Podcasts about drug evaluation

The FDA's Ban on NDT Medications: What You Need to Know Now The FDA has announced a ban will go in effect in one year on Natural Desiccated Thyroid (NDT) medications, including Armour, NP, and compounded thyroid meds. This isn't just about NDT, it could be the first move toward restricting all bioidentical hormone options. In this episode, I break down the FDA letter line-by-line, follow the money trail, and explain why NDT has been the gold standard for decades. I share what's at stake if this ban goes through, why T4-only medications fail most patients, and the critical differences between bioidentical and synthetic options. You'll hear clinical insights from my practice, where thousands have thrived on the right thyroid med combination, and you'll get clear steps for taking action, emailing the FDA, signing petitions, and protecting your right to choose the treatments that work for you. This is your health freedom alert. The decisions made now will affect your weight, energy, hormones, and quality of life for years to come. Sign this Petition: https://chng.it/RwB8mF72tY Subscribe to my Newsletter: https://health.dramie.com/newsletter Contact the FDA: Email: druginfo@fda.hhs.gov - The Division of Drug Information in the Center for Drug Evaluation and Research, specifically for questions about drugs.

Center for Drug Evaluation and Research Head George Tidmarsh will oversee the Center for Biologics Evaluation and Research on an acting basis after Vinay Prasad's abrupt departure hours after the recording of last week's episode of The Weekly. While the situation is being billed as temporary, rumors are swirling that structural changes may be afoot at the FDA with Commissioner Marty Makary looking for better drug, biologic alignment.Meanwhile, the agency has come under criticism for another recent decision—one apparently driven by CDER's Oncology Center of Excellence director Richard Pazdur: the rejection of Replimmune's advanced melanoma drug, RP1. According to reporting by multiple outlets, Pazdur opposed the consensus opinion of CBER staff to approve the drug. The research team behind Replimmune's Phase III study penned an open letter to the FDA on Friday responding to the issues outlined in the agency's complete response letter. Meanwhile, the FDA's Sarepta saga continues, highlighting “unprecedented” FDA leaks and a veritable communications disaster.On the business side of biopharma, Q2 earnings continue to unfurl, with Pfizer, Vertex, BioNTech, Merck and Moderna all reporting this past week. Merck's $3 billion savings push has claimed 6,000 jobs, contributing to a brutal July that saw the entire biopharma industry axe 7,900 employees, a 487% year-over-year increase, based on BioSpace tallies. Meanwhile, Pfizer CEO Albert Bourla confirmed he has been in direct contact with President Donald Trump to negotiate a path forward on Most Favored Nation drug pricing after the president sent letters to 17 Big Pharma companies—and posted on his Truth Social platform—asking them to comply with the policy within 60 days or face potential unspecified consequences.In other policy news, the Centers for Medicare and Medicaid Services is reportedly considering coverage of GLP-1 drugs for weight management and obesity—reviving a Biden era proposal the Trump admin scrapped earlier this year.Finally, in BioPharm Executive this week, we have a special report on the situation in China as international drugmakers swoop into the region to find new drug candidates, while other companies build their therapeutic farm systems from incubators and venture arms. And check out BioSpace's brand new Manufacturing Brief, where we bring you the latest news and analysis in the area of biopharma manufacturing, starting with a feature on how to make cell and gene therapies commercially viable.

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

Just a few weeks ago, it seemed like Sarepta had weathered a spate of bad news, after two patients died from liver injuries from its Duchenne muscular dystrophy gene therapy Elevidys. Then came news of a third patient death. Last Wednesday, the company announced a major restructuring and 500-person layoff.  Then, in just a few days time, Sarepta Therapeutics went from enjoying a notable stock bump in response to that corporate update to its lowest price in nearly 10 years as it halts shipments of Elevidys. In addition to requesting the shipment hold, the FDA revoked the company's technology platform designation and paused all clinical trials for Sarepta's limb-girdle muscular dystrophy (LGMD) gene therapy. The turmoil was set in motion by media reports that a patient who received the LGMD treatment had died—a fact the company chose not to disclose during an investor call. In other news, the FDA's Center for Drug Evaluation and Research gets a new director in biotech veteran George Tidmarsh, also an adjunct professor of pediatrics and neonatology at Stanford University's School of Medicine. Tidmarsh enters the agency at a time of mass layoffs as well as voluntary departures. Meanwhile, Replimmune and Roche suffer FDA rejections as therapies from Otsuka/Lundbeck and GSK fail to earn adcomm support, as the bar for acceptable controls and demonstrations of efficacy continue to change under FDA commissioner Marty Makary and CBER director Vinay Prasad.  Finally, Big Pharmas continue to pump billions into U.S. manufacturing, with Biogen and AstraZeneca joining the list of companies to have made such pledges, pledging $2 billion and $50 billion, respectively. These latest announcements come as President Donald Trump reiterates that pharma-specific tariffs of up to 200% could come as soon as Aug. 1. 

On June 4, 2021, the FDA approved Wegovy for the treatment of chronic obesity and overweight individuals. Dr. John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research, said, "Today's approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program. FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight." Read the full post at http://RunningAFEVER.com/413 Photo by Pavel Danilyuk: https://www.pexels.com/photo/woman-in-white-mesh-crop-top-and-pink-bra-7653700/

Last week's public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA's platform technology designation. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the events surrounding Sarepta's gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.BioCentury's analysts also assess Monday's appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA's Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656537#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys00:01 - Sponsor Message: IQVIA Biotech02:03 - Gene Therapy17:59 - Leading CDER27:00 - Venture ReportTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.George Tidmarsh, a biopharma veteran and adjunct professor at Stanford's medical school, has been appointed as the new head of the FDA's Center for Drug Evaluation and Research (CDER). His extensive industry experience will be valuable in his new government position. Data secrecy among cell and gene therapy developers is hindering progress in the field, causing fragmentation, stalling innovation, and delaying access to treatments. Meanwhile, Sarepta is facing challenges with its elevidys shipments and has lost platform designation for its technology. At the same time, Roche's phase III trial in COPD has failed, impacting the market path for astegolimab. Layoffs are happening at companies like GSK, Sail, and BioNTech. Experts are exploring new ways to overcome barriers in cell therapy production.Data secrecy among cell and gene therapy developers continues to hinder progress and access to treatments. Acadia has introduced a new team and pipeline with ambitious goals. Patients are fighting for access to Brainstorm's ALS drug after promising real-world data. Moderna's withdrawal of its flu vaccine has left combination flu/COVID-19 vaccines in limbo. In other news, Sarepta is facing challenges with its DMD gene therapy, Ultragenyx's gene therapy for Sanfilippo syndrome is rejected by the FDA, GSK's Blenrep loses an adcomm vote, and BMS' anemia drug Reblozyl fails a Phase III trial. The FDA is experiencing layoffs and employee turnover amid an overhaul. Vinay Prasad overruled reviewers on Moderna's COVID-19 shot for kids. Upcoming events include a webinar on AI for real-world research and job opportunities in the biopharma industry. Readers are encouraged to provide feedback and suggest topics for future coverage.

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

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in the Pharma and Biotech world. Sarepta Therapeutics has recently experienced an 18% increase in its stock value following a significant business overhaul, which included staff layoffs and pipeline shifts. Analysts are cautiously optimistic about the company's future. At the same time, patients are advocating for access to Brainstorm Cell Therapeutics' ALS drug, Nurown, after promising results from an expanded access program. In other news, Novartis is in the process of reshoring its drug manufacturing operations in the US, a move that may take several years to complete. Additionally, a notable number of employees have departed from the FDA's Center for Drug Evaluation and Research amidst an overhaul by the Department of Health and Human Services. These developments underscore the continuous changes and challenges within the pharmaceutical industry. Sarepta Therapeutics recently announced a strategic overhaul, which involved cutting 500 staff members and shifting focus to sirna platform assets. This decision came after two patients passed away following treatment with its Duchenne muscular dystrophy gene therapy, Elevidys. The company has also added a black box warning for acute liver injury and failure to Elevidys as it pivots away from gene therapy programs.

Robert F. Kennedy Jr. testified in front of the House Committee on Energy and Commerce Tuesday, where Democrats confronted the health secretary on hot button issues ranging from his recent overhaul over the CDC's Advisory Committee on Immunization Practices (ACIP) committee, Kennedy's recently published—and error-ridden—MAHA report, and his threat to ban government scientists from publishing in certain medical journals.  Meanwhile, at the FDA, the mass exodus of senior leadership continues. On Monday, Jacqueline Corrigan-Curay, acting head of the Center for Drug Evaluation and Research (CDER), announced her retirement as of July. This follows the ouster of Nicole Verdun—the wildly popular director of the FDA's Office of Therapeutic Products—and her deputy, Rachael Anatol. Their involuntary departure sent shock waves through the biopharma industry, as Verdun had been considered a stabilizing force at the rapidly reshaping agency.  Speaking of the revamped ACIP, the new panel will meet for the first time Wednesday and Thursday to discuss COVID-19 vaccine safety, maternal and pediatric RSV vaccines and more, as experts question the experience and anti-vaccine views of some of Kennedy's recently appointed members and others express concern about the potential politicization of the committee.   On the clinical front, Eli Lilly, Novo Nordisk and others presented new data from their next-generation obesity programs at the American Diabetes Association's 85th Scientific Congress. After failing to impress investors—and meet its own high expectations—with CagriSema, Novo sought to reassure investors by touting a safety profile “in line with the GLP1-RA class,” and Eli Lilly reported that bimagrumab, when used alongside Novo's Wegovy, led to additional weight loss while also preserving muscle mass.  Finally, we recap BIO2025, where Jef Akst, Lori Ellis and Heather McKenzie moderated panels on cell and gene therapy, cybersecurity and AI, and accelerating market entry for rare disease treatments. Relevant to the latter discussion, congressional Republicans dropped the Orphan Cures Act from their version of President Donald Trump's “One Big Beautiful Bill Act,” and congresspeople, including Rep. Gus Bilirakis (R-Fla.) at Tuesday's hearing asked Kennedy to commit to supporting the priority review program for rare pediatric diseases, which expired at the end of last year.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. The FDA's Center for Drug Evaluation and Research (CDER) head, Jacqueline Corrigan-Curay, is leaving the agency in July, becoming the latest in a series of FDA leaders to depart. Eli Lilly is facing concerns about gastrointestinal side effects for their weight loss pill, Orfoglipron, despite brushing off these worries. Vertex's cell therapy for diabetes shows promise, but questions remain about its market potential. HHS Secretary Robert F. Kennedy Jr. has restacked the CDC's vaccine advisory committee, claiming conflicts of interest within the previous group, which experts argue may impact the committee's apolitical nature. Prothena has downsized following a failure in an Al amyloidosis trial, and Novavax is adapting to regulatory uncertainty. Overall, the FDA is experiencing significant turnover in leadership, and challenges persist in drug development and regulation.

```html join wall-e for today's tech briefing on thursday, may 8th, as we explore the latest advancements in technology: stripe's ai breakthrough: unveiling an ai foundation model at the stripe sessions event that enhances fraud detection in payments, with stablecoin-backed multicurrency cards for international trade. openai & fda collaboration: discussions to integrate ai into the drug evaluation process with "cdergpt," aiming to accelerate drug development timelines while managing technological uncertainties. tesla's trademark challenge: the u.s. patent and trademark office's rejection of the "robotaxi" trademark; implications for tesla's upcoming ride-hailing service. anthropic's innovative api: launch of an api enabling claude ai models to perform web searches, allowing for real-time information and reasoning capabilities. apple's ai search engine consideration: potential integration of ai-powered tools from openai and perplexity into safari, a move that could redefine traditional search engine use. stay tuned for tomorrow's tech updates! ```

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Former FDA Commissioner Robert Califf has spoken out as layoffs continue at the FDA, with the latest cuts affecting the Center for Drug Evaluation and Research (CDER). The layoffs are part of a larger reduction of 10,000 jobs at the Department of Health and Human Services. In addition, biopharma markets are in chaos following the departure of Peter Marks from the FDA's Center for Biologics Evaluation and Research (CBER).Carisma Therapeutics has laid off most of its staff and is considering selling off assets and winding down fully. Analysts are calling for President Donald Trump to reconsider his appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services. The departure of Peter Marks from the FDA has caused shares in the biopharma markets to tumble.Trilink offers custom guide RNAs (grRNAs) for CRISPR-based therapy discoveries. Despite market challenges, the cell and gene therapy sector has seen a 30% investment surge. Companies like Tenaya are cutting their workforce to fund development of gene therapies.Overall, the biopharma industry is facing uncertainty and instability as layoffs continue and key figures depart from regulatory agencies.

Show Notes for Episode 42 of “The 2 View” – Pink cocaine, holiday heart syndrome, pertussis, research updates on Zepbound and Semaglutide, and much more. Segment 1 – Pink cocaine What is Pink Cocaine? Dea.gov. DEA: United States Drug Enforcement Administration. https://www.dea.gov/pink-cocaine What is Pink Cocaine? Poison.org. POISON CONTROL: National Capital Poison Center. https://www.poison.org/articles/pink-cocaine Segment 2 – Holiday heart syndrome Blackburn R, Ajetunmobi O, Mc Grath-Lone L, et al. Hospital admissions for stress-related presentations among school-aged adolescents during term time versus holidays in England: weekly time series and retrospective cross-sectional analysis. BJPsych Open. Cambridge University Press. Cambridge Core. Published November 19, 2021. https://www.cambridge.org/core/journals/bjpsych-open/article/hospital-admissions-for-stressrelated-presentations-among-schoolaged-adolescents-during-term-time-versus-holidays-in-england-weekly-time-series-and-retrospective-crosssectional-analysis/924EE2CD1A8CFAC30E7090674FCEAF72 Carey M, Al-Zaiti S, Kozik T, Pelter M. Holiday Heart Syndrome. ECG Puzzler. Researchgate.net. AJCC: American Journal of Critical Care. American Association of Critical-Care Nurses. https://www.researchgate.net/profile/Mary-Carey/publication/260446497HolidayHeart_Syndrome/links/573dda6308ae298602e6d0b1/Holiday-Heart-Syndrome.pdf Ettinger P, Wu C, De La Cruz Jr C, Weisse A, Ahmed S, Regan T. Arrhythmias and the “Holiday Heart”: Alcohol associated cardiac rhythm disorders. Sciencedirect.com. ScienceDirect. American Heart Journal. https://www.sciencedirect.com/science/article/abs/pii/000287037890296X Greenspon AJ, Schaal SF. The “holiday heart”: electrophysiologic studies of alcohol effects in alcoholics. Ann Intern Med. PubMed. NIH: National Library of Medicine: National Center for Biotechnology Information. Published February 1983. https://pubmed.ncbi.nlm.nih.gov/6824246/ Jain A, Yelamanchili V, Brown K, Goel A. Holiday Heart Syndrome. Nih.gov. NIH: National Library of Medicine: National Center for Biotechnology Information. Updated January 16. 2024. https://www.ncbi.nlm.nih.gov/sites/books/NBK537185/ Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. AHA | ASA Journals. Published November 30, 2023. https://www.ahajournals.org/doi/10.1161/CIR.0000000000001193 Segment 3 – Pertussis CDC. About Whooping Cough. Whooping Cough (Pertussis). Updated April 2, 2024. https://www.cdc.gov/pertussis/about/index.html Center for Drug Evaluation, Research. FDA Drug Safety Communication: Death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age. FDA: U.S. Food and Drug Administration. Published June 28, 2019. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-death-resulting-overdose-after-accidental-ingestion-tessalon Pertussis. Who.int. World Health Organization. https://www.who.int/health-topics/pertussis Simma L, Gesch M. Eyelid Ecchymoses and Subconjunctival Hemorrhage in Pertussis. N Engl J Med. Published December 11, 2024. https://www.nejm.org/doi/full/10.1056/NEJMicm2409052 Something sweet – Research updates: Zepbound and Semaglutide Ernst D. Zepbound Approved for Obstructive Sleep Apnea in Patients With Obesity. Monthly Prescribing Reference. MPR: Medical Professionals Reference. Published December 20, 2024. https://www.empr.com/news/zepbound-approved-for-obstructive-sleep-apnea-in-patients-with-obesity/?utmsource=eloqua&utmmedium=email&utmcampaign=NWLTRMPRTOPTDrug-DatabaseSS-LAS-LI1-LI2-9654122924_AL&hmemail=1f%2FJfEV7hN5vJr6vg%2FQRqK0NA6IXtyO3&sha256email=092493d8223fdfa40d9e995176d13e5fc5b5211674db9deb440c025fd462c80c&hmsubid=&nid=1639413404&elqtrack=True Semaglutide shows promise as a potential alcohol use disorder medication. Research Update. Nih.gov. NIH: National Institute on Alcohol Abuse and Alcoholism. Published March 13, 2024. https://www.niaaa.nih.gov/news-events/research-update/semaglutide-shows-promise-potential-alcohol-use-disorder-medication Recurring Sources Center for Medical Education. Ccme.org. http://ccme.org The Proceduralist. Theproceduralist.org. http://www.theproceduralist.org The Procedural Pause. Emergency Medicine News. Lww.com. https://journals.lww.com/em-news/blog/theproceduralpause/pages/default.aspx Trivia Question: Send answers to 2viewcast@gmail.com Be sure to keep tuning in for more great prizes and fun trivia questions! Once you hear the question, please email us your guesses at 2viewcast@gmail.com and tell us who you want to give a shout-out to. Be sure to listen in and see what we have to share! Looking forward to another year together!

BioCentury's analysis of the technologies behind last year's biotech series A raisers sees progress in nanoparticles, CAR cell therapies, degraders and antibody-drug conjugates. On the latest BioCentury This Week podcast, BioCentury's editors discuss the trends spotted in 2024's crop of more than 150 series A rounds — from top therapeutic areas and modalities to the leading investors funding the innovation.The editors turn to Washington for takeaways from BioCentury's “exit interview” with Patrizia Cavazzoni, the recently departed director of FDA's Center for Drug Evaluation and Research, and checks in on FDA and NIH's turbulent transition under Trump 2.0.Finally, the podcast team previews BioCentury's upcoming fourth East-West Summit, which will focus on globalizing Asia innovation and the red-hot “Newco Model” in Singapore March 3-5, and the twenty-fifth Bio€quity Europe, which will be held in Belgium in May. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/65483700:01 - Sponsor Message: ICON Biotech01:57 - Series As: Trends in Innovation12:18 - BioCentury Conferences Preview18:45 - Insights from FDA's Cavazzoni21:58 - Turbulence at FDA, NIHTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

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/

Bindu Kanapuru is a hematologist–oncologist physician in the Office of Oncologic Diseases at the FDA's Center for Drug Evaluation and Research. Stephen Morrissey, the interviewer, is the Executive Managing Editor of the Journal. B. Kanapuru and Others. Autopsy of a Drug Withdrawal — The Case of Melphalan Flufenamide. N Engl J Med 2024;391:2177-2179.

In this episode, Dr Camidge sits down with Jeanne Fourie Zirkelbach, PhD, a clinical pharmacologist in the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the FDA.  Drs Camidge and Zirkelbach discuss how Zirkelbach got her start in the pharmacokinetics field; her involvement with Project Optimus, an initiative by the FDA's Oncology Center of Excellence that works to reform dose-optimization and -selection paradigms in oncology drug development; and how her research with patient-reported outcomes emphasizes the importance of keeping patient needs, preferences, and experiences at the forefront of drug development to minimize the effects of cancer treatment on quality of life.

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act) 15:51 International Harmonization Efforts 22:36 Combination Products and Policy Work 30:10 The Importance of Advocacy and Education 35:22 Closing Thoughts and Personal Insights Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor's degree in Bioengineering from the University of California, Berkeley, his doctorate and master's degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.

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

Dr. Theresa Michele, MD from the Office of Nonprescription Drugs within the FDA's Center for Drug Evaluation and Research and Dr. Ilisa Bernstein, PharmD Senior Vice President for Practice, Policy and Partnerships from the American Pharmacists Association, APhA, are our guests on this episode of "Q&A with FDA" Q&A with FDA provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA's Division of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions but never asked. C.E. for this episode here: https://www.fda.gov/drugs/news-events-human-drugs/qa-fda-podcastRSS feed for Q&A with FDA

The rates of alcohol use disorder increased significantly since the onset of COVID-19, making this a major public health issue, though it's not discussed as frequently as opioid overdoses. Over 140,000 Americans die from the effects of alcohol in an average year (more than from drug overdoses). Ten percent of Americans over the age of 12 have Alcohol Use Disorder. And according to the 2023 Alcohol Abuse Statistics, 60% of Americans increased their alcohol consumption during COVID-19 lockdowns. In this podcast, we are joined by Dr. Iilun Murphy, Director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research (CDER), and returning is Dr. Marta Sokolowska, CDER's Deputy Center Director for Substance Use and Behavioral Health to discuss the recent first generic approval to Vivitrol, a one-month extended-release injectable naltrexone that is used to help people recovering from opioid or alcohol dependence.

In this Chinese-language podcast, Brian Yang and Dexter Yan discuss China biotech topics including the annual IND and NDA report from Center for Drug Evaluation, ESMO's China data and Shanghai International Biotech Industry Week. https://scrip.citeline.com/SC149259/Chinese-Language-Podcast-ESMO-China-Data-Annual-CDE-Report-Shanghai-Biotech-Week

According to the National Association of Boards of Pharmacy, for the past 10 years, industry experts have consistently estimated that, at any given time, there are between 30,000 and 40,000 active illegal online pharmacies. Today, we are joined by Commander Lysette Deshields, an FDA officer in the United States Public Health Service Commissioned Corps. CDR Deshields is a Regulatory Officer in the Supply Chain Security Branch in the Office of Drug Security, Integrity and Response, Office of Compliance within the FDA's Center for Drug Evaluation and Research. She will be discussing FDA's BeSafeRx campaign, a national initiative to educate consumers and health care professionals about the potential dangers of buying medicine from unsafe online pharmacies, along with identifying safe online pharmacies so that consumers can make more informed decisions when purchasing prescription medicine online, and tools that healthcare professionals can use to guide patients.

My guest today is CDR Stephen Chang.  He's a pharmacist and an Officer in the United States Public Health Service Commissioned Corps.  He's an advocate for public health, and during our interview, we discuss how he got from pharmacy school to working for the FDA, settings he's worked in, roles he's served, deployments he has been on, what he thought he would be doing upon graduation when he was just a pharmacy student, and advice for students and pharmacists who are considering their career options.  If you're interested in a career in public health, you need to listen to our conversation!   Thank you for listening to episode 239 of The Pharmacist's Voice ® Podcast! To read the FULL show notes, visit https://www.thepharmacistsvoice.com/podcast.  Select episode 239. Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out!   Apple Podcasts   https://apple.co/42yqXOG  Google Podcasts  https://bit.ly/3J19bws  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt BIO (August 2023) CDR Stephen Chang, PharmD, MPH, currently is a Senior Clinical Policy Advisor at the U.S. Food and Drug Administration (FDA), Centers for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Immediate Office, Post Market Programs and works from San Francisco, CA. He earned his Doctor of Pharmacy (PharmD) from the Philadelphia College of Pharmacy, University of the Sciences in 2008, and his Master of Public Health from the University of Washington in Seattle in 2015. He also completed a PRESCIENT Postdoctoral Fellowship at the University of California, San Francisco. CDR Chang has a broad range of professional certifications and training in the areas of executive management and leadership, pharmacy-based immunization delivery, and emergency preparedness, epidemiology, biostatistics, translational/precision health, data science. He has numerous research publications and speaker engagements as well as professional honors and awards.  As a Senior Clinical Policy Advisor, CDR Chang serves as an expert and resource for Office and Center staff and Management within the Centers for Devices and Radiological Health (CDRH). This support includes providing expertise, direction, and feedback on policies, procedures, and program support on all aspects of regulatory and scientific policy to the seven Offices of Health Technology, Office of Regulatory Programs and Office of Clinical Evidence pertaining to the collection and use of Post Market data related to medical device use and performance.  Of his 15-year career in federal service and in the United States Public Health Service, he most recently served as an Associate Director in the Division of Hepatology and Nutrition, Office of New Drugs (OND), Centers for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration and as a Senior Medicaid Enterprise Systems State Officer at the Centers for Medicare and Medicaid Services (CMS).  Previously, he also served as an outpatient pharmacist in the Federal Bureau of Prisons (BOP). 

In this episode of Q&A with FDA, we hear from Dr. Marta Sokolowska, Deputy Center Director for Substance Use and Behavioral Health in FDA's Center for Drug Evaluation and Research, discuss the Agency's vision as it relates to encouraging harm reduction, including expanding availability and access to lifesaving overdose reversal products. Dr. Sokolowska delves into the impacts of the recent approvals of nonprescription naloxone nasal spray as well as prescription nalmefene nasal spray, another medication for opioid overdose. 

Artificial intelligence seems to be overturning every part of life. How about this one: AI and its country cousin, machine learning, working together to develop new drugs. To see how AI can help and what some of the risks might be, Federal Drive Host Tom Temin spoke with the Food and Drug Administration's Associate Director for Policy Analysis, within the Center for Drug Evaluation and Research, Dr. Tala Fakhouri. Learn more about your ad choices. Visit podcastchoices.com/adchoicesSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Artificial intelligence seems to be overturning every part of life. How about this one: AI and its country cousin, machine learning, working together to develop new drugs. To see how AI can help and what some of the risks might be, Federal Drive Host Tom Temin spoke with the Food and Drug Administration's Associate Director for Policy Analysis, within the Center for Drug Evaluation and Research, Dr. Tala Fakhouri. Learn more about your ad choices. Visit megaphone.fm/adchoices

Urban Dictionary: mann's assumptionThe Who - Won't Get Fooled Again - YouTubeTalking Heads - Once in a Lifetime (Official Video) - YouTubeWiFi Networking Equipment for Home & Business | TP-LinkFood Safety TalkWatch - AppleNoom: Stop dieting. Get lifelong results.White House Plumbers | Official Website for the HBO Series | HBO.comThe Food Section | Hanna Raskin | SubstackCoronation of Charles III and Camilla - WikipediaIAFP Annual Meeting - International Association for Food ProtectionAmerican Association for Agricultural Education - 2023 National Conference | Raleigh, NCSeaman A. Knapp - WikipediaRutgers Law Cannabis CertificateSanitize vs. Disinfect: Know the Difference2023 Biennial Meeting | Conference for Food Protection | Conference for Food ProtectionReport - Disinfectant Committee (DC) | Council III | 2023 Biennial Meeting | Conference for Food Protection | Conference for Food Protection‎Disinfectant Committee Guidance DocumentTajah Blackburn - United States Environmental Protec… | ZoomInfoCenter for Drug Evaluation and Research | CDER | FDAThe Battle Over Refrigerating Butter: ‘Enough Is Enough'Butter with Olive Oil and Sea Salt | Land O'Lakes41: Butter at Room Temperature — Risky or Not?quixotic pronunciation459. AI-Generated Recipes — Risky or Not?Survival of acid adapted and non-acid adapted Salmonella Typhimurium in pasteurized orange juice and yogurt under different storage temperatures - Avelino Álvarez-Ordóñez, Lorena Valdés, Ana Bernardo, Miguel Prieto, Mercedes López, 2013449. Pepper Mill Over a Pot — Risky or Not?Multistate Outbreak of Salmonella Thompson Infections Linked to Seafood Exposure — United States, 2021 | MMWR

Dr. Bruce Hennessy, a gastroenterologist with the American Society for Gastrointestinal Endoscopy, discusses UnitedHealthcare's decision to require new prior authorization for 61 procedures, including colonoscopies. In response to provider and patient concerns, UHC has amended its prior authorization requirements. The Medicaid work requirement has been stripped from the debt ceiling negotiations bill; Valerie Jensen, Associate Director for Drug Shortages in the Center for Drug Evaluation and Research at the FDA, outlines the challenges and potential solutions to the ongoing drug shortages; and the Consumer Product Safety Commission recently released some new stock photos that include people with physical disabilities. UnitedHealth backs off contentious prior authorization plan UnitedHealthcare Letter FDA Report: Drug Shortages NPR News Article: People with disabilities aren't often seen in stock photos. The CPSC is changing that  

This week on Pharm5: Cost Plus Drug Co. adds Invokana products Gohibic (vilobelimab) EUA for COVID-19 Makena (hydroxyprogesterone caproate injection) withdrawn from market APL treatment oral tretinoin shortage Federal judge strikes down ACA's OCP and PrEP coverage     Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD   References: Mark Cuban CostPlus Drug Company - Medications. http://bit.ly/3KjKYS5. Accessed April 6, 2023. Invokana® (canagliflozin) affordability. Janssen CarePath for Healthcare Professionals. http://bit.ly/3nWANLm. Published October 18, 2022. Accessed April 6, 2023. Center for Drug Evaluation and Research. FDA authorizes Gohibic (vilobelimab) injection. U.S. Food and Drug Administration. http://bit.ly/3nWDsVm. Published April 4, 2023. Accessed April 6, 2023. Gohibic [highlights of emergency use authorization]. Jena, Germany: InflaRx GmbH. Published April 2023. Accessed April 6, 2023. FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena. U.S. Food and Drug Administration. http://bit.ly/3ZMOY35. Published April 6, 2023. Accessed April 6, 2023. Drug shortage detail: Tretinoin capsules. ASHP. https://bit.ly/3KhQ2pT. Published March 20, 2023. Accessed April 6, 2023. Treatment of acute promyelocytic leukemia (APL). American Cancer Society. http://bit.ly/3mb3Nif. Accessed April 6, 2023. Cingam SR, Koshy NV. Acute Promyelocytic Leukemia. National Center for Biotechnology Information. http://bit.ly/3nGw5RV. Accessed April 6, 2023. Phillips C. Help Desk for Oncologists Treating People with a Rare Leukemia Pays Big Dividends. National Cancer Institute. http://bit.ly/40EtxT3. Published February 2, 2023. Accessed April 6, 2023. Braidwood Management, Inc., et al. v. Xavier Becerra, et al. Civil Action No. 4:20-cv-00283-O. Supreme Court of Texas, 2022. Accessed April 6, 2023. Judge strikes down Obamacare provisions requiring insurers cover some preventive care services. NBCNews.com. https://bit.ly/3MncZKV. Published March 30, 2023. Accessed April 6, 2023. Burwell v. Hobby Lobby and birth control. Planned Parenthood Action Fund. http://bit.ly/419fPaq. Accessed April 6, 2023. Stolberg SG, Abelson R. Federal judge strikes down Obamacare requirement for free preventive care. The New York Times. http://bit.ly/3nSSAU1. Published March 30, 2023. Accessed April 6, 2023.

Hour 1 * Guest: Dr. Scott Bradley, Founder and Chairman of the Constitution Commemoration Foundation and the author of the book and DVD/CD lecture series “To Preserve the Nation.” In the Tradition of the Founding Fathers – FreedomsRisingSun.com * Sam and the Good Dr. Discuss Constitutional Currency, AKA ‘Honest Money'! * Fauci, others suppressed Brit recommendation to use ivermectin against COVID – Conclusion called for ‘immediate' approval for use – WND.com * Testimonials arose about how it was effective, even though federal officials, celebrities and others condemned it. They publicly ridiculed those who would use a “horse paste,” even though that was only one form of ivermectin. * The Asahi Shimbun, Kowa Co., the huge Japanese pharmaceutical company, confirmed ivermectin proved an “antiviral effect” against Omicron and other coronavirus variants. * a new report by Emmy Award-winning investigative journalist Sharyl Attkisson reveals Anthony Fauci, and others, suppressed a recommendation at the outset of the pandemic that Ivermectin be used against the killer. * A leading British physician and World Council for Health co-founder Dr. Tess Lawrie, who is director and founder of a doctors' organization called the British Ivermectin Recommendation Development Group (BIRD), emailed 31 Food and Drug Administration (FDA) officials, including the Director of the Offfice of New Drugs in the Center for Drug Evaluation and Research Peter Stein; Center for Biologics Evaluation and Research Director Peter Marks; and then-Acting FDA Commissioner Janet Woodcock; and copying several leading foreign medical figures, with an email titled ‘URGENT: The BIRD meeting and recommendation on COVID-19 prevention and treatment.'” * Lawrie's cover letter states: ‘BIRD panel conclusions are that ivermectin should be approved immediately for prevention and treatment of Covid-19:'” – The British Ivermectin Recommendation Development Panel recommends Ivermectin for the prevention and treatment of Covid-19 to reduce morbidity and mortality associated with Covid-19 infection. * “Rather than educate the public about the supposed reasons for their rejection of the Ivermectin-use recommendation, the FDA, NIH, and Fauci's former agency have blacked out their responses in these documents,” explained Judicial Watch President Tom Fitton. Hour 2 * Guest: Lowell Nelson – CampaignForLiberty.org, RonPaulInstitute.org * 3 Years to Slow The Spread: Covid hysteria and the creation of a never-ending crisis – Jordan Schachtel. * A letter from John Adams to Abigail: “Liberty once lost is lost forever. When the People once surrender their share in the Legislature, and their Right of defending the Limitations upon the Government, and of resisting every Encroachment upon them, they can never regain it.” * Ron Paul Challenged the Coronavirus Tyranny from the Beginning – Adam Dick. * Covid, Courage, and Cowardice – Jordan Schachtel. * “How did you behave in the face of this public panic?” * Jordan writes, “Courage is unique because it is almost impossible to be courageous and popular at the same time. If courage were popular, it wouldn't be brave. If courage was common, it wouldn't be courageous.” * Unsound Banking: Why Most of the World's Banks Are Headed for Collapse – Doug Casey, LewRockwell.com * Bank deposits–until quite recently–were of two kinds: time deposits and demand deposits. --- Support this podcast: https://podcasters.spotify.com/pod/show/loving-liberty/support

* Guest: Dr. Scott Bradley, Founder and Chairman of the Constitution Commemoration Foundation and the author of the book and DVD/CD lecture series “To Preserve the Nation.” In the Tradition of the Founding Fathers - FreedomsRisingSun.com * Sam and the Good Dr. Discuss Constitutional Currency, AKA 'Honest Money'! * Fauci, others suppressed Brit recommendation to use ivermectin against COVID - Conclusion called for 'immediate' approval for use - WND.com * Testimonials arose about how it was effective, even though federal officials, celebrities and others condemned it. They publicly ridiculed those who would use a "horse paste," even though that was only one form of ivermectin. * The Asahi Shimbun, Kowa Co., the huge Japanese pharmaceutical company, confirmed ivermectin proved an "antiviral effect" against Omicron and other coronavirus variants. * a new report by Emmy Award-winning investigative journalist Sharyl Attkisson reveals Anthony Fauci, and others, suppressed a recommendation at the outset of the pandemic that Ivermectin be used against the killer. * A leading British physician and World Council for Health co-founder Dr. Tess Lawrie, who is director and founder of a doctors' organization called the British Ivermectin Recommendation Development Group (BIRD), emailed 31 Food and Drug Administration (FDA) officials, including the Director of the Offfice of New Drugs in the Center for Drug Evaluation and Research Peter Stein; Center for Biologics Evaluation and Research Director Peter Marks; and then-Acting FDA Commissioner Janet Woodcock; and copying several leading foreign medical figures, with an email titled 'URGENT: The BIRD meeting and recommendation on COVID-19 prevention and treatment.'" * Lawrie's cover letter states: 'BIRD panel conclusions are that ivermectin should be approved immediately for prevention and treatment of Covid-19:'" - The British Ivermectin Recommendation Development Panel recommends Ivermectin for the prevention and treatment of Covid-19 to reduce morbidity and mortality associated with Covid-19 infection. * "Rather than educate the public about the supposed reasons for their rejection of the Ivermectin-use recommendation, the FDA, NIH, and Fauci's former agency have blacked out their responses in these documents," explained Judicial Watch President Tom Fitton.

This week on Pharm5: Novo Nordisk insulin price cuts Akorn Pharma closing, potential drug shortages Zavzpret (zavegepant) migraine nasal spray Daybue (trofinetide) for Rett Syndrome 2023 Match Results Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Novo Nordisk to lower U.S. prices of several pre-filled insulin pens and vials up to 75% for people living with diabetes in January 2024. Novo Nordisk. http://bit.ly/42hziHz. Accessed March 16, 2023. Lilly cuts insulin prices by 70% and caps patient insulin out-of-pocket costs at $35 per month. Eli Lilly and Company. https://bit.ly/3ZQXVcf. Published March 1, 2023. Accessed March 16, 2023. Murphy T. Novo Nordisk plans price cuts for several insulins. AP NEWS. http://bit.ly/3JNzgjz. Published March 14, 2023. Accessed March 16, 2023. Kekatos M, Bakshi N, Coburn J. Nationwide shortage of asthma medication albuterol could worsen in hospitals. ABC News. https://bit.ly/3JfD1wA. Published March 9, 2023. Accessed March 16, 2023. Supply chain disruption due to manufacturer closure: Akorn Pharmaceuticals ceases operations. End Drug Shortages Alliance. https://bit.ly/3JqLZHi. Published March 7, 2023. Accessed March 16, 2023. Pfizer's Zavzpret™ (zavegepant) Migraine Nasal Spray Receives FDA Approval. Pfizer. http://bit.ly/42kQJag. Published March 10, 2023. Accessed March 16, 2023. Lipton RB, Croop R, Stock DA, et al. Safety, tolerability, and efficacy of zavegepant 10 mg nasal spray for the acute treatment of migraine in the USA: A phase 3, double-blind, randomised, placebo-controlled multicentre trial. The Lancet Neurology. 2023;22(3):209-217. doi:10.1016/s1474-4422(22)00517-8 Sargent J, Kirchner JR, Davis R, Kirkhart B. Oral sumatriptan is effective and well tolerated for the acute treatment of migraine: results of a multicenter study. Neurology. 1995;45(8 Suppl 7):S10-S14. Center for Drug Evaluation and Research. FDA approves first treatment for Rett syndrome. U.S. Food and Drug Administration. http://bit.ly/3TjSD6U. Accessed March 16, 2023. Aislinn Antrim E. FDA approves Trofinetide for treatment of Rett syndrome in adult, pediatric patients. Pharmacy Times. http://bit.ly/40fK3bq. Published March 13, 2023. Accessed March 16, 2023. ASHP match statistics. ASHP Match | Statistics of the Match. http://bit.ly/42e4Ga1. Published March 15, 2023. Accessed March 16, 2023. Schedule of dates. ASHP Match | Schedule. https://bit.ly/3I8MJA7. Published March 15, 2023. Accessed March 16, 2023.

This week on Pharm5: Walmart, CVS Claim Pharmacist Shortage Changes to Paxlovid, Lagevrio, and COVID vaccines EzriCare eyedrops linked to bacterial outbreak New FDA approvals: Jayprica, Orserdu, Jesduvroq GoodRx sells health info to advertisers Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Valinsky J. CVS and Walmart Cut Pharmacy Hours, close some locations earlier, citing staffing shortage | CNN business. CNN. http://bit.ly/3RpgS2F. Published January 27, 2023. Accessed February 2, 2023. Keagy J. American Pharmacists Association on move to cut pharmacy hours. American Pharmacists Association. http://bit.ly/3JB0v0Q. Published January 30, 2023. Accessed February 2, 2023. Paxlovid, Lagevrio prescriptions no longer need a positive COVID-19 test. Becker's Hospital Review. http://bit.ly/3DC3Jh3. Published February 1, 2023. Accessed February 2, 2023. Fact sheet for healthcare providers: emergency use authorization for Paxlovid. New York, NY: Pfizer. https://bit.ly/3RvXNvO. Revised February 1, 2023. Accessed February 2, 2023. Fact sheet for healthcare providers: emergency use authorization for Lagevrio (molnupiravir) capsules). Rahway, NJ: Merck & Co. https://bit.ly/3HsLo72. Revised February 1, 2023. Accessed February 2, 2023. Bulloch M. FDA Advisory Committee vote to simplify covid-19 regimen. Pharmacy Times. http://bit.ly/3jweY3t. Published February 1, 2023. Accessed February 2, 2023. O'Mary L. Bacterial outbreak linked to EzriCare eyedrops: CDC. Medscape. http://bit.ly/3l3tOz9. Published February 1, 2023. Accessed February 2, 2023. Update: Multistate Cluster of VIM- and GES-producing Carbapenem resistant Pseudomonas aeruginosa associated with Artificial Tears. https://bit.ly/3DDHrey. Published January 20, 2023. Accessed February 2, 2023. Center for Drug Evaluation and Research. Novel drug approvals for 2023. U.S. Food and Drug Administration. http://bit.ly/3wO6ckC. Accessed February 2, 2023. Pagliarulo N. FDA approves cancer drugs from Lilly, Menarini. BioPharma Dive. http://bit.ly/3DEgnfc. Published January 30, 2023. Accessed February 2, 2023. FDA approves first oral treatment for anemia caused by chronic kidney disease for adults on dialysis. U.S. Food and Drug Administration. http://bit.ly/3RsL64E. Accessed February 2, 2023. FTC enforcement action to Bar Goodrx from sharing consumers' sensitive health info for advertising. Federal Trade Commission. http://bit.ly/3l50F6C. Published February 1, 2023. Accessed February 2, 2023.

“It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events,” Teresa Knoop, MSN, RN, AOCN®, nurse consultant in Nashville, TN, told Jaime Weimer, MSN, RN, AGCNS-BC, AOCNS®, oncology clinical specialist at ONS, during a conversation about the latest updates and approvals in oncology pharmacology. You can earn free NCPD contact hours after listening to this episode and completing the evaluation linked below. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 1 contact hour of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by January 13, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Participants will report an increase in knowledge related to the latest updates and approvals in oncology pharmacology. Episode Notes Complete this evaluation for free NCPD. Oncology Nursing Podcast Episode 126: Oncology Clinical Trials and Drug Development ONS Voice articles: S. Food and Drug Administration (FDA) updates Drug reference sheets Predictive and Diagnostic Biomarkers: Identifying Variants Helps Providers Tailor Cancer Surveillance Plans and Treatment Selection Help Patients Understand Biomarker Test Results and Clinical Trials Options Use ClinicalTrials.gov to Find the Right Cancer Research Studies for Your Patients ONS Biomarker Database ONS Genomics and Precision Oncology Learning Library ONS Immuno-Oncology Learning Library ONS Oral Anticancer Medication Learning Library ONS Biosimilars Learning Library ONS Seal of Approval Library Oral Chemotherapy Education Sheets Intravenous Cancer Treatment Education Sheets Clinical Journal of Oncology Nursing article: Clinical Trials: Nursing Roles During the Approval Process and Pharmacovigilance of Biosimilars FDA resources: Drug development and approval process Oncology/hematologic malignancies approval notifications Ongoing cancer accelerated approvals Verified clinical benefit cancer accelerated approvals Withdrawn cancer accelerated approvals Project Renewal Biosimilars review and approval Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) Project Livin' Label Oncology Center of Excellence To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From Today's Episode “Full approval through the Center for Drug Evaluation and Research (CDER) and FDA means that those drugs have gone through the laboratory testing, human clinical trial testing, and very extensive clinical trials to make sure that they are effective and that the benefits of those drugs outweigh the risks.” TS 02:28 “In 1992, CDER established a new program that would help these drugs get expedited, particularly in life-threatening or serious diseases like cancer. So they established an accelerated approval pathway for these promising therapies. They were hoping to shorten that period of time, and a number of our cancer-fighting drugs have come onto the market through this accelerated approval pathway.” TS 04:29 “When a drug gets an FDA approval, whether it be accelerated or final, then typically they get approved for one, possibly two indications on that first approval. But there are clinical trials ongoing in other diseases and in other indications. So we will then see drugs—after those clinical trials are conducted—taken to CDER for approval for that new indication.” TS 24:02 “The exciting thing for our patients is that new indications often treat more advanced cancers in which you discover a biomarker and could give patients potential treatment options when other options may have been exhausted.” TS 27:43 “It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events. Many of these drugs are designed so patients have to stay on them for extended periods of time, or at least they get the greatest benefit by staying on it for extended periods of time. Our patient education is key in helping patients do that.” TS 34:50 “In 2023, I think we will continue to see many new drugs that are approved. We will see new indications. I think particularly we will continue to see cellular therapy agents developed—we'll see them gain new indications. I would be willing to forecast that we're going to see more and more of specific immunomodulatory drugs or those antibody drug conjugates—all of those drugs that are designed to treat the cancer in a couple of different ways.” TS 37:29

This week on Pharm5: Bivalent booster for kids Jynneos protects against monkeypox Dexcom G7 approved for diabetes Rezlidhia (olutasidenib) approved for AML PCAT retirement in 2024 Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Coronavirus (COVID-19) update: FDA authorizes updated (bivalent) covid-19 vaccines for children down to 6 months of age. U.S. Food and Drug Administration. https://bit.ly/3UIOuIP. Accessed December 8, 2022. Webinar November 29, 2022 - flu, RSV, COVID-19 and other respiratory threats this fall and Winter. Centers for Disease Control and Prevention. http://bit.ly/3Bf21AX. Published November 16, 2022. Accessed December 8, 2022. Reduced risk for Mpox after receipt of 1 or 2 doses of JYNNEOS vaccine compared with risk among unvaccinated persons - 43 U.S. jurisdictions, July 31–October 1, 2022. Centers for Disease Control and Prevention. https://bit.ly/3FzvTdL. Published December 8, 2022. Accessed December 8, 2022. Dexcom G7 receives FDA clearance: The most accurate continuous glucose monitoring system cleared in the U.S. Business Wire. https://bit.ly/3UMwMnv. Published December 8, 2022. Accessed December 8, 2022. Center for Drug Evaluation and Research. FDA approves Olutasidenib. U.S. Food and Drug Administration. https://bit.ly/3W2vSo5. Accessed December 8, 2022. Pharmcas Community. Retirement of the Pharmacy College Admission Test (PCAT). https://bit.ly/3Y9EomW. Published December 6, 2022. Accessed December 8, 2022.

This week on Pharm5: Tamiflu backorder ADHD medications & CVD risk Paxlovid dispensing guidance EUA pulled for last remaining COVID-19 monoclonal antibody ASHP Midyear Meeting Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Current drug shortages. ASHP. https://bit.ly/3Fk0Keo. Accessed December 1, 2022. Center for Drug Evaluation and Research. Drug shortages. U.S. Food and Drug Administration. https://bit.ly/3B2DGhC. Accessed December 1, 2022. Weekly U.S. Influenza Surveillance Report. Centers for Disease Control and Prevention. https://bit.ly/3gQ77MW. Published November 28, 2022. Accessed December 1, 2022. Zhang L, Yao H, Li L, et al. Risk of cardiovascular diseases associated with medications used in attention-deficit/hyperactivity disorder. JAMA Network Open. 2022;5(11). doi:10.1001/jamanetworkopen.2022.43597 HQ APhA. APhA has created a pharmacist decision-making support tool for paxlovid. use it in your practices to help assess whether a prescription for Paxlovid is appropriate. Twitter. https://bit.ly/3H6F3Q7. Published November 30, 2022. Accessed December 1, 2022. FDA pulls U.S. authorization for Eli Lilly's Covid Drug Bebtelovimab. Reuters. https://bit.ly/3UiQyHa. Published November 30, 2022. Accessed December 1, 2022. Midyear clinical meeting 2022 - ASHP. MCM22. https://bit.ly/3B1dunI. Accessed December 1, 2022.

Mobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial participants. Following the discussion, the FDA representatives hold open Q&A. Topics include: Guidance updatesThe requirements to test all of these digital health technologiesEfforts the agency is putting in place to harmonize the requirements across the boardGuidance to the industry in terms of how we create the harmonization. What do we need to disclose? And in what timeframe?FDA update on approval of additional clinical measures Speakers: Lauren Oliva, PharmD, Director, Global Regulatory Policy, Lead, Digital Health Regulatory Policy, BiogenAnindita Saha, Assistant Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDALeonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDAElizabeth Kunkoski, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA

Experts from the FDA and CDC continue their discussion on tecovirimat, or TPOXX, for the treatment of monkeypox in infected individuals. In part two of this mini-series, experts answer physicians' questions about treatment for monkeypox. Guests include Adam Sherwat, MD, Deputy Director, Office of Infectious Disease at FDA's Center for Drug Evaluation and Research; Brett W. Petersen, MD, MPH, Deputy Chief, Poxvirus and Rabies Branch, CDC's Division of High-Consequence Pathogens and Pathology; and Timothy Wilkin, MD, MPH, Professor of Medicine and Assistant Dean for Clinical Research Compliance for Human Research Protections at Weill Cornell Medicine and TPOXX clinical trial lead.

This week on Pharm5: Imjudo (tremelimumab) FDA approved Tecvayli (teclistamab-cqyv) FDA approved Cancer incidence up, mortality down Pharmacies administered >50% of COVID vaccines AGA Obesity Treatment Guidelines Connect with us! Listen to our podcast: Pharm5 Follow us on Twitter: @LizHearnPharmD References: Imjudo (tremelimumab) in combination with Imfinzi approved in the US for patients with unresectable liver cancer. AstraZeneca. https://bit.ly/3NevJKX. Published October 24, 2022. Accessed October 27, 2022. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab Plus durvalumab in unresectable hepatocellular carcinoma. NEJM Evidence. 2022;1(8). doi:10.1056/evidoa2100070 Center for Drug Evaluation and Research. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. U.S. Food and Drug Administration. https://bit.ly/3zqMixF. Accessed October 27, 2022. Cronin KA, Scott S, Firth AU, et al. Annual report to the nation on the status of cancer, part 1: National cancer statistics. Cancer. October 2022. doi:10.1002/cncr.34479 Hunter E. Overall cancer death rates have declined, but rates among racial/ethnic minorities have not followed suit. Pharmacy Times. https://bit.ly/3gPg4G0. Published October 27, 2022. Accessed October 27, 2022. Grabenstein JD. Essential services: Quantifying the contributions of America's pharmacists in COVID-19 clinical interventions. Journal of the American Pharmacists Association. 2022. doi:10.1016/j.japh.2022.08.010 @JAPhAJournal. IN PRESS: Pharmacists delivered over 350 million clinical interventions during COVID pandemic. #TwitteRx #pharmacists #COVID19. Posted October 25, 2022. Accessed October 27, 2022. https://bit.ly/3U1xn4N. Grunvald E, Shah R, Hernaez R, et al. AGA clinical practice guideline on pharmacological interventions for adults with obesity. Gastroenterology. 2022;163(5):1198-1225. doi:10.1053/j.gastro.2022.08.045

Experts from the AMA, FDA and CDC discuss tecovirimat, or TPOXX, for the treatment of monkeypox in infected individuals. The discussion provides background on tecovirimat, including its current status, availability and access while the drug is under an investigational new drug application. Guests include Adam Sherwat, MD, Deputy Director, Office of Infectious Disease at FDA's Center for Drug Evaluation and Research; Brett W. Petersen, MD, MPH, Deputy Chief, Poxvirus and Rabies Branch, CDC's Division of High-Consequence Pathogens and Pathology; and Timothy Wilkin, MD, MPH, Professor of Medicine and Assistant Dean for Clinical Research Compliance for Human Research Protections at Weill Cornell Medicine and TPOXX clinical trial lead.

On this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss: - FDA Human Factors Review for Combination Products (CDRH, CDER/DMEPA, OCP) - Human Factors vs. Usability Engineering vs. Design Validation - Risk Management and User Risk - Summative HF Evaluation and Sampling Shannon is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products. Formerly, Shannon worked as Team Lead for Human Factors in FDA's Center for Devices and Radiological Health (CDRH) and as human factors reviewer within the Center for Drug Evaluation and Research (CDER), Division of Medication Error Prevention and Analysis (DMEPA).

As a midlife woman your diabetes risk increases as hormones change. This episode intends to help you realize that you are in control. We include what may be reminders for many of you, or new points of awareness for others. This may be for you or for loved ones struggling with insulin resistance, pre-diabetes, or diabetes. In this episode I interview Dr. John Whyte, the Chief Medical Officer for WebMD, about his new book. Take Control of Your Diabetes Risk is available wherever books are sold and yet don't go get it yet, tune into this episode. You're going to love the simple tips reminding you of easy ways not to only avoid disease, but to feel better.  Strength training to increase muscle which acts like a sponge for blood sugar. During Open Enrollment for the Flipping 50 Cafe you can gain access to made-for-menopause strength training programs and coaching from the leading hormone balancing fitness expert.  Listen for the mic drop moment, followed by a comment we can each relate to all too well.  We discuss some resources I'll add to the show notes as well.  My Guest:  Dr. John White is the Chief Medical Officer, WebMD. In this role, he leads efforts to develop and expand strategic partnerships that  create meaningful change around important and timely public health issues. Prior to WebMD, he served as the director of professional affairs and stakeholder engagement at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.  00:00 Questions we answer in this episode: 02:30 why do we have a diabetes epidemic in the US?  05:26 knowing genetics play a small percent, are genetics largely to blame or is it something else?  08:28 is it possible to either reverse diabetes entirely, or only to prevent it from occurring if you're at risk?  are there issues specific to midlife women and diabetes? 20:42 how do hormones play a role?  what's the role of stress in diabetes risk?   what kinds of exercise choices do you find make the biggest difference? 31:12 are there types of exercise that don't help much at all specifically with diabetes and blood sugar? Connect with Dr John Whyte:  https://www.webmd.com/takecontrol/diabetes On Social Media: Twitter: https://www.twitter.com/drjohnwhyte Linked In: https://www.linkedin.com/in/john-whyte-00092833/ The book you'll want for your library:  https://www.amazon.com/Take-Control-Your-Diabetes-Risk/dp/0785240640/ref=sr_1_1?crid=497HJ4ETSJVQ&keywords=take+control+of+your+diabetes+risk&qid=1654539216&sprefix=take+control+%2Caps%2C80&sr=8-1 Resource mentioned in this episode:  Continuous Glucose Monitor (for $25 off your first month, Rx not required): https://www.flippingfifty.com/glucose  Other Episodes You May Like Related to Diabetes Risk: How a Continuous Glucose Monitor Could Help Weight Loss: https://www.flippingfifty.com/glucose-monitor/ My 30-Day Glucose Monitor Experiment: What Happened: https://www.flippingfifty.com/glucose-monitor/ 4 Ways Blood Sugar Could Halt Your Fat Burning and Weight Loss: https://www.flippingfifty.com/glucose-monitor/ Join the Free Diabetes Summit Now (July 2022) 

Almut Winterstein, RPh, PhD, FISPE, is the Professor and Chair of the Department of Pharmaceutical Outcomes and Policy, the Dr. Robert and Barbara Crisafi Chair for Medication Safety, and director of the Center for Drug Evaluation and Safety at the University of Florida College of Pharmacy.As an expert in drug safety she has chaired the Food and Drug Administration's Drug Safety and Risk Management Advisory Committee. She also leads the Consortium for Medical Marijuana Clinical Outcomes Research created by Florida's state legislature. I learned so much in talking with her and think you will as well!

Today, we're talking about IMLYGIC® (talimogene laherparepvec or T-VEC).  In my pronunciation episodes, I say a brand drug name and its generic, break both drug names down into syllables, explain which syllable or syllable(s) have the emphasis, reveal the source(s) of my information, and put the written pronunciations of both in the show notes so that you see them and use them right away. The purpose of these pronunciation episodes is to provide the intended pronunciations of drug names from reliable sources. I want you to feel confident saying drug names and less frustrated learning them.   Thank you for listening to episode 159 of The Pharmacist's Voice ® Podcast! To read the full show notes, visit https://www.thepharmacistsvoice.com.  Click on the podcast tab, and search for episode 159.   What is IMLYGIC® (talimogene laherparepvec)?  It's a treatment for a skin cancer called melanoma. IMLYGIC® = imm LY jik (I prefer to write it imm LYE jik.) Verbal/audio pronunciation source:  IMLYGIC® Healthcare Provider Video Written pronunciation source:  IMLYGIC® medication guide on the FDA's website https://www.fda.gov/media/94135/download    T-VEC = T-VEC Pronunciation sources:  none   talimogene laherparepvec = tal IM oh jeen la HER pa REP vek Verbal/audio pronunciation source:  IMLYGIC® Healthcare Provider Video Written pronunciation source:  USP Dictionary Online If you can't access the USP Dictionary Online for a written generic drug name pronunciation, and the drug name wasn't mentioned verbally in a video published by the drug sponsor, you can also call the drug sponsor's drug information department, and ask for help (during normal business hours).  Another option is calling the Division of Drug Information at the FDA's Center for Drug Evaluation and Research during normal business hours.  Calling either may sound intimidating, but if you're a voice actor, and you need to get it right, do the right thing.  Use reliable sources; put drug names into your own words; and say them with confidence.  You can do this! When you can see and hear a drug name pronunciation, it will be easier for you to say.  If you like easy, get both!  If YOU'RE interested in picking a drug name for a future pronunciation episode, please visit www.thepharmacistsvoice.com, and click the contact tab.  Either leave me a voicemail message or type out a written message using the contact form.  I'd love to hear from you! If you know someone who would like this episode or needs to hear it, please share it with them.   Thank you for listening to The Pharmacist's Voice ® Podcast Episode 159!   Thank you USP Legal Department for permission to use written pronunciations from the USP Dictionary Online in my YouTube videos and podcast show notes. Mentioned in this episode The Pharmacist's Voice Podcast Episode 155/Pronunciation Episode 5 The Pharmacist's Voice Podcast Episode Pronunciation 148/Episode 4 The Pharmacist's Voice Podcast Episode 142/Pronunciation Episode 3 The Pharmacist's Voice Podcast Episode 138/Pronunciation Episode 2 The Pharmacist's Voice Podcast Episode 134/Pronunciation Episode 1 IMLYGIC® website (accessed 6-26-22) https://www.imlygic.com  IMLYGIC® Healthcare Provider Video (you can hear the pronunciation of IMLYGIC) IMLYGIC® medication guide on the FDA's website https://www.fda.gov/media/94135/download (you can see the pronunciation of IMLYGIC) Medication Guide tab on IMLYGIC's website USP Dictionary Online (USAN) sales page (you can see the written pronunciation of talimogene laherparepvec.  Division of Drug Information at the FDA/CDER (look at the “Contact Us” section)

About John WhyteJohn Whyte, MD, MPH, is a well-known physician and writer who has spent nearly two decades informing the public about health issues. WebMD's Chief Medical Officer is Dr. Whyte. Whyte leads efforts to build and deepen strategic relationships that result in significant change around critical and relevant public health challenges in this capacity. Prior to joining WebMD, Whyte worked at the US Food and Drug Administration's Center for Drug Evaluation and Research as the director of professional relations and stakeholder engagement. Whyte worked with health care professionals, patients, and patient advocates to provide a focal point for advocacy, improved two-way communication, and collaboration, as well as to assist them in navigating the FDA on matters relating to medication development, review, and safetyLearn more about Previva Health Group:Website: https://previva.com/ LinkedIn: https://www.linkedin.com/company/previva-health-group/Learn more about John Whyte:LinkedIn: https://www.linkedin.com/in/john-whyte-00092833

This week on Pharm5: Monkeypox vaccine for work-related exposure to orthopoxvirus Lymphoma drug Ukoniq (umbralisib) loses FDA approval Psychedelic, synthetic psylocibin tested for use in severe depression Expanding uses for antineoplastic agent azacitidine Addendum to the 2022 Standards of Medical Care in Diabetes References: Use of JYNNEOS (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022. Centers for Disease Control and Prevention. https://bit.ly/3MkpYtq. Published May 27, 2022. Accessed June 2, 2022. FDA withdraws lymphoma drug approval after investigation. Medscape. https://wb.md/3GJIMRw. Published June 1, 2022. Accessed June 2, 2022. Melville NA. Psilocybin effective up to 12 weeks in severe depression. Medscape. https://wb.md/3xeigg5. Published June 2, 2022. Accessed June 2, 2022. DRUGS@FDA: FDA-approved drugs. accessdata.fda.gov. https://bit.ly/3Mr6kvT. Accessed June 2, 2022. Center for Drug Evaluation and Research. FDA approves azacitidine. U.S. Food and Drug Administration. https://bit.ly/3xdSoRw. Published May 20, 2022. Accessed June 2, 2022. FDA approves Ivosidenib/Azacitidine for certain patients with newly diagnosed AML. The ASCO Post. https://bit.ly/3GHaoGY. Published May 26, 2022. Accessed June 2, 2022. Addendum. 10. cardiovascular disease and risk management: Standards of medical care in diabetes–2022. diabetes care 2022;45(suppl. 1):S144–S174. Diabetes Care. May 2022. doi:10.2337/dc22-ad08 Aspirin use to prevent cardiovascular disease: Preventive medication. Recommendation: Aspirin Use to Prevent Cardiovascular Disease: Preventive Medication | United States Preventive Services Taskforce. https://bit.ly/3m93gtn. Published April 26, 2022. Accessed Jun 2, 2022.

This week on Pharm5: FDA and DEA warn of online CII sales Ultomiris (ravulizumab) improves ADLs and QOL for up to 60 weeks in patients with myasthenia gravis Fidaxomicin's biomolecular specificity to C. diffunveiled Sotrovimab has lost its EUA for treatment of COVID-19 Results from Phase II of ASHP's Residency Match Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD References: McCarthy L-J. FDA and DEA warn online pharmacies illegally selling Adderall to consumers. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-and-dea-warn-online-pharmacies-illegally-selling-adderall-consumers. Published April 12, 2022. Accessed April 12, 2022. Ultomiris® (ravulizumab-CWVZ) demonstrated sustained improvements in functional activities and quality of life in adults with generalized myasthenia gravis through 60 weeks. AstraZeneca US. https://www.astrazeneca-us.com/media/press-releases/2022/ultomiris-demonstrated-sustained-improvements-in-functional-activities-and-quality-of-life-in-adults-with-generalized-myasthenia-gravis-through-60-weeks.html. Published April 6, 2022. Accessed April 14, 2022. Ultomiris (ravulizumab-CWVZ). Package insert. Alexion Pharmaceuticals, Inc; 2018. Cao X, Boyaci H, Chen J, Bao Y, Landick R, Campbell EA. Basis of narrow-spectrum activity of fidaxomicin on Clostridioides difficile. Nature. April 2022. doi:10.1038/s41586-022-04545-z Rockefeller University. How a narrow-spectrum antibiotic takes aim at C. Diff. EurekAlert! https://www.eurekalert.org/news-releases/948950. Published April 6, 2022. Accessed April 14, 2022. Center for Drug Evaluation and Research. FDA updates Sotrovimab Emergency Use Authorization. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization. Published April 5, 2022. Accessed April 14, 2022. Person, Kavya B AM. Worldwide covid cases surpass 500 mln as Omicron variant BA.2 surges. Reuters. https://www.reuters.com/business/healthcare-pharmaceuticals/worldwide-covid-cases-surpass-500-mln-omicron-variant-ba2-surges-2022-04-14/. Published April 14, 2022. Accessed April 14, 2022. Schedule of dates. ASHP Match | Schedule. https://natmatch.com/ashprmp/schedule.html. Published April 13, 2022. Accessed April 14, 2022. ASHP Match Statistics. ASHP Match | Statistics of the Match. https://natmatch.com/ashprmp/stats.html. Published April 13, 2022. Accessed April 14, 2022.

This week on Pharm5: CVS and Walgreens lift limits on at-home COVID-19 tests Enjaymo (sutimlimab) approved for use in adults with cold agglutinin disease The FDA's draft guidance for development of non-opioid analgesics is open for public comments until April 11th, 2022 SURPASS-5 shows promising results for A1c lowering and weight loss at 40-weeks with tirzepatide Mark Cuban's CostPlus Drug Company has launched with limited formulary References: Oshin O. CVs, Walgreens remove limits on at-home covid-19 tests. TheHill. https://thehill.com/policy/healthcare/public-global-health/593033-cvs-walgreens-remove-limits-on-at-home-covid-19-tests. Published February 6, 2022. Accessed February 10, 2022. Enjaymo [package insert]. U.S. Food and Drug Administration Website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761164s000lbl.pdf?utm_medium=email&utm_source=govdelivery. Revised February 2022. Cold agglutinin disease. NORD (National Organization for Rare Disorders). https://rarediseases.org/rare-diseases/cold-agglutinin-disease/#:~:text=Cold%20agglutinin%20disease%20(CAD)%20is,subtype%20of%20autoimmune%20hemolytic%20anemia. Published November 17, 2020. Accessed February 10, 2022. Commissioner of the FDA takes steps aimed at fostering development of non-addictive alternatives to opioids for acute pain management. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-aimed-fostering-development-non-addictive-alternatives-opioids-acute-pain-management?utm_campaign=&utm_content=1644424858&utm_medium=FDA%2CU.S.%2BFood%2Band%2BDrug%2BAdministration&utm_source=facebook%2Clinkedin. Accessed February 10, 2022. Center for Drug Evaluation and Research. Development of non-opioid analgesics for acute pain; draft guidance fo. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-acute-pain-draft-guidance-industry. Accessed February 10, 2022. Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous Tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes. JAMA. 2022;327(6):534. doi:10.1001/jama.2022.0078 Costplusdrugs.com. https://costplusdrugs.com/. Accessed February 10, 2022. Connect with us! Listen to our podcast: Pharm5 Watch us on TikTok: @LizHearnPharmD Follow us on Twitter: @LizHearnPharmD