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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

xWave Technologies, an Irish Healthtech start-up, today announced that it has won its first competitive UK tender covering 8 NHS Trusts in the Northeast of England. xWave will provide its proprietary clinical decision support (CDS) software to GPs across the region serving over 3 million patients, helping them access the right diagnostic test for patients at the right time. To fund ambitious expansion plans, xWave, headquartered at NovaUCD in Dublin, has also launched a crowdfunding campaign on the Spark Crowdfunding platform with €725K already committed by existing shareholders. Mitchell O'Gorman, CEO, xWave Technologies, said, "As providers of CDS technology, we empower clinicians to select the most appropriate imaging tests for their patients. This is in keeping with the company mission of 'best test first' for patients. This contract win is a validation of the value that xWave brings in helping reduce patient waiting lists and easing pressures on health services. We want to bring this important solution to new markets with this funding round on the Spark Crowdfunding platform, while further developing our AI capabilities in this area." He added, "In total, this year alone, our annual recurring revenue has reached €500k. This is why we're fund raising. We have the right technology, and we can scale very rapidly to capture our share of what is a massive worldwide market." xWave CDS leverages clinical decision support technology to significantly help referral and vetting processing for radiology clinicians to help patients get the most appropriate scan first, and fast. Timely and accurate diagnosis of patients can give the best health outcomes possible. In radiology the US FDA has estimated that up to 50% of advanced radiology scans may be unnecessary and not of benefit to the patients that they are performed on. This can result in long waiting lists and poor patient outcomes, including delayed diagnoses, missed diagnoses and unnecessary radiation exposure. It also costs health systems substantial sums of money spent annually on unnecessary radiology scans. xWave CDS addresses these issues by ensuring that patients are referred for the best test for them at the right time. Chris Burge, CEO, Spark Crowdfunding, said, "This is another great investment opportunity for anyone willing to invest from €100 upwards. There are attractive tax breaks as well, providing an ideal chance to start building a personal share portfolio or nest egg." Investments made into the xWave opportunity attract EIIS relief. xWave has previously raised €2.8 million in funding including €250k from Enterprise Ireland.

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

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

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

Introduction: Pink Sheet reporter and editor discuss the FDA's latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion (:36), as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned (13:32). More On These Topics From The Pink Sheet Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie: https://pink.citeline.com/PS155225/Celebs-Bring-Extra-Scrutiny-To-Advertisements-US-FDA-Tells-AbbVie Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn: https://pink.citeline.com/PS155205/Lilly-Challenges-US-FDA-Classification-Of-Obesity-Drug-Retatrutide-Citing-Chevron-Overturn Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges: https://pink.citeline.com/PS155211/Life-After-Chevron-US-Supreme-Court-Ruling-Cited-In-FDA-Exclusivity-Decision-Challenges US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide: https://pink.citeline.com/PS155226/US-FDA-Biologics-Designation-As-Price-Protection-Lilly-Charts-New-Course-With-Retatrutide

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

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

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

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

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

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

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

The McCullough Report with Dr. Peter McCullough – The American Out Loud News platform congratulates Dr. Bowden, her co-plaintiffs Dr. Robert Apter, Dr. Paul Marik, and Boyden, Gray & Associates, the DC-based law firm, who fought against fraudulent, public deception by the US FDA. In our first interview, let's listen to the reaction to this stunning development from lead Texas plaintiff Dr. Mary Talley Bowden, who is an authority on...