Fresenius Kabi的动态

Shanti Pharmaceuticals congratulates Takeda on the positive results from their phase 3 studies of soticlestat in patients with Dravet syndrome and Lennox-Gastaut syndrome. While narrowly missing the primary endpoints, soticlestat demonstrated promising efficacy in secondary measures such as caregiver and clinician global impression of improvement and seizure intensity scales. These findings underscore its potential to address unmet needs in treating these challenging conditions. We look forward to continued advancements that improve patient outcomes worldwide. #ShantiPharmaceuticals #HealthcareInnovation #PatientCare #EpilepsyResearch

?? * JUST ANNOUNCED * Agios Pharmaceuticals has announced the successful completion of #patientenrollment in its Phase 3 RISE UP #clinicalstudy, evaluating the investigational oral medication #mitapivat for its effectiveness and safety in treating #sicklecell disease in individuals aged 16 and older. The Phase 3 RISE UP study trial has enrolled over 200 #patients in total. The trial's primary endpoints include haemoglobin response and the annualized rate of sickle cell pain crises, which are significant indicators of the disease's impact on patient #QualityOfLife. The company's Chief Medical Officer, Dr. Sarah Gheuens, expressed gratitude to patients, investigators, and advocates for their role in achieving full enrollment. The company anticipates reporting the topline results from this comprehensive 52-week study in late 2025. It is also noteworthy that mitapivat has shown promising results in two Phase III studies for transfusion-dependent #thalassemia (#TDT) and non-transfusion-dependent thalassemia (#NTDT), thus Agios is actively planning to submit a #MarketingApplication for mitapivat targeting alpha- or beta-thalassaemia patients to regulatory authorities in the #US and #EU by the end of 2024. https://lnkd.in/dxqGdxXp...

Pre-order our upcoming 2024 Canadian Reimbursement and Forecasting Timelines (CRaFT) Subscription now for this May! The 2024 CRaFT Report includes detailed analysis and insights on files processed by CADTH and the pCPA, and associated timelines for F/P/T funding in Canada. The insights and analysis in the 2024 CRaFT Report will help pharmaceutical companies make more informed decisions and optimize their market access strategies with an aim to achieve faster and broader patient access for their therapies in Canada. Content highlights: ? Developments in HTA & analysis of trends ? Analysis of pCPA process phase timelines and volumes ? pCPA developments & negotiation trends ? Provincial time-to-listing trends and market access timelines (divided into oncology and non-oncology products) ? NEW pCPA Targeted Negotiation Process (TNP) analysis The subscription also includes: ? NEW Monthly Market Access Update ? NEW Mid-year Update of listing data from BC, AB, ON & QC You can also add the Drugs for Rare Diseases (DRD) Sub-Report, which offers a complete analysis with insights related to drugs for rare diseases. Don't miss out on this valuable resource and pre-order now! For more details and to download our free sample report, please visit: https://ow.ly/EEQf50QY8m9 #MarketAccess #HealthTechnologyAssessment #HTA #MORSEConsulting

$LLY - Eli Lilly wins US approval for drug to slow Alzheimer’s disease -Lilly's drug, branded as Kisunla? (donanemab-azbt), is approved by the FDA. -Kisunla to cost $12,522 for 6 months course -Kisunla to cost $695.65 per vial Per Eli Lilly Press Release: -Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39%? -Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment with Kisunla in 12 months -Once-monthly infusions of 30 minutes reduced amyloid plaques on average by 84% compared to the start of the study

Only put off until tomorrow what you are willing to die having left undone. Sanofi and Regeneron have received FDA approval for their groundbreaking drug, Dupixent, for the treatment of chronic obstructive pulmonary disease (COPD). This marks the sixth indication for Dupixent and a significant milestone in the field of respiratory medicine. The drug has been approved as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. This approval is a game-changer for patients suffering from COPD, providing them with a new and effective treatment option. Dupixent has already proven its efficacy in treating various other conditions, and this latest indication further solidifies its position as a blockbuster drug. As an investment advisor, I urge you to consider the potential impact of this FDA approval on the healthcare industry and your investment portfolio. Investing in companies like Sanofi and Regeneron can provide long-term growth opportunities, especially in the context of advancements in healthcare and the increasing demand for innovative treatments. Don't miss out on the potential benefits of investing in healthcare and utilizing Health Savings Accounts (HSAs) to optimize your financial planning. Act now and seize the opportunity to grow your wealth while contributing to the betterment of healthcare and the well-being of individuals and families. #HSA #investing #healthcare #health #family #wellness ?????????????

In the initial 10 medicines under the IRA, there is a huge variance in terms of how much each company's revenue is dependent on that medicine - here's a fresh take on the relative impact: There are arguably 3 main factors that determine the IRA's impact on a company's financial performance: 1. The discount itself - lots of discussion on that, with the key being that since CMS didn't publish current net prices, it's hard to know how much the discount really is, as the list price isn't a relevant comparator because it's not what people actually pay. 2. The expected LOE: Entresto is a case in point - Novartis has explicitly said it assumes generic competition beginning in 2025 in the US, so its price concessions to CMS, which impact only 2026 onwards, will have less impact than they would have had otherwise. 3. How important that product is to the company's overall revenue: Here is where there is a big variance - Fiasp/NovoLog is a great example. While insulin is among the most recognizable and highly discussed class of medicines affected by the IRA, the entire 'fast-acting insulin' category, which includes Fiasp and NovoLog, accounted for only ~5% of Novo Nordisk's total 2023 revenue. Meanwhile, Jardiance and Eliquis both account for more than a quarter of their respective company's revenue, and have 3 years of additional patent protection beyond 2026, which means the impact will be more substantial. CMS is due to report the next 15 medicines to be included in the IRA by Feb 1, 2025. It will be important to see if they continue to choose medicines close to LOEs, or if they become more selective, which will no doubt have magnified impacts on both patients and companies.

Look at the first list of 10 drugs negotiated by CMS under the Inflation Reduction Act in the US. (Note: as mentioned by the author, negotiated price should not be compared with the List price since the List price was never the price at which drug was purchased)

February was a busy month in the Priority Review Voucher (PRV) market, with several high-profile redemptions and progress towards an extension of the Rare Pediatric Disease PRV program beyond 2024. We have compiled five key developments moving the PRV market in the past month, involving Valneva, GSK, Vertex Pharmaceuticals and argenx.? ? #PRV #RareDisease #PriorityReviewVoucher #FDA #BournePartners #InvestmentBanking #PharmaceuticalIndustry #Innovation #2024Trends

IRA's First 10 IRA means "Inflation Reduction Act". It authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for selected drugs that are high expenditure, single source drugs without generic or biosimilar competition. The IRA directs HHS to identify annually a limited number of costly medications and set their MFPs (Maximum Fair Prices) for Medicare. #IRA #MFP #HHS

DelveInsight’s analysis reports that the inflammatory bowel disease (IBD) market includes ～5 million diagnosed cases of ulcerative colitis and Crohn’s disease across the 7MM. The market is anticipated to grow significantly, driven by advancements in treatment options and increasing patient needs. Key companies making strides in the IBD space include Arena Pharmaceuticals, Inc., Pfizer, Abivax, The Janssen Pharmaceutical Companies of Johnson & Johnson, Celgene, and others. Notable emerging therapies are Etrasimod (APD334), obefazimod (ABX464), TREMFYA (guselkumab), and ZEPOSIA (ozanimod). These innovative treatments are set to enter the market soon and are expected to bring transformative changes to IBD management. Get More Detailed Information: https://lnkd.in/g4PyCuMD #InflammatoryBowelDisease #IBD #HealthcareMarket #PharmaceuticalInnovation #Etrasimod #ABX464 #TREMFYA #ZEPOSIA #DelveInsight #MarketAnalysis #Biopharma #ClinicalTrials #Biotech #Pharma #MedicalResearch #HealthcareInnovation #PharmaDevelopment #PharmaNews #marketgrowth?#marketforecast #healthcare #healthcareconsulting #marketresearch #healthcare #pharmaceutical #business