Matteo Boemi’s Post

The FDA approved Fresenius Kabi's Tyenne biosimilar for Genentech's Acterma (tocilizumab), making it the 𝗳𝗶𝗿𝘀𝘁 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿 𝘄𝗶𝘁𝗵 𝗯𝗼𝘁𝗵 𝗜𝗩 𝗮𝗻𝗱 𝘀𝘂𝗯𝗰𝘂𝘁𝗮𝗻𝗲𝗼𝘂𝘀 𝗳𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗽𝗽𝗿𝗼𝘃𝗲𝗱 𝗶𝗻 𝘁𝗵𝗲 𝗨.𝗦. The approval allows Tyenne to treat inflammatory and immune diseases like rheumatoid arthritis. Fresenius Kabi plans to launch Tyenne in more countries, following its initial launch in 10 nations. The biosimilar is part of Fresenius Kabi's efforts to expand its biosimilars portfolio for immunology and oncology-related diseases. Tyenne's approval marks Fresenius Kabi's third FDA-approved biosimilar. 𝗔𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹𝗹𝘆, 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗮𝗽𝗽𝗿𝗼𝘃𝗲𝗱 𝗦𝗮𝗻𝗱𝗼𝘇'𝘀 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀 𝗝𝘂𝗯𝗯𝗼𝗻𝘁𝗶 𝗮𝗻𝗱 𝗪𝘆𝗼𝘀𝘁, 𝗰𝗼𝗺𝗽𝗲𝘁𝗶𝗻𝗴 𝗮𝗴𝗮𝗶𝗻𝘀𝘁 𝗔𝗺𝗴𝗲𝗻'𝘀 𝗣𝗿𝗼𝗹𝗶𝗮 𝗮𝗻𝗱 𝗫𝗴𝗲𝘃𝗮, 𝗿𝗲𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝗹𝘆, 𝗳𝗼𝗿 𝘁𝗿𝗲𝗮𝘁𝗶𝗻𝗴 𝗼𝘀𝘁𝗲𝗼𝗽𝗼𝗿𝗼𝘀𝗶𝘀 𝗮𝗻𝗱 𝗽𝗿𝗲𝘃𝗲𝗻𝘁𝗶𝗻𝗴 𝘀𝗸𝗲𝗹𝗲𝘁𝗮𝗹-𝗿𝗲𝗹𝗮𝘁𝗲𝗱 𝗲𝘃𝗲𝗻𝘁𝘀 𝗶𝗻 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘄𝗶𝘁𝗵 𝗰𝗲𝗿𝘁𝗮𝗶𝗻 𝗰𝗮𝗻𝗰𝗲𝗿𝘀. #marketintelligence #competitiveintelligence #pharmaceutical #marketsmind

𝐁𝐫𝐢𝐝𝐠𝐞𝐁𝐢𝐨 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐀𝐓𝐓𝐑𝐢𝐛𝐮𝐭𝐞-𝐂𝐌 𝐒𝐭𝐮𝐝𝐲 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐀𝐜𝐨𝐫𝐚𝐦𝐢𝐝𝐢𝐬 𝐢𝐧 𝐀𝐓𝐓𝐑-𝐂𝐌 BridgeBio Pharma, Inc. (Nasdaq: BBIO) BridgeBio, a biopharmaceutical company focused on genetic diseases and cancers, announced positive results from five new analyses of clinical endpoint events from its Phase 3 ATTRibute-CM study of acoramidis in ATTR-CM. These results were presented at the 2024 International Symposium of Amyloidosis (ISA). The Phase 3 study showed that acoramidis, an investigational small molecule stabilizer of TTR, significantly increased serum TTR levels, correlating with improved clinical outcomes, including reduced risk of mortality and cardiovascular hospitalization. Key findings include: A 30.9% reduction in risk of death with every 5mg/dL increase in serum TTR at day 28. A 5.5% reduction in cardiovascular mortality risk for each 1mg/dL increase in serum TTR at day 28. A 4.7% reduction in first cardiovascular hospitalization risk for each 1mg/dL increase in serum TTR at day 28. Dr. Mathew Maurer Matthew Maurer of Columbia University commented, “The data confirm that higher serum TTR levels are directly correlated with improved clinical outcomes.” BridgeBio has submitted a New Drug Application (NDA) to the FDA, with a PDUFA action date of November 29, 2024, and a Marketing Authorization Application (MAA) to the European Medicines Agency. #GeneticDiseases #Cardiology #ClinicalTrials #DrugDevelopment #HealthcareInnovation #ATTRCM #Acoramidis #TTRStabilizer #BridgeBio #FDAApproval #MedicalResearch #ISA2024 #PatientCare

🔬🎉Otsuka has received breakthrough #therapy designation from the FDA for its rare kidney disease drug, sibeprenlimab. ℹ The breakthrough therapy designation is for sibeprenlimab's use in immunoglobulin A nephropathy (IgAN), also known as Berger's disease. This condition occurs when antibody immunoglobulin A builds up in the kidneys, leading to inflammation and damage. The #FDA's decision was based on positive Phase II data from the ENVISION trial, which showed #significant reductions in 24-hour urine protein creatinine ratio (uPCR) and clinically relevant changes in estimated glomerular filtration rate (eGFR) compared to placebo. ➡ Sibeprenlimab is a humanized monoclonal antibody that binds to APRIL, a tumor necrosis factor cytokine. It plays a #crucial role in B-cell signaling, particularly in driving IgA class switch recombination and the production and survival of IgA-secreting plasma cells. 💡 This breakthrough #designation is an important milestone that recognizes the potential #value of sibeprenlimab for people living with IgAN, one of the most common causes of kidney failure. #Otsuka and #Visterra are committed to #advancing the Phase III trial for sibeprenlimab. #Otsuka #Visterra #kidneydisease #IgAN #Sibeprenlimab #FDAApproval #PharmaceuticalInnovation #RareDiseaseTreatment #SymmetricTraining

As per DelveInsight Business Research LLP, the Fabry Disease market in the 7MM is likely to cross USD 2.4 billion by 2032 with a 35% contribution from conventional enzyme replacement therapies. All in all, the Fabry disease market conditions are conducive to the growth of novel drugs and the trend will continue unperturbed for a few years in the absence of any major disruptions such as biosimilars or other factors. Currently, companies such as JCR Pharmaceuticals Co Ltd, Sangamo Therapeutics, Inc., Sanofi, Chiesi Group, Protalix Biotherapeutics, among others are actively working in the therapeutics domain to capture the market share. Get a more detailed insight into the evolving Fabry Disease therapeutics market: https://lnkd.in/dP28eV9u #healthcare #biotechnology #lifesciences #pharmaceutical #market #marketforecast #marketanalysis #clinicaltrials #clinicalresearch #fda #healthcaremarket #healthcareindustry #marketoutlook #fabrydisease

Boehringer Ingelheim is setting an ambitious course with plans to launch 25 new treatments by 2030, despite challenges with Cyltezo. This pivot to their late-stage pipeline, including significant advancements in treatments for rare cancers and liver diseases, highlights a robust commitment to innovation. Their strategy raises critical questions: ▪️ How will Boehringer integrate such a significant number of new treatments effectively? ▪️ What impact will this have on the broader healthcare landscape? #HealthcareInnovation #Pharmaceuticals #StrategicPlanning

The estimated total incident cases of Multiple Myeloma in the 7MM were approximately 65,500 in 2022. The dynamics of the Multiple Myeloma market are anticipated to change in the coming years owing to the launch of novel drugs and the number of healthcare spending across the world. Some of the leading companies such as Johnson & Johnson (Janssen Inc.), Pfizer, AbbVie, Roche (Genentech), Regeneron, Bristol Myers Squibb, Celgene, Arcellx, Novartis, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Inc., Heidelberg Pharma AG, Rapa Therapeutics, Takeda, and others are actively developing novel Multiple Myeloma drugs. Get more detailed insights, at: https://lnkd.in/dWV_SCyH #healthcare #biotechnology #lifesciences #market #marketforecast #marketanalysis #fda #healthcaremarket #healthcareindustry #marketoutlook #multiplemyeloma

Positive Phase III Results: Atrasentan Reduces Proteinuria Significantly in IgA Nephropathy Patients Novartis has reported positive results from its Phase III ALIGN study on atrasentan, showing its effectiveness in treating IgA nephropathy. The interim analysis revealed that atrasentan reduced proteinuria levels in IgAN patients. Novartis plans to seek accelerated approval from the FDA based on these results. This is a significant step forward in developing atrasentan as a therapy for IgAN. Novartis recently acquired atrasentan and zigakibart through its acquisition of Chinook Therapeutics, enhancing its offerings for rare kidney diseases. The ALIGN study will continue to evaluate kidney function, with results expected in 2026. For more details please click the link! https://lnkd.in/gnsFm9gu #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

🔟 Best Selling Drugs of 2023💸 ⚕ 2023 may not go down as the brightest year for the pharma sector, but the entry of Novo Nordisk’s #Ozempic (#semaglutide) into the ranks of top-selling drugs like Keytruda, Dupixent, and Eliquis signals a new era in the treatment of metabolic disease. 🔵 The rise of metabolic disease drugs underscores the growing global burden of #obesity and #diabetes. With #Ozempic’s sales reaching $13.9 billion in 2023, a 38% increase, GLP-1 therapies seem poised to play a significant role in the treatment of metabolic disease. ⏺ Oncology: 33.9% ⏺ Immunology and Inflammation: 18.4% ⏺ Metabolic Diseases: 16% ⏺ Cardiovascular and Blood Disorders: 12.9% ⏺ Neurology and Mental Health: 5.6% ⏺ Others: 13.4% 🔵 While #metabolic #disease treatments made significant strides, #oncology drugs continued to dominate the list of bestsellers! #Keytruda, a strong-selling #cancer immunotherapy since the mid-2010s, maintained its position as the highest-grossing drug with sales of $25 billion, a 19% increase from 2022! 🔵 It’s likely that metabolic disease could soon overtake #immunology as the second-largest sales category in the coming years. On a related note, AbbVie juggernaut #Humira had a sales decrease of 32.2% compared to the previous year thanks to biosimilar competition after Humira’s patent exclusivity expired. 1️⃣ #Keytruda (#pembrolizumab)⏩ Merck 2️⃣ #Dupixent (#dupilumab)⏩ Sanofi-Regeneron 3️⃣ #Eliquis (#apixaban)⏩ Pfizer-Bristol Myers Squibb 4️⃣ #Comirnaty (#covid19 #vaccine)⏩ Pfizer-BioNTech SE 5️⃣ #Humira (#adalimumab)⏩ AbbVie 6️⃣ #Ozempic (#semaglutide)⏩ Novo Nordisk 7️⃣ #Eylea (#aflibercept)⏩ Regeneron-Bayer 8️⃣ #Biktarvy (#bictegravir #emtricitabine #tenofovir #alafenamide)⏩ Gilead Sciences 9️⃣ #Stelara (#ustekinumab)⏩ Johnson & Johnson 🔟 #Darzalex (#daratumumab)⏩ Johnson & Johnson ⏹ Source: Drug Discovery & Development Scientome | ساینتوم ##pharmaindustry #topseller #top10 #revenue #biotechnology #bigpharma #businessreport

🔬 Exciting Breakthrough in Liver Disease Treatment! 🔬 Boehringer Ingelheim's innovative drug, #Survodutide, is making waves in the #pharmaceuticalindustry with its "groundbreaking" results in treating metabolic dysfunction-associated steatohepatitis (#MASH), a severe form of #liverdisease. In a pivotal Phase II trial, a staggering 83% of patients treated with Survodutide showed a significant improvement in their condition, outperforming the #placebo group by a wide margin. This promising GLP-1 receptor dual agonist has not only demonstrated efficacy in MASH treatment but also shown potential in addressing #fibrosis, a common complication of liver diseases. The trial's success paves the way for Survodutide as a leading treatment option for patients with substantial unmet medical needs, offering new hope for those suffering from MASH and fibrosis. MASH, a progressive liver condition linked to #metabolic dysfunctions such as #obesity and insulin resistance, poses a significant health challenge worldwide. Survodutide's dual mechanism targeting both GLP-1 receptors and glucagon receptors may offer a holistic approach to treating this complex disease, emphasizing the importance of innovative treatments in improving patient outcomes. As we await more detailed results from secondary endpoints, the pharmaceutical community is abuzz with the potential impact of Survodutide on liver health and beyond. #boehringeringelheim's commitment to advancing treatment options for interconnected #cardiovascular, #renal, and #metabolic diseases underscores the critical role of research and development in transforming patient care. Stay tuned for more updates on this exciting development in liver disease treatment and join us in celebrating this significant milestone in pharmaceutical innovation. Connect, Repost & Follow for more info on the pharmaceutical industry 🌍 #BoehringerIngelheim #Survodutide #MASH #liverdisease #GLP1 #fibrosis #pharma #pharmaceutical #pharmaindustry #europe #pharmaceuticalindustry #healthcare