Guidance on Pulse Oximetry Testing Among Diverse Individuals, 1996-2024 Addressing Racial and Ethnic Bias in Pulse Oximeters—A Wicked Problem Evaluating the Accuracy of Pulse Oximetry in Children According to Race

In a new show from Macrodose:The Curve, James Meadway and Grace Blakeley break down the week's biggest economic stories and what they mean for all of us.In this excerpt, they discuss the recent German federal election results and how Die Linke managed to turn things around (1:08).In the full episode, James and Grace look at how US food imports are at a record level, and some recommended reading on the global debt crisis.FULL SHOW: ⁠⁠Patreon.com/macrodose

Palestinian civilians are expected to be allowed to return to northern Gaza if a ceasefire and hostage exchange deal is finalized. At her confirmation hearing today, President-elect Donald Trump's pick for attorney general said she wouldn't enforce an “enemies list.” Firefighters in California face several more critical hours of dangerous winds fuelling wildfires. The US Food and Drug Administration is cracking down on a popular ingredient. Plus, America's largest fuel pipeline is temporarily shut off. Learn more about your ad choices. Visit podcastchoices.com/adchoices

We'll tell you why power to more than 20,000 households in Southern California could be intentionally shut off. Pete Hegseth, President-elect Donald Trump's pick for defense secretary, is walking back some previous statements during his confirmation hearing. We have the latest on a ceasefire and hostage exchange deal between Israel and Hamas. The US Food and Drug Administration wants packaged food labels to have more information. Plus, a country known for high temperatures is hitting record lows. Learn more about your ad choices. Visit podcastchoices.com/adchoices

President-elect Donald Trump named billionaire Scott Bessent as his pick to serve as the next secretary of the Department of the Treasury. Plus, Trump announced his picks for critical remaining public health roles in his incoming administration -- Dr. Janette Nesheiwat as US surgeon general; Dr. Marty Makary as US Food and Drug Administration commissioner; and Dr. Dave Weldon, a former congressman from Florida, as director of the US Centers for Disease Control and Prevention. Learn more about your ad choices. Visit podcastchoices.com/adchoices