Farah Rose Buszka Pharm.D., BCPS, CHCP’s Post

Paediatric Patients Benefit from FDA Approval of NexoBrid for Severe Burns Treatment The FDA has approved NexoBrid by MediWound and Vericel® Corporation for pediatric burn patients, expanding its previous use for adults. The approval was based on positive results from the Phase III Children Innovative Debridement Study, which demonstrated NexoBrid's effectiveness in treating 145 pediatric patients. This breakthrough represents a significant advancement in burn care, offering a safer and less invasive treatment option for young patients. It also highlights the potential of proteolytic enzyme therapies in wound care, with MediWound continuing to innovate with products like EscharEx for chronic wounds. NexoBrid's approval not only transforms pediatric burn care but also solidifies MediWound's role in the evolving wound care industry, which is expected to grow to $38.8 billion by 2030. For more details please click the link! https://lnkd.in/dFUaps5g #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Our real-world evidence experts have reviewed the latest decision on GAMMAGARD LIQUID. Start reading "FDA Approves GAMMAGARD LIQUID Based on Safety Data From an RWE Study" - https://lnkd.in/et3NiwzY -- Background: The recent approval of GAMMAGARD LIQUID by the FDA for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), is a great example of the power of RWE to inform regulatory decision-making. The approval was based on data from a single-arm Phase III study and a large observational, retrospective comparative safety study assessing the off-label use of GAMMAGARD LIQUID and other intravenous immunoglobulin products for the treatment of patients with CIDP. #RWE #realworldevidence #rwd #realworlddata

Justify Dose And Rationality: CDSCO Panel Tells Dr. Reddy's Lab On Sacubitril- Valsartan Tablets 25 Mg Noting that the proposed protocol is insufficient to prove the clinical relevance of the lower strength of Sacubitril/Valsartan (12mg/13mg), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Dr. Reddy’s Lab to submit a revised protocol with more justification on the proposed dose and its rationality for further evaluation. This came after Dr. Reddy’s Lab applied for the manufacture and market of Sacubitril and Valsartan tablets 25mg (as additional strength) indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction with bioequivalence (BE) and clinical trial (CT) waiver. #drreddylabs #cdsco #sacubitrilvalsartan #sacubitril #valsartantablets #heartfailure

IVIG, Plasmapheresis Comparable in Long-Term Efficacy for Treatment of Myasthenic Crisis: Though both treatments come with positives and negatives, ultimately, individual patient clinical presentation and accessibility will determine the proper treatment for myasthenic crisis. #finance #pharmacy #lifesciences

It is an exciting day! All dosing has completed in MLD's Phase I clinical trial of PPI-1011. I am extremely proud of this study which was designed to extensively evaluate the safety of a first-in-class plasmalogen precursor following both single and multiple dose administrations. The top-line results support the safety of PPI-1011 in humans and move us one-step closer to testing PPI-1011's efficacy in the RCDP patient population. https://lnkd.in/exgQVfFf

🚨 FDA Approves Guselkumab (Tremfya) for Ulcerative Colitis! 🚨 Exciting news! The FDA has approved guselkumab (Tremfya) for adults with moderately to severely active ulcerative colitis (UC). Based on the QUASAR study, this IL-23 inhibitor marks a significant advance for UC patients. David Rubin, MD of University of Chicago Medicine stated, “Treatment with TREMFYA resulted in significant improvement in chronic UC symptoms and normalization of the intestinal lining.” A major step forward in UC care! #UlcerativeColitis #FDAApproval #Tremfya #Guselkumab #IBD #DavidRubin #Healthcare #ClinicalResearch #Gastroenterology Johnson & Johnson

#OnlineFirst w/ #PMT #JPharmTechnol now, Weaver & colleagues w/ @HowardUniversitySchoolofPharmacy emphasize the important role of #pharmacists in management of acute or chronic #sicklecelldisease https://lnkd.in/e3P3AFuZ #pharmacy #diseasemanagement #patientcare

Synergy Healthcare is thrilled to share groundbreaking developments in the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The Food and Drug Administration (FDA) is on the verge of approving the first-ever medicine specifically designed to combat this serious liver disease. Developed by Madrigal Pharmaceuticals, the pill, known as resmetirom, targets a protein in the liver, effectively reducing liver fat, inflammation, and scarring associated with MASH. If approved, resmetirom will mark a significant milestone in healthcare, offering hope to patients with advanced stages of MASH where current treatments have shown limited effectiveness. At Synergy Healthcare, we pride ourselves on being at the forefront of clinical research, especially in metabolic and neurological diseases. The potential approval of resmetirom represents a significant step forward in addressing the unmet medical needs of patients suffering from MASH. The addressable market for drugs to treat advanced MASH is substantial, with an estimated 315,000 individuals in need of effective treatment. Resmetirom's innovative approach and promising clinical trial results position it as a potential game-changer in the field of liver disease treatment. We commend the dedication and perseverance of researchers and scientists, including those at Madrigal Pharmaceuticals, for their tireless efforts in bringing new therapeutic options to patients in need. Stay tuned for more updates as we eagerly await the FDA's decision on resmetirom, and let's continue our collective efforts to advance healthcare and improve patient outcomes! 💊💪 #SynergyHealthcare #ClinicalResearch #MASHTreatment #Resmetirom #HealthcareInnovation #LiverDiseaseTreatment #FDAApproval #MedicalBreakthroughs 🔗 https://lnkd.in/ekjzn4uy

FDA Approves Ocrevus Zunovo for 2 Forms of Multiple Sclerosis: The approval marks the first and only twice yearly, health care professional-administrated injection for both forms of multiple sclerosis (MS). #finance #pharmacy #lifesciences

Topical / transdermal NSAIDs is a great alternative. Or even first step approach.