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Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous NephropathyObinutuzumab demonstrated superior complete remission rates at 2 years compared with tacrolimus in primary membranous nephropathy in the phase 3 MAJESTY trial, supporting a potential new B-cell–targeted standard of care.Ixekizumab, Tirzepatide Effective Together for Psoriasis and Obesity or OverweightIn adults with moderate-to-severe plaque psoriasis and obesity or overweight, combination therapy with ixekizumab and tirzepatide achieved superior skin clearance and weight reduction at 36 weeks compared with ixekizumab alone.AREXVY Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSVReal-world data from over 2.5 million patients showed GSK's AREXVY vaccine was 75.6% effective against RSV-related hospitalization, with additional signals suggesting reduced in-hospital major adverse cardiovascular events in older adults.COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRDCOMP360 synthetic psilocybin met the primary endpoint in its second phase 3 trial in treatment-resistant depression, demonstrating significant symptom reduction at week 6 versus low-dose control and advancing toward potential regulatory submission.Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip PlatformPreclinical data using a human liver-on-a-chip model suggest Thykamine may exert dose-dependent antifibrotic and anti-inflammatory effects in MASH, supporting further translational development.

Accurately defining the population of patients with short bowel syndrome (SBS) and intestinal failure has long been a challenge in gastroenterology. In an effort to bring greater clarity to the field, Alan Buchman MD, MSPH, a professor of Clinical Surgery and Medical Director of the Intestinal Rehabilitation and Transplant Center at the University of Illinois at Chicago and director of gastroenterology at Elevance Health, led the introduction of new, more specific ICD-10-CM codes for SBS, along with corresponding updates to World Health Organization ICD-11 classifications. His recent real-world US claims analysis presented at the ASPEN 2026 Nutrition Science and Practice Conference examined how widely those codes have been adopted and what that adoption, or lack thereof, reveals about disease burden and clinical practice.Key Interview Time Stamps0:00:00 What prompted this analysis of ICD code adoption in short bowel syndrome?0:01:17 Key findings 0:03:33 Understanding reasons for variability in code adoption0:04:36 The potential benefits of improved coding accuracy 

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!Top 5 Healthcare Headlines for February 1-7, 2026:1. FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic ReactionsThe FDA issued a Complete Response Letter for sublingual dibutepinephrine after identifying human factors issues that could compromise safe use during anaphylaxis, underscoring the importance of reliable administration in emergency settings.2. Positive Topline Data Released on Roflumilast Cream in Infants with Atopic DermatitisPhase 2 data indicate roflumilast cream was well tolerated in infants with atopic dermatitis and showed early signs of clinical improvement, supporting potential expansion of topical PDE4 inhibition into this very young population.3. FDA Accepts Resubmitted BLA for RelabotulinumtoxinA for Glabellar and Lateral Canthal LinesThe FDA accepted Galderma's resubmitted BLA for relabotulinumtoxinA following manufacturing process updates, allowing regulatory review to resume for treatment of glabellar and lateral canthal lines.4. Upadacitinib Regulatory Applications Submitted for Adults, Adolescents with VitiligoAbbVie submitted regulatory applications seeking to expand upadacitinib use to adults and adolescents with non-segmental vitiligo, positioning a systemic JAK inhibitor as a potential option for this underserved condition.5. VESPER-3: Positive Results of Long-Term GLP-1 PF'3944 in Overweight and Obesity Without T2DPositive phase 2b results suggest Pfizer's long-acting GLP-1 receptor agonist may support sustained weight management with extended dosing intervals in patients without diabetes.

In this episode of Liver Lineup: Updates and Unfiltered Insights, Nancy Reau, MD, and Kimberly Brown, MD, turn their attention to metabolic dysfunction–associated steatotic liver disease (MASLD) and metabolic dysfunction–associated steatohepatitis (MASH), conditions that now dominate hepatology clinics but continue to pose major diagnostic and therapeutic challenges. As new drugs enter the clinic and others advance through the pipeline, the hosts explore what meaningful progress looks like in a disease space defined by heterogeneity, comorbidities, and ongoing uncertainty around long-term outcomes.Key episode timestamps:0:00:00 – Intro + global MASLD burden and mortality; who progresses to severe liver disease.0:03:00 – Very low disease awareness; advanced MASLD often missed.0:06:32 – Weak FIB‑4–based referral patterns; need automated pathways.0:10:54 – Alcohol underreporting; role of PEth in honest discussions.0:15:18 – “Modest” alcohol still harmful in MASLD; no truly safe level.0:19:40 – Semaglutide/GLP‑1 benefits on liver outcomes beyond weight loss.0:23:22 – FGF‑21 agents improving portal hypertension in advanced disease.0:24:03 – Carvedilol less effective for variceal bleed prevention in MASLD.0:28:45 – Closing remarks; call for better disease control and systems of care.

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Nancy Reau, MD, and Kimberly Brown, MD, tackle a paradox that continues to define viral hepatitis care: despite curative therapies for hepatitis C and highly effective suppression for hepatitis B, global and domestic elimination goals remain out of reach. The conversation reframes viral hepatitis not as a “finished” chapter in hepatology, but as an ongoing public health challenge shaped by missed screening, gaps in linkage to care, and uneven adoption of evidence-based interventions.Key episode timestamps:0:00:00 – Hepatitis elimination gaps; dialysis-unit success; primary-care screening barriers.0:04:30 – Statins in HBV/HCV: reduced HCC/decompensation; safety in compensated disease.0:08:41 – GLP‑1 agonists: improved liver outcomes and cancer/cardiometabolic profile; safety concerns addressed.0:13:21 – HBV functional cure and Bepi: niche role, durability, small but meaningful responder group.0:19:28 – HBV/HDV: disease severity; new mAb + siRNA regimen; comparison with existing options; access issues.0:23:28 – Bulevirtide durability data; real‑world compassionate-use case with recompensation and early HCC.

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Kimberly Brown, MD, and Nancy Reau, MD, break down new research on liver transplantation, hepatocellular carcinoma (HCC), and the ongoing evolution of surveillance strategies in chronic liver disease. Drawing on their extensive experience as transplant hepatologists, Brown and Reau place new data into practical context, highlighting where evidence may meaningfully inform practice and where unanswered questions remain.Key episode timestamps:0:00:00 – Introduction0:00:19 – Frailty & Transplant Evaluation0:02:54 – How Centers Use Frailty Measures0:04:37 – Practicalities of the Six‑Minute Walk0:06:10 – MELD 3.0 and Sex/Size Disparities0:08:42 – Exception Points & Size Constraints0:10:05 – Need for a Dynamic MELD System0:10:19 – Immunotherapy as Bridge/Downstaging for HCC0:13:34 – Real‑World Use of IO Around Transplant0:15:22 – Managing Rejection Risk0:19:03 – MASLD Population & Surveillance Gaps0:20:21 – Adherence to HCC Surveillance0:22:42 – Practical Barriers: AFP, Ultrasound, Radiology Reports0:24:02 – Shift Toward Blood-Based Surveillance0:26:01 – How AFP-L3 and DCP Are Used in Practice0:27:39 – Rising AFP, Imaging Strategy & Broader Trend to Blood Tests0:28:27 – Guidelines vs Real-World Practice0:29:37 – Closing Thoughts on Guidelines & Early Detection

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Kimberly Brown, MD, and Nancy Reau, MD, break down several of the most consequential hepatology developments of 2025, focusing on practical advances in the management of patients with advanced liver disease. From renal protection in metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis to long-debated questions around albumin dosing and emerging tools for monitoring hepatic encephalopathy at home, the discussion centers on how new data may begin to shift everyday clinical decision-making.Key episode timestamps:0:00:00 – Dapagliflozin in MASLD cirrhosis with ascites0:04:41 – Clinical perspective on dapagliflozin & management strategy0:06:37 – Albumin for hyponatremia in cirrhosis0:12:28 – How clinicians currently use albumin in practice0:18:43 – Low‑dose vs conventional‑dose albumin in high‑risk SBP 0:25:03 – Beacon device: at‑home critical flicker frequency for HE0:27:47 – Future of at‑home HE monitoring & closing remarks

In this episode of Liver Lineup: Updates & Unfiltered Insights, hosts Nancy Reau, MD, and Kim Brown, MD, take on a recent consequential and controversial public health decision: the US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices' (ACIP) vote to remove the universal birth-dose hepatitis B vaccine recommendation for infants born to mothers who test negative for HBV.Key episode timestamps:0:00:00 – Introduction and initial reactions0:01:40 – Hep B as an anti‑cancer vaccine & global perspective0:03:59 – Transmission, testing gaps, and implementation problems0:07:48 – Infant risk, carrier status, and long‑term protection0:10:14 – Broader health and oncology implications0:11:48 – Personal stance and closing thoughts

In this special edition episode of Liver Lineup, recorded as part of HCPLive's This Year in Medicine series, hosts Nancy Reau, MD, and Kimberly Brown, MD, break down the most consequential updates of the year across primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and autoimmune hepatitis (AIH), highlighting data that may reshape both near-term management and longer-term treatment strategies.Key episode timestamps:0:00:00 – Intro0:00:40 – Underuse of second‑line therapy in PBC0:03:40 – Long‑term data on PPAR agonists (elafibranor, seladelpar) in PBC0:09:35 – PSC: elafibranor (Elmwood trial) and CCL24 mAb (nabokitug)0:15:56 – Cholestasis symptoms: fatigue and pruritus and PPAR impact0:20:20 – Autoimmune hepatitis: limitations of current therapy; new agent 

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by guest Jessica Mellinger, MD, to discuss rising prevalence, new care models, and evolving concepts in alcohol-associated liver disease (ALD).Key episode timestamps:0:00:00 – Introduction0:00:30 – Prevalence of alcohol use & ALD under-recognition0:04:22 – Origin and design of the integrated ALD clinic0:06:50 – Expansion and outcomes of integrated care0:10:33 – Workforce and access challenges0:12:21 – Metabolic ALD (MetALD) concept0:15:18 – GLP‑1 agonists for metabolic disease & AUD0:19:09 – “Food noise,” food addiction, and ultra‑processed foods0:22:38 – Liver transplantation in ALD & Dallas criteria0:27:27 – Outcomes after relapse & closing

In this episode of Liver Lineup: Updates & Unfiltered Insights, host Nancy Reau, MD, sits down with Kris Kowdley, MD, to discuss evolving approaches in cholestatic liver disease, with a particular focus on primary biliary cholangitis (PBC).Key episode timestamps:0:00:00 – Guest intro & evolution of PBC therapy0:07:34 – Redefining biochemical response & earlier assessment0:16:26 – OCA withdrawal & positioning PPARs/fibrates0:22:16 – Diagnosing AMA‑negative PBC0:25:58 – Genetic cholestasis panels & PFIC spectrum0:29:45 – Symptom burden, pruritus, & IBAT inhibitors0:35:17 – Bone health & closing remarks

In this episode of Liver Lineup: Updates and Unfiltered Insights, hosts Nancy Reau, MD, and Kimberly Brown, MD, sit down with Mary (Maru) Rinella, MD, a professor of medicine and director of Clinical Trials and the Metabolic and Fatty Liver Program at the University of Chicago, to discuss the rapidly evolving therapeutic landscape for metabolic dysfunction-associated steatohepatitis (MASH).Key Episode Timestamps:0:00:00 – Introduction & guest bio0:01:02 – Current therapy landscape & GLP‑1 overview0:03:51 – Do GLP‑1s help non–weight losers?0:05:21 – Combining GLP‑1s and resmetirom0:07:23 – Pipeline GLP‑1 combinations & phase 2 data0:09:26 – Advanced disease, sarcopenia & risk–benefit in cirrhosis0:13:29 – Introduction to FGF‑21 agonists0:14:04 – Symmetry (efruxifermin) trial & reading the data0:17:51 – Endpoints, “lack of progression,” and FDA hurdles0:19:41 – Need for non‑invasive surrogates0:21:02 – FGF‑21 mechanism & other liver diseases0:22:57 – Alcohol intake, GLP‑1s, FGF‑21 & MetALD0:25:49 – 10‑year outlook & future toolbox0:27:35 – Closing

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!Top 5 Healthcare Headlines for January 18-24, 2025:1. Phase 2 Data Show NS002 Intranasal Epinephrine Acts Faster Than EpiPenInterim phase 2 data suggest NS002 intranasal epinephrine may provide more rapid systemic exposure than intramuscular autoinjectors, supporting its potential as a needle-free option for anaphylaxis management.2. AHA 2026 Heart Disease and Stroke Statistics: Progress and Pitfalls, With Latha Palaniappan, MD, MSThe AHA's 2026 Heart Disease and Stroke Statistics highlight persistent gaps in cardiovascular prevention and outcomes despite advances in treatment, with continued emphasis on heart disease and stroke as leading causes of mortality in the US.3. New CHEST Recommendations Guide Biologic Use for Severe AsthmaCHEST released updated guidance to help clinicians individualize biologic selection for severe asthma based on patient characteristics, disease phenotype, and available evidence.4. Topical Steroid Concerns in Dermatology Highlighted in Nationwide SurveyA nationwide survey underscores widespread patient and caregiver concerns about long-term topical steroid use in chronic inflammatory skin diseases and a perception that current management strategies are largely reactive rather than preventive.5. Amlitelimab Effective, Safe for Atopic Dermatitis in Patients 12 Years and OlderPhase 3 data show amlitelimab was effective and well tolerated in adolescents and adults with moderate-to-severe atopic dermatitis, supporting its role as a targeted, non–T-cell-depleting biologic option.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!Top 5 Healthcare Headlines for January 11-17, 2025:1. FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2DThe FDA cleared Medtronic's MiniMed Go Smart MDI app for pediatric and adult patients with type 1 or type 2 diabetes, enabling integrated smart pen and sensor–based decision support to improve insulin dosing with multiple daily injections.2. FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDDThe FDA approved ProlivRx as the first at-home, physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded adequately to antidepressant treatment.3. FDA Requests Removal of Suicidal Ideation and Behavior Warning From GLP-1 RA TherapiesThe FDA requested removal of suicidal ideation and behavior warnings from GLP-1 receptor agonist labels after determining there is no increased risk associated with these therapies.4. FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental GlomerulosclerosisThe FDA extended the review timeline for sparsentan's supplemental NDA in focal segmental glomerulosclerosis, delaying the PDUFA decision without requesting additional safety or manufacturing data.5. FDA Approves New Narcan Packaging, Aiming to Boost Carry RatesThe FDA approved new, more portable packaging for over-the-counter Narcan nasal spray to improve usability, reduce stigma, and increase the likelihood that naloxone is carried and available during overdose emergencies.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!Top 5 Healthcare Headlines for January 3-10, 2025:Here are one-sentence, clinician-focused summaries with titles restated and no statistics included:1. FDA Approves Caplacizumab-yhdp (Cablivi) as First Pediatric aTTP TherapyThe FDA approved caplacizumab for adolescents with aTTP, making it the first therapy specifically indicated for pediatric patients with this condition.2. Pemvidutide Gets Breakthrough Therapy Designation for MASHThe FDA granted Breakthrough Therapy Designation to pemvidutide for MASH, supporting its accelerated development based on promising mid-stage clinical data and alignment on a registrational phase 3 program.3. FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA NephropathyThe FDA granted Priority Review to the BLA for atacicept, advancing a potential new biologic therapy for adults with IgA nephropathy.4. FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen DeficiencyThe FDA approved a higher-dose presentation of Fibryga, expanding dosing flexibility for fibrinogen replacement in patients with acquired fibrinogen deficiency.5. FDA Accepts for Priority Review sBLA for Teplizumab for Children With Stage 2 T1DThe FDA accepted a Priority Review sBLA for teplizumab to expand its use to younger children in order to delay progression to clinical type 1 diabetes.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for December 28-January 3, 2025: 1. FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care The FDA granted 510(k) clearance to StimLabs' Theracor, marking the first umbilical cord–derived wound care device available in a sheet formulation. 2. FDA Approves Tradipitant (NEREUS) for the Prevention of Vomiting Induced by Motion The FDA approved tradipitant as the first new pharmacologic option in decades for preventing motion sickness–related vomiting. 3. FDA Issues Complete Response Letter for Relacorilant for Hypercortisolism The FDA issued a CRL for relacorilant, citing the need for additional evidence of effectiveness despite positive findings from completed trials. 4. FDA Issues Complete Response Letter for ONS-5010 for Wet AMD The FDA again declined approval of ONS-5010 for wet AMD, reiterating that confirmatory evidence of efficacy is required to support the application. 5. FDA Accepts, Grants Priority Review to AXS-05 sNDA for Alzheimer's Disease Agitation The FDA accepted and granted Priority Review to the sNDA for AXS-05, advancing a potential new treatment option for agitation in Alzheimer's disease.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for October 12-18, 2025: 1. FDA Accepts Inhaled Insulin (Afrezza) sBLA for Pediatric Diabetes The FDA accepted MannKind's sBLA for Afrezza inhaled insulin to expand its use to children and adolescents with type 1 or type 2 diabetes. 2. FDA Approves Updated Indication for Upadacitinib (Rinvoq) in IBD The FDA broadened upadacitinib's indication to allow use in ulcerative colitis and Crohn disease when tumor necrosis factor blockers are not clinically appropriate. 3. FDA Clears First Blood Test to Rule Out Alzheimer-Related Amyloid Pathology The FDA cleared Elecsys pTau181 as the first blood test to help rule out Alzheimer-related amyloid pathology in older adults with cognitive symptoms. 4. Digital Therapeutic Reduces Negative Symptoms of Schizophrenia in Phase 3 Trial A phase 3 study showed a prescription digital therapeutic significantly reduced negative symptoms in schizophrenia when used alongside antipsychotic therapy. 5. APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint Iptacopan demonstrated meaningful efficacy in slowing kidney function decline in adults with IgA nephropathy, supporting future regulatory submissions.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for October 5-11, 2025: 1. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years The FDA approved roflumilast cream 0.05% for mild to moderate atopic dermatitis in children aged 2–5 years, expanding Arcutis' roflumilast portfolio. 2. Nerandomilast Nets First New FDA Approval for Idiopathic Pulmonary Fibrosis in Over 10 Years Nerandomilast became the first newly approved therapy for idiopathic pulmonary fibrosis in over a decade, offering a well-tolerated option that slows lung function decline. 3. LUCENT-3: Mirikizumab (Omvoh) Shows Sustained Benefit in Ulcerative Colitis Through 4 Years Long-term data confirmed mirikizumab provides durable clinical, endoscopic, and quality-of-life benefits for ulcerative colitis up to four years, even in patients who failed prior advanced therapy. 4. Bax24: Baxdrostat Achieves Primary Endpoint in Treatment-Resistant Hypertension Baxdrostat met its primary endpoint in a phase 3 trial for treatment-resistant hypertension, supporting its potential role as a new option for difficult-to-control blood pressure. 5. Topical Bimiralisib Shows 92% Clearance Rate for Patients with Actinic Keratosis  Phase 2 data showed topical bimiralisib achieved high lesion clearance with favorable tolerability in patients with actinic keratosis.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for September 28-October 4, 2025: FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis The FDA approved guselkumab as the first IL-23 inhibitor for children ≥6 years with moderate-to-severe plaque psoriasis or active psoriatic arthritis. FDA Approves Remibrutinib for Chronic Spontaneous Urticaria Remibrutinib, a selective BTK inhibitor, gained FDA approval for adults with chronic spontaneous urticaria based on sustained efficacy in phase 3 trials. Novo Nordisk Resubmits Insulin Icodec (Awiqli) Injection BLA for Type 2 Diabetes Novo Nordisk resubmitted its once-weekly insulin icodec BLA for type 2 diabetes after addressing prior FDA concerns. Novo Nordisk Submits Denecimig (Mim8) BLA for Hemophilia A Novo Nordisk filed a BLA for denecimig as prophylaxis for hemophilia A, supported by FRONTIER program data. VESALIUS-CV: Evolocumab (Repatha) Achieves Primary Endpoints in Patients with ASCVD Evolocumab reduced major cardiovascular events in ASCVD patients without prior MI or stroke in the phase 3 VESALIUS-CV trial.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for September 5-September 14, 2025: 1. FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA The FDA determined no advisory committee is needed for sparsentan's sNDA in FSGS, which remains under review with a January 2026 decision date. 2. Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market Intercept will withdraw obeticholic acid from the US PBC market after an FDA request and related clinical trial holds. 3. FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials The FDA accepted a proposal to qualify FibroScan liver stiffness measurement as a surrogate endpoint for MASH trials, supported by multiple industry partners. 4. FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD eGenesis received FDA clearance to begin clinical testing of a genetically engineered porcine kidney transplant in patients with ESKD. 5. First in Class Cat, Birch Allergen Blockers Succeed in Phase 3 Trials Regeneron reported phase 3 success for novel allergen-blocking antibodies targeting cat and birch allergies, with confirmatory trials planned.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for August 31-September 5, 2025: 1. Mitapivat PDUFA for Thalassemia Delayed to December  The FDA extended the review timeline for mitapivat in thalassemia, with a new decision date set for December 2025. 2. Arcutis Submits sNDA for Roflumilast Cream 0.3% for Psoriasis in Children Aged 2-5 Years Arcutis submitted an sNDA seeking to expand roflumilast cream's indication to include plaque psoriasis in children as young as 2. 3. Zilebesiran, RNAi for Hypertension, Heads to Phase 3 Cardiovascular Outcomes Trial Alnylam is advancing zilebesiran into a phase 3 outcomes trial to evaluate its impact on cardiovascular risk in patients with uncontrolled hypertension. 4. RestorAATion-2: WVE-006 Achieves Durable Serum AAT Protein Production in AATD Wave Life Sciences reported durable serum AAT protein production with WVE-006 in AATD, supporting its potential for disease modification. 5. Phase 3 Data Show Amlitelimab Effective in Adults, Adolescents with Atopic Dermatitis Sanofi announced phase 3 results showing amlitelimab improved disease severity and skin clearance in moderate-to-severe atopic dermatitis.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! FDA Accepts Priority Review Application of Omidubicel for Severe Aplastic Anemia  The FDA accepted a priority review application for omidubicel, a cell therapy under investigation for severe aplastic anemia. FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy  The FDA approved an updated REMS label for sparsentan, easing monitoring requirements for patients with IgA nephropathy. FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD The FDA issued a complete response letter for ONS-5010 in wet AMD, citing insufficient efficacy evidence from the phase 3 program. ACC Releases Respiratory Disease Vaccination Guidelines for Adults with Heart Disease The ACC released new guidance recommending vaccination against respiratory infections for adults with cardiovascular disease to improve prevention and access. Orforglipron Delivers Weight Loss, A1C Reductions in Phase 3 ATTAIN-2 Trial Eli Lilly reported phase 3 results showing orforglipron improved weight and glycemic control in adults with obesity or overweight and type 2 diabetes.

In this podcast, expert Suneel Udani, MD, discusses the management of chronic kidney disease (CKD) and CKD-associated fluid overload, including an overview of treatment guidelines and various available therapies.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for August 17-23, 2025: 1. FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks The FDA approved donidalorsen (DAWNZERA) for preventing HAE attacks in patients 12 years and older, supported by phase 3 OASIS trial data. 2. FDA Grants Atumelnant Orphan Drug Designation for Congenital Adrenal Hyperplasia Atumelnant received FDA Orphan Drug Designation after phase 2 results showed rapid, sustained reductions in key biomarkers for congenital adrenal hyperplasia. 3. Semaglutide Reduces Medical Costs, Healthcare Resource Utilization in Heart Failure A real-world analysis found semaglutide 2.4 mg reduced all-cause medical costs by 28% and inpatient hospitalization costs by 55% in patients with obesity and heart failure. 4. RE104 Reduces Postpartum Depression Symptoms by Day 7 in Phase 2 RECONNECT RE104 significantly reduced depressive symptoms by day 7 in patients with postpartum depression, meeting the phase 2 RECONNECT trial's primary endpoint. 5. Dyslipidemia, Other Metabolic Syndrome Factors May Raise Parkinson's Disease Risk People with metabolic syndrome had about a 40% higher risk of developing Parkinson's disease compared with those without the condition.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for August 10-16, 2025: FDA Approves 2 Generic Iron Sucrose Injections for Iron Deficiency Anemia in CKD  The FDA approved 2 generic versions of iron sucrose injection for treating iron deficiency anemia in patients with CKD, expanding access to therapy. FDA Approves PharmaTher's Ketamine for Surgical Pain Management  The FDA approved PharmaTher's ketamine formulation for surgical pain management following resolution of earlier application deficiencies. HFSA and ASPC Release Statement on Shifting to Prevention in Heart Failure  The HFSA and ASPC issued a joint statement urging clinicians to prioritize prevention and early risk management in heart failure care. Zopapogene Imadenovec First Immunotherapy Approved for Recurrent Respiratory Papillomatosis  The FDA approved zopapogene imadenovec as the first immunotherapy for recurrent respiratory papillomatosis, offering a new treatment option. AHA & ACC Release New Guidelines for High Blood Pressure to Reduce CVD Risk  The AHA and ACC released updated hypertension guidelines recommending earlier intervention to lower cardiovascular disease risk.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for August 3-9, 2025: FDA Approves Fremanezumab to Prevent Episodic Migraine in Children The FDA has expanded fremanezumab's indication to include pediatric patients 6–17 years old, making it the first CGRP antagonist approved for preventing episodic migraine in this population. ATTAIN-1: Orforglipron Achieves Up to 12% Weight Loss in Phase 3 Obesity Trial  Orforglipron, an investigational oral GLP-1 receptor agonist, met all primary and secondary endpoints in phase 3, supporting its potential as a weight-management therapy. Oral Berotralstat Shows Strong Safety, Efficacy in Young Children with HAE Interim phase 3 data support oral berotralstat as a safe and effective prophylactic therapy for hereditary angioedema in children aged 2–11 years. Aflibercept 8mg Noninferior to Aflibercept 2mg in Diabetic Macular Edema  Aflibercept 8 mg demonstrated noninferior visual acuity outcomes to 2 mg dosing in DME, with potential for reduced injection frequency. Despite Advances, IBS Continues to Impact Patients' Daily Lives, Productivity  A new national survey reveals ongoing quality-of-life and productivity burdens among IBS patients despite greater awareness and expanded treatment options.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for July 7-13, 2025: FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More Finerenone (Kerendia) was approved on July 14, 2025, to reduce cardiovascular death and heart failure hospitalizations in adults with HFmrEF or HFpEF, based on data from the FINEARTS-HF trial. Baxdrostat Meets Efficacy Endpoint in Phase 3 Trial for Resistant Hypertension In the phase 3 BaxHTN trial, baxdrostat significantly reduced systolic blood pressure in patients with resistant hypertension, supporting its potential as a first-in-class aldosterone synthase inhibitor. FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease The FDA approved an updated irrigation flow rate for the VARIPULSE Platform, which has been used in over 10,000 procedures with a reported neurovascular adverse event rate of less than 0.5%. Palopegteriparatide Provides Sustained Response in Adults with Hypoparathyroidism Palopegteriparatide showed durable 3-year improvements in biochemistries, kidney function, and quality of life across all forms of hypoparathyroidism in the phase 3 PaTHway trial. FDA Grants Orphan Drug Designation to Taladegib, Potential Idiopathic Pulmonary Fibrosis Treatment Taladegib received Orphan Drug Designation on July 16, 2025, as a potential treatment for idiopathic pulmonary fibrosis, currently being studied in the phase 2b WHISTLE-PF trial.

In this episode, hosts Kimberly Brown, MD, and Nancy Reau, MD, discuss the progress and persistent challenges in eliminating hepatitis C (HCV). With highly effective, short-course oral therapies now available, Brown and Reau emphasize that curing HCV is more achievable than ever. The discussion explores the major policy, clinical, and structural milestones enabling this effort—and the critical gaps in diagnosis, treatment access, and health policy that still impede progress.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for June 30-July 6, 2025: Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema The FDA approved sebetralstat (Ekterly) on July 7, 2025, as the first oral, on-demand treatment for hereditary angioedema attacks in patients aged 12 and older, backed by phase 3 KONFIDENT trial data. Rilparencel Improves eGFR Slope in Phase 2 CKD, Diabetes REGEN-007 Trial Rilparencel significantly slowed kidney function decline in CKD patients with diabetes in the REGEN-007 trial, showing dose-responsive eGFR slope improvements after two injections per kidney. J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse J&J filed a supplemental NDA for lumateperone after phase 3 data showed a 63% reduction in schizophrenia relapse risk compared to placebo. FDA Publishes CRLs for Past Drug, Biological Product Applications The FDA publicly released over 200 Complete Response Letters from 2020–2024 to increase regulatory transparency and help accelerate future drug approvals. FDA Grants TSND-201 Breakthrough Therapy Designation for PTSD TSND-201 (methylone) received Breakthrough Therapy designation for PTSD on July 10, 2025, offering a potential rapid-acting alternative to SSRIs, which can take up to 12 weeks for full effect.

In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Roland Mattern, director of marketing for eSight, about the development and clinical potential of the eSight Go – a fifth-generation wearable low-vision device designed to enhance central visual function in patients with conditions such as macular degeneration, diabetic retinopathy, and Stargardt's disease. 00:00 - Intro 02:06 - History of eSight 05:43 - Difference Between 4th and 5th Generation eSight Go 07:51 - Patient Experiences with the eSight Go 10:22 - Returning to Daily Life with the eSight Go 13:27 - Why Retina Specialists Don't Hear About the eSight Go 17:07 - Next Steps for eSight

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for June 16-22, 2025: Pemvidutide Shows Significant MASH Effects, Weight Loss at 24 Weeks in Phase 2b IMPACT Trial Topline phase 2b data show pemvidutide achieved significant rates of MASH resolution and fibrosis improvement alongside meaningful weight loss at 24 weeks, positioning it as a promising candidate for metabolic liver disease treatment. FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis The FDA approved a belimumab autoinjector for at-home subcutaneous use in children as young as five with active lupus nephritis, providing the first approved biologic self-injection option for pediatric SLE and LN. Phase 3 Trial Results Announced for Sotatercept-csrk in Pulmonary Arterial Hypertension Positive phase 3 results show sotatercept-csrk added to background therapy reduced time to clinical worsening events in adults with PAH, supporting its potential as an effective treatment for this high-risk population. Compass Pathways' COMP360 Psilocybin Shows Benefit in Phase 3 TRD Trial COMP360 psilocybin demonstrated a significant reduction in depression symptom severity in treatment-resistant depression, meeting the primary endpoint in a pivotal phase 3 trial. Once-Monthly Obesity Drug, MariTide, Achieves Weight Loss Up to 16% at 1 Year Phase 2 data indicate once-monthly MariTide induces substantial weight loss of up to 16% over one year, with additional improvements in glycemic control, highlighting its promise for obesity and type 2 diabetes management.

In this episode of Medical Ethics Unpacked, hosts Dominic Sisti and Steve Levine welcome Jason Schwartz, PhD, associate professor at the Yale School of Public Health, for a discussion on vaccine ethics, public health infrastructure, and the challenges of maintaining trust in immunization programs. Together, they explore how the COVID-19 pandemic reshaped public attitudes toward vaccines, while also underscoring long-standing tensions between individual autonomy and collective responsibility. Schwartz, whose work focuses on vaccine policy and history, offers perspective on the systems and institutions, such as the CDC's Advisory Committee on Immunization Practices (ACIP), helping to translate scientific evidence into public health recommendations. This episode comes at a time when ACIP is once again in the headlines as HHS Secretary Robert F. Kennedy Jr. recently replaced all 17 members with a new slate of individuals, citing concerns about groupthink and conflicts of interest. The move has generated widespread commentary about the role and value of such expert advisory bodies in shaping public health decisions, especially in the face of growing skepticism and political scrutiny. Ethical questions about equity, communication, and responsibility are threaded throughout the discussion. The hosts and Schwartz reflect on what it means to make fair vaccine recommendations in the context of incomplete data, and how institutions can maintain public trust amid scientific uncertainty. They also discuss how the infrastructure behind public health decisions—committees, advisory boards, and interagency coordination—can either strengthen or undermine confidence depending on how they function and how well they are understood. Chapters 00:00 – Introduction and Vaccine Policy in Crisis 03:00 – The Long History and New Politics of Vaccine Skepticism 09:30 – Erosion of Public Health Infrastructure and Expert Advisory Systems 14:50 – Why Vaccines Became a Political Flashpoint 19:10 – Clinician Ethics and the Vaccine-Hesitant Patient 32:00 – Data, Misinformation, and the Future of Vaccine Trust References: Stone W. RFK Jr. names new slate of vaccine advisers after purging CDC panel. NPR. Published June 11, 2025. Accessed June 17, 2025. https://www.npr.org/sections/shots-health-news/2025/06/11/nx-s1-5430870/cdc-vaccine-experts-rfk-jr Asturias EJ, Brewer NT, Brooks O, et al. Advisory Committee on Immunization Practices at a Crossroads. JAMA. Published online June 16, 2025. doi:10.1001/jama.2025.10776

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for June 2-8, 2025. FDA Approves Clesrovimab RSV Immunization for Newborns and Infants The FDA has approved clesrovimab (Enflonsia) for the prevention of RSV lower respiratory tract disease in infants, based on results from two late-stage clinical trials evaluating its safety and efficacy. FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV The FDA has expanded the indication for glecaprevir/pibrentasvir to include treatment of acute hepatitis C virus infection in adults and children aged three years and older, regardless of cirrhosis status. FDA Approves Prednisolone Acetate Ophthalmic Suspension for Ocular Inflammation Prednisolone acetate ophthalmic suspension 1% has received FDA approval as a topical steroid treatment for steroid-responsive ocular inflammation, with product launch expected later in 2025. FDA Grants Fast Track Designation to Mavorixafor for Chronic Neutropenia The FDA has granted Fast Track designation to mavorixafor for the treatment of chronic neutropenia, supporting its ongoing phase 3 evaluation following earlier approval for WHIM syndrome. Iptacopan (Fabhalta) Hits Primary Endpoint in Phase 3 APPULSE-PNH Trial Phase 3 data show iptacopan (Fabhalta) is effective and well-tolerated in adults with PNH who transitioned from anti-C5 therapy, achieving key hematologic outcomes and symptomatic improvement.

In this episode of Liver Lineup: Updates & Unfiltered Insights, hosts Kimberly Brown, MD, a professor of Medicine at Michigan State University and Wayne State University, associate medical director of the Henry Ford Hospital Transplant Institute, and medical director of Transplant Outreach Services at Henry Ford Hospital, and Nancy Reau, MD, a professor of internal medicine, the Richard B. Capps Chair of Hepatology, associate director of solid organ transplantation, and the section chief of hepatology at Rush University Medical Center, continue their discussion on notable abstracts presented at the 2025 European Association for the Study of the Liver (EASL) Congress. If you haven't already, be sure to check out part 1 here! Key Episode Timestamps 0:00:00 LITMUS Study 0:05:47 Norursodeoxycholic Acid in PSC 0:10:12 GLOBE Score for PBC 0:15:11 Conclusion Arbutus, and VIR. Relevant disclosures for Brown include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal.

In this episode of Liver Lineup: Updates & Unfiltered Insights, hosts Kimberly Brown, MD, a professor of Medicine at Michigan State University and Wayne State University, associate medical director of the Henry Ford Hospital Transplant Institute, and medical director of Transplant Outreach Services at Henry Ford Hospital, and Nancy Reau, MD, a professor of internal medicine, the Richard B. Capps Chair of Hepatology, associate director of solid organ transplantation, and the section chief of hepatology at Rush University Medical Center, highlight 4 key abstracts presented at the 2025 European Association for the Study of the Liver (EASL) Congress. Key Episode Timestamps 00:00:01 Introduction 00:00:45 Efimosfermin Alfa in MASH 00:05:56 PEth Testing 00:13:19 RETRACT-B 00:20:44 Linerixibat in PBC Relevant Disclosures for Reau include AbbVie, Gilead, Salix, Arbutus, and VIR. Relevant disclosures for Brown include Mallinckrodt Pharmaceuticals, Gilead, Salix, Intercept, Ipsen, and Madrigal.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for May 12-18, 2025. FDA Approves Once-Daily Roflumilast (ZORYVE) Foam 0.3% for Scalp and Body Psoriasis The FDA approved once-daily roflumilast (Zoryve) foam 0.3% for treating plaque psoriasis on the scalp and body in patients aged 12 and older. This marks the fifth overall indication for roflumilast, adding to its existing approvals in psoriasis and atopic dermatitis. FDA Warns About Rare, Severe Itching After Stopping Cetirizine or Levocetirizine The FDA issued a warning about severe pruritus that can occur after stopping long-term cetirizine or levocetirizine use. Manufacturers will be required to add a label warning noting that symptoms may improve if the medications are restarted. FDA Approves Susvimo for Treatment of Diabetic Retinopathy The FDA approved Genentech's Susvimo, a ranibizumab delivery system, as the first continuous refillable treatment for diabetic retinopathy. Susvimo offers sustained vision maintenance with refills needed only once every nine months. Olezarsen Cuts Triglyceride Levels at 6 Months in Essence Study The Essence study showed olezarsen significantly reduced triglyceride levels in patients with moderate hypertriglyceridemia at ASCVD risk. Monthly doses achieved about 60% reductions, with most patients reaching normal triglyceride levels after six months. Ruxoprubart Shows Efficacy for PNH in Interim Phase 2 Trial Results Interim Phase 2 results showed ruxoprubart met all primary efficacy endpoints in adults with paroxysmal nocturnal hemoglobinuria. The therapy led to transfusion avoidance, improved hemoglobin, reduced LDH, and increased PNH clone size at 12 weeks.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for May 5- 11, 2025: FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis The FDA will review Travere Therapeutics' application for full approval of sparsentan in FSGS, with an advisory committee meeting planned ahead of a January 2026 decision. FDA Accepts BioCryst's NDA for Berotralstat Oral Granules in Children With HAE The FDA is evaluating berotralstat oral granules for pediatric hereditary angioedema, which could become the first oral preventive therapy for children under 12. SURMOUNT-5: Tirzepatide (Zepbound) Proves Benefit over Semaglutide (Wegovy) for Obesity Tirzepatide demonstrated superior weight loss outcomes compared with semaglutide in the SURMOUNT-5 trial for patients with obesity. Crinecerfont Reduces Steroid Use for Pediatric CAH in Phase 3 Analysis Crinecerfont lowered steroid requirements while maintaining hormone control in children with classic congenital adrenal hyperplasia, regardless of baseline characteristics. Type 1 Diabetes Diagnosed in Adulthood Heightens Cardiovascular Risk Adults diagnosed with type 1 diabetes face increased cardiovascular and all-cause mortality risks, regardless of age at diagnosis, according to long-term national data.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for April 28-May 4, 2025: Obicetrapib Achieves Robust LDL-C Reductions in Phase 3 ASCVD Trials Obicetrapib significantly reduced LDL-C as monotherapy and in combination with ezetimibe in ASCVD patients inadequately controlled by statins, according to Phase 3 data presented at EAS 2025. MAR001 Cuts Remnant Cholesterol, Triglycerides by 50% in Phase 2a Trial MAR001, a novel ANGPTL4-targeting monoclonal antibody, reduced remnant cholesterol and triglycerides by over 50% in high-risk patients, suggesting a promising new cardiovascular intervention strategy. Oral Zervimesine Reduces Geographic Atrophy Lesion Growth in Phase 2 Trial Zervimesine (CT1812) slowed lesion progression in geographic atrophy secondary to AMD in Phase 2 MAGNIFY trial results, offering a potential oral treatment option. UBX1325 Matches Aflibercept in Vision Gains for DME at 36 Weeks UBX1325 demonstrated noninferiority to aflibercept in visual acuity gains in patients with diabetic macular edema over 36 weeks in the Phase 2b ASPIRE study. Roflumilast Foam 0.3% for Scalp, Body Psoriasis Effective, Safe for Patients Roflumilast foam 0.3% achieved significant efficacy and rapid symptom control in scalp and body psoriasis, with an FDA decision expected by late May 2025.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for April 21-April 27, 2025: FDA Approves Pz-cel (Zevaskyn) Gene Therapy for RDEB The FDA has approved pz-cel, the first autologous gene therapy for RDEB, following pivotal Phase 3 data demonstrating efficacy and safety in wound healing. FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis Upadacitinib has been approved for giant cell arteritis, supported by Phase 3 data showing its potential to induce sustained remission and reduce corticosteroid reliance. FDA Approves Nipocalimab Generalized Myasthenia Gravis for Adults, Children Nipocalimab received FDA approval for gMG in antibody-positive patients aged ≥12, expanding therapeutic options across major serotypes. Semaglutide Improves Steatohepatitis, Fibrosis in Phase 3 MASH Trial Phase 3 trial results show semaglutide significantly improves steatohepatitis and fibrosis markers in patients with MASH, without worsening liver histology. Increased Fasting Blood Glucose Triples Risk of Heart Damage in Adolescents International data links elevated fasting glucose and insulin resistance in adolescence to markedly increased future risk of heart damage, especially among females.

Introducing Liver Lineup: Updates & Unfiltered Insights — an exciting new podcast delivering timely, candid perspectives on the most pressing topics in the fast-moving world of hepatology. Created by Nancy Reau, MD, and Kimberly Brown, MD, and hosted by HCPLive, this series dives into the cutting edge of liver disease research, clinical care, and real-world practice. Intended for hepatologists, gastroenterologists, and other clinicians managing liver disease, Liver Lineup will unpack the latest research, debate emerging controversies, and spotlight developments that could shape — or sharpen — day-to-day practice, all with unfiltered perspective and clarity. Brown is division chief of gastroenterology and hepatology and the Associate Medical Director of the Henry Ford Hospital Transplant Institute at Henry Ford Hospital. She is also a Professor of Medicine at Wayne State University Reau is a professor of internal medicine, the Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and the section chief of Hepatology at Rush University Medical Center. In the inaugural episode, Brown and Reau introduce the mission behind Liver Lineup and share why they created the podcast. Driven by a shared commitment to education, clinical excellence, and elevating the conversation around liver disease, the hosts describe their hope to offer practicing clinicians a clear, concise, and engaging way to keep up with the latest news and innovations in hepatology. They aim to highlight data that's not only new, but meaningful — spotlighting developments that can improve patient care today and shape best practices tomorrow. Together, the Brown and Reau set the stage for what's to come: expert commentary on major liver meetings including Digestive Disease Week, European Association for the Study of the Liver Congress, The Liver Meeting from the American Association for the Study of Liver Diseases, and the American College of Gastroenterology Annual Meeting; coverage of key topics like MASLD, liver cancer, viral hepatitis, and transplant; and conversations with colleagues across the hepatology spectrum. From debates over practice-changing data to discussions on care pathways and diagnostics, Liver Lineup aims to keep clinicians informed, engaged, and ready to translate insight into impact. Looking ahead, Brown and Reau preview upcoming episodes covering major hepatology updates from Digestive Disease Week 2025 and European Association for the Study of the Liver Congress 2025 — with more to follow throughout the year.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for March 31-April 6, 2025: Cedars-Sinai Study Finds AI Tool Could Improve Care in Virtual Urgent Care Settings A Cedars-Sinai study suggests AI tools may enhance guideline adherence and decision-making quality in virtual urgent care, though clinician oversight remains essential. FDA Accepts Biologics License Application for ONS-5010 for Wet AMD The FDA has accepted a resubmitted BLA for ONS-5010, a proposed ophthalmic formulation of bevacizumab for wet AMD, advancing it toward potential approval. Socioeconomic Status Impacts Pediatric Preemptive Kidney Transplant Rates, Study Finds A retrospective study linked lower socioeconomic status to reduced access to preemptive kidney transplants in pediatric patients, underscoring ongoing disparities in care. FDA Clears Dexcom G7 15 Day CGM System The FDA has cleared the Dexcom G7 CGM system for 15-day use in adults, offering extended wear and continued improvements in diabetes monitoring technology. Icotrokinra Clears Skin Among 75% of Adolescents with Plaque Psoriasis New phase 3 data show once-daily icotrokinra improves skin clearance and maintains a favorable safety profile in adolescents with moderate-to-severe plaque psoriasis.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 Healthcare Headlines for March 23-30, 2025: Zetomipzomib Shows Promise for Autoimmune Hepatitis in Phase 2a PORTOLA Trial Zetomipzomib demonstrated steroid-sparing biochemical remissions in refractory autoimmune hepatitis patients, aligning with AASLD treatment guidelines in the Phase 2a PORTOLA trial. Solriamfetol Significantly Reduces ADHD Symptoms in Axsome's Phase 3 Trial Solriamfetol met its primary endpoint in the Phase 3 FOCUS trial, significantly improving ADHD symptoms, with a higher proportion of patients achieving clinical response compared to placebo. Sozinibercept for Wet AMD Misses Primary Endpoint in Phase 3 COAST Trial Sozinibercept combined with aflibercept failed to meet the primary endpoint for visual acuity improvement in wet AMD, showing no added benefit over aflibercept monotherapy. FDA Approves Gepotidacin (Blujepa) for Uncomplicated UTI The FDA approved gepotidacin for uncomplicated urinary tract infections based on Phase 3 trials demonstrating non-inferiority to nitrofurantoin in female adults and adolescents. FDA Issues CRL for Etripamil Nasal Spray (Cardamyst) in PSVT The FDA issued a Complete Response Letter for etripamil nasal spray, citing manufacturing and control issues while confirming no concerns regarding its clinical safety or efficacy.

Welcome back to New Insight with Veeral Sheth, MD! Veeral Sheth, MD, is joined by Rich Small, the CEO of Neurotech, to discuss the historic approval of revakinagene taroretcel (ENCELTO) a groundbreaking encapsulated cell therapy for macular telangiectasia type 2 (MacTel). This approval marked the first and only FDA–approved treatment for MacTel, a neurodegenerative disease of the retina that can cause progressive and irreversible vision loss. Speaking with Sheth, Small recounted the long journey of Neurotech, which began in 2007, emphasizing the perseverance required to bring ENCELTO to market. He detailed his transition from Chief Financial Officer to CEO in 2016 and highlighted his team's commitment, many of whom have been with the company for over a decade. The conversation explored the scientific foundation of ENCELTO, which uses genetically modified cells to release neurotrophic factors that protect photoreceptors in the retina. Unlike previous treatments that relied on best corrected visual acuity (BCVA) as a clinical endpoint, ENCELTO's approval was enabled by advancements in imaging technology that allowed for direct measurement of photoreceptor health. Sheth and Small discussed the ideal patient profile for ENCELTO, noting that early intervention is key to preserving vision in MacTel patients. With ENCELTO's approval secured, Small indicated the next step is widespread adoption, introducing ENCELTO.com as a patient service hub designed to streamline diagnosis, treatment, and access to care.  #Ophthalmology #Podcast #RareDisease

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! New ACP Guidelines Recommend Adding Triptan to NSAID or Acetaminophen for Migraines The American College of Physicians now recommends adding a triptan to NSAIDs or acetaminophen for moderate to severe acute migraines and urges clinicians to initiate combination therapy early. Automated Insulin Delivery Effectively Lowers HbA1c in Type 2 Diabetes  Tandem Diabetes Care's Control-IQ+ automated insulin delivery system led to greater HbA1c reduction than continuous glucose monitoring alone in adults with insulin-requiring type 2 diabetes. FDA Approves Guselkumab (Tremfya) For Crohn's Disease  The FDA approved guselkumab for moderately to severely active Crohn's disease based on phase 3 trial data demonstrating superior efficacy over ustekinumab on endoscopic endpoints. FDA Approves Oral Iptacopan (Fabhalta) as First C3 Glomerulopathy Therapy  The FDA approved iptacopan as the first therapy for C3 glomerulopathy, with phase 3 data showing significant proteinuria reduction and sustained efficacy at 12 months. FDA Approves Vutrisiran (AMVUTTRA) for ATTR-CM  The FDA expanded vutrisiran's approval for cardiomyopathy in transthyretin-mediated amyloidosis, making it the first RNAi therapeutic to reduce cardiovascular mortality and hospitalizations in ATTR-CM.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 healthcare headlines for March 9-16, 2025: 1. CagriSema Yields Nearly 16% Weight Loss in Phase 3 REDEFINE 2 Trial In the Phase 3 REDEFINE 2 trial, CagriSema showed weight reduction in adults with obesity or overweight and type 2 diabetes, outperforming placebo. 2. Lorundrostat Significantly Lowers Blood Pressure in Key Hypertension Trials The Phase 3 Launch-HTN and Phase 2 Advance-HTN trials showed lorundrostat effectively reduced blood pressure in uncontrolled or resistant hypertension with a favorable safety profile. 3. PharmaTher Receives New Early June FDA Goal Date for Ketamine PharmaTher announced the FDA set a new Priority Review goal date of June 4, 2025, for ketamine to treat anesthesia, pain, mental health, and neurological conditions. 4. FDA Awards Fast Track Designation to ATSN-201 Gene Therapy for XLRS The FDA granted Fast Track designation to ATSN-201 for X-linked retinoschisis, allowing Atsena Therapeutics to seek Priority Review for their gene therapy. 5. FDA Approves First Interchangeable Biosimilar for Omalizumab The FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar to Xolair for asthma, CRSwNP, IgE-mediated food allergy, and CSU.

Video version available on HCPLive! In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Riad Sherif, MD, chief executive officer of Oculis, about the company's groundbreaking advancements in ophthalmic therapeutics. The discussion delves into Oculis' clinical pipeline, particularly OCS-05, a neuroprotective agent demonstrating promising results in acute optic neuritis. The Phase 2 ACUITY trial showed that OCS-05 preserved retinal ganglion cells (RGCs), reduced axonal loss, and improved low-contrast visual acuity. Importantly, patients receiving OCS-05 experienced significantly fewer multiple sclerosis relapses, suggesting broader neuroprotective potential. Administered intravenously alongside corticosteroids, the therapy could represent a paradigm shift in preserving vision in acute optic neuritis and beyond. Sheth and Sherif also explore Oculis' lead candidate, OCS-01, a topical treatment for diabetic macular edema (DME) that utilizes Optireach™ technology to penetrate the retina. With two ongoing Phase 3 trials (DIAMOND 1 and 2), OCS-01 has the potential to offer a non-invasive alternative or adjunct to intravitreal injections, expanding treatment options for patients with DME. Additionally, Oculis' OCS-02, a TNF inhibitor for dry eye disease, integrates a biomarker-driven precision medicine approach, ensuring targeted therapy for responders and potentially revolutionizing dry eye treatment. Looking ahead, Oculis is focused on executing its clinical programs, particularly finalizing patient randomization in the DIAMOND trials, advancing precision medicine for inflammation, and expanding indications for OCS-05 in neuroprotection. Sherif envisions OCS-05 as a potential game-changer, addressing significant unmet needs in ophthalmology and neurology by preserving vision and improving quality of life for patients facing vision-threatening diseases. Key Episode Timestamps 00:00:06 Introduction to New Insight 00:01:13 Riad Sherif's Journey from Physician to CEO 00:05:23 Challenges of Balancing Medical and Business Roles 00:09:44 Oculis' Portfolio and Recent Developments 00:14:40 OCS 05 and Its Clinical Applications 00:20:22 Oculis' Team and Leadership Philosophy 00:24:35 Future Goals and Vision for Oculis

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let's dive into the latest updates impacting clinicians and healthcare providers like you! Interested in a more traditional, text rundown? Check out the HCPFive! Top 5 healthcare headlines for February 16 - 23, 2025: 1. Sotagliflozin Cuts MACE Risk By 23% in Patients with Type 2 Diabetes, CKD Dual SGLT1/2 inhibition with sotagliflozin significantly reduced both heart attacks and stroke in a prespecified secondary analysis of the SCORED trial. 2. Nebokitug (CM-101) Gets FDA Runway for PSC Approval Chemomab completed an end-of-phase 2 meeting with the FDA and has aligned on the design of a phase 3 registration study for nebokitug (CM-101) in PSC. 3. FDA Clears IND Application for Zabalafin Hydrogel Treatment of Atopic Dermatitis Alpyn's Investigational New Drug application's clearance by the FDA for the new Zabalafin Hydrogel for atopic dermatitis follows positive phase 2a clinical findings. 4. Expert Panel Develops Consensus Definition, Clinical Tool for Anaphylaxis Care A 46-member expert panel created a consensus anaphylaxis definition, overview, and clinical tool to aid clinicians in recognition and management across settings. 5. FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy) The US supply of semaglutide and semaglutide 2.4 mg now meets or exceeds current and projected demand, ending the long-running shortages of these blockbuster drugs.