Podcasts about pink sheets

When Congress returns from spring break next week, its first order of business will be writing a budget reconciliation bill that's expected to cut taxes but also make deep cuts to Medicaid. But at least some Republicans are concerned about cutting a program that aids so many of their constituents. Also this week, the Supreme Court heard a case that could threaten the availability of no-cost preventive care under the Affordable Care Act. Alice Miranda Ollstein of Politico, Tami Luhby of CNN, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News' Julie Rovner to discuss these breaking stories and more. Also this week, Rovner interviews KFF Health News' Rae Ellen Bichell about her story on how care for transgender minors is changing in Colorado. Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: MedPage Today's “Medical Journals Get Letters From DOJ,” by Kristina Fiore. Alice Miranda Ollstein: The New York Times' “A Scientist Is Paid to Study Maple Syrup. He's Also Paid to Promote it,” by Will Evans, Ellen Gabler, and Anjali Tsui. Sarah Karlin-Smith: The Tampa Bay Times' “Countering DeSantis, $10M Hope Florida Donation Came From Medicaid, Draft Shows,” by Alexandra Glorioso and Lawrence Mower. Tami Luhby: Stat's “In Ireland, a Global Hub for the Pharma Industry, Trump Tariffs Are a Source of Deep Worry,” by Andrew Joseph. Hosted on Acast. See acast.com/privacy for more information.

After the 2002 Bali bombings killed 202 people, 88 of them Australian, Dr. Pamela Craig was sent into the centre of the crisis. As a forensic odontologist, her job was to help identify the victims, many burned beyond recognition. In this episode, Pam takes host Liz Porter inside the high-stakes world of disaster victim identification, from the Bali mortuary to other mass casualty scenes. Hear how dental forensics brings closure to families, and what it takes to face this kind of devastation again and again. This episode contains graphic descriptions of mass casualty events, and infant death. If you or anyone you know needs help, contact Lifeline on 13 11 14. See omnystudio.com/listener for privacy information.

The Department of Health and Human Services underwent an unprecedented purge this week, as thousands of employees from the National Institutes of Health, the FDA, the Centers for Disease Control and Prevention, and other agencies were fired, placed on administrative leave, or offered transfers to far-flung Indian Health Service facilities. Altogether, the layoffs mean the federal government, in a single day, shed hundreds if not thousands of combined years of health and science expertise. Lauren Weber of The Washington Post, Rachel Cohrs Zhang of Bloomberg News, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News' Julie Rovner to discuss this enormous breaking story and more. Also this week, Rovner interviews KFF Health News' Julie Appleby, who reported and wrote the latest “Bill of the Month” feature about a short-term health plan and a very expensive colonoscopy. Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: Stat's “Uber for Nursing Is Here — And It's Not Good for Patients or Nurses,” by Katie J. Wells and Funda Ustek Spilda. Sarah Karlin-Smith: MSNBC's “Florida Considers Easing Child Labor Laws After Pushing Out Immigrants,” by Ja'han Jones. Lauren Weber: The Atlantic's “Miscarriage and Motherhood,” by Ashley Parker. Rachel Cohrs Zhang: The Wall Street Journal's “FDA Punts on Major Covid-19 Vaccine Decision After Ouster of Top Official,” by Liz Essley White. Hosted on Acast. See acast.com/privacy for more information.

It's the Trump administration vs. the federal courts, as the Department of Government Efficiency continues to try to cancel federal contracts and programs and fire workers — while federal judges continue to label those efforts illegal. In the haste to cut things, jobs and programs are being eliminated even if they align with the new administration's goal to “Make America Healthy Again.” Rachel Roubein of The Washington Post, Sarah Karlin-Smith of the Pink Sheet, and Jessie Hellmann of CQ Roll Call join KFF Health News' Julie Rovner to discuss these stories and more. Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: The Washington Post's “The Free-Living Bureaucrat,” by Michael Lewis. Rachel Roubein: The Washington Post's “Her Research Grant Mentioned ‘Hesitancy.' Now Her Funding Is Gone.” by Carolyn Y. Johnson. Sarah Karlin-Smith: KFF Health News' “Scientists Say NIH Officials Told Them To Scrub mRNA References on Grants,” by Arthur Allen. Jessie Hellmann: Stat's “NIH Cancels Funding for a Landmark Diabetes Study at a Time of Focus on Chronic Disease,” by Elaine Chen. Hosted on Acast. See acast.com/privacy for more information.

President Donald Trump has said he won't support major cuts to the Medicaid health insurance program for people with low incomes, but he has endorsed a House budget plan that calls for major cuts, leaving the program's future in doubt. Meanwhile, thousands of workers at the Department of Health and Human Services were fired over the holiday weekend, from the National Institutes of Health, the FDA, and the Centers for Disease Control and Prevention, with possibly more cuts to come.Alice Miranda Ollstein of Politico, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico Magazine, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News' Julie Rovner to discuss these stories and more.Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: KFF Health News' “Pain Clinics Made Millions From ‘Unnecessary' Injections Into ‘Human Pin Cushions'” by Brett Kelman. Alice Miranda Ollstein: The Washington Post's “U.S. Reverses Plan To Shut Down Free Covid Test Program,” by Lena H. Sun and Carolyn Y. Johnson. Joanne Kenen: Wired's “The Ketamine-Fueled ‘Psychedelic Slumber Parties' That Get Tech Execs Back on Track,” by Elana Klein. Sarah Karlin-Smith: Fortune's “The Dietary Supplements You Think Are Improving Your Health May Be Damaging Your Liver, Research Warns,” by Lindsey Leake. Hosted on Acast. See acast.com/privacy for more information.

President Donald Trump's choice to lead the vast Department of Health and Human Services, Robert F. Kennedy Jr., faced sharp questioning from senators this week, particularly over his history of vaccine denialism. Meanwhile, the Trump administration's second week has been even more disruptive than its first, with an on-again, off-again funding freeze that left many around the country scrambling to understand what was going on. Sandhya Raman of CQ Roll Call and Sarah Karlin-Smith of the Pink Sheet join KFF Health News' Julie Rovner to discuss these stories and more. Also this week, Rovner interviews Nicholas Bagley, a University of Michigan law professor, who explains how the federal regulatory system is supposed to operate to make health policy.Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:Julie Rovner: 404 Media's “Medical Device Company Tells Hospitals They're No Longer Allowed to Fix Machine That Costs Six Figures,” by Jason Koebler.Sandhya Raman: ProPublica's “Dozens of People Died in Arizona Sober Living Homes as State Officials Fumbled Medicaid Fraud Response,” by Mary Hudetz and Hannah Bassett.Sarah Karlin-Smith: CBS News' “Wind-Blown Bird Poop May Help Transmit Bird Flu, Minnesota's Infectious Disease Expert Warns,” by Mackenzie Lofgren. Hosted on Acast. See acast.com/privacy for more information.

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/

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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/

President-elect Donald Trump has made his choices to fill some top jobs at the Department of Health and Human Services. They include controversial figures who were vocal critics of the Biden administration's handling of the covid pandemic and have proposed sweeping changes to the agencies they would lead. Meanwhile, the Supreme Court heard its first two health-related cases of the term, challenging a Tennessee law barring transgender medical care for minors and, separately, challenging the FDA's handling of e-cigarettes. Joanne Kenen of the Johns Hopkins University and Politico, Shefali Luthra of The 19th, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News' Julie Rovner to discuss these stories and more. Also this week, Rovner interviews KFF Health News' Bram Sable-Smith, who reported and wrote the latest KFF Health News-Washington Post Well+Being “Bill of the Month” feature, about an emergency room bill for a visit that didn't get past the waiting room. Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too: Julie Rovner: The New Yorker's “The Texas OB-GYN Exodus,” by Stephania Taladrid. Shefali Luthra: The Washington Post's “Post Reports” podcast's “A Trans Teen Takes Her Case to the Supreme Court,” by Casey Parks, Emma Talkoff, Ariel Plotnick, and Bishop Sand. Joanne Kenen: ProPublica's “For Decades, Calls for Reform to Idaho's Troubled Coroner System Have Gone Unanswered,” by Audrey Dutton. Sarah Karlin-Smith: Stat's “What YouTube Health Is Doing To Combat Misinformation and Promote Evidence-Based Content,” by Nicholas St. Fleur. Hosted on Acast. See acast.com/privacy for more information.

Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization (:30), as well as the changes Dr. Mehmet Oz, President-elect Donald Trump's controversial selection of to run the US Centers for Medicare and Medicaid Services, could impose if confirmed (22:35). #pharma #business More On These Topics From The Pink Sheet Trump's US FDA User Fee Cycle: ‘An Underappreciated Threat': https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/trumps-us-fda-user-fee-cycle-an-underappreciated-threat-GVVSHUIRXBDOHDLWQXHSLC2U4A/ Medicare Price Negotiation Under CMS Chief Oz May See Early 2025 Test: https://insights.citeline.com/pink-sheet/agency-leadership/medicare-price-negotiation-under-cms-chief-oz-may-see-early-2025-test-UOROAUBSE5CWJC65XK6Q5I37SE/ CMS Administrator Nominee Oz Is ‘Communicator' In Sync With RFK's Healthy Living Focus: https://insights.citeline.com/pink-sheet/agency-leadership/cms-administrator-nominee-oz-is-communicator-in-sync-with-rfks-healthy-living-focus-CHOJUI4DWVCWRFQMBZXCQYAGB4/

Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump's potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS (:37), whether lasting changes are coming to the FDA (13:00), and Commissioner Robert Califf's request that industry help preserve the agency status quo (18:18). More On These Topics From The Pink Sheet Speed Of Novel Approvals In Jeopardy As RFK Jr. Lands US HHS Secretary Nod: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/speed-of-novel-approvals-in-jeopardy-as-rfk-jr-lands-us-hhs-secretary-nod-PBKQI3K2XBHK5F53ZBHRD6VX2Q/ Three Ways Trump Could Disrupt The US FDA: https://insights.citeline.com/pink-sheet/legislation/elections/three-ways-trump-could-disrupt-the-us-fda-5KPABNKMKVBWNMFBQGU6H6ZWKU/ Industry Support Key To US FDA's Prospects Under Trump, Califf Says: https://insights.citeline.com/pink-sheet/legislation/elections/industry-support-key-to-us-fdas-prospects-under-trump-califf-says-73IBZRFLQVEERACL64N74IK5GM/ Republican Sweep Creates Smoother Path For Biopharma Policy Priorities: https://insights.citeline.com/pink-sheet/legislation/elections/republican-sweep-creates-smoother-path-for-biopharma-policy-priorities-R2UH6ULEN5DKHOOV3KGYSMSETE/ Anticipation And Trepidation About Trump's Election Rise: https://insights.citeline.com/pink-sheet/legislation/elections/anticipation-and-trepidation-about-trumps-election-rise-YTCHNKQW4VA3PPY3GBF3BQLAOQ/

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/

With Election Day rapidly approaching, abortion is gaining traction as a voting issue, according to public opinion polls. Meanwhile, states with abortion bans are reviving the lawsuit — dismissed by the Supreme Court on a technicality this year — that could roll back the availability of the abortion pill mifepristone. Sarah Karlin-Smith of the Pink Sheet, Rachel Cohrs Zhang of Stat, and Victoria Knight of Axios join KFF Health News' Julie Rovner to discuss these stories and more. Also this week, Rovner interviews Tricia Neuman, senior vice president of KFF and executive director of its Program on Medicare Policy, about Medicare open enrollment and the changes to the federal program for 2025. Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: NBC News' “Crisis Pregnancy Center's Forms Give Rare Insight Into Anti-Abortion Practices,” by Abigail Brooks. Sarah Karlin-Smith: Vanity Fair's “Inside the Bungled Bird Flu Response, Where Profits Collide With Public Health,” by Katherine Eban. Rachel Cohrs Zhang: The Atlantic's “The Perverse Consequences of Tuition-Free Medical School,” by Rose Horowitch. Victoria Knight: NPR's “Why Catholic Bishops Are Donating Less To Oppose Abortion Rights Measures This Year,” by Rosemary Westwood and Jack Jenkins. Hosted on Acast. See acast.com/privacy for more information.

My guest on the show today is Paul Cerro, CIO of Cedar Grove Capital Management. Paul was recently on Andrew Walker's Yet Another Value Podcast having a conversation about Red Cat Holdings $RCAT - a company we actually interviewed, now way back in the day, in 2019 when they were still on the Pink Sheets. He did an awesome job on the show, and invited him on today to learn more about his investing philosophy, strategy and why it's not necessarily bottom fishing when looking at MicroCaps. For more information about Paul Cerro and Cedar Grove Capital Management, please visit: https://www.cedargrovecm.com/ We're excited to announce that we'll be partnering up with MicroCapClub for our full slate of investor conferences in 2025. Ian Cassel and his team at MicroCapClub have not only built and fostered the best community of MicroCap investors, but it's arguably one of the best investing communities, period. We couldn't be more thrilled to leverage our expertise in curating and hosting large scale MicroCap conferences, and teaming up with MicroCapClub to put together world class conferences for the MicroCap community. First up, the Planet MicroCap Showcase: VEGAS in partnership with MicroCapClub will be held on April 22-24, 2025 at the Paris Hotel & Casino in Las Vegas. Registration is now live, please visit: https://www.meetmax.com/sched/event_113149/conference_home.html. See you in Vegas! Planet MicroCap Podcast is on YouTube! All archived episodes and each new episode will be posted on the Planet MicroCap YouTube channel. I've provided the link in the description if you'd like to subscribe. You'll also get the chance to watch all our Video Interviews with management teams, educational panels from the conference, as well as expert commentary from some familiar guests on the podcast. Subscribe here: http://bit.ly/1Q5Yfym Click here to rate and review the Planet MicroCap Podcast The Planet MicroCap Podcast is brought to you by SNN Incorporated, The Official MicroCap News Source, and the Planet MicroCap Review Magazine, the leading magazine in the MicroCap market. You can Follow the Planet MicroCap Podcast on Twitter @BobbyKKraft

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/

Pink Sheet reporters and editors discuss Pfizer's abrupt decision to withdraw Oxbryta (:32), the US FDA's Oncologic Drugs Advisory Committee bringing sponsors of approved products back to discuss labeling changes while competitors are pending (10:46), and the new CEO of a generic industry trade association (27:34). More On These Topics From The Pink Sheet Pfizer Withdraws Oxbryta, But Overall Market Impact May Be Limited: https://pink.citeline.com/PS155302/Pfizer-Withdraws-Oxbryta-But-Overall-Market-Impact-May-Be-Limited EMA Discusses Fatal Events That Prompted Pfizer To Pull Oxbryta From Global Markets: https://pink.citeline.com/PS155296/EMA-Discusses-Fatal-Events-That-Prompted-Pfizer-To-Pull-Oxbryta-From-Global-Markets New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming: https://pink.citeline.com/PS155285/New-US-FDA-Adcomm-Trend--Approved-Cancer-Meds-Get-Another-Look-When-Competitors-Coming All Comers No More? US FDA AdComm Supports PD-L1 Threshold In Esophageal, Gastric Cancer: https://pink.citeline.com/PS155300/All-Comers-No-More-US-FDA-AdComm-Supports-PDL1-Threshold-In-Esophageal-Gastric-Cancer Pazdur Calls For 'Kumbaya' To Standardize ImmunoOncology Biomarkers: https://pink.citeline.com/PS155298/Pazdur-Calls-For-Kumbaya-To-Standardize-ImmunoOncology-Biomarkers New AAM CEO Looking To ‘Force Multiply' For US Generics Industry: https://pink.citeline.com/PS155294/New-AAM-CEO-Looking-To-Force-Multiply-For-US-Generics-Industry

Pink Sheet reporter and editors discuss the potential fallout if the US FDA's rare pediatric disease priority review voucher program is allowed to sunset on 1 October (:30), as well as an upcoming agency advisory committee meeting on potentially banning compounding of the now withdrawn pre-term birth prevention drug Makena (18:39). More On These Topics From The Pink Sheet US FDA's Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization: https://pink.citeline.com/PS155196/US-FDAs-Rare-Pediatric-Voucher-Program-Faces-Tight-Deadline-For-Reauthorization Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal: https://pink.citeline.com/PS155197/Ipsen-Outpaces-Market-With-Lucrative-Priority-Review-Voucher-Deal

Pink Sheet reporter and editors discuss new developments in the FDA's plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development. More On These Topics From The Pink Sheet Artificial Intelligence: CDER's New Council Takes Charge Of Oversight, Coordination: https://pink.citeline.com/PS155173/Artificial-Intelligence-CDERs-New-Council-Takes-Charge-Of-Oversight-Coordination AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role: https://pink.citeline.com/PS155156/AI-In-Drug-Development-Regulatory-Clarity-Needed-On-Inspections-Human-Role

Pink Sheet reporter and editors discuss the take-aways from the landmark first Medicare negotiated drug prices and what additional information remains outstanding. More On These Topics From The Pink Sheet Medicare Negotiation Announcement: Discounts From List Price Up To 79%, But Net Savings Unclear: https://pink.citeline.com/PS155128/Medicare-Negotiation-Announcement-Discounts-From-List-Price-Up-To-79-But-Net-Savings-Unclear Medicare Unveils Negotiated Prices, But Near-Term Opportunity To Learn From Process Is Limited: https://pink.citeline.com/PS155129/Medicare-Unveils-Negotiated-Prices-But-NearTerm-Opportunity-To-Learn-From-Process-Is-Limited Round 1 Of US Drug Price Negotiations Suggests Medicare Can Beat Original Part D System: https://pink.citeline.com/PS155130/Round-1-Of-US-Drug-Price-Negotiations-Suggests-Medicare-Can-Beat-Original-Part-D-System The Next 340B Battle: Discount Duplication With Medicare Negotiated Prices: https://pink.citeline.com/PS155043/The-Next-340B-Battle-Discount-Duplication-With-Medicare-Negotiated-Prices

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams' views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03). More On These Topics From The Pink Sheet ‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity: https://pink.citeline.com/PS155063/You-Shall-Not-Pass-Former-Surgeon-General-On-Why-US-Government-Should-Push-Trial-Diversity Gaps Found In Most Pharma Trial Diversity Policies: https://pink.citeline.com/PS155086/Gaps-Found-In-Most-Pharma-Trial-Diversity-Policies Zevra's Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment: https://pink.citeline.com/PS155091/Zevras-Arimoclomol-Use-With-Standard-Of-Care-Complicates-US-FDA-Adcomm-Efficacy-Assessment Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel: https://pink.citeline.com/PS155100/Back-To-White-Oak-US-FDA-Adcomms-Go-Fully-InPerson-Starting-With-Antimicrobials-Panel

Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS' Opdivo along with AstraZeneca's Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14). More On These Topics From The Pink Sheet Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval BMS's Opdivo May Be Next Casualty Of US FDA's Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation

The elevation of Vice President Kamala Harris to the top of the presumed Democratic presidential ticket is newly energizing the debate over abortion, while former President Donald Trump attempts to distance himself from more sweeping proposals in the “Project 2025” GOP blueprint put together by his former administration officials and the conservative Heritage Foundation. Lauren Weber of The Washington Post, Alice Miranda Ollstein of Politico, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News' Julie Rovner to discuss these stories and more. Also this week, Rovner interviews KFF Health News' Elisabeth Rosenthal, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” about a preauthorized surgery that generated a six-figure bill. Plus, for “extra credit” the panelists suggest health policy stories they read this week they think you should read, too: Julie Rovner: The Washington Post's “Online Portals Deliver Scary Health News Before Doctors Can Weigh In,” by Fenit Nirappil. Alice Miranda Ollstein: ProPublica's “A Lab Test That Experts Liken to a Witch Trial Is Helping Send Women to Prison for Murder,” by Duaa Eldeib. Lauren Weber: The Tributary's “Testimony: Florida Wrongly Cut People From Medicaid Due to ‘Computer Error,' Bad Data,” by Charlie McGee. Sarah Karlin-Smith: KFF Health News' “Why Many Nonprofit (Wink, Wink) Hospitals Are Rolling in Money,” by Elisabeth Rosenthal; and The Hollywood Reporter's “New York's Largest Hospital System Is Setting Its Sights on the Entertainment Business,” by Alex Weprin. Hosted on Acast. See acast.com/privacy for more information.

Editors from the Pink Sheet and Medtech Insight discuss the retirement of Jeff Shuren (:35), PBM executives again appearing unscathed after another Capitol Hill appearance (10:12), and the growing push to ensure the FDA's rare pediatric disease priority review voucher program is renewed (20:41). More On These Topics From The Pink Sheet Shuren Steps Down As US FDA Device Center Director: https://pink.citeline.com/PS155031/Shuren-Steps-Down-As-US-FDA-Device-Center-Director PBM Execs Stay On Message Amid Growing US Congressional Frustration At Hearing: https://pink.citeline.com/PS155030/PBM-Execs-Stay-On-Message-Amid-Growing-US-Congressional-Frustration-At-Hearing FDA Leadership Changes Tune On Pediatric Priority Review Voucher Benefit: https://pink.citeline.com/PS155019/FDA-Leadership-Changes-Tune-On-Pediatric-Priority-Review-Voucher-Benefit

Pink Sheet reporter and editors discuss the impact of a US and EU drug approvals analysis that found the US FDA still clears many novel products first, including most new cell and gene therapies and cancer treatments. More On This Topics From The Pink Sheet Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals: https://pink.citeline.com/PS154948/Pharma-Looks-To-America-First-US-FDA-Holds-Overwhelming-Lead-Over-EMA-In-Novel-Approvals Getting To Global Is A Hurdle For Cell And Gene Therapies: https://pink.citeline.com/PS154953/Getting-To-Global-Is-A-Hurdle-For-Cell-And-Gene-Therapies New Oncologics Overwhelmingly Approved In US Before EU: https://pink.citeline.com/PS154952/New-Oncologics-Overwhelmingly-Approved-In-US-Before-EU Approval Geography: Novel Agent Landscape Across US And EU: https://pink.citeline.com/PS154950/Approval-Geography-Novel-Agent-Landscape-Across-US-And-EU US FDA Offers Faster Route To Market Than EMA: Details On All 108 Approvals: https://pink.citeline.com/PS154951/US-FDA-Offers-Faster-Route-To-Market-Than-EMA-Details-On-All-108-Approvals

After an assassination attempt last weekend sent former President Donald Trump to the hospital with minor injuries, the Republican National Convention went off with little mention of health care issues. And Trump's newly nominated vice presidential pick, Sen. J.D. Vance of Ohio, has barely staked out a record on health during his 18 months in office — aside from being strongly opposed to abortion. Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Joanne Kenen of Johns Hopkins University and Politico Magazine join KFF Health News' Julie Rovner to discuss these stories and more. Also this week, Rovner interviews KFF Health News' Renuka Rayasam, who wrote June's installment of KFF Health News-NPR “Bill of the Month,” about a patient who walked into what he thought was an urgent care center and walked out with an emergency room bill. Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: Time magazine's “‘We're Living in a Nightmare:' Inside the Health Crisis of a Texas Bitcoin Town,” by Andrew R Chow.Joanne Kenen: The Washington Post's “A Mom Struggles To Feed Her Kids After GOP States Reject Federal Funds,” by Annie Gowen.Alice Miranda Ollstein: ProPublica's “Texas Sends Millions to Crisis Pregnancy Centers. It's Meant To Help Needy Families, But No One Knows if It Works,” by Cassandra Jaramillo, Jeremy Kohler, and Sophie Chou, ProPublica, and Jessica Kegu, CBS News.Sarah Karlin-Smith: The New York Times' “Promised Cures, Tainted Cells: How Cord Blood Banks Mislead Patients,” by Sarah Kliff and Azeen Ghorayshi. Hosted on Acast. See acast.com/privacy for more information.

Darius Foroux, author of the upcoming book 'The Stoic Path to Wealth,' joined the podcast to discuss his, well, stoic approach to investing. This podcast episode was recorded on Tuesday, June 25, 2024 and was made available to premium subscribers the following day -- without ads or announcements. For more information on premium subscriptions, visit our Substack. Content Highlights How interest in philosophy rekindled his interest in investing after the great financial crisis (1:32); A brief introduction to stoicism, a 2,300 year-old philosophy that is distinct from cynicism (4:08); How to apply this to investing (6:14); Isn't investing in indexes just the best way to go? (12:38); The '90/10' portfolio allocation: 90% in the S&P 500, 10% in individual stocks (17:24); The Dutch Stripe, trades in Amsterdam and on Pink Sheets (18:06); Background on the guest (28:54); The guest's second individual stock holding. Listeners will have heard about this one (33:01); How does a stoic combat FOMO (41:41). More Information on the Guest Website: DariusForoux.com; Twitter: @DariusForoux; Instagram: @DariusForoux; YouTube: @DariusForoux. Not investment advice.

Pink Sheet reporter and editors discuss what the FDA included in its long-awaited guidance on clinical trial diversity action plans, along with what was left out (:35), as well as an upcoming guidance on the use of artificial intelligence in regulatory decision-making (27:30). More On These Topics From The Pink Sheet Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says: https://pink.citeline.com/PS154894/Diversity-Action-Plans-Should-Be-Brief-And-Waiver-Requests-Filed-Early-US-FDA-Says Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups: https://pink.citeline.com/PS154895/Diversity-Enrichment-US-FDA-Guidance-Suggests-Sponsors-May-Need-To-Overenroll-Key-Groups US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year: https://pink.citeline.com/PS154868/US-FDA-Guidance-On-Artificial-Intelligence-For-Regulatory-Decision-Making-Expected-This-Year

Guest speaker, US-based Pink Sheet senior writer Sarah Karlin-Smith, joins Brian Yang and Dexter Yan in China to discuss the recent BIO Conference, updates to the planned US BIOSECURE Act and industry preparations for its impact. Dexter also discusses China biotech's data highlights from ASCO 2024.

Pink Sheet editors discuss the US FDA's consideration of regulatory changes to promote innovative clinical trial designs (:32), an NIH proposal to require patent licensees create plans to ensure access to the commercialized product (7:29), and lawmakers longing for the days when Janet Woodcock ran the FDA's Center for Drug Evaluation and Research (15:35). More On These Topics From The Pink Sheet ‘Antiquated' Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches US FDA Looking To Modernize Clinical Trial Regulations To Spur ‘Evolution' In Research: https://pink.citeline.com/PS154721/US-FDA-Looking-To-Modernize-Clinical-Trial-Regulations-To-Spur-Evolution-In-Research NIH Drug Patent Licensees Would Develop ‘Access Plan' Under Proposal; Pricing Commitments Optional: https://pink.citeline.com/PS154744/NIH-Drug-Patent-Licensees-Would-Develop-Access-Plan-Under-Proposal-Pricing-Commitments-Optional Woodcock Nostalgia: GOP Rep. Bilirakis Wants CDER To Recapture Her Flexible Approach: https://pink.citeline.com/PS154745/Woodcock-Nostalgia-GOP-Rep-Bilirakis-Wants-CDER-To-Recapture-Her-Flexible-Approach

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee (:30), whether industry would improve clinical trial diversity with tougher enforcement of the regulation (22:26), as some have suggested, and the FDA's use of platform technology ideas for gene therapies not participating in the program (33:07). More On These Topics From The Pink Sheet As Biosecure Bill Mores Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs: https://pink.citeline.com/PS154707/As-Biosecure-Bill-Mores-Forward-Clock-Ticking-For-Industry-To-Move-Away-From-Chinese-CDMOs BIOSECURE Act Update Offers Biotech Companies Eight Years to Divest Contracts With Firms Of ‘Concern': https://pink.citeline.com/PS154692/BIOSECURE-Act-Update-Offers-Biotech-Companies-Eight-Years-to-Divest-Contracts-With-Firms-Of-Concern Senate Work On Biosecurity Issues Continues Even As House Is Current Focus Of Legislative Activity: https://pink.citeline.com/PS154688/Senate-Work-On-Biosecurity-Issues-Continues-Even-As-House-Is-Current-Focus-Of-Legislative-Activity US FDA Asked To Tighten China Risk Control By Legislators As Markup Looms: https://pink.citeline.com/PS154675/US-FDA-Asked-To-Tighten-China-Risk-Control-By-Legislators-As-Markup-Looms ‘Do It Or We're Not Going To Approve Your Drug:' Industry Reps Ask FDA For Trial Diversity Sticks: https://pink.citeline.com/PS154696/Do-It-Or-Were-Not-Going-To-Approve-Your-Drug-Industry-Reps-Ask-FDA-For-Trial-Diversity-Sticks US FDA Using Platform Ideas Outside Of Formal Designations To Speed Cell and Gene Approvals: https://pink.citeline.com/PS154702/US-FDA-Using-Platform-Ideas-Outside-Of-Formal-Designations-To-Speed-Cell-and-Gene-Approvals

In this bilingual Chinese- and English-language edition, China-based editors Brian Yang and Dexter Yan, along with guest speaker Derrick Gingery from the Pink Sheet in the US, discuss the planned US BIOSECURE Act and markup vote. Brian and Dexter also look at recent R&D updates from Chinese biopharma firms on their antibody-drug conjugate pipelines. https://scrip.citeline.com/SC150255/China-Biotech-Podcast-BIOSECURE-Markup-Biotech-Pipeline-Updates Other podcasts in the series: https://soundcloud.com/citelinesounds/sets/chinese-language-biopharma

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA's advisory committee reform effort (:32), the agency's efforts to help the clinical trial modeling and simulation industry (16:22), and the UK's MHRA plan to use artificial intelligence to assist in drug application reviews (21:05). More On These Topics From The Pink Sheet US FDA Adcomm Reform: Does Listening Session Suggest No Major Near-Term Changes?: https://pink.citeline.com/PS150167/US-FDA-Adcomm-Reform-Does-Listening-Session-Suggest-No-Major-Near-Term-Changes US FDA Wants Advice About Advisory Committees: Try Having Some?: https://pink.citeline.com/PS154644/US-FDA-Wants-Advice-About-Advisory-Committees-Try-Having-Some US FDA Developing Model Master File System To Grow Modeling, Simulation Field: https://pink.citeline.com/PS154647/US-FDA-Developing-Model-Master-File-System-To-Grow-Modeling-Simulation-Field UK's MHRA To Use AI In Regulatory Review Process & RWD Analysis: https://pink.citeline.com/PS154643/UKs-MHRA-To-Use-AI-In-Regulatory-Review-Process--RWD-Analysis

A six-week abortion ban took effect in Florida this week, dramatically restricting access to the procedure not just in the nation's third-most-populous state but across the South. Patients from states with even more restrictive bans had been flooding in since the overturn of Roe v. Wade in 2022.Meanwhile, the CEO of the health behemoth UnitedHealth Group appeared before committees in both the House and Senate, where lawmakers grilled him about the February cyberattack on subsidiary Change Healthcare and how its ramifications are being felt months later.Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Rachana Pradhan of KFF Health News join KFF Health News' Julie Rovner to discuss these stories and more.Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too.Julie Rovner: ProPublica's “A Doctor at Cigna Said Her Bosses Pressured Her To Review Patients' Cases Too Quickly. Cigna Threatened To Fire Her,” by Patrick Rucker, The Capitol Forum, and David Armstrong, ProPublica.Alice Miranda Ollstein: The Associated Press' “Dozens of Deaths Reveal Risks of Injecting Sedatives Into People Restrained by Police,” by Ryan J. Foley, Carla K. Johnson, and Shelby Lum.Sarah Karlin-Smith: The Atlantic's “America's Infectious-Disease Barometer Is Off,” by Katherine J. Wu.Rachana Pradhan: The Wall Street Journal's “Millions of American Kids Are Caregivers Now: ‘The Hardest Part Is That I'm Only 17,” by Clare Ansberry.Click here for a transcript of the episode. Hosted on Acast. See acast.com/privacy for more information.

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation (:34), upcoming guidance on accelerated approval for gene therapies (14:15), and partisan attacks on the agency from Capitol Hill (27:13). More On These Topics From The Pink Sheet Rx Advertising: Interchangeability Doesn't Mean Clinical Superiority To Other Biosimilars, FDA Says: https://pink.citeline.com/PS150143/Rx-Advertising-Interchangeability-Doesnt-Mean-Clinical-Superiority-To-Other-Biosimilars-FDA-Says US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets' Of Use Scenarios: https://pink.citeline.com/PS150140/US-FDA-Gene-Therapy-Accelerated-Approval-Guidance-Will-Describe-Buckets-Of-Use-Scenarios Partisan Politics Returns To US FDA Congressional Oversight: https://pink.citeline.com/PS150114/Partisan-Politics-Returns-To-US-FDA-Congressional-Oversight

Pink Sheet editors discuss Medicare spending projections for the Alzheimer's treatment Leqembi (:28), Janet Woodcock's new post-FDA role (12:28), and ongoing preparations for new pneumococcal vaccines that will reach the market soon (17:28). #business #pharma More On These Topics From The Pink Sheet Medicare Spending Forecast For Leqembi Reflects CMS Angst About Alzheimer's Drug Costs: https://pink.citeline.com/PS150095/Medicare-Spending-Forecast-For-Leqembi-Reflects-CMS-Angst-About-Alzheimers-Drug-Costs Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm's Length: https://pink.citeline.com/PS150111/Woodcock-Takes-On-Rare-Disease-Challenges-In-Retirement-Keeps-FDA-Industry-At-Arms-Length Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck's V116: https://pink.citeline.com/PS150029/Change-Is-Constant-For-Pneumococcal-Vaccines-US-CDC-Prepares-For-Mercks-V116

Congress this week had the chance to formally air grievances over the cascading consequences of the Change Healthcare cyberattack, and lawmakers from both major parties agreed on one culprit: consolidation in health care. Plus, about a year after states began stripping people from their Medicaid rolls, a new survey shows nearly a quarter of adults who were disenrolled are now uninsured. Jessie Hellmann of CQ Roll Call, Sarah Karlin-Smith of the Pink Sheet, and Lauren Weber of The Washington Post join KFF Health News' Mary Agnes Carey to discuss these stories and more. Also this week, KFF Health News' Julie Rovner interviews Caroline Pearson of the Peterson Health Technology Institute. Plus, for “extra credit” the panelists suggest health policy stories they read this week that they think you should read, too: Mary Agnes Carey: KFF Health News' “When Rogue Brokers Switch People's ACA Policies, Tax Surprises Can Follow,” by Julie Appleby. Jessie Hellmann: Tampa Bay Times' “Vulnerable Florida Patients Scramble After Abrupt Medicaid Termination,” by Teghan Simonton. Sarah Karlin-Smith: Stat's “Grocers Are Pushing Legislation They Claim Would Enhance Food Safety. Advocates Say It Would Gut FDA Rules,” by Nicholas Florko. Lauren Weber: The New York Times' “Chinese Company Under Congressional Scrutiny Makes Key U.S. Drugs,” by Christina Jewett. Hosted on Acast. See acast.com/privacy for more information.

Pink Sheet reporter and editors discuss Richard Pazdur's call for more diverse opinions in FDA advisory committee meeting open public hearings (:36), agency questions about the stakeholders sponsors consult to execute clinical trial diversity plans (20:52), and Stealth BioTherapeutics' application for the Barth Syndrome candidate elamipretide getting reviewed (32:23). More On These Topics From The Pink Sheet Adcomm Open Public Hearings Have Become Too Sponsor-Driven – US FDA's Pazdur: https://pink.citeline.com/PS150077/Adcomm-Open-Public-Hearings-Have-Become-Too-SponsorDriven--US-FDAs-Pazdur Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations: https://pink.citeline.com/PS150081/Clinical-Trial-Diversity-Requires-Sponsors-Work-With-An-Assortment-Of-Patient-Advocates-Community-Organizations Stealth's Elamipretide Gets US FDA Review, But Same Questions Linger: https://pink.citeline.com/PS150070/Stealths-Elamipretide-Gets-US-FDA-Review-But-Same-Questions-Linger

Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed (:32), an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees (9:08), and Japan's PMDA opening an office in Washington D.C. (16:19). More On These Topics From The Pink Sheet Amylyx's Relyvrio Withdrawal May Trigger More Public Pledges Based On Confirmatory Trial Data: https://pink.citeline.com/PS150060/Amylyxs-Relyvrio-Withdrawal-May-Trigger-More-Public-Pledges-Based-On-Confirmatory-Trial-Data US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact': https://pink.citeline.com/PS149915/US-FDA-Envisions-Advisory-Committees-For-Allergy-Asthma-Biomarkers-With-Real-Impact Breaking Barriers: Japan's PMDA To Open First Global Office, In D.C.: https://pink.citeline.com/PS150044/Breaking-Barriers-Japans-PMDA-To-Open-First-Global-Office-In-DC

The Supreme Court this week heard its first abortion case since overturning Roe v. Wade in 2022, about an appeals court ruling that would dramatically restrict the availability of the abortion pill mifepristone. But while it seems likely that this case could be dismissed on a technicality, abortion opponents have more challenges in the pipeline. Meanwhile, health issues are heating up on the campaign trail, as Republicans continue to take aim at Medicare, Medicaid, and the Affordable Care Act — all things Democrats are delighted to defend. Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Lauren Weber of The Washington Post join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews KFF Health News' Tony Leys, who wrote a KFF Health News-NPR “Bill of the Month” feature about Medicare and a very expensive air-ambulance ride. Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too: Julie Rovner: KFF Health News' “Overdosing on Chemo: A Common Gene Test Could Save Hundreds of Lives Each Year,” by Arthur Allen. Alice Miranda Ollstein: Stat's “Fetal Tissue Research Gains in Importance as Roadblocks Multiply,” by Olivia Goldhill. Sarah Karlin-Smith: The Washington Post's “The Confusing, Stressful Ordeal of Flying With a Breast Pump,” by Hannah Sampson and Ben Brasch. Lauren Weber: Stateline's “Deadly Fires From Phone, Scooter Batteries Leave Lawmakers Playing Catch-Up on Safety,” by Robbie Sequeira. Hosted on Acast. See acast.com/privacy for more information.

Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access (:34), the SCOTUS reaction to the fight against misinformation (18:28), and the FDA's Oncologic Drugs Advisory Committee going against three negative product reviews (31:23). More On These Topics From The Pink Sheet Mifepristone Supporters Highlight Voter Trust In FDA Decisions Ahead Of Supreme Court Arguments: https://pink.citeline.com/PS149998/Mifepristone-Supporters-Highlight-Voter-Trust-In-FDA-Decisions-Ahead-Of-Supreme-Court-Arguments US FDA's Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments: https://pink.citeline.com/PS149985/US-FDAs-Anti-Misinformation-Campaigns-Look-Safer-After-Supreme-Court-Oral-Arguments The Dog That Didn't Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews: https://pink.citeline.com/PS149961/The-Dog-That-Didnt-Bark-ODAC-Gives-Nod-To-Three-Products-Despite-Negative-FDA-Reviews Eye On ODAC: Former Members, FDA's Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor's Experts: https://pink.citeline.com/PS149995/Eye-On-ODAC-Former-Members-FDAs-Pazdur-Talk-PreMeeting-Mindsets-Impact-Of-Sponsors-Experts

Pink Sheet reporters and editor discuss Vanda's decision to sue the FDA over the rejection of the Hetlioz jet lag indication (:30), Mark Cuban's comments at a White House event that the federal government and others should stop doing business with the big three PBMs (11:50), and the cut in non-user fee dollars in the FY 2024 FDA appropriations bill (24:49). More On These Topics From The Pink Sheet Vanda Appeals FDA's Denial Of Hetlioz Jet Lag Application As It Is Hit With CRL For Insomnia: https://pink.citeline.com/PS149914/Vanda-Appeals-FDAs-Denial-Of-Hetlioz-Jet-Lag-Application-As-It-Is-Hit-With-CRL-For-Insomnia Mark Cuban: Pharma's Secret Weapon In The Fight Against PBMs: https://pink.citeline.com/PS149899/Mark-Cuban-Pharmas-Secret-Weapon-In-The-Fight-Against-PBMs Congress Gives US FDA Austere Budget But Seeks Boosts On Inspections, IT, And ALS Activities: https://pink.citeline.com/PS149897/Congress-Gives-US-FDA-Austere-Budget-But-Seeks-Boosts-On-Inspections-IT-And-ALS-Activities

At last, Congress is getting half of its annual spending bills across the finish line, albeit five months after the start of the fiscal year. Meanwhile, President Joe Biden delivers his annual State of the Union address, an over-the-counter birth control pill is (finally) available, and controversy erupts over new public health guidelines for covid-19 isolation. Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Sandhya Raman of CQ Roll Call join KFF Health News' Julie Rovner to discuss these issues and more. Also this week, Rovner interviews Neera Tanden, the White House domestic policy adviser, about Biden's health agenda. Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too.Julie Rovner: NPR's “How States Giving Rights to Fetuses Could Set Up a National Case on Abortion,” by Regan McCarthy.Sarah Karlin-Smith: Stat's “The War on Recovery,” by Lev Facher.Alice Miranda Ollstein: KFF Health News' “Why Even Public Health Experts Have Limited Insight Into Stopping Gun Violence in America,” by Christine Spolar.Sandhya Raman: The Journal's “‘My Son Is Not There Anymore': How Young People With Psychosis Are Falling Through the Cracks,” by Órla Ryan. Hosted on Acast. See acast.com/privacy for more information.

For the first time, a jury has convicted a parent of a school shooter of charges related to the child's crime, finding a mother in Michigan guilty of involuntary manslaughter and possibly opening a new legal avenue for gun control advocates. Meanwhile, as the Supreme Court prepares to hear a case challenging the FDA's approval of the abortion drug mifepristone, a medical publisher has retracted some of the journal studies that lower-court judges relied on in their decisions. Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Rachana Pradhan of KFF Health News join KFF Health News' Julie Rovner to discuss these issues and more. Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too.Julie Rovner: The Alabama Daily News' “Alabama Lawmakers Briefed on New ‘ALL Health' Insurance Coverage Expansion Plan,” by Alexander Willis. Alice Miranda Ollstein: Stat's “FDA Urged to Move Faster to Fix Pulse Oximeters for Darker-Skinned Patients,” by Usha Lee McFarling. Sarah Karlin-Smith: The Atlantic's “GoFundMe Is a Health-Care Utility Now,” by Elisabeth Rosenthal. Rachana Pradhan: North Carolina Health News' “Atrium Health: A Unit of ‘Local Government' Like No Other,” by Michelle Crouch and Charlotte Ledger. Hosted on Acast. See acast.com/privacy for more information.

As science skepticism pervades politics, the Supreme Court will soon consider two cases that seek to define the power of “experts.” Meanwhile, abortion opponents are laying out plans for how Donald Trump, if reelected as president, could effectively curtail abortion even in states where it remains legal.Sandhya Raman of CQ Roll Call, Joanne Kenen of Johns Hopkins University and Politico Magazine, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News' Julie Rovner to discuss these issues and more.Also this week, Rovner interviews Samantha Liss, who reported and wrote the latest KFF Health News-NPR “Bill of the Month” feature about a husband and wife who got billed for preventive care that should have been fully covered.Click here for a transcript of the episode.Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:Julie Rovner: ProPublica's “Amid Recall Crisis, Philips Agrees to Stop Selling Sleep Apnea Machines in the United States,” by Debbie Cenziper, ProPublica, and Michael D. Sallah, Pittsburgh Post-Gazette.Joanne Kenen: The New York Times' “Elmo Asked an Innocuous Question,” by Callie Holtermann.Sarah Karlin-Smith: The Texas Tribune's “Texas Attorney General Requests Transgender Youths' Patient Records From Georgia Clinic,” by Madaleine Rubin.Sandhya Raman: The AP's “Community Health Centers Serve 1 in 11 Americans. They're a Safety Net Under Stress,” by Devi Shastri. Hosted on Acast. See acast.com/privacy for more information.

With days to go until a large chunk of the federal government runs out of money needed to keep it operating, Congress is still struggling to find a compromise spending plan. Meanwhile, the Supreme Court agreed to hear — this year — a case that pits federal requirements for emergency treatment against state abortion bans. Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Tami Luhby of CNN join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews American Medical Association President Jesse Ehrenfeld about the choppy waters facing the nation's physicians in 2024.Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:Julie Rovner: CNN's “Bottled Water Contains Thousands of Nanoplastics So Small They Can Invade the Body's Cells, Study Says,” by Sandee LaMotte. Also, ScienceAlert's “It Turns Out Paper Straws Might Pose a Serious Problem Too,” by Carly Cassella. Also, The Washington Post's “How Plastic Hides in Supposedly Eco-Friendly Laundry Products,” by Michael J. Coren.Tami Luhby: KFF Health News' “Most People Dropped in Medicaid ‘Unwinding' Never Tried to Renew Coverage, Utah Finds,” by Phil Galewitz.Alice Miranda Ollstein: Stat's “Texas Taxpayers Wanted to Help the Poor Get Health Care. Instead They're Funding a Medical School at a Wealthy University,” by Rachel Cohrs.Sarah Karlin-Smith: The New York Times' “The F.D.A. Warned an Asthma Drug Could Induce Despair. Many Were Never Told,” by Christina Jewett and Benjamin Mueller. Hosted on Acast. See acast.com/privacy for more information.

Although Republicans have never united behind a replacement for the Affordable Care Act, 2024 GOP presidential front-runner Donald Trump said this week he wants to put the issue back on the national agenda. That delights Democrats, who have won at least two elections partly by defending the now-popular health law. Meanwhile, the Texas Supreme Court takes up a case brought by women who say their pregnancy complications further endangered their health due to the vagueness of Texas' near-total ban on abortions. Joanne Kenen of Johns Hopkins University and Politico Magazine, Sarah Karlin-Smith of the Pink Sheet, and Victoria Knight of Axios News join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews KFF Health News' Rachana Pradhan, who reported and wrote the latest “Bill of the Month” feature. Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too: Julie Rovner: KFF Health News' “Medicaid ‘Unwinding' Makes Other Public Assistance Harder to Get,” by Katheryn Houghton, Rachana Pradhan, and Samantha Liss. Joanne Kenen: KFF Health News' “She Once Advised the President on Aging Issues. Now, She's Battling Serious Disability and Depression,” by Judith Graham. Victoria Knight: Business Insider's “Washington's Secret Weapon Is a Beloved Gen Z Energy Drink With More Caffeine Than God,” by Lauren Vespoli. Hosted on Acast. See acast.com/privacy for more information.

A bitterly divided Congress managed to keep the federal government running for several more weeks, while House Republicans struggle — again — to choose a leader. Meanwhile, many people removed from state Medicaid rolls are not finding their way to Affordable Care Act insurance, and a major investigation by The Washington Post attributes the decline in U.S. life expectancy to more than covid-19 and opioids. Lauren Weber of The Washington Post, Victoria Knight of Axios, and Sarah Karlin-Smith of the Pink Sheet join KFF Health News chief Washington correspondent Julie Rovner to discuss these issues and more. Also this week, Rovner interviews physician-author-playwright Samuel Shem about “Our Hospital,” his new novel about the health workforce in the age of covid. Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too: Julie Rovner: The Atlantic's “Virginia Could Decide the Future of the GOP's Abortion Policy,” by Ronald Brownstein. Sarah Karlin-Smith: The Wall Street Journal's “Children Are Dying in Ill-Prepared Emergency Rooms Across America,” by Liz Essley-Whyte and Melanie Evans. Lauren Weber: ProPublica's “Philips Kept Complaints About Dangerous Breathing Machines Secret While Company Profits Soared,” by Debbie Cenziper, ProPublica; Michael D. Sallah, Michael Korsh, and Evan Robinson-Johnson, Pittsburgh Post-Gazette; and Monica Sager, Northwestern University. Victoria Knight: KFF Health News' “Feds Rein In Use of Predictive Software That Limits Care for Medicare Advantage Patients,” by Susan Jaffe. Hosted on Acast. See acast.com/privacy for more information.