Numab Therapeutics AG’s Post

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The electrocardiogram’s QT interval occupies a pivotal role in early drug development and has been the focus of clinicians for over 50 years as a biomarker of ventricular repolarization. Now, drug sponsors have options when it comes to proarrhythmic risk assessment of a new chemical entity. In our recent CPT tutorial, we described the regulatory framework for integrated arrhythmia risk prediction models for TQT substitution pathways (ICH E14/S7B Q&A 5.1 and 6.1), delineate potential reasons why a TQT substitution request may be rejected and discuss when a standalone TQT is recommended. #TQTwaiver #TQTsubstitution #ECGcorelab

Check out NPLB's latest Blog Post: 5 ways President Biden's #SOTU and Sen. Britt's response could advance biotech affordability & innovation for all of US: 1. Fix #IRA's small molecule penalty 2. Recognize true value of medicines to patients and society 3. Ensure Rx savings are for people, not PBMs 4. Extend IRA's $2K OOP Rx cap for all ACA plans 5. Treat US Biotech as a national defense priority https://lnkd.in/ez-pi_5z

TDD Made SIMPLE. You asked. We innovated. For your most common Targeted Drug Delivery refill experience - same drug, same dose, same concentration - the SynchroMed™ III system offers a streamlined "Refill Only" workflow for a more efficient refill process. See risk information: https://bit.ly/3AiLy12 Click here to learn more about the SynchroMed™ III system https://lnkd.in/dtmMtpFG or talk to your Medtronic Represenative about Targeted Drug Delivery therapy and SynchroMed™ III system. #MDTPainInterventions #TDD #TargetedDrugDelivery #SynchroMedIII Product usage represented may not be approved or cleared in all markets.

The electrocardiogram’s QT interval occupies a pivotal role in early drug development and has been the focus of clinicians for over 50 years as a biomarker of ventricular repolarization. Now, drug sponsors have options when it comes to proarrhythmic risk assessment of a new chemical entity. In our recent CPT tutorial, we described the regulatory framework for integrated arrhythmia risk prediction models for TQT substitution pathways (ICH E14/S7B Q&A 5.1 and 6.1), delineate potential reasons why a TQT substitution request may be rejected and discuss when a standalone TQT is recommended. Read the CPT tutorial: https://lnkd.in/eeaVxPvT #TQTwaiver #TQTsubstitution #ECGcorelab #CPTJournal, #ASCPTJournalFamily

Happy Independence Day! 4 of July is a time for Americans to remember and reflect on the principles of freedom and democracy that their country was founded upon. Today we honor the brave men and women who fought for their independence and remember the sacrifices that were made to secure the nation's freedom. https://lnkd.in/eM7UtE-8 #IndependenceDay #USA #GCT #GlobalClinicalTrials #CRO #clinicalresearch #drugdevelopment #medicine #pharma #clinicaltrials #clinicaltrial #gctrials #research 

BENLYSTA (belimumab) is a specific inhibitor of B-lymphocyte stimulator, was initially approved in 2011 for adults with SLE receiving standard therapy. Recently, in 2024, it gained US FDA approval for a 200 mg subcutaneous autoinjector for patients aged five years and older with active SLE. According to DelveInsight Business Research LLP, BENLYSTA is projected to achieve approximately USD 980 million in sales by 2034 in the US. However, sales are expected to decrease after 2025 due to the drug's patent expiration in the United States in 2025 and in Europe in 2026. Discover Expert Insights and Comprehensive Analysis with DelveInsight's Exclusive EULAR - European Alliance of Associations for Rheumatology 2024 Coverage @ https://lnkd.in/gBpFeusS #BENLYSTA #SLE #belimumab #FDAapproval #autoinjector #chronicillness #SLEtreatment #autoimmune #pharmaceuticals #patentexpiration

Stifel has resumed coverage of #biopharma company Scancell Ltd (AIM:SCLP, OTC:SCNLF) with a repeat of its 'buy' recommendation and 30p target price - a significant premium to the current 11p share price. The American #investmentbank cites Scancell's successful (and significantly upsized) £11.9 million capital raise as a major source for optimism going forward. The issue of new stock, at a 10.2% discount to the prevailing market price, extends Scancell's financial runway to mid-to-late 2025. This stability allows the immuno-oncology specialist to focus on pivotal clinical milestones in its SCOPE and ModiFY trials, with key data expected in 2024 and progression-free survival data from the SCOPE trial due in the first half of 2025, #Stifel said in a note to clients. More at #Proactive #ProactiveInvestors #AIM #OTC #SCLP #SCNLF #Scancell http://ow.ly/qaCF1057QlH

You’re invited to 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩 𝐈𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝟐𝟎𝟐𝟒 in 𝐁𝐚𝐬𝐞𝐥 𝐨𝐧 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟗!  Dive into discussions focused on achieving a competitive edge through integrated CDMO and CRO services. This is your chance to learn about the latest industry trends, hear from 𝐓𝐡𝐞𝐫𝐦𝐨 𝐅𝐢𝐬𝐡𝐞𝐫 𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐟𝐢𝐜, and see real-world success stories. Your collaboration is essential as we work together to redefine the clinical trial landscape.  𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐓𝐨𝐝𝐚𝐲: https://lnkd.in/gtTxbb2N #partnershipinsights #clinicalinnovation #thermofisherscientific #healthcaretrends #pharma #networking #patientfocus #futureofmedicine #clinicaltrials #lifesciences #basel2024 #therapeutics #collaboration #innovation #CDMO #CRO

We’re pleased to announce a $22 million royalty financing that allows us to advance our Phase 3 first-in-category investigational products Ovaprene®, a potential first FDA-approved hormone-free intravaginal monthly contraceptive, and Sildenafil Cream, 3.6%, a potential first FDA-approved treatment for female sexual arousal disorder, through key catalysts. The transaction underscores the significant potential of these candidates with Daré retaining the significant majority of their future economics and accelerates potential cash flows from the future commercial success of XACIATO™ and these candidates, providing non-dilutive capital at an opportune time to drive shareholder value. Learn more: https://lnkd.in/eR6Cw6_E