Steven De Hertefelt’s Post

It is hard not to be cynical in the benefit space! 😒 This week Merck announced that Keytruda has shown success with subcutaneous injection. For the world's bestselling drug, approved for 41 cancer indications (and counting), a form that doesn't involve an infusion in an infusion center would be a great step forward for patients. What else is exciting for Keytruda? 🎉 Keytruda is coming off patent in 2028! 🎉 Price should lower as competition is coming! 🛑 Unless everyone switches to subcutaneous, it says on patent, and continues to drive cost Back to cynical about something that should be exciting! 😒 It is hard not to think that this is coming out to protect profits versus coming out as a great needed improvement! 💡 Tip- Monitor your medical claims for Keytruda (you won't see this on pharmacy!). It is one of the most inflate infusions that we see and jump into work on! Reach out to me about what you are paying for a dose of Keytruda, and I will let you know where you stand with it! 💡 #Pharmacist #Pharmacybenefits #PBM #Medical #Oncology https://lnkd.in/g2vrQYVU

As early investors in Dyne Therapeutics, we are pleased to share they reported positive updates in their next-generation exon skipping program for Duchenne amenable to skipping exon 51. In their phase 1/2 Trial, Dyne-251 at dose of 10 mg/kg given once a month showed an average 3.2% normal dystrophin expression (7.6% normal dystrophin when adjusted for muscle content) at 6 months. Trends in functional improvements like the NSAA and other tests were observed, but non reached statistical significance at this time. Dyne-251 has fully enrolled cohorts for 20 and 40 mg/kg dosing and is reporting favorable safety profiles, while dystrophin and functional read outs for these higher doses will be coming in the future.    Dyne also reported positive safety, biomarker, functional, and patient reported outcome data in Type 1 Myotonic Dystrophy program (DM1), and anticipates providing updates by the end of the year on their plans for pursuing expedited FDA approvals in both DM1 and Duchenne. #FDA #DMD #DUCHENNE #CUREDUCHENNE #CLINICALTRIALS

The landscape of NSCLC treatment is evolving rapidly, and personalized medicine is at the forefront. Our latest blog post dives into a massive dataset of 80,000+ ALK, 35,000+ ROS1, 11,000+ EGFR, and more FISH results, shedding light on the prevalence of key mutations and the potential for more precise treatment plans. For pharmaceutical companies seeking to target clinicians and patients effectively, this data is a game-changer. Learn how these insights can revolutionize NSCLC care: https://bit.ly/3SkGEGT #NSCLC #PersonalizedMedicine #RealWorldData #PrognosHealth

The fourth quarter of 2024 is critical for the biotech industry, with 5 major FDA approval decisions on the horizon. These upcoming verdicts could impact everything from treatments for #cancer to #rarediseases 🧬 Stay ahead of the latest in #biotech and learn how these #FDA decisions could shape the future of healthcare.

💡 Reflecting on World ADC London last week, the event served as a hub for cutting-edge insights and discussions into new avenues for oncology treatment. A big topic at the conference was combination strategies. For many tumour types, a single treatment of ADC is insufficient due to the resistance mechanisms of ADC monotherapy and unachievable long-lasting disease control. Integrating ADC with different forms of therapy has proven to be a well-accepted strategy for overcoming drug resistance and achieving favourable treatment outcomes in preclinical and clinical studies. As the number of trials studying ADC combination therapies increases year on year. On average, almost half of the new ADC trials initiated each year were combination trials. So far, 816 ADC combination trials have been registered on the global trial registries, of which 166 were registered in 2023: #adc #adcs #antibodydrugconjugates #antibodydiscovery #trials #pharmaceutical #clinicalresearch #antibodies

1. Lisata Therapeutics received Orphan Drug Designation from the FDA for certepetide, aimed at treating cholangiocarcinoma. 2. Cholangiocarcinoma is a rare and aggressive cancer affecting bile ducts, with limited treatment options available. 3. The Orphan Drug Designation provides benefits like tax credits for clinical research and market exclusivity. 4. Kristen Buck, Lisata’s chief medical officer, emphasized the importance of certepetide in addressing unmet treatment needs for cholangiocarcinoma patients. 5. Certepetide enhances the effectiveness of anti-cancer therapies by improving tumor penetration and modifying the tumor microenvironment. 6. It has shown favorable safety and clinical activity in trials for pancreatic cancer and other solid tumors. 7. Lisata is conducting the BOLSTER trial, a Phase 2a study to evaluate the efficacy and safety of certepetide in cholangiocarcinoma. 8. Following the announcement, Lisata's shares rose by 4.3% in morning trading.

𝐇𝐔𝐓𝐂𝐇𝐌𝐄𝐃 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐬 𝐒𝐚𝐯𝐨𝐥𝐢𝐭𝐢𝐧𝐢𝐛 𝐟𝐨𝐫 𝐋𝐮𝐧𝐠 𝐂𝐚𝐧𝐜𝐞𝐫 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐢𝐧 𝐂𝐡𝐢𝐧𝐚 HUTCHMED (China) Limited HUTCHMED announces sNDA acceptance for savolitinib in China. If approved, savolitinib will expand its label indication to include treatment-naïve patients with NSCLC with MET exon 14 skipping alterations. Previously granted conditional approval for MET exon 14 skipping alterations in NSCLC, savolitinib, marketed as ORPATHYS® by AstraZeneca, is the first selective MET inhibitor in China. Phase IIIb trial data presented at conferences show promising efficacy and safety for savolitinib in treatment-naïve and previously treated patients. Responses occurred early, with a tolerable safety profile. NSCLC accounts for a significant portion of cancer deaths globally. MET aberrations play a crucial role in tumor growth and metastasis, making savolitinib a targeted treatment option. Savolitinib is marketed under the brand name ORPATHYS® in China and is included in the National Reimbursement Drug List. AstraZeneca and HUTCHMED collaborate on its global development and commercialization. #Savolitinib #NSCLC #LungCancer #METexon14 #CancerTreatment #PrecisionMedicine #ClinicalTrials #DrugApproval #Oncology #Pharmaceuticals #PrecisionOncology

Pathways of drug development in Oncology specifically looking into time and nature of initial FDA approval, summarised by Tanja Obradovic https://lnkd.in/dE5DCHbg National Pharmaceutical Council Julie Patterson James Motyka Rayan Salih, PharmD Jon Campbell John O'Brien #Cancer #FDA #CancerDrug #CancerTreatment #Medicine #Health #Oncology #OncoDaily

Earlier today, the Y-mAbs Therapeutics, Inc. management team held a conference call and webcast to discuss our fourth quarter and full year 2023 financial results and recent corporate developments.   We are excited by the progress made across the clinical, commercial and operational aspects of our business throughout the year, including:   - We successfully demonstrated proof-of-concept for the SADA PRIT technology platform in our GD2-SADA Phase 1 study. Additionally, the FDA cleared our IND for CD38-SADA.   - We achieved record quarterly and annual DANYELZA net product revenues and reached the high end of our full year 2023 net product revenue guidance. - Our Board of Directors appointed radiopharmaceutical veteran Michael Rossi as President and Chief Executive Officer, underscoring our commitment to drive innovation forward.   - We announced full year 2024 guidance and anticipate DANYELZA net product revenues to increase 16% at the midpoint compared to full year 2023.   As Y-mAbs reflects on a transformative 2023, we are dedicated to upholding a strong financial backbone and operational excellence that will continue to drive our mission of delivering better and safer cancer therapies to patients.   For more information and webcast replay details, see here: https://bit.ly/42X7cC6   $YMAB #Radiopharmaceuticals #PedicatricOncology