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𝐋𝐢𝐧𝐯𝐨𝐬𝐞𝐥𝐭𝐚𝐦𝐚𝐛 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐬: 𝐄𝐌𝐀 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐌𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐌𝐲𝐞𝐥𝐨𝐦𝐚 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Regeneron Pharmaceuticals Regeneron ph announces EMA acceptance for linvoseltamab's review to treat relapsed/refractory multiple myeloma. This investigational bispecific antibody aims to activate T cells and enhance cancer-cell killing. Key Points: EMA accepts Marketing Authorization Application for linvoseltamab. Targeting adult patients with relapsed/refractory multiple myeloma after three prior therapies. Supported by Phase 1/2 pivotal trial data (LINKER-MM1) shared in December 2023. FDA Biologics License Application (BLA) also submitted in December 2023. Multiple Myeloma Stats: Second most common blood cancer, with over 176,000 new cases globally each year. Linvoseltamab addresses disease progression in patients who have exhausted other therapies. Clinical Development Program: Phase 3 confirmatory trial (LINKER-MM3) is enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway. #Linvoseltamab #MultipleMyeloma #MedicalInnovation #EMAApproval #CancerResearch #HealthcareAdvancements #ClinicalTrials #Hematology

Happy to report that my chapter “Dose Optimization of Oncology Drugs: A Clinical and Regulatory Perspective”, in the Springer Nature book Dose Finding and Beyond in Biopharmaceutical Development (edited by Jingjing Ye, PhD, FASA, Ding-Geng Chen, Wen Zhou, Qiqi Deng,and Joe Cappelleri), is now available online! 🎉 🎉 🎉 Many thanks to the editors for the invitation to contribute, I’m proud to be part of the team that produced this important resource. #dosefinding #doseoptimization #drugdevelopment #therightdose #regulatory #fda https://lnkd.in/eWpAwx-4

Top 20 RNAi Therapeutic Companies of 2024 New-age therapeutics like RNAi have shown immense potential in shaping the future of the healthcare industry with advanced mechanisms of action. RNAi therapies show relatively low toxicity, making them safe, and highly effective medications. Like the previous year, Roche retains the topmost position with an R&D expenditure of $15.73B, followed by Novartis and AstraZeneca with $11.37B and $10.93B, respectively.  PharmaShots brings an illuminating report on the Top 20 RNAi Therapeutic Companies. To get a PDF copy of the report, reach out to us at connect@pharmashots.com Roche Novartis AstraZeneca Eli Lilly and Company GSK Sanofi Moderna Novo Nordisk Amgen Takeda Regeneron Biogen BioNTech SE Ionis Pharmaceuticals, Inc. Alnylam Pharmaceuticals Sarepta Therapeutics Jazz Pharmaceuticals Vir Biotechnology, Inc. Arrowhead Pharmaceuticals Arcturus Therapeutics #pharmashots #top20rnaicompanies #2023 #rnaitherapies #top20 #rna

Faron Pharmaceuticals Limited (AIM:FARN) (AIM: FARN) has received what it described as "very positive" feedback from the US Food and Drug Administration on the design of the Phase III clinical trial for its lead asset. This feedback could significantly streamline the development process.  Bexmarilimab has been designed to treat myelodysplastic syndrome, a type of cancer affecting bone marrow. The FDA acknowledged the challenges of running a comparative study in patients whose disease has returned or is resistant to treatment. Instead, it proposed a phase III evaluation for newly diagnosed high-risk patients. This means Faron will not need a separate study for patients whose disease has returned or is resistant. This guidance is part of the FDA's Project Frontrunner, an initiative that aims to bring promising cancer treatments to patients faster. More at #Proactive #ProactiveInvestors http://ow.ly/SHN8105AeUv

Weekly Market News! 💊 Sanofi, BioNTech, BMS, Surrozen, J&J, FTC, Merck KGaA, and Lindus have all been in the news this week. Sanofi has begun a full pipeline reprioritization with layoffs, while BioNTech's cancer vaccine has shown a 3-year immune response. BMS's schizophrenia drug has demonstrated long-term benefits, and Surrozen's Wnt mimetic antibody has proven effective in mice with lung fibrosis. J&J has added shockwave to its cardio collection with a $13.1B deal, and the FTC has requested more information on Boston Scientific and Axonics' $3.7B deal. Merck KGaA has signed a $1.4B biobuck ADC deal with Caris, and Lindus has launched an all-in-one CRO for respiratory trials. Stay informed on the latest news in the pharmaceutical industry. #pharmaceuticals #biotech #healthcare #news

#overall #survival #oncology #FDA database 2003-2021; food for thoughts concerning one of the most crowded research area. Novel pharmaceuticals increased patient survival by a median of 2.80 months (IQR, 1.97-4.60 months) for OS and 3.30 months (IQR, 1.50-5.58 months) for PFS. Initial indications more frequently received accelerated approval, supported by single-arm trials for advanced-line monotherapies, than indication extensions. https://lnkd.in/dxkvyikG https://lnkd.in/dSE_K8S7

Sanofi halts Denali's MS drug trial after Phase 2 failure Big news in the pharmaceutical world—Sanofi has stopped the trial of Denali's MS treatment after Phase 2 results failed to meet expectations. This outcome highlights the high-risk nature of drug development, especially in tackling complex diseases like multiple sclerosis. Read the full story to explore the details behind the decision, its impact, and what it means for future research efforts. #pharma #clinicaltrials #MSresearch #drugdevelopment #biopharma #Sanofi https://lnkd.in/ed4SPmEP

✨ Exciting News in #Oncology Treatment! ✨ AbbVie's monoclonal antibody Elahere has received full FDA approval for certain types of #ovarian #cancer treatment. 🎗️ 🔍 #Elahere, an antibody-drug conjugate targeting folate receptor alpha, is now approved for FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal #cancer in adult patients after one to three prior systemic treatments. 🚀 #AbbVie's acquisition of ImmunoGen, Inc. paved the way for Elahere's development, culminating in this significant milestone. The Phase III MIRASOL trial showcased its efficacy, demonstrating a 35% reduction in the risk of tumor progression compared to chemotherapy, along with meeting key secondary endpoints. 💡 Despite competition, Elahere's first-to-market advantage positions it strongly in the pharmaceutical landscape. GlobalData Healthcare's forecast suggests substantial revenue potential, projecting $2.8bn in 2029. Connect, Repost & Follow for more info on the pharmaceutical industry 🌍 #pharma #pharmaceutical #pharmaindustry #europe #healthcare #fda #ema #pharmacy #ra #qa #pharmaceuticalindustry #medicine

Simulation Study Reveals Challenges and Recommendations for EU Oncology Medicine Evaluations Under EUnetHTA21 Guidelines Researchers conducted a simulation study to evaluate the impact of adopting new methodologies for assessing oncology medicines in the European Union. The study focused on aspects such as orphan drug designation, ATMP status, target tumors, and data packages. The simulation revealed the challenges of obtaining comprehensive evidence for Joint Clinical Assessments (JCAs) and the need for early consultations and adapting to rapid scientific advances. The study also highlighted challenges in trial design and the need for innovative approaches. The study concludes with recommendations for improving the JCA process and calls for action from the European Commission and HTACG to address the challenges in oncology medicine assessment. For more details please click the link! https://lnkd.in/dcNhtdE7 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

🗞️ Last week’s Pharma industry news in Germany and Switzerland 🗞️ Novartis's Fabhalta® receives positive CHMP opinion for PNH treatment, marking it as a potential first oral monotherapy in Europe. Sandoz inaugurates a new antibiotic production facility in Austria, significantly increasing life-saving medicines' production capacity. Immatics reports significant 2023 financial results and clinical progress, with strategic plans for advancing cancer treatments into 2024. InflaRx N.V. announces development plans for INF904 in immuno-dermatology, with a Phase IIa trial expected to start by the end of 2024. BioNTech SE reports robust financials for 2023, highlighting progress in its COVID-19 vaccine distribution and oncology pipeline. BioNTech SE appoints Annemarie Hanekamp as Chief Commercial Officer to lead the global commercial strategy, including launching its first oncology product by 2026. The FDA approves Idorsia Pharmaceuticals Ltd's TRYVIO, a novel treatment for patients with inadequately controlled hypertension, marking a significant advance in blood pressure management. CENTOGENE extends its partnership with Takeda, focusing on providing genetic testing for patients with Lysosomal Storage Disorders, aiming to improve early diagnosis and access to treatments. #pharmaceuticalindustry #pharma #Monday_Pharma_News